Landmark Texas Supreme Court Decision Clarifies Learned Intermediary Doctrine in Centocor's Favor


Addressing the issue squarely for the first time, the Texas Supreme Court unanimously adopted the learned intermediary doctrine in the prescription-drug context, agreeing with Shook's argument that manufacturers are only obligated to warn doctors of the risks of prescription medicines. Shook attorneys represented Centocor both in trial court and on appeal. 

The plaintiff alleged that Centocor had not properly warned her about the possible side effects of Remicade®, a treatment for autoimmune diseases, because the company's warnings appeared in materials given to her physicians rather than to the patient. A jury and the appeals court agreed, awarding her damages.  Shook attorneys argued to the Texas Supreme Court that Centocor's warnings to the doctors were sufficient under the learned intermediary doctrine, which state appeals courts had already adopted in the prescription-drug context. The Texas Supreme Court ordered that the plaintiff take nothing because she had not proved that an alternative warning to the doctors would have prevented their injuries, freeing Centocor from the adverse judgment and establishing the learned intermediary doctrine as Texas law. Centocor, Inc. v. Hamilton, No. 10-0223, 2012 WL 2052783 (Tex. 2012).

Additional information on the decision appears in Shook's Drug & Device Bulletin, and Madeleine McDonough and Jennifer Stonecipher Hill co-authored a preview of the case before its conclusion in a chapter of Top 20 Food and Drug Cases, 2010 & Cases to Watch, 2011.