Hundreds of thousands of Americans have been implanted with a device known as an IVC blood clot filter. This filter is supposed to stop blood clots from moving to the heart, potentially saving lives. And while some IVC filters have delivered truly miraculous results, many—especially those made by CF Bard—have proven to be deadly. The filter can dislodge from its position in the body and end up perforating the heart or lungs.
If you’ve been harmed by an IVC blood clot filter, you should speak to a lawyer. John Foy & Associates is one of the most respected medical device injury law firms in the country. We have experience with IVC filter cases and can help you understand your legal options. Call us at 404-400-4000 and get a free consultation today.
What is an IVC Blood Clot Filter?
An IVC filter is a device that fits into the inferior vena cava (IVC), the largest blood vein in the body. The IVC is the main vessel that brings blood from the lower half of the body back to the lungs and heart. Under some circumstances, however, blood clots can form in the lower body and then travel through the IVC. If these clots reach the heart or lungs they can cause a medical emergency and potentially death. An IVC filter is designed to prevent this.
People need IVC filters for many reasons, but all involve a high risk of forming blood clots inside the veins (venous thrombosis). This risk can be caused by:
- Genetic predisposition
- Prolonged bed rest
Regardless of the cause, an IVC filter should be a last resort. The best treatment for patients at risk of blood clots is medication such as blood thinners, or lifestyle changes like physical activity or a healthy diet. Doctors should always recommend these alternatives first in cases where they’re possible. In emergency situations, or if the patient cannot take blood thinners, an IVC filter may be appropriate.
Some of the most common IVC filters are manufactured by CF Bard. Bard filters include the Recovery, the G2 and the G2 Express.
How does an IVC filter work?
The filter looks like a tiny metal spider. It is placed inside the IVC vein through a minor surgical procedure. Once deployed, its “arms” rest against the sides of the vein, holding it in place. The device then forms a sort of “basket” or screening device. Blood can flow through the basket without difficulty, but blood clots cannot. A clot will become lodged in the arms of the device, and in theory, will not be able to make it to the heart or lungs where it could cause serious damage.
What can go wrong with these devices?
Unfortunately, IVC filters can be dangerous. They have a history of breaking (fragmentation) or moving out of place (migration). This can lead to a long list of serious health risks, including:
- “Tilting” of the filter inside the vein, allowing clots to move past it
- Fracturing of individual legs, which can lodge in the heart or lungs
- Movement of the entire filter into the heart or lungs
- Perforation (ripping) of the vena cava itself
These conditions can cause bleeding, hemorrhaging, heart failure, or sudden death. Virtually all of these circumstances require surgery, and some may require a pacemaker as well. In some cases, the filter migrates out of the vena cava entirely, entering the chest cavity or the bowels and causing additional bleeding.
CF Bard’s IVC filter known as the “Recovery” has a higher rate of complications than other filters, and is associated with 27 deaths.
There is also concern about the filters’ effectiveness. For example, one study found that patients with filters actually had a higher rate of blood clots from deep vein thrombosis (DVT). More than 35% of patients with filters experienced DVT in the study, while only 27% experienced it without filters. The IVC filter may actually be causing the very condition it was designed to prevent.
Can an IVC filter be removed?
Some IVC filters are designed to be removed, but most are not. The Recovery filter by Bard, and its successors the G2 and G2 Express, are meant to be permanent.
This makes removing a faulty device very risky. Removing a Recovery involves a second surgical procedure. If the Recovery filter has fragmented or moved out of place, may surgeons will refuse to do the operation because of the high risk involved. This can leave a patient with few options, even though their life is in danger.
A few specialists have dedicated themselves to removing faulty IVC filters. One such specialist, Dr. William Kuo of the Stanford IVCC Filter Clinic, has removed over 1,000 failed filters and says Bard’s filters are the most common failed filters.
Did Bard know that their filters are dangerous? Why weren’t patients warned?
Yes, CF Bard became aware early on that their filters were dangerous, and continued to develop and market them anyway.
The company commissioned its own internal study of the Recovery filter, which was completed in 2005. The study confirmed that Bard’s IVC filters had high rates of fragmentation, migration, and death risk—higher than any of its competitors. Even for a device that has inherent risks, Bard’s version was simply an inferior product.
Bard did not recall the product nor warn patients or doctors. Instead, they went ahead with the release of the G2 series of filters, which bore the same problems as the Recovery. At one point, a Bard executive raised red flags about the risk. He asked in an internal memo why patients should use the G2 at all when there are safer alternatives available. But the concerns still didn’t stop Bard from marketing the filters.
The G2 remained on the market until 2010, with over 160,000 of them implanted in patients. Since 2004, the FDA has received 921 reports of IVC filters going wrong, including over 300 that migrated out of place. Many of these were Bard products.
Who is liable for the problems caused by an IVC filter?
The manufacturer is liable when a filter breaks, migrates or injures the body. This applies to any manufacturer, not just CF Bard. But Bard is the most notorious IVC filter maker, and there are so many complaints against Bard that they’ve been consolidated into a single “mass tort”—a group lawsuit by all the victims of their filters.
If you or someone you love has been injured by an IVC filter, we can help you. There’s no way to reverse the damage that was done, but we may be able to help you get a financial recovery. Your recovery could pay for your medical bills, lost work time, ongoing treatment, and the pain you suffered.
The attorneys of John Foy & Associates know how to navigate an IVC filter case. We can help you join the mass tort against CF Bard, or pursue any IVC filter manufacturer. We offer a FREE consultation and we charge nothing unless we get you a financial recovery. Call 404-400-4000 and get your free consultation today.