FEDERAL PREEMPTION: GENERIC DRUGS
McKenney v. Purepac Pharmaceutical Company, (5th District, September 25, 2008) 83 Cal.Rptr.3d 810, 08 Cal. Daily Op. Serv. 12,747
A woman who alleged she suffered injuries as a result of using the prescription generic drug metoclopramide filed an action against the manufacturer. The plaintiff alleged that there were false and/or misleading statements in the labeling of the drug which downplayed the risk of tardive dyskinesia, which the plaintiff had contracted while taking the drug.
The trial court sustained the manufacturer’s demurrer to the complaint, finding that because a generic manufacturer of a drug must obtain approval by the FDA before issuing any label which deviates from the labeling previously approved by the FDA, all of the plaintiff’s claims were pre-empted by federal law. However, the court of appeal reversed, holding that the federal requirement that a generic drug have the same labeling as a reference drug does not necessarily pre-empt a state tort action against a generic manufacturer for failure to adequately warn of the dangers of the drug:
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