Rulings limit patients' ability to sue device firms, drugmakers

But consumer advocates and some physicians say the courts should continue to complement, not compromise, the FDA's role.

By Amy Lynn Sorrel — Posted May 12, 2008

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Some physicians and consumer advocates worry that a recent U.S. Supreme Court ruling and a pending case could take away a key agent in patient safety when it comes to medical devices and pharmaceuticals -- the courts.

In late February, justices ruled 8-1 that patients injured by certain medical devices approved by the Food and Drug Administration cannot sue the product's manufacturer. The court said federal regulations preempt state-based liability claims challenging the design or labeling of medical devices that clear the FDA's premarket approval process.

Allowing such lawsuits disrupts the system that the FDA uses to weigh the risks and benefits of new devices when evaluating their safety and effectiveness, Justice Antonin Scalia wrote for the majority in Riegel v. Medtronic. "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 this case, the plaintiff alleged that her husband had been injured by a faulty balloon catheter that burst during heart surgery. The man died. Medtronic said the FDA-approved product had been used improperly.

Another case pending in the Supreme Court could grant similar protection to pharmaceutical companies. Oral arguments in Wyeth v. Levine are scheduled to begin this fall. Meanwhile, the 3rd U.S. Circuit Court of Appeals in April blocked two lawsuits accusing drugmakers of failing to adequately warn patients of side effects. Judges said the cases conflicted with the FDA's labeling regulations. The plaintiffs alleged that the makers of Paxil (paroxetine) and Zoloft (sertraline) -- GlaxoSmithKline and Pfizer respectively -- did not include strong enough warnings about potential suicide risks associated with the antidepressants. The companies argued that was inconsistent with findings by the FDA, which explicitly refused such enhanced warnings for antidepressants due to a lack of scientific evidence, court records show.

Both the Supreme Court and the 3rd Circuit noted that the FDA has thorough processes for approving medical devices and medication warnings.

But some doctors and consumer advocates say the decisions come at a time when the FDA -- challenged by a lack of funding and resources -- cannot monitor the industries adequately. The courts, they say, have provided an important check on the system.

"It's the responsibility of [drug and device] manufacturers and the FDA to provide physicians and patients with adequate information to make informed decisions," said cardiologist William H. Maisel, MD, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston. "The problem is that hasn't happened, and one way that information has come to light is through the legal process."

Dr. Maisel pointed to a recent spate of drug and medical device recalls -- and subsequent lawsuits -- as examples of manufacturers' failure to disclose publicly any possible defects in their products. Once the problems have been discovered, he added, the companies and the FDA have lagged in passing that information along to doctors in a timely manner.

Baltimore City Health Dept. Commissioner Joshua M. Sharfstein, MD, said the FDA has limited authority to elicit certain information from drug and device companies. Without the threat of liability, manufacturers may have less incentive to disclose potential problems with their products, making the FDA's job more difficult.

"The system works best when there are multiple safeguards, and completely removing one of those safeguards may not be best for patients," said Dr. Sharfstein, who last year helped lead a petition asking the FDA to evaluate the safety of over-the-counter cough medicines for children.

For decades, the courts complemented the FDA's role, not contradicted it, said Allison Zieve, a lawyer with Public Citizen, a consumer advocacy group representing the plaintiffs in the medical device and drug cases before the Supreme Court.

Without that accountability, not only is patient safety endangered, "but there is no other mechanism for injured patients to get compensation," Zieve said.

Dissenting judges in both the Supreme Court and 3rd Circuit agreed that the courts have long provided an important check on the federal regulatory system.

Consistent standards

The FDA declined to comment. In court briefs, the government argued that agency regulations were intended to preempt liability claims challenging the safety, efficacy or labeling of certain approved medical devices or drugs. Manufacturers agree, saying they must be able to adhere to a single standard without being second-guessed by state juries lacking in scientific expertise.

"The FDA is the gold standard of regulatory approval," said Medtronic spokesman Rob Clark.

Medtronic supports reforms to improve the FDA, he said. But by allowing the courts to step in to address product safety, "we would be instituting requirements lay juries impose on [medical device] design without that level of diligence and clinical expertise." That could end up doing more harm than good by compromising the safety of a product shown to benefit a majority of patients, Clark said.

The Pharmaceutical Research and Manufacturers of America, an industry trade group that submitted a friend-of-the-court brief in Wyeth v. Levine, said court interference also could undermine the FDA's ongoing oversight of drug safety and impede patients' access to available treatments. In addition, conflicting or varying court decisions can distort the true risks and benefits of a drug and confuse doctors and patients, PhRMA argued in its brief.

Other recourse; doctors at risk?

David C. Vladeck, a Georgetown University law professor who specializes in health regulation, said medical device makers remain subject to liability if they fail to follow the FDA approval process. Still, the Supreme Court decision leaves patients with little remedy, he said.

"Consumers get the worst of both possible worlds. We don't have an FDA capable of guaranteeing safety, and now, when injured through no fault of their own, [patients] have to bear the consequences," Vladeck said.

Richard Samp, chief counsel with the Washington Legal Foundation, a public policy group that supports limits on lawsuits, said companies should not be penalized for following the FDA's rules. The foundation filed a court brief in Riegel v. Medtronic and plans to do so in Wyeth v. Levine.

Samp said states still can regulate device manufacturers -- for example, by requiring truthful advertising or packaging -- as long as the state mandates do not exceed or differ from FDA requirements. Physicians also can be held liable if they contributed to a patient's injuries, he said.

Meanwhile, congressional lawmakers might try to pass a bill to override the Supreme Court ruling.

"In enacting legislation on medical devices, Congress never intended to give blanket immunity to manufacturers from liability for injuries caused by faulty devices," Sen. Edward Kennedy (D, Mass.), chair of the Senate Committee on Health, Education, Labor & Pensions, said in a statement. "Congress obviously needs to correct the court's decision."

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Case at a glance

Are drug and medical device companies immune from personal injury suits when their products are FDA-approved?

The Supreme Court said FDA regulations preempt claims against medical device makers for certain approved products. The high court this fall will take up another case asking for similar protections for drugmakers.

Impact: Consumer advocates and some physicians say the courts have aided patient safety by flushing out potential problems with drugs and medical devices. Manufacturers say that in order to make safe products, they need one standard to follow without being questioned by layperson juries that lack the requisite scientific expertise.

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