The lawsuit was filed by Steven E., a man from Maryland who was injured by the Günther Tulip® Inferior Vena Cava Filter (“IVC Filter”) manufactured by Cook Medical, LLC.
The filter was surgically implanted in his body on March 14, 2012 at Arnot Ogden Medical Center in Elmira, New York.
Günther Tulip IVC Filter
Retrievable filters are increasingly implanted for prophylaxis in patients without blood clots who are at risk of a pulmonary embolism (blood clots in the lungs).
The problem is that “short-term” IVC filters are rarely removed after the patient’s risk of a pulmonary embolism subsides. As a result, many patients have suffered life-threatening long-term complications.
The use of IVC filters has decreased amid a growing safety controversy. A few days after the plaintiff received his filter, the Journal of the American Medical Association (JAMA) published this editorial: “How Could a Medical Device Be So Well Accepted Without Any Evidence of Efficacy?”
Cook Medical is accused of downplaying the risk of side effects and misleading doctors about safety risks. Temporary IVC filters were advertised as superior to permanent designs because they could be removed, but in practice, they showed higher rates of early complications.
The issue may be related to materials. Permanent filters are typically made of stainless steel or titanium, whereas temporary filters are made of flexible metals like nitinol (nickel-titanium alloy) to make them easier to remove.
The problem is that years of constant flexing movements inside the inferior vena cava can wear out the metal. If just one of the needle-like legs breaks off, it can travel to the heart and cause death.
These serious risks are why the FDA issued a Safety Alert in May 2014 asking doctors to consider removing IVC filters as soon as possible:
The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.”
The defendants are charged with strict products liability (failure to warn and design defect), negligence, negligence per se, breach of express warranty, and breach of implied warranty. The plaintiff is also seeking punitive damages, or extra compensation to punish the defendants for extremely bad behavior.
The lawsuit was filed on April 7, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-01118.
Cook Medical is currently facing approximately 1,500 other IVC filter lawsuits 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.
Editor’s note: For more information about IVC Filter lawsuits and your legal rights, please contact The Law Offices of Ben C. Martin.