CRIT Files Joint Amicus Brief in Support of Health Plans

On November 5, 2018, Yale Law School’s Collaboration for Research Integrity and Transparency (CRIT) and the leading nonprofit legal advocacy organization Public Justice filed a joint amicus brief in the case In re Avandia Marketing, Sales Practices & Products Liability Litigation (“In re Avandia Marketing”), Case No. 18-2259, currently pending before the United States Court of Appeals for the Third Circuit. The amicus brief argues that certain documents containing information on a diabetes medication with a contentious clinical and regulatory history should be made available to the public.

In 2010, health benefit providers (health plans) began bringing lawsuits against GlaxoSmithKline (GSK), alleging that GSK had deceptively marketed its diabetes drug Avandia (rosiglitazone maleate). (GSK previously pled guilty to misconduct involving Avandia and other drug products, including failure to report certain safety data to the FDA.) During the In re Avandia Marketing litigation, the parties submitted various documents to the trial court. These documents include clinical, marketing, and regulatory information on Avandia. At GSK’s request, and over the objection of the health plans, the trial court sealed the summary judgment documents, keeping them secret from the public. In the In re Avandia Marketing appeal, the health plans now ask the Third Circuit to unseal the documents so that the public may see their contents.

CRIT and Public Justice submitted their amicus brief in support of the health plans and in support of unsealing the disputed documents. These documents could provide doctors and patients with important information on the risks and benefits of Avandia and could shed additional light on the scope of GSK’s misconduct. The amicus brief explains that the district court failed to apply the correct legal standard in deciding to seal the documents. The amicus brief explains why the public has rights, under both the common law and the U.S. Constitution, to access these documents.

“We hope that our amicus brief helps to inform the Third Circuit of the correct legal standard for sealing court documents, and we hope that the Third Circuit orders the documents unsealed so that the public may learn more about the risks and benefits of Avandia,” said Margaret E. McCarthy, Executive Director of CRIT.

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. A recent CRIT white paper explains the importance of transparency in clinical research.

Public Justice is a national public interest legal organization that specializes in precedent-setting, socially significant civil litigation, with a focus on fighting corporate and governmental misconduct.