January 17, 2007

The Role of Litigation in Defining Drug Risks

Author Affiliations

Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.

JAMA. 2007;297(3):308-311. doi:10.1001/jama.297.3.308

In the past decade, several widely used prescription medications have been observed to cause life-threatening 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.1 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.2 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.3 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.

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