High Court to rule on preemption in medical device case.

The U.S. Supreme Court recently heard oral arguments on the scope of federal preemption of state law products liability actions under the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act. (Medtronic, Inc. v. Lohr, Nos. 95-754 and 95-886 (argued Apr. 23, 1996).)

Congress enacted the MDA in 1976 to extend the jurisdiction of the Food and Drug Admirtistration to the regulation of medical devices. Section 360k(a) expressly preempts any state "requirement . . . which relate; to the safety or effectivcness of the device," and which is different from or in addition to a federal requirement under the statute. Most federal courts have held that products liability awards constitute a state "requirement." The Ninth Circuit, however, has ruled that Congress did not intend to eliminate state products liability lawsuits. (Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir. 1995).)

In the case before the Supreme Court, Lora Lohr's heart pacemaker malfunctioned, necessitating extensive medical treatment. The district court granted summary judgment for the defendant, ruling that the MDA expressly preempted state products liability claims. The Eleventh Circuit affirmed in part, holding that Lohr's claims of manufacturing defect and failure to warn were preempted but that her claims of defective design were not. Lohr v. Medtronic, Inc., 56 F.2d 1335 (11th Cir. 1995). Both sides petitioned for certiorari, and the Court granted both petitions.

ATLA filed an amicus curiae brief, arguing that Congress did not intend preemption of the state "requirement" to include products liability actions.

Harvard Professor Arthur Miller, representing Medtronic, opened with the statement that Congress intended the preemption provision to be "very, very broad." It was Congress's purpose, he said, to sweld device manufacturers from tort liability so as to encourage innovation.

A number of justices were dearly skeptical. Justice Sandra Day O'Connor asked whether there was any evidence that Congress thought it was eliminating products liability claims, noting that it recently passed legislation that merely capped punitive damages for device makers. Chief Justice William Rehnquist remarked that the term "requirement" is not self-explanatory as including products liability suits. Justice Antonin Scalia questioned Miller's assertion that damage suits are preempted even where the company violated FDA regulations. "That's an extraordinary sweep," interjected the chief justice. Justice Ruth Bader Ginsburg observed that it would be odd for Congress to oust state tort law only with respect to medical devices and not for drugs as well.

Justicc Stephen Breyer suggested that in view of the fact that the text of the preemption provision appears to be ambiguous, it would not be appropriate to defer to the FDA's own interpretation of the provision. The agency has consistently construed the MDA as not preempting products liability lawsuits. Professor Miller responded that the FDA's interpretation was "untenable."

Brian Wolfman, staff attorney for Public Citizen representing Lohr, argued that the term "requirement" does not encompass damage actions. Most of his argument, however, focused on the fact that the pacemaker had been marketed under a "grandfather" provision that exempted it from premarket approval for safety and effectiveness. Hence, he contended, there is no federal requirement with respect to this product to preempt state law.

The United States also participated in oral argument, represented by Deputy Solicitor General Edwin Kneedler. He said the government's position is that the term "requirement" can include state common law, a retreat from the FDA's interpretation. However, Kneedler agreed with the plaintiffs position that, in the absence of premarket approval of the particular device, there is no federal "requirement" to displace state law.

A decision is expected before the Court's summer recess, probably late this month.