The lawsuit was filed by Anthony L., a man from Florida who was implanted with the Cook Celect® Vena Cava Filter on February 23, 2013 at Holy Cross Hospital in Fort Lauderdale, FL.
Celect is an intravenous filter that prevents pulmonary embolisms (blood clots in the lungs) by catching blood clots as they travel through a major vein called the inferior vena cava (IVC).
The FDA approved Celect in 2007 as a retrievable IVC filter for short-term protection against blood clots. Cook Medical introduced Celect as an updated version of a permanent filter called the Gunther Tulip.
Studies immediately raised concerns about reports of patients who were injured when the Celect’s sharp metal legs punctured through their vein within 90 days. The Celect’s new design may have reduced tilting, but studies suggest the addition of four “unprotected primary struts” may have also increased the risk of early vein penetrations.
In 2014, a study of 690 patients with Celect found that 39% punctured the vein within 30 days, and 80% within 90 days. Furthermore, 13.2% of patients had at least one filter strut poking into their intestines, aorta, or muscle.
Vein perforation do not usually cause symptoms. When symptoms do appear, it is usually because the filter has poked into a nearby organ. Patients may not realize they have a problem until symptoms appear. They may even delay a procedure to remove the filter until it gets stuck permanently.
The FDA warned about the long-term risks of “short-term” IVC filters in 2010, after receiving 921 injury reports over the previous five years. The risk vs. benefit profile begins to favor IVC filter removal between 29 and 54 days post-implant. According to the FDA:
Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
Lawyers accuse Cook Medical of failing to warn about side effects, selling a dangerously defective medical device, and advertising it as safe despite inadequate safety studies.
The lawsuit was filed on February 23, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00582.
It will be centralized with around 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.