The FDA Doesn't Provide Consumers with Injury Protection

You would have heard some heated comments between Energy and Commerce Committee chairman Henry Waxman, D-Calif., Rep. Steve Buyer, R-Indiana, had you tuned into the debate over a new law to provide legal remedies where medical devices only meet minimum governmental standards. Waxman said patients should not be barred from seeking justice through the courts. The FDA's ability to protect the public has plummeted, said Waxman, because the agency is severely underfunded. Buyer retorted that Waxman’s reasoning was "bizarre logic."


Georgetown law professor David Vladeck, soon to be the Federal Trade Commission's consumer protection chief next month, said a recent Supreme Court's decision is "the worst of both worlds" for consumers. The FDA, said Vladeck, can't possibly assure that every medical device on the market is safe, and because of Riegel, consumers can’t rely on the tort system if they're injured by a malfunctioning device.