An IVC filter is a medical device used to catch and filter out life-threatening blood clots. They are used in patients who are at risk for forming clots, especially after surgery. The filter is implanted in the inferior vena cava (IVC), a major vein in the leg that sends blood to the heart and lungs. The filter traps any clots moving in that direction, which can then prevent dangerous clots from getting to the heart, lungs, or brain.
Certain manufacturers of IVC filters, including C.R. Bard and Cook Medical, have been found to have filters that are defective and which may cause patients more harm than good. These filters have come loose or broken, perforated the IVC and even moved to other parts of the body causing damage. A number of people affected by these faulty devices have filed lawsuits and are hoping to be awarded settlements.
IVC Filters – How They Work
An IVC filter is a small device that catches clots in the inferior vena cava. A blood clot is dangerous because it can move through blood vessels and cause blockages in the lungs, heart, or brain, which can be fatal. Some people are at an increased risk for developing clots and are typically given blood thinners to reduce that risk. For those patients who can’t take these medications, an IVC filter may be used instead.
The IVC is the largest vein in the body and carries blood from the legs up to the lungs and heart. Clots most often form in the legs, so this little filter sits in the vein and allows blood to flow through it. Any clots moving through the vein will be trapped in the filter. Filters may be permanent or retrievable, removed after the risk of clots has passed.
Risks of IVC Filters
All surgical procedures carry risks and all IVC filters present certain risks to patients. They could break or loosen and come out of place, causing damage to the vein or other organs. They may let a clot pass through and travel to the lungs or heart.
These risks are fairly low in most filters, but some have proven to be riskier than others. These defective products are the ones that are leading to IVC filter lawsuits. The U.S. Food and Drug Administration (FDA) issued a warning in 2010 about the risks of failed filters. The agency reported that it collected 921 reports of incidents occurring with the filters since 2005.
The adverse reports included instances of filters migrating out of place in the vein, perforating the vein, and breaking off small pieces. The FDA came to the conclusion that some of these instances occurred because filters had not been removed when they should have. In other words, the filters had outlived their lifespans and should have been taken out.
This conclusion and further study led to another FDA warning in 2014 that recommended all retrievable filters be removed as soon as possible once the risk of blood clots has passed. The warning also stated that long-term implantation of filters could actually cause complications from blood clots and dangerous blockages.
Defective IVC Filters
While the FDA concluded that any filter could pose a risk and that they should be removed from patients as soon as is possible, there is also evidence that certain filters pose more of a risk than others. Five filters in particular have been the subject of lawsuits over possible defects that make them more dangerous than other IVC filters. These include C.R. Bard’s Recovery, G2, and G2 Express filters, and Cook Medical’s Gunther Tulip and Celect filters.
Study of Cook IVC Filter Risks Leads to Lawsuits
A study that was published in 2015 found that Cook’s IVC filters had a 43 percent rate of perforation of the vena cava. This was compared to another brand of filter, which caused zero cases of perforation. In the study, all patients had their filters removed after two months and then were monitored for nearly three years.
That the Cook filter caused significantly more perforation than another brand could lead to the conclusion that it is defective. This has given a boost to people suing Cook over the damage and health problems they experienced after having a filter implanted. Proving that the filter was defective could help these lawsuits win settlements from the company.
Bard Knew the Risks of IVC Filters
C.R. Bard is also facing the possibility of being found negligent because evidence has come to light that the company knew about risks associated with their IVC filters. A report from 2004 found that Bard knew about the risk that their Recovery filter could break and leave pieces behind in a patient. The company had received numerous complaints and reports about this and yet did not relay the risk to the FDA or to the public. The company actively hid the results of the report.
As lawsuits mounted over the damage caused by their filters, the report came to light and became public knowledge. Bard has continued to claim that the report should never have been made public and that they had the right to keep it internal. The company has tried to stop plaintiffs in lawsuits from using the report as evidence of negligence. In some cases it has been allowed as evidence, while in others it has not.
Individuals have filed lawsuits against both Bard and Cook, and several of those have been consolidated into a multi-district litigation in Indiana against Cook. Bard is facing a multi-district lawsuit in Arizona. The number of cases consolidated is in the hundreds, but others are still pending.
Some of the claims plaintiffs are making in lawsuits include that Bard covered up the risks of its three defective filters, that it misrepresented the safety of its devices, and that it is negligent in the harm caused to patients. Some of the plaintiffs experienced broken filters that migrated out of place, including one case in which the filter moved all the way to the heart and caused permanent health problems. Other plaintiffs experienced damage to the lungs after broken filters migrated there.
Plaintiffs suing Bard and Cook are looking for compensation for the paint and suffering they experienced. Many of these people are living with permanent and expensive health problems. They have felt traumatized by events, have experienced a lot of pain, and many have lost income due to being unable to work. They hope to win compensation in the multi-district lawsuits and in individual cases to help make up for the suffering and expense caused by these defective IVC filters.