Cook Medical faces a new lawsuit alleging that a patient’s IVC filter placement and design was defective, causing serious health consequences.

Plaintiff Gail T. recently filed a lawsuit against Cook Inc., Cook Medical LLC, and William Cook Europe ApS, alleging that following IVC filter placement of her Gunther Tulip IVC filter, she suffered from health complications. Gail claims that she underwent IVC Filter placement in May 2010 and later experienced health problems related to the defective nature of the product.

The inferior vena cava is a blood vessel which returns blood to the heart from the lower part of the body including the legs and pelvis. Some people experience deep vein thrombosis, or clotting in the deep blood vessels of the legs and pelvis. Clots formed here can travel up to the lungs where they are considered pulmonary emboli. This condition is very dangerous as it limits the amount of oxygen the lungs can provide to the rest of the body.

IVC filters are small devices which are placed in the inferior vena cava. The design of the devices typically includes wires which break up clots in patients with deep vein thrombosis, lowering the risk of blockages. IVC filter placement is typically recommended for patients with recurrent pulmonary embolism, lowering the risk of further blockages and damage in the lungs.

Gail’s IVC filter, the Gunther Tulip IVC filter, has a top hook and four anchoring struts which are supposed to anchor the device to the blood vessel. Each anchoring strut has a branching wire piece, forming the “flower” shape and breaking up clots that may pass through the blood vessel.

The lawsuit claims that Cook IVC filters are associated with serious complications following IVC filter placement. Complications allegedly include tilting, perforation, fracture, breakage, and migration. The complaint alleges that Cook knew or should have known of their products’ tendency to tilt, perforate, fracture, break, and migrate, yet did not warn patients and physicians of the possibility.

Gail claims that the “defect was attributable to the design’s failure to withstand the normal anatomical and physiological loading cycles exerted in vivo”. This means that the design of the IVC filter is allegedly unable to stay in place under the force of blood moving through the blood vessel following IVC filter placement.

One study reported by the Cardiovascular Interventional Radiology found that 100% of Cook filters imaged 71 days after IVC filter placement caused some degree of perforation of the vena cava wall. The same study reported that tilting occurred in 40% of the IVC filters, and all of the tilted filters demonstrated perforation. The study looked at data from Gunther Tulip and Celect IVC filters implanted between July 2007 and May 2009.

Gail accuses the defendants of strict products liability – failure to warn, strict products liability – design defect, negligence, breach of warranties, and violation of state consumer protection laws. The lawsuit seeks compensatory damages, punitive damages, disgorgement, restitution, court costs, and attorneys’ fees.

The IVC Filter Lawsuit is Case No. 1:18-cv-01575-SEB-MPB and is part of the IVC Filter MDL, In re: Cook Medical Inc IVC Filters Marketing, Sales Practices, and Products Liability Litigation, Case No. 1:14-ml-2570-RLY-TAB, in the United States District Court for the Southern District of Indiana.