Allocating Liability for Deficient Warnings on Generic Drugs: A Prescription for Change

Allocating Liability for Deficient Warnings on Generic Drugs: A Prescription for Change

Sarah C. Duncan · 13 Vand. J. Ent. & Tech. 1, 185

Abstract

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (“HatchWaxman Act”) to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn—the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, the generic company has much less control over the warning label than the pioneer company. Courts thus far have attempted to compensate injured plaintiffs by either holding the brand-name manufacturer liable for injuries caused by a competitor’s product, or holding the generic manufacturer liable for label deficiencies it did not create. This Note discusses alternatives to redress injured individuals: (1) clarifying the role of generic drug manufacturers in the label formation and amendment process by the FDA; (2) labeling of generic drugs by the FDA; and (3) creating a federal trust fund, similar to the Vaccine Injury Compensation Trust Fund, to compensate plaintiffs who prove deficiencies in generic drug labels.