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The U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided to consolidate all IVC filter lawsuits filed against C.R. Bard, centralizing cases filed throughout the federal court system before one judge in Arizona for coordinated pretrial proceedings.
There are currently about two dozen Bard Recovery filter lawsuits and Bard G2 filter lawsuits pending in U.S. District Courts nationwide, with additional cases over problems with the inferior vena cava (IVC) filters expected to be filed in the coming months and years.
All of the complaints involve similar allegations that plaintiffs experienced complications after having the small blood clot filters implanted into the inferior vena cava. While the filters are designed to “catch” blood clots, preventing them from traveling to the lungs and causing a pulmonary embolism, they have been linked to hundreds of adverse event reports where they puncture the vena cava, tilt out of position or fracture and cause small fragments to travel to the heart or lungs.
In a transfer order (PDF) issued on August 17, the U.S. JPML determined that the similar questions of fact and law raised in the cases justify coordinated pretrial proceedings. As a result, cases pending throughout the federal court system will be transferred to U.S. District Judge David G. Gampbell, who will preside over the multidistrict litigation (MDL) proceedings.
The process is designed to reduce duplicative discovery into common issues raised in the Bard IVC filter lawsuits, avoid conflicting pretrial rulings on similar issues from different judges and to serve the convenience of the parties, witnesses and the courts.
Similar MDL proceedings have been established for all Cook Medical IVC filter lawsuits, involving problems with the Cook Celect or Gunther Tulip filters. There are currently more than 100 complaints over those products centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.
Although Bard opposed the establishment of centralized proceedings for cases involving their products, arguing that the litigation in several of the cases is already very advanced, and that IVC filter settlements have already been reached in many cases, the U.S. JPML disagreed.
“Several of the pending cases have completed discovery and some are near trial. Given the ongoing overlapping discovery disputes, we find that centralization still would promote efficiencies,” the panel determined. “While it may be that some cases are too advanced to substantially benefit from inclusion in centralized proceedings, the parties have not specifically identified any that should be excluded. The Panel has held that the transferee court is in the best position to identify claims that should be excluded from an MDL.”
Concerns Over IVC Filter Problems
All of the complaints involved in the Bard and Cook IVC Filter litigation raise similar claims, arguing that the manufacturers designed and sold retrievable devices that were unreasonably dangerous and defective.
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 promote settlement negotiations to resolve cases brought by individuals who have experienced problems.