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Swift Pace Welcomed for New Pradaxa MDL


The first hearing for the newly-created Pradaxa MDL has been scheduled for October 3, 2012, at 1:30 PM at the United States Courthouse in East St. Louis, Illinois.  On August 8, 2012, the Judicial Panel on Multi-District Litigation (JPML) granted the plaintiffs’ request for establishment of an MDL and assigned all of the pending Pradaxa personal injury and wrongful death cases to Judge David Herndon, who was overseeing the largest number of filed Pradaxa cases prior to the decision of the JPML. These cases are known as “tag-alongs” to the multi-district litigation.  MDL No. 2385, which is formally known as In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, includes individual lawsuits that were originally filed or removed to federal courts located in Florida, Oklahoma, Tennessee, Kentucky, Connecticut, Illinois, Ohio, New York, and Louisiana.  These Pradaxa lawsuits were filed against Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Corporation, Boehringer Ingelheim USA Corporation, and Boehringer Ingelheim Vetmedica, Inc.  In the future, when new Pradaxa cases are filed in the federal court system, they will be identified as potential tag-alongs to MDL No. 2385 and will be transferred from local federal courthouses to Judge Herndon’s courthouse in Southern Illinois by the Clerk for the Judicial Panel on Multi-District Litigation, which is based in Washington, DC and oversees dozens of pending MDL proceedings involving drug, medical device, environmental, consumer fraud, and other mass tort class action and individual claims.

Judge Herndon refused to stay the dozen or so Pradaxa cases pending before him when the request for an MDL was filed before the JPML.  At the first status conference held in mid-July, Judge Herndon made a number of important rulings with regard to document preservation, production of FDA-related documents (including the new drug application [NDA] and adverse event reports [AER] for Pradaxa), the format for production of corporate documents (the first wave of documents are expected to be produced before September 1st), and issues relating to foreign defendants.  Those orders will remain in effect for now.

Boehringer Ingelheim also filed motion to dismiss these first-filed cases on various legal bases under Rule 12(b)(6) of the Federal Rules of Civil Procedure with assertions that the plaintiffs’ complaints failed to state a proper cause of action against Pradaxa’ s manufacturer for various reasons.  Those motions were fully briefed by the parties, and Boehringer’ s requests for dismissal were denied by the court in late July.

On August 17, 2012, Judge Herndon issued a series of orders on behalf of MDL 2385, which cover a number of threshold issues and will significantly expedite the litigation, including:

  • Establishment of a master docket for filings that apply to all of the pending Pradaxa lawsuits;
  • Filing procedures for new complaints, including prohibition against including more than one plaintiff in  complaint filed to initiate a new lawsuit;
  • Requirement of attorney registration and use of the Court’s CM/ECF electronic filing system;
  • Documents that need to be filed by attorneys for the parties in advance for the October 3rd Status Conference;
  • Requirement that plaintiffs’ attorneys with pending Pradaxa lawsuits meet and confer amongst themselves and with defense counsel with regard to dispositive motions; evidence preservation; privilege issues (such as HIPPA concerns, communications between defendants and plaintiffs’ medical providers, protection of Boehringer Ingelheim’s trade secrets, etc.); limits on discovery; and the timeframe within which fact discovery as well as expert witness discovery might be completed.
  • Initial instructions regarding creation of a bellwether trial process to identify representative cases to be tried before the MDL judge in approximately 1 ½ to 2 years from now;
  • Requirement of mediation of cases prior to scheduling for bellwether trial settings;
  • Extensions on deadlines for Boehringer Ingelheim to answer complaints until after the October 3rd hearing;
  • Stay was issued until October 3rd on most new discovery requests or disclosure requirements, as one of the next steps in the MDL process will be the establishment of uniform standards for discovery from plaintiffs (usually in the form of a Plaintiffs’ Fact Sheet which combines traditional interrogatories and a request to produce);
  • Procedure implanted for preservation of testimony from a party who is ill and may not survive until the time when case-specific or generic depositions are begun in the MDL;
  • Deadlines established for applications by plaintiffs’ counsel for appointment to serve as lead counsel or as a member of the plaintiffs’ steering committee who will be appointed by the Court after review of the application and an interview;
  • Detailed instructions on preserving the confidential information that might be gathered during the course of the Pradaxa litigation, including trade secrets, protected health information, attorney/client privileged communications, and other sensitive information or data that is afforded special legal protections;
  • Duty of all parties to preserve documents and information that might be discoverable in the litigation; and
  • Protocols for the production of paper and electronic documents, databases, metadata, translations, and other important evidence.

Judge Herndon’s initial orders recognize the seriousness of the injuries sustained by the plaintiffs as well the need for the Pradaxa litigation to move as expeditiously as possible, especially in light of the advanced age of some of the injured plaintiffs.  Judge Herndon also noted that Boehringer Ingelheim has an interest in having trials occur quickly in the Pradaxa litigation, so that the drug manufacturer may assert its vigorous defenses in the Pradaxa litigation.  Prescribing physicians and the medical community as a whole were also noted as interested parties in the litigation.  Judge Herndon noted that he hoped to have the first trials in the Pradaxa MDL in approximately 18 to 24 months after the scheduling order is entered, which could occur as early as October.  This is a very fast pace for MDL litigation, but absolutely appropriate given the nature of the claims asserted by Pradaxa plaintiffs.

Our firm and its local counsel filed one of the first Pradaxa personal injury lawsuits against Boehringer Ingelheim in the Southern District of Illinois, which was assigned to Judge Herndon.  The lawyers at Searcy Denney supported the petition for establishment of the Pradaxa MDL before Judge Herndon, and have been involved in the national coordination of the litigation.  The firm represents a number of additional plaintiffs who have suffered catastrophic personal injuries or wrongful death due to GI bleeds, intracranial hemorrhage, or other harm caused by ingestion of Pradaxa, and intend to continue filing individual lawsuits against the manufacturers of Pradaxa in either the MDL or the coordinated state court venues available in California or Connecticut for Pradaxa victims in the coming months.

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