Heymach v. Cardiac Pacemakers, Inc.

OPINION OF THE COURT

Richard M. Klein, J.

The issue before the court is whether plaintiff’s State law tort claims are preempted by Federal law.

*585In 1976, Congress enacted the Medical Device Amendments to, in the words of the statute’s preamble, “provide for the safety and effectiveness of medical devices intended for human use.” (Pub L 94-295, 90 US Stat 539 [MDA].)

The case at bar presents the question whether a premarket approval (PMA) granted under the Federal Medical Device Amendments preempts a State common-law negligence action against the manufacturer of an allegedly defective pacemaker.

The…