The Restatement (Third) of Torts: Products Liability: The ALI's Cure for Prescription Drug Design Liability

Article excerpt

"It has not been a well-kept secret. Anyone familiar with the law of products liability knows that [the Restatement (Second)] is out of date and requires revision." (1)

"We conclude that [the Restatement (Third)] has no basis in the case law ... Accordingly, we do not adopt ... the Third Restatement." (2)


In 1997, the American Law Institute ("ALI") adopted the Restatement (Third) of Torts: Products Liability ("Restatement (Third)"). (3) After over thirty years as the definitive, yet somewhat confusing road map along the products liability highway, the Restatement (Second) of Torts ("Restatement (Second)") was turned on its head. Before new case law involving the Restatement (Third) has been given a chance to develop, commentators have risen either to praise the Restatement (Third) as a clear guide to the chaotic products liability maze, (4) or to reject it as a pro-defense, industry-favoring curtailment of manufacturer liability. (5)

Few disagree that the Restatement (Third) radically changes the nature of prescription drug design litigation. (6) Critics of the Restatement (Third) assert that the new standard sets a nearly impossibly high threshold for plaintiffs seeking to hold prescription drug manufacturers liable for defective design. (7) One court has agreed, describing the Restatement (Third) as setting a "[s]tandard that will never allow liability [for the defective design of prescription drugs]." (8) Some critics argue that the Restatement (Third) effects sweeping changes to prescription drug design litigation, and "comes very close to eliminating design defect claims altogether." (9) Other commentators argue that the Restatement (Third) is not a true "restatement" of the law at all, but rather a complete revision. (10)

The Restatement (Third)'s reporters respond that these changes are not only justified, but necessary. (11) The failure of the Restatement (Second) in bringing about judicial uniformity has led courts to carve out their own respective "niches" in the law. (12) Due to evolving notions of strict liability and its application to prescription drug manufacturers, the analytical framework provided by the Restatement (Second) is hopelessly out of date. (13) According to the reporters, "Anyone familiar with the law of products liability knows that [the Restatement (Second)] requires revision." (14)

Historically, safer alternative drug designs have often been unavailable. As a result, most prescription drug litigation has involved failure to warn and manufacturing defect claims, as opposed to claims that drugs have been defectively designed. (15) In the past two decades, however, courts have begun to take cognizance of design defect claims involving prescription drugs. (16) As courts are increasingly confronted with claims of defectively designed prescription drugs, they may look to the ALI for guidance on how to proceed. (17)

Courts and commentators have long debated the proper judicial treatment of defective design claims involving prescription drugs. Some commentators have argued that prescription drugs, as a product category, are fundamentally different from other consumer products. (18) A number of courts have agreed, citing a public policy supporting the research and development of new prescription drugs, and have sought to limit prescription drug manufacturer liability for defective design. (19) Other courts have refused to create a bright-line distinction between all prescription drugs and other consumer products. (20) According to its reporters, the Restatement (Third) clarifies murky judicial doctrine and reconciles these competing viewpoints. (21) Whether the ALI properly balances the societal utility of developing new prescription drugs against the need for liability for defective drug designs has been hotly debated.

Part I of this Note will trace the history and evolution of strict liability for defectively designed prescription drugs. …


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