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Justices weigh right to sue in drug case

October 27, 2008
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For nearly a century, Americans have been able to sue drug companies for deaths or injuries caused by medicines. According to The Wall Street Journal, the pharmaceutical industry and other big businesses are hoping the Supreme Court will sharply curb that right. In a case called Wyeth v. Levine, which the court will hear next week, a Vermont guitarist named Diana Levine lost an arm to gangrene caused by an improperly administered nausea drug. A Vermont jury awarded her $6.7 million in damages from Wyeth, accepting her argument that the drug maker should have put stronger warnings on the label. In its appeal of the verdict, the drug maker says the drug''s label was approved by the Food and Drug Administration, and it argues the federal regulator''s judgment should trump state law on issues of product safety. Many lawsuits are based on state consumer-safety regulations that often are stronger than federal standards. The Chamber of Commerce, the nation''s largest business lobby, has called the battle the business case of the century. The Bush administration has long promoted the idea that federal law pre-empts state lawsuits. It has weighed in on Wyeth''s side before the Supreme Court. The details of the Wyeth case give both sides hope. Ms. Levine, who lost her livelihood, and her story are likely to arouse sympathy. Wyeth offered her a settlement of less than $2 million, which Ms. Levine turned down because her medical expenses and expected lost wages were higher. But Wyeth points out, the case doesn''t involve any allegations that the company deliberately sold a drug it knew was dangerous. Wyeth says it complied with FDA guidelines on how to label the nausea drug. It didn''t strengthen its warning label to comply with stronger Vermont state law. The company argues that it can''t rush to the FDA for talks on changing the label every time an issue arises in one of the 50 states, and it also believes it can''t change the label on its own. Ms. Levine''s lawyers say Congress never intended to stop drug makers from proactively toughening warnings to doctors and consumers. They say FDA guidelines are the floor, not the ceiling, when it comes to safety standards. The most immediate impact of a ruling would fall on the drug industry. While details differ, pre-emption would have given drug makers a stronger position in many lawsuits in recent years that involved drugs used in accordance with FDA-approved labels. Consumer groups cite such cases in arguing that the FDA makes mistakes and companies hide information. They say patients'' right to sue -- in state court if necessary -- is the only deterrent to corporate misbehavior. The New England Journal of Medicine has published an editorial in Ms. Levine''s favor making these points. Wyeth’s attorney acknowledges that victims will have a harder time getting compensated for medical costs and lost wages if the Supreme Court rules in Wyeth''s favor. The attorney also suggested that Congress should consider establishing a fund to help such victims, as it has for vaccine-related injuries. If Congress swings heavily Democratic in this year''s elections, which take place the day after the court hears the Wyeth case, some Democrats say they will push forward bills to undo pre-emption and guarantee the right to sue for damages. Ms. Levine says she was stunned when the FDA joined in the case against her and when the Justice Department''s solicitor general filed a brief.

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