Cook Medical Inc. faces allegations that a defective design led to inferior vena cava filter complications.

In an IVC filter lawsuit against Cook Medical, plaintiff Jean G. claims that she was physically injured as a result of a defective design in Cook Medical Inc.’s Cook Celect Vena Cava Filter. She had the device installed on Jan. 18, 2010, in New York. She seeks punitive damages against the company, claiming that the company was negligent in producing a defective product and in failing to warn its customers of the defect.

Litigation Addresses Inferior Vena Cava Filter Complications

Gordon’s lawsuit is part of a multi district litigation filed against Cook Medical Inc. over inferior vena cava filter complications.

The inferior vena cava is a vein that returns blood to the heart from the lower parts of the body. In some cases, thrombi, or blood clots, travel from vessels in the legs and pelvis through the vena cava into the lungs.

In a condition called “deep vein thrombosis,” thrombi can develop in deep leg veins. If thrombi reach the lungs, they are considered “pulmonary emboli.” IVC filters, like the Cook IVC filter, are retrievable filters that are used to prevent “thromboembolic events.”

Cook Medical designed a line of inferior vena cava filters that come under attack in the litigation. They include the following models of filters:

• Günther Tulip Vena Cava Filter
• Cook Celect Vena Cava Filter
• Gunther Tulip Myere
• Cook Celect Platinum

The multi-district litigation describes Cook’s “tulip” design as follows:

“The Gunther Tulip Vena Cava Filter has a top hook and (4) anchoring hooks for fixation and on each strut, it has a “flower” formation that is shorter than the strut where a wire piece branches out on each side of the strut forming an overall “flower” type formation on each strut.” Allegedly, Cook Medical Inc. advertised the filter to be a “safe and effective treatment for prevention of recurrent pulmonary embolism via placement in the vena cava.”

According to the multidistrict litigation, inferior vena cava filter complications resulted from the design of the filter. Allegedly, the filter was unable to withstand normal anatomical and physiological pressures. As a result, the filter was ineffective, plaintiffs claim.

Additionally, the multidistrict legislation argues that the design of the filter made it unreasonably hard to retrieve during surgical procedures, though the filter was theoretically designed and marketed to be retrievable.

The Cook IVC Filter multi-district legislation alleges that the inferior vena cava filter complications that resulted from the filter’s defective design were quite severe — patients had experienced severe injury and death. Inferior vena cava complications may include “tilting, perforation, fracture, breakage, and migration” of the filter took place while it is inside a patient’s body.

According to the Cook Defective IVC Filter multi-district legislation, Cook Medical Inc. “intentionally recklessly, and/or negligently advertised, labeled, promoted, marketed, sold and/or distributed its IVC Filters as a safe medical device when in fact Cook had reason to know, and/or did know, that its IVC Filters caused serious injury and death.”

The multidistrict legislation takes issue with the FDA’s 510(k) clearance process that the device had to go through before it reached the public, noting that the device was not required to go through clinical testing before being marketed.

The Cook Medical Inferior Vena Cava Filter Complications Multidistrict Legislation is Case No. 1:14-ml-2570-RLY-TAB MDL No. 2570, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.