Amicus News

Supreme Court Hears Arguments in MDA Preemption Case

At the first meeting of the 1995-96 AAJ Amicus Curiae Committee, the Committee decided that its top priority would be to fight against federal preemption of product liability actions under the Medical Device Amendments to the federal Food, Drug and Cosm etic Act. The Court granted review of a case presenting that question. Medtronic, Inc. v. Lohr, Nos. 95-754 and 95-886 (cert. granted Jan. 19, 1996).

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

In the case before the Supreme Court, Ms 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 product liability claim s. The Eleventh Circuit affirmed in part, holding that Ms Lohrs 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.

AAJ filed an amicus curiae brief, arguing that Congress did not intend preemption of 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 purpose, he stated, to shield device manufacturers from tort liability so as to encourage innovation. A number of justices were clearly skeptical. Justice O'Connor asked whether there was any evidence that Congress thought it was eliminating product liability claims, noting that Congress recently passed legislation that merely capped punitive damages for device makers. Chief Justice Rehnquist remarked that the term "requirement" is not self-explanatory as including product liability suits. Justice Scalia questioned Miller's assertion that damage suits are preempted even where the com pany violated FDA regulations. Thats an extraordinary sweep, interjected the Chief Justice. Justice Ginsburg observed that it would be odd for Congress to oust state tort law only with respect to medical devices, but not for drugs.

In view of the fact that the text of the preemption provision appears to be ambiguous, Justice Breyer suggested, would it not be appropriate to defer to the FDAs own interpretation of the provision. The FDA has consistently construed the MDA as not pree mpting product liability lawsuits. Professor Miller responded that the FDAs interpretation was untenable.

Brian Wolfman, staff attorney for Public Citizen representing Ms. 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" pr ovision 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 stated that the governments position is that the term requirement can include state common law, a retreat from the FDAs interpretation. H owever, Kneedler agreed with 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 Courts summer recess, probably in late June. A copy of AAJs amicus brief can be downloaded from AAJ/NET at www.justice.org in the Courts section. A limited number of bound copies are available upon request to Jeffrey White.

Phone: 202-965-3500 x310

FAX: 202-955-0920

E-Mail: jeffrey.white@justice.org