A defective IVC filter is to blame for injuries suffered by a man who filed suit against Cook Medical in July.
A Gunther Tulip IVC filter was implanted in the plaintiff on Dec. 26, 2005. The tiny cage-like device was intended to trap blood clots before they went up to the heart or lungs, where they would become potentially deadly pulmonary embolisms.
However, the lawsuit claims the small struts on the device can break away and migrate to other parts of the body, causing injury. The filter also has a tendency to tilt, posing the possibility of a strut perforating the wall of the vena cava.
The plaintiff says problems with the defective IVC filter were known to Cook, which continued to promote the device as safe and effective. The filter allegedly is not strong enough to withstand the normal force and pressure of blood pumping through the vena cava.
Cook claimed the conichrome material made the IVC filter’s frame less at risk of fracture. A 2012 look at 50 patients who had received the Cook Guther Tulip or Cook Celect IVC filters between 2007 and 2009 showed that after 71 days, all of the filters had perforated the vena cava wall to some degree. In most cases, the analysis indicated the perforation would worsen.
The possibility of filter fracture, tilt or migration is further complicated when the device becomes impossible to remove because tissue growth has anchored the filter or a piece of it.
Although some IVC filters were designed to be temporary and others to be permanent, the FDA recommended all IVC filters be removed after the threat of a blood clot had passed and within 54 days of implantation if possible.
The plaintiff could be forced to undergo medical treatment because of the defective IVC filter. He might continue to need medical monitoring such as regularly scheduled CT scans or other imaging studies. His future monitoring could include cardiac catheterization or similar procedures to detect possibly migrated pieces of the filter.
In some cases, open heart surgery is necessary to determine where the fractured pieces of the device have traveled.
Defective IVC Filter Puts Patients at Risk
Patients who cannot tolerate anticoagulant medication, commonly known as blood thinners, are candidates for an IVC filter to prevent blood clots. When an IVC filter is implanted in the inferior vena cava vein, the tiny cage is supposed to stop blood clots from traveling from the lower extremities to the heart or lungs.
While the idea behind the IVC filter sounds logical, the defective IVC filter can be more of a danger than a solution. In at least one case, a blood clot forcefully made its way through a woman’s system, pushing the filter along until it punctured her heart.
The FDA received 921 adverse event reports regarding defective IVC filters between 2005 and 2010. Among the complaints:
- 56 filters fractured
- 70 filters perforated the vena cava wall
- 146 devices had parts break away inside the body
- 328 reports of devices migrating to other parts of the body
If you or someone you love has been injured by a defective IVC filter, you could be eligible for compensation through legal representation. Contact the attorneys at McDonald Worley today for a FREE case evaluation.