The national law firm of Parker Waichman LLP has filed a lawsuit in U.S. District Court for the District of Connecticut against Boehringer Ingelheim Pharmaceuticals, Inc on behalf of a Tennessee man who alleges that his use of Pradaxa caused a cerebral hemorrhage.
According to the lawsuit the plaintiffs began using the prescription blood-thinner Pradaxa on February 22, 2011 and used it until he suffered a cerebral hemorrhage on April 23, 2011. The complaint says that Pradaxa levels in the blood are difficult to assess, and because there is no known reversal agent for the drug, bleeds can not be stopped.
The lawsuit says that the FDA approved Pradaxa in October 2010 for the prevention of stroke in patients with non-valvular atrial fibrillation. Boehringer Ingelheim claims that Pradaxa has fewer drug interactions than Coumadin (warfarin), and that patients do not have to have frequent laboratory tests for blood levels of the drug, for patient-by-patient dosage adjustments.
As of November 2011, at least 260 fatal bleeding events were reported by Boehringer Ingelheim, the lawsuit says, and that the FDA announced on December 2011, that it was initiating an investigation into the serious bleeding event connected with Pradaxa. The lawsuit alleges that the Boehringer Ingelheim knew about the life threatening, irreversible bleeds associated with Pradaxa, and failed to warn consumers and their physicians about them, nor did the defendant warn about the irreversible nature of the drug in the ‘warnings and precautions’ section of the warning label.
The lawsuit charges the drug maker with negligence, strict products liability, failure to warn, design, marketing and manufacturing defects, breach of implied and express warranty, fraudulent misrepresentation, negligent misrepresentation, deceptive trade practices, and gross negligence.