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With a mounting number of IVC filter lawsuits being filed by individuals throughout the U.S., Cook Medical is calling for the litigation over their products to be split into two phases, with compensatory and punitive damages bifurcated.
Since October 2014, all Cook Celect and Cook Gunther Tulip IVC filter lawsuits have been consolidated in the federal court system as part of an MDL, or multidistrict litigation.
The cases are centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana for coordinated discovery and a series of “bellwether” trials designed to gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout several hundred lawsuits.
In a motion (PDF) filed on August 24, Cook Medical asked Judge Young to bifurcate the issue of punitive damages at trial and during discovery, separating the issue of whether damages should be awarded that are designed to punish the company for it’s behavior in manufacturing and marketing the IVC filters, delaying such questions until after a determination is made about any compensatory damages, which are designed to compensate individuals for injuries they may have suffered.
“Cook Defendants respectfully submit that bifurcating punitive damages in this manner at trial will allow the Parties and the jury to focus on the pertinent issues of liability and compensatory damages without being improperly influenced by evidence concerning Cook Defendants’ revenues, product margins, net worth, employee pay, or other potentially inflammatory financial information, which would be relevant only to calculating a monetary award of punitive damages,” argued the medical device manufacturer in the motion.
The request also calls for Judge Young to prevent the plaintiffs from obtaining discovery that is only relevant to the issue of punitive damages until it has been established that the issue will likely be presented at trial, arguing that Cook Medical is a privately held company and the order would prevent the “intrusive (and likely unnecessary) disclosure of extremely sensitive, non-public information.”
IVC Filter Litigation
IVC filters are implanted into the inferior vena cava for individuals at risk for a pulmonary embolism. The devices are designed to “catch” blood clots that may break free elsewhere in the body. However, a number of individuals have suffered severe and debilitating IVC filter complications.
All of the lawsuits over Cook IVC filters raise similar allegations, claiming that the retrievable device was defectively designed and posed an unreasonable risk of failing once it is implanted. In addition, plaintiffs allege that the manufacturer failed to adequately warn about the importance of removing the IVC filter once the risk of a blood clot has passed.
Similar claims have been raised in Bard G2 IVC filter lawsuits and Bard Recovery IVC filter lawsuits, which are centralized as part of a separate MDL in the federal court system, before U.S. District Judge David G. Campbell in the District of Arizona.
In August 2010, the FDA issued a warning about the risk of IVC filter problems, indicating that the agency had received hundreds of adverse event reports where filters broke free and travelled to other areas of the body or caused other injury.
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.
As part of the coordinated pretrial litigation for cases against both Cook and Bard, it is expected that a series of early trial dates will be scheduled to help the parties gauge how juries will respond to certain evidence and testimony over the long-term risks associated with the IVC filters.
While the outcomes of these test trials will not be binding on other cases, it may facilitate IVC filter settlement negotiations to avoid the need for hundreds of individual trials to be held throughout the U.S.