Pharmaceutical Drug Product Liability Litigation Short Course

1 credits · Law School

No part of modern tort law is more important, more complex, and more contentious than that which pertains to personal injuries allegedly caused by defective pharmaceutical drugs, medical devices, and consumer products. This course, focusing specifically on product liability lawsuits filed against pharmaceutical drug manufacturers, will consider the theory and practice of such litigation before and after the Supreme Court’s landmark decision in Wyeth v. Levine. We will review the development and the current operation of product liability law, highlighting its distinctive procedural, substantive, and remedial aspects. The following topics will be addressed: (1) how product liability litigation typically arises; (2) key categories of claims including manufacturing defect, design defect, and failure to warn; (3) other product liability claims including breach of warranty, fraud and misrepresentation, violation of state deceptive trade practices and consumer protection statutes; and infliction of emotional distress; (4) concepts of general and specific medical causation; (5) key themes and theories often asserted by plaintiffs; (6) key defenses often asserted by defendant-manufacturers including Daubert challenges, alternative medical causation, learned intermediary doctrine, and statute of limitations; (7) types of damages including economic and non-economic compensatory damages and special problems posed by the availability of punitive damages; and (8) the drug approval process, preemption, and other implications of the U.S. Food and Drug Administration regulations. Enrollment Limited. Pass/Fail. [1]