A man has filed a lawsuit alleging he was implanted with an IVC filter to prevent blood clots that caused him serious injuries.

Plaintiff Thomas W. said he was implanted with the Denali Vena Cava Filter on Dec. 14, 2014. This particular inferior vena cava (IVC) filter is made by C.R. Bard Inc. and Bard Peripheral Vascular, Inc. His wife is a plaintiff, as well, alleging loss of consortium with her injured husband.

The inferior vena cava is a large vein that carries blood from the lower body to the heart. IVC filters are tiny cage-like medical devices that are placed in the inferior vena cava to stop blood clots from traveling to the lungs, where clots can become potentially fatal pulmonary embolisms.

Patients Who Need Filters to Prevent Blood Clots

Patients who are at risk of blood clots may be prescribed blood thinning medications. People who cannot tolerate these medicines might receive an IVC filter. Most known IVC filters manufacturers include C.R. Bard and Cook Medical.

Risk factors for dangerous blood clots include those with the following conditions:

• Deep vein thrombosis (DVT): a clot that forms a majority of the time in a major vein in the leg, but it can form in an arm, pelvis or other large vein in the body.
• Pulmonary embolism (PE): If a clot detaches from where it was formed, it can travel to the lungs. When a blood clot becomes stuck in the lungs, the clot can disrupt blood flow and become fatal.

Nearly 900,000 Americans are affected by DVT every year, and 100,000 die as a result.

Alleged Problems with Bard IVC Filters

Originally designed to be permanent implants, IVC filters have been on the market since the 1960s.

“In order to increase sales of these devices, Bard sought to expand the market for prophylactic use among nontraditional patient populations that were temporarily at risk of developing blood clots,” alleges the IVC filter MDL.

Bard projected that by targeting patients who needed bariatric, trauma, orthopedic or cancer treatments, the company would triple its sales.

In July 2003, the Bard Recovery IVC filter was the first retrievable IVC filter to be approved by the FDA. Despite years of reports of the device breaking, perforating vein walls, migrating or tilting, the Recovery filter was used as a blueprint for future Bard IVC filters.

The FDA cleared the Denali IVC filter to prevent blood clots in May 2013. Made of Nitinol, the Denali had extra anchoring systems built in to reduce the chances of the filter migrating from its originally implanted position – filter placement is key.

The “Denali filter was likewise plagued with the same manufacturing and design defects that were causing damage to the general public in Bard’s predecessor retrievable filter family,” alleges the Bard IVC filter complaint.

In 2015, NBC News uncovered confidential reports that Bard had paid for a study that indicated its Recovery IVC filter was related to more deaths, device fractures and device migration than the filters made by other medical device companies. Instead of recalling the Recovery filter, Bard released similar filters to prevent blood clots under different names; all other filters had similar failures.

The IVC Filter Lawsuit is Case No. 2:19-cv-02202-DGC, and is part of the Bard IVC MDL, In re: Bard IVC Filters Products Liability Litigation, MDL No. 2641, in the U.S. District Court for the District of Arizona.