Supreme Court rules FDA has exclusive authority to regulate medical devices

Transplant News, March, 2008

The US Supreme Court has ruled that the US Food and Drug Administration (FDA) pre-market approval (PMA) process for medical devices preempts state tort lawsuits approved through that process.

The court ruled 8 to 1 that Congress has granted the FDA the exclusive authority to assess the proper balance in its pre-market review of the medical device in the case, Riegel V. Medtronic.

The decision of the Court is the first ever to rule on the legal effect of FDA pre-market device approval on tort lawsuits.

A Syllabus of the decision prepared by the Reporter of Decisions (of court decisions) for the convenience of the reader described Riegel v. Medtronic as follows: "Charles Riegel and his wife, Donna brought suit against Medtronic after a Medtronic catheter ruptured in Charles Riegel's coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held the Medical Device Amendments of 1976 (MDA) pre-empted the Riegels' claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit affirmed."

Stephen Ubi, president and CEO of the Advanced Medical Technology Association AdvaMed), called the ruling "a win for patients and public health and safety."

"The FDA - and not a patchwork of state regulations or multiple jury verdicts - should determine the safety and effectiveness of medical technology," Ubi said. "We are pleased the ruling will allow the FDA to continue its science-based approach to approvals and prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles."

"(The) ruling also expressly recognizes the rigorous pre-market approval process which entails extensive pre-clinical and clinical testing and thorough expert FDA review and risk analysis to ensure their safety and effectiveness" Ubi noted. "In addition, PMA-approval devices must comply with other rigorous post-market requirements including quality systems regulations, adverse event reporting and post-market surveillance. This is why many consider the FDA approval the gold standard for safe and effective medical devices."