CRIT works with attorneys from the Media Freedom & Information Access Clinic (MFIA) to pursue key litigation advancing transparency and integrity.
ClinicalTrials.gov Enforcement Litigation
Charles Seife and Peter Lurie v. U.S. Department of Health and Human Services
February 2020
A ruling from a federal judge on February 24, 2020, will dramatically expand the public’s right to access results of clinical trials studying drugs and medical devices. The ruling is the latest development in a lawsuit brought by the Yale Media Freedom and Information Access (MFIA) and NYU Technology Law & Policy (TLP) Clinics on behalf of Charles Seife and Dr. Peter Lurie, with the support of CRIT.
December 2018
On December 7, 2018, Yale CRIT attorneys working with Yale’s MFIA student clinic filed suit on behalf of Charles Seife and Dr. Peter Lurie to demand that NIH, FDA, and HHS comply with their legal obligations to notify the public of failure to report clinical trial results on ClinicalTrials.gov.
Collaboration for Research Integrity and Transparency v. U.S. Department of Health and Human Services, National Institutes of Health, and Food and Drug Administration
July 2018
The Media Freedom and Information Access Clinic (MFIA) filed a complaint on behalf of CRIT, urging a federal district court in Connecticut to compel the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA) to comply with their legal obligations to notify the public of researchers' failure to report clinical trial results on ClinicalTrials.gov.
FOIA Litigation
Charles Seife v. Food and Drug Administration and Department of Health and Human Services (ongoing)
CRIT, in collaboration with attorneys from the Media Freedom & Information Access Clinic (MFIA), assisted an investigative journalist and NYU journalism professor, Charles Seife, in filing a Freedom of Information Act (FOIA) request to the FDA for documents and data regarding the approval of Exondys 51 (eteplirsen) for Duchenne Muscular Dystrophy. When the requested documents were not received, attorneys from MFIA Clinic filed suit.
MFIA attorneys filed a motion for partial summary judgment, challenging the FDA's denial of an expedited processing request. On July 27, 2017, pursuant to a court order, the FDA stipulated to an expedited schedule for release of the requested information. Throughout the second half of 2017, the FDA produced thousands of pages of requested documents. However, some of the documents were heavily redacted, and the FDA continues to withhold other key documents, alleging that they contain confidential commercial information submitted by Sarepta. In early 2018, Seife published an in-depth investigative piece in Scientific American, "Is the FDA Withholding Data about a Controversial Drug to Protect its Manufacturer?" based on what he has learned from the lawsuit.
The FDA and Sarepta Therapeutics moved for summary judgment, arguing that the withheld documents should not be released to Charles Seife. MFIA attorneys cross-moved for summary judgment, arguing that the withheld documents should be provided to Charles Seife. MFIA attorneys also moved to stike the testimony of one of Sarepta's employees.
The Media Freedom & Information Access Clinic (MFIA) continues to litigate the case. Key documents in the case are below.
Complaint and Answers
Plaintiff's Motion for Partial Summary Judgment Regarding Expedited Processing
Motions for Summary Judgment
Freedom of Information Act Litigation, Treatment Action Group and Global Health Justice Partnership, v. Food and Drug Administration and Department of Health and Human Services
As part of efforts to make the clinical data submitted to the Food and Drug Administration (FDA) publicly transparent and accessible, the Global Health Justice Partnership (GHJP) and Treatment Action Group (TAG) submitted a Freedom of Information Act (FOIA) request to the FDA for documents and data regarding 2 drugs used to treat Hepatitis C, Sovaldi and Harvoni. When the requested documents were not received, TAG and GHJP filed suit. CRIT, in collaboration with attorneys from the Media Freedom & Information Access Clinic (MFIA), litigated the case in federal court. We received trial protocols, clinical study reports and adverse event reports as well as other useful documents from the FDA.
Amicus Briefs
Amicus Brief in the Matter of Food Marketing Institute v. Argus Leader Media
March 2019
On March 25, 2019, CRIT, Public Citizen, and the Center for Science in the Public Interest filed a joint amicus brief at the Supreme Court in Food Marketing Institute v. Argus Leader Media, No. 18-481. The brief was prepared with the assistance of students and supervising attorneys in Yale Law School's Media Freedom and Information Access Clinic (MFIA). The amicus brief urges the court to reject efforts to broaden exemption from FOIA disclosure for confidential commercial information.
Amicus Brief in the Matter of Avandia Marketing, Sales Practices & Products Liability Litigation
November 2018
CRIT, in collaboration with Public Justice, PC, and the Media Freedom and Information Access Clinic (part of the Abrams Institute for Freedom of Expression at Yale), filed an amicus brief in the Matter of Avandia Marketing, Sales Practices & Products Liability Litigation, United Food and Commercial Workers Local 1776 and Participating Employers Health and Welfare Fund and J.B. Hunt Transport Services, Inc. v. GlaxoSmithKline LLC, an appeal in the Third Circuit Court of Appeals. Our amicus brief addresses overbroad sealing of drug company documents, improperly keeping them from public view despite an important public health and safety interest.
Amicus Brief in Nicopure Labs, LLC v. Food & Drug Administration
June 2018
Attorneys from CRIT and the Yale Law School Abrams Institute for Freedom of Expression filed an amicus brief on behalf of Yale Law School Professors Robert C. Post, Jack Balkin, and Amy Kapcynski, in Nicopure Labs, LLC v. Food and Drug Administration, an appeal in the D.C. Circuit Court. The case addressed the ability of the FDA to regulate advertising regarding modified-risk tobacco products, such as e-cigarettes and vaporizers.
Collaboration on Amicus Brief in Federal Trade Commission, et al. v. Quincy Bioscience Holding Co., et al.
March 2018
CRIT joined a consortium of public health groups as amici in an amicus brief filed by Public Citizen, Inc. in Federal Trade Commission, et al. v. Quincy Bioscience Holding Co., et al., a case in the U.S. Court of Appeals for the Second Circuit, a case alleging false or misleading statements in product labeling and advertisements for a dietary supplement marketed for improved memory.
Collaboration on Amicus Brief in Public Citizen, Inc., Natural Resources Defense Council, And Communications Workers of America, AFL-CIO v. Donald J. Trump, et al.
May 2017
CRIT joined a consortium of public health groups as amici in an amicus brief filed by Gupta Wessler PLLC in Public Citizen, Inc., Natural Resources Defense Council, And Communications Workers of America, AFL-CIO v. DONALD J. TRUMP, et al., a case in the D.C. Circuit Court challenging Executive Order No. 13771, commonly known as the “two-for-one” order.
Amicus Brief in Expressions Hair Salon v. Schneiderman
December 2016
CRIT, in collaboration with the Media Freedom & Information Access Clinic (MFIA), submitted an amicus brief in December 2016 to the United States Supreme Court in a case dealing with ability of government agencies to regulate the words used by merchants in conveying prices. Our brief informed the court of the ways that a broad ruling could negatively impact the FDA's ability to regulate medical product advertising and marketing. The court's eventual decision was narrow.
Technical Assistance in Settlement Provisions
CRIT researchers and staff, in collaboration with the Media Freedom & Information Access Clinic, provide technical assistance to attorneys regarding model settlement clauses in litigation, designed to increase data sharing regarding medical products.
