By Brian Wolfman
In Wyeth v. Levine, the Supreme Court held generally that the FDA's marketing approval of a drug and its labeling does not preempt a state-law personal-injury suit premised on the inadequacy of that labeling. The scope of the Supreme Court's no-preemption ruling may depend on whether, and in what circumstances, the FDA had reviewed and rejected a warning of the kind that the plaintiff claims would have prevented her injuries. An article that I wrote right after Wyeth came down discusses this issue in some detail.
After Wyeth, many observers predicted that most, if not all, state-law prescription drug liability claims would not be preempted, and post-Wyeth decisions in the lower courts have, in fact, rejected preemption. There continues to be significant disagreement, however, over cases involving claims that a family of anti-depressant drugs called selective serotonin re-uptake inhibitors (SSRIs) in some situations cause (or help cause) patients to become suicidal. To oversimplify a bit, the makers of these drugs, even after Wyeth, argue that the regulatory history at the FDA shows that the agency would not have approved a suicide warning on the drugs, thus meeting what they believe is the test for preemption under Wyeth. Yesterday, in Mason v. Smithkline Beecham Corporation, the Seventh Circuit rejected this argument in a case brought by a twenty-three-year-old woman who committed suicide two days after she started taking Paxil, a popular SSRI. In other words, the Seventh Circuit rejected preemption under Wyeth.
After Wyeth, many observers predicted that most, if not all, state-law prescription drug liability claims would not be preempted
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Laying foundations and simplifying a bit, manufacturers of these drugs, argue that the regulatory history of the FDA, indicates that the agency had not approved a warning of suicide with drugs.
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