Does 'Mutual Pharmaceutical Co., Inc. v. Bartlett' Herald The Demise Of The 'Failure-To-Withdraw' Theory?

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to say, without proof of a feasible alternative design or a viable warning theory, that a product should be outright withdrawn from distribution.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.

The maker of a generic drug, in order to receive federal approval, must show that the drug has the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name equivalent, i.e., an identical design and label. 21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii).

Federal law prohibits generic pharmaceutical manufacturers from independently changing their drugs' labels. PLIVA v. Mensing, 131 S. Ct. 2567, 180 L.Ed. 2d 580 (2011) (failure-to-warn claims against generic manufacturers are pre-empted by the FDCA's prohibition on changes to generic drug labels). In Mensing, the Eighth Circuit held that the manufacturers of metoclopramide, or generic Reglan, could have "simply stopped selling the product" after learning that patients were developing tardive dyskinesia. See Mensing v. Wyeth, Inc., 588 F.3d 603, 611 (8th Cir. 2009), rev'd, 131 S. Ct. 2567, 180 L.Ed. 2d 580 (2011). The Supreme Court reversed Mensing without specifically addressing the "failure-to-withdraw" theory, and on...

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