A new lawsuit was filed on Sept. 19, 2018, against Cook Medical Inc. by a patient claiming that an Inferior Vena Cava (IVC) device caused blood clot filter complications.

Plaintiff Dennis A. is currently a resident of the state of Arizona. His implantation with the Cook IVC device that purportedly led to blood clot filter complications took place in the state of California in 2008.

Dennis says he had a Gunther Tulip Vena Cava Filter implanted on Sept. 12, 2008, in the City of San Jose at Santa Clara Medical Center. The procedure was undertaken and completed by Dr. Stan Zipser.

The plaintiff’s complaint regarding the medical device joins other similar Cook lawsuits for blood clot filter complications under multidistrict litigation (MDL) No. 2570.

Dennis is bringing several causes of action against the IVC manufacturer and distributor from the master long-form complaint. These include Strict Product Liability (SPL)—Failure to Warn, SPL—Design Defect, Negligence, Negligence Per Se, Breach of Express Warranty, Breach of Implied Warranty, Violations of Applicable State Consumer Protection Laws for Arizona, California, and Oregon, and Punitive Damages.

Dennis is seeking, along with the plaintiffs of other cases, a trial by jury with a favorable decision on his behalf that includes compensation for the pain and suffering caused by the blood clot filter complications, loss of wages and earning power, medical expenses past, present, and future, and all attorney and court fees. The plaintiff is also requesting that punitive damages be assessed against the company.

What is an IVC Filter?

An IVC filter like the Gunther Tulip is placed in the major vein which runs parallel to the abdominal aorta and returns deoxygenated blood to the heart. The Gunther Tulip IVC filter has four struts to stabilize it in the vein and a flower formation which surrounds each of them. The device also has a top hook.

This group of devices is used to filter blood clots created in the lower extremities that could cause a condition known as Deep Vein Thrombosis (DVT). DVT clots can move systemically throughout the circulatory system and cause Pulmonary Embolism (PE). PE can be the instrument of respiratory arrest, cardiac arrest, and stroke.

While IVC filters used to be permanently implanted devices, the desire to expand and corner the market drove companies like Cook to create what was supposed to be a removable line of filters for those that had short-term risk of developing clot problems.

Cook IVC filters were pushed through the approval process with the U.S. Food and Drug Administration (FDA) via Section 510(k) of the Medical Device Amendments. The 510(k) review allows for newer devices to piggyback on similar devices on the market and bypass lengthy safety studies.

These devices were later found to be difficult to remove and allegedly caused blood clot filter complications such as perforation of the vena cava wall, migration within the system interfering with circulation, and other problems.

The Blood Clot Filter Complications Lawsuit is Case No. 1:18-cv-02881-TWP-DLP in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.