The lawsuit was filed by Richard B., a man in Wanamingo, Minnesota who was injured by the Günther Tulip® Inferior Vena Cava Filter (“IVC Filter”) manufactured by Cook Medical Inc.
The IVC filter was surgically implanted in his body on September 13, 2005 at Central Washington Hospital in Wenatchee, Washington, where he was living at the time.
Seven years later, he went to Cannon Falls Medical Center in Minnesota suffering from abdominal pain in April 2017. Imaging scans “revealed displaced struts adjacent to the aortic bifurcation,” according to the lawsuit.
The “struts” of an IVC filter are the needle-like wire legs that help anchor it inside the vein. If the struts break off, they will travel in the bloodstream until they get stuck in the aorta, heart, lungs, or other vital organs. This can potentially cause sudden death as a result of severe irregular heart rhythm.
Strut displacement can also allow the filter to tilt or move out of position, where it may fail to trap blood clots or cause other serious complications. Displaced filters are often impossible to remove. According to the lawsuit, strut fractures are a result of serious design flaws:
The Cook Filter suffers from a design defect causing it to be unable to withstand the normal anatomical and physiological loading cycles exerted in vivo.”
The plaintiff will need regular CT scans as long as the IVC filter remains in his body. He may also need cardiac catheterization or other endovascular procedures to find broken pieces of the Gunther Tulip IVC Filter. If complications occur, he may require emergency open heart surgery to remove the filter.
Cook Medical is accused of continuing to advertise the Gunther Tulip IVC Filter as safe and effective even though clinical trials were not sufficient to support long-term or short-term efficacy.
Lawyers say Cook Medical knew the filter was subject to breakage, migration, and vein perforation, but failed to warn about these risks. Instead, the Gunther Tulip was specifically advertised as “reduces the risk of fracture.”
The lawsuit was filed on May 26, 2017 in the King County Superior Court of the State of Washington — Case No. 17-2-13521-6 SEA.
Cook Medical is now facing approximately 2,000 other IVC filter lawsuits in state and federal courts nationwide. Most of these lawsuits are 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 attorney Ben C. Martin of The Law Offices of Ben C. Martin in Dallas, Texas. He serves as the plaintiffs’ co-lead counsel in the Cook IVC Filter MDL.