The lawsuit was filed by Paul T. a man who was implanted with the C.R. Bard Denali® Vena Cava Filter on December 31, 2014 at a hospital in Illinois.
The Denali is currently the only Bard IVC filter still on the market. Five earlier models — Recovery, G2, G2 Express, Eclipse, and Meridian — were sold for just a few years and pulled off the market without recalls.
All of these filters were approved by the FDA with 510(k) applications, which allows new devices on the market without new clinical trials, so long as the device is “equivalent” to an earlier device. New devices are typically advertised as substantial improvements.
The problem is that over time, slight design changes add up — but without clinical trials, there is no way to know if new filters like the Denali have the same hazards as older filters like the Recovery.
Recovery was introduced in 2003 and withdrawn in 2005, soon after Bard’s own studies raised concerns about fractures and migrations. It was later linked to a 40% 5-1/2 year fracture risk.
Soon after pulling Recovery off the market without a recall, Bard introduced the G2 and G2 Express — but only sold them until 2010. Two years later, studies estimated a 38% 5-year fracture risk.
Denali has only been on the market since May 2013, but it has already been associated with concerning reports of fracture and embolization.
Embolization occurs when the needle-like legs of an IVC filter (called “struts”) break off and travel in the bloodstream until they get stuck — usually in the heart, lungs, or veins that carry blood to other organs.
One of the most alarming case reports was published in 2015, describing a 46 year-old woman who was implanted with a Denali filter before surgery. When she returned 6 months later to have it removed, she reported severe chest pain.
During removal, surgeons found two broken components of the Denali filter — including one in her heart that punctured through wall and caused cardiac tamponade.
The broken Denali filter required open-heart surgery to remove. When the pieces were analyzed, experts said the metal broke after months of flexing in the vein as it naturally pulsated with blood:
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 say Bard knew — or should have anticipated — problems with the Denali because the same problems were associated with older filters like the Recovery and G2. Hundreds of people who were injured accuse Bard of selling defective devices and failing to warn about safety risks.
The lawsuit was filed on January 18, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-00156.
It will be centralized with over 1,366 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.