Plaintiffs who have filed either a Gunther Tulip or Cook Celect IVC filter lawsuit across the U.S. have requested that the cases be centralized as part of a Multidistrict Litigation (MDL). The application brought before the U.S. Judicial Panel on Multidistrict Litigation by the plaintiffs requests that the lawsuits be transferred as a MDL to the U.S. District Court for the Southern District of Indiana.

While the defendant, Cook Medical, initially disputed the MDL transfer due to nature of the IVC filter lawsuits all claiming various device defects, they did agree that the the Southern District of Indiana was a proper choice of venue.

There are 27 individual Cook Medical IVC filter lawsuits currently pending in 11 different districts.

What is an IVC Filter?

When an anticoagulant medication cannot be used to treat a patient for blood clots, one option is to have an inferior vena cava (IVC) filter implanted into the main vein in order to capture the clots and stop them from traveling to the heart or lungs. An IVC filter is a small, cage-like device that is placed into the vena cava in order to trap blood clots and keep them there until the body can dissolve them.

Blood clots pose serious health risks to patients if they are not treated. Blood clots that occur in the legs are referred to as deep vein thrombosis (DVT) and if the clots move from the legs to the heart or lungs it can cause life-threatening conditions including heart attacks, breathing difficulties, and pulmonary embolism.

IVC filters can either be implanted for temporary or permanent blood clot treatment; however, the U.S. Food and Drug Administration warns that serious complications may occur when temporary IVC filters are not removed. 

IVC Filter Complications

While the FDA has approved IVC filters to be used for blood clot treatment, the agency cautions that there are some common IVC filter complications that could occur including:

• Filter migration
• Access site thrombosis
• IVC thrombosis
• Deep vein thrombosis (DVT)
• Caval penetration
• IVC filter fracture

The FDA allows IVC filters to be implanted for the following medical conditions:

• Anticoagulant therapy fails to work in thromboembolic diseases
• Treating pulmonary thromboembolism when blood thinners shouldn’t be used
• Recurring pulmonary embolism when anticoagulant use has failed
• Emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced

The U.S. Food and Drug Administration warned in 2010 about IVC filter perforation and injury after receiving hundreds of adverse event reports that claimed the filter broke off and traveled to other areas of the body.

By 2014, the FDA started recommending that physicians remove IVC filters between 29 and 54 days after implantation due to long term complication risks.

IVC Filter Studies

According to plaintiffs who have filed an IVC filter lawsuit, several studies indicate that there are serious design defects to the medical device. They allege that a study published in Cardiovascular Interventional Radiology discovered that 100 percent of Cook Celect and Gunther Tulip IVC filters pierced through the vein wall within 71 days.

In another study published in the Journal of the American Medical Association, researchers found that eight percent of IVC patients experienced a pulmonary embolism regardless of the medical device.

IVC Filter Lawsuits

Plaintiffs who have filed a Cook Celect or Gunther Tulip IVC filter lawsuit all allege similar injuries due to the implantation of the device. According to IVC filter lawsuits, the filter not only perforates the main vein it was placed it, but then travels to nearby organs including the liver, aorta, and bowels. There are some that claims the filters break into pieces which then travel to the heart or lungs.