Posted: September 8th, 2015
In the second part of an in-depth investigation into safety concerns surround the Bard Recovery IVC Filter, NBC News looked into allegations that key regulatory documents were forged into to secure FDA approval for the potentially fatal medical device. In their report, NBC News interviewed former Senior Regulatory Affairs Specialist for C.R. Bard, Kay Fuller, about her role in acquiring FDA approval for the Bard Recovery IVC filter after the agency had rejected a previous application by the medical device manufacturer. The Food and Drug Administration did not view the Recovery, a 1.5 inch metal implement meant to catch dislodged blood clots, preventing injury to be any safer than the prior generation of IVC filter released by C.R. Bard.
According to Kay Fuller, she maintained “serious concerns about the Recovery [IVC filter]” after a human clinical trial showed troubling data, and C.R. Bard refused to furnish her with safety performance test results. Fuller’s attempt to alert C.R. Bard officials about the safety of the IVC filter were met with inaction and resistance.
“It was basically, you know, if you continue to pursue these questions, that I was going to be asked not to be on the team…I was shocked.”
Fuller informed her supervisor that she would not sign off on the application to the FDA without appropriate action being taken to ensure the safety of the IVC filter. However, the company submitted an application with what Fuller maintains is not her signature. She reported her allegations to the FDA, who will not comment on action taken in response to her tip. C.R. Bard has stated that any allegations of forgery are “flatly untrue”.
With reports of death and injury growing, C.R. Bard stopped selling the Recovery IVC filter in 2005, after 34,000 patients were implanted with the device. It has never been formally recalled by the company or the Food and Drug Administration. Internal documents reviewing the safety of the Recovery IVC filter found it to be responsible for a higher rate “of relative risk for death, filter fracture and movement than all its competitors”.
It is currently estimated that more than 20,000 people still have Bard IVC filters implanted. If you or a loved one have been implanted with an IVC filter and suffered death or injury, you may be eligible for compensation. Please fill out the contact form on this page, or call Arentz Law Group at 1-800-305-6000 for a free review of your claim no matter where you live.