Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the drug with knowledge of the allegedly associated GI issues.

Drug manufacturers have a duty to warn consumers directly of all material, foreseeable risks associated with the use of their product. Such warnings are generally rendered in a label applied to the product and on the insert that accompanies the product. In situations where the product is recommended or prescribed to the consumer by a learned third party, such as a physician or clinician, an exception to the duty to warn exists. This exception is known as the learned intermediary doctrine. The learned intermediary has a duty to warn the consumer of all benefits and risks associated with the recommended product. Entrusted with the duty to properly advise patients of the benefits and risks associated with prescribed drugs, if a clinician is aware of a side-effect and yet still elects to prescribe that drug, a manufacturer’s duty to warn may be discharged if a court deems that the learned intermediary exception applies.

Testimony elicited from treating physicians in the aforementioned cases established that the respective clinician knew of the potential GI complications associated with the drug, and despite this knowledge, still prescribed the medication.  Had the manufacturer included a different warning regarding potential GI issues with its product, the treaters confirmed each still would have prescribed the drug to the respective patient.  By so testifying, the respective clinicians satisfied the two components necessary to apply the learned intermediary doctrine: 1) the physician or clinician knew the benefits and risks associated with the product; and 2) warnings issued by the manufacturer with the product did not mislead the learned intermediary, nor were the warnings considered inadequate.

The judge’s decision effectively substantiates that the manufacturer produced a label with sufficient warnings regarding GI issues associated with the use of its drug, in those cases. With this decision in place, summary judgment may be granted to the defendant in the balance of cases in the mass tort, where testimony of a learned intermediary confirms the clinician knew of the alleged GI risks, but prescribed the medication anyway.

The strategy employed by the manufacturer and its attorneys to depose the treating physicians and establish that they would have prescribed the drug regardless of any different warning was rewarded in this case. Gaining an understanding of the state of the science is important before embarking on depositions of a treating physicians. Understanding the individual medical conditions of the plaintiffs included in a mass tort is also important as their physicians decision to prescribe or not is dependent upon their individual presentation.

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