Duty To Warn and the Learned Intermediary Doctrine in New York: Does the Duty Require Instructions About How To Mitigate Risk?

The U.S. Court of Appeals for the Eleventh Circuit recently certified “unsettled questions of Alabama law” to the Alabama Supreme Court related to “failure-to-warn” claims. Blackburn v. Shire US, 18 F.4th 1310, 1321 (11th Cir. 2021). The fundamental question is: “Consistent with the learned intermediary doctrine, may a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks?” Id. Although New York and Alabama may not have much else in common, it does seem that in this regard they are similar—New York courts have not yet answered this question directly. Still, there certainly are clues to suggest how the issue might be resolved in New York. In most instances, precise mitigation instructions likely go beyond the obligations imposed by the learned intermediary doctrine. An exception might be found if the mitigation strategy was unknown to the medical profession generally and the manufacturer had special knowledge that it did not communicate to the U.S. Food & Drug Administration (FDA). Absent these circumstances, however, the learned intermediary doctrine and federal preemption law would, in all probability, preclude a failure-to-warn claim based on a failure to provide mitigation instructions.

Learned Intermediary Doctrine and Mitigation Instructions. Under New York law, a failure-to-warn claimant must show “(1) that a manufacturer has a duty to warn; (2) against dangers resulting from foreseeable uses about which it knew or should have known; and (3) that failure to do so was the proximate cause of harm.” Bustamante v. Atrium Med., No. 18-CV-08395, 2020 WL 583745, *6 (S.D.N.Y. Feb. 6, 2020); see also In re Fosamax Prods. Liab. Litig., 924 F. Supp. 2d 477, 486 (S.D.N.Y. 2013). Mitigation instructions may be appropriate with products sold directly to and for use by consumers. See, e.g., Alicea v. Gorilla Ladder Co., 181 A.D.3d 512, 512 (1st Dep’t 2020). With regard to prescription products like pharmaceuticals or medical devices, New York has adopted the learned intermediary doctrine which requires, as part of the proximate cause, showing “that an appropriate warning would have affected the course of treatment of the plaintiff’s physician.” In re Fosamax Prods. Liab. Litig., No. 06-MD-1789, 2010 WL 1257299, at *5 (S.D.N.Y. March 26, 2010) (emphasis added). Other cases indicate that the warning must be “adequate.” Bustamante, 2020 WL 583745, at *6.