Rethinking Conscious Design Liability for Prescription Drugs: The Restatement (Third) Standard Versus a Negligence Approach
35 Pages Posted: 2 Apr 2010 Last revised: 23 Oct 2013
Date Written: 1994
The American Law Institute is presently drafting a new approach to prescription product design liability in its proposed Restatement (Third) of Torts. This new approach would reduce confusion surrounding prescription products by almost completely immunizing them from design defect liability. The proposed new Restatement justifies its near-immunity standard by arguing that prescription product designs are unique in their potential for helping some classes of consumers while hurting others, that warnings defect claims provide consumers sufficient protection, and that the Food and Drug Administration approval process lessens the need for design liability.
This Article challenges these arguments and contends that a near-immunity standard provides too much protection for manufacturers and too little protection for consumers. However, this Article agrees that prescription products merit some special protection and rejects applying a strict liability standard to such products. Instead, this Article supports utilizing a middle-ground negligence test for prescription product design liability. Applying a negligence test would offer prescription products designers significant protections not available under a strict liability standard but would not allow the negative consequences of nearly immunizing drug manufacturers from design liability.
Keywords: torts, restatement, prescription, medication, medicine, drug, pharmaceutical, liability, design defect, immunity, consumer protection, product liability, negligence
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