Cook Medical Inc. is facing a new Gunther Tulip IVC filter lawsuit alleging the company failed to warn about potentially devastating device complications associated with their product.

The Gunther Tulip IVC filter lawsuit was filed by a man from Virginia, which is joining a growing multidistrict litigation (MDL) consisting of claims alleging similar injuries.

Like other patients, plaintiff Joel R. had the Gunther Tulip IVC filter implanted to help mitigate the risk of potentially fatal blood clot complications and had no reason to believe he was at risk for any serious side effects.

He filed the Gunther Tulip IVC filter lawsuit soon after discovering Cook Medical may have known about their device’s potentially defective nature, based on previous FDA warnings.

IVC Filter Overview

IVC filters are small cage like devices that are directly implanted in the body’s inferior vena cava, which is the largest vein in the human body and a vital part of the circulation system. These devices work by trapping blood clots forming in the legs and pelvis, and preventing them from traveling to the heart and lungs.

IVC filter use ultimately prevents potentially fatal blood clot related injuries, which makes IVC filters good alternatives for patients that cannot be prescribed anticoagulant treatment. With these benefits in mind, Joel had the Gunther Tulip IVC filter implanted on Oct. 28, 2008.

Joel says he followed all care instructions from his physician. However, he and his physician were not aware of the potential long-term complications associated with the IVC filter at the time of use.

It was not until two years later, in 2010, that the FDA issued a warning regarding IVC filter complications, stating the devices were only meant for short term use and should be removed as soon as possible.

IVC Filter Complications

According to the 2010 FDA warning, the agency had received 921 injury reports of serious IVC filter complications stemming as far back as 2005. These incident reports consisted of:

• 328 reports of IVC Filter Migration
• 146 reports of IVC Filter Component Detachment
• 70 reports of IVC Filter Perforation of Inferior Vena Cava Vein
• 56 reports of IVC Filter Fracture

In this warning, the FDA stressed the importance of short term use of IVC filters, stating that the longer the IVC filter stays inside the patient’s body, the higher the likelihood of device complications.

The FDA released a later warning in May 2014, stating that an IVC filter should be removed between 29 to 54 days after the device is implanted.

If the IVC filter breaks apart and migrates away from its implant site in the patient, the device can become very difficult or impossible to remove and can severely complicate the patient’s health. Plaintiffs say Cook Medical either knew or should have known about these potential problems, but failed to warn their customers – which is a major argument in the growing Cook Medical IVC filter MDL.

According to his Gunther Tulip IVC filter lawsuit, Joel would not have agreed to have the device implanted if he had known about its high device failure rate.

Joel’s Gunther Tulip IVC filter lawsuit is joining the Cook Medical MDL No. 2570, where it will stand alongside other claims alleging similar IVC filter injuries.

The Gunther Tulip IVC Filter Lawsuit is Case No. 1:18-cv-03920-TWP-TAB, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.