Drug and Medical Device Product Liability (And Related) Claims

Drug and device product litigation brings together a multiplicity of causes of action, both statutory and common law, and intersects with the different regulatory regimes governing branded drugs, generic drugs, and medical devices. This course, presented by attorney Andrea Bierstein, explores the different causes of action that are commonly used in drug and device product liability litigation, highlights common variations in state laws, and dissects issues that arise in proving these cases. The course further looks at some types of related claims, such as consumer fraud and third-party payor claims, that may be brought alongside traditional product claims. Ms. Bierstein also untangles the numerous Supreme Court and circuit Court of Appeals decisions concerning the operation of federal preemption in product liability litigation involving branded drugs, generic drugs, and medical devices. Overall, the course provides an overview of the legal framework for this important and growing area of litigation.

Learning Objectives

I.     Review the causes of action used to bring claims involving injuries arising from pharmaceutical drugs and devices

II.    Grasp issues involved in proving the causal connection between a drug or device and the plaintiff’s injuries, including general and specific causation, the “learned intermediary” doctrine, and expert witnesses and Daubert challenges

III.   Know the effect of direct-to-consumer advertising on pharmaceutical drug and device claims

IV.   Understand how federal preemption affects the various types of pharmaceutical and device product claims