The lawsuit was filed by Paul P., a man from New York who was injured by the Denali® Inferior Vena Cava Filter (“IVC Filter”) manufactured by C.R. Bard and Bard Peripheral Vascular, Inc.
The IVC filter was surgically implanted in his body on December 24, 2013 at a hospital in New York.
The Denali is a 6th-generation Bard IVC filter for either permanent or temporary use. It catches blood clots in the bloodstream to prevent a Venous Thromboembolism (VTE), a life-threatening complication in which blood clots develop in the legs and travel to the lungs or heart.
All of Bard’s previous generations of IVC filters were associated with high rates of fracture and embolization of broken fragments. All of these older IVC filters were also pulled off the market without recalls.
The Denali is the only Bard IVC filter left on the market. Bard tried to fix fracture problems on its older generations of IVC filters by completely re-designing the Denali when it was introduced in 2013.
The Denali was re-designed with completely different materials and a new manufacturing process using single-piece laser-cutting technology. Unfortunately, there are already reports of it fracturing.
For example, a case report in 2015 described a 46 year-old woman who was implanted with a Denali IVC filter before her bariatric surgery. She returned within 6 months to have it removed, complaining of a 1-week history of severe chest pain.
During the retrieval procedure, two fractured filter fragments were identified, including one in her heart. She required open-heart surgery to remove the broken piece. According to the case report:
During open-heart surgery, the fragment was found traversing through the ventricular wall resulting in cardiac tamponade. Electron microscopic fragment analysis revealed high-cycle metal fatigue indicating the filter design failed to withstand this patient’s natural inferior vena cava biomechanical motions.”
Lawyers accuse C.R. Bard of failing to warn about side effects, manufacturing and selling a defective medical device, negligence, breach of implied and express warranty, fraudulent misrepresentation, fraudulent concealment, and violations of state laws prohibiting fraud.
The lawsuit was filed on April 17, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-01136.
There are now around 1,700 other IVC filters lawsuits against C.R. Bard in a centralized 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.