WHEN THE Supreme Court upheld a $6.7 million award Wednesday to a Vermont woman who lost an arm in a botched drug injection, the verdict went against not just the drug maker but also the Food and Drug Administration. The drug company, Wyeth, argued that the FDA's approval of the injection method and label warnings about its risks immunized the company against lawsuits in state courts. But the judges were only too aware of the FDA's long history of failure to keep unsafe drugs off the market.
The 6-to-3 ruling sends two messages. It tells President Obama that he can waste no time fulfilling his pledge to strengthen the FDA. Justice John Paul Stevens's opinion for the majority specifically refers to the agency's limited resources.
Second, the ruling tells the pharmaceutical industry that it bears final responsibility for the way its products are made and administered. It cannot hide behind the approval of an FDA that has shown a weakness for approving drugs before they are sufficiently tested and then failing to monitor closely the drugs' often harmful side effects once they are on the market.
At issue in Wednesday's ruling was not the drug itself, the anti-nausea medication Phenergan, but the warning on its label for how it should be administered. Diana Levine lost an arm to gangrene after a clinic worker mistakenly injected the drug into an artery. Injection into a vein is one of three methods of administering the drug. After successfully suing the clinic, Levine's lawyer also persuaded a Vermont jury that Wyeth's label on the drug should have carried a much stronger warning against the injection method. Stevens pointed out that, prior to Levine's treatment, there had been 20 other cases in which injections of Phenergan had led to gangrene and amputation.
Wyeth said it should not be found liable because the FDA had approved the label warning. The court rejected that view, stating that the law and FDA regulations make it clear "that the manufacturer bears responsibility for the content of its label at all times." The decision echoes another case in which the court did not let industry use federal law as a shield: the December ruling that consumers can sue tobacco companies over the marketing of "light" cigarettes.
Critics of the court's Levine decision worry that it will cause pharmaceutical companies to steer away from innovative drugs in favor of modest improvements to existing medications. It need not have that effect, however, if companies would test their new medications more thoroughly before bringing them to market, and then do a better job of monitoring adverse events and reacting to them decisively.