The Recovery inferior vena cava filter device is designed to catch blood clots in the vascular system before they can reach the heart or lungs. The invesigation reports that 27 deaths and 100s of non-fatal problems related to the device have been reported.
Ex-regulatory specialist Kay Fuller spoke to NBC News about the filter, which she was hired on to help secure FDA clearance for in 2002, according to the report. Fuller said she had “serious concerns” about the device, and clinical trials had raised red flags about its safety.
When Fuller presented the concerns, according to the report, she was rebuffed.
“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,” Fuller told NBC News. “And I was shocked.”
Fuller told NBC News she informed her boss she would not sign an application for FDA approval until the issues were resolved, but a copy of the application was submitted with her signature on it.
While Fuller did not accuse Bard of forging her signature, she stated that the signature on her document was not her own, according to the report. After the incident, Fuller said she resigned from Bard after reporting her concerns to the FDA.
Bard did not recall the device, but did hire public relations firm Hill & Knowlton to develop and run a “crisis communications plan” over concerns that bad press could affect the company’s stock value and reputations. Bard also commissioned an independent medical expert to run a confidential study, according to NBC News.
In 2005, Bard sold the Recovery device and replaced it with a newer version of the filter, according to NBC News.