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IVC Filter Litigation Moves Forward as Cook Medical Agree to Bellwether Trial Process

Jul 5, 2016

Cook Medical has reportedly reached an agreement over bellwether trial process with the plaintiffs in several hundred lawsuits involving Cook's IVC (inferior vena cava) blood-clot filters. IVC filters are implanted in the inferior vena cava-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.

IVC filter recipients have experienced severe pain, bleeding, further clots, and other life-threatening complications. The filters have moved from the original implantation site and have lodged in another area of the body; sometimes the filter tilts and then does not effectively trap clots; “legs” of the filter have broken off and either become embedded in the vein or an organ or a clot forms around the fragment. When the filter moves or becomes lodged in another spot it may be difficult or impossible to remove, leaving the patient at risk for further injury.

While some IVC filters are intended to be permanent, most are temporary and should be removed when the blood-clot risk has passed. 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.

In late May, Cook announced a bellwether trial process and several cases are expected to be chosen for trial expected begin in September 2016. The cases chosen will come from among about 400 cases in a multidistrict litigation (MDL) in the Southern District of Indiana, according to Digital Journal. A bellwether process has also been set up for cases against device maker C.R. Bard, though the selection of Bard bellwether cases is not expected to be completed until 2017. The Bard cases are centralized in the District of Arizona.

In the bellwether trial process, a small number of representative cases are selected to be the first cases to go to trial. The outcome of bellwether trials gives the parties insight into how juries will react to evidence and arguments that will be presented repeatedly. The outcome of the bellwether cases often influences how the remaining cases are handled, either through additional individual trials or through a settlement.

NBC News, after a lengthy investigation of IVC filters, said that reports of injuries and deaths emerged soon after Bard's Recovery filter came to market in 2002. Bard 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.

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