Bard May Have Forged Signature on Key Documents to Gain Approval for IVC Filter
According to a recent NBC News Investigation on the dangers associated with certain IVC filters, Bard may have even hired a public relations firm to help with a cover up while delaying pulling the dangerous devices from the market.
San Diego, CA, September 27, 2015 (Newswire.com) - At least 27 deaths and several hundred non-fatal injuries have been linked to one type of inferior vena cava (IVC) filter since the medical device was approved by the FDA, and now there is new information indicating that one of the largest IVC filter manufacturers may have dismissed early warning signs of potentially fatal flaws. If true,. this could be a serious violation and open the company up to even more potential litigation according to Ford and Associates Nationwide Legal Service, a leading firm dealing with IVC Filter Lawsuits.
Furthermore, according to a former insider at C.R. Bard, which manufactures the Recovery and G2 blood clot filters, the medical device maker may have actually forged a signature on the documents submitted to the FDA for approval of its Recovery device. If you received an IVC filter implant, and you have since suffered complications like device fracture, migration or inferior vena cava perforation, contact a reputable product liability lawyer today for legal help.Bard May Have Forged Signature on Key Documents to Gain Approval for IVC Filter
Alleged Risks of IVC Filter Implants
The IVC filter is a device is designed to sit inside the inferior vena cava and prevent prevent blood clots from traveling to the heart and lungs, where they could cause pulmonary embolism and other serious complications. However, serious concerns have been raised recently about the potential for the medical devices to fracture or otherwise fail, puncture the inferior vena cava, and travel to other parts of the body, possibly causing damage to nearby organs. In fact, in August 2010, the FDA issued a safety announcement warning consumers and the medical community that the agency had received more than 900 reports of adverse events associated with IVC filters, and recommended that the implants be removed within 29-54 days, to reduce the risk of device complications.
Bard Reps May Have Forged Signature on Key Documents
In an exclusive interview with NBC News, a former regulatory specialist at C.R. Bard, Kay Fuller, reveals that she had serious concerns about the safety and effectiveness of Bard’s Recovery blood clot filter. According to Fuller, there was a small clinical trial that had raised red flags about the IVC filter, yet when she expressed these concerns to the company, “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 says. As a result, Fuller stated that she would not sign the application for the medical device until the issues were resolved, yet Bard went ahead and submitted its application to the FDA with what appears to be Fuller’s signature on it. Fuller, however, says that the signature is not hers.
Injuries and Fatalities from Bard’s Recovery Filter
Approximately one quarter of a million IVC filters are implanted in patients every year, and after it garnered approval from the FDA in 2002, Bard sold patients about 34,000 Recovery filters. Unfortunately, over the past ten years, Bard’s Recovery IVC filter has been associated with as many as 27 deaths and about 300 injuries, including filter fracture, filter migration and perforation of the inferior vena cava. Even as reports of injuries and fatalities were growing though, Bard refused to issue a recall of its blood clot filter. Instead, the company commissioned a litigation consultant to conduct a confidential study, which indicated that the Recovery filter had higher rates of relative risk for death, device fracture and filter migration than its competitors.
An Experienced Product Liability Lawyer Can Help
The alleged side effects of Bard’s Recovery device and other IVC filters continue to be an issue today, and reports indicate that some complications linked to the implants may be fatal. In one instance, a 55-year-old woman received an IVC filter implant after suffering a brain aneurysm in 2004. According to her son, “everything was fine” when she was discharged from the hospital, but she died just one week later. An autopsy showed that, instead of blocking a blood clot, which the devices are designed to do, a clot actually pushed the entire IVC filter into her heart and punctured it. If you or a loved one has been adversely affected by alleged side effects of IVC filters, consult an experienced IVC filter attorney today to explore your possible compensation options.