This section contains the nature of the case and procedural background.

Alpha Edwards (P) sued under wrongful death for the death of her husband. P's husband died of a nicotine-induced heart attack as a result of smoking cigarettes while wearing two Habitrol nicotine patches. Habitrol is manufactured by Basel (D). P claimed that the warnings on the product were inadequate to warn of the fatal risk associated with smoking and overuse of the product. A good warning was given to physicians providing the patch, but the user inserts did not mention the possibility of fatal or cardiac-related reaction to a nicotine overdose but did indicate that an overdose might cause a person to faint. The doctor's warning was quite explicit and properly conveyed the threats of an overdose. The court took it as fact that D complied with the FDA's mandate that specific warnings reach the ultimate consumer. D claims that the learned intermediary doctrine bars liability because the doctor was given a complete warning. The federal court hearing the action certified to the state supreme court the question of the scope of the learned intermediary rule.

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