A patient has filed an IVC filter injuries lawsuit against Cook Medical alleging the medical device is faulty.

Plaintiff Mell M. allegedly was implanted with a Cook Celect Vena Cava Filter in July 2013. Mell’s complaint joins an MDL against Cook that includes many other plaintiffs who allege they have suffered similar IVC filter injuries and problems.

IVC (Inferior Vena Cava) filters are tiny cage-like medical devices that are implanted in the inferior vena cava to capture blood clots before they can travel to the lungs, resulting in a potentially life-threatening pulmonary embolism. The inferior vena cava is the vein that returns blood to the heart from the lower part of the body.

Because the devices are so small, IVC filters are quite fragile. They look like miniature spiders with moveable legs that form the bars of the cage. These legs allegedly can break off and travel through the bloodstream to other parts of the body.

IVC filters are implanted in patients who for some reason cannot tolerate blood-thinning medications and are at risk for blood clots. Patients who must undergo surgeries or who suffer serious injuries often develop an increased risk of blood clots.

An IVC filter also might be chosen over a blood thinner if an invasive surgery or severe injury could prompt uncontrollable bleeding.

Allegations of IVC Filter Injuries

“Cook IVC filters are associated with, and cause, an increased risk for serious injury and death as a result of adverse events including tilting, perforation, fracture, breakage, and migration,” alleges the Cook MDL.

The complaint goes on to allege that Cook knew of IVC filter injuries and device failures but intentionally failed to warn about the issues for fear of negatively affecting sales. The MDL alleges the IVC filters “are unreasonably dangerous” and that no warnings of the potential of serious or fatal IVC filter injuries were provided.

The Cook Celect Vena Cava Filter implanted in Mell has four anchoring struts for fixation and eight secondary struts designed to help the filter center itself within the vein and improve clot-trapping capability. The Cook Celect was designed as a retrievable filter, meaning the device should be able to be safely removed from the patient’s vein once the risk of pulmonary embolism has passed.

According to the Cook Celect MDL, a review of 115 patients who received Cook Celect IVC filters between December 2005 and October 2007 allegedly showed that even though filter insertion was successful in all cases, the retrieval was a problem in several cases.

In another review of patients with a Cook Celect IVC filter implanted between August 2007 and June 2008, researchers allegedly found the Celect IVC filter led to a relatively high incidence of filter leg penetration. The study indicated four filters tilted significantly right after implantation.

A total of 18 patients who had follow-up CT scans of their abdominal areas and seven of them allegedly had filter-related problems, including penetration of filter legs in four patients. One patient allegedly suffered fracture and migration of filter components.

The IVC Filters Injuries Lawsuit is Case No. 1:18-cv-04081-JMS-MPB and is part of the Cook Medical, Inc. IVC Filters MDL, In re: Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Products Liability Litigation, MDL No. 2570, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.