A U.S. Supreme Court opinion ending a widows pursuit of damages from Medtronic over a ruptured balloon catheter forecloses some lawsuits against medical-device makers but is expected to have limited impact on providers, observers said.
The majoritys opinion, written by Justice Antonin Scalia and delivered on Feb. 20, concluded that federal law outlining the Food and Drug Administrations pre-market approval process for devices, which explicitly pre-empts any state-level efforts to regulate the industry, means that patients cant sue the manufacturers under state interpretations of liability.
Were other parties to these cases; were not the focus of the case in general, said Charles Reiter, general counsel for Loyola University Health System in Maywood, Ill. But, Reiter added, If plaintiffs are pre-empted from suing certain manufacturers of certain products, they are likely to look to healthcare providers for their remedy.
But healthcare lawyer Mike Ruggio, a partner in Polsinelli Shalton Flanigan Suelthaus, speculated that providers might be tempted to argue that the new shroud of immunity should cover them, too, as in: We should not be able to be sued, because the manufacturer itself is not allowed to be sued.
Democratic legislators quickly indicated they would work to change the law the court relied on to reach the conclusion, but court watchers wonder if the decision indicates a broader tendency toward deferring to federal law to the exclusion of state liability claims, including two pending drug cases.
The case at hand involved Charles Riegel, who needed emergency bypass surgery after the catheter the doctor was usingagainst the products indications, the opinion notesburst during an angioplasty in 1996. Riegel, who has since died, filed a lawsuit in U.S. District Court in Albany, N.Y., making a claim against the design, building and labeling of the catheter under New York common law.
Scalias opinion, affirming the New York judges decision to dismiss the lawsuit, concludes that the 1976 federal law known as the Medical Device Amendments gives the FDA exclusive authority to regulate medical-device makers. The law was intended to strengthen and clarify a patchwork of state efforts to protect consumers. Scalia writes that making companies liable under state law for FDA-approved devices disrupts the federal scheme no less than state regulatory law to the same effect.
The result only left open the possibility for consumers to bring claims against negligent device manufacturers if they can claim the company did not meet the FDAs minimum requirements, said Gerie Voss, regulatory counsel for the American Association for Justice, a trial lawyers trade group. Thats a small window.
Sen. Edward Kennedy (D-Mass.), a sponsor of the 1976 law, said in a statement that Congress obviously needs to correct the courts decision because otherwise, FDA approval will become a green light for shoddy practices by manufacturers.
The justices soon will decide similar questions involving drug companies. The court was scheduled to hear oral arguments Feb. 25 in a case involving Warner-Lambert Co.s diabetes drug Rezulin and whether federal law pre-empts a plaintiffs ability to make a claim under state law that the company defrauded the FDA.