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NBC News dropped a bombshell in the second part of its investigation into deaths and injuries associated with C.R. Bard’s Recovery IVC filter. The story, which aired on September 3, revealed that a possibly forged signature might have helped pave the way toward U.S. Food and Drug Administration approval of the device in 2002. NBC reported that the Recovery filter has been linked to at least 27 deaths and approximately 300 injuries.
Part Two of the report featured an interview with Kay Fuller, a veteran regulatory specialist hired by Bard after it was initially unable to obtain FDA clearance for the Recovery filter. The device, which is implanted in a patient’s inferior vena cava (the largest vein in the body), is designed to catch blood clots that form in the legs and keep them from entering the lungs or heart. However, pieces of the Recovery filter have broken off in some instances, lodging in major organs and leading to serious injuries and deaths. Lawsuits for Bard IVC recovery system complications continue to pile up against the already litigation heavy device manufacturer.
During her interview with NBC, Fuller stated that once Bard hired her she began to have significant concerns about the Recovery filter. She said the results of a small clinical trial raised red flags, as did the fact that Bard did not provide her with results of another critical safety performance test.
Fuller said that Bard officials inferred she would no longer be part of the team if she were to voice those concerns.
Fuller told NBC News she informed her boss that she would not sign Bard’s revised application for approval of the Bard Recovery filter to the FDA until the issues that concerned her were resolved to her satisfaction. However, the application was submitted anyway with Fuller’s signature – even though she said the signature that appeared on the form was not hers.
The report showed that the signature on that application was substantially different from another sample of Fuller’s signature at the time. Although Fuller would not say her signature was forged on the application, she was clear in saying she did not sign it. She stated that her name was signed without her knowledge.
Fuller resigned from Bard after reporting her concerns to the FDA, NBC reported. She said she does not know what the agency did with that information, and the FDA would not comment on whether or not it acted on her tip. No one from Bard agreed to be interviewed, but did say that any suggestion of forged documents was “flatly untrue.”
Approximately 34,000 Recovery filters were sold until the model was discontinued in 2005 and replaced with a newer version called the G2. NBC reported that, according to confidential Bard records obtained by the news organization, the Recovery filter is still implanted in about 20,000 people.
The IVC filter attorneys with Baron & Budd will be keeping a close watch on developments in this matter. In the meantime, we are investigating potential lawsuits involving the Bard Recovery filter as well as those from other manufacturers. Please complete our contact form and we will let you know if you qualify to file an IVC filter lawsuit.