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

On July 30, 2013 by Schnader

The Supreme Court’s recent decision in Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 186 L. Ed. 607 (2013) ended product liability claims against generic pharmaceutical manufacturers based on a theory of “failure-to-withdraw,” i.e., that generic manufacturers can satisfy conflicting requirements in federal and state laws by not selling their products. In states that use a “risk utility” test to determine whether a product is not reasonably safe, the existence of a feasible alternative design is a critical element of plaintiffs’ burden of proof. Where no alternative design can be claimed, plaintiffs argue that manufacturers should be liable for failing to withdraw their products from the market. The Supreme Court held that these claims are pre-empted with respect to generic drugs, and reiterated that state laws cannot act to ban federally-approved products. We believe that the Court’s rationale in Bartlett should extend further to litigation involving other products, and will enable manufacturers to avoid costly litigation when it is not feasible to make a better product with the same utility.

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