The lawsuit was filed by James B., a man from Texas who was implanted with the C.R. Bard Denali® Vena Cava Filter on May 14, 2016.
Denali is a filter that catches blood clots in a major blood vessel called the inferior vena cava (IVC). It has been on the market since 2013 and is currently the only filter that C.R. Bard still sells — the rest were withdrawn without recalls.
Denali was quickly approved based on its “equivalence” to these other filters, but it is advertised as “innovative” with a “completely new design.” Two similar filters made by C.R. Bard have been linked to a 40% 5-year fracture risk.
Denali is marketed as a permanent filter, but the longest safety study lasted two years. There are already reports of it fracturing under normal conditions.
In one case report from 2015, a 46 year-old woman nearly died when her Denali IVC filter broke in several pieces and punctured her heart.
The piece was examined under a microscope. Experts blamed “high-cycle metal fatigue, indicating the filter design failed to withstand this patient’s natural inferior vena cava bio-mechanical motions.”
C.R. Bard is accused of selling a defective medical device, inadequately testing it for safety, and failing to warn about side effects.
The lawsuit was filed on December 2, 2016 in the U.S. District Court for the District of Arizona — Case No. 2:16-cv-04180.
It will be centralized with over 1,100 other IVC filter lawsuits now pending against C.R. Bard in Multi-District Litigation (MDL No. 2641)— In Re: Bard IVC Filters Products Liability Litigation.
The plaintiff is represented by Ben C. Martin of The Law Offices of Ben C. Martin in Dallas, Texas. He serves on the plaintiffs’ steering committee of the Bard IVC Filter MDL.
