DC Medical Malpractice & Patient Safety Blog

A group of malpractice victims who met with White House officials last year have just sent this new letter to the President:

January 28, 2011

President Barack Obama
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

Dear President Obama:

On March 1, 2010, the undersigned five survivors of medical negligence and family members had the honor of meeting with the White House Office of Public Engagement about the issue of medical malpractice. We were extremely grateful for this opportunity.

We noted in our July 7, 2009 letter to you requesting this meeting that, “People like us and our families certainly do not feel as though doctors and hospitals practice too much ‘defensive medicine,’ or that lawsuits against negligent providers are frivolous, or that there is any justification for eliminating or restricting the right to jury trial in medical malpractice cases.” We wanted the opportunity to explain to you why patients injured by medical malpractice should not be blamed for our nation’s health care costs, and that the only real medical malpractice problem in this country today is the unacceptable amount of preventable errors and negligence.

We asked for a chance to be heard and we were hoping that we were. For example, one of the things for which we asked at this meeting was that you not continue to use the language “frivolous lawsuits” to describe this nation’s malpractice problems. Frivolous medical malpractice lawsuits are rare; medical errors are rampant. This language is incredibly hurtful to those of us who have been devastated by medical negligence and have sought justice in the courts.

At this meeting, we were told that this was one request that seemed “doable.” It is now apparent that the results of this meeting were not communicated. Therefore, we are again respectfully requesting a White House meeting, but this time with you or an office that will communicate the results of the meeting to you directly.

Thank you for considering this request. We look forward to hearing from you.

Sincerely,

Molly Akers,
New Lenox, IL

Kaitlyn, Mark, and Dr. Amy Fought,
Blacksburg, VA

Dylan Malone,
Everett, WA

Kathy, Scott, and Steven Olsen
Chula Vista, CA

Patty Skolnik
Denver, CO

A panel of experts set up to probe the effectiveness of opioid treatment agreements has decided not to support the universal utilization of these arrangements, also known as pain agreements or pain contracts.

Pain agreements outline the risks and benefits of opioid therapy, explain what is expected of the patient, educate the patient about how to store the drugs and help the patient distinguish between acceptable and unacceptable drug-taking. Physicians who provide pain management to patients with chronic pain may require such agreements to avoid liability issues if patients misuse their medications.

However, critics say the agreements can result in a more adversarial physician-patient relationship (because the physician can “fire” the patient if he or she doesn’t adhere to the terms of the “contract”).

The real problem, many critics maintain, is the lack of pain specialists. As a result, primary care physicians, many of whom lack appropriate training in pain management, may take the path of least resistance and overprescribe pain medications at the request of patients.

The panel of physicians and pain-policy experts, which was convened by the Center for Practical Bioethics, a Kansas City, Mo.-based think-tank, concluded it could not support the universal utilization of pain contracts at this time due to “the lack of data about the benefit of pain agreements/contracts, concerns about increasing disparities and further stigmatization of pain patients, and other possible unintended consequences, coupled with the importance of preserving the integrity of medicine from inappropriate outside influence.”

Source: American Medical Association News

For more information and analysis of the panel’s conclusions, click here.

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.

An overdose of news media hype has long been a problem for consumers who want high quality health care but don't want to bounce from health fad to health fad. Naive and uncritical journalists who write about health care issues are a huge source of the hype overdose. So it's great to learn about a Web resource that systematically and thoroughly reviews health news and rates the quality of the stories.

The site is the somewhat stodgily named HealthNewsReview.org. With a foundation grant, it employs a team of medical journalists and physicians to critically review health news in major publications. The stories get rated on a scale of one to five stars, based on how well the following issues were addressed:

* What's the total cost?
* How often do benefits occur?
* How often do harms occur?
* How strong is the evidence?
* Is this condition exaggerated?
* Are there alternative options?
* Is this really a new approach?
* Is it available to me?
* Who's promoting this?
* Do they have a conflict of interest?

The site says its goal is: Holding Health and Medical Journalism Accountable. And it lives up to that by naming names and taking no prisoners on current health news.

A recent Wall Street Journal piece that suggested Vitamin B12 as a potential cure-all got a low two-star rating for putting out a series of unsubstantiated claims with loose anecdotes and little evidence.

A Denver Post article on an "anti-gravity treadmill" scored a lowly one star for glorifying an unproven product.

NPR and CNN Health scored highly for their well done columns on the recent research about antibiotics for kids with middle ear infection.

I give the site five stars for being a very useful resource. It asks the right questions about medical news and gives straight answers. I'm particularly keen on conflicts of interest and other things that tend to get underplayed in much coverage: for example, the hidden harms of touted new medical devices.

Article first published as Hype Busters: Helping Patients Get Better Health Care With a Dose of Skepticism on Technorati.

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

A new style of cosmetic liposuction leaves patients fully awake with only local injections of lidocaine to control their pain at the site where the doctor is suctioning their body fat. It's a bad idea all around -- dangerous, painful, and a potential tragedy to boot.

The "Awake" treatment is touted as a way for patients to experience their liposuction fully awake. But why would anyone want to? It's not better for patients. It only allows the operating doctor to skip the extra charge of having an anesthesiologist or nurse anesthetist present to keep the patient sedated safely.

Lidocaine, the local anesthetic drug typically used in so-called "tumescent liposuction," is no cakewalk drug. Too much injected into a patient's system can travel to the heart and numb the nerve fibers that transmit the electrical impulses that make the heart fire -- causing a rhythm disturbance or complete cardiac arrest.

A client of mine went into cardiac arrest and suffered severe brain damage before her heart could be restarted, in a liposuction procedure a few years ago in Montgomery County, Maryland. Her heart stopped for this very reason: too much lidocaine injected too quickly into her body fat. We brought a successful malpractice lawsuit for her against the plastic surgeon, but nothing could restore her health.

Lesson for patients: Anyone undergoing any type of surgery whatsoever should insist on at least the presence of a certified nurse anesthetist, and a doctor specializing in anesthesiology should be present too in the building to provide backup for any emergencies.

A chapter in my book, "The Life You Save," details this issue and other points about how to get the safest surgery.

Here is a news article alerting consumers about the dangers of the "Awake" technique.

To avoid the risk of "severe liver injury," the Food and Drug Administration (FDA) wants manufacturers of prescription combination products containing acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. Manufacturers also will have to update warning labels on these products to alert consumers about the potential risks.

Acetaminophen, better known as Tylenol, its most popular brand name, is a pain reliever and fever reducer sold over the counter (OTC) as well as in prescription products in combination with other ingredients, such as codeine (Tylenol & Codeine), oxycodone (Percocet) and hydrocodone (Vicodin). The FDA action affects prescription products only, not OTC medications.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

The elimination of higher-dose prescription combination acetaminophen products will be phased in over 3 years. “There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” Kweder said. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

Because of continued reports of liver injury, FDA also wants to see boxed warnings, the agency’s strongest warning for prescription drugs, added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time or drank alcohol while taking acetaminophen products.

Source: Food and Drug Administration.

Click here for more information and a list of affected products.

A West Virginia couple who had been awarded more than $1.5 million in damages in a medical malpractice case only to have the award cut by two-thirds is challenging the state law that caps medical malpractice payouts to victims.

The husband developed rhabdomyolysis after being given a combination of medications at a West Virginia hospital. A jury awarded the couple $1.5 million for pain and suffering and $129,000 for medical expenses and lost wages, greatly exceeding West Virginia’s malpractice damages cap.

The cap, originally $1 million when enacted in 1986, has been cut repeatedly and now stands at $250,000 for most cases and $500,000 for the most severe. The cap applies no matter how many plaintiffs there are, so multiple plaintiffs have to split the award, which can be no more than $500,000.

In the rhabdomyolysis case, the man was awarded $1 million for his pain and suffering and his wife $500,000, but their claim was reduced to $500,000 in total for both of them. The couple is arguing that the damages cap is unconstitutional because it interferes with the right to a trial by jury and prevents the jury from making the ultimate decision in the case.

Lobbyists representing physicians and insurance groups have filed a brief in the case arguing that the caps should remain in place in order to keep malpractice insurance rates affordable and to prevent physicians from leaving the state. The case has been appealed to the West Virginia Supreme Court.

Source: Renal and Urology News December 2010

A wrongful death and medical malpractice lawsuit has been filed against a Vancouver, Wa., pain clinic by four plaintiffs who allege the clinic prescribed excessive amounts of pain medications, causing overdose deaths and addictions.

The estates of two patients who died of opiate overdoses are suing Vancouver Payette Clinic in Clark County, Wa., circuit court, along with two other plantiffs who allege the clinic prescribed them "grossly excessive" amounts of controlled substances that caused physical and mental injuries.

"Payette Clinic practitioners knew or had reason to know that the massive quantities of controlled substances they were prescribing were either being diverted by patients and sold in the illegal drug market, or being taken by their patients at great risk to the patient's own health," the suit says.

The clinic was previously been linked to the Dec. 9, 2008 overdose death of an 18-year-old girl.

The lawsuit contends that between January and November 2007, five people prescribed opiates by the clinic died from prescription overdoses, ranging from methadone to morphine intoxication.

The suit contends the clinic failed to do pill counts or give its patients random drug tests to control the massive amount of pills prescribed. It said a man died from a drug overdose Sept. 29, 2009 after a nurse practitioner prescribed him over 5,000 morphine sulfate tablets, in addition to other drugs, between June 2007 and July 2008. At the time of his death, he had over 2000 200-mg morphine sulfate tablets in his possession.

The Payette Clinic was raided by federal narcotics agents in March 2009. By December 2009, the advanced nurse practitioners at the clinic forfeited for 2 years (until December 2011) their licenses to prescribe Class II opiates, including oxycodone, Oxycontin, methadone or morphine.

Source: The Oregonian

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.

Now that President Obama has signed historic food-safety legislation into law, the coalition of food industry, public interest and consumer groups that supported the new law must convince the new Congress – including the majority Republican House of Representatives pledged to shrink the federal bureaucracy – to fund it.

The law aims to shift the mission of the Food and Drug Administration (FDA) from reacting to tainted food after an illness occurs to preventing outbreaks in the first place.

Funding the new law would be “money extremely well spent to save money over the long run," Erik Olson, director of food and consumer safety programs at the Pew Health Group, says, pointing to a recent study that estimated that food-borne illnesses cost the country $152 billion a year in medical costs, lost productivity and other expenses – not including costs to the food industry when a product is recalled.

The Congressional Budget Office estimated that the food safety law would cost about $1.4 billion in its first five years, including the cost of hiring an estimated 2,000 additional food inspectors. Rep. Jack Kingston of Georgia, the ranking Republican on the Appropriations subcommittee that oversees the FDA, says the number of cases of food-borne illnesses in the U.S. does not justify the cost of the new law.

The FDA has yet to say how much of the new law can be implemented without additional funds from Congress, though FDA Commissioner Margaret Hamburg says that “some of the key elements of this bill need to be adopted no matter what.”

The new law requires manufacturers and farmers to develop strategies to prevent contamination and then continually test to make sure they work. The legislation also gives the FDA the authority to recall food; currently, it must rely on food companies to pull products voluntarily from the shelves. The law also gives the FDA access to internal records at farms and food-production facilities.

Under the law, importers would be required for the first time to verify that products and ingredients from overseas meet U.S. safety standards. Inspections of farms and food-processing operations would be stepped up and the FDA would be required to visit "high-risk" facilities --those where contamination is likely to occur -- once every five years initially and then once every three.

The measure will affect about 80 percent of the food supply that is regulated by the FDA, but does not affect meat, poultry and some egg products, which are overseen by the Department of Agriculture.

Source: Washington Post

Federal and Massachusetts state health investigators have cited a Boston teaching hospital for making at least three surgical errors in the last four months of 2010, all of which involved surgeons operating on the wrong vertebrae during spinal surgery. Two of the surgeries were performed by the same surgeon, whose name has not been released.

The spike in spinal surgical errors at the Beth Israel Deaconess Medical Center -- one of Harvard's teaching hospitals -- was notable, because hospitals across Massachusetts had reported only 11 similar incidents from 2006 through 2008. Officials noted that the incidents were unrelated and attributable to human error on the part of the surgeons.

Wrong-site surgical errors are considered to be “never” events (i.e. events that should not happen if the surgeon and medical staff follow the appropriate standards of medical care). The hospital said it had procedures in place to prevent such errors, and said it could not explain how the incidents happened if those procedures were being followed.

In a recent study, U.S. researchers found that errors in judgment were involved in 85% of wrong-site surgical errors and that in 72% of the medical mistakes in the operating room, the surgical team failed to take a “time out” to assess the situation and make sure their surgical plan was correct.

In all three cases at the Beth Israel Deaconess, the doctors completed the surgery without realizing that the vertebrae they were working on was undamaged and just below or above the part of the spine that was actually injured. Two of the errors were discovered during post-surgical X-rays, when patients continued to suffer back pains, and the third was discovered in a routine postoperative X-ray.

Source: About Lawsuits.com

You can view an abstract of the study in Archives of Surgery here.

The idea that doctors order unnecessary tests to avoid being sued has enough surface plausibility that people nod "of course" as if it's undeniable truth. The "fraud" of "defensive medicine" is two-fold: It doesn't really happen, at least not that anyone has ever proven, and even if it did happen, it would mean that doctors were committing fraud -- insurance fraud by ordering tests to protect their own rear ends and not to benefit the patient.

This is back in the news because the new Republican leadership of the House of Representatives wants to hold hearings about how cutting back on patients' rights to sue for redress when they've suffered preventable injuries from medical malpractice will allegedly improve the budget deficit.

Joanne Doroshow of the Center for Justice and Democracy has a new column in the Huffington Post that takes on this issue.

An excerpt:

While anonymous doctor surveys provide the principal foundation for the argument that widespread "defensive medicine" exists, credible organizations who have looked into the issue have had a very hard time identifying pervasive "defensive medicine," especially when managed care companies are paying the bill. For example, the Congressional Budget Office found tiny health care savings - "0.3 percent from slightly less utilization of health care services" - if severe tort reform were passed nationally. According to the CBO, if there is any problem at all, it's with Medicare, specifically its emphasis on "fee-for-service" spending, whereas private managed care "limit[s] the use of services that have marginal or no benefit to patients (some of which might otherwise be provided as 'defensive medicine')."

But there is another issue. In these anonymous surveys, doctors never actually identify specific tests or procedures they have conducted for the primary purpose of avoiding a lawsuit, let alone a service they would no longer perform if severe "tort reform" were enacted.

Read more here.