Medical Products Liability
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 claims such as those involving the Cox-2 inhibitor class of anti-arthritic drugs, such as Vioxx, and devices like implantable cardiac defibrillators. Such products continue to challenge the tort and the regulatory systems. 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 effectiveness of both pre-approval clinical trials and the post-market approval passive adverse event reporting system? Should an FDA approved product be subject to state product liability claims? Are courts and juries competent to make the judgment that a drug is defective in design? Particular attention is paid to the product liability litigation which has followed the withdrawal form the market of the drug Vioxx. Key medical studies and review articles, Vioxx trial transcripts, and other trial documents are used to examine the questions of causal relationship and adequate labeling which are at the heart of such cases.
We address the relationship of product liability claims to other doctrinal issues in tort law: medical malpractice, the learned intermediary doctrine, direct to consumer advertising, and the informed consent doctrine; federal preemption and the FDA regulatory compliance defense; problems of proof - using epidemiological, toxicological, and other scientific evidence to prove causation of harm; Multi-District Litigation, consolidation, and the use of bell-wether trials to shape litigation; immunities and alternatives to liability in tort - "blood shield" laws, the National Childhood Vaccine Injury Compensation Act; and recent immunities for developers of products deployed as countermeasures for bio-terror, pandemics, and epidemics.