State requirements are preempted only when the FDA has established specific counterpart regulations or there are other specific requirements applicable to a particular device; and pre-market approval imposes "requirements" and it is specific to individual devices.
Petitioners, a patient and his wife, sued respondent medical device manufacturer after a catheter ruptured in the petitioner patient's coronary artery during surgery. The catheter was a Class III device that received premarket approval from the Food and Drug Administration (FDA). The district court granted summary judgment in respondent’s favor on the ground that petitioners' state tort law claims were preempted under 21 U.S.C.S. § 360k(a) of the Medical Device Amendments of 1976 (MDA). The appellate court affirmed the district court's judgment. Petitioners sought certiorari review of the appellate court’s judgment. The Supreme Court of the United States affirmed the appellate court’s judgment.
Did the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 U.S.C.S. § 360k bar petitioners’ common-law claims, challenging the safety and effectiveness of a catheter that was given premarket approval by the Food and Drug Administration (FDA)?
The federal government had established "requirements applicable to" respondent's catheter within the meaning of the Medical Device Amendments of 1976, 21 U.S.C.S. § 360k(a)(1). Premarket approval imposed "requirements" under the MDA because the FDA required devices that received premarket approval to be made with almost no deviations from the specifications in the approval application. Further, New York's tort duties constituted "requirements" under the MDA. Thus, petitioners' negligence and strict liability claims that related to safety and effectiveness were based on New York "requirements" with respect to the catheter that were "different from, or in addition to" the federal requirements.