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As the U.S. Judicial Panel on Multidistrict Litigation (JPML) prepares to hear oral arguments later this week about whether to centralize all IVC filter lawsuits filed against C.R. Bard, the latest reports indicate that more than 100 similar complaints have already been brought against Cook Medical over problems with their competing products.
Inferior vena cava (IVC) filters are small devices implanted in patients at risk for a pulmonary embolism. The spider-like filters are designed to “catch” blood clots that may break free from in the deep veins, preventing the clot from traveling to the lungs. However, a growing number of lawsuits continue to be filed by individuals have have experienced complications from IVC filters manufactured by both Cook Medical and Bard.
At a hearing on Thursday, the U.S. JPML will consider a motion that seeks to consolidate the Bard IVC filter litigation before one judge.
Known as an MDL, or multidistrict litigation, the process is designed to reduce duplicative discovery into common issues raised by a large number of plaintiffs, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the courts.
Since October 2014, all lawsuits over Cook IVC filters have been centralized as part of an MDL, before U.S. District Judge Richard L. Young in the Southern District of Indiana.
At the time an MDL was established for the Cook IVC filter litigation, there were at least 32 complaints pending over the companies products. However, according to the latest update (PDF) released by the U.S. JPML on July 15, there are already at least 102 cases pending before Judge Young.
On July 30, the panel of federal judges will consider whether to transfer all Bard Recovery IVC filter lawsuits and Bard G2 IVC filter lawsuits to one judge for coordinated discovery and pretrial proceedings.
While Bard has opposed the creation of an MDL for their products, plaintiffs argue that the number of cases is expected to continue to increase in the coming months and years, with some suggesting that there may ultimately be several thousand cases involved in the IVC filter litigation.
Concerns Over IVC Filter Problems
All of the complaints brought against Bard and Cook involve similar allegations, indicating that retrievable IVC filters fractured, broke or moved out of place, often puncturing the vena cava and causing other internal injuries.
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.
As part of any coordinated pretrial proceedings, it is expected that a small group of cases will be prepared for early trial dates. Known as “bellwether” cases, the outcomes are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation, potentially promoting IVC filter settlements for individuals who have experienced problems.