The lawsuit was filed by Brandon T., a man from Arizona who was implanted with the Cook Celect® Vena Cava Filter in January 2011 at St. Vincent Healthcare in Billings, Montana.
Celect is a removable filter that is implanted in the inferior vena cava (IVC) to catch blood clots and prevent pulmonary embolisms. It has 12 needle-like wire legs around a retrieval hook.
The FDA recommends removing temporary IVC filters within 29-54 days, or as soon as a patient can take a blood-thinning medication. However, most studies show that retrieval rates rarely exceed 30%.
The problem is that the longer it remains implanted, the higher the risk of needle-like legs puncturing through the wall of the vena cava. This complication can make the filter impossible to remove.
One of the first studies to raise concerns about Celect was published in 2012. Perforation of at least one filter component through the vena cava occurred in 43 out of 50 (86%) of patients within 2.5 years.
Furthermore, all of the filters had some degree of perforation within 71 days, often as a progressive process. “Longer indwelling times usually result in vena caval perforation,” the researchers concluded.
In 2013, another study of 255 patients with Celect filters found that 126 (46%) perforated the vena cava within 9 months, on average. Only 2% of patients with Greenfield filters had a perforation in the same time.
In 2015, a study of 99 patients with the Celect found that 43% perforated the vena cava in 2 months, and 9% had “significant tilting.” No perforations occurred in 86 patients with the Option Elite IVC filter.
Cook Medical is accused of selling a defective medical device and failing to warn about potential side effects.
The lawsuit was filed on November 28, 2016 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:16-cv-03226.
It will be centralized with over 1,175 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. He is also on the plaintiffs’ steering committee of the Bard IVC Filter MDL.