The FDA's risky prescription

FOR YEARS, pharmaceutical companies have asked Congress to pass a law protecting them from liability lawsuits for drugs that have been approved by the US Food and Drug Administration. Members of Congress, knowing only too well the fallibility of the FDA in approving drugs and monitoring their safety after approval, have rightly refused.

Now one drug company is trying to get the Supreme Court to rule that an FDA-approved warning label on its drug shields it from a $6 million lawsuit by a woman who lost her forearm when the drug was badly administered. The company, Wyeth, is seeking to have the justices legislate from the bench by finding that an FDA-approved label gives the firm preemptive protection. The court should say no.

On Monday, the justices heard the sad details of the case of Diana Levine, a Vermont musician, who sought relief from a Wyeth drug for migraine nausea. There are three different ways to administer the drug, Phenergan, including one that risks causing gangrene. Wyeth's label warns of this possibility, but does not prohibit this method. Levine sued both the clinic that used the risky method and Wyeth.

In the past, the FDA never claimed, as it does now, that its approvals of drugs or their labels should protect drug makers from liability. This change in policy, which was opposed both by former FDA commissioners and current career FDA staff, is part of the Bush administration effort to free industry generally from tort suits. Former commissioner David Kessler's argument against preemption is that the FDA sees relatively little test data on a new drug once it is on the market.

Suits in state courts force drug companies to do better monitoring of drugs after approval, and the discovery process in such suits often reveals to the public and the FDA much of the internal data companies have on problems with a drug, both before and after its approval. From the justices' questions Monday it was unclear how they might rule. But two facts should give them pause: Some hospitals now prohibit the administration method that led to Levine's amputation, and another company, Pfizer, stopped allowing that method for its anti-nausea drug after it led to two amputations.

According to Levine's lawyer, there have been more than 20 cases of amputations involving Wyeth's drug in the years since the FDA approved its label. That should have caused the company either to forbid the risky method of administration altogether or include a much stronger warning against it on the label. The court should not let the FDA be Wyeth's scapegoat.