With bellwether trials set to begin in October, the federal court overseeing hundreds of IVC filter lawsuits filed against Cook Medical, Inc. appears to be exploring ways to resolve the massive litigation. According to an Order issued by the U.S. District Court, Southern District of Indiana on March 7th, a series of conferences will be convened over the summer to address a possible settlement.
Court documents indicate that 1,597 lawsuits are pending in the Southern District of Indiana, all of which were filed on behalf of individuals who suffered serious complications allegedly due to malfunction of Cook Medical’s Celect and Gunther Tulip inferior vena cava (IVC) filter. The proceeding’s first trial is scheduled to begin on October 2, 2017. As a bellwether trial, its outcome is expected to provide some insight into how juries might rule in similar IVC filter lawsuits involving Cook Medical’s devices.
The March 7th Order schedules a total of three settlement conferences:
“The Magistrate Judge will keep in strict confidence the confidential settlement information relayed by the parties and their counsel,” the Order states. “In order for these settlement discussions to be meaningful, counsel for the parties and their counsel must realistically assess their settlement positions and litigations risks, and work with the Magistrate Judge in good faith to determine whether a settlement can be achieved. Unrealistic assessments, including posturing, will be of no value and should be avoided.”
The Order noted that additional settlement conferences may be scheduled as the Court deems appropriate.
Cook Medical’s Celect and Gunther Tulip IVC filters are used to prevent pulmonary embolism in patients at risk for blood clots, but for whom standard anticoagulant therapy is inappropriate. The small, wire devices are implanted in the inferior vena cava to intercept clots before they can travel to the heart and lungs. Both the Celect and Gunther Tulip devices are retrievable, and are designed to be removed once a patient is no longer at risk or blood clots.
Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. The first was issued in August 2010, and disclosed that the agency’s medical device database had logged hundreds of adverse event 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 reminded doctors to remove IVC filters as soon a patient no longer requires protection from pulmonary embolism.
“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 alert stated. “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.”