Health Law Daily Patient’s failure to receive medication guide irrelevant due to learned intermediary doctrine
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Wednesday, April 10, 2019

Patient’s failure to receive medication guide irrelevant due to learned intermediary doctrine

By Wendy Biddle, J.D.

Patient’s son loses appeal when drug manufacturers raise learned intermediary doctrine defense in failure to warn of drug’s side effects case that resulted in death.

Drug manufacturers discharged their state-law duty to warn consumers of their drug’s risks when they gave a patient’s doctor an adequate warning as to the risks of amiodarone use, including pulmonary toxicity, which ultimately led to the patient’s death, the Fourth Circuit Court of Appeals ruled. The court held that South Carolina’s learned intermediary doctrine applied and the prescribing physician was the informed intermediary. The court also held that the FDA’s requirement that patients themselves be given the Medication Guide did not create an exception to South Carolina’s learned intermediary doctrine (Bean v. Upsher-Smith Pharmaceuticals, Inc., April 8, 2019, per curiam).

The patient was prescribed amiodarone by his physician to treat his non-life-threatening atrial fibrillation. At the time he prescribed the medication, the doctor was aware that a side effect of the drug was a risk of pulmonary toxicity. The patient, however, was not aware of the side effect, because he never received the FDA-mandated Medication Guide. The patient experienced that side effect and as a result died. Furthermore, the drug was not approved by the FDA for non-life-threatening atrial fibrillation so the doctor’s prescription was off-label.

The patient’s son brought suit against Upsher-Smith Pharmaceuticals, Inc and Taro Pharmaceuticals USA, Inc, the manufacturers of amiodarone, alleging that they had violated their duty under South Carolina state law to warn users of their product’s dangers. The suit also claimed that the manufacturers had unlawfully promoted amiodarone for off-label uses. The manufacturers moved to dismiss and the district court granted the motion. The district court held that the failure to warn claim was barred by South Carolina’s learned intermediary doctrine and the off-label promotion claim was dismissed as preempted by federal law. The patient’s son appealed the ruling on the failure to warn claim.

On appeal, the 4th Circuit noted that South Carolina law imposes on drug manufacturers a duty to warn that extends only to doctors or other medical personnel that are permitted to prescribe drugs. Therefore, the court determined that the prescribing physician was the learned intermediary and he was in the best place to decide what information the patient needed to give informed consent to his treatment. The doctor did receive all the warnings from the manufacturers as required by federal law.

The patient’s son seemed to argue that the warnings were ineffective because the manufacturer promoted the drug for off-label uses. Although they didn’t lie about the risks of the drug, he believed that they lied about the benefits. The court found that even if those allegations were true, it does not defeat the application of the learned intermediary doctrine. The court noted that when companies misrepresent benefits of a product they are subject to liability under different theories, such as negligent misrepresentation. Because the patient’s son declined to appeal the dismissal of the off-label promotion claims, he cannot revive that claim in response to the learned intermediary doctrine defense raised by the manufacturers.

Lastly, the court noted that although FDA regulations state that the patient himself should have received the Medication Guide, the federal requirement does not create an exception to South Carolina’s learned intermediary doctrine. That exception would contradict the FDA’s intent that the Medication Guide not alter the duty or standard of care for manufacturers. The court therefore affirmed the district court’s dismissal.

The case is No. 17-2263.

Attorneys: Samuel Callison Cole (Sam Cole Legal Services, PLLC) for Latham Sean Bean. Nicole M. Battisti (Morrison Mahoney LLP) and Mark C. Hegarty (Shook Hardy Bacon, LLP) for Upsher-Smith Pharmaceuticals, Inc. and Taro Pharmaceuticals USA, Inc.

Companies: Upsher-Smith Pharmaceuticals, Inc.; Taro Pharmaceuticals USA, Inc.

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