A Cook IVC filter MDL includes a complaint by a South Carolina woman who says she was injured by a Cook Celect Vena Cava Filter implanted in July 2010.

Plaintiff Sylvia R. added her lawsuit to the growing Cook IVC filter MDL, or multidistrict litigation. She alleges Cook “intentionally, recklessly, and/or negligently failed to act as to the known failures and injuries associated with its devices and/or failed to warn about and concealed, suppressed, omitted, and/or misrepresented the risks, dangers, defects and disadvantages of its IVC filters.”

Cook IVC Filter MDL Alleges Company Knew of Device Issues

IVC (Inferior Vena Cava) filters are small, cage-like medical devices implanted into the vena cava to physically trap and break up blood clots before they have a chance to travel from the legs and pelvic region 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. Patients who are unable to tolerate blood thinning medications are often candidates for the implantation of an IVC filter.

The Cook Celect IVC filter has four anchoring struts for fixation and eight independent secondary struts to help center the mechanism and to trap clots. The Cook IVC filter MDL alleges the company knew the struts could break off because they were not anchored strong enough to withstand the “normal anatomical and physiological loading cycles” within the human body.

Despite this knowledge, the IVC filters “were widely advertised and promoted … as safe and effective treatment for prevention of recurrent pulmonary embolism via placement in the vena cava.”

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 a study of 73 patients implanted with the Celect filter between August 2007 and June 2008, researchers found “a high incidence of caval filter leg penetration. Immediately after fluoroscopy-guided filter deployment in 61 patients, four filters (6.5%) showed significant tilt. Follow-up abdominal CT in 18 patients demonstrated filter related problems in 7 (39%), which included penetration of filter legs in four and fracture/migration of filter components in one.”

The journal Cardiovascular Interventional Radiology published a story March 30, 2011, finding that one hundred percent of Cook Celect and Guther Tulip IVC filters imaged after 71 of days of implantation “caused some degree of filter perforation of the venal caval wall.” The filters studied had been implanted between July 2007 and May of 2009.

That same study showed that 40 percent of the filters had tilted, and that all the tilted filters had shown vena caval wall penetration.

Based on studies like these, the Cook IVC filter MDL contends, Cook “knew or should have known that their IVC filters were more likely than not to perforate the vena cava wall.”

The Cook IVC Filter MDL is Case No. 1:14-ml-2570-RLY-TAB in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.