Inferior vena cava filters, more commonly known as IVC filters, are small and wiry implantable medical devices used to prevent blood clots, strokes, pulmonary embolisms, and deep vein thrombosis in patients at risk for dangerous thrombotic events, but for whom anticoagulant drugs have not worked.
When used in the appropriate situations and promptly retrieved, IVC filters can save lives. However, when left in place too long, IVC filters can become just as hazardous as the conditions they're used to prevent. After learning this the hard way, one South Carolina man has filed a lawsuit against his IVC filter's manufacturer.
IVC Filter Lawsuit Filed by Ronald D.
According to the lawsuit filed in March 2017 in the Philadelphia Court of Common Pleas, the plaintiff, Ronald D., was implanted with Argon Medical's Option ELITE® retrievable IVC filter in April 2015 at University Hospital in Augusta, Georgia.
One year later, in April 2016, Ronald returned to the same hospital to undergo an IVC filter retrieval procedure performed by the same doctor who implanted the device. However, when the doctor went to remove the IVC filter, he found it tilted to a 45-degree angle, with its retrieval hook deeply embedded into the wall of the inferior vena cava vein.
Despite extensive efforts to remove the embedded device, the doctor was forced to end the retrieval procedure with the IVC filter still in place.
Two months later, in June 2016, Ronald underwent a second retrieval procedure, this time performed by a different doctor. While this doctor was able to dislodge and remove the embedded IVC filter, the wall of the inferior vena cava sustained significant damage, putting Ronald at risk for serious internal bleeding and even death.
FDA Guidelines for IVC Filter Retrieval
The U.S. Food and Drug Administration (FDA) has received numerous reports of adverse events related to temporary IVC filters like the one Ronald's doctor implanted. In an effort to mitigate these poor health outcomes, the FDA issued a safety alert in 2010, warning that IVC filter complications steadily increase the longer the device remains in the body.
In 2014, the FDA issued a second safety alert, this time citing research that showed removing IVC filters between 29 and 54 days after implantation significantly reduced the risk of injuries and complications. When IVC filters are left in the body longer than 54 days, the risks of infection and vein or organ damage begin to outweigh the device's blood clot-dissipating benefits, according to the FDA.
In Ronald's case, the retrievable IVC filter was left in place for 358 days—far longer than the FDA recommends. Surprisingly, this isn't unusual. According to the Cleveland Clinic, the majority of retrievable IVC filters implanted in patients are never removed. Retrieval rates are as low as 20 percent.
FDA Approval Process for IVC Filters
Unlike most medical devices, the IVC filter used by Ronald's doctor—the Option ELITE—was not subjected to clinical trials before entering the U.S. market. The FDA granted the device's manufacturer, Argon Medical, fast-tracked approval through the 510(k) process, which allows new drugs or devices to bypass clinical trials as long as they're substantially similar to a drug or device that's already improved. In this case, the Option ELITE was similar to the original Option®, which was similar to various Bard and Cook Medical IVC filter devices.
Despite the similarities between the retrievable IVC filters on the market, once problems were discovered with some of the devices, other manufacturers don't appear to have taken any steps to mitigate such problems with their own devices, calling into question the effectiveness of the 510(k) fast-track approval process.
Are You Considering an IVC Filter Lawsuit?
Have you or someone you love suffer serious complications or health problems due to an IVC filter left in place too long? If so, McGartland Law's experienced legal team can help you pursue compensation from your device's manufacturer. Contact us today for a free, no-obligation case consultation.