Of the approximate 2000 lawsuits currently on file relating to the anticoagulant drug Pradaxa, the first case set for trial begins on September 8, 2014 and relates to a wrongful death action brought by a daughter, Suzanne Mackiewicz, on behalf of her father, Malachy Higgins. The Higgins case is one of four specific Pradaxa cases that were chosen to move forward as bellwether trials in the federal multidistrict litigation (MDL) established in August 2012 under the direction of U.S. District Judge David r. Herndon in the Southern District of Illinois.
All the Pradaxa MDL product liability lawsuits involve similar allegations, including:
- Pradaxa use caused patients to suffer severe and/or sometimes fatal uncontrolled bleeding;
- The makers of Pradaxa, Boehringer Ingelheim, did not offer sufficient warning of potentially fatal bleeding events and also failed to disclose that there was no conventional way to stop bleeding while using the drug or
- Prescribing doctors were not provided with an antidote to reverse and stop the blood thinning effects of the drug
What is Pradaxa?
Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. It received U.S. Food and Drug Administration approval in October 2010, and is characterized as an anticoagulant, a substance that prevents the clotting of blood. Pradaxa is the first new treatment alternative to warfarin, which is sold under the brand name Coumadin, in almost 60 years. On April 7, 2014, Pradaxa was approved by the FDA for treatment of Deep Venous Thrombosis and Pulmonary Embolism.
Problems with Pradaxa
From October 2010 through the end of March 2011, approximately 272,119 prescriptions were written for Pradaxa in the U.S., and during this same time period, 932 serious adverse event Medwatch reports were filed with the FDA, including at least 120 deaths and more 500 reports of severe, life-threatening bleeding. In April 2013, the FDA required that the Pradaxa label contain a boxed warning advising patients that discontinuing treatment with the drug increases the risk of stroke.
Studies have shown that although the chances of bleeding may be similar with Pradaxa and warfarin, Pradaxa may pose a more serious health risk. The reason why: although the effects of warfarin can easily be reversed with a dose of vitamin K and plasma, there is no known reversal agent for Pradaxa.
The Pradaxa Lawyers at Childers, Schlueter & Smith, LLC continue to review and file new Pradaxa Lawsuits on a rolling basis. If you have questions and need answers, please give us a call today at 1-800-641-0098 to learn how we can help.