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On Wednesday, a 6-3 court majority delivered a surprising yet appropriate decision. The justices upheld a $6.7 million jury verdict in favor of a musician from Vermont whose arm had to be amputated after she was injected with Phenergan, an anti-nausea drug made by Wyeth. She had arrived at a clinic complaining of a migraine headache. The drug label permitted intravenous injection but advised "extreme care" to avoid hitting an artery. The "likely" complications included irreversible gangrene.
Writing for the majority, Justice John Paul Stevens argued that it wasn't enough the Food and Drug Administration had approved the drug's labeling. In this instance, Congress did not make explicit that federal law trumped state lawsuits.
Stevens added valuable context. He noted that until a change in thinking during the George W. Bush administration, the FDA viewed such state injury lawsuits as complementary to its work. The agency's own advisory panel has acknowledged that with 11,000 drugs on the market, the FDA lacks the resources to ensure drug safety. Stevens argued that if Congress had wanted to pre-empt state lawsuits, it could have written explicit language in the law. It didn't do so, he noted, adding: "Evidently, it determined that widely available state rights of action provided appropriate relief for injured consumers."
The firm and fitting message was sent: As important as federal approval obviously is, it does not amount to blanket cover from injury lawsuits (unless lawmakers say so). A drugmaker must take its own share of responsibility, especially in revising labels to reflect new information about possible side-effects. (The plaintiff settled a lawsuit with the clinic.)
Ideally, this case would lead to giving the FDA the resources required to do its job more comprehensively and effectively. In that way, the words of Wyeth would have more credibility, the company insisting the agency is in the best position to weigh the risks and benefits of a drug. Until then, state courts provide patients a critical measure of protection.
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