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The Mensing Preemption

By Sara K. Thompson and Sean P. Jessee

Because the vast majority of jurisdictions apply the Learned Intermediary Doctrine, failure-to-warn analysis in nearly all jurisdictions will be focused solely on the adequacy of the warnings provided to the prescribing physician. Such jurisdictions also generally require the plaintiff to prove that the physician was unaware of the risk experienced by the plaintiff, such that the purported failure to warn of that risk was a proximate cause of the physician's decision to prescribe the allegedly harmful drug. Because these fundamental concepts control in any state applying the Learned Intermediary Doctrine, the interplay between the Learned Intermediary Doctrine and the Mensing preemption should bar nearly any claim a plaintiff may assert against a generic manufacturer for failure-to-timely-update its label to correspond with the branded drug's label, or for failure-to-communicate such a change to healthcare professionals. Most of these claims will fail at the initial pleading stage, for three main reasons.


Application of Pleading Requirements

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