CRIT Releases Report on Opposing Secrecy in Medical Product Litigation

On March 25, 2019, the Yale Collaboration for Research Integrity and Transparency (CRIT) released a conference report, Preventing the Use of Courts to Shield Essential Health Information: Rethinking Confidentiality in Medical Product Litigation.

Although the U.S. has a long history of open courts, with court records typically open to the public, that is not the case in many medical product cases. Protective orders and sealing orders are widely used in medical product litigation to keep information secret.  Information placed under seal cannot be shared. When information about health and safety risks uncovered in medical product lawsuits is kept secret, the FDA, researchers, health care providers, and the public are all deprived of needed information.

Margaret McCarthy, CRIT Executive Director, expressed hope that the report “will spark a broader discussion of the need to oppose the use of courts to shield access to essential health information.” As she explained, “The public’s interest in access to critical health and safety information should outweigh a corporation’s interest in avoiding adverse publicity.”

The report is the result of more than six months of collaboration. In September 2018, CRIT hosted a conference on court secrecy in medical product litigation. Plaintiffs’ attorneys, public interest attorneys, consumer protection attorneys, professors, and academic researchers met and discussed how to address the use of protective orders and sealing orders in medical product cases. The conference report includes best practices and principles to follow to allow access to health and safety information disclosed in medical product litigation, and to oppose efforts to keep health and safety information secret.

The Collaboration for Research Integrity and Transparency (CRIT) is an interdisciplinary initiative launched in 2016 at Yale Law School, Yale School of Medicine, and Yale School of Public Health, whose mission is to promote health by improving the integrity and transparency of biomedical and clinical research. Through research, advocacy, and litigation, CRIT is focused on ensuring that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products is accurate, comprehensive, accessible, and reliable.

CRIT is funded by the Laura and John Arnold Foundation and the Oscar M. Ruebhausen Fund at Yale Law School.