The role of litigation in defining drug risks.

IN THE PAST DECADE, SEVERAL WIDELY USED PRESCRIPTION medications have been observed to cause lifethreatening adverse effects, and some have been removed from the market. When an approved medication is found to be unsafe, the courts are sometimes called on to determine fault and allocate remedies for injured parties. But in modern prescription drug cases, litigation has taken on additional significance. There are often important gaps in the ascertainment and reporting of adverse effects associated with prescription drugs, and the balance of information presented to physicians about the risks and benefits of medications may understate the former and inflate the latter. However, once it approves a drug, the US Food and Drug Administration (FDA) has limited authority to mandate further collection of data to better define adverse effects or to ensure compliance with suggested alterations in marketing practices. In this environment, litigation brought by government agencies and individual patients can help uncover previously unavailable data on adverse effects, questionable practices by manufacturers, and flaws in drug regulatory systems. Litigation can exert its effect through the discovery process, in which each side shares previously unavailable information relating to the issue in dispute, as well as by motivating proper disclosure initially by presenting the possibility of substantial damages in cases of misconduct. However, some have argued that such litigation adds to the risk and cost of medication development and is a poor way to influence patient care decisions or health policy. Given this controversy, we sought to explore the role of litigation in uncovering new information concerning drug-induced illness and the impact of litigation on drug policy. We evaluated several products recently subject to involvement of the legal system: rofecoxib (Vioxx), cerivastatin (Baycol), dexfenfluramine (Redux), paroxetine (Paxil), troglitazone (Rezulin), cisapride (Propulsid), valdecoxib (Bextra), and olanzapine (Zyprexa) (TABLE). Litigation strategies reviewed included individual and class-action lawsuits against pharmaceutical manufacturers and government investigations of pharmaceutical manufacturers for potentially illegal business practices or financial market manipulation. We sought to define the intersections among the civil justice system, the regulatory apparatus, and the science of pharmacoepidemiology, including the effects of those interactions on drug safety research, clinical knowledge, and regulatory policy.