09192017Headline:

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Greg Webb
Greg Webb
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Court System Integral To Guaranteeing Drug Safety

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Editors from the New England Journal of Medicine, one of the nation’s most influential medical journals, are giving the Supreme Court unsolicited legal advice about a major case, Wyeth v. Levine, that could have major implications for litigation over potentially dangerous drugs, such as Vioxx. In a friend-of-the-court brief, the editors argued the Food and Drug Administration (FDA) is “in no position” to guarantee drug safety. Although the FDA is the “gold standard” in drug evaluation, the editors asked the justices to be skeptical. They go on to say that lawsuits can serve as a “vital deterrent” and protect American consumers if drug companies do not divulge the risks involved with their product; the FDA alone does not have the capabilities to act as the sole regulator for keeping the drug market safe. It is spread too thin and completely understaffed and underfunded. The court system is the last defense individuals have against manufacturers who have not made the risks from their product clear to the public.

In Wyeth v. Levine, Diane Levine lost her right arm below the elbow after being injected by the drug Phenergan, a medication for nausea, causing her to develop gangrene. She sued the manufacturer, Wyeth, claiming the company had an obligation to warn its consumers of the potential risk from the injection. The courts in her state agreed and awarded her $7 million. However, Wyeth appealed, arguing it was protected from lawsuits since state courts cannot overturn the FDA’s judgment. The FDA considers and approves the labeling for the drug and the manufacturer is generally banned from making unilateral changes to the approved labeling, so Wyeth believes it should not be able to be sued.

These medical editors joined with forty-seven state attorneys general and two former FDA commissioners in supporting Ms. Levine’s position, while the Bush administration is supporting Wyeth. Many people are closely watching this case since the Supreme Court recently ruled that manufacturers of FDA-approved medical devices are shielded from litigation in state courts. However, the statute that applies to the medical devices is different from the law that governs medications.