Published on September 9, 2015
NBC News has released the results of a year-long investigation into medical device manufacturer C.R. Bard and their “Recovery” blood clot filter. Part 1 of their report details the defects in the product; perhaps more shocking, Part 2 of their report asserts that C.R. Bard may have submitted the forged signature of a prominent regulatory scientist in order to get the defective product approved.
The NBC News investigation found at least 27 deaths associated with the Bard “Recovery” retrievable IVC filter, and at least 300 non-fatal problems were also reported. A confidential scientific study, obtained by NBC, showed that the “Recovery” blood clot filter had higher rates of relative risk for death, filter fracture, and movement than any competing device. NBC outlines cases in which pieces of the Recovery device broke off and migrated in the patient’s body. One patient experienced the entire device being pushed into the heart by a blood clot, puncturing her heart. Bard sold about 34,000 Recovery IVC filters until 2005 when it was replaced by the very similar G2 filter, which remains on the market today.
In 2002 C.R. Bard obtained FDA approval to sell the “Recovery” retrievable IVC filter. Permanent IVC filters have been used for decades to prevent blood clots. The filters, cone-shaped, porous little cages, are surgically placed in the inferior vena cava — the largest vein in the body — to catch and stop blood clots before they can reach the heart and lungs.
Retrievable filters are used in patients who cannot use blood thinners for a temporary medical reason. The “Recovery” device is far different in design than other IVC filters. It looks like a long-legged spider with 12 thin separate metal legs dangling from the top piece. The FDA rejected Bard’s first application to sell the device. Bard then hired regulatory specialist Kim Fuller to help them get FDA clearance.
Fuller told NBC News that she had serious safety concerns about the device, and complained to Bard that it was withholding important safety studies from her. She was told, in essence, that is she continued to question safety, she could leave the team. Fuller reported her concerns to the FDA and resigned from Bard.
NBC showed Fuller the Bard FDA application which contained her signature. She stated that she did not sign the application, and that it was not her signature. The FDA and C.R. Bard declined to be interviewed for the NBC News story, but Bard issued a statement calling any suggestion that Bard submitted forged documents to the FDA “flatly untrue”.
If you or someone you love has been injured by a defective blood clot filter, call the IVC filter lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no obligation consultation, or tell us your story using our online contact form. Like all legal claims, IVC filter claims have short, strictly enforced time limits, so do not delay seeking legal advice.