LAST WEEK, the US Supreme Court ruled that patients injured by defective medical devices have no right to sue for damages if the devices were approved by the Food and Drug Administration. The decision would be defensible if the 1976 law on FDA oversight of devices actually called for such a sweeping immunity from liability, or if the agency's review process for devices and drugs were uniformly thorough, science-based, and immune from commercial pressures. Neither is the case.
The 1976 law contains provisions that, according to its congressional supporters, were meant to keep states from requiring their own duplicative approval procedures for new devices. It was not meant to prevent suits by victims of defective devices. In the case before the Supreme Court, the suit was brought on behalf of a man injured during an angioplasty by the bursting of a balloon catheter for a coronary artery.
Senator Edward Kennedy is already working on a bill that would clearly establish the right of patients to sue. "Congress never intended," Kennedy said in response to the court decision, "that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices."
Blanket immunity for FDA-approved medical devices or drugs is especially undeserved after the succession of critical reports on the agency by the Institute of Medicine, the Government Accountability Office, and the FDA's own Science Advisory Board. The FDA has failed to ensure that researchers have no substantial financial interest in drugs or devices they are studying, and it has skimped on studies of products that show evidence of safety risks after they go on the market.
Earlier this month, the attorney general of New Jersey announced she was investigating possible conflicts of interest among doctors who participated in studies involving a synthetic spinal disk in which they had a financial interest. The FDA approved ProDisc in 2006 after studies indicated it was an effective alternative to conventional back surgery. But in one study submitted to the FDA, according to The
In his opinion for the majority in the catheter case, Justice Antonin Scalia said he was concerned that patients will lose the benefit of new medical devices if juries in all 50 states were allowed to award damages to patients who are injured by a few devices. But he assumes a level of professionalism at the FDA that is lacking, and he misconstrues the preemption wording of the 1976 law.
In the House, Representative Henry A. Waxman of California is also calling for legislation to correct what he calls "this nonsensical situation." Congress should act quickly to restore patients' right to go to court when they have been wronged.
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