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March 4, 2009 

Supreme Court Correct to Uphold Right of Injured Patients To Sue Drug Companies

Statement of Brian Wolfman, Director, Litigation Group at Public Citizen*

We are extremely gratified that the U.S. Supreme Court today in Wyeth v. Levine upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.

Drug companies are not perfect, and they sometimes fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels. Nor is the FDA perfect. It is overworked and underfunded, and it depends almost entirely on drug companies for information about the safety and effectiveness of drugs.

Perhaps most important, once a drug is marketed to thousands of people, we learn of things that we never knew in the clinical trials for that drug – problems that arise over the years as doctors prescribe and patients take the drug day in and day out.

For all these reasons, legal immunity for drug manufacturers – as called for by the drug companies and the Bush administration – would have been a huge mistake. We believe that the Supreme Court appreciated that. The Supreme Court also appreciated that the civil justice system is consistent with, and indeed helps support, FDA authority to make drugs as safe and as effective as possible. The court emphatically rejected the drug company and Bush administration argument that compensation for patients was an obstacle to the accomplishment of the FDA’s safety objectives.

Finally, and most important, there are real people involved here. The plaintiff in the case, Diana Levine, lost her arm because Wyeth did not take a simple step to warn her doctors of an avoidable risk of gangrene that was well known to the company – that its anti-nausea drug should not have been administered via the IV-push method. Today’s decision is a huge victory for Diana, for patients across the country and for public health.

For more information, visit http://www.citizen.org/documents/levinecertopp.pdf  andhttp://www.citizen.org/documents/preemptiontrialarticle.pdf.

* Brian Wolfman is the director of the Public Citizen Litigation Group and served as one of Diana Levine’s attorneys. He was lead counsel for Ms. Levine at the certiorari stage in the Supreme Court and has represented many plaintiffs in pre-emption cases before the Supreme Court and other courts.

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