Amicus News

No. 8. June 26, 1996

NO PREEMPTION, SUPREME COURT TELLS MEDICAL DEVICE MAKERS

The U.S. Supreme Court today ruled that the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act do not preempt state product liability causes of action against device manufacturers. Medtronic, Inc. v. Lohr, No. 95-754 (June 26, 19 96).

Lora Lohr had a cardiac pacemaker to correct an abnormal heart rhythm. The pacemaker failed, necessitating an emergency surgery and a succession of additional surgical procedures. She brought a product liability action alleging that the failure was due t o a defect in the pacemaker lead, manufactured by Medtronic. The federal district court dismissed the claim as preempted by the MDA. The Eleventh Circuit ruled that her claims for defective design were not preempted, but that claims of negligent manufactu re and failure to warn were preempted.

The Supreme Court held that none of Lohrs causes of action were preempted, including a state cause of action for violation of federal standards. Four dissenting Justices agreed that the claims based on design defect and violation of federal standards ar e not preempted, but would have held the negligent manufacture and failure to warn causes of action were barred.

Justice Stevens, for the plurality, emphasized the strong presumption against federal preemption of state law. In determining the scope of the express preemption of state requirements in the MDA, 21 U.S.C. 360k(a), he looks to the congressional purpos e underlying the statute. Justice Stevens dismissed as implausible Medtronics contention that Congress intended to shield manufacturers from claims by injured consumers. For Congress to have intended such sweeping preemption without comment would be s pectacularly odd.

Justice Breyer, concurring and dissenting in part, reached the same result as the plurality by a different avenue. Where the text of the statute could be construed as preempting state law, in the absence of a clear congressional command, Justice Breyer w ould give great deference to the interpretation of the administrative agency charged with administering the law. Here, the FDA has consistently stated its position that state product liability actions are not preempted.

Justice OConnor, concurring and dissenting in part, stated that the express preemption of state requirements clearly encompasses state tort causes of action. However, she found that only the manufacturing and labelling requirements of the FDA were suf ficiently applicable to the device to be preemptive.

The Courts decision overturns the great majority of lower federal court decisions, which had found preemption under the FDA. Moreover, the decision casts doubt on the preemptive effect of other statutes.

For further information , please contact Jeffrey White.

Phone: 202-965-3500 x310
FAX: 202-955-0920
E-Mail: jeffrey.white@justice.org