Device maker Cook Medical has reportedly reached agreements in trial process involving several hundred lawsuits filed against Cook Medical over the use of their IVC (inferior vena cava) blood clot filters.
In late May, a bellwether trial process was announced and several cases are expected to be chosen for trial expected begin in September 2016. The cases are part of a multidistrict litigation (MDL) in the Southern District of Indiana, comprised of about 400 lawsuits, Digital Journal reports.
A bellwether program has also been set up for cases against C.R. Bard, though the selection of bellwether cases in the Bard litigation is not expected to be completed until 2017. The Bard cases have been centralized in the District of Arizona.
The bellwether trial process allows a small number of representative cases to go to trial to give the parties an idea of how juries will react to their evidence and arguments. The outcome of the bellwether cases can influence how the remaining cases are handled, either through additional individual trials or through a settlement.
IVC filters implanted in the body’s largest vein to prevent blood clots from traveling from the lower body to the heart or lungs, where they can be dangerous. IVC filters are used for patients who are unable to take blood-thinning drugs or for whom the drugs do not work well enough.
The cases against Cook and Bard arise from allegations that the IVC blood-clot filters the companies manufactured are defective and dangerous. Legal documents in the cases indicate that many plaintiffs are arguing that the filters caused serious and sometimes life-threatening side effects about which they were not adequately warned.
Among the dangers reported in the lawsuits: IVC filters move from the original implantation site and have lodged in another area of the body; some filters tilt and do not effectively trap clots; parts of the filter can break off and either become embedded in the vein or an organ or a clot forms around the fragment. Filters that move or become lodged in another spot may be difficult or impossible to remove, leaving the patient at risk for further injury. IVC filter patients have experienced severe pain, bleeding, further clots, and other life-threatening complications.
In a yearlong investigation of IVC filters, NBC News learned that reports of injuries and deaths began soon after Bard’s Recovery filter came to market in 2002. Bard, however, did not recall the Recovery and the filter remained on the market until 2005, when it was replaced with the similar G2 filter series. But according to Bard’s own records and hundreds of reports to the FDA, the G2 filter series did not solve the problems. G2 filters stayed on the market until 2010.
Some IVC filters are intended to be permanent, but most are temporary and should be removed when the patient is no longer at risk for blood clots. The Food and Drug Administration (FDA) recently recommended that it is best to retrieve IVC filters between 29 and 54 days after implantation to avoid the risk of the device breaking or migrating elsewhere within the body.