Consumer protection was on trial before the U.S. Supreme Court last week in a case regarding whether medical patients can sue drug manufacturers in state court if a drug's warning label is incomplete. While Wyeth vs. Levine involves a personal and tragic story, the case has the potential for much wider sweep that could handicap the ability of consumers and patients to sue when injured by federally regulated products.
Diana Levine, a professional guitarist, went to a clinic in Vermont in 2000 to relieve her migraine and the nausea that resulted. She was given the antinausea drug Phenergan, which was mistakenly injected into an artery rather than a vein. The result was gangrene, a fate that others had suffered over the years when Phenergan was improperly administered in this way. For Levine, the error resulted in the amputation of much of her right arm.
Levine settled her case against the clinic and then sued the drug's manufacturer, Wyeth, for failing to give sufficient warnings of the potential adverse effects of an injection accidentally hitting an artery. A jury awarded Levine nearly $7-million in compensatory and punitive damages. The verdict was upheld by the Vermont Supreme Court.
In its appeal to the Supreme Court, Wyeth claims that because the Food and Drug Administration approved the drug's warning label, state courts are pre-empted by federal law and have no authority to impose additional liability. The manufacturer says having to worry about meeting stiffer labeling standards in various states is contrary to what the law intends.
But 47 states, including Florida, as well as consumer advocates and medical groups submitted briefs on behalf of Levine. They say that allowing suits in state courts for damages when injuries arise is one of the key methods of ensuring drug safety.
In the past, the federal government has generally taken the position that FDA regulations and review and state tort liability compose a complementary system of protection for patients.
But the Bush administration has shifted this stance, now siding with pharmaceutical companies over injured patients. It argued before the high court that state courts may not consider failure-to-warn cases if the FDA has approved the labeling.
It is no surprise that the Bush administration, with its penchant for big business, would take that position. But if the justices agree, the implications could go beyond faulty drug warnings, barring state lawsuits for harms caused by a host of regulated products, including motor vehicles and chemicals.
Last term, the justices ruled 8- 1 that makers of federally approved medical devices were immune from state lawsuits when injuries arose. But that case is easily distinguishable since the statute regulating those devices explicitly granted federal pre-emption. Pharmaceutical companies should not get the same protection, and if they want it so badly they should be asking Congress, not the courts.