The lawsuit was filed by Barbara W., a woman who was implanted with the Cook Celect® Vena Cava Filter in November 2009 at a hospital in Fort Worth, Texas.
She claims that Cook Medical is liable for her injuries because the company sold a defective medical device and failed to warn about safety risks.
Celect is a temporary blood clot filter that is implanted in the inferior vena cava (IVC). It was approved in 2008 without clinical trials because it was nearly identical to the Günther Tulip.
Both filters may have similar design flaws. In one recent study, all of the filters had some degree of perforation within 71 days, 40% were tilted, and 86% punctured through the vena cava within 2.5 years.
In another study, 43% of patients who were implanted with the Celect had at least one strut perforation through their vena cava within two months. Nearly 9% also had “significant tilting,” researchers said.
Because the risks increase over time, the FDA recommends removing temporary IVC filters within 29-54 days. Unfortunately, less than 20% are ever removed.
The lawsuit was filed on November 8, 2016 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:16-cv-03048.
The case will be transferred into Multi-District Litigation (MDL No. 2570), where more than 1,000 similar lawsuits have been centralized — 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 in Dallas, Texas.