Hot Topics for Trial Lawyers
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Fifth Leans on Learned Intermediary Doctrine in Failure to Warn Case
Posted 5/9/08 Alex B. Roberts, Beck, Redden & Secrest, L.L.P.On April 24, 2008, a panel of the Fifth Circuit affirmed a summary judgment in favor of drug manufacturer Wyeth Pharmaceuticals in Ackermann v. Wyeth Pharms., No. 06-41774 (5th Cir., Apr. 24, 2008). This case out of the Eastern District of Texas alleged that inadequate warnings on Wyeth’s antidepressant Effexor caused the plaintiff’s husband to commit suicide.The Fifth Circuit held that the learned intermediary doctrine barred the plaintiff’s claims of strict liability and failure to warn. The record showed that the decedent’s physician was aware of claims that modern antidepressants might lead to an increased rate of suicide, that he carefully monitored the plaintiff’s husband for significant signs of suicidal tendencies, and that he would not have altered the course of treatment if different warnings had been provided. Under the learned intermediary doctrine, a warning to an intermediary such as a doctor fulfills a supplier’s duty to warn its consumers. The doctrine thus excuses a drug manufacturer from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers. Wyeth moved for summary judgment on the plaintiff’s warnings claims based on the learned intermediary doctrine and federal preemption; the district court granted the motion. Ackerman v. Wyeth Pharms., 471 F. Supp. 2d 739 (E.D. Tex. 2006).
The Fifth Circuit panel consisted of Chief Judge Edith Jones, and Circuit Judges Wiener and Clement. Affirming the district court’s grant of summary judgment, the court found that there were no genuine fact issues regarding whether any inadequacy of the warning was a producing cause of the plaintiff’s husband’s death. The prescribing physician “would have prescribed Effexor even had the warnings been stronger.”
The Fifth Circuit avoided weighing in on the hot-button issue of whether pharmaceutical failure-to-warn claims are preempted by FDA approval. The U.S. Supreme Court will consider that issue next term in Wyeth v. Levine, No. 06-1249.
Meanwhile, the Third Circuit ruled that the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the FDA has explicitly refused to order such warnings. Colacicco v. Apotex, Inc., ”>Colacicco v. Apotex, Inc., No. 06-3107 (3d Cir., Apr. 18, 2008). Writing for the majority, Judge Dolores K. Sloviter said the FDA has “actively monitored” the possible risk of suicide from taking the class of antidepressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs “are without scientific basis and would therefore be false and misleading.”
The pharmaceutical preemption cases follow on the heels of the Supreme Court’s decision in Riegel v. Medtronic, 06-179, decided in February 2008, holding that suits against medical device manufacturers for claims arising out of FDA-approved medical devices are preempted by the Food, Drug, and Cosmetic Act.