A Cook Celect lawsuit has been filed by a woman who claims she was injured by the inferior vena cava (IVC) filter.

Plaintiff Karen S. says she was implanted with a Cook Celect Platinum IVC filter on June 1, 2013 for the prevention of pulmonary embolisms.

IVC filters are tiny, cage-like mechanism implanted into the vena cava to physically trap and break up blood clots before they have a chance to travel to the heart or lungs. The inferior vena cava is a vein that returns blood to the heart from the lower part of the body.

In some patients, blood clots develop deep in the leg veins. This condition is called deep vein thrombosis or DVT. When the clot reaches the lungs, it can cause a pulmonary embolism or PE.

Patients who are unable to tolerate blood thinning medications are often candidates for the implantation of an IVC filter.

Cook Celect Lawsuit Alleges Company Knew Devices Were Defective

The Cook Celect has four anchoring struts for fixation and eight independent secondary struts to help center the mechanism and to trap clots.

The Cook Celect lawsuit alleges the company knew the struts could break away because they were not designed to withstand the “normal anatomical and physiological loading cycles” of the human body.

The Cook filters were designed to be retrievable. But a study found that of 130 retrieval attempts made between July 2006 and February 2008, 33 failed. Either tissue grew around the small hooks of the IVC filters, or the struts had penetrated the vena cava wall.

In another study of filters implanted from July 2007 through May 2009, the journal Cardiovascular Interventional Radiology reported that “one hundred percent of the Cook Celect filters and Gunther Tulip filters imaged after 71 days of implant caused some degree of filter perforation of the venal caval wall.”

The Cook Celect lawsuit contends Cook “knew or should have known that their IVC filters were more likely than not to perforate the vena cava wall.”

The company is accused of failing to disclose to doctors and patients “that its Cook Filters were subject to breakage, tilt, inability of removal, and migration even though they knew or should have known the same was true.”

Instead, Cook “did not accurately reflect the serious and potentially fatal adverse events” possible with the IVC filters, the plaintiff claims.

The Cook Celect lawsuit says that if the company had provided adequate warnings, Karen and other patients would have refused the implantation of the device.

Karen and other patients suffer “permanent and continuous injuries, pain and suffering, disability and impairment” in addition to emotional trauma, says the Cook Celect lawsuit. Those implanted with the IVC filters “have lost their ability to live a normal life” and have lost earnings while racking up medical bills.

The Cook Celect Lawsuit is Case No. 1:17-cv-02474-LJM-MJD in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.