chapter  4
31 Pages

Impact of Drug Products Liability on Needs for Pharmacoepidemiologic Studies and Expertise

WithSidney H. Willig

Evidence consisting of analysis of pharmacoepidemiologic studies of drugs subject to drug products liability litigation are of prime importance to both plaintiff and defendant when the adequacy of the prescription drug package insert is at issue. The challenge to the pharmacoepidemiologist is to take the data available, plumb clinical experience, and determine whether an association manifest from the data is or differs from a causal connection. The act of gathering adverse reaction reports is itself salutary to the manufacturer as a public service and can provide early warnings of major design or labeling defects. In a cumulative sense, since many drugs are molecularly similar, relative safety profiles are created within certain classes of drugs on the basis of composition as well as therapeutic or diagnostic use. Within the clinical trials, the need to report adverse reactions was continued and the method gradually formalized, so that introductory product labeling reflected experience with the new drug.