The lawsuit was filed by Gregory R., a man from Pennsylvania who was injured by the Günther Tulip® Inferior Vena Cava Filter (“IVC Filter”) manufactured by Cook Medical.
The Günther Tulip IVC Filter was surgically implanted in his body on November 26, 2010 at Pottstown Memorial Medical Center in Pennsylvania by Dr. Brian Dunfee.
The Tulip was originally approved in the 1990s in Europe for permanent implantation. It was designed with a hook on one end, allowing doctors to retrieve it if necessary.
The FDA approved the Tulip for retrievable use in the United States in 2003. The approval was based on a 41-person study of patients who had the filter removed within 14 days. Only 63% were retrieved, 21% tilted in the vein within 11 days, and one filter migrated to the heart.
Since then, many other studies have found high rates of tilting and perforation associated with the Günther Tulip IVC Filter. These complications may not cause symptoms on their own, but they often make retrieving the filter more challenging and dangerous.
For example, a study of 175 patients in May 2008 found that 91% were tilted during retrieval attempts. Tilting “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing,” the researchers warned.
Tilting also increases the risk of vein perforation. The hook can easily become embedded in the wall of the vein, making it impossible to snare and retrieve. The needle-like legs of the filter can also hit nearby organs.
In 2013, a study of 160 patients with Günther Tulip IVC filters showed that 43% punctured the vein. The researchers concluded that the stainless steel Greenfield IVC filters “had a significantly lower rate of IVC perforation than Celect and Tulip filters.”
The defendants include Cook Inc., Cook Medical LLC, and William Cook Europe ApS. They are charged with failure to warn about side effects, selling a defectively designed medical device, and negligence.
The lawsuit was filed on April 8, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case Case 1:17-cv-01121-LJM-DML.
Cook Medical is facing over 1,750 other IVC filter lawsuits in a centralized federal 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.