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First Circuit: juries can second-guess FDA "safe and effective" finding

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Sulindac, like all NSAIDs, is capable of causing the rare (and horrific) reaction toxic epidermal necrolysis, and does so in about five or six patients a year. Nevertheless, the FDA, in evaluating the drug, recognized that the benefits outweighed the rare side effects, and approved the drug as "safe and effective." Karen Bartlett was in the very unfortunate one in a million, and suffered the rare side effect when she took generic sulindac. Her failure-to-warn theory was both a non-starter (her doctor never read the warnings) and, in any event, preempted by Pliva v. Mensing. But she was permitted to take a "design defect" theory to the jury. It's unclear how defendant Mutual Pharmaceutical was supposed to "design" sulindac differently; after all, it's a single molecule, and no one claimed that the inactive ingredients in the medication were at fault. But plaintiffs' theory was that the FDA was wrong, and that manufacturers should simply withdraw the drug from the market. A judge let this get to a jury, and let the jury consider the warning label in determining whether the drug was unreasonably dangerous, and, after the inevitable loss aversion bias kicked in, Mutual is now on the hook for $26 million. All this made possible by the Supreme Court's erroneous anti-business decision in Wyeth v. Levine. [Bartlett v. Mutual Pharmaceutical Co. (1st Cir. May 2, 2012) (via Bashman)].

Beck calls for Supreme Court review. I agree.

(Looking for good links on NSAIDs and SJS, I found that the search-engine-optimized websites for Stevens-Johnson Syndrome are all trial-lawyer sites, natch, with misleading names like "Skin Association.")

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


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The Manhattan Insitute's Center for Legal Policy.