[Skip to Navigation]
Special Communication
Health Care Policy and Law
October 28, 2019

Confidentiality Orders and Public Interest in Drug and Medical Device Litigation

Author Affiliations
  • 1Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
  • 2Collaboration for Research Integrity and Transparency, Yale Law School, New Haven, Connecticut
  • 3Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital/Harvard Medical School, Boston, Massachusetts
  • 4Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 5Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
  • 6Section of General Internal Medicine and National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 7Associate Editor, JAMA Internal Medicine
JAMA Intern Med. 2020;180(2):292-299. doi:10.1001/jamainternmed.2019.5161

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.

Add or change institution
Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    1 Comment for this article
    Other interventions and ethical considerations: Disclosure enhances payments to victims and the public interest
    David Egilman, MD. MPH. | Brown University
    In all cases, the discovery material should be provided to the FDA, Congress and the Department of Justice. Plaintiffs should be given authority to accept or reject confidentiality agreements; failure to do so violates the ethical obligation to serve the interests of the clients, many of who are more interested in the truth than money. Disclosure enhances the value of cases. It places immense political pressure on defendants to settle. Many of these cases involve public entities including the Department of Justice, attorneys general, and cities and towns. In these cases there is no conflict between the public and private rights; the public is the plaintiff.
    CONFLICT OF INTEREST: My son is an author. I testify in drug and device litigation