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From Products Liability Law Daily, May 27, 2015

Federal court refuses to carve out exception to learned intermediary rule

By Pamela C. Maloney, J.D.

Citing Illinois precedent establishing the state’s common law learned intermediary doctrine, a federal district court in Illinois refused to carve out exceptions to that doctrine for cases involving direct-to-consumer advertising or compensation to treating physicians. In an action seeking damages for the death of a patient whose suicide allegedly was linked to his use of Lexapro, the court also determined that the package insert and medication guide that had been provided to the patient with the prescription were adequate to advise him of an increased risk of suicide associated with the drug (Shah v. Forest Laboratories, Inc., May 26, 2015, Der-Yeghiayan, S.).

Background. The patient, Mahasukh D. Shah, had been prescribed Lexapro, a selective serotonin re-uptake inhibitor (SSRI), to treat depression and anxiety. After he committed suicide, his estate filed wrongful death and survivor actions against Forest Laboratories, Inc., the pharmaceutical company that manufactured the drug, alleging that the company failed to warn Shah about the increased risk of suicidality in young adults taking the drug. The pharmaceutical company moved for summary judgment based on the learned intermediary doctrine and the adequacy of warnings provided in the patient insert and medication guide.

Learned intermediary doctrine. Under the learned intermediary doctrine, the pharmaceutical company had a duty to warn the prescribing physician, not the patient, about the risks associated with the use of the drug. In this case, the court found no evidence that the pharmaceutical company failed to fully inform the patient’s treating physician of the risks associated with the SSRI or to provide the treating physician with updated warnings.

The estate argued, however, that other courts have found that the doctrine does not apply when pharmaceutical companies directly advertise their products to consumers or when a physician is compensated by a drug manufacturer and asked the Illinois court to recognize these exceptions. The court declined to alter the Illinois common law, noting that the Illinois Appellate Court had considered the issue in recent years and had upheld the doctrine with no exceptions. The court further explained that there was no evidence that the patient had observed any advertising or that the treating physician had failed to provide all necessary warnings to the patient at the time the drug was prescribed. Because the facts showed that the pharmaceutical company had conveyed all necessary information concerning the risks associated with the drug to the patient’s treating physician, the company was entitled to summary judgment.

Adequacy of patient warnings. The court further found that there was no evidence to indicate that when the patient had his prescription filled, he did not receive the 2008 package insert and medication guide. It was undisputed that the insert and guide contained warnings regarding the risks associated with the drug that had been approved by the FDA. Thus, the pharmaceutical company also was entitled to summary judgment on the issue of the adequacy of patient warnings.

The case is No. 10 C 8163.

Attorneys: Gary D. McCallister (Gary D. McCallister & Associates, Ltd.) for Mahasukh K. Shah. Randall D. Lehner (Ulmer & Berne LLP) for Forest Laboratories, Inc., and Forest Pharmaceuticals, Inc.

Companies: Forest Laboratories, Inc.; Forest Pharmaceuticals, Inc.

MainStory: TopStory WarningsNews ExpertEvidenceNews DrugsNews IllinoisNews

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