The lawsuit was filed by Anna L., a woman who was implanted with the Cook Günther Tulip® Vena Cava Filter on May 4, 2011 at Harbor View Medical Center in Seattle, Washington.
The Günther Tulip was originally designed as a permanent IVC filter, but it is also approved for temporary protection against blood clots.
The FDA has recommended removing temporary IVC filters as soon as the risk of blood clots has passed, ideally within 29-54 days. Complication rates increase the longer it remains implanted.
Despite warnings, retrieval rates are dismally low. One study in 2010 found that less than 30% of IVC filters were removed, and 25% of attempted retrievals were unsuccessful.
Many patients do not know the filter needs to be removed — or by the time they try to get it out, the filter has embedded or perforated their vein and can’t be removed.
The Günther Tulip has been linked to relatively high rates of perforation — 43% of patients (69 out of 120) developed a perforation after an average of 437 days, according to a study in 2013.
In another study, 86% of patients with the Günther Tulip or Cook Celect developed a perforation within 2.4 years, often as a progressive process. All of the patients had “some degree of vena caval perforation” within 71 days of being implanted with the filters.
The inferior vena cava is the largest vein in the body, but it has remarkably thin walls because it carries blood under low pressure. The needle-like legs of an IVC filter are designed to dig into this vein.
IVC filters often puncture the vein, but most patients have no idea because it does not usually cause symptoms. The bigger problem is that it increases the risk of other side effects like filter tilt, organ perforation, or blood clots. It can also make the filter harder to remove.
Lawyers say the Günther Tulip is defective and poses “unreasonably dangerous” safety risks. Cook Medical is accused of failing to warn about side effects and inadequately testing it for long-term use.
The lawsuit was filed on January 12, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00111.
It will be centralized with over 1,225 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.