Colorado Law Blog

Yesterday the U.S. Supreme Court ruled in a medical malpractice case, Riegel v. Medtronic, holding that the federal law, Medical Device Amendments, preempts any state laws regarding medical devices where the device manufacturer complied with federal requirements. By now, everyone is aware of how little protection is frequently offered by “federal requirements” when oversight is provided by agencies such as the Food and Drug Administration or the Consumer Product Safety Commission. Now state law can offer no protection against the negligently designed or manufactured medical device so long as federal requirements are satisfied – feel safer?

The Supreme Court found that Food and Drug Administration approval of medical devices preempts personal injury claims filed under state laws. Justices voted 8 to 1 in favor of preempting devices such as internal defibrillators that meet FDA specifications and were approved by the agency prior to being marketed to the public. Wednesday’s decision in Riegel v. Medtronic concerned only devices that were approved for market under the Medical Device Amendments of 1976.

In this case, Charles Riegel received a balloon catheter made by Medtronic which subsequently ruptured due to overinflation. Riegel developed a heart block and underwent emergency surgery. The Riegels later brought claims against Medtronic in the United States District Court for the Northern District of New York. The court found that the Riegels claims were preempted under the Medical Device Act, and the Second Circuit Court affirmed the decision. In this opinion, the Supreme Court affirms.

The Supreme Court held that state law claims regarding medical devices are preempted under the Medical Device Amendments (MDA) where the device manufacturer complied with federal requirements. In the opinion, the Court notes that review of the MDA turns on the definition of “requirements” in the statute. The decision states: “Absent other indication, reference to a State’s ‘requirements’ includes its common-law duties.” Thus, the holding expands beyond conflicting State regulations and statutes, which Congress was addressing in the MDA.

It appears that the Court tried to limit the decision in several ways.

• The opinion applies to medical devices only (not approved drugs) based on the preemption language included in the Medical Device Amendments.
• The Court draws a distinction between state law claims made regarding devices approved under substantial equivalent review requirements and §510(k) pre-market approval requirements.
• The Court discusses the extensive FDA review process for Class III medical devices only, rendering the application of the opinion to Class I and II devices uncertain.
• The Court expressly states that the decision does not apply to cases where the manufacturer did not comply with federal requirements.

Justice Scalia, writing for the Court, asserts that the “Dalkon Shield failure and its aftermath demonstrated the inability of the common law tort system to manage the risks associated with dangerous devices.” The opinion claims that lay juries do not appreciate the benefits of medical devices. “A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”

In her dissent, Justice Ginsburg’s first footnote states that the “Court’s holding does not reach an important issue outside the bounds of this case: the preemptive effect of §360k(a) where evidence of a medical device’s defect comes to light only after the device receives pre-market approval.”

For the complete opinion click here.

Posted by Linda Chalat at 04:38 PM | Permalink | Comments (0) | TrackBacks (0)

This week USA TODAY reported the discovery of a number of lawsuits that alleged corporate malfeasance in cases of pharmacy errors at Walgreens and CVS. Many were settled, and nearly all the settlements included confidentiality agreements.

Pharmacies have two major reasons to insist on confidential settlements. First, to avoid bad publicity in a field where public trust is important. Second, to keep potentially damaging information from plaintiff lawyers.

The problem is such agreements make it difficult to detect patterns of errors at pharmacies, though it's in the public interest to know if they exist. And just about any corporate defendant insists on some element of confidentiality as part of the settlement terms. Though plaintiffs’ attorneys appreciate the bad public policy established by these confidentiality terms, the lawyer’s duty is to the client whose interest may well be best served by the financial terms of the settlement.

Barry Furrow, director of the health law concentration at the Drexel University College of Law, writes textbooks on health law. "There's a whole world of research that's very hard to do," he says. "It is hard to find out much of anything, even if I talk to lawyers, because they can't tell me much. It's hard to spot patterns and see what's going wrong."

Walgreens disputes the assertion that it typically asks for confidentiality in settling such cases. "Rather than a strict policy," the chain said in a written statement, "we consider each case as unique and handle it individually." But few if any details regarding resolution of lawsuits filed against it are available to the public.

CVS, (CVS) which also answered in a written statement, said: "Confidentiality agreements are a common practice for all businesses in commercial transactions and in litigation. By including the confidentiality provision, CVS follows standard procedures typical for resolution of any liability claim."

Walgreens was required to supply recent prescription-error data chainwide in a Tennessee federal lawsuit filed by the family of Trey Jones, a 5-year-old mistakenly given an anabolic steroid. But U.S. District Court Judge Aleta Trauger granted Walgreens' motion for a protective order. She wrote that lawyers for Jones' family were entitled to the information for purposes of pretrial discovery, "but not for purposes of making a publicity 'splash' against the defendant."

A typical settlement includes boilerplate language such as this: Terms are "confidential and are not to be publicized, revealed, disclosed or discussed directly or indirectly with any representative of the print or electronic media, or to any professional or trade publication or organization."

Errors are generally not made public by state pharmacy boards unless disciplinary action is taken — even in cases of death or serious injury — according to Carmen Catizone, executive director of the National Association of Boards of Pharmacy.

North Carolina is the only state that makes public all errors involving death or serious injury, though the National Association of Boards of Pharmacy has tried for 10 years to persuade other states to mandate such reporting. After significant errors such as the Givens case make news, there are demands that errors be tracked. "But once that initial outrage dies down," Catizone says, "the issue is left to politics. Then we lose."

Posted by Linda Chalat at 12:56 PM | Permalink | Comments (0) | TrackBacks (0)

A Minnesota woman who was declared brain dead last month left the hospital Wednesday after a miraculous recovery. The 65-year-old suffered a massive cerebral hemorrhage in January. Life support had been disconnected. Somehow, she regained consciousness as her family began planning her funeral.

Dr. Martin Richards of United Hospital says "I think she probably had some stunning of her brain and then as that insult kind of resolved, at least partially, she was able to regain function."

In Georgia, Nonnie Hawkins had hoped for the same type of outcome, standing beside her daughter's hospital bed, steeling herself for a final goodbye. Physicians at DeKalb Medical Center, minutes earlier had disconnected a machine that was breathing for 18-year-old Tara Bottoms-Hawkins. Hawkins thought her daughter was in a coma, as she had been for four months. But doctors said the young woman was brain-dead.

It was March 18, 2004, two days after Tara gave birth to a premature son, bucking the predictions of some doctors who said the fetus wouldn't survive. She thanked each of the physicians for everything they had done to bring her grandson into the world, then accused them of having her daughter’s blood on their hands.

Thousands of people die daily across the country, almost all before they're declared brain-dead. That designation usually comes into play when a person suffers a traumatic injury or stroke and is attached to devices that maintain organ function.

When doctors determine the brain is not working anymore, families and hospitals usually agree that life support should then be removed. Sometimes, however, the family disagrees with the diagnosis.

That was the case with Nonnie Hawkins. About 10 minutes before her daughter was taken off the ventilator, Hawkins says people were gathered around the bed praying and pleading aloud, "Please wake up, the baby needs you," when Tara moved her hand. When Hawkins went to get the neurologist, he said it was just a reaction from the spine, she said.

Hawkins filed a lawsuit against DeKalb Medical Center, the doctor and DeKalb Neurology Associates on May 15, 2006, on behalf of her grandson. The lawsuit alleges medical malpractice, wrongful death and negligence. Hawkins said she never consented for the hospital to take her daughter off the ventilator. At the crux of the case is whether Tara was brain-dead or just brain-damaged.

Georgia law leaves the final decision on discontinuing treatment for brain-dead patients to doctors, not family members. DeKalb Medical Center tried to have the case dismissed, but the Georgia Court of Appeals said no, noting that for "incompetent adult patients" who may have some brain function remaining, the decision to terminate life support rests with the family.

The court has not yet ruled whether Tara's brain had ceased functioning, or whether a glimmer of life remained. DeKalb Medical Center maintains she was brain-dead, and that their decision to stop treating her was appropriate. The medical center appealed to the state Supreme Court. Beyond that, the hospital declined comment for this story.

Medical experts say that continuing to treat a brain-dead person is irresponsible and unethical. Nurses and doctors are already in short supply, as is hospital bed space.

But it may be more about money. Insurance companies won't pay for treatments to a brain-dead person, so hospitals have to eat those expenses.

People avoid discussing their end-of-life wishes until it's too late. Disputes between families and hospitals crop up because both sides think they know what's best. An advanced directive can sometimes provide guidance as to the patient's wishes. It tells caregivers whether to withhold or maintain life-sustaining treatment if a person is terminally ill, in a coma or in a persistent vegetative state.

An advance directive is a legal form or statement made by an individual to express preferences about life-sustaining treatment in the event they become unable to make such decisions or communicate them in the future. The Colorado bar Association provides a sample form of a “Living Will.”

Posted by Linda Chalat at 10:58 AM | Permalink | Comments (0) | TrackBacks (0)

A Santa Rosa woman who was badly injured by a bulldog has settled her lawsuit against the dog owner for $1 million. Wendy Rydberg will receive $900,000 and her husband and two children will receive about $33,000 each.

Rydberg suffered several facial injuries when a 90-pound American bulldog bit her face as she walked her own dog to pick up her kids. She spent four days in the hospital and has had three surgeries to minimize scars on her nose, cheek and lips.

The bulldog's owner was charged with misdemeanors and sentenced to four months in jail. The animal was killed by animal control officials. Sonoma County adopted tougher animal control measures after the attack on Rydberg and others.

Colorado has seen tougher animal control laws as well. In November 2005, the Aurora City Council adopted an ordinance banning pit bulls from the city.

Residents who already owned pit bulls were allowed to keep the dogs with restrictions, which include licensing, obtaining $100,000 in insurance in case the pit bull bites someone, and muzzling the dogs when they are taken out of the home.

Among the findings in a recent report evaluating the effectiveness of the ban:

• More than 635 pit bulls were euthanized in 2006, the first year of the ban, but only 173 in 2007; and 758 were impounded in 2006, compared with 269 last year.

• Also, the city issued 238 summonses for violations of the ban in 2006, compared with 137 last year.

• There was a slight increase, from eight to 11, in the number of dogs that bit humans between 2006 and 2007, but overall bites to humans and animals were down from 2003.

For the most part, officials were pleased with the ordinance's effect in regulating pit bulls.

Denver also has a pit-bull ban, and has prevailed when residents have tried to challenge it in civil court.

For an overview of Colorado law regarding dog attacks, see Beware Friends with with Fangs.

Posted by Linda Chalat at 12:49 PM | Permalink | Comments (0) | TrackBacks (0)

There is no medical malpractice lawsuit crisis in America, according to analysis released last month by Public Citizen. The new report, “The Great Medical Malpractice Hoax,” dispels oft-repeated myths of dwindling doctors and spiraling insurance premiums used to support limits on the ability of injured patients to seek redress in the courts.

Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 by Ralph Nader to represent consumer interests. The advocacy group reviewed publicly available information from 1990 to 2005 from the federal government’s National Practitioner Data Bank (NPDB), which contains data on malpractice payments made on behalf of doctors as well as disciplinary actions taken against them by state medical boards or hospitals. According to the analysis, the total number of malpractice payments paid on behalf of doctors, with judgments and settlements, declined 15.4 percent between 1991 and 2005, and the number of payments per 100,000 people in the country declined more than 10 percent. In addition, the average payment for a medical malpractice verdict, adjusted for inflation, dropped eight percent in the same period.

The numbers show that patients do not win large jury awards for less serious claims but that payments usually correspond to the severity of injury. In 2005, less than three percent of all payments were for million-dollar verdicts and more than 64 percent of payments involved death or significant injury – while less than one-third of one percent were for “insignificant injury.”

“Despite assertions by the medical and business lobbies that physicians are leaving practice because of burdensome malpractice lawsuits, the number of doctors is increasing faster than the population,” said Laura MacCleery, director of Public Citizen’s Congress Watch group. “In recent years, medical malpractice insurers have been reaping huge profits, not paying out excessive jury awards. The false claims of a malpractice lawsuit crisis are really about putting profits ahead of patients. They distract from real health care reform designed to improve patient safety, enhance efficiency and cut costs.”

Public Citizen’s analysis indicates that to limit preventable patient deaths and injury and rising health care costs, reforms should reduce medical errors and tighten lax doctor discipline and oversight.

To improve patient safety and prevent errors, Public Citizen recommends that Congress establish a national mandatory adverse event reporting system so that hospitals share information that can help them correct faulty systems and practices. To combat medication errors, hospitals should invest in computer physician order entry systems. This would avoid mistakes associated with illegible handwriting and automatically check for errors or bad drug interactions. Despite a 2006 study by the Institute of Medicine concluding that medication error is one of the most common preventable mistakes and costs as much as $3.5 billion annually, fewer than five percent of hospitals have implemented such a system. Hospitals and medical practices should also limit physicians’ workweeks to reduce fatigue-induced error.

Improving physician oversight is vital to addressing the small percentage of repeat offenders who continue to practice despite being responsible for a majority of malpractice claims in America. The report documents that just 5.9 percent of doctors have been responsible for 57.8 percent of the number of malpractice payments from 1991 to 2005, with each of these doctors making at least two payments. The vast majority of doctors – 82 percent – have never had a medical malpractice payment since the NPDB was created in 1990. State medical boards, which are largely responsible for doctor discipline, should be given greater funding and staffing, and be required to provide stricter oversight to prevent dangerous doctors from practicing in their own or other states.

Colorado ranks 8th in the nation for tight state oversight of physicians for 2004-2006, as indicated by the rate of serious disciplinary actions per 1,000 doctors in each state. Click here to see the table of rankings.

Greater disclosure of offenders would also provide consumers with the information necessary to make informed decisions about their health care. Congress should lift the veil of secrecy on the national database by allowing the public access to the names of doctors – which are now kept secret – and state legislatures should require state medical boards to improve their Web sites to provide better quality and accessibility of information about doctor discipline.

For the full Public Citizen report click here.

Posted by Linda Chalat at 01:34 PM | Permalink | Comments (0) | TrackBacks (0)

A recent development in back care was hailed as a dramatic breakthrough. In a study of nearly 240 patients with lower back pain, the doctors performing the study concluded that the Prodisc, an artificial spinal disk, had worked much better than conventional surgery in which patients’ vertebrae were fused.

“As a surgeon, it is gratifying to see patients recover function more quickly than after fusion and return to their normal activities more easily,” Dr. Jack E. Zigler, a well-known spine specialist and one of the study’s lead researchers, said in a 2006 news release announcing the latest results of the Prodisc clinical trial.

Dr. Zigler had more than his patients’ interest at heart when he spoke of being “gratified.” Dr. Zigler, a spine surgeon at the Texas Back Institute, was the first doctor in the United States to perform the Prodisc disk surgery in October 2001. Texas Back, considered one of the nation’s leading spinal medicine practices, has been among the most aggressive in advocating new devices like artificial disks. Yet confidential documents show that Dr. Zigler invested at least $25,000 in early 2002 in a fund created to finance Spine Solutions. So did doctors at about half of the 17 research centers involved in the study. They stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year.

In early 2005, when Synthes submitted the Prodisc study to the F.D.A. as part of the company’s application for approval, it used results for 162 patients who had received the device and 80 who had spinal fusion surgery. The results did not include 50 Prodisc patients who were considered “training cases” — surgeries performed to let doctors learn how to implant the devices. Such training is fairly common in device trials. An additional 21 patients, about 10 percent of those studied, were also excluded from the reported results. An unusually large number of patients were not included, and some of those patients have said they fared poorly.

The F.D.A.’s rules allow clinical investigators to have financial ties with the maker of the device or drug they are studying — on the condition that such relationships are fully disclosed. Lawyers who have worked with the F.D.A. say that when it becomes aware of potential conflict, it tends to subject research to a higher level of scrutiny.

The F.D.A. now says it is checking to see whether there was adequate financial disclosure information about the Prodisc researchers during the clinical trial and at the time that the subsequent application for approval was submitted.

The way the Prodisc was tested and approved clearly demonstrates the conflicts of interest among many clinical researchers — conflicts that are seldom evident to doctors and patients trying to weigh the value of a new device or drug. Instead of serving as objective researchers who can identify potentially harmful or ineffective new devices or drugs, clinical researchers with conflicts may stand to profit by overstating the success of testing. Doctors in this country frequently have financial ties to the companies whose devices or drugs they recommend to patients.

Even though fusion surgery continues to be the treatment of choice, there is substantial debate over how many patients actually benefit from it. Now, artificial disks are drawing reconsideration. Thousands of patients worldwide have received the Prodisc, which sells for about $10,000 in the United States. But Medicare and several commercial insurers generally refuse to pay for the surgeries, which can cost tens of thousands of dollars.

And many of the Prodisc investor-researchers are now focusing their attention on newer spinal devices — often for companies with whom they also have financial ties. Dr. Zigler, for example, is a researcher for a new spine-stabilizing device made by Applied Spine Technologies, where he serves as a paid member of the company’s scientific advisory board.

But while doctors may easily move on to the next new treatment, many patients are still struggling with the aftermath of Prodisc procedures.

Posted by Linda Chalat at 01:32 PM | Permalink | Comments (0) | TrackBacks (0)