Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers

69 Pages Posted: 16 Apr 2010 Last revised: 8 Feb 2011

See all articles by Allen Rostron

Allen Rostron

University of Missouri at Kansas City - School of Law

Date Written: February 3, 2011

Abstract

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient’s doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient’s doctor saw, and neither manufacturer could be held liable even if each acted negligently.

The California Court of Appeals recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue.

Although the decision has been the subject of scathing criticism, this Article argues that the California court’s ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court’s reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

Keywords: prescription drug, generic, brand-name, drug manufacturer, pharmaceutical, liability, negligence, FDA, information, warnings

JEL Classification: K10, K13, K20, K23, K32, K40, K41

Suggested Citation

Rostron, Allen K., Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers (February 3, 2011). Duke Law Journal, Vol. 60, 2011. Available at SSRN: https://ssrn.com/abstract=1591085

Allen K. Rostron (Contact Author)

University of Missouri at Kansas City - School of Law ( email )

5100 Rockhill Road
Kansas City, MO 64110-2499
United States

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