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Torts Keyed to Prosser
T.H. v. Novartis Pharmaceuticals Corp.
Citation:4 Cal.5th 145, 407 P.3d 18, 226 Cal.Rptr.3d 336
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Novartis Pharmaceutical Corporation (“Novartis”) (defendant) manufactured the brand-name drug Brethine until 2001. Six years later, T.H.’s mother, who was pregnant at the time, suffered injury from use of a generic form of Brethine. Under California law, a brand-name drug manufacturer has a duty to warn of known or reasonably knowable adverse effects arising from use of its drug. This duty to provide an adequate warning label applies to both the brand-name drug and its generic equivalents. Only the brand-name drug manufacturer may modify the drug’s label. Generic manufacturers must strictly follow the brand-name manufacturer’s label. T.H. (plaintiff) brought suit against Novartis, alleging the generic drug’s warning label failed to warn about the risks to fetal brain development and falsely represented that the drug was safe for use by pregnant women.
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