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Court Ruling On Preemption Leaves Window Open For False Advertising Suits

Executive Summary

FDA's failure to include false advertising claims in its policy on preemption implies that the agency "does not intend its review of promotional materials to preempt false advertising claims," according to a recent federal court decision

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FDA Preemption Policy Gets First Appeals Court Test With Zoloft, Paxil Cases

A federal appellate court will take up the issue of whether FDA approved labeling preempts state litigation claiming companies failed to warn of a product's risks, following years of conflicting rulings from district courts

FDA Preemption Policy Gets First Appeals Court Test With Zoloft, Paxil Cases

A federal appellate court will take up the issue of whether FDA approved labeling preempts state litigation claiming companies failed to warn of a product's risks, following years of conflicting rulings from district courts

The clinical value of drug litigation

Litigation against pharma companies can result in better definition of drug risks, Harvard University Medical School's Aaron Kesselheim and Jerry Avorn argue in a Jan. 17 JAMA article. In several cases involving SSRIs and COX-2s, lawsuits produced useful data that previously had not been publicly released, the authors say. Suits could also motivate "proper disclosure initially by presenting the possibility of substantial damages in cases of misconduct." Describing litigants as "drug safety researchers of last resort," the essay criticizes FDA's effort to pre-empt product liability claims (1"The Pink Sheet" Aug. 28, 2006, p. 7)...

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