C.R. Bard vena cava filters are allegedly prone to IVC filter complications symptoms, according to a recent lawsuit.

Plaintiff Pam B. says she had the Denali IVC filter, a product manufactured by Bard, implanted in October 2017. After her placement procedure, Pam reportedly started to experience IVC filter complications symptoms which were allegedly a result of the defective nature of the Denali filter.

The Denali IVC filter received FDA clearance in 2010 and reportedly represents a redesign of the Eclipse filter, one of Bard’s previous IVC filter models. The manufacturers had high hopes for this filter, with a 2015 performance study concluding that the filter represented “a promising balance of retrievability and freedom from the relatively high complication rates that have plagued past retrievable filter designs.”

However, researchers may have been let down due to allegations that the Denali IVC filter is defective and causes serious injury.

What are IVC Filters?

According to Johns Hopkins, inferior vena cava (IVC) filters are small devices which are placed in the vena cava vein to prevent clots moving from the lower body to the lungs.

Deep vein thrombosis (DVT) is when a clot forms in a vein of the body, most often the deep veins of the thigh or lower leg. These clots can then travel up the vena cava, become lodged in a blood vessel in the lungs, and form blockage or pulmonary embolism (PE).

IVC filters prevent pulmonary emboli by breaking up clots in the vena cava before they reach the lung. The filters are designed to secure themselves in the vein and break up the clots as blood flows towards the lungs and heart.

These devices may be a good treatment option for patients at a high risk for deep vein thrombosis, including those who recently had surgery, those with a leg injury, those with limited mobility, and others. Pam claims, however, that the Denali filter and other IVC filters manufactured by Bard are defective because they fail to withstand the normal force of blood flow through the vena cava.

This defect allegedly causes the IVC filters to tilt, migrate, and perforate the vena cava and internal organs.

Filter Complications

By the time patients experience IVC filter complications symptoms, Pam claims that they may already be experiencing life threatening complications.

“When IVC filter fractures occur, shards of the filter or even the entire filter can travel to the heart, where they can cause cardiac tamponade, perforation of the atrial wall, myocardial infarction, and/or death,” the IVC filter lawsuit claims.

“Bard IVC Filters similarly pose a high risk of tilting and perforating the vena cava walls. When such tilting occurs, the filters can also perforate the adjacent aorta, duodenum, small bowel, spine, or ureter, which may lead to and, upon information and belief, already have led to retroperitoneal hematomas, small-bowel obstructions, extended periods of severe pain, and/or death.”

As in lawsuits against other IVC manufacturers such as Cook Medical, Pam brings several claims in her lawsuit against Bard, including manufacturing defect, failure to warn, design defect, negligence, breach of warranties, fraudulent concealment, and violation of Kentucky consumer protection laws.

The IVC Filter Lawsuit is Case No. 2:19-cv-00555-DGC and is part of the Bard IVC Filter MDL, In re: Bard IVC Filters Products Liability Litigation, Case No. 2:15-md-02641-DGC, in the U.S. District Court for the District of Arizona.