DRUG/VACCINE RISKS: PATIENT DECISION-MAKING AND HARM REDUCTION IN THE PHARMACEUTICAL COMPANY DUTY TO WARN ACTION

Abstract

In this article, the duty of pharmaceutical companies to warn is explored in relation to the underlying values of patient control of decision-making and the avoidance of harm. The "learned intermediary" rule, applicable to the duty to warn with respect to prescription drugs and vaccines, is examined and the rationale for its existence criticized, particularly with respect to reproductive products. The adequacy of the warning is considered in the context of the system of testing, research, reporting and promotion within which adverse effects arise. Causation in drug/vaccine cases poses many of the classic dilemmas, along with novel problems and combinations. Patient safety and participation in decision-making require changes to some legal standards and a continuing awareness of the power relationships among the pharmaceutical company, doctor and patient.