To say a recent NBC News investigation cast pharmaceutical giant C.R. Bard and its Recovery IVC (inferior vena cava) filter in a negative light is putting it mildly. Not only did the report reveal that at least 27 deaths have been linked to the device, it also showed the company used some potentially questionable means in an effort to gain U.S. Food and Drug Administration (FDA) approval for the filter.
An IVC filter is made of metal and implanted into the inferior vena cava (the body’s largest vein) to catch blood clots before they can travel from the legs to the lungs and cause a potentially fatal pulmonary embolism. According to the investigation, over the last 10 years nearly 30 people have died after implantation of the spider-shaped device from C.R. Bard’s Recovery IVC filter alone. This does not include other filters manufactured by Bard, Cook, and other IVC filter manufacturers.
The problem with the device is that pieces of the filter can break off and move into other parts of the body, piercing major organs such as the liver, lungs and even the heart. As you can imagine, this can lead to serious injuries, including death. In some instances, a piece of an IVC filter can lodge into such a delicate area that a doctor cannot remove it – because the risks would outweigh the benefits. NBC reported that its investigators found government data showing that patients who had the Recovery filter implanted reported about 300 non-fatal issues.
A Tragic Story
The NBC report highlighted the story of a 55-year-old woman who had a filter implanted after suffering a brain aneurysm in 2004. According to her son, everything was fine when she left the hospital yet she died a week later. An autopsy revealed that the entire IVC filter migrated from her inferior vena cava to her heart which it punctured, thus killing her. Her family filed a claim against the IVC filter manufacturer seeking compensation for IVC complications.
While putting together a PR plan during a crisis is not out of the ordinary, something else revealed by the investigation is very troubling. NBC reported that after the FDA refused to grant medical clearance to the Recovery filter in 2002, C.R. Bard hired a regulatory specialist, Kay Fuller, in order to convince the agency the device should be approved.
Fuller told NBC that she had serious questions about the safety of the device based on the results of performance tests as well as clinical trials. But when she shared those concerns, she said she “received the message” that she would be removed from the Bard team if she continued to voice them.
No pharmaceutical company – no matter how large – should be able to get away with manufacturing devices that cause harm. The IVC filter attorneys with Baron & Budd are investigating potential lawsuits against Bard and other filter manufacturers.