Cook IVC (inferior vena cava) filters have been under fire lately because of a potential increased risk of vein perforation, device fracture, and migration of pieces to other parts of the body—all instances that can cause life-threatening conditions.
In response to an increasing number of Cook IVC filter lawsuits, the United States Judicial Panel on Multidistrict Litigation (JPML) brought all federally filed cases together in the Southern District of Indiana in October 2014 for pre-trial proceedings. Since that time, both parties have been working toward choosing a select few cases that will proceed as “bellwether” trials. These cases are intended to gauge juries’ responses to the evidence, and to potentially open the door to negotiation on future settlements.
There is some disagreement as to how the cases should proceed, however. In a recent motion submitted to the court on August 24, 2015, the defendants requested the litigation be split into two stages: the first to address liability and compensatory damages, and the second to address punitive damages, “if necessary.”
Cook Requests Court Bifurcate Punitive Damages
Punitive damages are designed to punish a defendant for wrong behavior. Many of the plaintiffs involved in the Cook MDL seek punitive damages against the company.
In their motion, Cook requested that these damages be separated from the others, to “allow the parties and the jury to focus on 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.”
Cook also requests that the court separate punitive damages during the discovery phase, to promote efficiency and avoid unnecessary prejudice against the defendants.
It’s unclear at this point how the court will respond.
Cook Filters Linked with High Rate of Perforation
Plaintiffs who bring lawsuits against Cook typically have suffered from side effects caused by the filters. The Cook Gunther Tulip and Celect filters are at issue in this litigation. These are both small, cage-like devices that are implanted into the inferior vena cava—the main vein ushering blood from the lower legs back to the heart. Once implanted, the devices are designed to “catch” blood clots before they can travel into the lungs, where they may cause pulmonary embolism (a blood clot in the lungs).
Studies have indicated that these filters have a high rate of strut perforation, however, which means that one or more of the “legs” or struts on the device breaks off and perforates the vein. Some may migrate to other areas of the body, such as the heart, where they can cause more damage.
In a recent 2015 study, for example, researchers compared Cook Celect with Option filters, and found that the Celect had a significantly higher rate of strut perforation.
FDA Warns of Cook Filter Side Effects
Amidst growing concern over IVC filters, the FDA released a safety communication in 2010, warning physicians about the risks of device migration, perforation, and fracture. At the time, they had received 921 reports of such problems related to the filters.
In 2014, the FDA released an updated communication, advising physicians to remove these filters within 29 to 54 days after implantation, as long as the risk for PE had passed.
