C.R. Bard Continued to Sell Potentially Deadly Blood Clot Filters
In part three of its three-part segment dedicated to the potential safety risks of IVC filters, NBC News discusses why medical device maker C.R. Bard replaced its problem Recovery filter, which was linked to 27 deaths and hundreds of non-fatal injuries, with a modified version the company knew almost right away had similar flaws. The spider-shaped Recovery and G2 series of blood clot filters designed and sold by C.R. Bard are implanted in the inferior vena cava, the largest vein in the body, to trap blood clots and prevent them from traveling to the heart and lungs. In total, blood clot filters are implanted in approximately 250,000 patients in the United States every year, most without incident, but the Recovery, G2 and G2 Express filters proved early on to be associated with a higher-than-expected rate of problems.
Bard Knew About Problems With G2, G2 Express Filters
According to confidential company records obtained by NBC News, C.R. Bard knew as soon as four months after they were approved by the FDA, that the company’s G2 and nearly identical G2 Express filters, designed to replace the discontinued Recovery filter, were associated with a higher-than-expected rate of failure. In a confidential memo written in December 2005, a Bard vice president voiced concerns about “problems with…migration,” “tilting” and “perforation” in connection with the company’s blood clot filters. In a later document that includes data through 2010, it is revealed that the G2 filter, like its predecessor, was associated with more filter fractures, migrations and reported adverse events than any other blood clot filter on the market.
Potentially Deadly Complications of IVC Filters
Rather than recalling the G2 or G2 Express, Bard decided to keep the blood clot filters on the market for five years, selling more than 160,000 of the devices. As a result, the G2 series of IVC filters has been linked to at least 12 deaths and hundreds of problems, according to Bard and FDA records. “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” said Dr. William Kuo, an interventional radiologist who runs a clinic that specializes in removing IVC filters. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
In one example of a Bard blood clot filter failing catastrophically, Chris Svedise, 69, received a G2 Express filter to reduce his risk of blood clots, and when he returned to his doctor last October to check on the filter, he learned that the device had migrated out of position. Two surgeons declined to remove the device because of its precarious position near Svedise’s heart, but Dr. William Kuo was able to use an advanced technique to remove the filter. During emergency surgery, Kuo discovered that three of the filter’s legs had fractured and traveled to Svedise’s lungs, and two partially fractured legs broke away completely during the procedure, one traveling to his heart and nearly killing him.
Contact an Experienced IVC Filter Attorney Today
Despite C.R. Bard’s claims that the makers of the Recovery and G2 filters “steadfastly believe in the safety and efficacy of these devices when used as instructed,” critics are calling for the company and the FDA to take stronger action to protect patient safety. “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety,” Dr. Kuo said, “absolutely these devices should have been recalled.” If you received an IVC filter in the past, and you have since suffered complications like filter fracture, filer migration, or perforation of the vena cava, you may be entitled to compensation for your injuries. Contact a reputable IVC filter attorney today to discuss your legal options.