Cook Medical, Inc. and C.R. Bard, Inc. continue to face mounting lawsuits over their retrievable IVC filters, with nearly 4,000 filings recorded against the companies in two separate federal litigations.
According to a report issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on May 15th, Cook Medical has been named a defendant in at least 1,918 product liability claims involving its Gunther Tulip and Celect IVC filter blood clot filters. Those cases are currently undergoing coordinated pretrial proceedings in a multidistrict litigation underway in U.S. District Court, Southern District of Indiana.
C.R. Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the subject of 1,851 injury claims, all of which have been consolidated in the U.S. District Court, District of Arizona.
IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for individuals at risk for pulmonary embolism, and who are unable to use 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.
Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
In May 2014, the FDA issued a second alert to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.
“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”
Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.