The lawsuit was filed by Robin A., a woman from California who was implanted with the Cook Celect® Vena Cava Filter on February 2, 2011 at Providence Tarzana Medical Center.
Celect is an intravenous filter that is implanted in the inferior vena cava, a vein that carries “used” blood from the body into the lungs to be re-oxygenated and pumped into the body by the heart.
Celect has 12 wire legs called “struts” that dig into the vein and stop blood clots before they hit the lungs or cause a pulmonary embolism.
The FDA approved Celect in 2007 for retrievable use, but it did not go through clinical trials because it was “equivalent” to the Günther Tulip.
Unfortunately, both Celect and Günther Tulip are linked to high rates of vein perforation. In one study, all filters had “some degree” of perforation within 71 days, and 86% punctured the vein by 2.4 years.
Celect is linked to an extraordinarily high rate of early vein perforations, unlike the Tulip. In 2014, a study of 265 patients with Celect found that 39% perforated the vein within 30 days, and 80% within 90 days, with rates increasing over time.
Early vein perforations were blamed on an “unprotected primary strut” design flaw in a study in 2007. This design was supposed to fix tilting issues with the Günther Tulip. Instead, it may have created problems.
The inferior vena cava has remarkably thin walls because it carries blood under low pressure. Over time, the needle-like legs of an IVC filter dig into the vein as it pulsates with blood. Many filters eventually puncture through and cause organ damage.
Patients may not realize they have a problem because vein perforations do not always cause symptoms. Without symptoms, patients might delay a procedure to remove the filter until it is too late. It is often impossible to remove IVC filters stuck in the vein.
Lawyers accuse Cook Medical of downplaying these serious side effects, inadequately warning patients about risks, and selling a defective medical device that was never properly tested for safety.
The lawsuit was filed on February 21, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00549.
It will be centralized with approximately 1,500 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.