Accountability on Trial

Monday, November 3, 2008

DIANA LEVINE walked into a Vermont clinic in 2000 seeking relief from a migraine headache and nausea. A few weeks later, her right hand and forearm had to be amputated because a physician's assistant wrongly injected the anti-nausea drug Phenergan into an artery, rather than a vein.

Ms. Levine settled a lawsuit against the clinic. She also filed suit against the drug's manufacturer, Wyeth, claiming that the company was negligent and failed to warn about the heightened dangers of administering the drug intravenously using a syringe, rather than by means of an IV drip or an injection directly into muscle. A Vermont jury awarded Ms. Levine, once a professional guitarist, almost $7 million in compensatory damages; the Vermont Supreme Court upheld the verdict.

Wyeth is challenging that result before the U.S. Supreme Court, which is scheduled to hear the case today. The company argues that it should be immune from suit because the Food and Drug Administration approved the drug's label, which included a warning about the hazards of injecting the drug into an artery; the label also refers to IV drip as the preferred method of intravenous administration, although it does not exclude use of a syringe. Wyeth argues that allowing a state jury to second-guess the FDA labeling requirements undermines the carefully crafted rules and expert determinations of federal regulators. Wyeth supporters in the business and medical communities also worry that such litigation essentially creates a patchwork of inconsistent rules across the country that could lead to confusion and subvert innovation. These arguments have some merit, but Wyeth and its allies should not prevail.

Last term, the justices overwhelming sided with manufacturers of medical devices in a similar matter. The companies also argued that they could not be sued by consumers for products that had been approved by the FDA. But in that case an eight-justice majority determined that Congress had explicitly written that immunity into the law. There is no such language in the law that governs drug manufacturers. Lawmakers have amended the food and drug laws numerous times in the past few decades alone. And they are well aware that state tort lawsuits such as the one filed by Ms. Levine are relatively common. Yet they have declined to write into law the kind of shield from lawsuits that Wyeth seeks. Congress's silence speaks volumes, and the justices should respect that determination. If Wyeth and other pharmaceuticals want change, they should take their case to Congress.

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