In this year the Cook Medical have faces 818 federal lawsuits till the mid of August. The number of lawsuit increasing day by day against the manufacturers. As a result to speed the process of handling complex cases and avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and courts the establishment of multidistrict litigation for all Cook IVC filter lawsuits is designed. The entire lawsuit alleges similar allegations that the medical devices were defectively designed and caused users to experience complications after receiving the filters to reduce the risk of pulmonary embolism.
Recently a man from Virginia filed a personal injury and defective product liability lawsuit against the Günther Tulip® Vena Cava Filter. According to the plaintiff, Christopher Ellingsen the Günther Tulip® Vena Cava Filter injured his internal organs. He accuses the manufacturer of negligence for selling a defective medical device, failing to warn about side effects, and concealing safety risks. In 2004, he was implanted with the vena cava filter at Vidant Memorial Center in North Carolina and after few months from implantation the device injured his internal organs. The lawsuit was filed on August 29 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) under the Case No. 1:16-cv-02308.
The Günther Tulip Vena Cava Filter and It’s Complications
The Gunther Tulip IVC Filter is designed with 12 wires for filtering, which is twice as many as other conical filters, including four legs that are each 44-mm in length. The Gunther-Tulip inferior vena cava filter (Cook Medical Inc, Bloomington, Ind) was one of the first inferior vena cava (IVC) filters to be approved by the U.S. Food and Drug Administration for retrieval and are used in those patients who may develop a PE and cannot be treated by using anticoagulant medication. The devices are placed in the inferior vena cava, the largest vein in the body, to prevent blood clots that form in the legs and pelvic area from breaking loose and moving to the lungs.
The Günther Tulip™ Vena Cava Filter has been used for over a decade in patients around the world to prevent the dangerous and deadly effects of pulmonary embolism. Despite preventing deadly effects of pulmonary embolism the device is associated with severe risk and complications. IVC filter complications are very serious and can be life threatening If it is not retrieved when a patient is not at risk of a pulmonary embolism. The FDA safety communication states that the risk of device perforation greatly increased the longer the device stayed in the body and recommending they be removed after 39 days, but before 54 days. The complications include:
- Embolization
- Fracture
- Migration
- Organ damage
- Additional surgery and even death
The Günther Tulip™ Vena Cava Filter was jointly developed by William Cook Europe with Professor R.W. Günther. The Cook Gunther Tulip IVC Filter System is a medical device approved by the FDA in 2003. It was followed by the Cook Celect IVC Filter System, which was approved by the FDA in 2008. It has been on the market in Europe since 1992 and the United States since 2003. Cook Medical obtained approval for the IVC filters under the controversial FDA 510(k) fast track approval process, which allowed them to perform only minimal testing before selling the devices for use in patients nationwide.
Lawsuits have been filed against the device makers by both patients and their families seeking compensation for injuries caused. IVC Filter Lawsuits moves forward with selection of three lawsuits for bellwether trials beginning in 2017. The lawsuits claim that manufacturers failed to warn the general public about the potential health risks associated with the device. Before implanting the IVC Filters physicians should be covering both the risks and benefits of the devices with patients carefully.
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