Patients taking Pradaxa are faced with an unacceptable risk of irreversible bleeds. We believe Pradaxa should be immediately recalled by its manufacturer to protect patients in the United States and abroad.
- Ryan L. Thompson
San Antonio, TX (PRWEB) March 06, 2012
Mikal C. Watts and Ryan L. Thompson of Watts Guerra Craft LLP filed the first three landmark federal court Pradaxa lawsuits just this week: Lege et al v. Boehringer Ingelheim Pharmaceuticals Inc et al, Cause No. 6:12-cv-00572, in the U.S. District Court for the Western District of Louisiana; Bivens et al v. Boehringer Ingelheim Pharmaceuticals, Inc et al, Cause No. 3:12-cv-00103, in the U.S. District Court for the Eastern District of Tennessee, Northern Division; and Hawkins et al v. Boehringer Ingelheim Pharmaceuticals Inc et al, Cause No. 6:12-cv-45, in the U.S. District Court for the Eastern District of Kentucky, London Division.
Watts, known internationally for his handling of vehicle rollover cases and the BP Multidistrict Litigation (MDL No. 2179), and his Pradaxa team of nearly 60 dedicated pharmaceutical defect staff members, all led by Thompson, are closely watching the ongoing U.S. Food and Drug Administration (FDA) investigation into Pradaxa and its potentially deadly side effects. The FDA is now investigating post-marketing reports of serious bleeding events and deaths in patients taking Pradaxa (dabigatran etexilate).
Pradaxa was approved in October 2010 by the FDA for the prevention of stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is the most common heart rhythm condition in the world. Patients with this condition typically require blood-thinning medications such as the well-known warfarin. Pradaxa was the first alternative to warfarin approved in nearly 60 years. Problems were quick to follow. In November 2011, Boehringer Ingelheim confirmed at least 260 fatal bleeding events in patients taking Pradaxa.
Pradaxa side effects have prompted safety advisories in Japan and Australia and have led to labeling updates in Europe and the United States. The FDA recently required the German pharmaceutical manufacturer Boehringer Ingelheim to update its Pradaxa label after receiving a large number of adverse event reports from consumers. The January 2012 label change added minimal information regarding the dangers of bleeding events and the lack of a reversal agent for Pradaxa. The drug remains devoid of a “black box warning” or an FDA recall.
If you or someone you care about took Pradaxa and suffered a personal injury or passed away, you may have a pharmaceutical defect claim against the manufacturer of Pradaxa. You should speak to an experienced product liability lawyer quickly to make sure your claim is filed within applicable time limitations.
Mikal C. Watts, Ryan L. Thompson, and the pharmaceutical litigation team of Watts Guerra Craft LLP have handled hundreds of thousands of mass action claims across the United States, and have won some of the most significant legal victories in American history. For more information about Watts Guerra Craft LLP, please visit our new Website, find us on Facebook, or follow us on Twitter.
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