Pre-emption Defense: Pharma Must Show Record Of Interaction With FDA
The Supreme Court's ruling in Wyeth v. Levine, which limits the circumstances in which companies can claim FDA-approved labeling pre-empts state product liability suits, is going to require companies to have a detailed dialogue with FDA
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A New Jersey appeals court vacated a $2.6 million jury verdict against Roche and ordered a new trial to determine if its acne drug Accutane (isotretinoin) caused a plaintiff's inflammatory bowel disease
While the Supreme Court's landmark ruling in Wyeth v. Levine dashes pharmaceutical industry hopes for broad protection from product liability lawsuits, it will not trigger any sea change in litigation. Instead, the opinion seems likely to maintain the status quo and restrict the situations in which companies can claim they provided adequate warning of a drug's risks
The pharmaceutical industry is reeling from a court ruling that found brand name manufacturers are liable for the warnings on generic versions of their products