Risks in FDA-Approved Medical Device and Flaws in FDA Procedures Exposed with Help from MFIA Clinic

A newly published study in Annals of Internal Medicine describes the significant safety risks posed by a commonly used blood clot filter and transparency gaps in the procedures of the Food & Drug Administration (FDA) that allowed the device to gain regulatory approval. These public disclosures are the product of years of advocacy by Yale Law School’s Media Freedom and Information Access Clinic (MFIA). 

Working with Yale cardiologist Dr. Harlan Krumholz, MFIA students succeeded in forcing the filter’s manufacturer, Cook Medical, to lift court-imposed confidentiality restrictions on documents it had provided to lawyers during discovery in a product liability lawsuit. The effort was part of a MFIA project to demonstrate how the public interest is damaged by the use of routine protective orders in cases involving critical health and safety concerns, and to win recognition of a public right of access to discovery documents in such cases.

The Celect Filter and MFIA’s Fight for Transparency

Cook Medical’s device, known as the Celect filter, was designed to prevent blood clots from reaching the lungs. It received FDA approval in 2007 and was advertised as having a “95% success rate.” However, internal documents produced by Cook Medical in litigation raised serious questions about this claim of reliability. Early testing of the filter showed serious risks, such as punctured blood vessels in animal studies and adverse outcomes in human trials that did not follow guidelines. However, some of these findings were kept from both the FDA and the public.

Dr. Krumholz learned of these problems with Celect after he was retained as an expert witness for the plaintiff in a 2014 product liability lawsuit challenging the Celect. He was provided access to the documents provided by Cook Medical and quickly identified public health concerns with Celect but could not share his concerns with either the FDA or the public because he was bound by a protective order to keep confidential all information in Cook Medical’s documents other than what the court might permit him to disclose at trial. Concerned about the public health implications of the confidentiality order, Krumholz sought help from MFIA to challenge the restrictions.

MFIA’s Legal Advocacy

MFIA took on the fight in 2020 as part of a partnership with Yale’s schools of law, medicine, and public health that aimed to enhance the transparency of clinical research. The clinic prepared legal papers to make the case that the gag order placed on Krumholz violated his First Amendment rights and that a compelling public interest required disclosure of the information. More broadly, MFIA argued that companies should not be permitted to suppress critical health data under the authority of a routine protective order entered without a judicial determination of good cause for confidentiality of the information at issue. 

After confronting Cook Medical with its objections to the confidentiality restriction on Dr. Krumholz, and extended negotiations among counsel, MFIA secured Cook’s agreement in 2022 to release Krumholz from most confidentiality restrictions, allow him to disclose Cook’s internal documents, and publish research based on the Cook data.

Krumholz’s Study Exposes Public Health Risks and Regulatory Failings 

Building on this legal victory, Krumholz and his team analyzed the unsealed documents. Their findings, published today, reveal significant gaps in the data presented to the FDA during Celect’s approval process. This analysis found that Cook Medical’s internal reports omitted substantial risks, including several instances of deaths and serious complications. According to Krumholz’s study, Cook’s lack of transparency led both patients and healthcare providers to make medical decisions without fully understanding the risks associated with Celect. The study emphasizes that the foundation of medical practice relies on trust — a foundation that Celect shook when vital health and safety information was kept hidden. 

MFIA’s Broader Impact on Medical Device Transparency

This case illustrates the important role that legal clinics like MFIA can play in ensuring that essential health information is accessible to the public. 

Floyd Abrams Lecturer in Law David Schulz ’78, director of the MFIA clinic, clarified the broader issues raised by this case. 

“Court confidentiality orders often obstruct critical information from reaching the public,” Schulz said. “Our success in the Celect case illustrates the importance of public access to information that is often only available through civil litigation, and the need for limitations on routine protective orders in cases involving public health and safety.”

The complete study, published on Nov. 19, 2024, can be found in Annals of Internal Medicine, with contributions from Kushal Kadakia, Behnood Bikdeli, Aakriti Gupta, Sanket Dhruva, Joseph Ross, and Harlan Krumholz.