Drug Design Liability: Farewell to Comment K
45 Pages Posted: 1 May 2015
Date Written: April 29, 2015
Abstract
Half a century ago the reporter for the Second Restatement of Torts, William Prosser, drafted Comment k to § 402A, defining the liability of drug companies for defective prescription products. Prosser’s attempt to shelter drugs from design defect liability has confused courts and commentators alike. Courts at first interpreted Comment k to immunize drug manufactures from design-based liability; more recently, a growing number have begun to interpret the Comment to allow such actions. However, there is wide disagreement regarding the conditions under which courts should permit drug design claims. Courts have articulated no fewer than eight different tests, all relying on Comment k. This article examines the historical origins of Comment k and explains why it has confused so many judges and academics. The authors argue that the tests adopted by courts in reliance on Comment k are seriously flawed. In its stead, the article advocates that a drug manufacturer should held liable for defective drug design only when the drug is not fit for use by any class of patients. All other drug-related claims should be based on findings that the drug either contained a manufacturing defect or was marketed with inadequate warnings.
Keywords: 402a comment K; drug design; design to warning
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