C.R. Bard Knowingly Sold Deadly IVC Filters
July 8, 2016
01/05/2016 - C.R. Bard, a major medical device manufacturer, which developed a blood-clot filter associated with 27 deaths and hundreds of injuries, replaced the device with a modified version which it knew had similar dangerous flaws. Despite this knowledge, the company continued to market the IVC filter to thousands of unsuspecting physicians and patients. Confidential documents revealed that employees of the medical device giant voiced concerns about the G2 series filters within four months after the product was approved by the FDA. However, instead of taking corrective action and recalling the G2 and G2 Express filters, Bard sold another 160,000 devices over the next five years. Hundreds of injuries and at least 12 deaths are linked to the G2 series filters.
The spider shaped Bard filters are implanted into the interior vena cava to stop blood clots from moving to the heart and lungs, which could be fatal. Each year nearly 250,000 filters are implanted in the U.S. without incident. Bard is one of 11 manufacturers that make these devices. However, a confidential study commissioned by Bard revealed that the Recovery filter had higher rates of failure including death, filter fracture and movement than all of its competitors. An outside physician who conducted the study indicated that, “further investigation…is urgently warranted.” Bard failed to heed these warnings, instead replacing the Recovery filter with the G2 series. Internal Bard records showed that the G2 failed to solve the filter’s problems.
The knowledge of the filter’s problems rose to the highest level at Bard. In 2005, A Bard vice president voiced concern regarding the G2 and the “problems with…migration, tilting and perforation,” and questioned why the company was not using another filter on the market that had virtually no complaints. Another confidential document revealed that the G2 series filters had more fractures, migrations and reported problems than any of its competitors. Despite this knowledge, Bard kept the devices on the market for 5 more years until 2010.
Dr. William Kuo, an interventional radiologist at Stanford Health Care’s IVC filter Clinic, specializes in removing failed blood clot filters, has removed over 1,000 filters to date. He noted, “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.” He strongly believes that, “The Recovery and G2 series filters should have been pulled from the market. Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.”
The FDA has also dropped the ball on IVC filters. The agency has indicated that it has, “investigated the risks of all of these devices, not just Bard’s and issued safety communications about the risks associated with IVC filters.” In 2010 and 2014, the agency recommended that doctors should consider removing the filters as soon as the blood clot danger has passed. Meanwhile, thousands of patients remain at risk with defective IVC filters implanted in their bodies. If you or a loved one has an implanted IVC filter, contact the attorneys at Ennis &Ennis, P.A. for a free confidential consultation by calling or visit us online at www.Ennislaw.com and fill out an online form.