A Pennsylvania man recently filed a new IVC filter lawsuit against manufacturer C.R. Bard. According to a report in the Daily Hornet, the case was filed in the U.S. District Court for the District of Arizona, which is the location of the current consolidated Multidistrict Litigation for Bard IVC filters. Currently, over 2,000 cases are pending in that court.
The plaintiff claims that after being implanted with a Bard G2 IVC filter, he suffered from serious side effects. He seeks in excess of $75,000 in damages.
Plaintiff Claims Bard G2 IVC Filter is Defectively Designed
According to his complaint, the plaintiff was implanted with the Bard G2 IVC filter on April 10, 2008. Doctors implanted the filter at a Pennsylvania hospital to help reduce the risk of a venous thromboembolism. This is a condition in which a blood clot forms in a vein deep in the body. These types of clots are risky, as they can travel back through the bloodstream to become trapped in the lungs, causing a pulmonary embolism (PE), heart or brain causing serious, potentially life-threating injuries.
The FDA approved the use of the Bard G2 (“second generation”) IVC filter in 2005. The manufacturer developed the device as a replacement for their Recovery Filter System, which they removed from the market that same year. The G2 was supposed to be an improvement over the Recovery Filter System, but the plaintiff notes that the two designs were strikingly similar.
Both are small, spider-like devices that are placed in the main vein that runs from the legs back up to the heart (the inferior vena cava). Once implanted, they are supposed to trap any blood clots and hold them until they dissipate so they can’t travel on to the heart and lungs and cause damage.
Yet many issues have been reported with the Recovery, including the struts (which are the legs) breaking off and migrating to other areas of the body where they can pierce organs and tissue. There are also reported incidences of the devices themselves caused blood clots. The plaintiff in this case alleges similar problems and related injuries with the G2 filter.
Studies Indicate Bard IVC Filters Could Cause Serious Injuries
Within just a couple years of being on the market, the Bard G2 IVC filter was associated with similar complications and problems as the Bard Recovery. IVC filters are so risky that many scientists have started to question their use.
In a 2010 study, for example, researchers looked at medical data from patients who received a Bard Recovery or Bard G2 IVC filter, and found that 16 out of 80 of the filters fractured after implantation, and 25 had at least one fragment cause a clot to the heart, presenting life-threatening complications.
That same year, the FDA released a safety communication warning that all IVC filters could cause serious injuries, including blood clots and organ perforation. In May 2014, they updated that communication to state that the filters should be removed as soon as the risk of pulmonary embolism had passed. They added that optimal removal time was between 29-54 days after implantation.
An investigation by NBC News revealed that Bard was concerned about the G2 filter, but continued to sell it anyway until 2010. At least 12 deaths and hundreds of complications have been linked to this series of filters.