A woman has filed a lawsuit alleging her Denali vena cava filter failed to perform the way it should have.

Plaintiff Patricia P. says she was implanted with the vena cava filter in October 2015.

Patricia alleges that even though she was implanted with a Denali vena cava filter in 2015, she was diagnosed with a blood clot and post-thrombotic syndrome in December 2016. In May 2018, she says a CT scan revealed that her IVC filter is tilting and possibly embedded in the wall of her vein.

Her lawsuit joins an MDL against C.R. Bard currently making its way through the district court system in Arizona.

Inferior vena cava filters such as the Denali vena cava filter by C.R. Bard are sometimes implanted in patients who are at risk for blood clots. The tiny cage-like devices are designed to capture blood clots, stopping them from traveling from the lower part of the body to the heart or lungs.

For some patients, blood clots develop in the deep veins of the leg, a condition known as deep vein thrombosis or DVT. When a blood clot reaches the lungs, it is called a pulmonary embolism or PE.

Doctors might prescribe blood thinners, also known as anticoagulants, to patients at risk of DVT or PE. If patients are unable to tolerate such medications, the doctor might opt to surgically implant an IVC filter in an attempt to stop blood clots from traveling upwards in the body.

Denali Vena Cava Filter Complaints

The Denali vena cava filter was cleared by the FDA in May 2013. Made of Nitinol, a nickel-titanium alloy, the Denali filter’s design was based on previous Bard filters.

The Denali did feature newly designed anchoring systems to try to reduce the chances of filter migration and vein wall penetration.

Unfortunately, according to the Denali vena cava filter lawsuit, the Denali filter followed in the footsteps of its predecessors because “soon after its introduction to the market, reports were made that the Denali filters were fracturing, perforating, migrating, and/or tilting in the patients in which they were implanted.”

The Denali vena cava filter lawsuit alleges Bard knew or should have known of the allegedly defective condition of its filters, which could fail, placing patients in serious danger of injuries or death. Bard allegedly underestimated the pressure that the ebb and flow of blood within the human body would have on the filters, which were susceptible to metal fatigue.

The Denali filters had “an unreasonable risk of fracture of portions of the filters” and of migration, tilting and perforating the wall of the vena cava, alleges the lawsuit.

In addition, the filters had “insufficient strength or structural integrity to withstand normal placement within the human body,” which placed patients at risk of potentially life-threatening injuries.

The Denali Vena Cava Filter Lawsuit is Case No. 2:18-cv-03123-DGC 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.