No Recourse for the Injured

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http://www.nytimes.com/2008/02/22/opinion/22fri1.html?ref=opinion

Consumers are already at the mercy of the all-too-fallible Food and Drug Administration. So it is especially disturbing that the Supreme Court ruled this week that patients injured by defective medical devices cannot sue for damages in state courts if the device was approved for marketing by the F.D.A. and made to the agency’s specifications.

That means that any consumer harmed by a faulty device — whether it be an implanted defibrillator, a heart pump or an artificial knee — will have no chance of fair compensation and the manufacturers will have a dangerous sense of impunity. This decision is particularly unsettling at a time when the Bush administration has been working overtime to weaken federal regulations, and regulatory agencies, and to pre-empt the power of states to impose tougher standards.

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When it passed the 1976 law, Congress almost certainly had no intention of removing the right to sue. Senator Edward Kennedy, the Senate sponsor of the law, and Representative Henry Waxman, who sat on the House panel that approved it, have both said that Congress had no intention of granting the manufacturers immunity from lawsuits over injuries caused by their devices.

Congress should move quickly to pass corrective legislation and be prepared to do the same in other areas if the Supreme Court extends its pre-emption doctrine to drugs and other products.