We are pleased with today’s decision of the Judicial Panel on Multi-District Litigation with regard to MDL No. 2385 styled In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation. The Judicial Panel, a group of federal judges who oversee multi-district litigation (also known as MDLs), held a hearing on Thursday, July 26, 2012, in Cleveland. At that hearing, the Panel heard arguments from mass tort lawyers around the country seeking coordination of the Pradaxa lawsuits pending in the federal court system before various judges in Illinois, Cleveland, South Florida, or Boehringer’s home state of Connecticut. The Searcy Denney firm advocated for consolidation of the Pradaxa cases before Judge Herndon in East St. Louis, Illinois (just outside of St Louis), where the firm has filed one of the first Pradaxa cases in the country.
The Judicial Panel agreed that Judge Herndon was best suited to oversee MDL No. 2385 and ordered that the first 21 individual lawsuits filed in federal courts in Connecticut, Florida, Kentucky, Illinois, Kentucky, Louisiana, Oklahoma, and Tennessee be transferred to Judge Herndon for pre-trial consolidation. The JPML’s order indicates that there have been an additional 19 lawsuits filed against the manufacturers of Pradaxa that are potential tag-along cases from New York, Georgia, and Ohio that will also ultimately be transferred to Judge Herndon for supervision along with new lawsuits that are filed in the federal system in the coming months.
This JPML ruling is a very positive development for plaintiffs who have suffered injuries or died following their ingestion of Pradaxa, as Judge Herndon has already issued a number of key rulings that will help to expedite the litigation effort. Judge Herndon held a status conference in mid-July which was attended by Brenda Fulmer of Searcy Denney as well as other plaintiff and defense lawyers who represent the parties in the dozen individual Pradaxa lawsuits then pending in the Southern District of Illinois. At that hearing, Judge Herndon provided guidance and subsequently entered orders on a number of critical issues, including preservation of evidence, formatting of electronic documents for production, confidentiality of certain produced documents (such as trade secrets), and rulings regarding proper defendants in the lawsuit. Judge Herndon has also ruled in favor of the plaintiffs in denying a series of motions to dismiss filed by Boehringer Ingelheim and related entities regarding the sufficiency of the complaints filed by the plaintiffs in the first 8 cases filed in the Southern District of Illinois. Clearing this first procedural hurdle is important and will permit the plaintiffs to move quickly towards the scheduling of a trial date for the initial bellwether trials in the MDL. Judge Herndon ordered that the defendants produce the first round of document discovery in late August, including the new drug application filed with the FDA and adverse event reports filed by patients, physicians, and the manufacturer over injuries suffered by patients that were likely caused by ingestion of Pradaxa.
It is estimated that approximately 275,000 prescriptions were written for Pradaxa from the time that the drug was approved by the FDA in October of 2010 through March of 2011. Sales of Pradaxa appear to have decreased somewhat in late 2011 and early 2012 after numerous reports of adverse events associated with the drug. An unprecedented number of adverse event reports have been filed with the FDA and drug safety regulators in foreign countries over the past two years, including hundreds of patient deaths due to Pradaxa initiating gastrointestinal bleeding, intracranial hemorrhage, and other bleeding episodes in patients, especially elderly patients with chronic renal insufficiency who are unable to properly clear Pradaxa from their bodies which can cause the drug to quickly build up to toxic levels. There have also been a number of Pradaxa patient deaths and severe injuries attributed to the fact that the drug does not have a reversal agent to undo the anti-clotting effects in case of trauma or the need for emergency surgery. The anti-clotting effects of Coumadin, the primary competing drug for Pradaxa, can easily be reversed in patients.