Pharmaceutical Company – Duty to Mitigate Warned-Of Risks

Blackburn v. Shire U.S., Inc., and Shire, LLC, [Ms. 1210140, Sep. 30, 2022] __ So. 3d __ (Ala. 2022). Answering certified questions by the Eleventh Circuit Court of Appeals, the Court (Mendheim, J.; Parker, C.J., and Bolin, Wise, Bryan, Stewart, and Mitchell, JJ., concur; Shaw, J., dissents; Sellers, J., dissents with opinion), holds that “1. Consistent with the learned intermediary doctrine, a pharmaceutical company’s duty to warn may include a duty to provide instructions about how to mitigate warned-of risks [and that] a plaintiff establish that a failure to warn caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug?”

The Court first declines to “address the parties’ arguments concerning federal preemption,” because “certified questions concern Alabama law, not federal law.” Ms. *9.

Mark Blackburn was prescribed LIALDA by his gastroenterologist, Dr. Dino Ferrante to manage his Crohn’s disease. LIALDA is manufactured by Shire U.S., Inc., and Shire, LLC (collectively “Shire”). After taking LIALDA for between 12 to 16 months, Blackburn developed advanced chronic interstitial nephritis, diminishing his kidney function to 20% of normal capacity. In pertinent part, the “Warnings and Precautions” portion of the label stated “[i]t is recommended that patients have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy. Exercise caution when using LIALDA in patients with renal dysfunction or a history of renal disease.” Ms. *3. Dr. Ferrante testified that “periodically” to him meant once a year. Ms. *6.

After reviewing its prior learned-intermediary decisions, the Court concludes “nothing in Alabama’s learned-intermediary doctrine prevents Blackburn from asserting a claim alleging that a failure to provide adequate monitoring instructions violates Shire’s duty to warn.” Ms. *25.

In answering the second question, the Court rejects Shire’s argument that to establish causation Blackburn had to demonstrate Dr. Ferrante would not have prescribed the drug but for the inadequacy of the warning. The Court explains

The [Wyeth, Inc. v.] Weeks, [159 So. 3d 649 (Ala. 2014)] Court was not attempting to encapsulate the entirety of duty-to-warn law with respect to prescription-drug manufacturers; it was simply providing a summary in the context of a case alleging misinformation about the side effects of a drug. As Blackburn notes, several federal-court decisions applying Alabama law have intimated that a plaintiff may demonstrate causation by showing that a different warning from a prescription-drug manufacturer would have caused the plaintiff’s physician to act differently, even if the physician still would have recommended the drug.

Ms. *27.

The Court concludes its analysis “[a]llowing a plaintiff to demonstrate causation by presenting evidence indicating that the physician would have changed his or her course of treatment or monitoring of the plaintiff when a failure-to-warn claim concerns allegedly inadequate instructions for mitigating warned-of risks makes logical sense, and it is not foreclosed by Alabama precedent.” Ms. *35.

Justice Sellers dissents and “would hold that, once a prescription-drug manufacturer complies with its duty to warn of the known risks associated with a particular prescription drug, it is incumbent upon the learned intermediaries, not the drug manufacturer, to decide how to monitor patient compliance, the effectiveness of the drug, and the side effects incident to the drug's use that should be mitigated.” Ms. **41-42.

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