Joan Wiseman, a resident of California, filed a complaint in August against Cook Medical alleging the company’s retrievable IVC filter is a “defective medical device” that caused her internal injuries that could have been life-threatening.
An IVC filter is a cage-like device implanted in the inferior vena cava, the largest vein in the body. Its purpose is to catch blood clots, preventing them from reaching the heart or lungs, particularly in patients that cannot take anticoagulation medication.
Wiseman claims that the device used was defective. It was a Celect IVC filter, made by Cook, which has been under fire recently with more than 800 federal lawsuits in a Multi-District Litigation (MDL) alleging IVC filter failure resulting in injury.
According to Wiseman, the IVC filter fractured, and a broken arm of the device made its way through the right ventricle of her heart, then inflicted damage to internal organs.
The Celect filter was recently the subject of a study performed at the University of California, San Francisco, where researchers observed the “incidence, magnitude, and impact” of not retrieving the filter, a design meant to be implanted temporarily, in a timely manner.
Medical records identified 272 filters placed between July 2007 and May 2009. When 50 of those patients received a follow-up CT scan unrelated to the filter, all patients showed “some degree” of vena caval perforation after 71 days. In 40 percent of those patients, the filter was tilted, all of which had perforated the vein.
Other medical device companies that manufacture IVC filters are facing similar lawsuits, including Johnson & Johnson subsidiary Cordis, and C.R. Bard, the maker of the Recovery filter. The Recovery has been linked to 27 deaths and hundreds of non-fatal injuries.