Abstract
The article reviews current doctrines for holding manufacturers of pharmaceuticals liable for failing to adequately warn of potential adverse effects. The article explains basic concepts of product liability and reviews current cases that address which adverse effects require warnings and to whom the warnings must be given. The article also examines the interactions between compliance with Food and Drug Administration (FDA) regulations and potential civil liability.
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References
1.
Restatement of Torts (Second) § 402A comment k.
2.
Brown v. Superior Court, 44 Cal. 3d 1049, 751P.2d 470 (Cal. 1988 ).
3.
Note, Hill v. Searle Laboratories: The Decline of the Learned Intermediary Doctrine in Favor of Direct District Patient Warnings of Drug Product Risks, 42 Ark. L. Rev. 821, 832–34 (1990 ).
4.
Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 389 (1984 ).
5.
21 CFR § 201.57.
6.
Abbot v. American Cyanamid Co., 884 F.2d 1108, 1114–15 (4th Cir.), cert, denied, 488 U.S. 908 (1988 ). Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974).
7.
21 CFR § 201.57(5).
8.
21 CFR § 314.70(6)(2).