News Report Questions Why C.R. Bard Continued to Sell Defective Blood-Clot FiltersJan 5, 2016
Medical device maker C.R. Bard replaced a defective blood-clot filter associated with more than two dozen deaths and hundreds of injuries with a version Bard knew had similar and potentially fatal flaws soon after it was put on the market.
In a report aired on December 31, 2015, NBC News said it had obtained records indicating that within four months of receiving Food and Drug Administration (FDA) clearance to sell the G2 filter, Bard was expressing concern about reports of failures for G2 filters, which replaced the Recovery filter. But instead of recalling the G2 and G2 Express filters, Bard kept them on the market for another five years, until 2010, and sold more than 160,000 G2 filters in that time.
At least 12 deaths and hundreds of problems are now linked to G2 filters, according to Bard and FDA records, NBC News reports. Dr. William Kuo, who runs Stanford Health Care's IVC Filter Clinic, which specializes in removing failed blood-clot filters, said, "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." Kuo add that the number and severity of complications "makes it obvious that it was never safe to be implanted."
In one instance, Dr. Kuo performed emergency surgery to remove a G2 Express filter that had moved dangerously close to the recipient's heart. Dr. Kuo, who estimates he has removed about a thousand failed filters, performed the surgery after two other surgeons declined to attempt the retrieval because of the filter's dangerous position. During surgery, Dr. Kuo discovered that three legs had already broken off the filter and traveled to the man's lungs. Two partially broken legs broke away during the operation and one traveled into the right ventricle and could have killed the man.
Each year, about 250,000 people are implanted with blood-clot filters to prevent blood clots from moving into the heart and lungs, where they could be fatal. The spider-shaped Bard filters are implanted in the inferior vena cava - the largest vein in the body. Some filters are intended to remain in the body permanently, other are removed when the clot danger has passed. When pieces of a filter migrate, the patient can experience severe pain, bleeding, further embolus, and other life-threatening complications.
In 2005, just three years after the Recovery filter came to market, Bard replaced it with the G2 filter series. But hundreds of reports to the FDA indicate that the modified G2 filters did not solve the problems. In a December 2005, a Bard vice president expressed concern about the filter's "migration," "tilting" and "perforation" of the inferior vena cava, yet G2 filters remained on the market until 2010.
On July 13, 2015, the FDA sent Bard a warning letter citing eight violations of federal law involving IVC filters. The letter indicated that Bard had misfiled several customer complaints, including the report of one patient's death Bard faces numerous lawsuits over injuries associated with Bard IVC filters. In August 2015, the suits were consolidated into a multidistrict litigation in the District of Arizona. Such consolidation makes complex litigation more efficient by eliminating duplicate discovery and avoids inconsistent pretrial rulings.