Does Mutual Pharmaceutical Co., Inc. v. Bartlett Herald the Demise of the "Failure-To-Withdraw" Theory?

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In most states that use a “risk utility” test to determine whether a product is “not reasonably safe” (i.e. defective) as designed, an alternative design for the product is generally considered to be a critical element of the plaintiff’s proof. See, e.g., Restatement (Third) of Torts, § 2; Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 108, 7462 N.Y.S.2d 398, 402-03, 450 N.E.2d 204 (1983) (outlining New York’s risk utility approach). Where an alternative design cannot be claimed or argued, the argument is typically failure to warn. See, e.g., Liriano v. Hobart Corp., 92 N.Y.2d 232, 677 N.Y.S.2d 674, 700 N.E.2d 303 (N.Y. 1998) (manufacturers can be liable for failure-to-warn even if the substantial modification defense would preclude liability for design defect).

Where a plaintiff can argue neither alternative design nor failure to warn, one fall back position is that the product is so dangerous, and its danger so far exceeds its utility, that it ought not have been marketed at all. This theory, often called “failure-to-withdraw” or “stop-selling” theory, is typically an unappealing one for a plaintiff. Products enter the stream of distribution, and become successful, because of their utility. Presumably the plaintiff, plaintiff’s employer, or plaintiff’s doctor found the product to be useful, which is why the product was used. The more remote a plaintiff’s argument of danger or defect is, the less likely any court or jury is to allow for a liability finding. It is, in short, a big pronouncement for a court or jury to say, without proof of a feasible alternative design or a viable warning theory, that a product should be outright withdrawn from distribution. This fringe theory has been advanced as to certain types of guns, tobacco products, alcoholic beverages and, pertinent to this Alert, generic drugs.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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