A woman has filed an IVC filter injuries lawsuit after the implant allegedly caused her severe harm.

Plaintiff Rachel F. of Georgia says that in February 2010, she received a G2 Vena Cava Filter made by C.R. Bard. Her complaint of injuries joins a multidistrict litigation (MDL) against Bard currently making its way through the court system over an IVC filter problem.

An IVC (Inferior Vena Cava) filter is a small cage-like medical device designed to capture blood clots in the inferior vena cava before the clots have the opportunity to travel through the bloodstream to the lungs, where they could become a deadly pulmonary embolism.

The filter has several short struts that are commonly called the “arms” and several longer struts that are referred to as the “legs.”

These filters are used in patients with an increased risk of blood clots, but who are not able to take blood-thinning medications for some reason.

The G2 Vena Cava Filter used in Rachel’s case was designed as a retrievable filter. IVC filters were originally designed to be permanent implants.

Bard’s first retrievable IVC filter was cleared by the FDA in 2003, but according to the IVC filters injuries MDL, “[t]his ‘clearance’ was obtained despite lack of adequate testimony on the safety and efficacy of the new line of devices.”

A study published in the Annals of Surgery in October 2015 indicated that not only were IVC filters ineffective at preventing a pulmonary embolism, but also the filters purportedly caused thrombi to occur.

The Annals of Surgery study reported that nearly twice the percentage of patients with IVC filters died compared to those who did not receive them, and more than twice the relative percentage of patients developed a pulmonary embolism, the condition the filters were designed to prevent.

Retrievable IVC Filter Injuries

Bard’s first retrievable filter, the Recovery filter, allegedly caused a variety of injuries because the filter “fractured, migrated, or perforated the vena cava, caused thrombus and clotting, and caused serious injury, including death,” according to the filter injuries MDL.

By July 2004, Bard allegedly knew at least 12 filter migrations had resulted in four deaths, and of 17 filter fractures, six resulted in strut embolization to the heart. Early studies found the Recovery filter had a fracture and migration rate of 21 to 31.7 percent, much higher than other IVC filters. More recent figures reportedly show fracture rates as high as 40 percent five and a half years after implantation.

When Bard released the G2 that was used in Rachel, the G2 IVC filter was predicted to have fracture rates as high as 37.5 percent from the date of implantation, according to the IVC filter injuries MDL.

A report from NBC News in December 2015 found that Bard expressed concerns about the failure rate of the G2 IVC filters within four months of the G2 receiving FDA clearance, which was in 2005.

Dr. William Kuo, an interventional radiologist at Stanford Health Care’s IVC Filter Clinic at the time of the NBC News report, told NBC that the G2 IVC filters were never safe for implantation, based on the number of reported complications and the rate of severe filter failures.

The IVC Filter Injuries Lawsuit is Case No. 2:!9-cv-00261-DGC and is part of the C.R. Bard IVC Filter MDL, In re: Bard IVC Filters Product Liability Litigation, MDL No. 2641, in the U.S. District Court for the District of Arizona.