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A panel of federal judges are set to consider whether all Cook IVC filter lawsuits filed in U.S. District Courts throughout the country should be centralized before one judge for coordinated pretrial proceedings, as part of an MDL, or Multidistrict Litigation.
In response to a motion filed by some plaintiffs in July, seeking to establish an MDL for all lawsuits over Cook Celect and Gunther Tulip IVC filters, the U.S. Judicial Panel on Multidistrict Litigation will hear oral arguments tomorrow at a hearing in Louisville, Kentucky.
At the time the request to centralize the cases was filed, Cook Medical faced at least 27 different IVC filter lawsuits that were pending in 11 different districts. Plaintiffs requested that the litigation be transferred to the U.S. District Court for the Southern District of Indiana to reduce duplicative discovery in the lawsuits, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
In a response (PDF) filed on August 15, Cook Medical opposed the transfer, suggesting that because the lawsuits involve different device failures with various Cook vena cava filter products, consolidating the cases as part of one MDL was not appropriate.
The company maintains that the Gunther Tulip and Celect IVC filters are two different devices that should be handled as separate entities. The brief points out that there are 14 different variations on the market and notes that the 27 cases involve at least seven different IVC filters.
According to the manufacturer, informal coordination between the districts could achieve the same goals as an MDL. However, should the U.S. JPML decide to establish the centralized proceedings, Cook Medical indicates that it consents to the selection of the Southern District of Indiana as the most appropriate district.
Cook IVC Filter Complications
All of the complaints involve similar allegations that plaintiffs suffered various injuries as a result of complications with Cook IVC filters, including perforation of the vena cava, filter tilt or issues where the filters fractured or broke, allowing small pieces to travel to the heart or lungs.
IVC filters, or inferior vena cava filters, are spider-like devices that are implanted into the vena cava to “catch” blood clots that may break off and travel to the lungs, causing a pulmonary embolism. The devices are commonly used when anticoagulant therapy is contraindicated or has not been effective.
According to allegations raised by plaintiffs in the lawsuits over the Cook IVC filters, a study was published in the medical journal Cardiovascular Interventional Radiology in April 2012, which found that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.
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.
A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.
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.
In addition to lawsuits against Cook Medical, similar claims have been filed against C.R. Bard in recent years involving problems with their Bard Recovery IVC Filter and Bard G2 IVC Filters. According to allegations raised in the complaints, Bard knew for years that their IVC filters were prone to fracture, which can cause severe complications, including death, but failed to warn doctors and patients.