A recent three part NBC News Investigation has raised serious concerns regarding the safety and FDA Approval Process of some IVC Filters.
San Diego, CA, January 28, 2016 (Newswire.com) - The IVC Filter is a medical device implanted in thousands of Americans at risk for blood clots. Serious concerns have been raised including whether the manufacturer told all it knew about potentially fatal dangers associated with the devices.
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 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
According to the NBC News investigation, over the course of a decade, at least 27 deaths and approximately 300 other non-fatal problems have been associated with the Recovery IVC filter, one of the devices manufactured by Bard. The Recovery, a one-and-a-half-inch metal trap, was designed to sit inside a major vein, the vena cava, and block blood clots from traveling to the heart or lungs, where they can be fatal. Instead, in many cases the device is migrating, fracturing, perforating, or actually causing clogs instead of preventing clots and in some cases this has turned out to be deadly for the device recipients.
Dodi Froehlich, 45, had an IVC Filter implanted after severe injuries in a car accident put her at elevated risk for blood clots. The filter was intended to block clots from reaching her heart or lungs; instead, it nearly killed her.
Four months after the IVC filter implant, she developed a severe headache and passed out. “In that two seconds of being in the ambulance, I started flat-lining,” Froehlich told NBC News. Testing revealed a piece of the filter had broken off and pierced her heart, and she had to have emergency open-heart surgery.
“My family was notified,” she said. “The priest was brought in.” Fortunately, surgeons were able to remove the broken piece during emergency open-heart surgery and save Froelich’s life, but not all Recovery recipients have been so lucky.
In another example cited by the NBC investigation, Gloria Adams, then 55, was given an IVC filter after suffering a brain aneurysm in 2004. Her son Kevin Keech told the NBC investigators “everything was fine” when she was discharged from the hospital, but shortly after, she was dead. The autopsy showed that instead of the filter preventing a blood clot, the device was instead pushed into her heart by a clot, puncturing it. “I didn’t get many answers at that point,” Kevin said.
After problems with the Recovery IVC filters began, instead of pulling the device from the market, Bard hired a public-relations firm, Hill and Knowlton, which circulated a crisis management plan to the Bard management team, warning that “unfavorable press” could damage stock prices and have a negative impact on the company’s and products’ reputation.
Initially getting clearance from the FDA took more than one attempt. After the agency rejected an earlier application for the Recovery IVC filter device, Bard recruited a veteran regulatory specialist named Kay Fuller, to help give it another shot. NBC News reported that Fuller raised concerns about how Bard handled that application. According to Fuller, the company failed to provide her with important test results and that a clinical trial raised concerns.
Fuller told NBC, “I was pretty concerned there were going to be problems with this product.” However, when she voiced those concerns, she was told that she would be removed from the team if she continued to pursue the matter. “I was shocked,” she told the NBC investigation.
According to Fuller, she informed her superiors that she would not sign the application until the issues were resolved. Still, Bard submitted the application to the FDA with what clearly appeared to be Fuller’s signature.
“That’s not my signature,” Fuller told the NBC investigators when they showed her a copy of the document. A sample of her signature from that time is clearly different from the one submitted on the application.
That leads to the question, was her signature forged? “I will tell you I did not sign it,” Fuller told NBC, continuing that her name was signed on the application without her knowledge. Fuller said she resigned from Bard, but not before reporting her safety concerns to the FDA. “I never knew what they did after that,” she said.
The FDA won’t say if it acted on Fuller’s tip and denied requests for an interview. In a statement, it said it “takes very seriously” any complaints about “forgeries and device issues.”
Fuller is not the only one who has had concerns regarding this product and similar medical devices. According to attorney Ben Bertram, one of the leading litigation attorneys when it comes to IVC Filter injury lawsuits, there likely will be serious safety problems going forward with these devices. Bertram stated that upward of 250,000 IVC filters were implanted each year since 2012 and that with the retrievable filters, if they are not removed within a fairly finite period of time, a high percentage of the devices “may become difficult or impossible to retrieve”. Furthermore, there may be legal issues related to the retrieval kit also produced by Bard, as it was never itself approved for its use by the FDA.
With the recent news regarding the dangers associated with IVC filter implants and the questionable and tactics allegedly used by the manufacturers to get some of these devices to market, a number mass tort law firms are signing up alleged victims to be part of a potential case against the IVC filter device manufacturers. Signing up for to be part of suit is fairly easy on the part of the victims. Firms around the country are signing potential victims up now. To become part of a mass tort, there is generally no cost up front and the majority of the research and paperwork is done by the law firms making it a fairly simple process for the plaintiffs. To get a free case review to potentially become part of the potential lawsuit, contact the IVC Filter Legal Center or complete the quick form at http://www.ivcfilterlawsuit.info/ or call 888-733-9229 to determine your eligibility immediately.