The lawsuit was filed by Randy B., a man from Florida who was injured by a Celect® Inferior Vena Cava Filter (“IVC Filter”) manufactured by Cook Medical LLC and William Cook Europe ApS.
The IVC filter was surgically implanted in his body on April 5, 2010 at Sacred Heart Hospital in Pensacola, Florida by Dr. Harry R. Cramer.
The purpose of the filter was to catch blood clots before they get stuck in the lungs. This complication is also known as a Venous Thromboembolism (VTE) and it commonly causes death in patients who are immobilized as they recover from surgery or injuries.
These patients may not be able to take a blood-thinning drug, so doctors sometimes implant a temporary IVC filter in their inferior vena cava to catch blood clots floating in the bloodstream.
The problem is that studies show that only about 30% of these “temporary” IVC filters are actually removed. Less than 10% are removed from trauma patients, despite studies showing that IVC filters do not save lives in trauma and increase their risk of developing blood clots.
The Celect IVC Filter is associated with a high rate of vein penetration, especially in the first few months. This complication can make the filter impossible to remove. Many people require multiple retrieval procedures. When IVC filters can’t be removed, they increase the risk of blood clots instead of preventing blood clots.
In 2015, a study of 99 patients who received the Celect IVC found a 43% rated of vein penetration within 2 months. In 2012, another study of 27 patients found that all of them had “some degree” of vein perforation within 71 days, often as a progressive process. The researchers concluded:
Longer indwelling times usually result in vena caval perforation by retrievable Günther Tulip and Celect IVC filters. Although infrequently reported in the literature, clinical sequelae from IVC filter components breaching the vena cava can be significant. We advocate filter retrieval as early as clinically indicated and increased attention to the appearance of IVC filters on all follow-up imaging studies.”
Cook Medical is accused of failing to warn about side effects, selling a defective medical device, negligence, breach of implied and express warranty, and inadequately studying the Celect IVC filter for safety.
The lawsuit was filed on April 11, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-01150.
Cook Medical is now facing 1,700 other IVC filter lawsuits in a centralized 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.