The Mensing Preemption

Application of Pleading Requirements

Failure-to-update claims are often deficient on their face because the plaintiff generally will lack sufficient facts to allege specifically how the failure-to-update played a direct and proximate role in the physician's decision to prescribe a drug. Even if a plaintiff can establish that a label change was not promptly made, this fact will be insufficient to support a product liability claim if the drug was not prescribed during the time between the brand label change and the generic label change, or if the label change deals with an issue that bears no logical relationship to the injury alleged. As a threshold matter, a plaintiff must allege that he or she would not have been prescribed the drug in the manner in which he or she ingested it if the label change had been timely made by the generic manufacturer, or else such claims will fail due to insufficient pleading. Similarly, failure-to-communicate claims must allege that the failure-to-communicate proximately caused the plaintiff's prescribing physician to prescribe the medication in a way that he or she would not have if the warning had been more fully disseminated or directly communicated. Plaintiffs must additionally allege the communication of the new warning to the prescribing physician would have been received and viewed prior to prescribing the drug and would have altered the physician's decision to prescribe the drug.