Sunday, February 28, 2010

Seventh Circuit finds no preemption in suicide case; Levine begins to show its influence

The most important case in the area of products liability last year was undoubtedly Wyeth v. Levine (available here). For a lot of discussion on this case you can go to the labels “FDA” and “pharmaceuticals” on the right panel of this blog. As you probably know, although the Court found that preemption did not exist in Levine, it held that there could be preemption if the manufacturer showed there was clear evidence the FDA would have rejected the proposed change in the drug’s label. The Supreme Court, however, did not clarify what constitutes “clear evidence.” As expected, therefore, lower courts now have to address this unanswered question. A few months ago, the Eighth Circuit rejected a preemption argument in In re Prempro Products Liability Litigation, 586 F.3d 547 (8th Cir. 2009). And now, last week, the Seventh Circuit issued another opinion rejecting a preemption argument in Mason v. SmithKline Beecham Corp (available here). In this case, a 23 year old committed suicide just two days after she started taking Paxil, a popular antidepressant. Her parents sued the manufacturer of the drug claiming it was negligent (among other things) for not warning that taking Paxil increases the risk of suicide, especially among young adults. In an opinion issued before the Supreme Court decided Levine, the district court granted summary judgment for the defendant concluding that that the plaintiffs’ claims were preempted under federal law because the warnings they said should have been included about Paxil conflicted with the FDAapproved warning labeling for the drug. In light of the decision in Levine, the Seventh Circuit reversed and remanded concluding that the defendant did not meet its burden of demonstrating by clear evidence that the FDA would have rejected a label change warning about the risk of suicide by young adults. UPDATE: (3/5/10) For a short article critical of the decision in Mason by the Drug & Device Law Blog go here.

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