The maker of a medical device implanted in thousands of Americans at risk for blood clots may have misled the FDA, the public, and doctors about the device’s potentially fatal flaws. The Bard Recovery blood clot filter may be fatally flawed.
Bard Recovery Filter in 27 Deaths
NBC News announced that at least 27 deaths have been associated with the Recovery filter — a tiny umbrella skein contraption inserted for some ten years into the body’s largest vein, the inferior vena cava.
U.S. government data shows the Recovery, made by C.R. Bard, is responsible for some 300 other non-fatal problems. But even “non-fatal” problems can result in life changing injuries.
Filter Broke, pierced Heart
NBC detailed the story of Dodi Froehlich, 45, who received a Recovery filter after a 2004 car accident. Ms. Froehlich was believed to be at high risk for clots. The filter was supposed to stop them from reaching her heart or lungs. Four months after being implanted, Ms. Froehlich developed a severe headache and passed out. She told NBC News she started flat lining in the ambulance.
Tests showed a piece of filter had broken off and pierced her heart. She needed emergency open-heart surgery to save her life. Surgeons were able to remove the broken piece, but other Bard Recovery recipients have been less lucky.
Filter punctures Heart, kills Woman
Gloria Adams was 55 when she needed a filter after a brain aneurysm in 2004. Her son Kevin Keech said “everything was fine” when she was discharged from the hospital. A week later, she was dead.
An autopsy showed that instead of the filter stopping a clot, a clot pushed the entire device into her heart, puncturing it.
“I didn’t get many answers at that point,” her son said.
Bard Spin Control – style trumps substance
Bard responded to Recovery problems by hiring a public-relations firm, Hill and Knowlton. H&K circulated a crisis management plan to Bard management, warning that “unfavorable press” could damage stock prices and ruin reputations. NBC News said the company also retained an outside doctor to conduct a confidential study.
Bard Recovery Blood Clot Filter Flawed
NBC News reported that the doctor consultant found the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors. The doctor wrote, “Further investigation…is urgently warranted.”
Bard fails to recall Recovery Device
But even as death and injury reports climbed, Bard decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a variant version and a shiny new name, G2.
250,000 Filters Implanted per Year
About a quarter million blood clot filters are implanted each year in patients who can’t tolerate blood thinners. Eleven companies sell filters them in the U.S., but NBC said Bard’s Recovery filter stood out early as a risky device.
NBC News on the Trail
Bard officials declined NBC News’ requests for interviews. The company issued a statement that claimed all its filters have been “appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate “significant benefits to patients.”
Recovery rejected Regulatory Expert’s Concerns
Bard needed more than one attempt to gain FDA clearance for the Recovery. FDA rejected one application for the Recovery, so Bard recruited Kay Fuller, a veteran regulatory specialist, to help try again in 2002. In an interview with NBC News, Ms. Fuller questioned Bard’s handling of that application. She said the company failed to give her important safety performance test results. She said a small clinical trial raised red flags.
The woman whom Bard hired to earn FDA clearance told NBC: “I was pretty concerned there were going to be problems with this product.” When she voiced those concerns, she was told she would be removed from the team if she continued to press those concerns.
Part Two of NBC News’ Investigation on Sept. 3 2015 will examine whether C.R. Bard forged Kay Fuller’s signature on a key document submitted to the FDA.