C.R. Bard and Cook Medical are now named defendants in more than 4,500 product liability lawsuits involving their retrievable IVC (inferior vena cave) filters.
According to an update provided by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on July 17hth, at least 2,432 IVC lawsuits have been filed against Cook Medical over patient injuries allegedly associated with its Gunther Tulip and Celect blood clot filters. Those cases have been centralized in a multidistrict litigation underway in U.S. District Court, Southern District of Indiana.
C.R. Bard’s Recovery, G2, Meridian, and Denali IVC filter lines are the subject of 2,213 injury claims, all of which have been consolidated in the U.S. District Court, District of Arizona.
IVC filters are placed in the body’s largest blood vessel in order to block blood clots from reaching the heart and lungs. The small, cage-like devices are intended to treat people at risk for pulmonary embolism who cannot take standard blood-thinning medications.
The blood clot filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism. However, a 2013 case study published in JAMA Internal Medicine found that only 8.5% of retrievable IVC filters were removed successfully.
Plaintiffs who have filed IVC filter lawsuits against Cook Medical and C.R. Bard allege that the companies’ devices are prone to fracture, migration and other problems that can result in life-threatening complications. They also claim that the defendants failed to properly warn doctors about the importance of IVC filter retrieval.
In 2010, the U.S. Food & Drug Administration (FDA) disclosed that it had received more than 900 adverse event reports related to retrievable blood clot filters, including incidents of migration, embolization, perforation of the inferior vena cava, and IVC filter fracture. Four years later, the agency issued a second alert urging doctors to remove temporary blood clot filters within 29 to 54 days of their implantation in order to reduce the risk of patient harm.
“For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided,” the agency said. “The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”