Motion Filed to Centralize Bard IVC Filter Lawsuits in Federal MDL
With a large number of product liability lawsuits likely to be filed over complications with Bard inferior venous cava (IVC) filters, a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation to centralize all federal cases before one judge for coordinated proceedings.
IVC filters are small devices that are implanted into the inferior vena cava to “catch” blood clots that may break free inside the deep veins of the body and travel toward the lungs, preventing a pulmonary embolism.
The spider-like filters contain several legs, or struts, that expand inside the vein. However, the Bard Recovery filter, and a second-generation version known as the Bard G2 IVC filter, have been linked to a large number of problems where the filters failed and the legs either broke off or allowed the filter to move other parts of the body, piercing the inferior vena cava or other vital organs.
According to a motion (PDF) filed by a group of plaintiffs on May 18, C.R. Bard currently faces at least 25 lawsuits pending in 23 different U.S. District Courts, and hundreds of additional complaints are likely to be filed in the coming weeks or months.
All of the lawsuits involve similar allegations that Bard IVC filters are defective and that the manufacturer failed to adequately warn the medical community and patients about the risks associated with having one of the devices implanted.
“Defendants knew or should have known that their IVC filters were likely to fracture, tilt, perforate the vena cava wall and/or migrate, and thus cause injury,” the petition states. “Despite their knowledge, Defendants failed to disclose to physicians, patients or to the Plaintiffs that their IVC filters were subject to fracture, tilt, perforation and migration. Defendants then continued to promote their IVC filters as safe and effective, despite the absence of adequate clinical trials to support long or short term efficacy and even after studies have shown them to lack such efficacy.”
Although some of the cases have been pending for several years, only a handful of settlements have been reached by Bard in individual lawsuits scheduled for trial. The motion indicates that the manufacturer has refused to enter into meaningful negotiations to resolve large numbers of claims and that plaintiffs’ counsel collectively has more than 200 other cases ready to move forward.
The plaintiffs seek to have the Bard IVC filter cases centralized as part of a multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Texas, before U.S. District Judge James E. Kinkeade, or, alternately, under U.S. District Judge Robert C. Jones in the District of Nevada. Plaintiffs argue that centralization would prevent duplicate discovery, avoid conflicting rulings and serve the convenience of the court, witnesses and both parties.
In October 2014, the U.S. JPML granted a similar request to centralize all Cook Celect and Gunther Tulip filter lawsuits, which raised nearly identical allegations over another brand of IVC filter. The Cook IVC filter MDL was centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.
IVC Filter Complications
Concerns over the safety and effectiveness of removable IVC filters have been a subject of much debate within the medical community in recent years, with several different types of filters manufactured by C.R. Bard, Cook and other companies linked to reports of severe and sometimes fatal complications.
In August 2010, the FDA issued an alert about the risk of problems with removable IVC filters, indicating that the agency had received more than 900 adverse event reports. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.
The FDA recommended that doctors remove the filters once the danger of the clot has passed, to reduce the risk of the filters breaking free and traveling through the body.
In April 2012, a study published in the medical journal Cardiovascular Interventional Radiology indicated that nearly 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.
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.
Over the past three years, Bard has reportedly reached confidential settlements in individual cases, often as trial was about to begin or underway. Plaintiffs’ attorneys indicate that additional cases will be pursued through the court system, since no progress has been made to reach a large Bard IVC filter settlement.
“There is little reason to believe that the strategy of picking off the cases one by one on the eve of trial will ever change given that the Bard Defendants have refused to enter into any meaningful global settlement discussions,” according to the motion seeking an MDL. “Though bellwether trials [through an MDL] may not be the answer to resolution of the IVC filter litigation, less than five percent of cases, filed and unfiled together, have been resolved over the several years of this current litigation.”
Bard is expected to file a response to the MDL petition by June 9, and the U.S. JPML is likely to hear oral arguments on the motion at an upcoming hearing session in San Francisco, California that is scheduled for July 30.