We have received a tremendous response to reports of the U.S. Supreme Court’s ruling in the Wyeth v. Levine case. We are extremely gratified that the High Court upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries. As we have learned in litigation, drug companies are far from perfect. They sometimes fail to identify and inform doctors and the Food and Drug Administration of problems with their products or their products’ labels.
Unfortunately, we have also learned that the FDA is not perfect. The regulatory agency is overworked and underfunded. As a result, the FDA has to depend almost entirely on drug companies for information about the safety and effectiveness of drugs. We have seen how that simply hasn’t worked very well. I don’t believe that it ever will.
Perhaps most importantly, once a drug is marketed to thousands of people things are discovered that weren’t known during the clinical trials for that drug – problems that arise as doctors prescribe and patients take the drug day in and day out. For all these reasons, legal immunity for drug manufacturers – as requested by the drug companies and pushed by the Bush Administration – would have been a huge mistake. Obviously, the Supreme Court appreciated that fact. The High Court seemed to appreciate 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 arguments by the drug company and the Bush Administration that compensation for patients was an obstacle to the accomplishment of the FDA’s safety objectives.
The Levine case brought to the public’s attention that real people are affected adversely when immunity from lawsuits is given to any group including manufacturers. 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, which was very well known to the company. Its anti-nausea drug should not have been administered by way of the IV-push method. The decision was not only a huge victory for Diana Levine, but for patients all across the country. And it was clearly a victory for public health.
Brian Wolfman, the director of the Public Citizen Litigation Group, served as one of Diana Levine’s lawyers. Brian, who was lead counsel for Ms. Levine at the certiorari stage in the Supreme Court, has also represented many Plaintiffs in preemption cases before the Supreme Court and other courts. All American citizens owe Brian and all of the other lawyers who worked on the Levine case a tremendous vote of thanks.
Source: Public Citizen
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