Patient Safety News: Bard Recovery IVC Filters Linked to Deaths and Injuries
A recent NBC Nightly News investigation revealed that 27 deaths and 300 non-fatal complications have been linked to inferior vena cava (IVC) filters made by C.R. Bard.
The Bard IVC filters, implanted to catch blood clots before they reach the heart and lungs as an alternative to blood thinner, was designed to be removed after the risk of blood clots has subsided.
The filters can sometimes end up being left in patients because doctors didn’t tell patients they were implanted, or patients forgot they were there, especially after a traumatic injury.
The metal struts in the small, spidery medical devices can break and travel to other parts of patients’ bodies, mainly the heart and lungs, threatening their lives.
The filters are inserted into the largest vein in the body, the inferior vena cava (IVC). Symptoms of a filter fracture can include chest pain and shortness of breath. Internal bleeding, constant and severe pain in the heart, chest, and elsewhere are among the complications. Emergency medical treatment can involve cardiac catheterization or a CT scan to find where the filter is located.
Over the course of 10 years, after U.S. Food & Drug Administration approval in 2002, deaths and non-fatal injuries surfaced. Medical studies conducted from 2005 to 2010 discovered a failure rate of between 21 and 31.7 percent for the Bard Recovery filter.
Bard sold the Recovery until 2005, when they replaced it with a modified filter under a new name. NBC News discovered that as of 2006, Bard’s own records showed that at least 20,000 people still had the devices implanted.
NBC News also found that after the problems with the filters were discovered, Bard public relations firm Hill and Knowlton advised Bard management that “unfavorable press” could affect the company’s image and its stock prices.
NBC revealed that a confidential Bard study done by an outside doctor found that the Recovery filter had higher risks of movement and breakage than competitors’ filters. Despite the evidence, Bard didn’t issue a device recall. NBC alleges that Bard forged the signature of their FDA regulatory specialist on an application for FDA approval after she raised concerns about the device failures noted in a clinical trial.
Multiple lawsuits have been filed claiming that Bard IVC filters can break and damage organs. The complaints allege that Bard was aware that their IVC filters were prone to failure, but the company didn’t adequately inform doctors and patients about that risk.
Berman & Simmons represents people who have been injured by a number of dangerous drugs and medical devices including IVC filters. Medical malpractice attorneys Susan Faunce and Michael Bigos suggest that patients who have had an IVC filter implanted check with their medical providers to see if it was a Bard Recovery.
“Patients who have had Bard Recovery IVC filters implanted or have experienced symptoms of a Recovery breakage should contact us for a free consultation,” said Faunce and Bigos. “They may be entitled to compensation.”