Did a medical device company forge a document to receive FDA approval?

An NBC News investigation has revealed that device company C.R. Bard's blood-clot filter may be associated with more than two dozen deaths and hundreds of complications. Additionally, NBC suggests one of the forms C.R. Bard submitted to the Food and Drug Administration to obtain device approval may have been forged.

Kay Fuller, a veteran regulatory specialist, was recruited by C.R. Bard in 2002 to help secure FDA clearance for the Recovery, a one-and-a-half-inch metal trap designed to sit in a major vein and stop blood clots from reaching the heart and lungs.

Ms. Fuller told NBC News that she raised concerns about the safety of the device after a small human clinical trial raised red flags, and the company refused to provide important safety performance test results. She claims she refused to sign C.R. Bard's application until her concerns were addressed.

After she was told that she would be asked to leave the team if she pursued her line of questions, Ms. Fuller reported her safety concerns to the FDA and resigned, according to the report.

Despite her concerns, a copy of C.R. Bard's FDA application appears to include Ms. Fuller's signature.

"That's not my signature," Ms. Fuller told NBC News when shown a copy of the application. "I will tell you I did not sign it."

The regulatory specialist added that her name was signed on the application without her knowledge, NBC News reports.

C.R. Bard stopped selling the Recovery device in 2005, although it was never officially recalled. Still, the device company estimates that, as of 2009, there are roughly 20,000 people still walking around with the device implanted in them.



More articles on medical devices:
Device may cut UTI detection time from 24 hours to 70 minutes
High-risk medical devices may not be backed by enough clinical research
FDA releases new guidance for cleaning 'unsafe' scopes

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars