The lawsuit was filed by Cynthia T., a woman from Arizona who was implanted with the Cook Günther Tulip® Vena Cava Filter on June 19, 2007 at John C. Lincoln Dear Valley Hospital in Phoenix.
IVC filters are implanted in a vein to catch blood clots and prevent Venous Thromboembolism (VTE). This condition occurs when blood clots from the legs (deep vein thrombosis) travel in the bloodstream and get stuck in the lungs (pulmonary embolism).
Günther Tulip Vena Cava Filter
Permanent IVC filters have been on the market in the U.S. since the 1976 — the same year the FDA started regulating medical devices — and they were approved with little supervision on effectiveness.
Things did not change much over the years. In October 2003, Günther Tulip became the second “temporary” IVC filter ever to be approved by the FDA, but it did not go through clinical trials.
Hospitals in some parts of the U.S. (especially the South Atlantic region) started routinely implanting temporary IVC filters in high-risk patients. Today, studies estimate that at least 15% of hospital patients with a pulmonary embolism receive an IVC filter.
Temporary IVC filters went mainstream based on theoretical safety advantages, but without much evidence. The assumption is directly contradicted by a growing amount of hard scientific evidence.
For example, trauma patients who were implanted with an IVC filter did not survive longer than trauma patients who did not, according to a study at Boston Medical Center that was published in January 2017 by JAMA Cardiology. Researchers warned:
The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place.”
Death rates associated with pulmonary embolisms are declining nationwide, regardless of IVC filter use, which suggests hospitals are doing a better job of taking care of these patients without implanting IVC filters.
There may also be growing concern about the long-term risks of routinely implanting IVC filters. Fewer than 10% are ever removed from trauma patients, and ironically, a common long-term risk is developing blood clots.
Günther Tulip is approved as a permanent implant, but studies have shown high rates of vein perforations within the first two years. One study study found that all patients had “some degree” of vein perforation within 71 days, often as a progressive process. Another study found a 43% perforation rate within 437 days, on average.
Lawyers accuse Cook Medical of negligence for downplaying the risk of side effects, aggressively promoting dangerous medical devices, failing to adequately investigate the risk of complications, and more.
The lawsuit was filed on January 26, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00252.
It will be centralized with over 1,370 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.
Editor’s note: For more information about IVC Filter lawsuits and your legal rights, please contact The Law Offices of Ben C. Martin.