A shocking series of reports aired on NBC News earlier this month discussing the results of a year-long investigation into a blood-clot filter called Recovery.
The report revealed that the device, (which was) “implanted in thousands of people, was associated with 27 deaths and hundreds of other non-fatal problems after it received FDA clearance.”
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 could be deadly.
Medical giant C.R. Bard manufactured the device. A former insider at the company raised questions about how the device got approval from the FDA.
Graphic Courtesy NBC News
NBC stated that “In 2002, medical giant C.R. Bard recruited Kay Fuller, a veteran regulatory specialist, to help secure FDA clearance for its Recovery blood clot filter, after the agency had turned down a previous application.”
Fuller said that she had serious concerns about the Recovery. But when she voiced her concerns, Bard officials didn’t seem to want to hear them.
“It was basically if you continue to pursue these questions, that I was going to be asked not to be on the team,” Fuller said. “I was shocked.”
Fuller says she told her boss she would not sign the application until the issues were resolved. Bard submitted its application to the FDA with what appears to be Fuller’s signature on it.
There are now questions about whether the signature was forged.
“I will tell you I did not sign it,” Fuller said, adding 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.
NBC News went on to say Bard executives declined to be interviewed, but said any suggestion the New Jersey-based company submitted forged documents to the FDA is “flatly untrue.”
About a quarter of a million blood clot filters are implanted in patients each year, most without incident. Eleven companies sell them in the U.S., but Bard’s Recovery filter stood out early as a risky device.
After receiving FDA clearance, Bard sold about 34,000 patients Recovery filters. Records show that over the course of a decade, the filter was associated with 27 deaths and several hundred non-fatal problems.
Even as reports of deaths and injury were growing, Bard decided not to recall the Recovery. Instead, they hired a public relations firm that brought in an outside doctor to look into the alleged issues connected with the filters.
Even this doctor concluded: ‘The filter had higher rates of relative risk for death, filter fracture and movement than all its competitors. Further investigation is urgently warranted.”
NBC News added that “Bard sold the Recovery until 2005 and then replaced it with a modified version with a new name. As of 2009, Bard’s own confidential records estimated there were more than 20,000 people still walking around with them.”
Our team of lawyers at Theodoros & Rooth pay close attention to cases like this. We echo a recommendation from NBC. “If you believe that you may have a filter implanted we urge you to see your doctor to see what brand of filter you have and whether it should be removed.”
Finally, if you or someone you know has had a Bard Recovery filter implanted and have suffered from harmful side effects, call us at Theodoros & Rooth. We stand ready to discuss your situation at no charge. We have over 110 years combined experience with cases involving defective medical devices. If we determine you have a case, Theodoros & Rooth will fight for your rights and get you the compensation that you deserve.