The Role of Litigation in Defining Drug Risks
- Aaron S. Kesselheim, MD, JD;
- Jerry Avorn, MD
- Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.
- Corresponding Author: Aaron S. Kesselheim, MD, JD, Division of Pharmacoepidemiology and Pharmacoeconomics, 1620 Tremont St, Suite 3030, Boston, MA 02120 (akesselheim{at}partners.org).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- DRUG REACTION, ADVERSE
- DRUG INDUSTRY
- JURISPRUDENCE
- LIABILITY, LEGAL
- UNITED STATES FOOD AND DRUG ADMINISTRATION
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 …
