The lawsuit was filed by Walter S., a man who was implanted with the C.R. Bard Denali® Vena Cava Filter at a hospital in Washington state on March 12, 2016.
Denali is currently the only inferior vena cava (IVC) filter that Bard still sells, but it may have similar design flaws as older filters.
Denali is a 6th-generation IVC filter that was approved by the FDA in 2013. Previous generations were plagued by high rates of fracture and migration. Bard tried to address these issues on the Denali by using completely new materials and single-piece laser-cutting technology.
Unfortunately, fractures continue to be reported. In one case report from January 2015, a 46 year-old woman needed emergency open heart surgery when her Denali filter fractured within less than 6 months.
Her doctors were able to remove the body of the filter and one broken fragment. The other fragment traveled to her heart and punctured through the ventricular wall, resulting in cardiac tamponade.
The broken fragments were examined under a microscope. According to the report:
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.”
The study highlights why IVC filters are so dangerous. IVC filters have up to 12 sharp metal legs called “struts” that dig into the inferior vena cava, a major blood vessel with extremely thin walls. This vessel naturally flexes with heartbeats, breathing, and blood pressure.
The struts of an IVC filter must also withstand near-constant flexing movements — but anyone who has played with a paperclip can show you how repeated movements can snap a metal wire into pieces.
Fragments of an IVC filter can become deadly missiles when they snap in the inferior vena cava, a vein that goes straight to the heart. Fragments can also get stuck in the lungs, kidney, or other veins, but this does not always cause symptoms. Patients may not know their filter fractured until suffering major heart problems or death.
Lawyers accuse C.R. Bard of downplaying these risks and inadequately studying the Denali IVC filter for severe complications.
The lawsuit was filed on March 7, 2017 n the U.S. District Court for the District of Arizona — Case No. 2:17-cv-00680.
It will be centralized with around 1,470 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.