The Fiction of Non-Preempted Pre-Market Design Defect Claims For Prescription Drugs

Litigation attorney Eric Alexander authored an article featured on Drug & Device Law discussing the Tepezza design defect claim case. Mr. Alexander examines the issues of what a design defect claim with a prescription drug looks like and whether it can survive preemption over time. He also explains that the proper preemption analysis would look at the plaintiff’s factual allegations to see if they were sufficient to establish a design defect claim under the applicable state law and then compared that to the federal requirements. In Tepezza, the plaintiff brought design defect and negligent design claims under the law of an unspecified state (Virginia or Illinois) for alleged “hearing loss and/or tinnitus” from the use of an FDA-approved prescription biologic for an eye disease. Finally, he breaks down the three things that supported the Tepezza court conclusion.

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