The Gist: Could FDA approval shield a maker of medical products or devices from negligence? Should it?

By Tommy Sangchompuphen, JD
for The Medical-Legal News

In what some legal experts are regarding as a classic federalism clash between medical device manufacturers and plaintiff attorneys asserting state common law claims, the U.S. Supreme Court on Dec. 4, 2007, heard oral arguments in a case that could prevent some injured patients from seeking redress through the state court system.

In Riegel v. Medtronic, the Supreme Court is confronted with the high-stakes question for injured patients and medical device manufacturers alike: Are state law product liability claims involving medical devices that received pre-market approval by the FDA preempted by a provision of the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act?

The Riegel case is the first of two — and possibly three — preemption cases that the Supreme Court will hear and decide this term, which partly reflects the Bush administration’s effort to federalize product safety standards in the interest of uniform regulation nationally, said attorney Mark Herrmann, a partner in Jones Day’s Chicago office and an editor of a blog on pharmaceutical and medical device product liability litigation at druganddevicelaw.blogspot.com.

The case was brought by the widow of a New York man who suffered severe medical complications when a balloon catheter manufactured by Medtronic burst during a procedure to clear his arteries. The widow’s lawyer asked the Supreme Court to reverse lower court decisions that blocked her lawsuit against Medtronic on the basis of preemption.

In rejecting the Riegel suit, the lower courts reasoned that if the plaintiffs reached trial and won, the damages would amount to a state requirement different from the federal FDA requirements because the complaint depended on state law.

The 1976 federal statute specifically said that states could not maintain requirements that were different from federal standards. But Congress did not specify that those federal standards preempted state common law claims, and medical device manufacturers did not make that argument until recently, Herrmann said.

But despite the lack of specific language regarding the preemption of state common law claims, some legal experts following the case are predicting a win for the medical industry.

“In passing the Medical Device Amendments of 1976, [Congress] said no state shall impose any device requirements different from or in addition to federal requirements, which are established through the [pre-market approval] process,” said attorney David L. Wallace, a partner in the New York office of Chadbourne & Parke LLP.

“Everyone agrees a state legislature can’t do it,” Wallace added. “If that’s so, then why should, of all things, a judge or lay jury be allowed to second-guess the expert, scientific judgment of a federal regulatory body expressly charged by Congress with assessing the safety and effectiveness of… medical devices?”

During oral arguments, several of the Supreme Court justices questioned the lawyers from both sides about the appropriateness of permitting a jury’s judgment about the safety and effectiveness of a medical device to second-guess the FDA’s approval process.

Justice Antonin Scalia noted, “What’s going on is simply one jury has decided that, in its judgment, there was a safer device that should have been used; and because of the judgment of that one jury, the manufacturer is placed at risk in selling a device that scientists at the FDA had said is OK. I find that extraordinary.”

Justice Anthony Kennedy expressed a somewhat similar concern. “The jury is doing the same thing that the FDA did,” Kennedy said.

James M. Beck, a defense lawyer at Dechert LLP in Philadelphia, said he is “cautiously optimistic” that the Court has at least five votes to uphold preemption based on the questions asked by the justices and the arguments made by counsel. “If I were a betting man I’d bet in favor of preemption,” he said. “But I’m not a betting man, and that’s why I’m cautiously optimistic.”

Still, Christine M. Humphrey, a founding partner of Fuerst Humphrey Ittleman in Miami with 14 years of FDA experience, said she is “hopeful that the Supreme Court realizes the reality that FDA clearance or approval does not equate to a manufacturer’s compliance with what is submitted on paper.”

“Manufacturers should not enjoy 100 percent shielding from liability at the state level,” she said, adding that physicians should still bear liability for off-label uses.

But some legal experts have expressed concern over the abilities of the FDA to adequately protect the American public from potentially dangerous medical devices, pointing to the FDA’s reliance on sloppy, inaccurate, incomplete or falsified test data in its pre-market approval process.

“The FDA isn’t infallible,” said Lucinda Jesson, a professor at Hamline Law School in St. Paul, Minn., saying that the FDA is underfunded and increasingly being criticized.

Humphrey added, “The FDA is supposed to serve as a watchdog. It is rare that an agency can effectively function as a watchdog when there is a commingling of duties and a severe lack of resources. I think that the FDA is suffering from both.”

But attorneys for medical device manufacturers say that such criticisms of the FDA are misplaced.

“The FDA carries a pretty big stick in its dealing with those it regulates,” Wallace said. “Failing in any of its obligations to the FDA, by fraud or otherwise, in seeking pre-market approval… can cost a manufacturer dearly in terms of serious criminal and civil penalties, not to mention reputational damage.”

Wallace added, “The FDA is quite capable of policing and monitoring regulatory compliance and its relationship with manufacturers, and does.” •

Tommy Sangchompuphen is a licensed attorney and legal writer based in Ohio. He is a graduate of the University of Minnesota Law School.