This course explores the concepts of product defect and strict liability in tort; manufacturing and design defects, and inadequate warning claims particularly as they arise in drug and medical device contexts. What does it mean for a drug to be declared “safe and effective” given the limited power of both pre-approval clinical trials and the post-market approval passive adverse event reporting system. The course will address the relationship of product liability claims to the principal doctrinal issues in tort law (warranty, strict liability, negligence).
Drawing on the record of recent trials, decisional, regulatory, and statutory law this course focuses on the complex field of drug and medical products liability and will explore claims such as those involving the Cox-2 inhibitor class of anti-arthritic drugs (Vioxx) which resulted in substantial settlements; and claims arising from defective implantable cardiac defibrillators which the Supreme Court found to be barred by federal preemption law. Attention will also be given to vaccine liability and the schemes which replace tort liability with narrow administrative remedies.