Healthy Skepticism Library item: 12133

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Publication type: news

Greenhouse L.
Supreme Court Hears Medical Device Case
New York Times 2007 Dec 5
http://www.nytimes.com/2007/12/05/washington/05bizcourt.html?_r=1&ref=health&oref=slogin

Full text:

WASHINGTON, Dec. 4 – Whether a federal statute pre-empts state law is a familiar issue at the Supreme Court, one the justices will face multiple times during the current term alone.

But during an argument on Tuesday, none of the court’s many precedents appeared to offer a clear path to answering the question in the latest case: whether the manufacturer of a medical device approved for sale by the Food and Drug Administration can be sued for damages under state law if the device injures a patient.

The device at issue was a balloon catheter that burst during an angioplasty, causing serious injury to the patient, Charles R. Riegel. He and his wife, Donna, sued the manufacturer, Medtronic, which had received approval to market the device in 1994, two years before the incident. Two lower federal courts in New York dismissed the suit on the ground that the F.D.A.’s “premarket approval” precluded the imposition of liability under state law.

The Supreme Court last looked at a medical device case in 1996, when it ruled that devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At that time, the federal government itself argued against pre-emption.

But in 2004, the Bush administration reversed the government’s position and began to take the manufacturers’ side, as it did before the justices on Tuesday in an argument by a deputy solicitor general, Edwin S. Kneedler. Explaining the change in policy, Mr. Kneedler said that in 2004, the F.D.A. “recognized that there would be a serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits if a state jury could reweigh those.”

A question in this case, Riegel v. Medtronic Inc., No. 06-179, is whether the court will give the government’s position the usual deference it accords an agency’s interpretation of its basic statute.

The federal law at issue is the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

Beginning with a case in 1992 about warning labels on cigarette cartons, the Supreme Court has treated the word “requirement” as including not only obligations directly imposed by state laws and regulations, but also the award of damages by state tort systems.

For a jury to say, “Well, gee, it should have been done differently in this particular situation” is the equivalent of imposing a requirement in addition to federal approval, Theodore B. Olson, the lawyer representing Medtronic, told the justices.

“The F.D.A. is the right place for these decisions to be made and this balancing process to occur,” Mr. Olson said, adding that while “nothing is perfectly safe,” it would harm consumers to “discourage the marketing of products that might save our lives.” Medtronic no longer makes the balloon catheter, called Evergreen, involved in the case.

While Mr. Olson’s argument clearly found traction with some justices, most notably Justice Antonin Scalia, the lawyer for the plaintiffs, Allison M. Zieve, was also effective in sowing doubts that “premarket approval” by the agency was rigorous enough to justify shielding the manufacturer from state liability.

Ms. Zieve, a lawyer with the Public Citizen Litigation Group, conceded that the law would prevent a state from imposing its own premarket approval process that differs from the federal one. But she said that premarket approval was a preliminary judgment of safety and effectiveness that did not relieve a manufacturer of an obligation to make a device better and safer.

Premarket approval was not “irrelevant to the tort suit” but was not by itself adequate to invoke pre-emption, Ms. Zieve said.

Several justices, including Anthony M. Kennedy, David H. Souter and John Paul Stevens, expressed concern about shielding manufacturers during a regulatory “hiatus,” after a manufacturer had discovered a problem with an approved device but before the F.D.A. had learned of it or taken action.

“There could be a newly discovered risk that the F.D.A. never knew about and, nevertheless, the claim would be pre-empted?” Justice Stevens asked Mr. Olson.

“Yes, and that’s a judgment that Congress made,” the company’s lawyer replied.