A lawsuit has been filed against the Cook Günther Tulip Vena Cava Filter by a woman who was implanted with the device back on June 21, 2012, at the Lehigh Valley Hospital in Allentown, Pennsylvania. The filter implanted in the plaintiff is one of the oldest on the market, first being approved in 1992 in Europe as a permanent implant.
The Günther Tulip was made of Conichrome and had a hook on the end of it for easy removal from the body. The filter was sold as both a short-term IVC filter and a permanent solution by Cook Medical.
Tulip received approval in 2000 as a permanent filter. The filter was initially denied approval due to retrieval, so Cook Medical performed a 41-person study that assessed retrieval of the filter in 14 days.
During the study, just 26 (63 percent) of the filters were retrieved. One of the filters moved to the heart of a patient and nine filters (21 percent) tilted in the veins of the patients after an average of 11 days in the body. The results of this study led to the approval of the filter by the Food and Drug Administration (FDA) in October of 2003.
Tilting, which has been named in various other recent studies, leads to perforation of the veins. It can also cause the hook to become imbedded in the veins, making it almost impossible to retrieve the filter. A 2013 study discovered that 43 percent (69 of 160 filters) had perforated through a vein.
The lawsuit filed by the plaintiff from Pennsylvania accuses Cook Medical of downplaying the side effects of the filter, selling defective medical devices, and not adequately studying the filter for safety. The lawsuit was filed in the U.S. District Court for the Southern District of Indiana on March 9.
The new lawsuit will be centralized with close to 1,500 other IVC filter lawsuits that are pending in litigation across multiple districts.
An experienced personal injury attorney can answer all of your defective medical devices questions in Nashville, Tennessee.
Source: Daily Hornet, "Pennsylvania Woman Files IVC Filter Lawsuit," March 10, 2017