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CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.


Appeals Court Rules in Favor of Transparency in Avandia Marketing Suit

May 15, 2019

In November 2018, CRIT, along with Public Justice, submitted an amicus brief in In re Avandia Marketing, Sales Practices & Products Liability Litigation (“In re Avandia Marketing”), Case No. 18-2259, before the United States Court of Appeals for the Third Circuit, in favor of the Appellant health plans.

Two health plans had sought to unseal key documents in the case, so that they could be included in publicly filed appeal documents, and the trial court had denied their request, keeping the documents hidden from public view. We argued in the amicus brief that the trial court applied the wrong standard in refusing to unseal the documents, and urged the appellate court to reverse the ruling of the trial court based on the common law right of access and the First Amendment public right of access.

In a May 15, 2019 decision, the Third Circuit reversed the trial court’s decision, and held that the trial court applied the wrong standard, in placing the burden on the health plans to justify why the documents should be unsealed, rather than on the drug manufacturer, GlaxoSmithKline LLC(GSK) to justify why continued sealing was merited. The appeal court ordered the trial court to conduct a document-by-document review, first under the common law right of access, and if that standard were not satisfied, under the First Amendment.

Once of the justices, Circuit Judge Restrepo, wrote a concurring decision indicating that the First Amendment public right of access extends to documents submitted in connection with motions for summary judgment.

The court’s decision, and in particular, the concurrence, adopts the reasoning advocated in our amicus brief. This represents a significant victory for transparency advocates. The Third Circuit’s clear statement that the trial court applied the wrong standard in denying release of the documents is unequivocal.  By requiring a document-by-document review, the court decision emphasizes that determination of whether documents should be unsealed  is not a perfunctory assessment but merits careful consideration of the public right of access.