A newly published study in Annals of Internal Medicine has exposed significant safety risks associated with Cook Medical's Celect filter, a device approved by the FDA to prevent blood clots from reaching the lungs. The study also highlights transparency gaps in the FDA's procedures that allowed the device to gain regulatory approval despite early testing showing serious risks.
The research, led by Yale cardiologist Dr. Harlan Krumholz, analyzed previously sealed internal documents from Cook Medical. These documents were initially protected by court-imposed confidentiality restrictions stemming from a product liability lawsuit. Yale Law School’s Media Freedom and Information Access Clinic (MFIA) successfully challenged these restrictions, enabling the release of critical information.
Internal Data Omitted Risks
The Celect filter received FDA approval in 2007 and was marketed as having a “95% success rate.” However, the newly released internal documents revealed that Cook Medical omitted substantial risks from the data presented to the FDA. These omissions included instances of deaths and serious complications observed in early testing and human trials that did not adhere to established guidelines.
According to Krumholz's study, Cook Medical's lack of transparency led to patients and healthcare providers making medical decisions without a full understanding of the risks associated with the Celect filter. The study emphasizes the critical role of trust in medical practice, which was undermined by the concealment of vital health and safety information.
MFIA's Role in Unsealing Documents
MFIA's involvement began in 2020 as part of a partnership between Yale's schools of law, medicine, and public health, aimed at enhancing transparency in clinical research. The clinic argued that the confidentiality order placed on Dr. Krumholz violated his First Amendment rights and that a compelling public interest warranted the disclosure of the information. After negotiations, MFIA secured Cook Medical's agreement in 2022 to release Krumholz from most confidentiality restrictions, allowing him to disclose internal documents and publish research based on the data.
Implications for Medical Device Regulation
The study underscores the importance of public access to information in cases involving public health and safety. David Schulz, director of the MFIA clinic, emphasized that court confidentiality orders often obstruct critical information from reaching the public. The Celect case highlights the need for limitations on routine protective orders in cases involving public health and safety, ensuring that essential health information is accessible to both healthcare professionals and patients.
