Paxil and The Learned Intermediary Defense

The learned intermediary defense appears to be alive and well in the State of Georgia. For years it seems that drug companies have been able to rely on the venerable learned intermediary defense to avoid liability in personal injury cases brought by plaintiffs that have obtained their products through a physician prescription. The defense has recently come under scrutiny in light of the marketing attempts by drug companies that intended to inform the public about their products. The trial lawyers’ bar seems to be asserting that the advertisements by the drug companies are attempts to provide warnings to the public.

Last week the U.S. Court of Appeals for the Eleventh Circuit considered the defense. In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010), the court upheld the trial court’s grant of summary judgment in favor of the defendant. In Dietz, the plaintiff brought a wrongful death claim in which the surviving spouse claimed that her husband’s suicide was proximately caused by his use of Paxil. *1. The plaintiff actually brought the claim under three theories: strict liability, negligence and breach of warranty. Id. The defendant raised the learned intermediary defense, an affirmative defense under Georgia law. Id.

The facts in Dietz were that the plaintiff’s husband had visited his family physician with “anxiety, depression, insomnia, and stress, but expressed that he had no suicidal ideation.” Id. His physician prescribed him to take Paxil as well as a sleep aid, Ambien. Id. Eight days after obtaining his prescription and after he began to take the drug, he committed suicide. Id.

The decedent’s family physician testified during a deposition that the decision to treat the decedent with Paxil was an appropriate decision and that even after reviewing the results of an updated prescription information sheet, there was nothing that about the new information that would have made him decide to not prescribe Paxil to the decedent. Id. *2. The Dietz court reviewed the long-standing doctrine of the learned intermediary defense:

[T]he manufacturer of a prescription drug … does not have a duty
to warn the patient of the dangers involved with the product, but instead has a
duty to warn the patient’s doctor, who acts as a learned intermediary between the
patient and the manufacturer. The rationale for the doctrine is that the
treating physician is in a better position to warn the patient than the
manufacturer, in that the decision to employ prescription medication …
involves professional assessment of medical risks in light of the physician’s
knowledge of a patient’s particular need and susceptibilities.

Id. at *1 (internal citations omitted). The court then went on to hold that the plaintiff could not establish that the defendant’s alleged failure to warn the physician about the increased risk of suicide associated with Paxil proximately caused the decedent’s death. Id. at *3. The court’s decision hinged upon the doctor’s testimony that even after reviewing the new prescription drug information sheet and the warnings mandated by the U.S. Food and Drug Administration, he still would have prescribed the drug. As such, the learned intermediary (decedent’s physician) had an adequate warning and the potential chain of causation proffered by plaintiff was severed.

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