Supreme Court Immunizes Device Manufacturers Even If Their Products Are Unreasonably Dangerous

The Supreme Court in an 8 to 1 decision held that The Medical Device Amendments of 1976 (MDA) preempted lawsuits alleging common law tort causes of action. The decision, certainly not unexpected, will make it difficult for patients injured by defective medical devices to be compensated for their injuries.

          Donna Riegel had brought suit against Medtronic after a Medtronic catheter ruptured in her husband’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 that the MDA preempted 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 and now so does the Supreme Court.      

          Writing for the majority, Justice Scalia reasoned that the FDA spends substantial time reviewing each device application and grants premarket approval only if it finds there is a “reasonable assurance” of its “safety and effectiveness. . . It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”  Attacking the jury system which has done as much to protect consumers from dangerous drugs and devices as the agency viewed by many as too friendly to BigPharma, Scalia wrote that  jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts because a jury “sees only the cost of a more dangerous design, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court.” Apparently Scalia is unfamiliar with the way product liabilty cases are tried. Manufacturers in such cases always present evidence of the benefits their product provides.

          Such a decision does real harm to consumers and ignores the history of unreasonably dangerous drugs and medical devices which slipped through the many hours of FDA scrutiny. While plaintiff’s lawyers are an easy target for critics, they have repeatedly uncovered the dangerous propensities of medical devices and drugs which had received the safe and effective stamp of approval by the federal agency charged with protecting consumers but has all too often answered to industry.

         In its opinion, the Court leaves for another day the question of whether suits against drug manufacturers should similarly be preempted. While we are not optimistic with respect to how the Court will answer that question, drug manufacturers cannot rely on a federal statute such as the MDA to support their argument that they should be immune from suit even if they release drugs whose benefit does not outweigh the potential for harm.

Alan Milstein