A total of 78 Pradaxa bleeding lawsuits are now pending in the multidistrict litigation in U.S. District Court, Southern District of Illinois. According to a report from The Madison Record, U.S. District Judge David Herndon has scheduled the Pradaxa litigation’s first conference for October 3, 2012, and has expressed a desire that the Pradaxa bleeding lawsuits proceed “expeditiously.”
Pradaxa, known generically as dabigatran, was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent strokes in patients with an irregular heartbeat called non-vavular atrial fibrillation as a warfarin replacement. Both Pradaxa and warfarin can cause internal bleeding, but there are readily available antidotes for warfarin bleeding. Pradaxa lawsuits allege the drug caused serious, uncontrollable bleeding side effects, including gastrointestinal bleeding and cerebral hemorrhaging for which there is no reversal agent.
The FDA launched a review of Pradaxa this past December over reports of bleeding-related side effects, while regulators in Europe and Japan have directed Boehringer Ingelheim to strengthen warnings for the drug. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, the FDA received 3,781 adverse event reports associated with Pradaxa in 2011. These included 541 deaths, 2,367 reports of hemorrhage, 291 reports of kidney failure and 644 reports of stroke. Pradaxa was also a suspect in more than 15 cases of liver failure reported to the FDA.
All of the lawsuits pending in the Pradaxa (Dabigatran Etexilate) Products Liability Litigation (MDL 2385) allege that Boehringer Ingelheim failed to warn the public about the risk of severe and potentially life-threatening bleeding associated with Pradaxa, and specifically, the lack of an antidote. The Pradaxa multidistrict litigation was established last month by the U.S. Judicial Panel for Multidistrict Litigation (JPML). At the time, only 21 Pradaxa side effects lawsuits had been filed in federal courts around the country, the majority of them in the Southern District of Illinois before Judge Herndon. The Pradaxa claims now pending in the litigation originated in 19 federal jurisdictions, The Madison Record said.
“The Court’s initial finding that this litigation shall move expeditiously is grounded from the Court’s reading of the record as it now stands,” Judge Herndon wrote in the Pradaxa litigation’s first case management order. “It is clear that whether the number of plaintiffs remain static or increase, the allegations that have been made are quite serious.”
Judge Herndon stated in his order was his goal to start the litigation’s first Pradaxa trial within 18 to 24 months. Judge Herndon’s also directed attorneys who wish to apply for leadership positions in the litigation, including plaintiffs’ liaison counsel and plaintiffs’ lead counsel and/or a plaintiffs’ steering committee, should do so no later than September 21, 2012. He will also appoint attorneys to leadership positions for the defense, but because Boehringer Ingelheim is the only defendant, Judge Herndon has asked the drug maker to advise him which attorneys it prefers for those roles.
Judge Herndon is likely to make good on his promise of an expeditious Pradaxa litigation. He is currently presiding over thousands of lawsuits filed in the Yaz and Yasmin multidistrict litigation in the Southern District of Illinois. In choosing to transfer the Pradaxa litigation to Judge Herndon, the U.S. Judicial Panel on Multidistrict Litigation praised his handling of the Yaz and Yasmin lawsuits.