Last night, NBC Nightly News aired the second half of a two-part report on a dangerous medical device known as The Recovery, a blood clot filtration device manufactured by 11 companies throughout the U.S. One of these manufacturers, CR Bard, is currently facing numerous lawsuits for failing to warn the public of the high risk the device posed to patients. So far, use of the IVC filtration device has been linked to 27 fatalities and hundreds of complications.
Implanted in 250,000 people each year, the IVC filter is a small wire trap that is surgically placed into the largest vein in the body. When it works correctly, the small metal arms are supposed to trap blood clots before they have a chance to reach the heart or lungs, where they can become fatal. Unfortunately, the product does not always work as intended. The NBC report highlighted the story of one woman who suffered a life-threatening injury when a piece of the filter broke off and pierced her heart. In another case, instead of trapping clots, a clot ended up pushing the device into a woman’s heart, piercing it and causing her death.
The device was submitted for FDA clearance in 2002 but was rejected. Kay Fuller, a veteran regulatory specialist, was hired to help try again. Dr. Fuller raised several concerns about the product but was told that if she continued to pursue those questions, she would be removed from the team. She refused to sign the FDA application until her concerns were addressed.
Her concerns never were addressed, because the FDA application, containing a forgery of her signature, was eventually approved. Fuller resigned from the company, but not before filing a private report of her concerns with the FDA. What they did with that information is a mystery, as they never fully addressed her allegations. CR Bard denies having any responsibility for the forged document, calling the accusations “flatly untrue.” The FDA has declined to comment on the matter.
More than 34,000 filters were sold until 2005, and the product was never officially recalled. As of 2006, it is estimated that approximately 20,000 people have been implanted with the device, and experts believe that the longer the devices stay implanted, the greater the risk it poses.
If you have a filter implant, check with your doctor immediately to see who the manufacturer is and discuss whether it should be removed.
You or a loved one may be entitled to financial compensation if you have suffered injury from the dangerous IVC filter device. The Atlanta personal injury lawyers at Schneider Hammers are available to review your case during a FREE consultation –call us today at (770) 884-4626.