The lawsuit was filed by Austin B., a man from Louisiana who was implanted with the Cook Günther Tulip® Vena Cava Filter on June 19, 2009 at Earl K. Long Medical Center in Baton Rouge.
Cook Medical gained approval for the Günther Tulip in the U.S. in 2000, and it became one of the first FDA-approved retrievable filters in 2003. At the time, doctors were already using it as a temporary filter.
The problem is that studies have shown higher rates of vena cava perforation the longer the Günther Tulip remains implanted.
The inferior vena cava (IVC) is the largest vein in the body, but it has remarkably thin walls because it carries “used” blood under low blood-pressure. When the needle-like legs of an IVC filter dig into the walls of the vena cava, they sometimes puncture through.
In one study from 2013, 43% of patients implanted with the Günther Tulip (69 out of 120) developed a perforation. Another study from 2012 also found high rates of perforation associated with the Tulip. All of the filters developed “some degree” of perforation within 71 days, often as a progressive process.
While perforations do not always cause symptoms or need treatment, they do make the filter harder to remove. In some cases, the filter is impossible to remove and must remain in the patient forever. There is also a risk of sharp pieces of the filter cutting nearby internal organs.
The second Cook IVC filter trial has been set for October 2017, and it involves a man from Illinois who was implanted with a Günther Tulip in 2011. It perforated his vena cava and remains in his body because it was too dangerous to remove.
Lawyers accuse Cook Medical 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 Southern District of Indiana (Indianapolis Division) — Case No. 1:16-cv-03274.
It will be centralized with over 1,100 other IVC filter lawsuits now pending in Multi-District Litigation (MDL No. 2570) — In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices, and Products Liability Litigation.
The plaintiff is represented by Ben C. Martin and Thomas Wm. Arbon of The Law Offices of Ben C. Martin.
Ben C. Martin is a trial attorney based in Dallas, Texas who serves as the plaintiffs’ co-lead counsel in the Cook IVC Filter MDL.