August 7, 2014

Manufacturer Yanks Cancer-Spreading Device from the Market

As lawsuits mount over the incidence of cancer associated with the use of a medical device in the surgical removal of uterine fibroids, Johnson & Johnson announced last week that it’s recalling all of the power morcellators it has manufactured in recent years.

And early this week, a major East Coast health insurer said it no longer would cover the gynecological procedure involving power morcellation.

Power morcellation surgery has become quite popular because it’s performed laparoscopically. That’s a minimally invasive procedure whose small incision prompts faster recovery, less pain, less bleeding and less opportunity for site infection. The morcellator, whose market is dominated by J&J, cuts up the fibroids into tiny bits that can be removed through the incision.

But the machine has been associated with the risk of spreading aggressive forms of uterine cancer in patients in whom cancer was never even suspected. Earlier this year, we wrote about the shock of women finding out they had advanced cancer only after undergoing what is generally a fairly benign procedure. We followed up a couple months later with a report about the FDA issuing morcellation warnings.

Now, as reported on AboutLawsuits.com, J&J contacted doctors known to use the devices with the admission that the risk of spreading cancer is too high with morcellators, and that it has no future plans to manufacture or sell them. With about 72% of the market, J&J has asked hospitals to voluntarily return all of the laparoscopic surgery power morcellators.

According to Reuters, health insurer Highmark Inc., with 5.2 million customers in Pennsylvania, Delaware and West Virginia, will stop covering the procedure as of Sept. 1.

At an FDA meeting, it was determined that as many as 1 in 350 women who undergo laparoscopic surgery for uterine fibroid removal might have unsuspected sarcoma, and cancer cells within the uterus that could be spread throughout the body by power morcellation.

Although in April the FDA urged doctors to stop using the procedure, last month an FDA advisory committee split on whether to recommend severe safety warnings on power morcellator or a total power morcellator recall. We wonder why there was any doubt, given that the panel acknowledged that there was no known way to make morcellation for uterine fibroid removal safe.

It’s unknown when the FDA will make a final recall decision, but J&J didn’t wait for it to pull their devices. In the face of the lawsuits, everyone’s wondering why adequate warnings weren’t issued long ago, and whether manufacturers made devices as safe as they could have.

Luckily, for women in need of uterine fibroid removal, there are options beyond power morcellation — traditional surgical hysterectomy performed vaginally or abdominally; catheter-based blocking of the uterine artery; high-intensity focused ultrasound; drug therapy and laparoscopic hysterectomy or fibroidectomy without use of morcellation.

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August 6, 2014

Surgery Remains a Questionable Treatment for Migraines

The extreme pain and frequency of migraine headaches lead some sufferers to seek any treatment short of beheading, but recent research questions the effectiveness of a surgical solution.

Migraine surgery is often called “nerve decompression” or “trigger point release” surgery. It was developed, according to a report on AboutLawsuits.com, after some plastic surgery patients reported relief from migraines following facial rejuvenation surgery (“face lift”).

Scientists at the Brigham and Women’s Hospital in Boston reviewed two migraine studies of trigger point surgery, and found that neither made a compelling case for the treatment. Their report hasn’t been published, but was presented at the annual conference of the American Headache Society in June.

According to the National Institutes of Health, more than 1 in 10 people around the world suffer from migraines. The pain often is an intense throbbing on one side of the head, and patients generally are sensitive to light and sound, often experiencing nausea and vomiting as well.

The disorder is a dysfunction within the brain, and according to AboutLawsuits, researchers are skeptical that such a highly complex brain problem can be alleviated by the removal of facial muscle.

Surgery is never the first plan of action for treating migraines; generally, it has been reserved for patients whose symptoms don’t respond to medications or lifestyle interventions. The source of the problem, according to an information backgrounder by Massachusetts General Hospital, is the trigeminal nerve, a large nerve branch in the face and neck that can trigger migraines. Once the nerve is irritated or stimulated, it sends a chain of messages that culminate in a migraine attack.

The surgery removes the irritated portion of the nerve or the muscle around it. Sometimes it involves other nerves or muscles in the face or neck. Mass General says that surgical treatment “can provide a long-term solution for patients who are severely or chronically affected by migraines. Many studies have reported over 90 percent effectiveness, with most patients enjoying significant to complete relief of their migraines after migraine surgery.”

The website does not specify those studies.

Dr. Paul Mathew, leader of the review study, said his team found flaws in the methods of the two original studies, and that the evidence doesn’t support the claims that migraine surgery is the best treatment for migraine headaches.

The first study reviewed involved only 75 patients, half of whom were given the migraine surgery and the others were offered a fake surgical procedure. The success rate for the first group was quite high — more than 8 in 10 patients reported a 50% decrease in migraines. But nearly 6 in 10 patients who got the fake procedure also reported a decrease in migraines.

Researchers say the studies are flawed and the surgery cannot be judged to be truly effective in relieving migraines. They say there were problems with how patients were recruited for the surgery, questions about them being administered migraine medication before the surgery and if any medication was taken following surgery.

Like all surgery, this one has risks, including sagging eyelids, neck weakness, wound healing problems and nerve injury. Permanent side effects include persistent itching and numbness in areas affected by the surgery.

And although it’s generally a same-day procedure involving minimally invasive technique, the surgery is expensive, at nearly $15,000. Most insurance companies don’t cover it. Usually, it’s performed by a plastic surgeon, not a migraine specialist.

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July 15, 2014

How to Shop Smartly for a Plastic Surgeon

When a celebrity “has work done” and the job goes wrong, it’s splashed all over the tabloids. When it happens to you, it doesn’t make the news, but the results are equally devastating.

Dr. Patrick Hsu, a plastic surgeon, recently wrote on KevinMD.com that the number of people having plastic surgery is increasing, and that the number of bad outcomes is increasing right along with them. Hsu wants potential patients for plastic surgery, whether the procedure is elective or medical, to know how to find the right surgeon.

As always, it’s best to get more than one opinion about a nonemergency medical procedure, and plastic surgery is no different. To enhance your chances of getting the best outcome, Hsu advises all patients to ask prospective plastic surgeons these questions:


  • Are you board certified?

    Confirm that your surgeon is board certified by either the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. Such certification proves that he or she has spent five years training and has passed multiple examinations. Each board’s website lists surgeons that are certified by them.


  • How many times have you done this procedure?

    You don’t want a surgeon who’s new on the job. He or she should have done at least 100 or more of the procedure you’re having, per year, for many years. Do not agree to the surgery under the knife of someone learning to master the skill.


  • What are the risks and complications of this procedure?

    Long before the surgery, discuss with your doctor of choice all the risks and complications your procedure might present. You can’t adjust to a less than perfect outcome if you have no idea that such a thing could occur. Ask how often such risks occur, and what to do if they happen to you. Remember: No surgery is risk-free.

    The most common risks of plastic surgery are scarring, bleeding and infection.


  • May I see some before-and-after photos of people you have performed this surgery on?

    A surgeon with nothing to hide has no problem showing you his or her work. Insist on seeing photos not only for quality assurance, but to see if you like the transformation. Still, your outcome could be different. But this sort of review is the most visual sense of what’s likely to happen.



“By making sure that you ask the right questions, not only your surgery will be worry-free,” Hsu says, “but your recovery as well.”

We’re not sure any medical procedure is worry-free, but preparation goes a long way toward minimizing the concern.

To learn more about cosmetic procedures, see our blogs and our backgrounder on the topic.

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June 19, 2014

Harmed Patient Deplores Failure to Investigate Bad Surgical Outcome

Medical mistakes are a fact of life, and they’re always troubling. But the problem’s compounded when an adverse outcome has been reported and no one bothers to investigate.

That’s what happened nearly four years ago at the Cleveland Clinic when government inspectors investigating a claim threatened to sever the renowned facility’s right to receive Medicare payments because, according to a story on ModernHealthcare.com, they were stonewalled by hospital officials.

David Antoon, a retired Air Force colonel, had accused Cleveland Clinic of failing to investigate when he claimed that someone other than his authorized surgeon had performed the prostate cancer procedure that left him seriously injured.

Hospital personnel, according to reports from the Centers for Medicare & Medicaid Services (CMS), would not make available to the feds all of the notes in Antoon's complaint file, and the doctor who said he performed the surgery would not talk about how the hospital handled the case.

Before his surgery, Antoon was a commercial 747 pilot. The operation left him incontinent. He’s bewildered not only that the hospital compounded the problem of its own making, but that there’s no oversight agency in medicine similar to the one in his profession, the National Transportation Safety Board, that addresses safety failures.

“You cannot keep things concealed in aviation,” he told Modern Healthcare. In medicine, “They're just gathering data points from patient complaints. And every data point is a damaged life or a death.”

Like many hospitals, Cleveland Clinic Health System has a track record of burying patient complaints. As Modern Healthcare reports, in 2012, CMS inspectors threatened again to slam the door on nearly $1 billion in Medicare reimbursements when hospital officials acknowledged their failure to investigate a complaint that surgeons had implanted a heart stent without having the patient’s consent.

Last summer, Cleveland was threatened with suspension from participation in Medicare after its officials told a patient there was no evidence that a surgeon failed to remove a needle used in a procedure. The truth was that the hospital had an X-ray clearly depicting the needle.

Although the hospital wouldn’t make anyone available to be interviewed by Modern Healthcare, it defended itself in an email: “Cleveland Clinic sees more than 5 million outpatient visits per year, has nearly 160,000 admissions and the highest acuity [the sickest of the sick] of patients in the country. We are committed to providing the best care and safest environment for our patients.”

The clinic also blamed deficiencies in the state's inspection system for the high number of CMS deficiencies.

It’s true that pure numbers don’t give a complete picture of a hospital’s treatment and safety success; those with sicker populations necessarily will have poorer outcomes, in terms of pure numbers. But the troubling thing about this situation is the denial — of a problem, of access to information.

Modern Healthcare examined tons of federal inspection reports showing that, between 2010 and 2013, Cleveland spent 19 months on “termination track,” the term for a facility skating on thin Medicare ice because of patient complaints and insufficient follow-up.

Cleveland has lots of company; as reported in the magazine, the clinic “is far from alone in facing the only sanction the CMS can apply to hospitals when serious safety problems and violations of informed consent rules are brought to light by patient complaints. An analysis of Medicare inspection data found that between 2011 and 2014 there were at least 230 validated serious incidents … that led the agency to threaten hospitals with losing their ability to serve Medicare patients unless they immediately fixed the problems.”

During that window, at least 9,505 complaints were lodged with the CMS, involving 1,638 hospitals. Only the most serious complaints result in threats of being cut off from government funding, and only rarely do the feds make good on them.

The problem endures because of regulatory limitations: Unlike with nursing homes, the CMS doesn’t have the authority to levy fines against hospitals that violate the rules.

“The absence of meaningful sanctions,” says Modern Healthcare, “provides a loophole for officials at some hospitals to engage in prolonged negotiations with CMS inspectors when confronted with patient-safety complaints, which typically conclude with the hospital promising to revamp policies and beef up staff training. The result, safety advocates say, is a regulatory system unable to respond to problems in a manner that ensures the problems won't happen again once the inspectors have left the premises.”

One reason we have advised consumers to approach hospital ratings with a wary eye is because sometimes, serious incidents and responses to individual cases aren’t reflected in a hospital’s overall ranking. They don’t seem to have much impact on accreditation by the Joint Commission, the voluntary organization funded by hospitals and whose only enforcement power is to withdraw accreditation. “The commission, whose inspection reports are not made public,” Modern Healthcare reports, “has consistently awarded the Cleveland Clinic good quality-of-care ratings.”

Cleveland eventually corrected each problem cited by the CMS. Antoon, the former pilot, has become a vigorous patient-safety advocate who has an ongoing medical-malpractice case against the Cleveland Clinic and his physicians there. But, as he told Modern Healthcare, no amount of money can repair his physical or emotional damage.

“This stopped being about me a long time ago. This is about a fraudulent, broken medical system where patients are injured and nobody is accountable. The airplanes are still crashing. Doesn't anybody care?”

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June 11, 2014

"Distracted Doctoring" Puts Patients at Risk and Practitioners in Trouble

When you’re anesthetized and under the knife in an operating room, you assume your surgical team is concentrating on you, not texting on an iPad. For one heart patient, however, that assumption was wrong.

Pacific Standard Magazine’s unsettling review of distractions during medical procedures described the circumstances of a malpractice case in Texas when a 61-year-old woman died after a relatively low-risk cardiac procedure to correct her irregular heartbeat.

Dr. Christopher Spillers, the anesthesiologist, had been using his iPad throughout the operation. In his deposition in a subsequent malpractice lawsuit, the surgeon testified that the anesthesiologist hadn’t noticed the patient’s dangerously low blood-oxygen levels until “15 or 20 minutes” after she “turned blue.”

Spillers had been known to text, read ebooks and post on Facebook during other procedures. He excused himself by saying that he monitors blood oxygen and blood pressure at least every five minutes.

Did he go to med school? The brain begins to die after just a few minutes without oxygen.

The Texas case isn’t unique. A neurosurgeon in Colorado settled a medical malpractice case with a patient he paralyzed during a surgery in which he had made no fewer than 10 phone calls. A nurse at an Oregon hospital was caught checking airfares on a computer in the operating room.

Dr. Peter Papadakos, an anesthesiologist with the University of Rochester and an expert on the fascination with electronics that leads to “distracted doctoring,” told the magazine, “Airline pilots don’t allow themselves to be distracted by social media, because they themselves do not want to die.” To ensure health-care providers also spurn these distractions, he said, would be to say, “If there’s a wrong-site surgery or other error, we will shoot everybody in the OR.”

Digitally connected practitioners often say that they use electronic devices to keep medical records or research medical information. But when interfacing with patients, such uses should be fairly limited. The Health Insurance and Portability and Accountability Act (HIPAA), the federal regulation that protects the privacy of an individual’s health information, makes the use of these devices for most kinds of communicating with or about patients illegal. “Even if the purpose of the use is valid,” the magazine says, “the decision to use a device for any reason not immediately relevant to the patient is indefensible.”

Even worse, the culprits know they’re wrong. In 2011, a presentation at an American Society of Anesthesiologists conference offered survey data showing that “nurse anesthetists and residents were distracted by something other than patient care in 54% of cases — even when they knew they were being watched. … [M]ost of what took their time were pleasure cruises on the Internet.”

A 2010 survey published by Perfusion, a journal for the technicians who operate bypass machines used in heart surgery, found that:


  • 56 in 100 respondents admitted to using cellphones during procedures;

  • 78 in 100 said that cellphone use posed a risk to patients;

  • 42 in 100 said that having a cellphone conversation during surgery was always unsafe;

  • 52 in 100 said that texting during surgery was not safe.


So most perfusionists believe that using a cellphone while operating the heart-lung machine is unsafe, but most do it.

As the magazine suggests, this behavior isn’t about “distracted doctoring,” it’s about addiction. The term “distracted” isn’t “adequate to describe the phenomenon of health-care providers who habitually use electronic devices for nonmedical purposes during appointments and procedures,” it says. These practitioners “aren’t momentarily distracted: They’re deciding to interact with Facebook friends or Twitter followers instead of the patient in front of them.”

Papadakos is in favor of studies to understand this form of compulsion and to eliminate it. Well, maybe, but what’s wrong with a common-sense solution? Personal electronic use should not be allowed during any patient interaction, period. Personal cellphones should not be allowed in an operating room.

As the magazine asks, “A surgeon addicted to alcohol or an illegal drug wouldn’t be allowed to operate while drunk or drinking — so why are physicians addicted to their iPhones and technicians given to texting still allowed in the operating room?”

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June 2, 2014

Treating Kidney Stones Often Has Complications

People who have suffered kidney stones say there’s nothing more painful. But according to new research, for a disturbing number of patients, treating them can cause complications requiring emergency follow-up. All the more reason to heed some good advice about how to prevent them in the first place.

Kidney stones are small, hard pebbles formed in the kidneys from minerals and acid salts. They pass through the urinary tract, from the kidneys to the bladder. Before passing them painfully during urination, victims often suffer from extreme pain in the back, side, abdomen and/or groin. Sometimes there’s nausea and vomiting. As horrible as it to have kidney stones, generally they cause no permanent damage.

As reported in the journal Surgery, researchers from Duke Medicine have determined that as many as 1 in 7 patients receiving treatment for kidney stones experience complications requiring emergency care.

The study analyzed the outcomes of more than 93,000 privately insured patients who had undergone treatment for kidney stones. Their initial procedures, which cost an estimated $10 billion per year, included:


  • shock wave lithotripsy — the most common U.S. treatment that uses shock waves targeted externally at a kidney stone to break it into tiny bits;

  • ureteroscopy — an endoscope passed through the urethra, bladder and into the upper urinary tract that enables removal of the stone;

  • percutaneous nephrolithotomy — a small incision in the back that enables the use of a miniature fiberoptic camera and other small instruments to remove the stone.


The researchers tallied emergency department visits or hospital admissions among this population within 30 days of their original procedure. As would be expected, patients who had had their initial treatments at hospitals that did high volumes of the procedure were much less likely to have complications.

The least common complications occurred following shock wave lithotripsy, affecting 12 in 100 patients. People treated with ureteroscopy, had about 15 in 100 unplanned visits. (But emergency visits associated with shock wave lithotripsy had higher costs associated with the emergency visits, at more than $32,000.) Costs for emergency complications of nephrolithotomy were the highest — more than $47,000, on average.

Researchers said that patients, especially those who had received the minimally invasive treatment, might not be prepared for complications. “From the patient perspective, an unplanned emergency department visit or hospital admission after a low-risk ambulatory procedure is a significant event,” said the lead researcher, Dr. Charles D. Scales, in a Duke Medicine statement. “Kidney stones are excruciatingly painful and primarily affect people who are of working age. These patients face not only the cost of treatment, but also the financial difficulties from time off work due to pain and treatment.”

That seems a rather obvious observation, but Scales’ point is the need to identify the causes of the complications, and figure out how to avoid them. His concern primarily is financial, and of course costs should concern everyone. But if you’re the one whose kidney stone adventure never seems to end, the most important message here is how to avoid them in the first place.

The National Kidney Foundation (NKF) is an excellent resource for understanding the causes and treatments of kidney stones. About 1 in 10 people, it estimates, will experience a kidney stone at some point, and their incidence appears to be rising.

Here are six ways the NKF says you can ward off this painful experience:

1. Monitor your sweat. Saunas, heavy exercise and hot weather can promote the formation of kidney stones from lack of water and, therefore, less urine production. The more you sweat, the less you urinate, which encourages stone-causing minerals to settle and bond in the kidneys and urinary tract.

So if you sweat, drink a lot of water.

2. Monitor your consumption of oxalate. Many foods contain this organic acid, including fruits and vegetables, nuts and seeds, legumes, grains, chocolate and tea. Foods especially high in oxalate are peanuts, rhubarb, spinach, beets, chocolate and sweet potatoes.

Unless you’re prone to forming kidney stones, you needn’t cut out these foods, just eat them in moderation, and when you eat them, also eat foods rich in calcium. That helps oxalate and calcium bind to one another in the stomach and intestines before the kidneys begin processing, making it less likely that kidney stones will form.

3. Monitor your consumption of purines. Not all stones are the same. Besides oxalate, uric acid can encourage the formation of kidney stones. Meat and most high-protein foods have high concentrations of a natural chemical compound called purines, which produce uric acid. It boosts the overall acid load the kidneys must excrete, and makes urine more acidic. That invites uric acid stones to form.

So cut down on high-purine foods, including organ meats (liver, tongue, sweetbreads), ham, veal, venison, bacon, beef, anchovies, sardines, lobster, shrimp and codfish. Cauliflower as well, is high in purine.

4. Don’t be afraid of calcium. Many people attribute kidney stones to consuming too much calcium, but a diet low in this mineral actually increases your risk of developing stones. Instead of cutting back on calcium, reduce the amount of sodium in your diet.

5. Citrus is your friend. Drink lemonade or limeade. Chronic kidney stones often are treated with potassium citrate, but studies have shown that fruits and juices high in natural citrate offer the same stone-preventing benefits. Watch the sugar content, though, because it can increase kidney stone risk. Try sugar-free lemonade, or make your own by mixing lime or lemon juice with water and using a tiny amount of sugar or a substitute.

6. Continue your care. Having a kidney stone one time greatly increases your chances of having another. Studies have shown, however, that about 15 in 100 kidney stone patients didn't take prescribed medications, and more than 4 in 10 did not follow the nutritional advice that might keep stones from recurring. So … comply with post-treatment advice to minimize the changes for recurrence.

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May 25, 2014

Harmful Spine Treatment Infuse Got an Assist from the FDA

The lawsuit-generating spinal treatment Infuse was approved by the FDA in 2002, and, according to a disturbing investigative report by the Milwaukee Sentinel and MedPage Today, the feds gave it the nod even though concerns about its safety were raised and it had been tested on so few patients as to make conclusions about its usefulness meaningless.

The problems caused by the spinal implant, which is supposed to encourage bone growth and fuse the gaps between vertebrae after fusion surgery, resulted in Medtronic, its manufacturer, recently agreeing to pay $22 million to settle about 950 lawsuits, and reserving another $140 million to settle an anticipated 3,800 additional claims.

"It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product," said one Sentinel/MedPage source, a chief of spinal surgery at a major metropolitan hospital.

The FDA approved Infuse not as a life-saving drug or an intervention that reduces disability significantly; it was approved as an alternative to traditional spinal fusion surgery.

As the story notes, testing new biologic agents usually requires clinical trials involving 1,000 to 3,000 people. But because the FDA invited Infuse on the market as a combination device, not a biologic agent, its trial involved a paltry 277 subjects. Medtronic’s website refers to Infuse as “biologic device.”

Biologic drugs, as the Sentinel/MedPage story explains, also are known as bio-pharmaceuticals. “They replicate natural substances in the body such as hormones, antibodies, or, in the case of Infuse, growing bone. Traditional drugs are made by combining chemicals. But biologics are manufactured in a living microorganism, such as plant or animal cells, and can pose special safety risks such as infections, immune system disorders and cancers.” One study found that about 1 in 4 of 174 biologic drugs had been the subject of safety-related regulatory actions after they got on the market.

Because Infuse was approved in a "noninferiority" trial, Medtronic did not have to prove it was any better than the traditional treatment.

"It should not have gone through the device approval process," a health researcher in orthopedic surgery told the Sentinel/MedPage "It should have gone through the biological testing process."

The story’s revelations won’t surprise readers of this blog (see our post, “Medtronic Spinal Treatment Is Riskier and No Better than Bone Graft ”); it showed that more than 6,500 reports of Infuse-related problems have been registered with the FDA's medical device reporting system since Infuse was approved.

The complications include cancer, sterility and pain.

Adding another “ick” layer to the approval of a product that harms people, according to the Sentinel/MedPage, is the group of spine surgeons who received millions of dollars in royalties from Medtronic and who had co-authored papers failing to acknowledge the link between Infuse and several serious complications. In some cases, the medical journals publishing the papers didn't fully disclose Medtronic's financial relationship with the authors.

Can you say “conflict of interest”?

So questionable was this product even among orthopedists that The Spine Journal, according to the Sentinel/MedPage, dedicated a whole issue to its deficiencies. It referred to research that found that Infuse had complication rates 10 to 50 times greater than the complication rates estimated in the papers written by the doctors whose priority wasn’t helping patients get well, but helping their own bottom lines.

The FDA, for its part, issued the usual “what, me?” response to Sentinel/MedPage inquiries. An email from its spokeswoman said Infuse was approved based on clinical and nonclinical data that "demonstrated a reasonable assurance of safety and effectiveness," and that an advisory panel of outside experts reviewed the evidence and voted unanimously to recommend approval.

She said the FDA has reviewed the thousands of adverse events reports about Infuse, post-approval studies and medical literature, and continues to believe there is a reasonable assurance of safety.

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May 18, 2014

Protecting Yourself from the Thousand-a-Day Toll of Medical Error

Scary new numbers have been issued on how many patients die from medical malpractice and medical errors in hospitals.

Despite incremental improvements in addressing medical errors, a recent comprehensive analysis published in the Journal of Patient Safety estimated that 440,000 people die every year as victims of medical errors they experienced as hospital patients. That's more than 1,000 every day.

440thousand-blog-5-17-14.jpeg

We mentioned the study last month in our blog, “Another If/Then Review of Hospital Safety Ratings.” Its author, John James, is founder of Patient Safety America, whose newsletter is a sobering reminder of just how vigilant medical consumers must be to remain safe.

Luckily, a Consumer Reports examination of the James study, and how it can be applied, is a big boost in safety self-help. It, too, was mentioned in last month’s blog.

The large number of patients James identified had suffered mistakes including getting the wrong drugs, developing infections from careless hospital staff hygiene and failing to receive tests or treatments they should have.

“Four-hundred-forty-thousand is a frightening figure,” James said to Consumer Reports. It represents more than 1,000 deaths per day, and more than half of the deaths each year in U.S. hospitals. “And it makes patient harm in hospitals the nation’s third-leading cause of death, trailing only heart disease and cancer,” James said.

The number is an estimate because a lot of what goes on in the hospital isn’t recorded and because death can result from several factors, and teasing out the underlying medical cause from the screw-up is difficult and inexact.

Still the figures aren’t really surprising, given the wealth of information about medical error since the Institute of Medicine said as many as 98,000 hospital patients per year die from medical errors 15 years ago. We’ve written often about government efforts to track problems experienced by Medicare patients (see our blog, “Hospitals Show Small Improvement in Patient Safety”), but James analyzed the results of four key hospital safety studies published between 2008 and 2011 that dug a little deeper, estimating the number of deaths caused by errors that go unrecorded or result from missed diagnoses.

“The truth is that whether it’s 100,000 or 200,000 or 400,000 deaths a year is almost immaterial,” he told Consumer Reports. “What matters is that too many people are dying in hospitals because of medical mistakes, not enough is being done to stop it and patients need more information.”

Consumer Reports offers several ways to get it. Its Hospital Safety Score, as our blog last month noted, includes information for 2,591 hospitals in all 50 states and the District of Columbia. It has new information about hospital mortality rates. The mortality figures use two measures, hospital patients admitted with medical conditions (heart attack, for example), and surgical events.

For the medical problem patients, the figures reflect the chances that a patient who has had a heart attack or been diagnosed with heart failure or pneumonia will die within 30 days of entering the hospital. Only 35 hospitals nationwide earned a top rating in the measure, and 66 hospitals got the lowest rating.

“The differences between high-scoring hospitals and low-scoring ones can be a matter of life and death,” according to John Santa, M.D., medical director of Consumer Reports Health. For example, pneumonia patients at Cedars-Sinai Medical Center in Los Angeles (top rated in this category, with a 7% chance of dying within 30 days) compared favorably with similar patients at Delano Regional Medical Center in Central California — 22% chance of death. Pneumonia patients in top-scoring hospitals are at least 40% less likely to die within 30 days of admission than similar patients in low-scoring hospitals.

More hospitals rated better for surgical patients (those with serious but treatable complications such as blood clots) who died in the hospital — 173 got a top rating, and 228 hospitals got the lowest rating. But here, too, the differences between high- and low-scoring hospitals were striking: For every 1,000 patients who develop serious complications in a top hospital, 87 or fewer die versus 132 in a low-rated hospital. Patients in top-rated hospitals are at least 34% less likely to die than similar patients in low-rated hospitals.

Seven hospitals in the country earned a top rating in both medical mortality and surgical mortality:


  • NYU Langone Medical Center, New York City

  • Olympia Medical Center, Los Angeles

  • Presence Saint Joseph Hospital, Chicago

  • Providence Hospital, Southfield, Mich.

  • South Pointe Hospital, Warrensville Heights, Ohio

  • St. Alexius Medical Center, Hoffman Estates, Ill.

  • UPMC McKeesport, McKeesport, Penn.


Three hospitals got the lowest score in both measures:

  • Conway Regional Medical Center, Conway, Ark.

  • Highland Hospital of Rochester, Rochester, N.Y.

  • Lake Cumberland Regional Hospital, Somerset, Ky.


The reasons some hospitals routinely offer safer care than others have to do with communication and accountability.

You can look up how hospitals are rated in your area here.

To learn how to survive during and thrive after a hospital stay, link to Consumer Reports’ hospital survival guide.

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May 14, 2014

Blood Transfusions Can Save Your Life … and Raise Your Risk of Infection

Blood transfusions are a common hospital procedure. But according to a study published last month in the Journal of the American Medical Association (JAMA), the more red blood cells hospital patients receive, the higher their risk of infection.

Researchers from the University of Michigan Health System and the VA Ann Arbor Healthcare System concluded that the highest risk was among elderly patients who had hip or knee surgeries. The fewer the number of transfusions, the lower the risk of infection. For every 38 hospitalized patients considered for a red blood cell transfusion (RBC), one would be spared a serious infection if fewer transfusions were used.

According to a story on the U-M website, the result was “most likely due to the patient’s immune system reacting to donor blood [known as transfusion-associated immunomodulation or TRIM]. Transfusions may benefit patients with severe anemia or blood loss; however, for patients with higher red blood cell levels, the risks may outweigh the benefits,” said lead author Jeffrey M. Rohde, M.D., at the U-M Medical School.

Transfusions often are given in the case of anemia or to replace blood loss during surgery.

According to U-M, approximately 14 million red blood cell units were used in the U.S. in 2011, mostly for hospitalized patients. Recent guidelines promote a lower threshold of hemoglobin (blood protein that transports oxygen and gives blood its red color), but only about 1 in 4 hospitals that responded to the National Blood Collection and Utilization Survey reported using them after surgery. Only 3 in 10 hospitals reported having a blood management program to optimize the care of patients who might need a transfusion.

The researchers evaluated all health-care-associated infections that were reported after patients received donor blood in 21 randomized, controlled trials. They included life-threatening infections such as pneumonia and bloodstream and wound infections.

As you might expect, risks of additional hospital infections were especially high for patients who already had sepsis, in which the body’s immune system overreacts to an infection. It’s a dire situation that can lead to organ failure and death. (See our recent blog, “Boy’s Death from Misdiagnosis Points Up CDC’s Inadequate Sepsis Information.”) This study showed that patients with sepsis were twice as likely to develop additional infections when they received more transfusions.

So what can you do to minimize the chances of getting a transfusion unnecessarily? The Choosing Wisely campaign (a national effort that encourages physicians, patients and other health-care stakeholders to ponder and discuss medical tests and procedures that might be unnecessary and/or can cause harm) recommends that patients and their loved ones/advocates who are planning a hospital stay discuss transfusions in advance of their admission.

Ask your doctor and the hospital’s patient advocate these questions:


  • What can I do before hospitalization to prevent or decrease my likelihood of developing anemia?

  • How can blood loss can be minimized when I am hospitalized? Would any of the options be available for me?

  • What are the criteria the hospital uses to decide whether or not I would need a blood transfusion?

  • Will you keep me and my family informed during the hospitalization regarding these options, the number and types of transfusions that I was given and tell me what I can do to help?

Keep in mind that your diet, the medications you take and medical conditions you might have (kidney disease, for example) can affect your chances of developing anemia, and whether you will need a transfusion. Discuss these factors with your doctor so you can work together before, during and after your hospitalization.

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April 2, 2014

Study Hopes to Draw Spine Surgery Guidelines

As our newsletter, “Better Care for Your Aching Back,” observed in September, back pain is the fifth most common complaint patients bring to their primary care doctors, and inappropriate treatment for back trouble is widespread.

This reality is the motivator behind an effort to collect comparative results of upper spine surgical outcomes in order to enable doctors and patients to better assess which surgical approach is the best, safest and most cost-effective for each situation.

As explained last month in the Wall Street Journal, (WSJ) the study examines treatment for spinal cord compression, which is the most common spinal cord problem in Americans older than 55. Three different surgical techniques currently are used for the condition, known as cervical spondolytic myelopathy (CSM).

As people age, they’re more likely to have neck stiffness, arm pain, numbness and weakness in the hands and legs, which are symptoms of normal wear and tear signifying degenerative changes in the upper spine. Strenuous activity, including sports, can make it worse.

The chronic condition can narrow the spinal canal, which puts pressure on the spinal cord. Compression coupled with repetitive motion damages the cord to the point where it’s difficult to move one’s extremities, and can even lead to paralysis.

Bones, disks and ligaments can all contribute to compression of the spine. Bone “spurs,” abnormal growths in the spine can be a factor.

Surgery is recommended, necessary, even, with severe compression, although physical therapy and other less invasive measures are therapeutic in less-severe cases.

One procedure, known as front or ventral decompression and fusion, involves cutting through the front of the neck, moving the voice box and esophagus to reach the spine, removing disks and bone spurs and fusing the vertebrae.

The two other techniques involving cutting through the back of the neck and either fusing the vertebrae or performing a laminoplasty, which enlarges the spinal canal to relieve pressure on the spinal cord and nerves.

No large, randomized studies have compared the merits of the three techniques.

"In spine care,” Dr. Zoher Ghogawala, a neurosurgeon, told the WJS, “we are faced with a lot of people suffering and desperate for treatment, but there is a lack of information about what the best option is based on their specific symptoms and diagnosis." Ghogawala is co-director of the Comparative Research Effectiveness Center at Lahey Health's Lahey Hospital and Medical Center, which is affiliated with Tufts University.

Given the confusion over best practice for these spinal procedures, patients generally get whichever one their surgeon has done the most, Ghogawala said. But that might not be the one that’s best for their circumstances.

Ghogawala, whose team devised the study, estimates that the number of CSM surgeries has nearly doubled in the last decade, to maybe as many as 200,000 a year. The cost for those procedures is estimated to be $4 billion a year in hospital charges alone.

According to the WSJ, studies indicate that 2 in 3 CSM patients improve with surgery, but complication rates might be as high as 17 in 100. Readers of this blog are aware of the reasons to be wary of spinal fusion surgery.

Ghogawala’s three-year study to compare the three surgical technique involves 10 large U.S. medical centers. One of its sponsors is the Patient Centered Outcomes Research Institute, which we’ve written about before as the congressionally mandated agency charged with helping to determine the most effective treatments using objective, science-based standards. The National Institutes of Health and a private foundation also are subsidizing the work.

One spinal compression patient profiled by the WSJ was a marathon runner and tennis player when he first began to feel numbness and clumsiness in his hands and pain across his shoulders and up his back. An MRI of his neck showed that vertebrae, disks and bone spurs were pressing heavily on his spinal cord.

He was advised by a neurologist to address the condition immediately. He sought several other opinions. “They were all very convincing about the best way — but every single one of them was dramatically different,” he said. “Here you are as a patient trying to figure out what's best for you, but how do you sort this out?"

Ghogawal’s study is the best effort so far to be able to do that.

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March 3, 2014

Obstetricians Call for Fewer Cesarean Sections

You know when a professional association recommends doing fewer procedures for which its members get paid, there’s probably a good reason. That’s the case with delivering a child by cesarean section.

The American Congress of Obstetricians and gynecologists (ACOG) recently called on its members and all medical practitioners to stop doing so many C-sections. As explained by the Associated Press (AP), new guidelines direct doctors to give otherwise healthy women more time to deliver their babies vaginally before assuming that labor has stalled.

It’s the latest news in a years-long effort to prevent unnecessary C-sections, which have become increasingly popular, often for reasons of convenience more than good medicine.

According to the Centers for Disease Control and Prevention (CDC), nearly 1 in 3 women in the U.S. gives birth by cesarean.

Sometimes, the procedure is necessary to save the life of the mother or the baby. Sometimes, it’s necessary because labor was unwisely induced with oxytocin (Pitocin), a hormone that stimulates uterine contractions. Sometimes, it’s a matter of parents trying to squeeze child birth into the schedule of life events. And sometimes, it’s about doctors fearful of being sued if someone thinks they waited too long for vaginal delivery.

In crafting the guidelines, ACOG and the Society for Maternal-Fetal Medicine found that a primary reason for a first-time C-section is labor that’s progressing too slowly. But slow is not the same as troubled, at least not always. Performing a C-section has definite risks, and the procedure greatly raises the chances of a subsequent pregnancy also ending in a C-section. Like any surgery, if it isn’t medically necessary, it’s a bad idea.

As noted in our C-section backgrounder, the risks of C-section include premature delivery (thanks to Pitocin); injury to the mother’s ureters (tubes that carry urine from the kidneys to the bladder), bowels or other pelvic organs; a higher likelihood of uterine rupture in future pregnancies.

Common sense and a reordering of priorities is the best defense against parents whose timetable is more important than good health care, but in the case of obstetricians overly concerned about making mistakes, well, these guidelines are the latest “best evidence” that labor can take longer than you want. Provided the practitioner is monitoring the mother and the fetus for serious distress resolved only by surgery, being sued for making a waiting mistake isn’t a reasonable concern.

‘‘Labor takes a little longer than we may have thought,’’ Dr. Aaron Caughey told AP. He’s a co-author of the guidelines.

Caughey told AP that when it comes to labor, every woman is different. ‘‘My patients ask this every day,’’ he said, and that the answer can ‘‘run the gamut from six hours long, start to finish, to three and four days,’’ and any woman who endures that should win a medal.

Complicating the answer to “when is a long time too long a time?” is that the art of assessing the progress of labor might have advanced since many doctors learned about the different stages of labor in medical school.

According to the AP, a study from the National Institutes of Health in 2012 found that one stage can take 2½ hours longer now than it did in the 1960s, when many labor definitions were set.

That might be because today’s mothers are older and weigh more, but also because of changes in obstetric practice, such as more use of pain medicine, which can slow labor.

Considering these changes and the world we live in, for pregnancies that involve otherwise low-risk mothers and fetuses:


  • Obstetricians should not order a C-section just because the first and longest phase of labor is prolonged. That’s when contractions are mild and far apart, and the mother’s cervix is barely dilated. Doctors used to consider it stalled if it lasted longer than 20 hours for a first-time mom, or 14 hours for returning mothers.

  • Obstetricians should consider that "active labor’’ begins later than once thought — not until the cervix is dilated 6 centimeters instead of the outdated 4 centimeters. That’s when contractions become stronger and more frequent, and the cervix begins to dilate more rapidly until the woman eventually is ready to push.

    It’s a key change because many doctors won’t admit women to the hospital until they’re in active labor, unless they need more care for another reason.


  • Obstetricians should allow women, if they’re not too tired, to push at least two hours if they have delivered before, three hours if it’s their first baby. They may push longer if they had an epidural (pain medicine), as long as the doctor can see progress.

  • Obstetricians should consider using forceps as a safe alternative to certain cesareans if they’re used by an experienced, well-trained physician. Few physicians today undergo the training.


Find out what a doctor’s cesarean rate is before choosing an obstetric practice. Discuss vaginal delivery versus C-section with your obstetrician long before your due date. Ask if he or she is familiar with the new guidelines, and what he or she considers as “normal labor.”

Long before you’re in the delivery room, you should know how the doctor supports women in labor, what he or she considers too long and agree about both. If your doctor says labor has stalled, ask if either you or the baby is in danger if you continue waiting.

No one wants to prolong labor. But neither does anyone want an adverse outcome, for this pregnancy or one you’re yet to experience.

Tragic cases of babies being born with brain damage do happen because of malpractice by either the doctor or nurses in not carefully monitoring the baby's heartbeat and responding quickly when the baby shows signs of distress from not getting enough oxygen. These are the types of situations the Patrick Malone law firm confronts each year. Our firm website has extensive resources for parents of children with birth injuries.

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February 25, 2014

Hospital Promotion: Poor Judgment Looks Like Conflict of Interest

For all its techno-wonder, robotic technology is fraught with problems, including organ damage, that make it unsuitable for many surgical procedures. It also has a record of poorly trained surgeons, not to mention the under-reporting of adverse outcomes.

Then there’s conflict of interest, or what sure looks like it.

A story covered by ProPublica.org, the investigative news site, examined the role of a dozen members of the surgical team at the University of Illinois Hospital and Health Sciences System who were featured prominently in an advertisement for the da Vinci robot. The copy read, “We believe in da Vinci surgery because our patients benefit.”

Paul Levy, former chief executive of the prestigious Beth Israel Deaconess Medical Center in Boston, was among readers who had a problem with the ad. “While I have become accustomed to the many da Vinci ads,” he told ProPublica, “I was struck by the idea that a major university health system had apparently made a business judgment that it was worthwhile to advertise outside of its territory, in a national ad in the New York Times.

At the bottom of the ad for the robotic device, made by Intuitive Surgical Inc., was this notice: “Some surgeons who appear in this ad have received compensation from the company for providing educational services to other surgeons and patients.”

Ah.

When you are paid to promote a technology for which your patients also pay when they are subject to it, it looks as though cashing in is more important than ensuring that a procedure is the best possible treatment for the problem at hand. Is that what happened here?

Robotic surgery is a minimally invasive procedure in which the surgeon uses a computer to remotely control small instruments. The systems are expensive, and because they’re hot, new technology with marketing potential, surgical facilities that invest in them are highly motivated to use them, whether or not the robotic method is the best one for a given surgery.

As we’ve pointed out, in some cases such as hysterectomy and prostatectomy, they often aren’t.

For a long time medical professionals have been subsidized by pharmaceutical and medical device companies, and we’ve written about Dollars for Docs, a ProPublica database of who is getting paid by these commercial interests.

And although ads featuring physician testimonials for prescription drugs and medical devices are common, featuring a whole hospital department gave Levy pause.

“I was stunned that a public university would allow its name and reputation to be used in that way,” he said, and after reading the university’s website, concluded that the ad violated the university’s code of conduct and administrative procedures, and probably even state law.

Levy began a series in his blog, "Not Running a Hospital,” about the ad. One post read, “The University has allowed its reputation to be used in a nationally distributed advertisement produced and owned by a private party, in benefit to that party's commercial objectives. This is not consistent with ‘exercising custodial responsibility for University property and resources.’”

Later posts noted that some of the white-coated people featured in the ad weren’t doctors, or even medical professionals.

As it turned out, the ad was paid for by Intuitive, and neither the university nor the people depicted were paid for appearing. Still, it was questionable enough that the university asked Intuitive to suspend the ad, and announced it was using the incident as a teaching moment; it promised to assess its policies about these kinds of promotions.

Levy’s indictment didn’t exactly endear him to the university. A university official told ProPublica that the Boston Globe had called out Levy for lapses in judgment over a personal relationship with a female employee when he was with Beth Israel Deaconess. Levy was fined $50,000 by the hospital’s board of directors, copped to his errors and apologized.

ProPublica wanted to know how Levy’s past was relevant to the kerfuffle over the da Vinci ad. The university official said, essentially, consider the source.

As ProPublica makes clear, the cross-pollination of caregivers and device makers isn’t unusual. Hologic Inc. advertised in a trade journal last year using the staff of Methodist Hospitals in Indiana to promote its mammogram machine. Accuray, which makes the CyberKnife, a competitor of da Vinci, offers physician testimonials in its website videos, which don’t disclose if the doctors have been paid.

So although the Illinois University story is muddied with misinformation and drowning in bad blood, you have to get back to basics: When the medical establishment appears to engage in a conflict of interest, it isn’t thinking about patient safety; it’s thinking about its bottom line.

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February 17, 2014

A Real, If Remote, Risk of Spreading Cancer with Surgery for Uterine Fibroids

Every year, hundreds of thousands of women undergo what can be routine surgery to remove benign fibroid tumors from their uterus. But the “routine” can be dangerous, perhaps life-threatening, because of the potential to spread cancer.

The concern, as explained last week in the New York Times, is over the procedure called morcellation, which cuts or grinds the tissue to be removed into tiny pieces suitable for extraction through a small incision. Smaller incisions, of course, are less invasive than surgery in which the whole abdominal cavity is opened, so it’s generally preferred because there’s less risk of infection, blood loss and other complications, less pain and a shorter time of recovery.

Morcellation can be performed by knife or a device with a spinning blade. The latter, especially, is worrisome, according to two articles published in the Journal of the American Medical Association (JAMA), because it can spray bits of uterine tissue or fibroids around the surgical cavity. Although fibroids are benign, the tissue can grow on other organs, causing pain, infection or bowel obstruction. And the spinning blades can cut abdominal organs and blood vessels.

But the scariest potential harm is that in a few cases, a sarcoma, a rare tumor that’s difficult to diagnose, can be hidden in the uterus or mistaken for a fibroid, and morcellation appears to spread cancer cells throughout the patient’s abdomen. Advanced cancer follows.

Not only are uterine sarcomas rare, they’re usually not diagnosed until after the initial surgery, when the tissue is analyzed by a pathologist.

According to the American Congress of Obstetricians and Gynecologists (ACOG), says The Times, nearly 500,000 women in the U.S. had hysterectomies to remove their uterus in 2010; about 11 in 100 involved morcellation.

One of the authors of a JAMA study, Dr. Kimberly Kho, professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center, had patients who had undergone morcellation of fibroids or the uterus consult with her because of abdominal complications.

They required additional surgery to remove lumps of uterine tissue or fibroids growing on the liver, appendix or bladder.

One well-reported case of such complications concerned Dr. Amy Reed, an anesthesiologist whose story was told in the Wall Street Journal. After her surgery to remove fibroids, she was found to have advanced cancer, apparently from a hidden sarcoma that might have been spread by morcellation.

Although Kho wants to ensure the medical community understands the risks of morcellation, she doesn’t believe it should be banned, because minimally invasive surgery has so many benefits for many patients.

“I do think, however, that we could be more prudent and conservative with whom we use these instruments on,” she told The Times, “and more systematic about preoperative evaluation to prevent morcellating detectable cancers.”

She suggests enclosing the tissue to be removed in a bag, then morcellating it inside the bag to prevent tissue dispersal. Called closed morcellation, that approach works in other types of surgery. But most gynecologists don’t know how to perform it, and it takes months to learn.

If you are planning to have fibroids or your uterus removed, discuss with your surgeon the technique he or she intends to use. Discuss the risks and benefits of open surgery in which the tissue is removed intact versus laparoscopy, the less invasive approach that requires smaller tissue for removal. Seek referrals for surgeons familiar with closed morcellation.

To learn more about hysterectomies, see the FAQ page from the ACOG.

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January 12, 2014

Common Knee Surgery Should Probably Be a Last Resort

Knee problems are a common marker of aging, and knee surgery to fix them is equally common. According to a recent study published in the New England Journal of Medicine (NEJM), you have to wonder why.

As summarized in the New York Times, “A popular surgical procedure worked no better than fake operations in helping people with one type of common knee problem, suggesting that thousands of people may be undergoing unnecessary surgery, …”

Arthroscopic repair of torn meniscus, which is the cartilage in the knee joint that keeps the bones from grinding on each other and serves as a stabilizer, is the most common orthopedic procedure in the U.S., according to the study; about 700,000 such operations are performed every year at a cost of about $4 billion.

Arthroscopy is used by orthopedic doctors to diagnose and sometimes treat disorders of the bones and joints, especially knees and shoulders. The patient undergoes anesthesia and a device is inserted into the joint through a small incision, enabling a view of the interior structures, including bone, ligament, tendons, cartilage, etc.

The new study confirmed findings of older research that suggested that for many patients with meniscal tears, physical therapy offers equivalent or better outcomes than surgical repair.

The surgery, called arthroscopic partial meniscectomy, involves identifying the damaged tissue and trimming and smoothing the torn bits.

The study isn’t a call to cease this procedure, just to use it more selectively. Some patients, the researchers said, are good candidates for it, including younger people and those whose problem is the result of an acute sports injury. “But,” The Times reports, “about 80 percent of tears develop from wear and aging, and some researchers believe surgery in those cases should be significantly limited.”

Patients in the new study all received anesthesia and incisions. But only some got the actual surgery; others got simulated procedures. They did not know which they had received.

A year later, most patients in both groups said their knees felt better; most said they would choose the same method again, even if it was fake.

The art of this science now appears to be who is the best candidate for slicing and dicing, and who should hit the gym under the watchful eye of a physical therapist?

Pain alone isn’t a driving diagnostic determinant. One consideration for the suitability of surgery is if knee pain is caused by the torn meniscus or something else, such as osteoarthritis, which often accompanies tears. Another possible factor is whether mechanical knee function is affected. Is the knee locking? Is it unstable?

“Take 100 people with knee pain; a very high percentage have a meniscal tear,” Dr. Kenneth Fine, an orthopedic surgeon, told The Times. “People love concreteness: ‘There’s a tear, you know. You have to take care of the tear.’ I tell them, ‘No. 1, I’m not so sure the meniscal tear is causing your pain, and No. 2, even if it is, I’m not sure the surgery’s going to take care of it.”

Some experts believe that even if surgery seems appropriate at some point, little is lost by trying physical therapy first, for something like six months. Any time you can avoid an invasive procedure and hospitalization, with their added risks of infection and other complications, you should exercise that option.

The new study admittedly was small — five hospitals and 146 patients, ages 35 to 65, with wear-induced tears and knee pain. About half of the subjects had mechanical problems such as locking or clicking knees.

Skeptics were concerned that it involved patients with only meniscal tears, not arthritis. They wondered if the tears were small, if the pain was caused by the kneecap, which would be complicating factors. One of the study’s authors said whether meniscal tears caused the participants’ pain was unknown, but that arthritis was an unlikely cause, because the patients didn’t seem to have it. About 1 in 10 meniscal tear patients have no arthritis, he said.

Most patients received spinal anesthesia, and remained awake, although some got general anesthesia. As described by The Times, “Surgeons used arthroscopes to assess the knee. If it matched study criteria, nurses opened envelopes containing random assignments to actual or sham surgery. In real surgery, shaver tools trimmed torn meniscus; for fake surgery, bladeless shavers were rubbed against the outside of the kneecap to simulate that sensation. Nobody evaluating the patients later knew which procedure had been received.”

After a year, each group reported similar improvement; two in the surgery group needed further surgery, and five in the fake-surgery group requested it.

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November 6, 2013

Defendant in Unnecessary Heart Stent Lawsuits Loses Again

Last month, we wrote about a fraud investigation showing the extreme degree to which stents are implanted into heart patients who don’t need them.

The overuse and/or inappropriate use of stents has been in the news a lot lately, and late last month a notorious abuser of this procedure was busted—again—by a jury of his peers.

As reported on AboutLawsuits.com, cardiologist Mark Midei and the St. Joseph Medical Center north of Baltimore were deemed liable to a local patient because the doctor breached the accepted standards of medical care by implanting a heart stent when he didn’t need one.

Midei has been in trouble for a while—we wrote about his unsavory stent lust a few years ago. At the time, St. Joseph had to pay $22 million to settle claims that it paid kickbacks to the cardiology group co-founded by Midei, who was accused of performing hundreds of unnecessary heart procedures. Scores of lawsuits were filed, and Midei was stripped of his license.

A U.S. Justice Department investigation into Medicare fraud first unearthed the problems with unnecessary heart stents and kickbacks between the hospital and the provider

As reported by AboutLawsuits, Midei had been considered a star cardiologist whose former patients said he told them that they had severe coronary blockages that required placement of a stent. A federal investigation concluded that they had only minor blockages that did not warrant stent placement.

Midei’s case now moves to the phase where jurors determine the amount of damages. The patient claims that he lost millions of dollars from scaling back his business because he was worried that the medical problems he never had would get worse.

Stents are implanted to keep blocked arteries open. The cost can be $10,000 or more.

Clinical guidelines say that the procedure isn’t appropriate unless an artery is blocked at least 70%. A review of Midei’s former patients showed that many were well under 50%; that’s usually considered “insignificant.” In some cases, says AboutLawsuits, patients found out later that even though they got stents, their arteries were only 10% blocked.

Settlements have been reached in nearly 250 lawsuits against St. Joseph and Midei, but, according to AboutLawsuits, dozens have yet to be resolved.

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October 6, 2013

How the Profit Motive Feeds the Risks of Coronary Stents

As retold in a story last month on Bloomberg.com, what happened to Bruce Peterson is characteristic of the troubling overuse in U.S. health care of cardiac stents. These tubular devices are surgically implanted to prop open arteries, and in the last 10 years, about 7 million Americans received one at a cost of more than $110 billion.

There’s no question that stents are appropriate and necessary for some heart attack patients to restore blood flow. But those cases represent only about half of the 700,000 stent procedures each year in the U.S.

Peterson was not among the appropriate patients.

He consulted cardiologist Samuel DeMaio for chest pain, and DeMaio implanted 21 stents in Peterson’s chest over an eight-month period. During one procedure, he tore a blood vessel and placed five of the metal-mesh tubes in a single artery, according to a Texas Medical Board staff complaint. Unnecessary stents weakened Peterson’s heart, exposed him to complications such as clots and ultimately was responsible for his death.

DeMaio, according to the Bloomberg story, paid $10,000 and was subject to two years’ oversight to settle the complaint over Peterson and other patients. He contended that his treatment had not contributed to Peterson’s death.

The Bloomberg investigation found that among the half of heart patients who are in stable condition and don’t need stents but electively get them, sometimes because of fraud. Injury and death are too often the result. The scenario reflects a system that rewards doctors for a higher volume of care instead of a higher quality of care. A cardiologist, says Bloomberg, gets paid less than $250 to discuss the risks of and alternatives to stents, but four times that much to implant one.

“Stenting belongs to one of the bleakest chapters in the history of Western medicine,” Dr. Nortin Hadler, professor of medicine at the University of North Carolina at Chapel Hill and a contributor to The Health Care Blog, told Bloomberg. “[T]he interventional cardiology industry has a cash flow comparable to the GDP of many countries,” he said, and doesn’t want to lose it.

Stenting abuse isn’t exactly routine, but it’s not rare. About 2 in 3 elective stents—more than 200,000 procedures a year—are unnecessary, according to Dr. David Brown of Stony Brook University School of Medicine in New York. Brown bases his numbers on eight clinical trials of 7,000 patients in the last decade, which he analyzed in the JAMA Archives of Internal Medicine. Two cardiology researchers who have studied the use of stents told Bloomberg that the number could be as low as half Brown’s estimate, and one said it is probably larger.

Some patients who got them are living with risks including blood clots, bleeding from anti-clotting medicine and blockages from coronary scar tissue.

Those complications were fatal for Monica Crabtree. She died after one of her arteries was torn in a stent procedure and became infected. Her widower received several hundred thousand dollars from a settlement of his lawsuit against her doctor, after another cardiologist reviewed the case and determined that the stent was unnecessary.

Other stent patients are alive, but live in fear.

Jim Simecek told Bloomberg that he worries every morning that a nick from shaving could bleed out of control. He must take blood-thinning medicine for life to ward off clots in the six stents implanted by a cardiologist who’s under federal investigation for his stent work.

Rhonda McClure got eight stents from a cardiologist who agreed to plead guilty to Medicaid fraud for falsifying records to justify a stent. McClure suffers from chest pain, shortness of breath and has been told that she may need more stents and surgery to keep her coronary arteries from closing.

Last year, reports to the FDA’s MAUDE site (Manufacture and User Facility Device Experience) linked cardiac stents to nearly 800 deaths. That was 71% higher, says Bloomberg, than the number found in the FDA’s public files for 2008. The 4,135 nonfatal stent injuries reported to the FDA last year from events such as perforated arteries and blood clots and other incidents were 33% percent higher than 2008 levels.

The FDA told Bloomberg that adverse-event reports tied to medical devices have increased overall due to agency efforts, and warned that data can be incomplete and unverified.

Still, since 2010, more than 1,500 patients have received letters from hospitals alerting them that their stents may have been unnecessary. The University of Pennsylvania Health System sent 700 such notices in April.

Several hospitals have settled federal allegations of charging for needless stenting and other suspect cardiac procedures. Investigations of stenting practices are underway in at least five states. In March, we blogged “Hospital’s Unnecessary Heart Procedures Were Routine.”

In July, a panel of experts assembled by the American Medical Association and the Joint Commission, which accredits hospitals, said that elective stenting was one of five overused treatments that too often “provide zero or negligible benefit to patients, potentially exposing them to the risk of harm.”

The popularity of cardiac stents boomed in the 2000s when they were found to be a more effective heart attack treatment than angioplasty, in which a small balloon is inflated to widen blood passages and then withdrawn. Stenting facilities, or catheterization labs, became hospital profit centers.

According to Bloomberg, at least five hospitals have reached settlements with the Justice Department over allegations that they paid illegal kickbacks to doctors for patient referrals to their cath labs.

According to Healthcare Blue Book, a website that tracks reimbursements, the average payment is about $25,000 per stent case from private insurers. Medicare pays less. Doctors who implant stents get separate fees averaging about $1,000.

The stent is inserted via a catheter through a small incision in the groin or wrist. The procedure usually takes less than 45 minutes.

If you are a cardiac patient and your doctor wants to implant a stent, get a second opinion, especially if your condition is stable and the surgery is deemed “elective.” Ask about alternative treatments. See “Treatment Choices for Stable Angina” on the website of the Informed Medical Decisions Foundation

You can also research reports filed on MAUDE, the FDA’s Adverse Event Reporting System (FAERS) and MedWatch.

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September 26, 2013

Consumer Group Calls for Warranties on Artificial Hips and Knees

Many car buyers are familiar with what’s known as a “lemon law”—the obligation of a car dealer to make good if the car you buy is defective. Consumers Union, the policy arm of the nonprofit that publishes Consumer Reports, is championing the idea of a lemon law—otherwise known as a warranty—for the artificial hips and knees implanted during replacement surgery.

Problems with these devices are well known: For example, see our blog about Consumers Union's effort for more rigorous medical device testing. Joint replacements often fail, the organization notes, and patients and insurers get stuck with the bill, not the manufacturers.

Nearly 1 in 5 hip replacements and 1 in 10 knee replacements each year are revisions, says Consumers Union, and the re-dos are often necessary because the original device was defective. Those follow-up surgeries generally require longer hospital stays than the initial procedures, which means additional risks of infection, bed sores (pressure sores) and other problems that result from additional surgery and bed confinement.

They’re also more expensive for the patient, the insurance company and, where relevant, Medicare.

“[M]anufacturers of hip and knee implants should give patients warranties, guaranteeing to replace defective devices at no cost. That … is not only fairer to patients, but might encourage companies to make their devices safer and more durable,” says the Consumers Union policy statement.

The organization’s Safe Patient Project tapped into an FDA database on hip and knee implant recalls over the last 10 years, and learned that every major manufacturer had recalled a product or line of products.

It cited the approximately 750,000 Americans who received metal-on-metal hip implants since 2003 that were promoted as lasting longer than more traditional devices made with ceramic and plastic. But not only were such devices more likely to fail, as we’ve reported, some patients experienced debilitating symptoms from the metal debris that corrodes over time, including heart damage and neurological problems.

Knee implants, Consumers Union says, haven’t been as deficient or as dangerous, but still, according to the Safe Patient analysis, hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong size part, a missing part or a part built for the opposite side for which it was intended.

In what universe should these errors in management and manufacturing be the responsibility of the patient or insurer?

A Consumer Reports investigation last year on dangerous medical devices found that most hip and knee implants are approved for market without being reviewed for safety and effectiveness under the FDA’s 510(k) law, known as “fast track” clearance. That means manufacturers only have to demonstrate that a device is “substantially equivalent” to a product on the market—it doesn’t have to go through rigorous testing to which completely new devices are subject.

“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” Lisa McGiffert, director of the Safe Patient Project, said in the policy statement. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”

Safe Patient wants the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc. and Zimmer Holdings Inc., to provide a 20-year warranty that:


  • covers the full cost of revision surgery, including the device itself, the surgeon and hospital costs and patient out-of-pocket costs;

  • establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient; and

  • does not eliminate the patient’s right to sue if he or she uses a warranty.

If you believe in your product, you should be willing to make such a promise to the people who buy it.

To review Consumer Reports’ hospital surgery ratings for hip and knee replacement, link here. For the organizations advice on smarter hip and knee replacement, link here.

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September 15, 2013

Complications of Robotic Surgery Are Under-Reported

By now, the problems stemming from use of the Da Vinci robotic surgical device are well known. We’ve blogged about its adverse outcomes for hysterectomies, prostate cancer, and a host of other disorders.

Now, a study published in the Journal of Healthcare Quality finds that of the approximately 1 million robotic surgeries performed since 2000, only 245 complications -- including 71 deaths -- were reported to the FDA. That’s a remarkably low number -- and a suspect one too.

By law, when a device malfunctions or there’s an adverse event with a device during a surgical procedure, the hospital where it occurred must report it to the manufacturer. That company is required to report the incident to the FDA. The study’s researchers say it’s not always happening.

As reported on HealthLeaders Media, “Injuries and death resulting from the minimally invasive Da Vinci surgical robot … have got to be far more numerous than the 245 cases reported to the U.S. Food and Drug Administration so far, Johns Hopkins University researchers contend.

“The team, led by laparoscopic pancreas surgeon Marty Makary, MD, drew that conclusion because he and his research team were able to find eight cases of patient harm or death from robot complications in public court records or media reports.

“But no report was made to the FDA's Maude (Manufacturer and User Facility Device Experience) database for five of those cases and for the other three, the report was improperly filed or filed late, after the adverse event was reported by a major newspaper.”

Robotic surgery is promoted as a minimally invasive procedure suitable for a range of problems involving body parts as diverse as gallbladders and heart valves. The surgeon directs remote-controlled instruments from a console. In some cases the instruments can work in smaller spaces than human fingers can.

But in addition to adverse outcomes, there have been problems with training on the device, and although robotic surgery is more expensive than more traditional laparoscopic procedures, the outcomes are equivalent.

Still, 11 years after FDA market approval, more than 1,400 units were operating on U.S. patients, and they were in as many as 400 in hospitals around the world.

Makary, an outspoken critic of deficient health care, said that if 6 in 10 of those very severe cases weren’t properly reported, there were probably many more that were less serious that also weren’t reported.

Makary wonders why, more than 10 years after Da Vinci was approved by the FDA, it’s the subject of debate. What took so long? “The data,” he said on HealthLeaders, “could have been captured and analyzed in the first few years and we could have had the discussion about which procedures robotic surgery provides benefit for, and for which procedures there is no difference, and for which procedures are there added risks and costs that make it unwise.”

Makary is no Luddite: He supports the development of new technologies for medicine, but to do so without rigorous tracking of their outcomes is an exercise untethered to utility. "[W]e have to evaluate new technology properly,” Makary told HealthLeaders, “so we don't over-adopt -- or under-adopt -- important advances that could benefit patients."

You can’t evaluate safety if the system of collecting data is subjective and covert. There’s a reason the FDA demands accounting and accountability, but as the Hopkins study shows, the demand does not result in universal compliance.

The researchers found that of the reported Da Vinci complications, the procedures most often associated with death were gynecologic (22 of the 71 deaths), urologic (15 deaths) and cardiothoracic (12 deaths). The cause of death most often was excessive bleeding. For adverse outcomes other than death by far the most complications were for hysterectomies—43 out of 100 injuries.

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August 21, 2013

Surgical Errors -- When Technology Is the Problem

Surgical errors are a common cause of medical malpractice lawsuits. Sometimes it’s the result of an horrific human mistake such as operating on the wrong body part or leaving a tool inside the patient. A new study shows that a significant number of surgical mistakes are caused by problems with the equipment or technology used.

We love technology, whether it’s our mobile device, our car’s GPS or a medical tool that makes us better. But using the wrong tool in a medical setting, or using it improperly, can be deadly.

For example, we’ve discussed the ongoing problems with the Da Vinci robotics system that’s promoted for a wide range of surgeries including those for bladder, colorectal, gynecologic, kidney, prostate and throat cancers.

The new study, published in BMJ Quality and Safety, involved a review of more than 19,000 scientific studies that examined problems arising during a variety of surgeries.

As discussed on AboutLawsuits.com, nearly 1 in 4 of all surgical errors was associated with the failure of equipment or technology.

Additional analysis found that more than 4 in 10 errors had to do with how the machines were configured or calibrated; nearly 4 in 10 concerned the lack of availability of equipment, and more than 1 in 3 involved malfunctioning machines.

Sometimes, as we’ve written, mistakes are made because people aren’t trained properly in the use of the equipment.

Regarding the severity of operating room errors, 1 in 5 was classified as “major”; 13 in 100 of those were the result of technical failures, and 8 in 100 were about problems in communication.

Surgical errors are demonstrably reduced when hospitals implement certain procedures, including safety checklists, (see our blog, “Checklists for Surgery Safety Cut Death and Injuries.”) and the BMJ study bolstered this approach. In operating rooms where equipment safety checklists were followed before surgery, the number of errors was cut by half. When equipment-specific checklists were employed—that is, certain guidelines are followed for certain tools—errors dropped by nearly 61%.

As AboutLawsuits noted, medical mistakes affect as many as 16 in 100 inpatients, and nearly half of reported medical errors concern surgical procedures.

If you or a loved one is scheduled for surgery, make sure you understand the procedure—who is performing it, what are his or her credentials (how many similar procedures has he or she done; is he or she board-certified in the specialty) and whether a certain technology or tool is being employed.

If it is, investigate its safety record on the FDA’s website and ask if your caregiver has a financial stake in the equipment. Keep in mind that practitioners and hospitals that have invested heavily in new technology are especially keen to use—and charge for—it. Those financial interests might impair the providers’ objectivity when it comes to the appropriate use of technology in your situation. (See our blog, "Conflicted Care: Physicians with a Financial Stake in the Medical Devices They Use.")

Sometimes, device sales representatives are admitted to an OR to advise the surgical team on the proper use of their product. These situations are fraught with the potential for abuse. You have the right to know if this situation pertains to your case. If so, ensure that your caregivers follow guidelines for outsiders in the OR devised by the ECRI Institute, an independent, nonprofit organization that researches safety, quality and cost-effectiveness of patient care.

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August 18, 2013

Judgment in Vaginal Mesh Trial Favors Plaintiff

Last month, we wrote about Donna Cisson, who had sued CR Bard Inc., which had sold vaginal mesh that the company itself had said was not suitable for human implantation. The mesh is surgically implanted to resolve urinary incontinence and pelvic organ prolapse, a condition in which the organs have dropped out of their normal position.

Cisson had claimed that the mesh caused her pain, bleeding and bladder spasms that required follow-up surgeries, but a mistrial was declared because of a mistake in testimony. Last week, however, Cisson won the case, and the federal jury assessed CR Bard $2 million in damages, reports AboutLawsuits.com. It’s the first of more than 25,000 federal lawsuits that have been filed over vaginal mesh.

Cisson’s judgment includes punitive damages.

Several vaginal mesh cases have been tried in state courts. Last year, according to AboutLawsuits, a California jury decided against CR Bard, for $5.5 million, and in March, a New Jersey jury assessed damages of $11.1 million for a different manufacturer’s mesh product.

See the FDA’s consumer alert about surgical mesh here.

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August 12, 2013

Conflicted Care: Physicians With a Financial Stake in the Medical Devices They Use

In reflecting on five years of “reading medical journals and writing to inform patients of the hazards of medical care,” patient safety advocate John James says he has “learned some difficult realities.”

Our blog posts frequently mirror his observations.

“Perhaps foremost is that when people want to believe that their health-care system is safe and just, their opinions are not going to be easily swayed by data and facts, regardless of how reliable the source may be. Secondly, people want to believe that physicians always have their interest at heart; this naïve supposition is not easily replaced by caution when seeking medical care. Thirdly, most people are less interested in preventing their own poor health than getting treatment when a preventable disease has gotten the best of them. Finally, most people cannot view the health-care industry in terms of how it affects less fortunate Americans – for them it is about me and my health care.”

In a poignant example of his second point, consider a recent fraud alert issued by the Department of Health and Human Services’ Office of the Inspector General. It addresses physician-owned businesses that market implantable medical devices “ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).”

We wrote about the alert when it was issued in the spring, and now, the Wall Street Journal probes the smelly entities knows as physician-owned distributorships (PODs).

“Surgeon in Probe Is Working in Detroit-Area Hospitals,” concerns the story of Dr. Aria Sabit. He had a decided preference for an obscure brand of spinal implants, but many of his surgeries had tragic outcomes. Dozens of medical malpractice lawsuits were filed. The California medical board, the FDA and the Department of Justice, the Journal reports, are investigating Sabit because he had “an ownership interest in the company that distributed, and profited from, the surgical devices he switched to, people familiar with the matter say.”

Federal prosecutors say Sabit is part of a broader civil investigation into a network of doctor-owned spinal-implant distributorships operated by two former medical-device company employees that earned millions of dollars for its investors over six years.

“Physician-owned distributorships … have proliferated in medicine,” the Journal writes. “Distributorships, whether owned by physicians or not, act as intermediaries between medical-device makers and hospitals: In exchange for marketing and stocking devices, the distributors get a cut of each sale. When surgeons own the distributorship, that commission goes into their pockets. And [because] surgeons often dictate to their hospitals which devices to buy, they can effectively steer business to themselves.”

Apparently, Sabit’s dicey doings didn’t dissuade other hospitals from seeking his “talents.” Sabit, the Journal reports, is a senior staff member at a Michigan hospital, and has privileges at several others in the region.

He continued to use spinal implants from Apex Medical Technologies, the distributorship in which he had an ownership, on patients in Michigan until last June.

In depositions for the malpractice cases filed against him in California, Sabit has been … inconsistent, sometimes saying he didn’t receive monetary benefit from Apex implants, sometimes saying he didn't know if he did.

“A Detroit Medical Center spokeswoman,” according to the Journal, “says it wasn't aware that Dr. Sabit owned part of a spinal-implant distributorship. ‘We are currently looking into this,’ she said.”

The spokeswoman told the paper that the medical center wasn't aware of any problems during Sabit's time in California when it recruited him to join its surgical staff in 2011, and only later learned about the malpractice suits when they were filed. He, of, course, has denied the allegations.

Another Wall Street Journal story, “Does My Surgeon Profit From My Implants?” delineates how the owner-and-provider role common among spine, hip and knee surgeons is spreading to cardiac surgeons, and how difficult it is for patients to know if their surgeon is involved in a POD, unless the doctor discloses the information.

Incorporation documents for PODs in the Reliance Medical Systems network, the Journal reports, name Adam Pike and Bret Berry or one of their business associates as officers. They say nothing about any surgeons or their ownership structure. “The only clue about the companies' business,” the story says, “is in their names, which all include the terms "Spine," "Spinal," "Medical," or "Surgical."

Pike is listed as a "registered agent," and Pike Industries Inc. and Berry Medical Enterprises Inc. are "managing members/managers." The company’s address is a post office box in Jacksonville, Fla.

This sounds more like a covert mail drop than a legitimate business.

The Journal says that Pike and Berry shared ownership of each POD with a different group of surgeons. Each investor got an equal stake and received an equal profit distribution based on the POD's overall sales.

The Reliance network grew to include at least 11 PODs in six states by last year, when Pike and Berry bought out all the surgeon investors when PODs starting drawing scrutiny from the Justice Department.

As we suggested earlier this year, if your doctor recommends a procedure, or if you are having surgery to implant a medical device, find out:


  • What is the purpose of this procedure/device, what results can I expect, and how soon?

  • Are there alternatives?

  • Why am I having the procedure at this particular facility?

  • What is your financial interest in the equipment used or the facility where it’s performed?


To report suspected fraud involving physician-owned entities, contact the Office of the Inspector General’s hotline at (800) 447-8477, or online here.

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August 5, 2013

New Surgical Rating Tool Gives Mediocre Grades to Major Institutions

Our "Better Health Care" newsletter focuses this month on how hospitals are rated for patient safety. Among the several ways it mentions for consumers to measure hospital performance is a new guide from Consumers Union, the outfit that publishes Consumer Reports.

As reported last week by Reuters.com, many of the 2,463 hospitals included in the Consumers Union (CU) effort are nationally renowned facilities, and some of them earned less than stellar ratings. “The Cleveland Clinic,” reported Reuters, “some Mayo Clinic hospitals in Minnesota, and Johns Hopkins Hospital in Baltimore, for instance, rated no better than midway between ‘better’ and ‘worse’ on the CU scale, worse than many small hospitals.”

The problem, as Patrick Malone’s newsletter notes, is that a rating organization has access to only some data, and many of them have an agenda; that’s why it’s best to look at several different measures, and understand the biases and variables that each brings to the task. Reuters affirms that CU had only limited access to data, so its ratings confirm the difficulty patients experience in seeking objective information on the quality of care at any given facility.

Last week’s report was the first of its kind for CU. It included hospitals in every state, and it measured only the quality of their surgical care. It analyzed the percentage of Medicare patients who died in the hospital during or after their surgery, and the percentage that stayed in the hospital longer than expected based on standards of care for their condition.

The ratings are based on Medicare claims and clinical records for 86 kinds of surgery, including back operations, knee and hip replacements and angioplasty. Adjustments were made to account for the fact that some hospitals treat older or sicker patients. Data on patients who were transferred from other hospitals were excluded because, according to CU, they are often difficult cases that shouldn’t be counted against the receiving hospital.

Specific complications such as infections, heart attacks, strokes, or other post-surgery problems aren’t teased out, but the researchers say the length-of-stay data indicates those issues.

“Some of the findings are counterintuitive,” says Reuters. “Many teaching hospitals, widely regarded as pinnacles of excellence and usually found at the top of rankings like those of U.S. News & World Report, fell in the middle of the pack.” (See our blog about the limitations of the U.S. News & World Report annual rankings.)

As Dr. Marty Makary, a surgeon at Johns Hopkins Hospital and author of "Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care," told Reuters, "For a complex procedure you're probably better off at a well-known academic hospital, but for many common operations less-known, smaller hospitals have mastered the procedures and may do even better [with post-surgical care].”

Some representatives from hospitals with disappointing ratings called into question whether the methodology reflected the full picture of quality of surgical care, saying that outcome data (how well patients undergoing a certain procedure fare in the longer term) is a better metric.

In the CU rating, several urban hospitals did well despite serving many poorer, sicker patients, whose outcomes usually skew figures downward. Rural hospitals usually outperformed more urban facilities, and some that are barely known outside their own region were stars.

Reuters observed that “hospital choice matters more for some procedures than others. Length of stay for hip and knee replacements and back surgery varied widely, for instance, while hospitals' scores for colon surgery and hysterectomy were more similar to one another.”

There’s a lot of hospital data out there you’re unable to see. According to Reuters, the American College of Surgeons collects data on things like the rate of infections at the surgical site and urinary tract infections through its National Surgical Quality Improvement Program. But it doesn’t release the data publicly because hospitals give the information to the program on a confidential basis. Still, about 1 in 5 of about 500 participating hospitals voluntarily reports some data to the federal Center for Medicare and Medicaid Services.

Some hospitals, including the Cleveland Clinic, make information about outcomes available on their websites. CU advocates for such greater "medical transparency,” and Dr. Peter Provonost of Johns Hopkins supports requiring hospitals to report patient outcomes just as the Securities and Exchange Commission requires public companies to report financial data.

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August 3, 2013

Medical Tourism: An Update with Eye-Popping Numbers

We've heard of traveling to Mexico or India for saving big bucks on expensive surgery, but now "medical tourism" is a realistic option for travel to Europe and other "first world" places too, with similar big savings.

The issue this highlights is not just pinching pennies, but why is American medical care so expensive, with no better outcomes?

Blog readers should check out this New York Times piece by reporter Elisabeth Rosenthal, who traveled to Warsaw, Indiana, home of the world's biggest manufacturers of hip and knee implants, to find out why those same implants cost so much more for Americans than when they are shipped overseas. Hint: One reason is the legal tangle created by Congress that makes it hard for Medicare and other insurers to negotiate better prices.

The article gives many examples. The first: a Colorado patient who flew to Belgium for a hip replacement, at a total cost of $13,660, which would have cost him as much as $100,000 in the U.S.

Readers who want to know more about medical tourism and medical "vacations" should check out our recent newsletter on the ups and downs of the concept.

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June 26, 2013

Medtronic Spinal Treatment Is Riskier and No Better than Bone Graft

In another example of newer-not-better, two new studies suggest that a controversial product intended to promote spinal bone growth provides no benefits over traditional spine surgery, and comes with the added risk of serious side effects.

As reported on AboutLawsuits.com, the independent reviews published in the Annals of Internal Medicine (here and here) analyzed data from all clinical trials for Infuse, manufactured by Medtronic.

The extra scrutiny was the result of Medtronic’s efforts to hide complication rates and potential side effects in earlier studies. If your product included a possible risk of cancer, you, too, might want to keep that discovery out of sight.

Infuse, as explained on AboutLawsuits.com, is a bone morphogenetic protein, or BMP, that’s implanted to encourage bone growth and fuse the gaps between vertebrae. Medtronic promotes Infuse as an alternative to traditional spinal surgery that harvests bone from another part of the body or a cadaver to encourage fusion of the vertebrae.

The FDA approved Infuse only for limited applications, but it has been used widely for off-label uses—those not officially approved, but not prohibited, although the manufacturer may not promote those uses. BMP is approved for tibia fractures, facial surgery and fusing damaged vertebrae in the lower spine, but when used in the upper and cervical spine, it has been linked to reports of cancer, sterility and pain caused by excessive bone growth.

Several lawsuits by patients experiencing these side effects have been filed.

The gravity of the issue is indicated by the fact that, according to an editorial in the Annals of Internal Medicine, two systematic reviews of this scale have never before been published simultaneously. One study was done by researchers in Oregon, and the other by researchers in England.

Both groups were given detailed data from 17 spinal studies using Infuse on more than 2,000 patients. They also got safety reports filed to U.S. regulators and other publications about the product.

As summarized by About Lawsuits.com, “Researchers indicated that it was hard to find a good reason to actually use Medtronic Infuse, and they also found significant reporting bias in previous studies by Medtronic, which overstated the benefits of the bone growth product.”

And from the Oregon researchers: “Our study shows that adverse events were underreported for more on- and off-label uses, with results not previously available to the public. Journal practices for sponsored supplements, trial registration and conflict of interest disclosure may have contributed to publication of an incomplete and sometimes misleading evidence base.”

Medtronic, according to Bloomberg.com, is the world’s largest manufacturer of spinal treatments.

Last year, Congress concluded that Medtronic had manipulated previous medical studies that appeared to minimize Infuse risks and overstate its effectiveness. The company paid $210 million to authors of studies sponsored by the company. The studies seem purposefully to have left out findings that suggested Infuse could increase the risk of male sterility, bone growth problems, cancer and back and leg pain.

That’s bad enough, but investigators said Medtronic officials also inserted language into scientific studies suggesting Infuse was better and less painful than the bone graft technique. One email exchange, according to AboutLawsuits.com, revealed that Medtronic employees urged that a complete list of adverse events linked to Infuse not be published in a 2005 study.

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May 30, 2013

Suggested Reading—What Your Surgeon Won’t Tell You

In a word-light, graphic-heavy web presentation, Reader’s Digest lists “50 Secrets Your Surgeon Won’t Tell You.” The dish ranges from what days of the week are best to schedule your elective operation to how to find out what exactly happened in the OR while you were under.

As Reader’s Digest summarizes, “Surgeons have our lives in their hands, but most of us know more about the people who cut our hair than the doctors who cut our bodies. Here, insider tips to become a smarter, healthier patient.”

To view the slideshow, link here.

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March 31, 2013

Training Short-Cuts for Robotic Surgery Have Tragic Results

Harm caused during robotic surgery has led to numerous malpractice lawsuits against surgeons who use the high-tech devices and product liability actions against manufacturers who make them. Last week we wrote about the statement from the American College of Obstetricians and Gynecologists advising caution in robotic use for hysterectomies.

Intuitive Surgical Inc., according to a story on Bloomberg.com, manufactured robots used in 367,000 U.S. operations last year. The company has been sued for putting patients at risk because it allegedly sold the devices to doctors without training them sufficiently in their use.

“At least 10 lawsuits have been filed over the last 15 months,” says the Bloomberg story, “alleging injuries from robot surgery, and almost all cite Intuitive’s training regimen.”

Among the adverse outcomes resulting from robotic surgery are tearing internal tissue and burning internal organs.

One patient at the wrong end of the robotic knife was Fred E. Taylor. His widow, Josette Taylor, sued Intuitive for complications Fred suffered after prostate surgery. He died four years later, partly, she claims, from “woefully inadequate” company training “designed to give surgeons a false sense of confidence.”

Taylor’s cancerous prostate gland was removed in 2008. It was his doctor’s first unsupervised surgery using the Intuitive device, according to the lawsuit. He lost 15 cups of blood during the 13-hour procedure. He suffered kidney failure, brain damage, permanent incontinence and a 1-inch tear in his rectum, the suit charges.

As Bloomberg reports, Scott Bildsten, the doctor who performed the surgery, had done about 100 prostate removals via the standard method, without any complications. Bildsten had done only two supervised robotic prostate removals before Taylor’s. Intuitive provided the overseeing physician and the hospital paid the fees.

The robots, called the Da Vinci system, cost about $1.5 million each, says Bloomberg, and nearly 1,400 U.S. hospitals have them. Remarkably, there is no universal, prescribed guideline for training the people who use them, unlike the standards for many other sophisticated surgical procedures. Many hospitals depend Intuitive for this instruction. But its priority, of course, is selling, not teaching.

“Sales reps should have nothing to do with credentialing,” Dr. David Penson, a urologist, told Bloomberg. “Of course they are going to do whatever they can to get that guy out there and using their equipment.”

Last year, says Bloomberg, robots and related products generated most of Intuitive’s $2.2 billion in revenue.

The FDA approved the robotic device in 2000. Documents obtained by Rick Friedman, Taylor’s attorney, showed that Intuitive told the agency then that it would design a 70-question quiz and a three-day training course for all operating-room personnel. But only months after the robot hit the market, Intuitive put a marketing official—not a medical professional—in charge of training. Off- site training was cut to one day and the test questions were cut to 10.

Documents from the Taylor complaint include Intuitive emails about training from marketing officials and sales personnel. One, from 2009, was by a company clinical sales representative. It told one hospital that had suggested that new robot surgeons have at least five supervised procedures was “on the high side” and might have “some unintended consequences.”

What the rep might have meant, it seems, is that such careful oversight would cost $15,000 per urologist. The email said a similar requirement “slowed down” development of robotic surgery at another hospital. When the first hospital indicated it would “most likely” lower its requirement, the rep was congratulated in another company email, Bloomberg reports: “… [N]ice job on taking charge and ownership of your programs.”

Another company email by a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries. Translation: We’re about numbers, not safety. We’re about sales, not outcomes.

Myriam Curet, Intuitive’s chief medical advisor, told Bloomberg that company training includes an online quiz, practice simulators and a one-day course at Intuitive’s headquarters in Northern California and 14 hospitals across the country. Doctors new to the procedure are supposed to observe at least one robot operation and perform mock operations with their team. Most hospitals require the first few operations be supervised by an expert, Curet said.

But there’s no credentialing, there’s no regulated oversight; it’s up to doctors to decide how much training they need, Curet said. “We cannot require anything.”

Which is why several parties might share responsibility for a tragedy like Taylor’s. People, like institutions, don’t always do the right thing without being required to do so. We’re not moved by Intuitive’s argument to have the Taylor lawsuit dismissed: “…[C]redentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital. It is not the responsibility of a medical device manufacturer like Intuitive.”

Tellingly, the hospital where Taylor underwent surgery didn’t dispute that Taylor suffered complications. It settled the case for an undisclosed amount.

The FDA shares responsibility for robotic device misuse and poor patient outcomes—it first required that Intuitive submit the Da Vinci for approval in its most rigorous device review category. That’s reserved for products that aren’t seen as equivalent to anything already on the market (otherwise, devices can qualify for a faster approval).

But in spring 2000, the FDA reversed that decision and moved the robot into a less stringent category. By July 2000, it was approved for marketing. The earlier three-day training program simply wasn’t required. The agency left the training the details “to the discretion of Intuitive Surgical,” said one official in a statement.

Like Josette Taylor, we are left to wonder—who guards the guards?

If you or a loved one is scheduled for surgery your doctor wants to perform robotically, ask:


  • Why is a robotic procedure preferable to traditional surgery?

  • What are the risks of each approach?

  • How many robotic surgeries have you performed with this device? (One expert told Bloomberg that it can take 200 operations to be proficient at robotic prostate cancer surgery; the Mayo Clinic says it can 90 procedures to be proficient in gynecological surgery.)

  • Ask how long the hospital has had the robotic equipment—some hospitals feel pressured to use expensive technology as much as possible to recoup costs, even if their staffs haven’t been adequately trained.


To see what reports and warnings the FDA has about medical devices and their safety, link here.

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March 24, 2013

Surgeons Advise Against Robotic Surgery for Most Hysterectomies

Sometimes, reality is lost in the love for medical device technology. Just because something’s new doesn’t mean it’s better. A recent statement by the president of the American College of Obstetricians and Gynecologists advises caution when it comes to robotic surgery for hysterectomies.

Dr. James T. Breeden states, “Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.”

As in other surgeries, patients are given general anesthesia for robotic surgery. The surgeon uses a computer to direct a robotic arm in the control of tiny instruments inserted through small surgical incisions. An endoscope—a thin tube with a camera at the end—enables the surgeon to see magnified, three-dimensional images on a monitor.

We’ve noted some of the harms of robotic surgery, including tearing internal tissue and burning internal organs, and that in some procedures, their outcomes are no better than those of traditional surgery.

Lawsuits are rising against surgeons who commit malpractice with robotic machines and against the manufacturers who make them.

As Breeden points out, outcomes are directly associated with a surgeon’s skill, not just the tools he or she uses. Skill comes with years of training and practice, and any new technology comes with increased complications while the learning curve is mastered.

“Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons,” Breeden says. “While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes.

Consequently, there is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.”

Because the incisions are smaller and the procedure less invasive, robotic hysterectomy usually means shorter hospitalization, less discomfort and faster recovery compared with other approaches. But, often, a hysterectomy can be performed vaginally, without any abdominal incision. That’s the least invasive and least expensive option. “Based on its well-documented advantages and low complication rates, this is the procedure of choice whenever technically feasible,” Breeden says.

When vaginal hysterectomy isn’t possible, laparoscopic hysterectomy is the second least invasive and costly option for patients. That involves a smaller abdominal incision than total abdominal hysterectomy (TAH).

Both vaginal and laparoscopic procedures require fewer days of hospitalization and shorter recovery than TAH, and they have proven records for excellent outcomes and cost efficiencies.

But hospitals spend a lot of money on fancy robotic technology, and many surgeons are like kids with the latest Game Boy—as the saying goes, when you’re a hammer, everything looks like a nail.

Even if safety weren’t a consideration—and it always should be the primary concern—robotic hysterectomy should be scrutinized for its expense, Breeden says. Robots cost more than $1.7 million, and have $125,000 in annual maintenance costs.

Breeden refers to a recent study in the Journal of the American Medical Association (JAMA) finding that the percentage of hysterectomies performed robotically jumped in the last three years from less than 1 in 100 to 1 in 10. They were more than $2,000 more expensive for the patient and showed no demonstrable benefit.

“Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that [robotic hysterectomy is] the best choice,” Breeden says. “Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health-care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.”

Cost concerns aside, patients must consider safety. As reported by AboutLawsuits.com, an increasing number of lawsuits have been filed resulting from the use specifically of the da Vinci robotic device.

Bloomberg News told the story of one patient. Uterine growths were removed with a da Vinci robot, described by her gynecologist as “the latest, greatest” technique available.

Five weeks later, she felt something pop while she was using the toilet, and glanced down to see her intestine protruding from her vagina. The vaginal wound had failed to heal properly. Four years later, Blooomberg reports, the 41-year-old has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life.

“It didn’t help me one bit, the robot,” she told the news site. “It forever changed my life for the worse.”

Robot systems made by Intuitive Surgical Inc., including the da Vinci, are linked to at least 70 deaths since 2009, says Bloomberg.

“Many of the complaints allege that a potential cause of the da Vinci problems is a lack of training provided for doctors who use the device, particularly at smaller hospitals where there is not a large volume of procedures,” AboutLawsuits notes. “In addition, lawsuits indicate that many hospitals feel pressured by competition and marketing to buy a da Vinci, and then doctors are encouraged to use the machine as often as possible to help the hospital recoup costs.”

Those are not compelling reasons for patients to agree to undergo the robotic knife.

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March 12, 2013

Longer Lives for Ovarian Cancer Patients: The Only Secret Is Experience

Two treatments are proven to lengthen the lives of women with ovarian cancer, but only 1 in 3 patients gets them, according to a new study. It's no mystery why. The old rule for better health care -- experience, experience, experience -- is proven out again.

Ovarian cancer is a bone-scary diagnosis because of its dismal prognosis. But the understandable fright causes many women to make illogical moves when they reach out for care: First, they often look to a familiar face for treatment, such as the obstetrician who birthed their children (who usually is qualified on paper to take out ovaries, but lacks big-time experience with ovarian cancer). Second, they think they have to get surgery in a matter of days, not weeks, and that leads them to grab onto whatever surgeon can see them first.

These are mistakes that can shorten lives. The two treatments that are shown to lengthen life of ovarian cancer patients are:

* Debulking surgery.

* Chemotherapy delivered directly to the inside of the abdomen, called intraperitoneal (IP) chemo.

The best advice for women with a new diagnosis of ovarian cancer is to get to a "center of excellence" for cancer treatment, and to make sure the surgery is done by a gynecologic oncologist. That's a gynecologist with extra training in women's cancers of the reproductive organs.

Also, make sure the surgeon does ovarian debulking surgeries at least about once a month, or a dozen times a year. The operation often takes six or more hours, and it's necessary to have a surgeon with the skill, experience and meticulous patience to take out all visible signs of the cancer from inside the lower abdomen.

The seeds of cancer are scattered like Rice Krispies, and the best result is for those women who get all visible cancer removed by the surgeon, and then get the pelvis washed out with IP chemo.

Read more about this in a takeout in the New York Times by Denise Grady.

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January 30, 2013

Should Mehmet Oz Operate on You?

If you're a patient facing serious heart surgery -- a transplant or a valve replacement, say, anything that requires surgeons to stop the heart from beating while they repair it -- you want the most skilled, experienced hands working inside your chest. All other things being equal, nobody wants a part-time doctor working on them.

But what if you could have "America's Doctor," Mehmet Oz, operate on you?

Before he became a television celebrity, Dr. Oz was an accomplished surgeon at New York-Presbyterian Hospital. He still is. He operates there every Thursday, and recently showed New Yorker writer Michael Specter what the inside of someone's chest looks like when the heart is completely stilled for intricate surgery. It created an arresting scene for Specter's profile of Oz, which he called, "The Operator." (You'll understand why the title is a double entendre when you read the piece, which you can find here.)

The reporter posed a hard question to Eric Rose, the surgeon who trained Oz:

I asked if he would place his confidence in a heart surgeon, no matter how gifted, who operated just once a week, as Oz does. “Well,” he replied, “in general you want a surgeon who lives and breathes his job, somebody who is above all devoted to that.” Again he mentioned Oz’s experience, but when I asked if he would send a patient to Oz for an operation, he looked uncomfortable. “No,” he said. “I wouldn’t. In many respects, Mehmet is now an entertainer. And he’s great at it. People learn a lot, and it can be meaningful in their lives. But that is a different job...."

Celebrity has a magnetic attraction. We all want to be around people who are famous and who dazzle us with their intelligence and personality. But does celebrity mix with surgery, where the surgeon's skills stay up-to-date only with constant practice?

No, it just doesn't.

UPDATE: John McKiggan, a top malpractice lawyer in Halifax, Canada, has written a blog on the same subject, pointing to the research on the number of hours of practice -- typically 10,000 -- that it takes someone in any field to become truly proficient. John says he would also decline Dr. Oz, and he notes that many hospitals have their own version of Dr. Oz, not a TV personality perhaps, but a senior surgeon who has taken on other duties that may have left him or her a bit rusty with the knife.

Bottom line: It pays to know in advance your surgeon's current work load and experience.

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January 26, 2013

Lawsuit Over Hip Implants Shows Company Hid Own Estimate that Huge Numbers of Patients Were Harmed by Defect

In 2010, Johnson & Johnson recalled an all-metal hip implant device because of a high failure rate and because the grinding of its components released tiny bits of metal that damaged tissue and bone. The company conducted an internal review of the device in 2011 that showed the implant would fail within five years in about 4 in 10 patients.

Only now, as reported by the New York Times, is that information coming to light.

J&J’s report is among hundreds of internal company documents, says The Times, expected to become public as the first of more than 10,000 lawsuits by patients who got the implant, the Articular Surface Replacement (ASR), went to trial yesterday.

Hip implants made of metal and plastic instead of the metal-on-metal design of the ASR often last for 15 years before they wear out, according to The Times. They can fail prematurely for a variety of reasons, but not at the rate of the recalled device. A premature replacement rate would be about 1 in 100 after a year, and 5 in 100 after five years.

J&J never released the dismal five-year failure results for the ASR. “But at the same time that the medical products giant was performing that analysis,” says The Times, “it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.”

We’ve written about the problematic history of metal-on-metal hip implants, and the new disclosure about hidden company documents once again puts Johnson & Johnson’s DePuy Orthopaedics division in the hot seat: What did company officials know about the device’s problem before its recall? What actions did they take or fail to take?

How many more failures of this shoddy device are about to occur? How many more patients who had the surgery are facing more painful and expensive surgeries to replace it?

As The Times reports, last year J&J took a $3 billion charge so that money could be reserved for patients and lawyers involved in the upcoming product liability lawsuits. DePuy, The Times says, has offered to cover the cost for patients to correct the problems.

That’s nice, but, really, if the company knew of the high potential for such problems and did nothing to address them before they harmed thousands of people, is that really much consolation?

The discovery last week of the internal report is only a tiny bit of what will become public knowledge if the company doesn’t settle, and the lawsuit proceeds to trial. Plaintiffs’ lawyers have been preparing for two years, and who knows what other ugly secrets J&J was protecting.

Approximately 93,000 people around the world have received an ASR; more than 31,000 of them live in the U.S. Some 7,000 separate ASR lawsuits have been consolidated in a federal court in Ohio, and another 2,000, says The Times, have been consolidated in a California state court.

The California case that brought the internal report to light involved a cancer patient who might not live much longer. The paper said DePuy has settled some ASR cases before trial, and it may do so in his.

Cold comfort, indeed. But a testimonial, at least, to the power of lawsuits to unlodge secrets of corporate wrongdoing.

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January 22, 2013

Kidney Disorder Often Treated with Unnecessary Surgery

The authors of an unsettling study recently published in The Lancet concluded that thousands of people have had kidneys removed unnecessarily because doctors misdiagnosed their disease.

As interpreted in a story on ScienceDaily.com, 1 in 5 people with kidney tumors, which are common in patients with a genetic disorder known as tuberous sclerosis complex (TSC), had a kidney removed; 4 in 10 had some kind of surgical procedure. But according to the researchers, a proper diagnosis could have prompted treatment that involved neither surgery nor kidney removal.

TSC, according to the National Institutes of Health, is characterized by the growth of numerous noncancerous (benign) tumors that can occur in the skin, brain, kidneys and other organs. Sometimes they lead to significant health issues, including developmental problems.

According to ScienceDaily, TSC affects about 40,000 people in the U.S.; as many as 7 or 8 in 10 develop kidney problems because its multiple tumors compress normal renal tissue. That can lead to kidney failure, bleeding and shock.

As lead author Dr. John Bissler, a nephrologist (kidney specialist) who co-directs the Tuberous Sclerosis Clinic at Cincinnati Children’s Hospital Medical Center, told ScienceDaily, "I can't tell you how many times I've heard from patients who say their doctors told them a kidney looks bad, is full of tumors, isn't working and has to come out. But you can do studies on these patients and find out that they have normal kidney function. The kidney looks bad, but it works. Doctors are unfamiliar with tuberous sclerosis, so when they see tumors, they think it's renal cell carcinoma [a type of kidney cancer], perform surgeries trying to help, but before long the kidney is gone. This approach is unnecessary. …”

As many as 8 in 10 TSC patients experience tumor growth on vital organs called angiomyolipomas, or AMLs. A drug called Afinitor (everolimus) can shrink them. The FDA approved everolimus last year to treat noncancerous kidney tumors that don’t require immediate surgery for patients with TSC. It had been approved previously as an antirejection drug for organ transplant patients.

Bissler’s study involved 118 TSC patients at 24 treatment centers in 11 countries. Within a few months, everolimus substantially reduced the size of angiomyolipoma tumors in more than 4 in 10 people. Tumor reduction lasted an average of more than five months.

Traditionally, treatment for AMLs was arterial embolization, which uses a catheter to block the artery and stop blood flow to the tumor. That procedure, however, also can damage healthy tissue.

Studies in the 1990s determined the cause of TSC to be two defective genes. When they malfunction, a protein in the cell triggers uncontrolled tumor cell and blood vessel growth. With the discovery, everolimus attracted interest as a treatment for TSC.

The science is evolving, and like all difficult medical disorders, there’s no single approach that works for everybody. But for people with TSC who may be facing surgery, it makes sense to seek the opinion of a specialist in this disorder, and to inquire about drug treatment.

Side effects of everolimus range from the annoying—dry mouth, dry skin—to the serious—seizures, irregular heartbeat, swelling of the lips and tongue... For a complete description of the drug’s indications and possible harms, link here.

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December 26, 2012

Surgical Mistakes That Never Should Happen Regularly Do

A couple of months ago, we posted a blog about surgical errors, specifically when the operating teams leave tools inside the patient. That’s an example of what’s known in the medical biz as a “never event.” That means it’s a mistake, a malpractice event, for which there is never any excuse and that should never happen.

Researchers from John Hopkins University School of Medicine published a story this month in the journal Surgery that disclosed that never events occur with shocking regularity. Leaving tools inside a wound, operating on the wrong body part or even the wrong body happen about 500 times a year. The researchers estimated that 80,000 never events occurred in U.S. hospitals between 1990 and 2010.

They said their estimates probably are on the low side.

The study said that malpractice claims were paid for 9,744 never events; payments totaled $1.3 billion. More than 6 in 100 never-event patients died, more than 32 in 100 suffered permanent injury and nearly 60 in 100 were temporarily injured.

According to the Washington Post, about half of those cases involved objects left inside the patient (usually sponges, as our story earlier this year noted). The other half were cases of the wrong body part being operated on, and 17 were people who weren’t supposed to have that surgery at all.

And those were only the cases for which claims were paid; if a patient didn’t experience or didn’t report harm, they weren’t represented in the study.

The Post said the study indicates which doctors are more likely to be involved with a never event—those who had been the defendant in prior malpractice claims. The data also showed that younger doctors were more likely to settle malpractice claims for never events.

Our friends at Pop Tort, the unfiltered civil justice blog sponsored by the Center for Justice & Democracy, remind us that only a tiny percentage of people injured by malpractice in this country file lawsuits, and the Johns Hopkins study assumed that 12 in 100 errors result in indemnity payments. Some people say only 3 in 100 such patients file claims. (Pop Tort refers readers to the Center’s resource, “Briefing Book, Medical Malpractice: By the Numbers.”)

As Pop Tort points out, the $1.3 billion paid out doesn’t include the additional health-care costs for the affected patients, most whom never file suit.

Although fining hospitals more severely for never events is a popular notion, Pop Tort proffers its own solution: “What if hospitals and medical societies stopped spending millions of dollars a year lobbying to limit the recovery to malpractice victims [see our post about malpractice “reform,”] and devoted that money instead to patient care? And how about a law that would double every jury award when a ‘never event’ caused the injury--a meaningful penalty where the money goes to the person actually injured (instead of a fine, where the money goes who knows where?) And stop demonizing injured patients and their attorneys. That would be a start.”

We applaud that approach, but more immediate solutions to the problem of never events, as the Washington Post noted, involve better hospital leadership and communication. “Hospitals that have implemented checklists have seen success in increasing communication between health-care providers. Others have reviewed their policies to see where patients might be slipping between the cracks, and made improvements that way.”

As the researchers wrote in Surgery, “We trail behind other high-risk industries that have used systematic approaches to successfully identify and reduce sentinel errors. Strategies used in other complex systems such as aviation may help provide a blueprint to examine both the individual and the institutional factors that contribute to these preventable and costly events.”

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November 1, 2012

Surgery Decisions Shouldn’t Be Larded With Conflicts of Interest

The health and medicine watchdog HealthNewsReview.org recently laid bare how regulatory absence can poison what’s supposed to be an objective, scientific analysis of the suitability of a surgical procedure.

In excerpting an article that has been accepted for future publication in Arthritis Care & Research, HealthNewsReview shows the wide cracks in how the FDA approves some medical devices. Known as the 510(k) expedited review process, the exercise allows certain devices to be approved for sale “without formal testing in clinical trials as long as they confer low or moderate risk to patients and are structurally similar to a previously approved device.”

We’ve examined how devices are approved by the FDA, and how nonsensical the 510(k) process can be. On its face, an expedited process has merit. Many people otherwise without treatment for their medical problems can receive relief faster when bureaucracy gets out of the way. But speed doesn’t always result in good medicine.

As the journal article points out, a “previously approved” device might have been approved under 510(k), “leading to daisy chains of approved devices going back for decades, most of which have not undergone rigorous premarket assessment in human subjects.”

And lax regulation invites conflicts of interest. Using a hypothetical example, the writers demonstrate how, because surgeons have few constraints on their choice of medical device, “many are able to decide for themselves when they wish to begin using newer models.”

In the authors’ scenario, a surgeon, Dr. Jones, reviews a total hip replacement procedure with the patient, a man in his 50s. Dr. Jones makes sure he understands his options, and the patient signs the surgical consent form. Everything seems kosher but, although the risks and benefits of total hip replacement were detailed, shouldn’t the patient have participated in the decision about which implant device to use?

The authors say that without regulatory demand, not all the evidence must be presented that would fully inform the patient about technical considerations and the surgeon’s personal beliefs and possible conflicts of interest.

What if Dr. Jones has received consulting fees from the manufacturer of one of the devices under consideration? As the authors note, “Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

Doesn’t the patient deserve to know that?

Doctors with financial interests in medical devices aren’t limited to orthopedics—the industry is rife with cross-pollination of science and commerce in all manner of devices and drugs. Among the most active players are pharmaceutical manufacturers and the doctors they pay for research, consulting, speaking, travel and entertainment to (see our post).

Patients can’t make a fully informed decision about surgery unless they’re offered a clear, complete picture of all aspects of the procedure. To that end, the article authors suggest that for their hypothetical hip-replacement, “the informed consent process … be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values.”

Yes, it’s challenging. But it’s necessary and only fair, for this and any surgical procedure.

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October 28, 2012

Hospital Studies Reinforce the Need for Consumer Savvy

Two studies about how hospitals care for patients confirm the wisdom of researching the facilities where you’re considering having an inpatient procedure, and for enlisting a strong patient advocate to act on your behalf once you’ve been admitted.

In our Better Health Care newsletter, we've addressed how to find the best hospitals and the importance of having someone to protect your interests while you’re hospitalized.

As reported on ScienceDaily.com, patients treated in “magnet” hospitals—or those recognized for their nursing excellence—recorded lower death rates than those in nonmagnet hospitals. The study, by the University of Pennsylvania School of Nursing, involved four states and 564 hospitals. The designation of “magnet” is conferred by the American Nurses Credentialing Center, and recognizes high-quality patient care, advanced nursing education and nursing innovation.

Approximately 400 U.S. health-care facilities are recognized as magnet hospitals, or about 8 in 100. The University of Pennsylvania study studied hospitals in California, Florida, Pennsylvania and New Jersey, representing more than 20 in 100 annual hospitalizations. Nearly 100,000 registered nurses were included in the study, which was published in the journal Medical Care.

Researchers analyzed data from 56 magnet and 508 nonmagnet hospitals with a focus on differences for surgical patients in the odds of mortality and “failure to rescue.” That term indicates measures taken to prevent adverse events, such as hospital-acquired infection, cardiac arrest, shock, etc. According to the Agency for Healthcare Research and Quality (AHRQ), this measure can signal the quality of monitoring, the effectiveness of actions taken once early complications are recognized, or both. The Pennsylvania researchers determined that magnet hospitals had 14 percent lower odds of death, and 12 percent lower odds of failure to rescue.

The study’s authors concluded that “Magnet recognition identifies existing quality and stimulates further positive organizational behavior that improves patient outcomes.”

Another study of interest to potential hospital patients was reported in the Annals of Surgery. It suggested that medical mistakes often are made during the postoperative care of patients who have undergone major elective surgery, putting them at risk for serious complications. Researchers found that patients at teaching hospitals routinely experience as many as five procedural mistakes during their recovery.

The most common of these errors are receiving the wrong drugs or drugs delivered the wrong way, and being given incorrect instructions, test results or diagnoses.

According to a story on Aboutlawsuits.com, more than half of what are known as “process failures” result in serious harm to patients; most, it appears, can be prevented.

The study was unusual in that its focus was what happens after, not during, surgery. The researchers investigated a large gastrointestinal surgery center and observed patients from the day after surgery until they were discharged. In 659 days of observed post-op care, there were 256 process failures. In more than 8 in 10 of those cases, the failure was preventable; in half of the cases, patients suffered harm as a result of the failure.

“Interventions to prevent process failures will improve the reliability of surgical postoperative care,” the study authors concluded, “and have the potential to reduce hospital stay.”

To find a magnet hospital, check out the resources of the American Nurses Credentialing Center.

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October 20, 2012

Starting a Dialog between Attorneys and Surgeons about Medical Malpractice (Part 2)

This is part 2 of my talk to the American College of Surgeons about medical malpractice and how attorneys for injured patients can work together with organized medicine to make for better, safer care (and fewer lawsuits as a result). (Click here for part 1.)

I want to tell some very short stories about clients of mine where we had to bring malpractice lawsuits against their surgeons. You see the view in these kinds of symposiums from 40,000 feet. Here is the view from sea level.

Mike Wood, backhoe operator:

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Mike Wood lost the median nerve controlling his left hand when a surgeon talked him into doing a procedure to open a blocked subclavian artery (under the shoulder blade) that was causing absolutely no symptoms. Instead of the standard approach through the groin or elbow, for percutaneous balloon access, the surgeon chose his own technique through the brachial plexus, cutting down through the tissue in the armpit, retracting the nerves, putting a catheter in the brachial artery and going upstream to unblock the subclavian. Mike Wood woke up in intense pain in the hand and he couldn't use first three digits. Another surgeon six weeks later found the median nerve swollen and dead in brachial area – a few millimeters from the suture that marked where the artery had been penetrated, and the area of damage matched the width of the retractor that must have pulled too hard and too long on the nerve.

Two vascular surgeons testified in defense at trial. They could cite no literature advocating the brachial plexus cut-down for what was supposed to be a non-invasive percutaneous (through the skin) balloon procedure, and they could cite no one they knew who did it this way. Nor did they unblock subclavian arteries this way. But they told the jury it was still OK.

They also testified about the indications for surgery. Despite the lack of any symptoms, and the lack of any support in the surgical literature for doing this surgery when the patient has no symptoms of pain in the arm or dizziness from the arm trying to grab blood flow from one of the arteries going up the back of the neck to the brain, they also said surgery was absolutely okay to do because of the possibility of future symptoms.

To me, Mr. Wood's case shows hows how overwhelming the case must be to win. And how the defense even defends the indefensible.

Another case: Jaime Vargas, bus mechanic:

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Gall bladder removal: The surgeon cut off the common bile duct (the connection from the liver to the intestines), failed to recognize what he had done for two days, and worse, he did his own roux-en-Y repair and made the arm going to the liver so short the patient got a series of infections in the new bile duct, eventually destroyed the liver and he died.

The surgeon had no explanation for the initial injury: Still, the case was defended by two surgeons, who said the operator had done nothing wrong in failing to convert to open surgery or failing to do x-ray of the bile ducts to make sure he was cutting in the right place. Eventually this case settled shortly before trial, but only after Mr. Vargas had died from liver failure.

One more quick example: Billy Boone, home builder:

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An ENT did surgery to clean out a benign growth behind his ear from his mastoid cavity, called cholesteatoma. Seventeen years before, another surgeon had done the same surgery, and had left a small hole in the base of his skull, but no injury. In the new surgery, the surgeon stuck an instrument through that hole into the base of his brain's temporal lobe. The operative report was silent about this. Only evidence was a CT scan two days post-op, done after patient complained of trouble reading the newspaper and retrieving names of close friends. CT scan showed a pencil diameter tract of air going from the base of the skull into the brain parenchyma, surrounded by a pool of blood.

The defense strategy was deny and defend. They couldn’t really say what had happened, but it had nothing to do with the surgery.

We won the trial, but the case went all the way to the highest court of Maryland. [Blog readers can find the decision here.]

I'm proud to say we made new law in Maryland for patients: giving them a right to know up front if their surgeon lacks experience in the type of surgery he proposes to do.

The Wood, Vargas and Boone cases had this in common – lack of experience by the surgeons.

Dr. Goldberg was a general ENT, not a neuro-otologist, no experience in revision mastoidectomies.

Wood’s surgeon was a cardiothoracic surgeon, not vascular, and had done this procedure once or twice before.

Vargas’s surgeon had been trained in the era of open gall bladder surgeries and was doing this laparascopically, which he had done maybe half a dozen before. More important, on the bile duct repair, he had done one previous in his entire life. A forty-five minute drive from this hospital was Johns Hopkins in Baltimore, which has full-time biliary surgeons who would not have made the basic error of the too-short roux-en-y arm that killed the patient.

American medicine has financial incentives that encourage inexperienced surgeons to not refer patients to better qualified surgeons. In fee for service medicine, the surgeon loses any fee if he refers the case out.

One legal reform could go a long way toward fixing this. If surgeons were employees of their hospitals, and not independent contractors, the employer would have both the muscle and the financial incentives to better supervise individual practitioners. It’s called enterprise liability.

• Enterprise liability: make the hospital (clinic, HMO, etc.) liable for everyone practicing within their institution, even “independent contractors.” This provides an incentive for meaningful peer review, meaningful institutional guidelines and enforcement. Lowers litigation expenses – one defendant, one set of attorneys. It also allows for more equitable spreading of the costs of insurance: instead of high-risk specialists being personally on the line for insurance premiums, the hospital can decide how to fairly allocate the costs of its coverage for all members of the surgical staff.

• Enterprise liability is already the rule in military and veterans’ health care. In fact, individual surgeons are immune from lawsuit. The patient must sue the federal government as the sole defendant.

Outside the government, medical practice is becoming more corporatized. Here in Washington, D.C., Johns Hopkins now owns two of our major hospitals. George Washington University has been buying up doctors’ group practices. Enterprise liability fits into a trend that’s already happening.

• A related concept is enterprise notice. Avoid patients having to sue all providers by letting them put on notice everyone, stop the statute of limitations clock, and add defendants later if discovery shows them to be culpable.

Let me turn to some of the other legal reforms you have been talking about today.

Here is one program that trial lawyers like me have no problem with, as long as it’s done in an even-handed and fair way. That is: Early offer/apology programs, or what I call "be open and honest with the patient."

Here are the essential elements I see for fairness in an early offer/apology program:

• Mandatory participation of all hospital staff, including non-employee physicians, in any apology program. Why? If not, patient who knows this is an “early offer/apology” hospital might think that failure to be approached means whatever happened to them was not a preventable compensable error.

• Right to hire own attorney: Advise patient in writing before any meeting. Encourage lawyer presence. No signing away legal rights without consult from independent counsel. Why? This is not a “full employment for lawyers” program but simply an evening of the scales concept. The hospital will have its own legal counsel, whether present in the room with patient meetings, or just behind the scene. Patients need their own counsel. Period. Any counsel must be completely independent from the hospital, not on any ‘favored attorneys’ list. This will ultimately protect hospital from later accusations of undue influence or fraud.

• Protect apologies from use in court but not facts of what went wrong.

• Stop clock on legal deadline for filing suit till end of talks between hospital and patient.

• Offer fair compensation.

• No penalties for patients who decline early offers.

This follows my simple litmus test: what would you want for a family member hurt by another medical provider that you’re not connected to.

Bottom line on early offers: Your institutions can do all of this now. You don’t need any laws passed to be open, honest and fair with your patients.

Let me speak to a couple of other reforms you have talked about today:

First, clinical practice guidelines, which you are calling "safe harbor" provisions.

• What you may not know is: We already use these in court, and the current system works well: Practice guidelines can be admitted into evidence by either side, with a sponsoring expert to explain. This is the rule under Federal Rule of Evidence 803-18 and similar rules in all states I know of except Minnesota.

• Allowing practice guidelines as “evidence” but not conclusive lets both sides explain to the fact finder why the guideline should or should not be given weight, based on:
– Relevance to this patient.
– Bias and conflicts of interest in the formulation of the guideline.
– Scientific evidence for the guideline.
– Guidelines that are conflicting, vague or otherwise wrong for this patient.

• The proposal for "safe harbor" guidelines as a One-way street – guidelines can exonerate but never implicate a doctor’s liability – is obviously unfair. You wouldn’t want that for a family member injured by medical care.

• If medicine really requires customized attention to individual patients, then guidelines will never be conclusive. If guidelines were conclusive in actual medical practice, that would turn doctors from the thinking professionals that they are now, into mere technicians. So why would you want conclusive guidelines in law that you would not want in medical practice.

• Last point on practice guidelines: I challenge people to show me a case where a doctor proved adherence to a relevant clinical guideline and still lost the case. I would not prosecute the case against that doctor and doubt if any sane colleague would.

Finally, health courts. I’ve already mentioned that having schedules of injury payments is a bureaucratic style solution that does not fit the way we typically work in America. Other problems:

First, there is no evidence of any unfair tilt in the current system toward patients. Quite the opposite.

Why does it happen over and over that indefensible cases go all the way to trial and even appeal, as in the cases of Mr. Wood and Mr. Boone.

Are juries biased? Absolutely yes. But not the way some of you might think. I wrote a book a few years ago about how patients can get better medical care so they never need the services of lawyers like me. And towards the end of the book – after I detailed a lot of common sense ways that patients can better participate in their own health care and improve its quality – I had a short passage about jury trials that I’m going to boil down here:

Seven studies over the past three decades have compared the outcome of jury trials with the private evaluations by the insurance company of their own doctors’ performance. The studies have been remarkably consistent: Even where doctor reviewers have rated the medical care “indefensible” or “poor,” plaintiffs win at trial no more than 50 percent of the time. When the doctor reviewers have rated the care “defensible,” the juries overwhelmingly agree, and vote for the defendant doctors 80 to 90 percent of the time. When different reviewers disagree about the quality of the care, and so the case is rated “unclear” or “a tossup,” the defendants still win around 70 percent of the time. Note the logical pattern in the research: As the evidence of negligence becomes more clear, the victim win rate goes up. But it almost never gets higher than 50 percent, even in the “indefensible” cases. Juries have a very heavy thumb on the scales of justice favoring the doctor defendant.

How are “indefensible” cases defended? For starters, juries never hear about the “indefensible” evaluations. Those are tucked into a very private file back at the insurance company headquarters. A skilled lawyer is hired to defend the case and is set loose to find an expert witness willing to defend the care. … the jury never hears about the turn-downs. For all the jury can see, the plaintiff has an expert, and the defense has an expert, and they’re both pretty glib, and so the benefit of the doubt goes to the doctor, who, after all, was only trying to help his patient.


So those of you who want to do away with juries and have professional fact finders or even “health courts”– just a friendly word of advice – be careful what you wish for. Any reasonably neutral decision maker will return verdicts for patients far more often than happens in our current 50 state system. You might want to look at what happens in federal courts with life-appointed judges from both political parties, who decide malpractice cases without a jury in lawsuits against government hospitals like the Veterans hospitals and military hospitals. The plantiff’s win rate before judges is considerably higher than for malpractice cases tried to juries, according to the U.S. Bureau of Justice Statistics.


More problems with health courts:

• First: Shift from negligence to preventability as the legal standard solves no problems. Fault is embedded in the idea that the harm could have been avoided. If we compensate all harms in hospitals, even non-preventable ones, the system loses all connection to accountability for doing poor job.

• Second: Who are we trying to help? Shouldn’t it be the patients who suffered the worst harms? Why would we shift to a system that in essence reduces payments to worst injured in order to fund payments for lesser injured? Patients with minor injuries can take care of themselves. It’s the crippled, maimed, paralyzed, brain-damaged patients, and family members of those killed, who need a system that tries to bring some measure of justice to what’s happened to them.

Let me wrap up:

I started this talk with the idea that both the leadership of surgeons and patient advocate attorneys want the same thing: to improve safety, reduce medical errors and have fewer injured patients knocking on my door and other attorneys.

We know that concerted safety reform efforts can have a dramatic impact on lowering malpractice payouts. Look at this slide that shows what happened at New York Presbyterian Hospital when they had a multi-year effort to reform the safety of their baby deliveries.

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This is from a study published in 2011 in the American Journal of Obstetrics and Gynecology.

They not only dramatically cut their payouts, more important, they had a lot fewer “sentinel events,” which means many more healthy babies.

This is just one program in one hospital. Safety reform is something you can do even without the cooperation of the plaintiff’s bar. If you don’t like lawyers, that could be your best revenge, by making medicine safer and cutting down on our business.

To me and attorneys who do the kind of work I do, the statistics are stunning, but numbers themselves are not really the point. (Here are a few more pictures of my clients. There are many more.)

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The point is that these are real human beings.

There are many more patients and many more stories just like these.

Their lives were broken by preventable medical events.

They need to be treated honestly and fairly by our compensation system.

They want us to pay it forward. To help make sure the same thing doesn’t happen to other people.

That’s the challenge for your and my professions.

(Click here for part 1 of my talk to the surgeons.)

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October 20, 2012

Starting a Dialog between Attorneys and Surgeons about Medical Malpractice

I was honored to be invited to speak the other day to a leadership conference of the American College of Surgeons about medical malpractice. They assured me I could leave my bullet-proof vest at home, and true to their word, the assembled surgeons were cordial and asked excellent questions. Even better, they told me how helpful it was to hear from an attorney for injured patients and how they plan to do it again.

I spoke about how patient safety efforts could make for better care and greatly reduce the need for patients to come calling at my office. And I highlighted how the surgeons, mulling over possible "reforms" in the civil justice system in how malpractice cases are decided, ought to consider what I said should be the litmus test of fairness:

Is this reform something you would advocate if the tables were turned, and instead of speaking for doctors you were advocating for a family member injured by care at some medical institution other than your own?

Here are excerpts from my talk:

I feel honored to be here. You might see me as an adversary. After all, I have sued many of your member surgeons. In fact, I think we are natural allies. And I think the more we recognize how closely allied the leaders of the American surgeons are with attorneys who represent injured patients, the better we can make progress in our shared goals.

What do we both want? Your profession and mine both want high quality surgical care for all patients – where the right patient gets the right operation at the right time, done in the right way, by the right surgeon.

We both know that ideal cannot always be met. When things go wrong, when patients get hurt through no fault of their own, when looking back we can see the patient’s injury was entirely preventable, then I hope that we share two more goals:

First, to learn lessons so it doesn’t happen again – so the individuals involved in causing the harm are held accountable if they’ve done something wrong, and to hold the system accountable if it’s done something wrong, and to fix it. That means retraining, educating, coming up with new checklists and protocols. Malpractice cases can provide a powerful tool for re-education and reform. Injured patients know this already when they come see people like us. I hear so many of them say: “The money is not so important. I just don’t want the same thing to happen to somebody else.”

Second goal: to fix the harm to the individual patient. In the kinds of tragic injuries that I and other patient advocates work with – the patient’s health cannot be restored. So our civil justice system uses money as a poor but necessary substitute – to compensate the patient with money for what cannot be replaced in kind.

“Compensate” comes from a Latin word meaning: to weigh one thing against another – literally to balance things out. That’s what justice does.

Yours is an ancient and esteemed profession. Every day, surgeons across America cure disease, relieve pain, and make lives better.

I see what we attorneys for injured patients do as another form of healing – helping to restore broken lives to some measure of independence and dignity. Helping to balance things out.

Part of the legal healing process that health care providers should want to encourage is restoring the patient’s trust in their own doctors and nurses. Trust is a vital ingredient in health care. When injured patients are treated fairly in the legal system, it helps restore their trust.

...

About our American civil justice system, I feel the same way that Winston Churchill felt about the democratic form of government: Democracy, he said, is definitely the worst form of government … “except for all those other forms that have been tried from time to time.” Likewise, the civil justice system is easy to criticize. It’s too expensive, it takes too long to reach resolution, it can be emotionally difficult on all the participants.

But it’s not broken. And like other democratic institutions, nothing better has been invented for the fair resolution of disputes. Our system is fair to the participants, in several fundamental ways. I can think of at least three.

First, our justice system is even-handed. The same rules apply to both sides.

Second, our justice system respects the uniqueness of each human litigant. There are no pre-fab boxes that people are stuffed into. On the patient’s side, that means you get to try to prove the full dimensions of the injury, with no artificial barriers like one-size-fits-all damages caps, or set schedules of payments like so much for an eye, so much for a brain. On the health care provider’s side, it means proving what was unique to the care in your case that might justify the care and explain the injury.

Third, our justice system respects and maximizes the freedom of the litigants. Each side runs its own lawsuit. Each litigant hires whatever lawyer he wants, pays him whatever they negotiate, hires whatever expert witnesses they want, and then they present their cases in a courtroom presided over by a professional judge trained in neutrality, and usually decided by a jury drawn from a cross-section of the community.

[To be continued in my next blog post; click here to read it.]

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October 9, 2012

Leaving Tools Inside the Patient after Surgery

Even when surgery is necessary, it’s scary. Common patient concerns include anesthesia, operating on the wrong body part, infection, and surgical stuff left inside your body after you are closed up. All these prospects are fairly remote, except for the risk of infection. But then you read a story like the one recently published in the New York Times and you wonder if you’ll ever consent to being cut open.

Four years after undergoing a hysterectomy, Sophia Savage experienced extreme pain and vomiting. A CT scan found that a surgical sponge, an artifact of her hysterectomy, had lodged in her abdomen. She underwent another operation to remove it, but it had adhered to her bladder and other viscera, and caused an infection that required the removal of a large segment of intestine.

Savage sued the original hospital and won $2.5 million in damages. But that award has been appealed, and her health has declined seriously. Unable to work, Savage has bowel problems, anxiety and depression. It’s a sad coincidence that nursing was her own former profession.

According to The Times, 4,000 cases of so-called “retained surgical items” occur every year in the U.S. Most of the items left behind are the gauzelike sponges used to absorb blood. A long operation might require dozens of them.

Failing to remove these infectious time bombs, experts say, is the result of surgical teams using a clunky method to account for their use. Usually, a surgical nurse keeps a manual count of sponges used, but an OR can be chaotic, and it’s easy to miscount. In 4 out of 5 cases in which sponges were left behind, the surgical team had declared them all accounted for.

Despite efforts by groups such as the Association of periOperative Registered Nurses and the American College of Surgeons many hospitals, The Times says, haven’t updated their procedures.

So patients are left at risk, Dr. Verna C. Gibbs, professor of surgery at the University of California, San Francisco, told The Times.

“In most instances, the patient is completely helpless,” said Gibbs, who is also the director of NoThing Left Behind, a national surgical patient safety project. “We’ve anesthetized them, we take away their ability to think, to breathe, and we cut them open and operate on them. There’s no patient advocate standing over them saying, ‘Don’t forget that sponge in them.’ I consider it a great affront that we still manage to leave our tools inside of people.”

Although sponges account for about 2 in 3 retained items, post-surgical patients are carrying around all sorts of stuff: clamps, scalpels, even scissors. But they’re easier to spot in a surgical cavity than balled-up, blood-soaked sponges, which are more likely to be left behind during abdominal operations and in overweight patients.

Technology to the rescue! Sponges can be tracked via radio-frequency tags, which are about the size of a grain of rice. As reported on PubMed.gov, one study reviewed 2,285 cases in which sponges were tracked using a system called RF Assure Detection, which alerts the team at the end of an operation if any sponges remain inside the patient. In this study, 23 forgotten sponges were recovered from nearly 3,000 patients. The cost was about $10 per procedure.

Another tracking system employs bar code technology. Every sponge is scanned before use and again when it’s retrieved.

But as effective as electronic tracking can be fewer than 1 in 100 hospitals use it, Dr. Berto Lopez, chief of the safety committee at West Palm Hospital in West Palm Beach, Fla., told The Times. His advocacy of the technology comes from personal experience: He was sued in 2009 for leaving a sponge inside a patient. Two nurses had assured him that all sponges had been accounted for, but they weren’t. Now he won’t operate in any hospital that does not use electronic tracking.

Depressingly, Lopez believes hospitals resist electronic tracking because they don’t want to spend the 10 bucks.

But Gibbs, of NoThing Left Behind, believes technology should augment manual counting, not replace it. Some hospitals, she told The Times, use inexpensive “counter bags” in which each sponge has its own compartment. If a compartment is empty at the end of an operation, a sponge is missing. Then the electronic tracking system can help find it.

Gibbs also believes that counting sponges should not be the responsibility of only nurses: Everyone in an operating room must share accountability. “Technology is but an aid,” Gibbs told the Times. “The way that safety problems are corrected and fixed is by changing the culture of the O.R.”

If you or a loved one is scheduled for surgery, inquire about the hospital’s procedures about retained surgical items. The hospital’s patient advocate and/or your surgeon should be willing to discuss it. Ask if there is a technological tracking procedure as well as a manual count. If you are not satisfied with the response, you might consider other hospital options.

To read about some surgical mistakes that proved to be learning opportunities, see our blog “Medical Mistakes that Led to a Greater Good.”

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August 13, 2012

Hospitals’ Profit Soars on Wings of Unnecessary Heart Procedures

A disturbing story published last week in the New York Times raised anew questions about how profit sometimes is the primary consideration in performing medical procedures. Following a major hospital chain’s paper trail, The Times told a story of widespread overuse of cardiology resources with serious implications for patient safety.

In 2010, Stephen Johnson, the chief ethics officer of HCA, the largest for-profit hospital chain in the U.S, received a letter from a former nurse at a Florida hospital claiming that a doctor there was performing heart procedures on patients who didn’t need them. A two-month internal investigation confirmed the charge in a confidential memo by Johnson. The doctor was slapped on the wrist, but the nurse lost his job. That decision, Johnson said in the memo, was because he blew the whistle on the cardiologist.

“But the nurse’s complaint,” The Times reported, “was far from the only evidence that unnecessary — even dangerous — procedures were taking place at some HCA hospitals, driving up costs and increasing profits.”

According to The Times, Medicare reimburses hospitals about $10,000 for a cardiac stent—a tiny tube that holds an artery open. But recently, doctors have been less eager to implant stents, preferring drugs to treat blockages.

Another invasive test, cardiac catheterization, which Medicare reimburses at about $3,000, is used to diagnose blocked arteries. A long, thin, flexible tube (the catheter) is inserted into a blood vessel in the arm, groin, or neck and threaded to the heart, where it is used to inject dye into the heart's blood vessels to take x-ray pictures.

Even if necessary, these procedures pose a range of risks from infection, nerve damage, pain to death. Cardiologists generally don’t operate on coronary arteries unless they show at least 70 percent blockage. (See our story about unnecessary surgery here.)

Although The Times’ story focused only on HCA, a story published last week by ProPublica, an independent investigative organization, said that the practice of inflating the need for cardiac procedures is widespread.

ProPublica referred to a study published last year in the Journal of the American Medical Association that found that only half of 144,000 nonemergency heart catheterizations were appropriate.

"It's presented in the media as if it's an aberrancy, when actually it's the rule," Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine told ProPublica. "The medical system is addicted to the revenues that it generates."

Last year, Medicare spent nearly $1 billion on the procedures that boost revenues for doctors and hospitals but cost taxpayers, raise insurance premiums and put patients at risk—about 3 in 100 patients experience serious complication.

Since 2002, HCA itself had uncovered evidence that some cardiologists at several of its Florida hospitals were unable to prove the need for many of the procedures they were performing. To justify them, according to internal HCA documents, doctors wrote inflated medical reports to make it seem as though they were necessary.

Approximately half of one HCA hospital’s cardiac catheterizations—about 1,200—were deemed to have been performed on patients without significant heart disease, according to a 2010 confidential review.

At one hospital, a 44-year-old man who came to the emergency room complaining of chest pain suffered a punctured blood vessel and a near-fatal irregular heartbeat after a doctor performed a procedure that an outside expert later suggested might have been unnecessary. The patient had to be revived.

In another incident at the same hospital, a woman with no significant heart disease went into cardiac arrest after a vessel was cut when a cardiologist inserted a stent. She was hospitalized for several days.

Last month, the U.S. attorney’s office requested information on reviews assessing the medical necessity of interventional cardiology services provided at 10 of HCA’s hospitals. The Justice Department, according to the Associated Press, also will review billing and medical records at 95 HCA hospitals.

HCA declined to provide evidence that it had alerted Medicare, Medicaid or private insurance companies of its findings, or that it reimbursed them for any procedures the company determined had been unnecessary, never mind that such action is required by law.

HCA told The Times that it took the steps necessary to improve patient care, and that “significant actions were taken to investigate areas of concern, to bring in independent reviewers, and to take action where necessary.”

But HCA declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. And some of the doctors accused in the reviews of performing unnecessary procedures still practice at HCA hospitals.

How “significant” can its actions have been?

The Times reviewed hospital communications and concluded that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line.

Maybe that’s because HCA is less concerned about doing no harm than in recouping expenses for its chronic bad behavior. In 2000, HCA settled one in a series of huge Medicare fraud cases with the Justice Department that tallied $1.7 billion in fines and repayments, mostly concerning charges of overbilling.

Only two years after that fraud settlement, HCA started uncovering the “questions regarding the medical necessity of some of the procedures” that remain problematic.

Today, the surgeon who inserted a cardiac stent after the whistle-blowing nurse (and others) had seen no blockages in the images of the patient’s artery continues to practice at the same HCA hospital. This, despite the fact that an outside heart specialist found problems with 13 of the 17 cases the surgeon performed, including unwarranted cardiac catheterizations and patients who were needlessly subjected to multiple procedures.

To learn more about options for treating coronary problems, visit the website of the Informed Medical Decisions Foundation.

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July 30, 2012

Prostate Surgery Often Presents More Problems Than It Solves

Routine screening for prostate cancer has been in the news a lot lately, and attention was renewed recently when the U.S. Preventive Services Task Force recommended that the PSA test be canceled for most men. Those experts concluded that only one life is saved for every 1,000 people screened over a 10-year period, that the rate of false positives is high and the side effects of treating them and cancers that are growing so slowly as to present little threat are unacceptable.

A new study published in the New England Journal of Medicine looked at surgery for early-stage prostate cancer patients and concluded much the same, as reported in the Los Angeles Times. “Most patients diagnosed with early-stage prostate cancer will live just as long if they simply watch their cancers rather than have them surgically removed.”

The problem with surgery as the default response to early-stage cancer is that the side effects are often worse than the disease—specifically, wound infection, urinary incontinence and sexual dysfunction. The study did find a slight benefit of surgery for patients with higher risk early cancers, including those whose blood levels of prostate-specific antigen (PSA) measure above 10 nanograms per milliliter or who had larger tumors whose cells appeared abnormal.

But for most men, "The trial gives us results that we have been waiting for in urology for quite some time," Mark S. Litwin, chairman of the UCLA department of urology, told the L.A. Times. "It confirms many of the recent reports that men with prostate cancer, by and large, can be safely managed with close monitoring."

That’s known as “watchful waiting,” and it’s rapidly being accepted as best practice for most patients with prostate concerns.

About half of the study subjects, who were tracked for about 10 years, died during the course of the study. Most of those deaths were not from prostate cancer, the authors noted, reinforcing the notion that more men die with prostate cancer than from it. Prostate disease affects 1 in 6 men.

The likelihood of death from any cause was the same for patients who had surgery and those who didn't.

Because only 1 in 10 of the study participants was younger than 60, its conclusions don’t necessarily apply to them. So for young patients, the jury is still out.

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April 29, 2012

Risk of Lethal Blood Clots Increases in Same-Day Surgery

Outpatient surgery is an increasingly popular medical option, thanks to the cost of inpatient care and the expanding capability of outpatient facilities. More than 6 in 10 surgical procedures are conducted on a same-day-to-home basis. They include operations for cancer, orthopedic and gastrointestinal problems and plastic surgery.

But as we recently wrote in a related post, ambulatory care centers lack the rigorous oversight that is standard protocol for hospitals.

Now, a new study published in The Annals of Surgery raises the flag of concern that outpatient procedures carry a higher risk of life-threatening blood clots than similar inpatient care. Hospital patients undergoing surgery generally are apprised of the possibility of venous thromboembolism (VTE), and how to thwart it. VTE is a blood clot that forms within a vein, usually in the calf in an immobile leg. It's potentially lethal because it can migrate to the lungs (pulmonary embolism, or PE) and impede the ability to breathe, sometimes fatally.

Unlike inpatients, people who under go outpatient surgery often are not warned to watch for signs of VTE, according to the study’s authors. Less than half of outpatient centers have VTE prevention guidelines. Worse, the study showed, even fewer adhere to them.

Approximately 300, 000 Americans die each year from PE each year, most because of a failure of diagnosis rather than unsuccessful treatment. Surgical patients and their caregivers must be aware of VTE symptoms in order to neutralize the threat.

Researchers analyzed a national registry of more than 200,000 outpatient surgeries across the country to design a paradigm to predict a patient’s risk for VTE. Their study showed that 1 in 84 patients at highest risk suffered a dangerous blood clot after surgery. It’s well-known that vein surgery and arthroscopic surgery boost the risk for VTE. Other risk factors include:


  • advanced age;

  • obesity;

  • longer surgery;

  • pregnancy;

  • active cancer.


The more of these factors a patient presents, the greater the risk.

“[The] data are in stark contrast to provider and patient expectations that outpatient surgery is a low-risk event,” said Christopher J. Pannucci, a surgeon at the University of Michigan and the the study’s lead author. “It also underscores the importance of evaluating a patient’s individual risk factors as opposed to procedure-type alone.”

The study signaled the need for better screening and prevention of venous thromboembolism especially for people who are obese and/or older than 65. Researchers advised that the informed consent process for outpatient surgery provide clear information about the risk for developing VTE, just as such guidelines are routine for inpatient surgery.

If you are scheduled to undergo same-day surgery, ask for the facility’s patient guidelines for preventing blood clots. If it has none, consider getting treatment elsewhere, or at least consult with your doctor about how to prevent VTE. No one is immune from this potentially lethal but quite preventable condition.

Medical malpractice is a huge problem in blood clot management, as this article on our firm's website discusses. You can read patient safety tips on blood clot prevention in another article here, which talks about the key warning signs of blood clots in the legs, and different warning signs of clots that may have moved to the lungs.

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April 16, 2012

Da Vinci Robotic Surgery Racks Up More Trouble

It’s another episode in the continuing drama of technology lust. Device manufacturers love to market their new, advanced and invariably expensive wares, hospitals love to leverage them for marketing and bill-enhancement, and doctors love them like middle-schoolers love the latest version of the iPad.

But the Da Vinci Surgical System continues to rack up a troubling record of patient harm. The robotic device, used in a variety of surgical procedures, enables surgeons looking at 3-D images through eyeholes to maneuver multiple arms with a joystick and perform surgery through tiny incisions. We’ve raised previous concerns about Da Vinci, and its most recent problem reports involve accidental tears and burns to internal organs, according to AboutLawsuits.com. Some of these adverse effects require multiple surgeries to repair, and some its patients have died.

Intuitive Surgical Inc., which manufactures Da Vinci, promotes the robot’s treatment of bladder, colorectal, gynecologic, kidney, prostate and throat cancers. It’s also marketed for coronary artery disease, endometriosis, heavy uterine bleeding, kidney disorders and obesity.

Questions about whether surgeons are being trained adequately in the use of the machine, and whether the higher cost of using it is worthwhile, are growing louder. A recent report by the Office of Medical and Scientific Justice joined the chorus of concern.

Da Vinci is complicated, and the journal Reviews in Urology said it can take 200 cases for some surgeons to become proficient with robotic surgery. Often, patients experience inferior outcomes while their doctors are scaling this learning curve. Some surgeons, the journal reported, simply don’t have patient volume sufficient to master the technique.

At a cost between $1 million and $2 million, the machines are used by hospitals to gain competitive edge, and surgeons may feel pressure to employ Da Vinci before they’re ready. In fact, the Journal of Clinical Oncology suggested that the increased cost of this technology over that of a traditional hysterectomy did not bring a noticeable benefit. The journal also said that women treated for endometrial cancer had about the same complication rates through traditional laparoscopy as they did with Da Vinci surgery, but that Da Vinci cost about $1,300 more.

Lawsuits prompted by the most common problems involve tears and burns to blood vessels, intestines and reproductive organs, complicated by the fact that problems generally aren’t apparent until after surgery, resulting in delayed treatment.

One lawsuit concerns a woman who suffered an artery burn during her hysterectomy. That prompted blood to pump directly into her body cavity, requiring three subsequent emergency surgeries. She died a couple weeks after the initial surgery. The lawsuit claims that Intuitive Surgical failed to adequately research the device or warn patients and the medical community that its use comes with substantial risk of complications and injuries.

Is Da Vinci defective? Is it defective only in less than skilled hands? Is it defective only for some applications?

Maybe lawsuits will answer these questions, maybe not. In the meantime, find out if there is a safer, equivalent means of performing your surgery. If your surgeon is adamant about using the device, ask how many such procedures he or she has performed. Ask how long the hospital has owned the device, and if you can see adverse reports about it. Consult the Manufacturer and User Facility Device Experience (MAUDE), a public database of voluntary reports of adverse events involving medical devices.

Just because your surgeon, your hospital and a manufacturer are excited about technology doesn’t mean it works for everyone.

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April 11, 2012

Ambulatory Care Facilities Lack Safety Scrutiny

Most people are aware of the increasing scrutiny of hospital performance in terms of patient safety. Better infection control and attention to readmission rates are among the criteria by which hospitals are measured and, in the case of Medicare, sometimes reimbursed.

But ambulatory facilities don’t fall within traditional hospital oversight, and a recent post on KevinMD by David B. Nash, dean of the Jefferson School of Population Health at Thomas Jefferson University, might raise some helpful consciousness about standards of care at these increasingly popular medical providers.

Ambulatory care facilities provide a range of medical services, including surgery, to outpatients who don’t require overnight care. (See our article, “Same Day Surgery.”)

We reported about one study concerning ambulatory surgery centers, but Nash invokes a report in 2000 by the Agency for Healthcare Research and Quality (AHRQ) noting that very little research actually has been done on medical errors and injuries in ambulatory settings. The AHRQ report made 11 recommendations to stimulate care standards research for ambulatory facilities.

Twelve years later, Nash notes, “almost none” of the recommendations has been implemented. This matters, he says, because a disproportionate and growing number of Americans are receiving care in ambulatory settings. “According to the American Medical Association,” he writes, “300 people are seen in ambulatory settings for every person admitted to a hospital.”

How hospitals care for patients is easier to study than how ambulatory centers do because hospital patients remain hospitalized for a longer period of time. Medical errors such as incorrect medication or the wrong dose of medicine are more difficult to track if the patient isn’t there when the symptoms present or the mistake is realized.

Sharpening the focus on ambulatory quality and safety is challenging because, unlike hospitals, such facilities don’t employ risk managers, compliance officers and chief quality officers to ensure that rules are established and followed. But something must be done, Nash says, because the vulnerability of patients in ambulatory centers was made clear by a recent study of outpatient malpractice claims.

Nash doesn’t say where the study was published, only that in 2009, paid malpractice claims tallied 4,910 for outpatient care and 4,448 for inpatient care. The total amount was higher for inpatient claims, but 2 in 3 of the outpatient claims involved major injury or death.

For the most common outpatient claims:


  • 45 in 100 were for diagnostic problems;

  • 30 in 100 were for treatment problems; and

  • 14 in 100 were for surgical problems.


Nash summarizes the researchers’ recommendations to improve ambulatory patient safety.

1. Conduct a large national study on the epidemiology (the incidence, distribution and control of disease in a given population) of ambulatory patient safety using accepted tools to screen for errors and chart reviews to detect harm in large ambulatory care clinics.

2. Identify and pursue an early and easily achievable goal, such as timely follow-up of abnormal test results.

3. Engage patients, their families and community organizations in ambulatory safety improvement efforts.

4. Link the ambulatory safety agenda to high-profile inpatient safety initiatives; for example, in concert with the initiative for reducing hospital readmissions, emphasize and study the role of ambulatory care clinicians in ensuring patient safety before, during and after hospitalizations.

5. Foster the development of a national system of clinics and practices that function as ambulatory safety “laboratories.”

The AHRQ has earmarked $74 million to research ambulatory quality and safety via health information technology, which signals the importance of increased scrutiny. But patients must be proactive as well.

If you intend to seek care from an ambulatory facility, ask to see its infection control procedures. If it doesn’t have one, go elsewhere. Find out if the providers who will treat you are board-certified in their fields. Research the facility’s medical professionals on your state’s medical licensing board’s website to find any complaints that have been lodged (states vary in their ability to track this activity, and in their ability to organize it for public consumption).

If you’re having surgery, find out the status of the surgery center’s license and certification, which enforce standards of care; just because the surgery center looks clean and professional doesn’t mean it meets professional standards. State health agencies keep a list of licenses for same-day surgery centers.

Ask: Who is giving me anesthesia? What are his or her qualifications? Ensure this person is at least a qualified registered nurse anesthetist, even for sedation.

Of course, if your problem is an emergency you might not have time for advance research. But you should always ask questions and persist until you’re satisfied with the answers.

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March 20, 2012

Surprise! This Medical Bill Isn’t Covered by Insurance!

Before your gall bladder surgery, you did everything you were supposed to. You made sure the hospital, lab and surgeon were part of your insurer’s provider network. You cleared the time off from work. You completed all the preliminary lab tests. You bought some cool new pajamas, and brought your own pillow to the hospital.

No wonder you felt sick when you received a whopping bill for anesthesia because the anesthesiologist you never even met was an out-of-network provider.

A recent story from Kaiser Health News (KHN) recounted tales from a New York investigation of patients who had been stung by surprise bills for medical services they either thought they had cleared in advance or had no idea they had incurred. Add to this the fact that insurers are shifting a greater percentage of the cost for out-of-network services to policyholders, and you have a lot of confused, righteously angry people.

Some of the bills were for treatment in an emergency room and others were scheduled medical services, often at in-network facilities. Here’s a sampling:


  • A patient had gotten approval for an in-network surgery but received a bill for $7,515 because an out-of-network surgeon assisted.

  • A patient requiring reattachment of his finger at an in-network emergency room received a bill for $83,000 bill from the out-of-network plastic surgeon who attended him.

  • A surgical patient woke up to find that at least six doctors had signed the chart. None of the names was familiar to the patient, and all had charged for the exam/consultation while the patient was sleeping. Their fees were billed at more than $7,500.


What you’re billed depends on the type of insurance you have. Health maintenance organizations (HMOs) often cover much of the cost of care, but only for in-network providers. Preferred provider organizations (PPOs) generally pay a portion of in-network services and charge policyholders a considerably larger portion for out-of-network care. Some insurers base those payments on a percentage of Medicare rates, which generally are much lower than usual and customary averages. The consumer, of course, pays the difference.

To avoid the unpleasant surprise of an unexpected or unexpectedly large medical bill, do your due diligence in advance if your treatment is not an emergency (and, depending on its nature, possibly even then). Get confirmation from your insurance provider that the people and facilities providing your care are covered under your policy, and at what percentage. Ask your insurance company representative for ways you might be able to lower your costs, and if the company has an online “cost estimator” enabling you to get ballpark figures for both in- and out-of-network care.

Visit FAIR Health, a nonprofit organization with a national database of billed medical and dental services. Consumers can estimate and plan their medical and dental expenditures from averages derived from their Zip code, and learn how much is covered by typical insurance plans.

If you receive a medical bill you feel is unfair, contact your state’s consumer affairs department; many offer designated sites for medical billing complaints and resolution.

To avoid insurance and billing errors, see our recent post by linking here.

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January 4, 2012

Robot Surgery of the Prostate: No Evidence of Better Outcomes for Patients

Surgery with the da Vinci robot to remove a cancerous prostate gland is guaranteed to dazzle the patient with the high-tech wizardry of it all. Problem is the outcomes in side effects that can disable men after prostate surgery -- incontinence and sexual dysfunction -- are no better than with conventional surgery. And the robot costs a lot more.

The latest of several studies to reach the same conclusion about the robot being less than it's cracked up to be is published in the Journal of Clinical Oncology. The authors randomly surveyed men who had had either robot or traditional surgery and found that both had high rates of sexual and urinary complications, with no advantage for the robot.

Dr. Michael Barry and his co-authors questioned whether this might be a case of "gizmo idolatry," the tendency in medicine to adopt new and expensive technology before there is real evidence of improved patient outcomes.

We've written before on our patient safety blog about benefits of the robot being oversold. Another critical issue for patients is the experience of the surgeon; the robot takes a lot more practice to get up to speed and reduce complication rates than does ordinary surgery.

As health care journalist blogger Gary Schwitzer notes, the marketing of the surgical robot gets hyped even more by naive news coverage with headlines like:

* Robot doctor – surgery of tomorrow
* Da Vinci puts magical touch on the prostate
* Cancer survivors meet lifesaving surgical robot
* Robotic surgeon’s hands never tremble
* Da Vinci is code for faster recovery

Once again, the take-home for patients is: Don't be dazzled by technology. What you want is a surgeon with a proven track record. Ask pointed questions, and don't assume that machines work better than experienced hands.

Article first published as Robot Surgery of the Prostate: No Evidence of Better Outcomes for Patients on Technorati.

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August 18, 2011

Awake by Mistake During Surgery: a Patient's Nightmare

No surgical patient wants to experience, or remember, the details of their operation, and the drugs given to put patients to sleep generally work nicely to create a blank slate in the mind for anything that happened after the anesthesiologist told the patient to start counting backward. But not always.

As many as 1 in 100 patients reports afterward that he or she was awake during the surgery, and can recount details of what was heard that make it clear it wasn't a dream. The psychic injury is worse because the paralysis that accompanies anesthesia usually means that aware patients can do nothing to signal to the doctor that they can hear what is going on.

Sometimes these patients are psychologically traumatized enough (with post-traumatic stress disorder) that they end up in the office of a malpractice lawyer like me, asking if they have a legitimate claim against the anesthesiologist or the surgeon.

The answer to that question is "Probably not," according to the latest research.

The problem is that while anesthesiologists have a rough idea of which patients are at high risk, nobody knows how to guarantee, or even improve the odds, that "intra-operative awareness" will not occur.

A study published this week in the New England Journal of Medicine assessed two possible ways of cutting the risk of intra-op awareness. One involved monitoring brain waves. The other involved measuring the concentration of anesthetic gases being exhaled by the patient. The study found that neither clearly worked, although there were fewer reports of intra-op awareness in the patients whose anesthetic gas levels were monitored.

You would think that if someone is awake by mistake during surgery, it means they weren't given enough anesthesia. But you would be wrong, according to the experts. Despite decades of research, we don't know that much about consciousness and memory, and their relationship to general anesthesia. And the ability to figure out during surgery who might still be awake when they look asleep is surprisingly rudimentary.

Here's the conclusion of an editorial on the subject that was also published in the NEJM, written by Gregory Crosby, M.D., an anesthesiologist at Brigham & Women's Hospital in Boston:

Monitors are meant to supplement, not supplant, clinical decision making, and depth-of-anesthesia monitors that reduce complex neurobiology to simple numbers are no exception. It is unreasonable to expect any such monitor to unfailingly detect conscious awareness — a specific and still mysterious property of the brain and mind — and neither patients nor physicians should think otherwise. Notwithstanding this and other weaknesses of current devices, a window into the anesthetized brain, albeit a foggy one, may still be useful, in conjunction with information from other monitors ... as a generic, all-purpose index of the brain's response to powerfully sedating drugs. Whether these devices add value in this way remains to be seen, but when minding the mind during sedation and general anesthesia, a little insight into how the brain is reacting is apt to be better than none, especially if it challenges historical ways of gauging anesthetic depth and catalyzes the search for something better.

Article first published as Awake by Mistake During Surgery: A Patient's Nightmare on Technorati.

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July 22, 2011

Malpractice in the Operating Room: Who Is Responsible?

It was supposed to be a routine hernia operation. But then the surgeon ordered the anesthesiologist to give the patient a blood-thinning drug. The anesthesiologist, who wasn't familiar with the drug, injected the drug directly into the patient's i.v. line, as soon as the surgeon ordered it. That was a double mistake, and it started a cascade of consequences for the patient, who later became our law firm's client.

The legal issue in the medical malpractice lawsuit we filed was: Who was responsible for the misuse of the drug? Just the anesthesiologist, who should have known better than to inject the drug intravenously, and so soon? Or the surgeon too?

That issue was finally resolved this week in our client's favor. Here is what happened.

The too-quick use of the drug Lovenox, which was intended to prevent blood clots in the legs after the surgery, caused bleeding in the spinal cord, with permanent nerve damage for our client. The use of the drug was against the "black box warning" on the drug's official labeling, which said doctors should wait after a spinal anesthetic at least several hours, and also against the official policy of the Washington, DC hospital where the surgery happened.

The anesthesiologist settled out of court on the eve of trial and turned over to the injured patient the anesthesiologist's cross-claim for "contribution" against the surgeon.

The trial court then ruled, after a hard-fought trial, that the surgeon was jointly responsible with the anesthesiologist for the injury.

After a long battle, the District of Columbia Court of Appeals affirmed the trial court's ruling in all respects. You can read the decision on our firm's website here.

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July 18, 2011

Bad News for Surgical Mesh and a Drug Infusion Device

A couple of implantable devices recently received new scrutiny with negative results.

Medtronic issued a “medical device correction” about possible diminished battery life of its infusion pump, the SynchroMed II. The device is surgically implanted to deliver painkilling medication.

According to About Lawsuits.com, of 140,000 implants worldwide, 55 were reported to have reduced battery performance. Designed to last 84 months, some batteries failed as early as 48 months. Medtronic issued a caution about the problem in July 2009, and an update earlier this month. And in February, certain models of the SynchroMed infusion pump were recalled thanks to a defective design that could result in an overdose during refill.

Pump failure can result in the return of pain, can cause patients to experience drug withdrawal and, for patients with multiple sclerosis who receive the drug baclofen, can be life-threatening.

The SynchroMed II is not being recalled, nor is it recommended that it be removed. Patients who have the device and whose symptoms reappear, or who hear a device alarm should contact their doctors immediately. For additional information, call Medtronic Patient Services, (800) 510-6735.

For women with pelvic organ prolapse, in which urinary and/or sexual organs droop or slip out of place, surgery is sometimes indicated. The FDA warns that if surgical mesh, rather than stitches, is implanted to strengthen the vagina, the risk of complications including tissue erosion, pain, infection, bleeding and urinary problems is greater. (Sometimes the mesh is implanted through the abdomen, which is not subject to the advisory.)

According to MedPage Today, “the number of adverse events linked to the device has been increasing in recent years.” Between 2008 and 2010, five times as many such events were reported than between 2005 and 2007.

"The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh," William Maisel, M.D., M.P.H., deputy director of FDA's center for devices and radiological health, said in a statement. "Mesh is a permanent implant--complete removal may not be possible and may not result in complete resolution of complications."

Although the mesh often corrects the anatomical issue, after reviewing reports for a 14-year period of use, the FDA concluded that the greater risk was not accompanied by greater clinical benefit than nonmesh surgery. Its advisory was issued in advance of a committee meeting in September to examine the safety and effectiveness of surgical mesh for the treatment.

As quoted by the McClatchy-Tribune News Service, Diana Zuckerman, president of the National Research Center for Women & Families, said an advisory wasn’t strong enough. “The troublesome issue is how is that going to affect what actually happens to patients as long as this product is still on the market and widely available.”

If your doctor has advised surgery to correct pelvic organ prolapse, be sure to discuss the implications of both mesh and stitches.

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July 9, 2011

Gender Differences in Who Survives Abdominal Surgery

Generally, a gut-check is an informal, instinctive assessment. But researchers at the University of San Diego Health System took matters literally in studying the impact of gender in major gastrointestinal surgery. They found that women are more likely than men to survive the procedure.

Published in the Journal of Surgical Research, “The Battle of the Sexes: Women Win Out in Gastrointestinal Surgery” examines the major differences that affect treatment success, and aims to create new therapies that improve survivability of surgical patients.

“[M]edical outcomes could be optimized by tailoring therapies based upon each individual’s unique genetic make-up as well as other characteristics. Gender is among the most important traits,” said Carrie Y. Peterson, M.D., lead author of the study. Among the procedures that fell under her scientific knife: stomach, intestinal, liver and pancreatic surgeries.

“The results suggest that female hormones might enhance the immune system -- a process previously shown in animal models and also observed in trauma patients,” said Peterson. “Thus, there is a hope that negating the effects of testosterone or giving estrogen to male patients could be considered part of a treatment plan.”

Other factors that might contribute to higher survivability rates:


  • females have more elective operations;

  • females have surgery more often in teaching hospitals; and

  • when symptoms occur, females seek medical attention sooner than men.

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June 15, 2011

Time of surgery doesn’t affect heart/lung transplant outcomes

A study examining outcomes of heart and lung transplant surgery has concluded that patients fare essentially the same whether the transplants are performed during the day or at night. Two smaller previous studies – one on kidney transplants and the other on liver transplants – had indicated that patients tended to fare worse if the operations took place in the middle of the night.

The new study, published in the Journal of the American Medical Association, took into account all of the nearly 30,000 heart and lung transplants performed in the United States over 10 years. Researchers were surprised by the results, which indicated that, contrary to conventional wisdom, patient outcomes had little to do with the time of the operation or the fatigue of the surgeon. Rather, they seemed to hinge on the reliability of the surgical team.

Unlike surgeons in other specialties, cardiothoracic surgeons almost always work in the operating room with the same team of highly specialized anesthesiologists, nurses, physician assistants and technicians. The team’s familiarity with and constant repetition of the same complex steps — placing patients on bypass machines, performing certain intraoperative studies, even executing specific suture sequences — may be the key to ensuring consistent performance, whatever the time of day.

When performing a transplant, “the surgeon isn’t doing a complicated operation in the middle of the night with an anesthesiologist who usually staffs gynecology procedures and a nurse who works in the orthopedic operating rooms during the day,” says Dr. Ashish Shah, a co-author of the study and assistant professor of surgery at the Johns Hopkins University School of Medicine. “We need to think about doctors less like airline pilots and more like a part of a special forces military team. Those teams carry out complex tasks at a very high level and under less than ideal physiologic or environmental conditions.”

Source: The New York Times

You can read an abstract of the study here.

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May 30, 2011

Physician learns about hospital errors the hard way

Doctors who aren't directly involved in patient safety issues often sail through their careers without much awareness of how commonly errors and malpractice infect hospitals, clinics and medical offices. Then they become patients, and suddenly their world is turned upside down.

Itzhak Brook, M.D., has been a doctor for more than 40 years. He is an infectious disease pediatrician at Georgetown University Hospital in Washington, D.C. Then he got throat cancer a few years ago.

His cancer was successfully removed, but then it came back. He had to have his voice box -- the larynx -- removed, and the throat was reconstructed.

It was then that the errors began to pile up, or, as he puts it, “mistakes occurred at all levels of my care.”

Dr. Brook recorded these incidents before, during and after his surgery:

* Surgeons had failed to timely diagnose the recurrence of his cancer. It was finally observed by an astute resident via a basic procedure that allowed visualization of the pyriform sinus, which was where his tumor was located. Had his experienced surgeons done the same basic procedure, his tumor most likely would have been observed and removed much earlier.

* Surgeons mistakenly removed scar tissue instead of the cancerous lesion. A week after the surgery, pathological studies revealed that the tumor was actually farther down in the pyriform sinus. This error could have been avoided if frozen sections of the lesion itself, not just its margins, had been analyzed in the operating room. As a result, he had to undergo additional surgery to remove the tumor, which was more difficult because of swelling and changes to the surgical site due to the original operation.

* While still in the ICU one day after surgery, he experienced an airway obstruction and couldn’t find his call button, which had fallen on the floor. Though he was only a few feet away from the nurses station, he was unable to get the attention of staff but was ignored. (He couldn’t call out because he no longer had a larynx).

* In what was probably the most serious error, he was fed soft food by mouth far too early, which, following laryngectomy with flap reconstruction, can lead to failure of integration by the flap. It took 16 hours before the feeding was stopped, and only after Dr. Brook brought this to the attention of a senior surgeon. The error occurred because the order to start feeding was in fact intended for another patient.

In addition, nurses and other staff:

Did not clean or wash their hands.

Did not use gloves.

Took oral temperature without placing the thermometer in a plastic sheath.

Used an inappropriately sized blood pressure cuff (which produced alarming readings).

Attempted to administer medications by mouth intended to be given by nasogastric tube.

Dissolved pills in hot water and fed them through the feeding tube (thus irritating the esophagus).

Delivered an incorrect dose of a medication.

Connected a suction machine directly to the port in the wall without a bottle of water.

Forgot to rinse the hydrogen peroxide used for cleaning the tracheal breathing tube (causing
severe irritation).

Did not write down verbal orders.

Fortunately, despite all these errors, Dr. Brook did not suffer any long-term consequences. Still, his experience made him realize that a hospital is the least safe place for patients, and that all hospitalized patients should have a dedicated patient advocate such as a family member or a friend at their bedside.

Dr. Brook writes extensively about his experiences as a throat cancer patient on his blog. He also lectures to medical groups to try to get doctors and nurses to understand the human costs of the epidemic of medical error.

You can also read Dr. Brook’s account of his hospital experiences in the Journal of Participatory Medicine.

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May 5, 2011

Laser Spine Surgery: Promises Too Good to Be True

It's a new story but an old story too: For-profit spine surgery centers recruit patients with promises of relieving their long-standing back pain with tiny cuts and high-tech lasers. Then comes a string of malpractice lawsuits from patients crippled by the surgery. Then the journalists mount the evidence: Big profits, many operations, little scrutiny from state or federal health regulators, and no evidence the high-tech stuff even works.

Bloomberg News just published this expose of malpractice issues at the Laser Spine Institute, which has surgery centers in Philadelphia, Tampa, Scottsdale and Oklahoma City.

One problem for patients is that there's no FDA for surgeons. Unlike drug companies which have to show scientific evidence that their products work, surgeons can make promises to patients about minimally invasive surgery and show testimonials from satisfied customers that make it all sound irresistible, even with no real scientific proof that their high-tech stuff works any better than what other surgeons offer.

The laser part of the surgery merely substitutes the laser beam for what other surgeons would accomplish with an electrical current. In both cases, the idea is to burn off sensitive nerve endings between the vertebrae. The problem is that no matter what device does the burning, the pain relief tends to be short-lived as the nerve endings grow back.

The other part of the typical surgery at Laser Spine Institute involves removing some of the bones surrounding the spinal cord when those bones have become overgrown and the spinal canal is narrowed and painful. That is standard back surgery. It's different at the Laser Spine Institute only in the doctors operating through smaller holes and viewing the operative site through telescopes (endoscopes) rather than direct vision.

Since the surgery is done at a same-day surgery center, patients are sent home or to hotel rooms afterward, and that can be a huge issue if something goes awry. For example, it's not uncommon that patients start bleeding near the spinal cord after back surgery. This can create a collection of blood near the spine that compresses the nerves and can cause paralysis and damage to nerves controlling bowel and bladder function -- known as cauda equina syndrome.

The Bloomberg article also documents malpractice issues with other for-profit spine surgery outfits that compete with Laser Spine for patients. Those include the Bonati Institute in Hudson, Florida and North American Spine of Dallas.

Another big problem with the business model of these spine outfits, which are competing for an estimated $73 billion that Americans spend annually seeking relief from back pain, is that surgeons are offered a "piece of the action" as investors in the profitability of the surgery center. That means that the more patients they send to surgery, and the bigger and more elaborate the operations they do, the more profit they make.

Sure enough, University of Michigan researchers found that surgeons increased their recommendations for back surgery by 87 percent after they became part owners of surgery centers. Their findings were published in the journal Health Affairs last year.


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May 2, 2011

Liposuction Produces Only Temporary Weight Loss

A pioneering new study of the popular liposuction surgery finds that the fat which a surgeon sucks out from one part of the body gets added back in elsewhere by Mother Nature.

The study published in the journal Obesity found that within a year, all the fat suctioned out in a liposuction was regained by the body -- not in the location of the liposuction but in other places such as the upper abdomen and shoulders.

Obesity researchers say that the body "defends" its fat, carefully regulating the total amount of fat in the body. So fat removed by surgery in this respect is no different from fat lost by dieting -- the body's natural mechanism tends toward putting that fact back on.

No one quite knows why liposuction fat doesn't come back in the same place, but researchers told the New York Times it may be due to the way that liposuction disrupts the fishnet structure under the skin where fat cells reside.

Since liposuction has been around since the 1970s, why hasn't a carefully controlled study like this been done before? It has a lot to do with surgeons who rely on anecdote to prove that their methods work, rather than careful statistical studies.

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February 19, 2011

Medical Malpractice in Breast Biopsies

Most breast lumps found in women need to be looked at under the microscope to make sure they're not cancer. But new research says too many women are getting unnecessarily aggressive open biopsies, which produce a scar, when most of them could get enough tissue for sampling with a simple needle stick.

About 1.6 million breast biopsies are done every year in the United States, with about 200,000 of those resulting in a diagnosis of invasive cancer, which requires more treatment. That means that about seven in eight women who undergo biopsy receive the good news of no cancer (or the pre-invasive diagnosis of ductal carcinoma in situ).

Needle biopsy is the gold standard for the initial investigation of most suspicious breast lumps, except for those that a needle cannot reach. It can be done with numbing local anesthetic and a quick needle stick, which sometimes needs to be guided by x-ray imaging when the lump cannot be felt. In that case the needle biopsy is done by a radiologist, not a surgeon.

An open biopsy requires a one-inch incision, which leaves a scar, and must be done with either general anesthesia or sedation. It costs about twice as much as a needle biopsy, both for the surgeon's fee and the hospital's fee. And that could be the economic motivator for the persistently high rates of open biopsies still done in the U.S., according to researchers.

The new study of breast biopsies in Florida found that three in ten were done by the more expensive and scarring open technique, when the rate should be less than one in ten.

A New York Times piece on the new study quoted Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., as saying it was “outrageous” that 30 percent of breast biopsies were done by surgery. The article went on:

He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.

“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

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January 27, 2011

Jury awards $250,000 for erroneous cutting of hepatic duct

A woman in Napa, Ca., has been awarded $250,000 in a malpractice suit against the surgeon who removed her gallbladder and erroneously cut her hepatic duct. The verdict includes $70,393 for past medical expenses and $179,607 for pain and suffering.

According to court documents, while performing a laparoscopic cholecystectomy (gall bladder removal), the surgeon cut the hepatic duct instead of the cystic duct. The plaintiff’s lawyers argued that the surgeon could have attempted to identify the correct duct before cutting it by taking an x-ray picture -- an intraoperative cholangiogram, which many surgeons routinely perform in conjunction with laparoscopic cholecystectomies.

The surgeon argued unsuccessfully that the technique he used was not only within the standard of care, but was common and typical for surgeons with his training and experience with this procedure, and that injury to the hepatic (common bile) duct is a well-known potential complication of any gallbladder surgery. He also maintained that the patient’s anatomy was abnormal, in that the cystic duct was adherent to and congruent with the hepatic duct, effectively mimicking the cystic duct.

Nearly 500,000 laparoscopic cholecystectomies (commonly referred to as lap choles) are performed in the U.S. every year. In 0.04% (200) of those cases, the common bile duct or the hepatic duct is improperly cut.

Source: Napa Valley Register

Footnote: Nearly all of the time, it is possible for the surgeon to identify the correct structure and cut the connection to the gallbladder. The hepatic duct delivers bile from the liver to the intestines, where it performs life-essential functions in breaking down fats in food.

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January 18, 2011

Patients ask judge to bar equipment maker from selling to back surgeon

Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein.

According to the complaint, Mylotec allegedly sold video-guided catheters to Rothstein, even though the catheters were not FDA approved for use with a laser. “Myelotec representatives were present during many of the spinal surgeries conducted in Ohio and knew or should have known that the company was placing patients at risk by promoting and permitting the alteration of its devices for non-FDA approved surgical use,” the complaint says.

Rothstein claims to have pioneered a non-invasive laser spine surgery called AccuraScope. The former patients allege Rothstein’s surgery left them with nerve damage, pain, weakness, numbness, paralysis and incontinence.

Rothstein declared bankruptcy in June 2010. At that time, there were 19 active malpractice cases against him. Previously, he had settled at least three cases and lost two trials, including a $5 million judgment for a Clark County woman who was left with permanent brain damage due to an overdose of pain medication. The bankruptcy case – which is still pending – halted the remaining malpractice cases.

Source: Dayton Daily News

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January 10, 2011

Surgeons' Sleep Deprivation and Patient Safety

Research shows that a surgeon who has been working for 24 hours is impaired as much as a drunk person in thinking and motor function. So should patients have a right to know if their doctor has been up all night?

Yes, say a group of sleep researchers, who argued for full disclosure of sleep deprivation in a recent article in the prestigious New England Journal of Medicine.

No, responded the American College of Surgeons, whose leaders say it should be up to the individual surgeon to decide if he or she is too tired to operate -- or if the surgeon needs to tell the patient before heading to the OR.

The debate shows that surgeons and hospital administrators are just beginning to consider some basic issues of fatigue and patient safety that in other contexts -- piloting airliners and driving large trucks on interstate highways -- have long been settled.

Surgeons understandably don't want to be subject to the welter of bureaucratic rules that truck drivers and pilots deal with. And patients might not like it either if a surgeon was required to announce that he would be starting their surgery but another doctor would come into finish it because the time would stretch beyond the first doctor's hour limit.

But some sensible limits could easily be put in place. For one, the opportunity for a surgeon to work inhuman hours is created by hospitals who let a surgeon sign up for overnight call, which often results in working all night in the OR, and let the same surgeon schedule elective non-urgent cases for the next day.

Why would a surgeon do this in the first place? The lure of money, as a number of commenters on the New England Journal of Medicine website candidly admitted. Which raises a problem with the American College of Surgeons' idea that surgeons should be left to their good judgment on when and when not to operate. Anyone who schedules back-to-back call nights with elective cases is not showing good judgment in the first place.

Another issue for patient safety is the surgeon who is well rested but inexperienced, for not having gone through sleepless nights filled with surgical cases. Residency training programs are now starting to limit young surgeons to 16-hour days, which many surgeons say is going to result in a generation of rested but green doctors.

The right of informed consent gives at least one answer to the conundrum. Every patient has a right to know what any reasonable patient would want to know going into a surgery. And since we would all pause before submitting to the knife with a surgeon smelling of alcohol, the same right should apply to the less obvious danger of the sleep-deprived surgeon. If a doctor wouldn't want a family member to undergo surgery with that glassy-eyed doctor, then the same right should apply to all patients.

This means patients should be told, and should be given the option of rescheduling or bringing in a fresh replacement to operate. This will be inconvenient for hospital schedulers and may cause some surgeons to lose income. But patients will ultimately be safer for it.

And if hospitals want to minimize patients getting upset for having their plans upended at the last minute, all they have to do is adjust their call schedules to make these up-all-night dilemmas a rare event.

Article first published as Should Patients Have a Right to Know When Their Surgeon Has Been Up All Night? on Technorati.

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November 17, 2010

Wrong operation teaches surgeon the value of pre-procedure protocols

An orthopedic surgeon who performed the wrong operation on a patient now says he no longer sees any burden in The Joint Commission’s (TJC) Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery. And he's gone on the record in a prominent medical journal to confess error and try to help other surgeons do it right.

TJC’s universal protocol recommends that surgeons:

1. Conduct a pre-procedure verification process.

2. Mark the procedure site before the procedure is performed.

3. Perform a time out.

The surgeon, David C. Ring, M.D., was treating a 65-year-old woman whom he had diagnosed 3 months earlier with trigger finger, a common disorder in late adulthood in which a finger or thumb snaps or locks before unlocking (like a trigger), caused by a swollen flexor tendon.

According to Dr. Ring’s own account, the correct arm had been marked at the wrist by the nurse but the planned incision site on the hand was not marked. Dr. Ring performed three other carpal tunnel procedures that day, one of which was performed on a patient who became extremely agitated before and after the procedure, causing the surgeon to vow that the next procedure would be the best carpal tunnel release he’d ever performed. In addition, the patient was moved to another operating room, resulting in a change of personnel which meant the nurse who had had performed the preoperative assessment would not be in the room during the procedure.

About 15 minutes after performing the carpal tunnel procedure, Dr. Ring realized he had performed the wrong surgery. After informing staff, he told the patient about the error, apologized and offered to perform the correct procedure. The patient agreed, and the trigger finger release was performed. Later, the patient’s son informed Dr. Ring that the patient had lost faith in him and would not return for followup care. A financial settlement was negotiated shortly after the event.

Dr. Ring asked that the case be published in the Case Records of the Massachusetts General Hospital to encourage the development and following of procedures that would minimize the risk of such events occurring again.

Source: New England Journal of Medicine

You can view and download a poster of the Universal Protocol here.

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November 16, 2010

Checklists for surgery safety cut death and injuries, new Dutch study shows

Any lingering doubts about the positive effects of comprehensive surgical checklist intervention should vanish following the release of a study conducted in the Netherlands and published in the New England Journal of Medicine.

The Dutch study evaluated the effects of a comprehensive surgical checklist intervention in six regional and tertiary care centers in the Netherlands and involved 11 distinct checklists applied
during different phases of preoperative, intraoperative, and postoperative care completed by
surgeons, anesthesiologists, nurses and other staff.

The checklists included nearly 100 items that address the availability of imaging information, equipment and materials, patient and operative site verification, communication of postoperative instructions between caregivers and discharge instructions. Outcomes improved substantially as a result of this intervention. The proportion of patients with one or more complications fell from 15.4 to 10.6%, while mortality dropped from 1.5 to 0.8%.

A large international study supported by the World Health Organization (WHO) released last year reported similar results, showing that checklists cut surgical morbidity and mortality almost in half. However, not everybody was convinced by the findings of the WHO study, because:

1. The pre-intervention/post-intervention study failed to control for confounding factors, such as the the “surgical Hawthorne effect,” which states that outcomes tend to improve rapidly when surgeons know they are being evaluated.

2. The study’s operating room checklist consisted primarily of common-sense items and processes of care that seemed unrelated to the most common serious complications of surgery, making it implausible for some that improved compliance with these practices could lead to such drastic reductions in morbidity and mortality.

3. Compliance of the eight study hospitals with the checklists had no bearing on the extent of improvement in outcomes. Overall compliance with processes of care on the checklists improved negligibly even in the two hospitals with the greatest reductions in morbidity and mortality, while conversely, the two hospitals with the greatest increase in compliance showed no change in outcomes.

The Dutch study avoided these pitfalls by including hospitals that had already been tracking their surgical outcomes with the same detailed registry for many years, so the results cannot be attributed to the effects of performance feedback.

It also documented a strongly positive relationship between checklist compliance and outcomes, in that patients with incomplete checklists had significantly more complications than those for whom checklists were more fully completed.

Finally, the study included a control group. At five similar hospitals that did not implement the checklist intervention, morbidity and mortality were unchanged during the study period.

An editorial published with the article concluded that surgery checklists now have advanced from a good idea to "standard of care."

Source: New England Journal of Medicine

You can view an abstract of the Dutch study here.

You can view an abstract of an editorial about the Dutch study here.

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October 15, 2010

Malpractice Questions Raised in Kansas High School Football Player's Leg Amputation

When Trevor Roberts' leg bones snapped during a high school football game near Wichita, Kansas, he received the standard orthopedic treatment: a resetting of the bones with a titanium rod to hold them in place. So why did he have to have an above-the-knee amputation because of gangrene six days later?

The surgeon who had to remove most of the boy's leg, Dr. Archie Heddings at the University of Kansas Medical Center in Kansas City, told USA Today he thought the health care system had failed Roberts in some way.

Dr. Heddings told the newspaper:

"To me, in all honesty, I think this is a failure of the doctor-hospital system. I don't want to impugn anybody. But ... one of the first things you're supposed to do when there's an open fracture is get tetanus and antibiotics. Then, you take that person to the operating room and you get out all the dirt, you get out all the bone that doesn't have soft tissue attached to it — that's dead bone — and you take out all the dead muscle. And then if there's any question 48 hours later, you take the patient back to the operating room and look at the wound and make sure there's no dead muscle. If there is dead muscle, those bacteria have something they can reproduce in. And they'll ... start wreaking havoc."

From the newspaper's account, the first surgery to put the leg back together occurred at a Wichita hospital on the same Friday night as the injury. The 17-year-old was sent to his home near Lawrence, Kansas on the following Sunday. Then he had a high fever and went to another hospital in Lawrence two days later. It's not clear what happened at that visit, but he didn't get definitive care until two more days when he was back in the Lawrence hospital with another fever and a blistered foot. That brought him to the care of the surgeon in Kansas City who told the young man he had to amputate to save his life.

An investigation is under way to get to the bottom of this sad story.

Read the whole newspaper account by clicking here.

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October 14, 2010

Specialized, high volume ambulatory surgery centers improve patient outcomes, study says

Ambulatory surgery centers (ASCs) that specialize and have high case volumes have better patient outcomes, according to a study by researchers at four U.S. universities.

The researchers found that the more a facility specialized in its services –and the higher its case volume for those services, the higher its patient quality scores. The researchers defined quality performance as the likelihood that an ASC patient undergoing surgery would avoid unplanned hospitalization within 30 days after the procedure.

To perform the study, which examined potential associations among ASCs organizational strategy, structure and quality performance, the researchers obtained claims data for arthroscopy and colonoscopy procedures performed from 1997 to 2004. “Quality performance” was determined by the likelihood that an ASC patient undergoing surgery would avoid unplanned hospitalization within 30 days after the procedure.

Ambulatory surgery, or outpatient surgery, is provided for patients requiring less than a 24-hour stay. ASCs have become more common across the country because (a) advances in surgical technology and anesthesia have made surgery easier on patients and so consequently more in demand; and (b) the cost of providing the same procedure in an ASC is often considerably less than hospital outpatient surgery.

According to a KNG study, the specialties with the highest percentage of Medicare-certified ASCs in 2007 were ophthalmology (19%) and gastroenterology (18%), followed by pain management (8%), orthopedics (7%) and dermatology (4%). Multiple specialty ASCs comprised 35% of the total.

Source: Medical Care Research and Review

You can view the KNG study here.

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September 15, 2010

Detailed heart surgery ratings now available

Until now, it’s been easier to rate appliances and restaurants than surgeons in most parts of the country, but that should change now that surgeons who perform cardiac bypass surgery are being rated on objective quality measures in Consumer Reports magazine.

The consumer magazine recently published ratings of 221 surgical groups in 42 states online. The same ratings will be available in the October print issue. To date, only a few states, such as New York, compile data-based ratings of physicians.

The data Consumer Reports used to rate the physicians was collected the Society of Thoracic Surgeons, which includes more than 90% of cardiothoracic surgeons in the U.S. in its membership. Physician groups, not individual surgeons, were rated either above average, average or below average based on (a) complication and survival rates; (b) the surgical technique used; and (c) the type of medication(s) the patient was sent home with after surgery.

An article in the New England Journal of Medicine called the move to make this data public “a watershed event in health care accountability.”

The 221 groups rated in Consumer Report represent less than a quarter of physician groups that perform bypass surgery in the U.S., as only surgical groups that allowed their information to be published were rated. Of these, only five were rated below average, which is fortunate, because the gap in treatment between a below-average and an above-average surgical group can be extremely wide; for instance, at an above-average hospital, patients had a 92% chance of receiving the recommended medications when leaving the hospital; at one of the below-average hospitals, patients had only a 24% chance of getting the recommended drug.

For now, the information is available only to people who subscribe to Consumer Reports online and print subscribers. However, STS says it will make the ratings freely available on its web site in a few months.

Source: New York Times
Visit the web site of the Society of Thoracic Surgeons (STS) here.

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September 14, 2010

New alliance creates tools to reduce pain medication misuse

A new patient safety organization has launched a range of online tools and other resources to reduce abuse of opioids by identifying the risks associated with their use. The materials from the CARES Alliance (Collaborating & Acting Responsibly to Ensure Safety) include several “safe-use” programs, tools and educational materials for patients, caregivers and healthcare providers.

They were developed using Failure Mode and Effect Analysis (FMEA), a scientific methodology that identifies where problems occur in the use of pain medications and the underlying causes of those problems. The FMEA research identified 79 areas where problems occur in the use of opioidsand 290 potential causes of those failures.

Tools now available include clinical materials and risk assessments for physicians, safe-use guides for patients and general education for all groups. The organization also plans to develop additional tools based on the research.

Jeffrey Gudin, MD, a pain management and addition specialist at the Englewood Hospital and Medical Center in Englewood, N.J., says that healthcare professionals need to do a better job of assessing our patients' pain medication needs and of communicating the risks of the medications they prescribe.

"Through the resources of the C.A.R.E.S. Alliance, patients, caregivers and health professionals will have access to information, tools and resources to help them better understand these risks and better ensure that the medications are used properly by only those for whom they are prescribed," he says.

The alliance, which is sponsored by Covidien, the largest producer of prescription pain medications in the U.S., also will work to ensure that patients suffering from chronic pain have access to necessary medications.

Source: Medical News Today
You can obtain tools and other resources here.

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September 13, 2010

Anesthetist or Anesthesiologist: What You Need to Know Before Surgery

Nurse anesthetists have been proven to deliver about as safe and high quality care as physician anesthesiologists, but there's still a key question every patient should ask before being put to sleep by a nurse anesthetist.

"Is there a doctor anesthesiologist nearby in case there's an emergency during my surgery?"

That's the question you need to get answered. In most hospitals and many free-standing surgery centers, the answer will be, "Of course, we wouldn't dream of putting patients to sleep without an anesthesiologist supervising the anesthetists." But in other facilities, particularly same-day surgery centers, the answer will be, "No, we don't think it's necessary."

And that "no" should give you pause.

Anesthesiologists have MD degrees and broad training in medicine. They also spend a lot more years learning anesthesia than nurses who come up through a "CRNA" program (Certified Registered Nurse Anesthetist). It costs about six times as much to train an anesthesiologist as an anesthetist, and the anesthesiologists are paid about double what nurse anesthetists get paid.

If something goes terribly wrong during surgery -- and luckily that's a rare event nowadays, thanks to improvements in anesthesia technology over the last thirty years -- I know who I want nearby. That's an anesthesiologist.

You can read more about this in a series of letters to the editor in the New York Times debating the merits of state governments passing laws that opt their state out of the Medicare requirement that surgery centers have an anesthesiologist supervisor.

I discuss anesthesia and other issues about safe surgery in my book, "The Life You Save."

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September 6, 2010

Patient safety authority finds frequent dosing errors with a narcotic drug

Healthcare providers need to know more about the efficacy and potency of hydromorphone, a pain killer frequently used as a morphine substitute in post-operative patients, to avoid medication errors and adverse drug reactions (ADR), says an advisory from the Pennsylvania Patient Safety Authority (PPSA).

Researchers hired by PPSA reviewed 1,694 medication error and 937 adverse event reports involving hydromorphone from January 2008 to October 2009. They identified lack of knowledge about hydromorphone potency and the difference in potency between morphine and hydromorphone as the most significant factors causing serious medication errors, particularly when a patient is switched from morphine to hydromorphone.

Hydromorphone is administered in doses that range from 0.4 mg to 2 mg, whereas patients may receive as much as 7-10 mg of morphine. Incorrect dosing may occur when prescribing, dispensing or administering hydromorphone when a physician, pharmacist or nurse confuses hydromorphone and morphine. Other medical errors noted in the study were giving patients the wrong drug and not noting a documented allergy.

Some adverse drug reactions to hydromorphone also may be preventable. The study found that of the 447 reported ADRs involving central nervous system or respiratory effects, 292 (65%) were preventable, and, of these, 205 (70%) resulted from dosing errors.

To reduce the number of medical errors and ADRs involving hydromorphone, the study recommended implementing risk reduction strategies such as constraints and standardization, which focus on system improvement. It also recommended writing hydromorphone with the first five letters capitalized (i.e. HYDROmorphone) to further distinguish it from morphine.

Source: Pennsylvania Patient Safety Authority
You can view the report here.

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July 20, 2010

Malpractice in Over-Diagnosis of Breast Cancer

A long article in the New York Times brings home the dangers of women undergoing disfiguring surgery or radiation for breast cancer they never had. The story is a familiar one to malpractice attorneys but not well enough known to the public: The critical job of determining if breast tissue is cancerous or not is sometimes left in the hands of inexperienced pathologists who are prone to error.

The problem is worse with diagnosis of "ductal carcinoma in situ" (DCIS), an early form of cancer that may or may not progress to truly invasive cancer. The criteria for DCIS are sometimes subtle and not all pathologists agree on them.

What can patients do to protect themselves?

As I write in my book, "The Life You Save," you should never have any kind of cancer surgery without at least one second opinion on the biopsy. You can have a top cancer pathologist review your tissue slides for a cost of at most a few hundred dollars, and it might even be covered by your insurance.

Second, make sure the pathologist who interprets your specimen has enough experience. The College of American Pathologists now says 250 cases a year are the minimum for competence in this field, and it is starting a special certification program for breast cancer pathology.

The Times' article features Monica Long, a nurse in northern Michigan who had disfiguring breast surgery for DCIS, only to learn later that she never had it. She also learned too late that the pathologist at her hospital had only seen 50 cases a year and was not yet certified in any kind of pathology when he gave the reading on her tissue.

Some women get so scared by the diagnosis of DCIS that they have BOTH breasts removed. As previously reported in this blog, having a healthy breast removed does not improve a woman's statistical odds of survival. And as many as two out of three cases of DCIS never progress to full-fledged cancer. But such is the power of the "C" word to frighten people into doing anything -- even undergoing mutilation unnecessarily -- to try to stay alive.

This makes it all the more imperative for the pathology community to develop better criteria for the diagnosis of DCIS, and to improve the certification program so that this scary diagnosis is not made unless it's truly warranted.

The Times' "Well" blog has compelling accounts written in by other patients. Click here to browse them.

Reading these stories compels me to make another point: Unless you are financially destitute, I think it's a bad idea to let insurance coverage drive important medical decisions. If the insurance company won't pay for getting a second reading on the biopsy, scrape up the dough and get it done yourself. You'll be glad you did.

Among other second opinion providers, the Armed Forces Institute of Pathology in Washington, DC, gives second readings at a modest cost.

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June 19, 2010

A Life-Saving Number: The Nurse-to-Patient Ratio

The greatest fear for any patient in the hospital, and the biggest nightmare for their families, is that something will go wrong suddenly and no one will respond until it's too late. Beeping monitors are no help if their alarms go unheeded. Patient safety experts know that one basic way to keep patients safe and prevent death or injury from malpractice is to have enough nurses on hand.

How many is enough? Nursing leaders got the state of California, after a 10-year fight with the hospital industry, to mandate minimum nurse-to-patient ratios: one nurse for every five post-surgery patients, one nurse for every two intensive care patients, one nurse for every four children in the pediatrics ward.

If you have a family member in the hospital, these numbers are worth keeping in mind. Ask the bedside nurse how many patients he or she is in charge of. And don't let hospital management confuse the issue by pointing out how many aides they have. Aides can plump pillows and give other comfort measures. But only a nurse can recognize when a patient is in peril and give lifesaving treatment.

A new study by a nursing professor at the University of Pennsylvania, Linda Aiken, asserts that mandatory minimum nurse-to-patient ratios like California's could prevent as many as 14 percent of post-surgery deaths in New Jersey hospitals and 11 percent in Pennsylvania.

Another important outcome of ensuring that nurses aren't overwhelmed by too many patients is that nurse burnout and job turnover go down, and overall quality of care improves, according to the study.

Theresa Brown, an oncology nurse in Pittsburgh, has an op-ed piece in the New York TImes asking why bills in Congress to mandate minimums nationally haven't gone anywhere.

Saving money, of course, is the issue. But that's a penny-wise answer. Saving lives can be a lot cheaper in the long run.

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May 28, 2010

Surgery for Back Pain: Less Is More

Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need -- and then those surgeries result in predictable complications.

The greed allegation sounds a bit harsh, but it comes straight from the top: The Journal of the American Medical Association, in an editorial by a leading Stanford orthopedic surgeon, Eugene Carragee, and in a study carried out by a group of doctors at Oregon Health and Science University led by Dr. Richard Deyo.

The Oregon study found that the rate of complex surgeries for back pain in Medicare patients jumped by 15-fold over a recent five-year period, but there was nothing in the patient population -- like increasingly complicated back deformities -- to justify the increase.

Joanne Silberner of NPR reported:

Deyo says there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. He offers several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," he says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as 10 times more. He says another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

The problem is that the more complex surgeries carry at least double the risk of a bad outcome, according to the Deyo study.

Most back pain that isn't relieved effectively with medicines or other non-surgical therapies is caused by disk herniation or spinal stenosis. Spinal stenosis is growth of bone near a nerve coming out of the spinal cord which presses on the nerve root and causes pain to radiate down a leg. The vast majority of patients who need back surgery because of spinal stenosis can be benefited from a fairly simple lumbar decompression. This involves removing bone, ligament and facet joint material which is compressing the nerve root. This operation has a high degree of success as it's been developed over the last 20 years.

According to Dr. Carragee's editorial, if the patient also has some deformity of the spine -- front to back or side to side -- the simple lumbar decompression can result in spine instability with increased deformity, so those patients might need a fusion where adjacent vertebrae are fixed together with bone grafts. But even here, simpler techniques get just as good results than more complex procedures that add metal or other instrumentation into the back.

A very small minority of patients, says Dr. Carragee, have spines that are so collapsed and twisted that the spine is unbalanced and tilted forward and the patient has severe pain and poor quality of life. These are the patients who might qualify for the complex surgeries now being done so commonly. Techniques have improved in the last ten years, but the surgeries in these patients still carry a very high complication rate -- 30 to 40 percent. And a lot more patients are getting the complex, multi-level surgeries than is warranted by the medical evidence, according to Dr. Carragee and other researchers.

Consumer Reports has rated spinal surgery as No. 1 on a list of overused tests and treatments.

As quoted by NPR, Dr. Deyo said he would like his study to alter the practice of medicine. "The effect I would hope it would have is to have surgeons and patients choose the least invasive procedure that would accomplish the surgical aim," he says. But he's pessimistic about it, unless there's a change in the financial incentives.

This is yet another area of medicine where it pays for patients to be skeptical and to get multiple opinions. It fits our natural instincts to think that bigger and more elaborate surgeries have a higher likelihood of success, but the human body proves over and over that it prefers minimal interventions.

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March 13, 2010

Removal of Healthy Breast in Cancer Patients: Overtreatment or Peace of Mind?

More and more women with cancer in one breast are now opting to have the other healthy breast removed as well, even though the statistics show survival odds don't improve by having both breasts removed and most patients end up with chests that are numb to sensation.

Peace of mind is cited by many of these cancer patients for their decision.

A new report by Tara Parker-Pope in the New York Times details this trend, and the Times' "Well" blog has a number of interesting comments from women and cancer experts.

As many as three in ten breast cancer surgeries in large urban cancer centers are for preventive removal of the healthy breast, the Times reported.

But what is prevented, exactly?

The only women who get a very slight survival bump from having their healthy breast removed are patients under age 50 who have estrogen-negative cancers that don't respond to drugs like Tamoxifen. For everyone else, there is no real advantage in having the second breast removed. When the second breast gets cancer, as happens sometimes, that is not "spread" from the original cancer but is a new, unrelated cancer.

The real risk that women face from the original cancer is that it has already spread beyond the breast, but removal of the second breast doesn't help that risk.

The most striking evidence of how afraid of cancer women are is with DCIS: ductal carcinoma in situ, which is not even considered true cancer by many experts because it either disappears or never progresses in two-thirds of women. Yet still many women with DCIS are electing to have not just the one breast removed, but both.

Ultimately, this is an intensely personal decision. But it helps to get the true facts first.

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October 14, 2009

Robotic Prostate Surgery: Surgeon's Volume Is Critical to Outcome

Prostate surgery with a robot called "da Vinci" is often sold to patients as the latest and greatest technology and a way to get a better outcome. But on the key long-term complications -- urinary incontinence and erectile dysfunction -- the "minimally invasive" robotic surgery may be no better than traditional surgery, and may be worse if the operator is inexperienced.

A new study in the Journal of the American Medical Association criticizes the benefits of the "minimally invasive" surgery as oversold. The operation does cut the average time in the hospital from three days to two, but brings with it both more short-term complications plus more long-term injuries like impotence.

The lead author is Dr. Jim Hu of Brigham and Women's Hospital in Boston. "There has been rapid adoption of minimally invasive radical prostatectomy, however, outcomes have not been superior," Hu said.

Surgeons are trained to use the robot in a weekend course with the manufacturer. Dr. Hu said that a big part of the problem could be surgeons not getting enough experience with the device. He said he has now done more than 700 robotic prostate surgeries, but "it took several hundred cases before I thought I was doing really well in preserving erectile function and continence."

Articles about the new study can be found here and here

The new study brings home an issue that is discussed at length in Patrick Malone's book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst. Choosing the right surgeon is key to success, and patients need to ask about the surgeon's volume of cases exactly like theirs. For robotic prostate surgery, it's easy to find a surgeon with hundreds of cases. If that's an option, why would anyone settle for a surgeon who has only done a few dozen?

.

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September 15, 2009

New Patient Safety Report Cards in Pennsylvania

Pennsylvania continues to lead the nation in showing how public health authorities can cast a little disinfecting sunshine onto the patient safety practices of hospitals.

In its latest report, the Pennsylvania Patient Safety Authority says that in 2008, a total of 194 surgery patients were sewed up with a foreign object still inside them. They have a term for it: RFO, for Retained Foreign Object.

To avoid leaving behind a sponge, needle or other instrument, the nurses and doctors involved in any surgery are supposed to go through a counting ritual. The problem is that the count doesn't always end correctly. In fact, the same Authority reported that last year, there were over 2,000 instances of incorrect counts, which doesn't always mean an object has actually been left behind.

One technique to follow up when there has been a discrepancy in the count is to do an x-ray of the affected area. That should show up any hidden objects.

The RFO problem is expensive for patients and hospitals. According to the Consumer Union Safe Patient Project, the average cost of a hospital stay for the corrective surgery and other problems that come from a retained object is $62,631.

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August 11, 2009

Vertebroplasty: Another Expensive Medical Fad?

Vertebroplasty is a popular surgical technique for treating patients who suffer "crush" fractures of their vertebrae due to osteoporosis, the loss of bone mass that often comes with old age. Two newly published studies suggest that this procedure is going the way of other medical "fads" that showed early promise but failed to show a real benefit after extensive testing.

Both new studies were published in the New England Journal of Medicine in August 2009, and they found that the surgery was no better than doing nothing at relieving the patients' symptoms. Here is how one put it into perspective for an online publication, Medscape Neurology.

Lead investigator of the second trial, Rachelle Buchbinder, PhD, from Monash University in Malvern, Australia, raised similar concerns to Medscape Neurology. "There have been numerous examples of treatments that have looked promising in noncomparative studies but have subsequently been shown to be no better than placebo, a sham procedure, or standard care."

Dr. Buchbinder cites arthroscopy for osteoarthritis of the knee, bone marrow transplantation for breast cancer, embryonic neurons for severe Parkinson's disease, and from her own work, shock-wave therapy for plantar fasciitis. She suggests that each of these looked promising early on, but didn't do well after rigorous study.

It had previously been argued that performing a randomized placebo-controlledtrial of vertebroplasty is unnecessary and unethical in light of the published results of numerous studies that suggest a benefit. But Dr. Buchbinder said that the take-home message from her trial is that vertebroplasty was no better than a sham procedure for improving pain, function, and quality of life after an osteoporotic spinal fracture.

"Both treatment groups improved by about the same amount," she said. "In view of the known potential adverse effects and no benefit, vertebroplasty should not be used in clinical practice."

The bottom line for patients is that this is just another in a long string of popular medical innovations that failed to pan out, so wise patients should be wary about undergoing any new-fangled treatment before it is of proven benefit.

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May 30, 2009

Surgical Stockings Found Ineffective at Preventing Blood Clots for Stroke Patients

In a study published this week in The Lancet, a British research team found that surgical stockings given to stroke patients for prevention of blood clots do not work, reports Sam Lister of UK’s Times.

The compression stockings provide graduated pressure and should reduce swelling in the legs. Studies have shown that, for patients immobilized after surgery, these stockings effectively reduce formation of blood clots, which can be deadly when the clots travel up to the heart or lungs and obstruct blood flow.

However, in the new Lancet paper, scientists followed 2,500 stroke patients in Britain, Italy and Australia, and found that the use of compression stockings made no significant difference in the occurrence of DVT (deep vein thrombosis, the blood clots in the deep veins of the legs that can travel to the heart or lungs). Patients who wore the stockings actually suffered additional symptoms that include skin breaks, ulcers and blisters.

The results of the study were also presented at the European Stroke Conference on May 27 in Stockholm. Researchers believe this study conclusively shows compression stockings should not be recommended to stroke patients.

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January 27, 2009

Can Diet Beat Surgery in Protecting the Heart?

In 2008 alone, more than a million Americans underwent various coronary procedures, including balloon angioplasty and coronary artery bypass surgery. However, while these expensive measures can be lifesaving for some, they do not necessarily do a better job at protecting most people’s hearts than a heart-healthy lifestyle would, Jane Brody writes in the New York Times. Essentially, the surgeries are like “‘doing cosmetic surgery on coronary arteries, making them look pretty, but it’s not treating the underlying biology of these arteries,’” Brody quotes the Miami cardiologist and author, Dr. Michael Ozner.

Dr. Ozner is an advocate of preventive coronary care, which he believes is safer, less costly, and more effective than intervention. Interventional cardiology that involves invasive coronary procedures has become lucrative for hospitals and doctors, costing $60 billion a year in the U.S. But such procedures have not been proven to “prevent heart attacks or coronary mortality in most patients.” Worse, they may even be harmful; Brody quotes a 2006 report revealing that the stents inserted in angioplasty can elevate the chance that “a dangerous clot will form in a coronary artery.”

So how do patients find out whether they are candidates for invasive coronary procedures? Dr. Ozner, who authored “The Great American Heart Hoax,” urges patients to seek an independent second opinion if their doctors recommend surgery to them. He said that “unstable patients” who have symptoms that really warrant surgical interventions are those who are in the middle of a heart attack or those with severe chest pain from minimal exertion. If you do not experience any chest pains or cardiac symptoms, you likely do not need surgery on your heart.

Brody writes in the second of her two columns on coronary care about the alternative treatments of the heart. Many of these preventive measures have been well-established and are widely known: selecting foods that are found in the Mediterranean diet (rich in fish oil, nuts, seeds, vegetables and fruits), maintaining good dental hygiene (gum diseases are linked to chronic inflammation), reducing chronic stress (with adequate sleep and regular relaxation activities), and exercising regularly (only 15 minutes of exercise a day for five days a week can make a lot of difference).

People who follow these tips can reduce their risks for heart problems by up to 50%, while avoiding the costly and risky surgeries that have yet to be proven to prevent coronary deaths.

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January 15, 2009

Making Surgery Safer by Using Checklists

An international research team has shown that death and complication rates from surgery can be dramatically improved by using simple checklists to make sure that safety measures are taken before, during and after each operation.

The research project, involving nearly 8,000 patients at eight hospitals around the world, was done as part of the World Health Organization's program called Safe Surgery Saves Lives. The results were published in January 2009 in the New England Journal of Medicine.

When the surgical teams at the hospitals used the checklists, they found that death rates were cut in half and non-fatal complications by one-third.

The nineteen items on the surgical safety checklist include basic items like verifying that the team has the correct patient and the correct surgical site, making sure the pulse oximeter (which measures oxygen in the blood) is working, making sure antibiotics have been given within one hour before the start of the surgery to prevent infection, and confirming that x-rays needed for the case are on display in the operating room. One other item on the checklist is to have all members of the surgical team introduce themselves by name and role; this is intended to give permission to lower-status team members to speak up at a later time if they notice something wrong. Click here for the entire checklist from the WHO (which is part of the United Nations).

The Patrick Malone law firm has prosecuted many lawsuits against hospitals where these basic preventive steps were not done and their absence led to tragedy. Examples include non-functioning pulse oximeters, surgery done on the wrong body part, and failing to prepare for known possible risks like heavy bleeding.

Patrick Malone discusses steps that patients can take to make sure their surgeons follow safe practices in his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, available at Amazon.

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January 11, 2009

Patients Benefit from Getting Second Opinions

When a doctor knows that his patient would receive better care elsewhere, should he inform the patient and send him to another provider? While this question is yet to be settled among bioethicists and physicians themselves, authors of an article published recently in the journal, Public Library of Science Medicine, think doctors have an ethical obligation to tell patients that better care is available to them, according to the New York Times’ Denise Grady.

Research has shown that facilities that perform high volumes of a certain procedure do it better than those that perform the procedure less frequently. The difference is substantial, especially in surgeries of pancreatic and esophageal cancer, although “the experience of the surgeon and the whole medical team [is] important in any major cancer surgery.”

Only a few courts around the country have decided whether doctors have a legal duty to inform patients that another doctor might have more skill and experience performing a planned surgery. One of them is Maryland's highest court, the Court of Appeals, thanks to a client of Patrick Malone named Billy Boone who suffered brain damage after an ear surgeon punched a hole into Mr. Boone's brain.

Mr. Boone's case shows that surgeons' skills make a difference in much more than cancer surgeries. The Maryland Court of Appeals decided that Boone had a legal right to know that his surgeon did not have extensive experience doing the ear surgery that Mr. Boone underwent.

Mr. Boone had an outpatient surgery in January 2000, to remove a benign growth from the mastoid cavity behind his left ear. Dr. Seth Goldberg, an ear nose throat surgeon, performed this surgery, called a mastoidectomy. Seventeen years before, Mr. Boone underwent the same procedure, in which another surgeon drilled out the same mastoid to remove a cheesy growth of skin debris called a cholesteatoma. Unknown to Boone, the surgeon had become lost at one point during the procedure and drilled a hole in the skull just above the mastoid, near the bottom of the brain's temporal lobe. But nothing happened to his brain, which was protected by the tough fibrous shell below the skull called the dura. Years later, when Dr. Goldberg prepared for the new surgery, he took some CT scan pictures of the bone anatomy and saw the pencil-sized hole in the side of the skull.

Dr. Goldberg's surgery seemed uneventful, but after Boone went home, he developed a short-term memory problem that ruined his ability to do carpentry; worse, he developed a problem controlling his temper that unleashed itself at stressful moments on whoever happened to be nearby. Later, his neurologist explained to the jury that Boone's outbursts could be traced to injury in the limbic system that modulates emotional response.

A CT scan showed that a hole had been poked from the pre-existing skull defect into Boone's brain. A small pocket of air could be seen in the temporal lobe, surrounded by a pool of blood. But it wasn't just air in the brain – it was something slightly denser than air, likely surgical gelfoam which could have made its way there only if Dr. Goldberg had pushed it in to try to stop bleeding after he punched the first hole.

The key moment for Mr. Boone came not in the surgery but a month before, when he sat down with Dr. Goldberg to go over the planned operation. Goldberg never volunteered the key information: that with the hole in the skull from the prior surgery, his surgery would be that much more difficult, could even result in an injury to the brain, and Mr. Boone might benefit from consulting with someone who regularly did "revision mastoidectomies," the technical term for this second go-round. A general ENT doctor who advertised his specialty in facial cosmetic work like nose jobs – he named his professional corporation the "Aesthetic Facial Surgery Center of Rockville" – Goldberg only had done occasional revision mastoid surgeries. His operation on Boone proved he wasn't up to the job. On the witness stand, Goldberg admitted he hadn't discussed with Boone the hole in the skull, the chance of brain damage, or the availability of sub-specialists called neurotologists. For Billy Boone, the jury's vote in his favor, and the Court of Appeals' affirmance of the award, gave him some vindication. For other patients, his win makes it easier to demand the information you need to make a sensible selection among surgeons. Of course, if you asked Billy Boone, he would trade in legal vindication for a healthy brain any day. It's too late for him, but not for the rest of us.

(Click here for more information on the Boone case, and follow this link to Mr. Patrick Malone's closing argument.)

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July 31, 2008

Senator Kennedy's Health Care and Yours

It is instructive and interesting to read about Senator Edward Kennedy's treatment for his brain tumor.

The linked article describes the change in direction between May 20th of this year, when Kennedy's brain cancer was first disclosed and surgery was not discussed as a possible treatment, and two weeks later, when neurosurgeons performed a "successful" surgery on his brain.

Why the change? From the article:

Precisely why Mr. Kennedy’s treatment course changed is not known; he and his doctors are not talking to reporters.

What is known is that a few days after Mr. Kennedy learned he had a malignant brain tumor in the left parietal lobe, he invited a group of national experts to discuss his case.

The meeting on May 30 was extraordinary in at least two ways.

One was the ability of a powerful patient — in this case, a scion of a legendary political family and the chairman of the Senate’s health committee — to summon noted consultants to learn about the latest therapy and research findings.

The second was his efficiency in quickly convening more than a dozen experts from at least six academic centers. Some flew to Boston. Others participated by telephone after receiving pertinent test results and other medical records.

As the article notes, Senator Kennedy called similar conferences of experts when one of his children was diagnosed with bone cancer and the other with lung cancer. He has been known to advise his colleagues in the Senate to use this method when dealing with an illness in the family.

Obviously, powerful senators can do things the rest of us cannot. Again, from the article:

Mr. Kennedy can tap leading doctors for answers in a way few patients could. His celebrity status aside, he has spent a career promoting insurance and other ways to improve the health of Americans. And he has had a track record of being thorough and diligent in researching medical options when relatives or friends have fallen ill.

Nevertheless, despite Kennedy's power and influence, there are ways in which the average person can imitate his example and seek second and third opinions on their medical care:

Several doctors not connected with Mr. Kennedy’s case said in interviews that they admired his resourcefulness in getting more opinions simultaneously. At the same time, these doctors said many average patients gained competent advice, without a command performance, by sending pertinent records to experts for their opinions.

Many patients search the Internet for medical information and ask that their scans and other data be sent electronically or by overnight services.

Then such patients visit, call or write the consultant.

The potential negative consequence of all this opinion-shopping is that people may focus on what they want to hear and disregard everything else. This is partly why the doctors quoted in the article strongly recommend actually meeting physicians whose advise you intend to take (rather than just sending records and receiving written responses). That way the physician can make sure your expectations are realistic and address your specific concerns.

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July 19, 2008

Medicare Won't Pay for Injuries Caused by Hospital Neglect

Starting October 1, 2008, Medicare will no longer pay for eight hospital-acquired conditions that could be prevented if hospitals followed the proper guidelines.

Those eight conditions are bed sores, objects left inside the patient during surgery, falls that occur when the patient is in the hospital, blood incompatibility, air embolism, mediastinitis (infection of the area between the lungs, which can happen after a heart bypass surgery), catheter-associated urinary tract infections, and certain bloodstream infections. In addition, several other conditions have been proposed as additions to the list.

The purpose of this change is to provide an incentive for hospitals and health care providers to avoid errors and prevent neglect of patients. If both Medicare and the patient refuse to pay for treatment of a hospital-acquired condition, then the hospital is stuck with the costs, and most hospitals would obviously wish to avoid that.

This is a long-overdue incentive for hospitals to reduce the incidence of these events and injuries which should never happen.

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May 2, 2008

Lasik's Painful Side-Effects

Lasik is a popular laser surgery done on the eyes to correct vision. However, last week Lasik patients went to Washington D.C. to speak to the Food and Drug Administration on harmful side-effects that they experienced as a result of the surgery, including the following:

(1) Severe eye pain

(2) Dry eye

(3) Blurred vision


The effects of intense chronic pain can have a devastating effect on people's lives. One case was particularly extreme. From the article:

Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway -- and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

"As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerard Dorrian read from his son's suicide note.

One quoted patient said he was considered a "success" by doctors despite experiencing terrible after-effects:

Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But he said, "For the last two years I have suffered debilitating and unremitting eye pain."

These patients are demanding clearer standards for who can qualify for Lasik, as well as better information from the FDA on how many patients suffer these various side-effects.

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March 21, 2008

Study Supports Reduction of Older Blood Use in Transfusions

A new study shows that heart surgery patients are more likely to die or suffer other problems if they get blood that has been sitting on the shelf for more than two weeks. The study, entitled Duration of Red-Cell Storage and Complications After Cardiac Surgery, was published in this week's New England Journal of Medicine.

From the linked Washington Post article:

A number of hospitals have re-evaluated long-standing practices and taken steps to minimize transfusions. One example: Duke University Medical Center in North Carolina has reduced its use of transfused blood products by 17 percent in the past 3 1/2 years.

Concern about the safety of older blood for cardiac patients is one reason for the change at Duke, said Dr. Sunil Rao, a Duke assistant professor of medicine who runs the cardiac catheterization labs at the Durham VA Medical Center.

If you will require a transfusion in the near future, this would be a good thing to ask your doctor and hospital about to find out their policy.

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January 11, 2008

U.S.A. Has the Most Preventable Deaths

Out of nineteen industrialized nations, the U.S. has the most deaths that could have been prevented by access to timely, effective medical care.

Ellen Nolte and Martin McKee of the London School of Hygiene and Tropical Medicine performed the study, looking at deaths before the age of seventy-five caused by numerous diseases and complications. They found that France performed the best by this measure--though France, and other countries that ranked higher than the U.S., spends less money on health care than the U.S. does.

Not only was the U.S. the worst in these rankings, but we Americans are also ranked four places lower than we were in the last study (which covered 1997 and 1998). We are getting worse and spending more money.

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November 28, 2007

Hospital Commits 3rd Brain Surgery on the Wrong Side of the Head

Rhode Island Hospital has, for the third time this year, done a brain surgery on the wrong side of the patient's head.

The hospital has been fined $50,000 and has received a reprimand from the state Department of Health. In this most recent instance, the patient was 82 years old. Fortunately, the patient was unhurt by the mistake. However, in one of the previous instances of this mistake at this hospital, the patient died as a result.

Rhode Island Hospital has said that it will be conducting a review of its procedures and implementing reforms. One such reform would be to allow nurses greater power in ensuring that procedures are followed correctly. Another would be to mandate better verification of surgery plans, which would require better communication between surgeons and other doctors. These reforms highlight a major factor in averting medical errors: teamwork. The multiple healthcare professionals involved in taking care of a patient need to be empowered to speak up if they see something going wrong. They also need to know what the others are doing, and to make sure that they are not acting contrary to the recommendations and instructions of other healthcare providers. Performing a surgery on the wrong side of the head is only one possible thing that could go wrong in the absence of communication. Another example would be giving a patient medications that, combined with medicine the patient is already taking, could cause problems. Such errors can be minimized through proper communication between healthcare professionals.

For more information: When Surgeons Cut the Wrong Body Part

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November 16, 2007

Plastic Surgery: Still Safe, but Know the Risks

The risks of plastic surgery have been in the news lately thanks to the death of Donda West, mother of Kanye West. West died following a "tummy tuck," a common plastic surgery operation. At this time, the cause of her death is unclear.

In the wake of her death, the American Society of Plastic Surgeons issued a press release.
They emphasize that plastic surgery is generally safe, but offer general suggestions as to what prospective patients should do to reduce their risk.

Research is the number one safety precaution: read studies about the risks and benefits of whatever procedure you are contemplating. Make sure you hear opinions from multiple sources: your primary care physician, your surgeon, medical journals and former patients who have undergone the procedure. Make sure you understand what will be happening to you every step of the way.

Furthermore, be sure to check the credentials of the experts who are giving you advice. The ASPS emphasizes making sure that your surgeon is board-certified and that your outpatient surgery center is accredited.

Most of these are common-sense procedures that ought to be applied to any surgery you may need to undergo. When it comes to plastic surgery, as it is often not part of an emergency procedure, you have the opportunity to take some time and research the risks before assuming them.

More resources:

FAQ from the ASPS on Outpatient Plastic Surgery

Ten Plastic Surgery Risks You Need to Know

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