A lawsuit has been filed against C.R. Bard Inc. and Bard Peripheral Vascular (Bard), alleging that Bard’s inferior vena cava (IVC) filters are prone to perforating organs and causing other cardiovascular injuries.

IVC filter perforation can lead to serious injury or death.

Plaintiff Solimar G. of Virginia joined the multidistrict litigation against Bard alleging she suffered complications following her IVC filter implant surgery. Solimar says she had Bard’s Denali Vena Cava filter implanted on Sept. 8, 2015.

Solimar claims in her IVC filter lawsuit that she suffered IVC filter perforation, and that the struts of the filter in her chest broke through the wall of her inferior vena cava.

IVC Filter Perforation Complications

The Bard lawsuit claims that Bard’s IVC filters not only cause serious damage to patients’ bodies, but also make it more likely that the patient will develop a pulmonary embolism, the condition that IVC filters are meant to prevent.

The plaintiffs in the lawsuit also claim that procedures using Bard’s devices often result in IVC filter perforation, or the puncturing of internal organs by parts of the device. IVC filter perforation can result in cardiac arrhythmia, cardiac tamponade, hemorrhage, or death.

According to the lawsuit, Bard was aware that at least one of their IVC filters was prone to fracturing, migrating, or perforating organs. On Feb. 9, 2004, barely one month after the launch of their Recovery filter, Bard was notified of the first death resulting from complications with this device.

Plaintiffs say that multiple studies have shown the Recovery filter to have fracture and migration rates as high as 30 to 40 percent.

Additionally, according to MAUDE, an FDA database for medical device reports, Bard IVC filters are connected to a significant percentage of all IVC filter related injuries. From 2004 to 2008, Bard filters were blamed for 64 percent of cases of device migration, 69 percent of cases of vena cava wall perforation, and 70 percent of all cases of IVC filter fracture.

Background on IVC Filters

An IVC filter is a cage implanted inside the inferior vena cava that catches blood clots from other parts of the body moving towards the lungs. The inferior vena cava is a vein that circulates blood from throughout the body and returns it to the heart. Occasionally, in people who are prone to blood clots, a clot will travel from the legs or pelvis, through the vena cava, and into the lungs. Blood clots in the lungs are called pulmonary emboli, and are extremely dangerous.

Patients with deep vein thrombosis (DVT), or a blood clot in a deep leg vein, are at risk for pulmonary emboli. Some people can undergo medical treatments, such as taking anticoagulant medications, to allay the risk. However, some people are not able to take these medications. In these cases, an IVC filter may be recommended.

IVC filters were first put on the market in the 1960s. Although they were originally designed to be permanently implanted, some designs are now removable. Often times, removal is suggested once the risk of clot is past.

In July 2003, Bard became the first medical device manufacturer to obtain FDA clearance for an IVC filter that could later be removed. Bard currently manufactures several retrievable IVC filters, including Recovery, G2, G2X (G2 Express), Eclipse, Meridian, and Denali. These devices are meant to be removed using Bard’s Recovery Cone Removal System.  

Who is Affected by IVC Filter Perforation?

The plaintiffs in the Bard IVC filter litigationare seeking damages including pain and suffering, bodily injuries, disability, emotional and psychological trauma, medical expenses, caregiving costs, loss of earning capacity, and punitive damages.

If you have been implanted with an IVC filter, you may qualify to join an IVC filter lawsuit, even if you have not suffered complications. The Bard IVC Filter Perforation Lawsuit is Case No. 2:18-cv-04591-DGC and is part of the Bard MDL, In re: Bard IVC Filters Products Liability Litigation, Case No. MD-15-02641-PHX-DGC, in the United States District Court for the District of Arizona.