German drugmaker to settle about 4,000 plaintiff’s Pradaxa claims for $650M -
Claimants’ Negotiating Counsel achieved a $650M Settlement in In Re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, hoping to resolve about 4,000 lawsuits against the drugmaker, Boehringer Ingelheim Pharmaceuticals, Inc. (BI). Plaintiffs’ steering committee was led by Roger Denton of Schlichter, Bogard & Denton; Tor Hoerman of Tor Hoerman Law; Seth Katz of Burg Simpson; Michael London of Douglas & London; and Mikal C. Watts of Watts & Guerra.
Mikal Watts released the following statement in conjunction with the news: “We are pleased that today’s settlement will bring justice and financial assistance to those hurt while taking Pradaxa. We are proud of the settlement we have achieved, congratulate the company on doing the right thing, and look forward to distributing these funds to our clients as expeditiously as possible.”
The anticoagulant, aggressively marketed as a more effective and easier to administer drug than rival Warfarin, was prescribed to lower stroke risk from sufferers of atrial fibrillation. Plaintiff’s counsel, however, initially pointed to significant problems in the RE-LY study (a.k.a. Randomized Evaluation of Long-term anticoagulant therapy released in 2009 by the European Heart Journal) used to move forward with the drug. Claims contend that BI failed to warn doctors and patients of bleeding risks associated with Pradaxa, particularly in higher risk patients, and that once hemorrhaging presented in patients there was no known antidote to reverse it. Within the first quarter of 2011, nearly 950 serious adverse events were reported with Pradaxa as the primary suspect of injury by the Institute for Safe Medication Practices. In August 2012, the federal court claims were consolidated in a multi-district litigation before Hon. David. R. Herndon.
In a press announcement released by BI, SVP and general counsel, Desiree Ralls-Morrison stated, “Time and again, the benefits and safety of Pradaxa have been confirmed. BI stands resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows BI to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives. This settlement does not change the facts about Pradaxa or its importance to patients. From the time Pradaxa launched, BI properly advised doctors and patients about its benefits and safety, working closely with FDA, European Medicines Agency (EMA) and other regulators to ensure doctors and patients had the information they needed.”
Though BI is currently refuting allegations with the results of a recent FDA study published earlier this year based on data collected between 2010 and 2013 from the National Prescription Audit (NPA) and IMS, Vector One®: Total Patient Tracker (TPT) Databases, evidence of internal concern that was uncovered in February cast doubt on whether or not BI should have taken further precautions back in 2009. The uncovered email chain documents employee concerns that some patients should have been closely monitored, as too little drug absorption could lead to stoke and too much, to internal bleeding. Employees pointed to significant variance in absorption from person to person, and that the suggestion to develop a test for this variance was shot down. The recommendation would have been in direct conflict with their marketing position of less risk and easier administration than rival drug, Warfarin.
Judge Herndon subsequently sanctioned BI nearly $1 million and ordered depositions to be switched from Germany to the United States over concerns of data fidelity. The following month, a federal appeals court held the sanctions but said the judge could not authorize the deposition move.
The first Bellwether trial was scheduled to begin in August of 2014.