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From Health Law Daily, October 23, 2017

Risperdal® label warnings adequate under learned intermediary doctrine

By Jeffrey H. Brochin, J.D.

Under Mississippi product liability law, a drug warning label which adequately warned the prescribing physician of any known adverse effects satisfied the state’s learned intermediary doctrine. The Mississippi Supreme Court ruled that the manufacturer’s failure to warn the patient of the product’s risks did not render the product defective or unreasonably dangerous Johnson & Johnson, Inc. v. Fortenberry, October 19, 2017, Coleman, P.).

Injury and trial. An elderly Mississippi resident was treated with Risperdal® for recurring psychotic episodes. About three years later, she developed tardive dyskinesia, a movement disorder caused by antipsychotic medications. She filed a complaint against Ortho-McNeil Janssen Pharmaceuticals, the manufacturer, seller, and distributer of Risperdal, and its parent company Johnson & Johnson. The case went to trial a jury found that the patient was harmed by Risperdal due to failure to provide adequate warnings and negligent marketing and misrepresentation. She was awarded damages totaling $1,950,000.

Mississippi’s learned intermediary doctrine. On appeal, the companies contended that they were entitled to judgment notwithstanding the verdict on the failure-to-warn claim because there was no evidence of any inadequacy in the Risperdal warning, and because they warned of the risk of tardive dyskinesia. The court noted that under the learned intermediary doctrine, the manufacturer’s failure to warn the patient of the product’s risks does not render the product defective or unreasonably dangerous so long as the manufacturer has adequately warned the prescribing physician who is the learned intermediary. A drug manufacturer would only have a duty to warn the consumer if there was no physician in the role of learned intermediary.

Warning label deemed unequivocal. The state Supreme Court found that the Risperdal label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs. The label stated that tardive dyskinesia "may develop in patients treated with antipsychotic drugs." The prescribing physician specifically testified that he considered the language of the label adequate to warn him of the risk of tardive dyskinesia in Rispderal users at the time he prescribed it to the patient. Based on the foregoing, the court found that the label adequately warned of the risk of tardive dyskinesia as a matter of law.

The case is No.: 2015-CA-01369-SCT.

Attorneys: Christy D. Jones (Butler Snow LLP) for Johnson & Johnson, Inc. and Ortho-McNeil-Janssen Pharmaceuticals, Inc. Timothy W. Porter (Porter & Malouf, PA) for Brenda Fortenberry.

Companies: Johnson & Johnson, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.

MainStory: TopStory CaseDecisions DrugBiologicNews PrescriptionDrugNews PLDrugNews SafetyNews MississippiNews

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