The lawsuit was filed by Michael P., a man from Texas who was injured by the Celect® Inferior Vena Cava Filter (“IVC Filter”) manufactured by Cook Medical, LLC.
The Celect IVC filter was surgically implanted in his body on August 25, 2015 at VA Medical Center in Syracuse, New York. The purpose of the filter was to prevent health problems associated with blood clots.
Instead, studies show a high risk of Celect IVC filters causing serious health problems. For example, one study found an 86% risk of vein perforation within 5 months, on average.
In another study, 39% of Celect IVC filters punctured the vein within 30 days, and 80% punctured the vein within 90 days. Remarkably, 13% also punctured the patient’s intestines, aorta, muscle, spine, pancreas, adrenal gland, liver, kidney, lymph node, or diaphragm.
The problem may be related to design. Celect IVC filters were not tested for safety in clinical trials because Cook Medical claimed it was “equivalent” to an older model known as the Günther Tulip IVC filter.
Cook Medical tried to fix tilting issues on the Günther Tulip by adding four new unprotected legs to the Celect. This design change reduced tilting rates, but it may have significantly increased the risk of early vein perforations.
In a case report of a Celect IVC filter that punctured the vein within 9 days, the researchers warned:
The new filter, unlike the older one, has unprotected primary struts. Only filters with an unprotected primary strut design have been associated with penetration injuries such as the one described in this case.”
Lawyers accuse Cook Medical of manufacturing and selling a defective medical device, downplaying serious safety risks, and inadequately testing the Celect IVC filter for safety hazards.
The lawsuit was filed on April 19, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-01225-SEB-DKL.
Cook Medical is facing 1,750 other IVC filter lawsuits nationwide. The cases are centralized 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.