Last week, the US Supreme Court struck a blow to the pharmaceutical industry when they ruled that litigants may sue for damages if they are harmed by unsafe drugs—even if the drug manufacturers have satisfied federal regulators.
In a 6-to-3 vote, the high court upheld a jury verdict of $6.7 million in favor of Diana Levine, a guitar-playing children’s musician from Vermont whose arm had to be amputated after she was injected with Phenergan, a common anti-nausea drug. She had gone to a clinic for treatment of a migraine. The drug’s manufacturer, Wyeth, had argued that its compliance with the FDA’s labeling requirements should immunize it from lawsuits.
Justice John Paul Stevens, writing for the majority, said there was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” He noted that allowing such lawsuits “provides incentives for drug manufacturers to disclose safety risks promptly.”
According to the Washington Post, the decision was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.
Thousands of product-liability suits have flooded state courts in recent years, with more than a third filed against drug companies. And the Supreme Court has been sympathetic to arguments that federal law should pre-empt state injury suits, as in last year’s medical device injury case, Riegel v. Medtronic.
Drug companies and other businesses, supported by the Bush administration, had hoped the Vermont case would establish even broader protections. Had last week’s decision gone the other way, Democratic leaders on Capitol Hill had been poised to introduce legislation making clear that FDA regulations did not preempt the lawsuits.
The New York Times reported that producers of goods as different as antifreeze, fireworks, popcorn, cigarettes, and light bulbs have sought to take refuge behind federal oversight in recent years to fend off litigation. After last Wednesday’s decision, those efforts are most likely to succeed if they are based on express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible.