November 27, 2014

Suggested Reading: How Counterfeit Surgical Screws Found Their Way to Market and Cost People Their Health

Over the summer, the Center for Investigative Reporting (CIR) broke the story of surgeons who used counterfeit screws and rods in spine surgery, causing crippling outcomes and mounting lawsuits. Now, the CIR has published the back story in a chilling tale of greed and regulatory sloth.

Ortho Sol makes precision screws for spinal fusion surgery. In 2009, it repossessed some of its screws after Spinal Solutions LLC failed to pay for them. An Ortho Sol executive noticed that some of the screws it got back were counterfeit, that Spinal Solutions had replaced high-quality, safe equipment, with cheap knockoffs that had been implanted in the necks and backs of who knows how many people in the U.S.

Two years later, a whistle-blower from Spinal Solutions tipped off the FDA about the counterfeiting, and even then, the feds didn’t shut down the company. “By the time Spinal Solutions went broke in 2013,” CIR reports, “the company had sold millions of dollars in implants to a nationwide network of surgeons.”

Some surgical patients have suffered debilitating pain and infections from the counterfeit screws, but others whose doctors were among the recipients of Spinal Solutions shipments that mixed legitimate and counterfeit screws are left wondering about their future.

“What do they do if they find out there are these bogus parts that can come unscrewed?” Susan Reynolds told CIR. Her doctor used Spinal Solutions screws in her surgery in 2009. “I’m a walking time bomb.”

Many doctors received lucrative consulting deals from Spinal Solutions, and in return, used the company’s implants for their surgeries at hospitals in California, Nevada, Texas, Wisconsin and Maryland. CIR has no evidence they knew the screws were counterfeit, but some doctors have been accused of with taking kickbacks for using them.

Read the whole story from the Center for Investigative Reporting here, And see our original blog about the defective equipment, “Counterfeit Equipment for Spine Surgery Spurs Lawsuits,” here.

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November 26, 2014

FDA Delays Regulation to Restore Legal Rights for Consumers Hurt by Generic Drugs

For several years, a legal battle has waged over whether generic drug manufacturers may change warning label information if the brand name drugs they replicate have not done so. So, to protect consumers from court rulings that left them vulnerable, the FDA proposed a regulation allowing generic drug makers to update their labels before receiving the agency’s approval. But now, the feds have delayed that action.

The problem with hamstringing companies that know their products might be harmful was described in our blog last year about a woman who took a generic drug for shoulder pain, and landed in a burn unit for two months in a medically induced coma when it had a devastating effect on her skin.

Permanently disfigured, she sued because the drug was “unreasonably dangerous,” and learned she wasn’t the first person to have suffered an adverse event — it was known that the generic drug’s rate of life-threatening conditions was comparable to another drug the FDA had recommended be removed from the market.

The U.S. Supreme Court originally prohibited injured patients from suing generic drug companies because the information on labels was deemed to be the exclusive responsibility of the pharmaceutical companies that developed the brand name drug. The court said that if the generic manufacturers are prohibited from printing warnings about drug side effects, patients shouldn’t be able to sue them when bad things happen after taking the drug.

As described in the Wall Street Journal’s Pharmalot blog, last year the FDA proposed a rule to allow generic drug makers to update safety warnings as they determined a need to do so. The rule was supposed to be finalized next month, but now, it won’t be published until nearly a year from now.

The questionable character of this industry was described last week on the civil justice site PopTort. It called out Ranbaxy, the country’s sixth largest generic drug maker, which has a history of “fabricating data, lying to regulators and forging documents.”

It took the FDA years to stop approving the compromised Ranbaxy drugs, and when it did, the company sued, claiming the feds had violated its constitutional rights and deprived it of rightful revenue.

“You see,” PopTort observes, “Ranbaxy believes it has a constitutional right not only to make money but also to sue to enforce that right. But anyone killed or injured by unsafe Ranbaxy drugs? They should have no legal rights at all, apparently.”

The proposed regulation, FDA officials have said, was meant to “create parity” between brand-name and generic drug makers. “Since the passage of the 1984 Hatch-Waxman Act,” Pharmalot noted, “generic drug makers have not been required to run tests to prove their medicines are the same as brand- name drug and, therefore, have not had to upgrade labels with safety information.”

The consumer advocacy organization Public Citizen, which had lobbied the FDA to address the generic labeling restriction that harmed people, wasn’t pleased about the delay. Pharmalot quotes Allison Zieve, head of the litigation group at Public Citizen: “The extra nine months or so of delay allows a safety gap to continue that can only lead to harm. No drug is safe in all situations. A drug is safe when used in accordance with labeling that accurately reflects the known risks. The sooner generic drug companies are allowed to make safety updates, the better for public health.”

Generic drug manufacturers protected by the Supreme Court’s ruling are concerned that the proposed rule will encourage lawyers to find situations that appear to be negligence if the drug makers don’t act quickly enough to add warnings to product labeling.

Well, shouldn’t potential cases of negligence be investigated and, if necessary, pursued? Do these companies truly think personal injury lawyers, who are paid only if they can prove their cases and win judgments for their harmed clients, have time to poke around in search of questionable events? So-called “ambulance chasers” make good fictional villains, but drug-harm litigation is long and laborious, and it’s ridiculous to think legions of people engage in it on spec.

The Generic Pharmaceutical Association, the industry’s trade/lobbying outfit, issued a think piece that concluded that such litigation could add $4 billion to the nation’s annual health-care bill, and that its survey of 450 physicians, physician assistants and pharmacists showed that the proposed rule would require additional time to keep current with labeling changes.

Yeah, doing the right and responsible thing can be time-consuming. Often, it’s faster just to slide dangerous products into the marketplace, and hope for the best.

According to Pharmalot, “The contentious nature of the debate [consumers versus drug makers] is apparently the reason for the delay. An FDA spokeswoman wrote us that the ‘FDA received a great deal of public input from various stakeholders during the comment period on the proposed rule. We are committed to reviewing and considering all of the comments received as we develop the final rule.’”

That sounds like the feds caved into industry pressure, not that the delay reflected prudent reconsideration.

If you think political leaders are lining up behind consumer safety, think again. “[S]ome lawmakers have questioned the authority of the FDA to propose such a rule,” Pharmalot reported. A House committee report said the rule has “the potential to threaten public health by creating unprecedented patients and provider confusion by having multiple labels for the same product,” which, according to Pharmalot, “would undermine a policy of having the same label for brand and generic drugs.”

So a better policy is to let the potential serious harm go unrecognized?

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November 24, 2014

Hospitals Also Are Guilty of Overusing Antibiotics

Despite years of consciousness-raising about the overuse of antibiotics and the consequent difficulty of developing new, effective drugs to fight infection, hospitals continue to give too many patients too many kinds of antibiotics.

A report recently published in the Journal of the American Medical Association (JAMA) concluded that about half of all hospital patients receive antibiotics they don’t need, and that the drugs put them at risk of side effects that could make them even sicker.

This careless practice contributes to the increasing resistance of pathogens to drugs.

As we regularly blog, because antibiotics are overprescribed, “superbugs” are flourishing, and developing new drugs to fight them is increasingly harder as the invaders get stronger and stronger.

In addition to hospitals, doctors overprescribe antibiotics for a variety of reasons, and patients demand them in the belief that doing something is better than nothing. In this case, it isn’t.

The JAMA study, as described on, involved researchers from the Centers for Disease Control and Prevention (CDC) who learned that often, the antibiotics weren’t even given to treat a diagnosed infection or because hospital patients had a significant risk of infection — they were being administered to prevent infection.

It’s one thing to take some vitamin C because you think it will help fend off a cold (research shows it won’t, but small amounts won’t hurt you), and it’s quite another to take a powerful anti-bacterial drug when you don’t harbor the pathogen, nor run the risk of being in contact with it.

Apart from building resistance to medicine, overprescribing antibiotics can cause serious harms. Levaquin, for example, is part of a class of medications known as fluoroquinolones. They have been associated with severe nerve damage, tendon ruptures and other problems, and lawsuits have proliferated against its manufacturer, alleging that it offered misleading and inadequate warnings about the risk of peripheral neuropathy (nerve damage).

The drugs do carry warnings about peripheral neuropathy, but earlier versions said the incidence was rare and often resolved when the drugs were no longer used. The warnings were strengthened in 2013 to say that the drugs can cause permanent nerve damage.

Peripheral neuropathy causes pain, burning, tingling, numbness, weakness and sensitivity to light touches, temperature and motion in the arms and legs.

The most commonly overprescribed antibiotics in hospitals were these brands, or their generic equivalents:

  • Levaquin

  • Vancocin

  • Rocephin

  • Zocyn

Of the more than 11,000 hospital patients surveyed in 2011 in 183 hospitals in 10 states, not only were half given at least one antibiotic, almost 1 in 3 were given two antibiotics, 12 in 100 got three, and more than 5 in 100 were given four different antibiotics. But only about 3 in 4 actually had infections.

Others were given the drugs when they had surgery, and for about 7 in 100, remarkably, there was no documented rationale for why they got antibiotics.

As AboutLawsuits noted, treating illnesses with several different types of antibiotics simultaneously increases the patient’s risk of future infection. Often, hospitals are generous with antibiotics in an effort to treat illnesses that are difficult to diagnose early. But even after a diagnosis was made, the study showed, patients were still on several types of antibiotics.

Many antibiotics treat only specific pathogens. So if they’re not wiping out certain pathogens, they’re making them stronger, and harder to treat with the meds that have been developed for them.

If you or a loved one is hospitalized, make sure you understand every drug you’re given, whether it’s oral, intravenous or topical (cream). If you don’t have an infection and you’re given an antibiotic, find out why.

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November 23, 2014

Calling Out the Corruption in Medical Care

When physicians air their grievances on the New York Times op-ed page about how health care in the U.S. is undermined by dark forces, even skeptics should pay attention.

In a commentary last week called “How Medical Care Is Being Corrupted,” Drs. Pamela Hartzband and Jerome Groopman declared that “financial forces largely hidden from the public are beginning to corrupt care and undermine the bond of trust between doctors and patients. Insurers, hospital networks and regulatory groups have put in place both rewards and punishments that can powerfully influence your doctor’s decisions.”

A doctor’s treatment decisions, of course, should be based on what’s best for the patient, not what’s best for the infrastructure that’s supposed to enable the best care, not thwart it.

Hartzband and Groopman, who teach at Harvard Medical School, explain that cold numbers are poor drivers of quality care. What’s commonly called “metrics,” or numerical standards doctors are supposed to meet under contracts for medical care that reward “pay for performance,” are derived from whole population studies. That is, they’re generic standards for large groups of people, not measures to be applied to individual patients. People are different, and although metrics are useful in research and in shaping policy, they’re woefully inadequate in the assessment and support of a single human being.

Metrics, the writers say, do not account for patient preference, differing opinions or optimal practice for a given doctor-patient circumstance. Yet metrics are what the industry demands from providers if they expect financial support.

“[D]octors are rewarded for keeping their patients’ cholesterol and blood pressure below certain target levels,” Hartzband and Groopman cite as an example. “For some patients, this is good medicine, but for others the benefits may not outweigh the risks. Treatment with drugs such as statins can cause significant side effects, including muscle pain and increased risk of diabetes. Blood-pressure therapy to meet an imposed target may lead to increased falls and fractures in older patients.”

But physicians who meet designated targets for such values might receive not only a bonus from an insurer, but high ratings on the company’s website. Patients and potential patients generally would assume the high rating denotes high quality. The doctors who don’t meet the values are penalized financially through lower payments and “shamed” by lesser status on the website when, in fact, they might well be the superior practitioner, from the patient’s perspective.

It’s a great business growth model, and a lousy model for understanding human variables.

Doctors are only human; they’re not immune from the pressure to comply with the metrics. They might feel, say the writers, “pressured to withhold treatment that they feel is required or feel forced to recommend treatment whose risks may outweigh benefits.”

When you have a choice of drugs to treat a certain problem, there’s as much art as science in figuring out which is best for the patient. Genetics, living circumstances, age, gender, mobility … lots of things figure into the decision of who should get what drug.

Insurance companies don’t care. The writers decry how often larger co-payments are imposed on certain drugs as a way to dissuade doctors and patients from choosing higher-cost medications that, in the artful judgment of the people who know best, are the best match.

The writers offer WellPoint as an example. It’s one of the largest private underwriters of health care. It recently “outlined designated treatment pathways for cancer and announced that it would pay physicians an incentive of $350 per month per patient treated on the designated pathway.”

Bad call. As Hartzband and Groopman note, oncologists (cancer doctors) are hardly unified about what is optimal in cancer care. They regularly treat patients who deviate from treatment guidelines, and embracing that deviation is what drives one of the most significant recent advancements in cancer treatment — the concept of customized care, of targeted therapy.

It used to be that everybody with a certain kind of cancer, for example, got the same kind of chemotherapy drug in the same dose. Some did fine, some didn’t. But now cancer patients might get one of several kinds of chemotherapy drugs, they might be switched around or they might get a combination, depending on their genetic profile, the severity of side effects and other factors.

So, should oncologists make chemotherapy (or any drug) decisions based on these factors or based on adverse effects on payment? “Further,” the writers note, “some health care networks limit the ability of a patient to get a second opinion by going outside the network. The patient is financially penalized with large co-payments or no coverage at all. Additionally, the physician who refers the patient out of network risks censure from the network administration.”

How dare actuarial interests put doctors in a moral dilemma when a patient asks, as he or she should, “Is this treatment right for me?” What if the insurer covers the cost of one drug, but the doctor doesn’t believe it’s the “right” treatment?

Is health policy always and only about what’s best for a whole population? Can policy never bend to the individual good?

“We fear this approach can dangerously lead to ‘moral licensing,’” write Hartzband and Groopman — “the physician is able to rationalize forcing or withholding treatment, regardless of clinical judgment or patient preference, as acceptable for the good of the population.”

As medicine moves away from the old paternalism when patients never questioned, much less participated, in their care, it’s moving toward a new paternalism imposed by the insurers and regulators that control payment.

The writers propose that these powerful outside interests be subject to the same kind of transparency that the Physician Payments Sunshine Act established to expose (with mixed results) potential conflicts of interest by physicians with financial ties to pharmaceutical and device companies. “We propose a similar public website to reveal the hidden coercive forces that may specify treatments and limit choices through pressures on the doctor.

“Medical care is not just another marketplace commodity,” they conclude. “Physicians should never have an incentive to override the best interests of their patients.”

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November 20, 2014

FDA Reminds Consumers that Nonprescription Drugs Can Impair Driving

Although many people believe that any medicine you can buy without a prescription can’t hurt you if you follow the directions, that’s not necessarily true — all drugs have potential side effects, and some over-the-counter (OTC) meds can impair your ability to think and react quickly enough to perform common functions as you normally would.

The FDA recently issued a warning to consumers that many common OTC drugs, including antihistamines, can make you drowsy, and compromise your ability to think and react quickly. People who take these drugs should ensure they’re functioning normally before they drive or use dangerous tools or machinery.

The warning reminded consumers to choose their nonprescription drugs carefully, and use them only as the directions dictate. And medicines specifically for adults should never be used by children — see our blog, “Feds Try Harder to Make Manufacturers Test Drugs for Use by Children.”

As described on, certain drugs are more likely to impair your ability to function. One such class is antihistamines, which are found in many common cold, flu and allergy medications to treat a runny nose, sneezing, itchy throat and watery eyes. Often, antihistamines are added to other active ingredients to reduce pain and fever, but often cause drowsiness.

Diphenhydramine, the active ingredient in Benadryl, can make you drowsy, unfocused and slow to react. Loperamide, the active ingredient in Imodium, which treats diarrhea, can cause drowsiness.

Drugs that treat nausea, vomiting and dizziness are called anti-emetics. They’re also listed in the FDA warning because they can make you sleepy and fatigued.

A drug’s effect can vary — sometimes you’re affected for a short time after you take it, and sometimes the effect can last hours. Some drugs leave you with a “hangover” effect the next day.

If you feel lousy enough to consider taking these meds, do so when you don’t have to drive or perform functions with equipment that has the potential to hurt you if your attention or dexterity isn’t up to par.

As AboutLawsuits noted, every drug has “Drug Facts” information to help consumers make safe choices. There’s also information about how the drug might make them feel, including warnings about drowsiness or driving.

If you take other medications, prescription or otherwise, ask your doctor before you add anything new, especially if you take sedatives or tranquilizers. Combining drugs can intensify or reduce the effect of another drug, or the combination can present a risk of harm neither on its own produces. Also, even OTC meds can interact with alcohol, supplements and some foods.

Pay attention to the active ingredients in all the drugs you take — the FDA warns against taking more than one medication with the same active ingredient, because that can cause additional side effects. Acetaminophen, the active ingredient in Tylenol, is a well-known example of too much of a good thing. Too much of this drug can damage your liver.

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November 19, 2014

Too Few Women Are Screened for Cervical Cancer

Earlier this year, experts concluded that most women don’t need annual pelvic exams, but they also confirmed that regular Pap tests are still necessary to screen for cervical cancer. The Centers for Disease Control and Prevention, however, recently concluded that millions of women are not getting this test.

According to the CDC, 8 million women 21 to 65 years old haven’t been screened for cervical cancer in the last five years. Like all life-threatening cancers, early detection is the best way to prevent or treat cervical cancer.

Every year, more than 12,000 U.S. women are diagnosed with cervical cancer, and for more than 4,000, it’s fatal. According to the CDC, more than half of women diagnosed with cervical cancer have never or seldom been screened.

A Pap test screens for abnormal cells that may develop into cancer. The test is not painful, and consists of a doctor scraping cells from the cervix for analysis by a lab. Generally, vaginal cells also are tested for the presence of the human papillomavirus (HPV), which causes most cervical cancers.

If abnormal cells are found, they can be removed before developing into cancer.

Because of its proven ability to prevent transmission of the virus, the HPV vaccine is recommended for middle-school boys and girls, before they become sexually active. Although boys, of course, can’t get cervical cancer, they can transmit the virus to their sexual partners.

Unfortunately, as we’ve blogged, the vaccine isn’t being given to everyone who should have it. Only 1 in 3 girls and 1 in 7 boys have finished the three-dose series that can protect against not only cervical cancer, but cancers of the penis, anus, mouth and throat.

Regular cervical cancer and HPV screening for women is simple and affordable — the Affordable Care Act (“Obamacare”) requires that health insurers provide all cancer screenings at no charge to the patient.

As explained by NBC News, CDC experts reviewed national surveys from 2012, and found that more than 11 in 100 women reported that they had not been screened for cervical cancer in the past five years, often because of a lack of health insurance: Nearly 1 in 4 women without health insurance and 1 in 4 without a regular doctor or other health-care provider said they hadn’t had a screening.

Lack of screening doesn’t just reflect lack of money. Dr. David Fishman, an expert on women’s cancers, told NBC that “Women who should be having Pap smears are not getting plugged in, and this is a significant problem in our country. The Pap smear, in my opinion, is the most powerful tool in the history of medicine to detect precancerous change such that no woman should ever die from cervical cancer.”

Annual cervical cancer screening isn’t necessary: The United States Preventive Services Task Force (USPSTF) and the American Cancer Society recommend that women 21 to 65 get either a Pap smear or a test for HPV every three years. Some experts believe that women older than 65 who have had three “clear” screens in a row needn’t be screened again, but others believe that’s too young to stop screening. A study this year suggested that women older than 65 might have a higher risk of cervical cancer.

Bottom line: if you’re female, get a Pap test and/or an HPV screen at least every three years, and more frequently if you’ve had a positive result in the past.

To understand what’s involved in the standard, but outdated pelvic exam, and why it’s different from a Pap test, see our blog.

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November 17, 2014

Robotic Technology Costs More and Has More Complications for Ovary and Cyst Removal

The use of robots in the surgical suite has a checkered history and a fat file of lawsuits by patients who suffered burns, bleeding and other serious harms. Another study has added to the record of woe: robot-assisted surgery to remove ovaries or ovarian cysts had more complications than more traditional and less invasive procedures, such as laparoscopy, and also was more expensive.

For these procedures, laparoscopy involves making a small incision into which surgical tools are inserted; robotic surgery involves the vaginal insertion of instruments controlled by the surgeon using a joystick. Screen-generated images guide both procedures.

As reported by (KHN), research by Dr. Jason Wright, chief of gynecologic oncology at Columbia University, suggests that removing ovaries with the help of a robot cost about $2,500 more than laparoscopic removal, and removing cysts cost $3,300 more.

Even more worrisome for most people than the additional cost, however, is that the women whose surgeries had been performed with the assistance of a robot were slightly more likely to have complications, including bladder injury, bowel obstruction or excessive bleeding.

We’ve called into question the widespread use of robotic surgery many times (here and here). Many people believe that although some disorders are appropriate for robotic technology, it’s overused because surgeons and hospitals make huge investments in the equipment, which encourages their maximum use, even if it isn’t the best option for certain procedures.

The Wright study reviewed the operations of nearly 90,000 women who had ovaries or cysts removed between 2009 and 2012, comparing the cost and safety of robotic surgeries with laparoscopy.

The study “really questions the utility of using robotic-assisted surgery,” Wright told KHN. “More studies need to be done before it’s accepted as the standard of care.”

The data didn’t show why there were complications. But recent reports of software glitches, battery malfunctions and difficulties in seeing through the robotic system’s lens were noted on the FDA’s Manufacturer and User Facility Device Experience database. We’ve blogged about poor surgeon training, as well.

Despite the extra cost and complications, Wright’s team said that the use of robots for these kinds of procedures is on the rise, from about 3.5 in 100 ovary removals in 2009 to 15 in 100 in 2012. Cyst removals showed a similar trend.

For now, according to Wright, “Patients need to understand the risks and benefits of different procedures… The newest, most high-tech thing that’s available isn’t necessarily the best.”

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November 16, 2014

Hospital Settles with Ebola Victim’s Family

Last week Texas Health Presbyterian Hospital settled the malpractice claims brought by the family of Thomas Eric Duncan, the man who died of Ebola because of serial mistakes the Dallas facility made.

Although the terms of the settlement weren’t disclosed, the family’s attorney, according to the Los Angeles Times, said it was comparable to what a jury might have decided in a civil lawsuit. In Texas, of course, that’s not much — it’s one of many states that cap malpractice judgments. In the Lone Star state, the maximum a harmed party may receive for pain and suffering against a physician is $250,000, and damages against a hospital are the same amount.

But the fast resolution tells a story beyond the fact that mistakes were made that demanded redress for the patient’s family. The underlying message is, that for all its initial missteps we blogged about last month (See “Ebola Patient’s ER Discharge Was Classic Malpractice”), ultimately the hospital did the right thing: The chief executive apologized to the family, and again publicly in a letter printed in local newspapers.

And when the settlement was announced, hospital officials repeated the apology in no uncertain terms.

Capping the amount aggrieved parties may receive as a result of medical malpractice is unfair, and undermines justice, especially when the amounts are as low as Duncan’s relatives presumably received. As PopTort, the civil justice blog, noted last week, Texas law essentially immunizes hospitals, which doesn’t exactly incentivize them to reduce errors and promote patient safety.

But at least the dirty laundry was washed with dispatch. We can only hope Presbyterian Hospital continues to do the right thing: Don’t screw up, and when you do, don’t dance around the truth — acknowledge what happened, who got hurt and make a meaningful gesture to make it better.

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November 13, 2014

Judge Smacks Down Nursing Home For Trying to Force Arbitration on Customers

A judge in Pennsylvania did the right thing last week in tossing out a mandatory arbitration clause in a lawsuit concerning neglect at a nursing home.

Readers of this blog know that forcing people into arbitration when there’s a dispute that rightfully belongs in a court of law is never good for the aggrieved party. (See our blog, “Arbitration Agreements: Bad for Consumers, Good for Nursing Homes”.)

Forced arbitration not only deprives you of your right to be heard in a court of law, often it’s demanded of people when they’re in a vulnerable, helpless state. Arbitration, which is always forced onto consumers by businesses, never the other way around, is promoted as an objective, time-efficient and money-saving approach to settling disputes.

But the opposite usually is true: Arbitrators with a reputation for rewarding the plaintiff often find themselves out of work because industries remove them from the list of suitable arbitrators both sides must use to select one. Arbitration doesn’t necessarily save time and legal fees, because even if the consumer wins, he or she still retains counsel in many cases, and must pay a share of the arbitrator fees.

The Pennsylvania case concerned Manor Care, according to It’s one of the largest nursing home management companies in the U.S. Its contract forced the family of a resident of a facility in Reading, Penn., to arbitrate their claim that their loved one was abused, and that the nursing home was negligent.

A woman discovered that her mother was taken to the nursing home by her day nurse. When the daughter arrived there, she was told to sign the arbitration agreement, as AboutLawsuits says, “during the emotional upheaval of discovering that her mother was there.”

Judge Jeffrey Sprecher ruled that the agreement was too heavily weighted in favor of the facility, was misleading and violated the law. He called the arbitration agreement “unconscionable,” and said that the daughter was not authorized to sign the agreement for her mother; that the agreement was designed so that the people signing it wouldn’t understand its effect.

“Most families and residents are unaware that they are signing away their right to file a nursing home lawsuit in the event the facility provides negligent or sub-standard care,” according to AboutLawsuits, “and that they have little choice but to sign the agreement when they are faced with the need to move themselves or a loved one into a skilled nursing facility.”

A similar forced arbitration agreement in a Florida Manor Care nursing home lawsuit also was found to be unenforceable in 2011. In that case, the Florida Supreme Court found that many of the provisions in the agreement, including a $350,000 cap on noneconomic damages and an agreement that the resident could never receive punitive damages, violated Florida law and could not be enforced.

Learn more about the evils of forced arbitration agreements on our blog, “Potential Dangers of Arbitration Agreements.”

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November 12, 2014

Too Many Stress Tests Involve Unnecessary Exposure to Radiation

Cardiac stress testing can be a useful tool to assess heart function, but since it became trendy for companies to subject their executives to treadmill stress tests as part of their annual checkups, the technology has grown too big for its britches.

That’s paraphrasing the results of a study published recently in the Annals of Internal Medicine. The study, as summarized by, showed that “Inappropriate use of cardiac stress testing — particularly testing done with imaging — is costing the U.S. health care system more than half a billion dollars,…”

But in addition to the cost, cardiac stress tests with imaging subject people to radiation, which the study says each year might lead to as many as 500 future cases of cancer. So the overuse of this technology isn’t just a waste of money, it’s a threat to patient safety.

The overuse of imaging tests, as readers of this blog are aware, often figure into discussion about rising health-care costs, and some of their providers are starting to get religion. As MinnPost noted, professional medical associations have issued new practice guidelines limiting their use, and the Choosing Wisely campaign says flat out that people with a low risk of heart disease probably shouldn’t have these tests, even if they have symptoms. That’s also true for people who have been diagnosed with heart disease but who have no symptoms.

The cardiac stress test involves the patient using a treadmill or stationary bike while being hooked up to devices that measure heart rate and blood pressure. Generally, the speed, elevation and/or resistance of the exercise machine are increased, requiring greater exertion.

When imaging is included, a radioactive substance is injected into the patient’s bloodstream at rest, then again during the exercise. The illuminated substance is tracked to the heart via a special scanner similar to an X-ray machine. It’s known as a nuclear stress test.

The researchers in the new study wanted to find out why the use of cardiac stress testing was on the rise in the U.S.: The number of cardiac stress tests performed every year has more than doubled in the last two decades, from 1.6 million per year in 1993-1995 to 3.8 million per year in 2008-2010.

That means, according to MinnPost, in 1993, 28 in every 10,000 patients visiting their doctor underwent a stress test. In 2010, it was 45 in 10,000.

Some of the inflated numbers, researchers said, reflect an aging population, a demographic at higher risk for heart disease. But that can’t explain why imaging as part of a standard stress test has grown so much. Not only is that component much more expensive, but, said MinnPost, “studies have found [they] don’t add much, if any, extra clinical value. The current study found that the proportion of cardiac stress tests done with imaging — primarily nuclear stress tests — has exploded, from 49 percent in 1993-1995 to 87 percent in 2008-2010.”

At least 1 in 3 of those imaging tests probably was inappropriate, the researchers concluded. They cost $494 million annually and exposed people to radiation that could lead 491 of them to develop cancer later in life.

The same number of stress tests that don’t include imaging would cost about $7.7 million a year.

Like so much else in the medical-industrial complex, the profit motive is a big factor here, the lead researcher suggested. When a facility has fancy, expensive equipment, it wants — and needs — to use it. “Nuclear imaging stress tests command higher reimbursement,” Dr. Joseph Ladapo of New York University’s Langone Medical Center told one reporter. “No one likes to talk about this but there is plenty of evidence that physicians respond to financial incentives.”

And, Ladapo noted, there’s a widespread belief that “more intensive technology equals better care, something that we are increasingly finding to not be true. And the behaviors or practices are passed down to trainees in residency programs, so it’s a hard cycle to break.”

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November 10, 2014

Electronic Medical Records Can Frustrate Doctors and Threaten Patients

When it comes to medical malpractice, doctors are concerned about something the rest of us haven’t thought much about —the use of electronic medical records.

Writing on, Neil Chesanow, senior editor of the site geared toward health care practitioners, explains how a doctor can be sued if his or her medical records compromise patient safety or confidentiality.

As we’ve written, although mistakes happen and some need to be corrected through legal means, the single best way a doctor can avoid being sued is to make the doctor-patient relationship a priority of care.

That means communicating often, and with respect. Studies have shown that health-care providers who admit their mistakes, and apologize, are less likely to be sued. This seems especially so in terms of record-keeping.

Being compensated for having been medically harmed isn’t about vengeance, it’s about rightful redress of grievances. And people who have strong relationships are much less likely to be aggrieved about mistakes of minimal consequence.

A lot of Medscape’s professional readers say that electronic health records (EHRs) are time-consuming and make patient visits longer. Many try to streamline their use, and in the process leave themselves vulnerable to malpractice lawsuits.

“Even if your EHR has a bug or design flaw,” Chesanow writes, “it's up to you to contact the vendor to get it fixed. Otherwise, if a patient is harmed as a result of the glitch, you may bear the blame in court. That's what the vendor contract you signed essentially says: The buck stops with you.”

Here are some ways physicians might try to make EHRs more efficient but that could put you at risk:

  • copying and pasting large pieces of text from one record to another

  • sharing a single password with several staffers in the practice

  • ignoring pop-up support prompts

Asking your doctor about these habits can be difficult; it can make him or her defensive. Practitioners are frustrated by the demands of insurance paperwork and medical facility administration; many feel like they’re forced to use a certain system, then held liable when it doesn’t work. Like everybody else, they get irritated by the idiotic demands by faceless corporations and technology that doesn’t work as it’s supposed to.

Here’s how one doctors expressed his frustration. "The software engineers employed by my office's EHR vendor are arrogant, unresponsive to my requests, and write a simple sentence so poorly that their emails are unintelligible. I am dismissed as a nuisance by the vendor because I don't have any financial authority over the EHR. From a malpractice standpoint, I feel my only options are to quit or keep a record of my complaints and how they have been ignored by the vendor."

So when you ask about how your records are kept, be sympathetic to their plight — a doctor who sees you as a partner instead of a difficult busybody is more likely to tell you what you need to know, and to protect your interests.

"The best doctors were the country doctors," one provider told Medscape. "Doctor to patient — not doctor to computer gizmos, and somewhere in this hole of technology is the patient. Could you throw me a rope, please?"

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November 9, 2014

Doctor Demonstrates How Malpractice ‘Reform’ Won’t Cut Health-Care Costs

Like abortion, gun control and Obamacare, medical malpractice is a hot-button issue that makes people claim crazy things to make a point. People who want the truth about the effect of malpractice “reform” on the cost of health care should listen to Dr. Aaron E. Carroll.

Writing last week in the New York Times, Carroll, a professor of pediatrics at Indiana University School of Medicine, reviewed statistics and studies to reach the conclusion captured in the title of his op-ed: “Malpractice Reform Won’t Do Much to Reduce Health Spending.”

We regularly weigh in on the pressures felt by harmed patients and their advocates when so many interests try to deprive them of their rights by capping the amount a jury can decide they are due. In his commentary, Carroll focuses on one claim these forces make that is demonstrably wrong: that if you “reform” the legal system, the cost of health care will drop.

“The rationale for malpractice reform as cost control is somewhat complex,” Carroll writes. “It assumes the existence of ‘defensive medicine,’ meaning that doctors order additional tests, or perform extra procedures or recommend more visits, all because they think those actions will protect them from being sued. Doctors fear an ‘epidemic’ of lawsuits so much that they practice wasteful medicine to shield themselves from nuisance cases, this theory goes.”

Fear, Carroll shows, should take a back seat in favor of fact.

As he notes, through examining the National Practitioner Data Bank’s statistics about malpractice payments made on behalf of doctors, there’s no “malpractice crisis”; the number of those payments has declined steadily for 10 years.

That doesn’t mean malpractice and protecting against it isn’t costly, but its relative expense pales in comparison to other health-care costs.

Carroll’s review of one study in 2010 showed that the estimated cost of malpractice to be more than $55 billion a year, including about $5.7 billion paid to plaintiffs for damages caused by medical error, and $4.1 billion for expenses such as legal fees and the administration of justice. The rest, about $45.6 billion, was for defensive medicine.

That’s a lot of money, but consider: That study concluded that the cost of the malpractice system was 2.4% of all health-care spending.

Even if you believe that health-care is more expensive because doctors are afraid of being sued, Carroll says, theoretically reform could reduce fear, and waste. It doesn’t.

“In 2003,” Carroll reminds us, “Texas passed a law that capped noneconomic damages at $250,000 per year. The idea was to decrease the number of suits, lowering overall indemnity payments, which would lead insurance companies to decrease premiums for malpractice insurance. This, coupled with reduced claims, would make doctors feel safer, and therefore reduce their practice of defensive medicine.

“Health care spending didn’t go down in Texas, though. In fact, Medicare spending per beneficiary went up more quickly in Texas after the change than it did in the rest of the country.”

As we reported last month, the New England Journal of Medicine published a study about the changes in emergency-room care in Texas, Georgia and South Carolina, which also capped damages in 2005. Compared with neighboring states without similar laws, those states had no significant changes in factors like how often imaging was used to rule out problems and and how many patients were admitted to the hospital.

In other words, “reform” didn’t change anything.

The evidence of how misguided it is to effect positive change through taking away harmed people’s right just mounts. Carroll looked at another study of more than 15 million medical insurance claims in 30 states with varying levels of risk of malpractice suits to compare how the same conditions were treated in states with high malpractice-suit risk and in states with low risk.

The difference wasn’t much. “[E]ven if malpractice premiums fell by as much as 30% (which would be huge),” Carroll summarizes, “overall spending on defensive medicine would drop only 0.4%.”

So, he suggests, even with capped damages and reduced indemnity payments, the cost savings aren’t always passed on to physicians in the form of lower malpractice insurance premiums, and so they don’t change their defensive behavior.

“Sometimes those savings are pocketed by insurance companies, as they appear to have been in Florida since malpractice reform passed there in 2003,” Carroll says. “If that happens, there’s no reason to believe doctors will practice much differently.”

But if fear of being sued does contribute to the practice of defensive medicine, it’s not the only thing that does. As Carroll notes, doctors order tests, procedures and consultations for lots of reasons. “The most glaring one is that usually physicians are paid for doing so. Other times, physicians want to play it safe not only because they might be sued, but also because they think it’s in the best interests of their patients to double- or triple-check some detail.”

He refers to a recent study in JAMA Internal Medicine that analyzed how many orders were defensive in nature, and how much of the decision for that procedure was defensive. The doctor subjects rated their own orders using a “defensiveness score” from 0 (not at all defensive) to 4 (completely defensive).

Defensive orders were not uncommon, but being defensive as the sole reason for ordering a test was, accounting for less than 3% percent of overall treatment cost.

“If we’re being honest,” Carroll says, “this is the waste we might trim by malpractice reform — and while 3 percent of medical spending is nothing to turn up our noses at, a one-time reduction of that amount, even if achievable, won’t do much for the long-term problem.

Meanwhile, other orders may also be “defensive,” but if they’re also being issued for reasons unaffected by legal reform, they would continue to made in the future.”

“… There are many legitimate reasons to reform the malpractice system,” Carroll concludes. “It just doesn’t appear that reducing health care spending is one of them.”

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