Edwards v. Basel Pharmaceuticals
Oklahoma Supreme Court
933 P.2d 298 (1997)
- Written by Mary Phelan D'Isa, JD
Facts
Alpha Edwards (plaintiff) brought a wrongful-death action against Basel Pharmaceuticals (defendant), the manufacturer of Habitrol nicotine patches, after her husband died of a nicotine-induced heart attack as a result of his smoking while he was wearing two Habitrol patches. Edwards alleged that Basel failed to adequately warn her late husband of the fatal risk associated with smoking and overuse of the patches. Although Basel had given physicians thorough warnings, it did not list the risk of a fatal or cardiac-related reaction to a nicotine overdose in its patient package insert. Basel contended that because its warnings satisfied Food and Drug Administration (FDA) requirements, it was not required to provide any additional warnings that may be required under state law. Edwards contended that compliance with FDA standards is not determinative and that the adequacy of Basel’s warnings should be determined by state law.
Rule of Law
Issue
Holding and Reasoning (Summers, J.)
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