Forged Signature May Have Helped Recovery Filter Gain Approval from FDA
In the second segment of its IVC filter investigation, published in September 2015, NBC News revealed that medical device maker C.R. Bard had recruited a regulatory specialist named Kay Fuller to help gain approval from the FDA for its Recovery blood clot filter, after the agency had rejected the company’s initial application. When Fuller refused to sign the application due to safety concerns though, Bard allegedly took matters into its own hands and forged Fuller’s signature on key documents submitted to the FDA, clearing the way for the potentially dangerous blood clot filter to become available to consumers. If you received an IVC filter in the past, and you have since suffered serious complications like filter fracture or migration, consult an experienced blood clot injury attorney today for legal help.
Side Effects Allegedly Linked to Recovery Filter
In an interview with NBC News, Kay Fuller revealed that, not only did Bard fail to relay important safety performance test results to her in regards to the Recovery filter, the company also threatened to let her go if she pursued her questions about the safety of the medical device, which a confidential study commissioned by Bard had shown was associated with higher rates of relative risk for death, filter fracture and filter migration than all other filters on the market. “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 said during the interview. “And I was shocked.” Despite Bard’s threats, Fuller said she would not sign the Recovery application until the issues were resolved.
Bard Suspected of Forging Signature on Key Documents
Instead of addressing the problems with its Recovery IVC filter though, Bard went ahead and submitted its application to the FDA with what appears to be Fuller’s signature on it. “That’s not my signature,” Fuller told reporters from NBC News when shown a copy of the paperwork. According to the regulatory specialist, she reported her safety concerns to the FDA and resigned from Bard. “I never knew what they did after that.” What Bard did, is eventually receive approval from the FDA for its Recovery filter and go on to sell approximately 34,000 of the filters in the United States. Unfortunately, according to reports, over the course of ten years, the device was associated with 27 deaths and nearly 300 non-fatal injuries.
C.R. Bard Refused to Recall Recovery Implant
In total, about a quarter of a million IVC filters are implanted in patients at high risk for blood clots every year, most without incident, but Bard’s Recovery filter stood out from the very beginning as a potentially deadly device. Even as reports of serious injuries and fatalities involving the Recovery filter continued to climb though, Bard decided not to recall the device. Instead, the company continued to sell the implant until 2005, and then replaced it with a modified filter featuring a similar design but a new name, the G2. As of 2006, Bard’s own records estimated that more than 20,000 people were still walking around with Recovery filters, which have been linked to reports of filter fracture, filter migration, perforation of the vena cava and death.
Contact a Skilled IVC Filter Lawyer for Legal Help
In one example of a Recovery filter failing catastrophically, Gloria Adams, then 55, had the blood clot filter implanted following a brain aneurysm in 2004. She died just one week later, when a blood clot pushed the device into her heart. If you believe you or a loved one has been harmed by side effects of an IVC filter like Bard’s Recovery device, contact a skilled product liability lawyer today to discuss your legal options. You may be entitled to financial compensation for your injuries, medical bills, lost wages, diminished quality of life, pain and suffering, and other damages, which you can pursue by filing an IVC filter lawsuit against the device manufacturing company.
NBC Investigation Recap – Part 1 – Blood Clot Filter Used on Thousands of Americans May Be Linked to Life-Threatening Side Effects
NBC Investigation Recap – Part 3 – C.R. Bard Continued to Sell Potentially Deadly Blood Clot Filters