Supreme Court Rules FDA Approval of Certain Medical Devices Protects Manufacturers From State Lawsuits

The U.S. Supreme Court on Wednesday ruled 8-1 that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts, the New York Times reports. According to the Times, federal law "makes no provision for damage suits against device makers," and, as a result, "injured patients have turned to state law and have won substantial awards" (Greenhouse, New York Times, 2/21).

The case before the Supreme Court involved Charles Riegel, a New York man who allegedly experienced severe complications in 1996 when a balloon in a catheter manufactured by Medtronic burst in his severely blocked right coronary artery (Egelko, San Francisco Chronicle, 2/21). Riegel and his wife, Donna, filed a lawsuit against Medtronic in 1999 (Biskupic, USA Today, 2/21). In the case, Riegel v. Medtronic, Riegel -- who died in 2004 of unrelated causes -- alleged that the catheter had design flaws and a misleading label (San Francisco Chronicle, 2/21). Medtronic had received FDA approval to market the catheter in 1994 (Greenhouse, New York Times, 2/21).

Two lower federal courts dismissed the lawsuit, based on the argument that the 1976 Food, Drug and Cosmetic Act protects manufacturers of medical devices approved by FDA from product liability lawsuits filed in state courts (USA Today, 2/21). The Supreme Court heard arguments in the case in December 2007 (Barnes, Washington Post, 2/21).

Opinions
In the majority opinion, Justice Antonin Scalia wrote that product liability lawsuits filed against medical device companies in state courts could undermine the balance between the benefits and risks of medications as determined by FDA (Snowbeck, St. Paul Pioneer Press, 2/20). Scalia also wrote that states cannot implement safety requirements for the medical devices that differ from federal requirements (AP/Philadelphia Inquirer, 2/21).

In a dissenting opinion, Justice Ruth Bader Ginsburg wrote, "It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices" (Moore, Minneapolis Star Tribune, 2/20).

Implications
The decision applies only to medical devices that have undergone the premarket approval process, the most thorough process used by the agency. In 1996, the Supreme Court ruled that FDA approval of medical devices through other processes does not protect manufacturers from product liability lawsuits filed in state courts (Washington Post, 2/21). Most medical devices currently on the market underwent a process in which FDA found them "substantially equivalent" to those marketed before the enactment of the 1976 law (Greenhouse, New York Times, 2/21).

The decision also applies only to medical devices, not to medications. The Supreme Court will hear similar cases that involve medications on Monday and in October (Harris, New York Times, 2/21).

According to the Times, the decision "was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation" of medical devices. In 2004, the administration reversed "longstanding federal policy" and began to argue that FDA approval of medical devices through the premarket approval process "overrides most claims for damages under state law," the Times reports (Greenhouse, New York Times, 2/21).

NPR's "All Things Considered" on Wednesday reported on the decision. The segment includes comments from Charles Fried, a professor at Harvard Law School; Tom Goldstein, a Supreme Court advocate and faculty member at Stanford Law School and Harvard Law School; and Caitlin Halligan, former chief appellate advocate for New York (Totenberg, "All Things Considered," NPR, 2/20). Audio of the segment is available online.