The 11th Circuit Court of Appeals recently relied upon the learned intermediary doctrine in affirming summary judgment in favor of Smithkline Beecham Corp. (“SBC”) in a lawsuit claiming that the antidepressant Paxil caused the decedent to commit suicide.  Dietz v. Smithkline Beecham Corp., No. 09-10167 (11th Cir. March 5, 2010).

In Dietz, the plaintiff’s late husband was diagnosed with major depression by his family doctor, who gave him a prescription for Paxil.  The decedent committed suicide shortly after he began taking Paxil.  The plaintiff sued SBC based on theories of strict liability, negligence, and breach of warranty.  During his deposition, the family doctor testified that he had considered the risks and benefits associated with Paxil before prescribing it and that, after reviewing the latest research on Paxil and suicide, he still considered his decision to be appropriate in light of all the circumstances.

Applying Georgia law, the lower court granted summary judgment in SBC’s favor on all of the plaintiff’s claims and the appeals court now affirmed.  The appeals court based its decision on the learned intermediary doctrine, which holds that the manufacturer of a prescription drug does not have a duty to warn a patient of the dangers involved with its product.  Instead, the manufacturer has a duty to warn the patient’s doctor, who “acts as a learned intermediary between the patient and the manufacturer.”  The doctrine is based on the rationale that the doctor is in a better position to warn the patient, because the decision to prescribe or not to prescribe medication depends on the doctor’s “knowledge of the patient’s particular needs and susceptibilities.”

In applying the doctrine, courts usually engage in a two-step inquiry: (1) Did the manufacturer provide the intermediary with an adequate warning? (2) If not, has the plaintiff demonstrated that the deficient warning proximately caused the alleged injury?  In Dietz, because the doctor testified that he would have prescribed Paxil to the plaintiff’s decedent even after reviewing the latest research regarding Paxil and suicide, the court found that the plaintiff could not establish proximate cause.

Please click here to read a copy of the court’s decision.