Blood Clot Filter Used on Thousands of Americans May Be Linked to Life-Threatening Side Effects
As part of a three-part series examining the alleged side effects of IVC filters, NBC News published an article last September raising questions about one blood clot filter in particular – C.R. Bard’s Recovery filter – including whether Bard disclosed to the public everything it knew about potentially fatal flaws in the filter’s design. If you received a Bard Recovery filter or another IVC filter to reduce your risk of blood clot-related injuries, and you have since suffered a severe complication like filter migration, filter fracture, or perforation of the vena cava, contact a knowledgeable product liability lawyer to discuss your legal options. You may have grounds to file a blood clot filter lawsuit against C.R. Bard, in order to pursue financial compensation for your injuries.
Risks of IVC Filter Injuries
According to a comprehensive investigation conducted by NBC News, the Bard Recovery filter was used on thousands of Americans before it was replaced with the similarly-designed G2 filter in 2005, and was linked to at least 27 deaths and approximately 300 non-fatal complications over the course of a decade. In one case, Dodi Froehlich, 45, received a Recovery filter after severe injuries she sustained in a car accident put her at a high risk for blood clots. Instead of protecting her from dangerous blood clots though, a piece of Froehlich’s Recovery filter broke off and pierced her heart, nearly killing her. She required emergency open-heart surgery, during which surgeons were able to remove the fractured filter.
IVC Filters and Wrongful Death
Unfortunately, other victims of IVC filter-related injuries haven’t been so lucky. Gloria Adams, 55 at the time, received a blood clot filter after suffering a brain aneurysm in 2004, and died just one week later. An autopsy showed that instead of the IVC filter capturing a clot and preventing it from traveling to her heart and lungs, a clot actually pushed the entire filter into her heart, puncturing it. Sadly, documents revealed in the ongoing IVC filter litigation suggest that C.R. Bard knew about problems with its Recovery filter, but instead of recalling the device, sold roughly 34,000 of the devices for nearly three years before replacing the filter with a modified version featuring a similar design, under the model name G2.
Bard Commissions Confidential Recovery Study
Around the time that C.R. Bard first became aware of problems with the Recovery blood clot filter, the company hired a public relations firm to protect its reputation, and retained an outside doctor to conduct a confidential study, which was eventually obtained by NBC News. According to the study findings, Bard’s Recovery filter had higher rates of relative risk for filter fracture, filter migration and death than all of its competitors. “Further investigation…is urgently warranted,” the doctor concluded. Still, Bard chose to conceal these problems from the public and the FDA, rather than issue the appropriate warnings, and continued to promote the IVC filter as a safe and effective way for patients who cannot tolerate blood thinners to prevent blood clots, pulmonary embolism and deep vein thrombosis.
Bard May Have Forged Signature on Key Document
C.R. Bard’s main argument in the face of significant criticism appears to be that all of its blood clot filters have been “appropriately cleared by FDA based on required and accurate documentation,” and that when used as intended, the devices demonstrate “significant benefits to patients.” What Bard would rather we didn’t know though, is that obtaining approval from the FDA for its IVC filter took more than one try. After federal regulators rejected its initial application for the Recovery filter, Bard hired Kay Fuller, a regulatory specialist, to prepare to try again. In our next segment covering the NBC News investigation, we’ll reveal how Bard may have forged Kay Fuller’s signature on a key document submitted to the FDA in pursuit of approval for the company’s Recovery IVC filter.
NBC Investigation Recap – Part 2 – Forged signature may have helped Bard Recovery IVC Filter gain FDA approval.
NBC Investigation Recap – Part 3 – C.R. Bard Continued to Sell Potentially Deadly Blood Clot Filters