A woman has filed a lawsuit after she says she was injured by a fractured IVC filter that was designed to prevent blood clots from reaching her lungs.

Plaintiff Jeanette C. said she received a C.R. Bard Recovery Vena Cava Filter implant in March 2005. According to her short form complaint, Jeanette said an April 2015 CT scan indicated her filter had “fractured, perforated and migrated.”

A fractured IVC filter could be dangerous, and other patients who have experienced this have filed lawsuits.

IVC (Inferior Vena Cava) filters are tiny cage-like structures that capture blood clots in the vena cava before they have a chance to travel through the blood to the lungs, where they could result in a deadly pulmonary embolism. IVC filters often are used in patients who are at risk for blood clots but are unable to tolerate blood-thinning medications.

IVC filters are fragile devices that can look like tiny spiders with moveable struts that can break off. These struts then potentially travel through the bloodstream to other parts of the body, where they can become dangerous. The Bard Recovery IVC filter consists of six short struts and six long struts, each of which is held together by a connection to a cap at the top of the filter.

Originally designed as permanent structures in the 1960s, most of today’s IVC filters are potentially retrievable.

The FDA issued a notice in 2010 that retrievable IVC filters should be removed from the patient as soon as the patient is out of danger of experiencing a blood clot.

Follow-up communication from the FDA in May 2014 recommended IVC filters be removed generally between 39 and 54 days after implantation to decrease the risks of a possible fractured IVC filter.

Dangers of Fractured IVC Filters

According to the fractured IVC filter lawsuit, Bard was the first manufacturer to market a “retrievable” IVC filter, which was the Bard Recovery model in July 2003.

“As recently as October 2015, an expansive article published in the Annals of Surgery concerning trauma patients inserted with IVC filters concluded that IVC filters were not effective in preventing pulmonary emboli, and instead actually caused thrombi to occur,” says the fractured IVC filter MDL.

The fractured IVC filter complaint claims that Bard immediately knew of numerous instances where the Recovery filter fractured, migrated, or perforated the vena cava and that these problems caused thrombus, clotting, serious injury, and in some cases, death.

The complaint alleges Bard received notice of the first death liked to the Recovery IVC filter in February 2004 via MAUDE, a database the FDA maintains to track medical device reports.

According to the fractured IVC filter MDL, Bard doubled-down on its public relations tactics to protect its brand rather than making the move to take the Recovery IVC filter off the market.

The fractured IVC filter lawsuit contends that “by February 2004, Bard had formed a crisis communication team and drafted at least four communiques to pass onto its sales force containing false information designed to be relayed to concerned doctors.”

The Fractured IVC Filter Lawsuit is Case No. 2:18-cv-01102 and is part of the Bard IVC Filters MDL, In re: Bard IVC Filters Products Liability Litigation, MDL No. 2641, in the U.S. District Court for the District of Arizona.