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JAMA Intern Med. 2019 Oct 28:1-8. doi: 10.1001/jamainternmed.2019.5161. [Epub ahead of print]

Confidentiality Orders and Public Interest in Drug and Medical Device Litigation.

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Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
Collaboration for Research Integrity and Transparency, Yale Law School, New Haven, Connecticut.
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
Section of General Internal Medicine and National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
Associate Editor.


Litigation involving drug and medical device manufacturers has the potential to reveal important information about product efficacy and safety as well as company marketing. Prevailing legal standards recognize the public's interest in having access to certain types of information in lawsuits. However, in practice, courts and litigants commonly use overly broad or unwarranted confidentiality orders, which can prevent the public from accessing important public health information that emerges during litigation. This Special Communication reviews the rules governing confidentiality orders and discusses the tension between these rules and prevailing legal practices relating to court secrecy in medical product litigation, including competing interests among manufacturers, plaintiffs, and courts. Using examples of successful efforts to challenge confidentiality orders, we describe how these prevailing legal practices can undermine access to information by patients, clinicians, and the US Food and Drug Administration and also obscure patterns of injury and disease associated with the drugs and medical devices at issue. We then discuss several ways to advance access to information important to public health that emerges during litigation, focusing particularly on the role of medical experts engaged in cases.

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