Boston, MAThe makers of retrievable IVC (inferior vena cava) filters face numerous lawsuits alleging the filters are linked to serious complications, including migration, fracture, tilting and perforation, putting patients at risk of life-threatening consequences. According to John Dalimonte, partner at the law firm of Karon & Dalimonte, LLP, the filters can perforate the wall of the vena cava, perforate adjacent organs and vessels, and a fractured filter strut can embolize to the heart, lungs, kidneys and liver.
IVC filters are implanted in patients to trap blood clots and prevent them from becoming pulmonary emboli. When they were first introduced on the market, IVC filters were permanent implants but over the last 10 years, they have been redesigned to be retrievable, meaning the physician can implant them and take them out at a later date. The first retrievable filters were introduced on the market in 2003. Among the manufacturers of IVC filters facing lawsuits are C.R. Bard, maker of the Recovery, G2 Filter and Eclipse; and Cook, which makes the Celect and the Gunther Tulip.
According to Mr. Dalimonte, “The vena cava is a dynamic vessel, and as it expands and contracts it could free up the filter, allowing it to migrate to the heart. The filter struts are prone to fracture and perforating the caval wall. The upper arm struts generally break at the filter’s cap and travel to the patient’s heart. This can kill the patient or require open heart surgery to remove the pieces.”
Dalimonte cites a study from the Journal of Vascular Interventional Radiology (February 2012) suggesting that after 5.5 years, 40 percent of patients who have a recovery filter (those that are retrievable) have experienced some sort of filter fracture. Meanwhile, retrievable filters may not have huge benefits over permanent filters. A study published in JAMA Internal Medicine (4/8/13) found that many retrievable filters are actually left implanted indefinitely. Authors of that study found that of 679 retrievable filters implanted from August 1, 2003 to February 28, 2011, at Boston Medical Center, only 58 were successfully removed, while 74 patients suffered a thrombotic event after filter placement.
According to Dalimonte, the first death linked to a retrievable C.R. Bard Recovery filter occurred on February 9, 2004. From that time until the redesigned G2 came out in September 2005, approximately 15 deaths were linked to the Recovery filter. Dalimonte says that number does not count non-fatal adverse events. An August 9, 2010 safety communication from the FDA warned that from 2005 to the time of the communication, the FDA received 921 adverse event reports involving IVC filters. Of those, 328 involved device migration, 146 involved embolization, 70 involved perforation of the IVC and 56 involved filter fracture.
“When the Bard G2 filter hit the market, it was swapped from shelves, which led doctors to believe it was an improvement to the Bard Recovery filter, but the G2 wasn’t cleared by the FDA for retrievability until January 2008,” Dalimonte says.
“By then, it was migrating toward the groin or feet, and perforating and fracturing. It had the same types of problems the Recovery filter had, but they continued to sell it through late 2010.”
Doctors reportedly use the retrievable filters on patients who might not have a risk of blood clot long term, such as those whose risk is linked to a traumatic event such as a car accident. In those patients, doctors prefer to remove implantable devices. However, on July 13, 2015, the FDA issued a warning to Bard, noting that the recovery cone marketed as being used to retrieve Recovery and G2 filters, had to be removed from operating rooms because the cones were not approved by the FDA to recover retrievable filters.
Because patients still have the filters implanted and because it can take a few years for fracture to develop, many adverse events are still occurring and lawsuits against the makers of IVC filters are still being filed. A multidistrict litigation (MDL 2641) has been set up in the C.R. Bard lawsuits in anticipation of hundreds of lawsuits being consolidated in federal court in Arizona. Meanwhile, MDL number 2570, IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation has been set up in the southern District of Indiana. That MDL has 117 lawsuits as of August 17, 2015.
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