Baltimore, MDIt’s ironic in a way that the inferior vena cava filter has the word “inferior” in its name, given the rash of lawsuits that have been forthcoming when plaintiffs find their IVC filter to have failed and caused in some cases grievous health issues when the device has either failed, or migrated away from its initial point of placement.
The inferior vena cava filter, or IVC filter, can be likened to a catcher’s mitt in an artery designed to snag blot clots before they find their way to the lung and cause what could potentially become a fatal pulmonary embolism. The IVC filter is fed through an artery and deployed with spider-like legs designed to both snag a blood clot and hold the IVC filter in place at the intended insertion point.
However, many an IVC filter lawsuit has alleged the device has migrated away from the insertion point, traveling dangerously close to or even impacting the heart. There have also been allegations the device has pierced arterial walls.
One of the most recent IVC filter lawsuits was filed pro se by plaintiff Monica Jeffries earlier this month in the US District Court for the Southern District of Maryland. In her lawsuit, Jeffries alleges that the IVC filter she received sometime prior to 2004 migrated away from the original point of insertion and perforated her vena cava. Jeffries claims to have suffered a myriad of health issues, including severe pain, weight loss, shortness of breath, asthma and confusion stemming, it is alleged, from the IVC filter.
Her inferior vena cava lawsuit is against Boston Scientific, the manufacturer of the Greenfield IVC filter - but there are other manufacturers and other lawsuits, including actions against the Bard G2 IVC filter and others.
“Despite having knowledge as early as 2004 of the unreasonably dangerous and defective nature of the product, the defendants consciously disregarded the known risks and continued to actively market and offer for sale the Greenfield filters,” the lawsuit states.
A growing issue is with the newer generation of filters that are designed to ward against the passage of blood clots as a hedge against pulmonary embolism for a finite period of time, then retrieved when the danger has passed. For its part, the US Food and Drug Administration (FDA) has issued two alerts over the problematic retrievable filters, the first in 2010 following the receipt of some 900 adverse event reports in its reporting database. A further warning was issued a little under four years later, at which point the FDA began urging doctors to remove retrievable IVC filters within one to two months once the danger for a pulmonary embolism had passed.
As in all things with the FDA, the risks associated by the IVC filters are outweighed by the benefits to the patient in the prevention of pulmonary embolism. That benefit/risk profile shifts once the danger has passed, with the FDA advising surgeons to remove the potentially problematic filters as soon as conceivably possible.
IVC filter lawsuits against Cook Medical have been consolidated for pretrial proceedings before US District Judge Richard L. Young in the Southern District of Indiana, since October of last year. Similar actions against C.R. Bard have been gathered before US District Judge David G. Campbell in the District of Arizona.
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