Boehringer Ingelheim announces comprehensive settlement of U.S. Pradaxa® (dabigatran etexilate mesylate) litigation
Burlington, ON, May 28, 2014 – Boehringer Ingelheim (BI) announced today that it has reached a comprehensive settlement of state and federal cases in the U.S. litigation regarding Pradaxa® (dabigatran etexilate mesylate) in the amount of $650 million USD.
“Time and again, the benefits and safety of Pradaxa® have been confirmed,” said Desiree Ralls-Morrison, senior vice president and general counsel, Boehringer Ingelheim USA Corporation. “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.”
BI is proud of its employees who have worked for years to research, develop and offer to patients such an important medication as Pradaxa®. Pradaxa®was the first novel oral anticoagulant approved by Health Regulators around the world to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).
“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,” said Desiree Ralls-Morrison.
There are approximately 4,000 US claims that the company seeks to resolve with this settlement. BI expects most, if not all, of the plaintiffs to accept the terms of the settlement and BI will vigorously defend against those who do not.
There are currently five product liability claims in Canada against Pradaxa®. These claims, as any other proceedings outside the US, are not covered by the terms of the US settlement and we intend to continue to vigorously defend each and every case outside the settlement agreement.
Pradaxa® 150mg BID is the only oral anticoagulant shown to be superior to warfarin in reducing ischemic strokes, with a similar rate of major bleeding events. Ischemic strokes account for nearly nine out of every 10 strokes caused by atrial fibrillation. The efficacy and safety of Pradaxa® was established in the pivotal RE-LY® trial, one of the largest stroke prevention clinical studies ever conducted in patients with NVAF. [1]
On May 13, 2014 the U.S. Food and Drug Administration (FDA) once again reaffirmed the positive benefit-risk profile of Pradaxa® when used as directed when it issued a Drug Safety Communication that included results from a Medicare study of more than 134,000 patients 65 years of age or older comparing Pradaxa® to warfarin. This study’s findings, except with regard to Myocardial Infarction (MI) (MI risk was similar for the two drugs), are consistent with the clinical trial results that provided the basis for the approval of Pradaxa®. As a result of these latest findings, the FDA still considers Pradaxa® to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.
As with any anticoagulant, there needs to be a balanced consideration of stroke risk reduction and bleeding risk. Patients should not stop taking their anticoagulant medication without first talking to their health care providers. Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.
About Pradaxa® (dabigatran etexilate mesylate)
Pradaxa®, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases. Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.
Clinical experience of Pradaxa® (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2 million patient-years of experience worldwide. Pradaxa® has already been in the market for more than 6 years and is approved in over 100 countries. Currently approved indications in Canada for Pradaxa® are:
- Prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate
- Prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery
About Boehringer Ingelheim (Canada) Ltd.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.
The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs more than 550 people across Canada.
For more information please visit www.boehringer-ingelheim.ca
For more information, please contact:
Sara McClelland
Boehringer Ingelheim Canada Ltd.
(905) 631-4713
sara.mcclelland@boehringer-ingelheim.com
Merry Garbutt
Boehringer Ingelheim Canada Ltd.
(905) 631-4632
Footnotes
[1] RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg BID) each administered in a blinded manner, with open label warfarin.