A California man has joined the multi-district litigation against Cook Medical over its inferior vena cava (IVC) filter, used worldwide in the practice of endovascular cardiology.
Plaintiff Mark P. filed his IVC filter lawsuit in the Southern District of Indiana, where IVC filter lawsuits have been centralized. Cook Medical is based in Bloomington, Ind. The master IVC filter lawsuit was filed on Jan. 30, 2015.
Each year, U.S. doctors implant some 49,000 IVC filters in patients.
An IVC filter is designed to filter blood clots—known as thrombi—that travel from the lower body to the heart and lungs. IVC filters can be surgically implanted, either temporarily or permanently, within the vena cava, which are two large veins on the right side of the body that return deoxygenated blood from the body into the heart. The inferior vena cava is the body’s largest vein.
Inferior vena cava filters are an alternative for patients who would otherwise use an anticoagulant to prevent a pulmonary embolism.
In some people, blood clots travel from the legs and pelvis, through the vena cava and into the lungs. When clots develop in the deep leg veins it is a condition known as deep vein thrombosis or DVT.
Deep venous thrombosis predisposes patients to pulmonary vascular occlusion. Between 400,000 and 650,000 people in the United States develop a pulmonary embolism each year and of those, between 50,000 and 240,000 dies.
When a blood clot reaches the lungs, it’s called a pulmonary embolism or PE. An IVC filter is designed to prevent thromboembolic events, which occur when a clot breaks loose and travels through the blood stream and plugs another vessel. If the clot plugs the lungs a pulmonary embolism occurs, while if it plugs the brain the patient suffers a stroke.
According to plaintiffs in the IVC filter lawsuits, Cook marketed its IVC filters as a safe and effective treatment to prevent recurrent pulmonary embolism. But, the complaints allege, Cook knew its filters had a design defect that resulted in the device not being able to withstand “normal anatomical and physiological” cycles within the body.
Numerous reviews of Cook filters have shown that the devices were defective, according to the master complaint.
A 2012 article published in the medical journal Cardiovascular Interventional Radiology reported that 100 percent of Cook Celect filters and Gunther Tulip filters, implanted between July 2007 and May 2009, caused some degree of filter perforation of the venal caval wall after 71 days.
The same study reported that tilt was seen in 40 percent of the implanted Gunther Tulip and Celect IVC filters and all tilted filters also demonstrated vena caval perforation.
The takeaway: Cook Medical knew or should have known that their IVC filters were more likely than not to tilt and to perforate, according to the master complaint.
Despite knowing that its IVC filters were unsafe, Cook failed to warn consumers or take action about the risks and injuries associated with the devices, the master complaint alleges.
The device-maker “concealed, suppressed, omitted, and/or misrepresented the risks, dangers, defects and disadvantages” of the IVC filters, it continues, and “intentionally, recklessly, and/or negligently advertised, labeled, promoted, marketed, sold and/or distributed” them, knowing that it was unsafe and caused serious injury and death.
IVC filter lawsuit plaintiffs maintain that Cook is liable for injuries caused by the devices because they “are unreasonably dangerous and not accompanied by adequate warnings about its danger.”
Mark is seeking judicial relief for breach of express warranty and implied, violations of applicable California law prohibiting consumer fraud, unfair and deceptive trade practices as well as punitive damages.
If you or a loved one was injured by an IVC filter, you may be entitled to compensation. Contact the experienced attorneys at McDonald Worley today for a FREE case evaluation.