Drug Design Liability: Farewell to Comment K

45 Pages Posted: 1 May 2015

See all articles by Aaron Twerski

Aaron Twerski

Brooklyn Law School

James A. Henderson

Cornell University - Law School

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

Suggested Citation

Twerski, Aaron D. and Henderson, James A., Drug Design Liability: Farewell to Comment K (April 29, 2015). Baylor Law Review, Forthcoming, Brooklyn Law School, Legal Studies Paper, No. 409, Available at SSRN: https://ssrn.com/abstract=2600601

Aaron D. Twerski (Contact Author)

Brooklyn Law School ( email )

250 Joralemon Street
Brooklyn, NY 11201
United States

James A. Henderson

Cornell University - Law School ( email )

Myron Taylor Hall
Cornell University
Ithaca,, NY 14853-4901
United States

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
108
Abstract Views
1,249
Rank
488,636
PlumX Metrics