This is not a pretty story. A medical device that was supposed to save lives was malfunctioning, injuring some patients and killing others. But its manufacturer left it on the market even though it “…had higher rates of relative risk for death.”
Three years after the FDA approved it in 2002, the company replaced it with a similar device. But it had a higher death rate too. It wasn’t until 2010 that the company, C.R. Bard, a giant medical device manufacturer based in New Jersey, finally admitted that “…at least 12 deaths and hundreds of problems were linked to its G2 series filters...” according to a major investigative report by NBC News that aired on New Year’s Eve, 2015.
Why were the Bard devices so dangerous?
The Bard blood clot filters look like skinny bird cages. Some say they resemble very long-legged spiders. Doctors insert them in the largest vein in the body – the vena cava – to catch and hold dangerous blood clots moving toward the heart and the lungs, usually traveling from the legs, until the life-threatening clots can be dissolved. One third of those with undiagnosed and untreated blood clots in the lungs (pulmonary embolisms) do not survive, according to the Mayo Clinic. If a clot reaches the heart, it can cause heart failure.
But the legs of these spider-like blood clot filters can break off, travel thorough the vein and pierce the heart and lungs. The entire filter can also migrate, lodging dangerously near those vital organs. The Bard filters can also tilt, letting blood clots travel past them. As FDA records and the manufacturer’s own record shows, Bard filters have a higher failure rate than other venal filters in use today.
Why didn’t the FDA intervene?
That’s what one of the most prominent surgeons in America would like to know. Dr. William Kuo, with Stanford Health Care’s IVC Filter Clinic, is a specialist who operates on failed blood clot filters. They are notoriously hard to remove. Kuo says all the Bard filters should have been recalled 10 years ago “…in the interest of public safety.” He believes the American public can no longer “…rely on the FDA to properly regulate these devices.”
The FDA’s medical device problem
According to a New York Times report, the FDA’s “…regulatory oversight has not kept pace with the increasing complexity…” of medical device technology and high risk devices “…are approved on the basis of just one clinical trial,” when new medications require two clinical trials for FDA approval. A 2015 investigation by Consumer Reports, revealed that manufacturers can get the FDA to approve a new medical device by filing out some paperwork and “…paying a user fee of about $4,000.” As a result, defects may not become apparent until patients die or suffer catastrophic injuries.
What can victims do?
Wayne Wright has been helping victims of bad drugs and defective medical devices for more than 30 years. He can represent you against C.T. Baird and Cook Group, manufacturers of the Bard Recovery filter, the Bard G2 filter and the Bard G2 Express Filter. His legal expertise has earned more than $237 million for clients across the United States in the last seven years. He has been voted one of the Top 100 Trial Lawyers in America. Consultations with the Wayne Wright law firm are free.