The lawsuit was filed by Julie D., a woman from Missouri who was implanted with the Cook Günther Tulip® Vena Cava Filter on June 2, 2014 at University Hospital in Columbus.
The Günther Tulip was approved for retrieval in 2003. It is implanted in the largest vein in the body — the inferior vena cava (IVC) — where it catches blood clots to prevent pulmonary embolisms.
The walls of the vena cava are incredibly thin because the vein carries blood under low blood-pressure. When the needle-like legs of an IVC filters dig into the vein, they sometimes puncture through.
The problem is that a number of recent studies have found increasing rates of perforation the longer the Tulip remains implanted in a patient.
In 2013, a study of 160 patients with the Tulip found that 69 (43%) perforated through the vena cava within an average follow-up of 14 months.
In 2012, another study of 50 patients with the Günther Tulip and Celect IVC Filters found that 86% developed a perforation within 2.3 years. Furthermore, all of the filters had “some degree” of perforation within 71 days, often as a progressive process.
Perforations usually do not cause symptoms or require treatment. However, they often make the filter difficult to remove — in some cases, removal is not possible. Sharp pieces of the filter can also poke into internal organs can cause lacerations or bleeding.
Cook Medical is accused of failing to warn about side effects, selling a defective medical device, and inadequately testing it for safety.
The lawsuit was filed on December 7, 2016 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:16-cv-03305.
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.
Editor’s note: For more information about IVC Filter lawsuits and your legal rights, please contact The Law Offices of Ben C. Martin.