A widow is suing Boehringer Ingelheim in the U.S. District Court in Philadelphia, alleging that the drug Pradaxa caused her husband’s death. The medication, which is prescribed to treat a heart condition called atrial fibrillation, allegedly caused her husband to suffer from renal failure and intracerebral bleeding. Pradaxa has only been on the market since 2010, but there are already a number of lawsuits and safety issues concerning the anti-coagulating medication.
The Plaintiff, Nancy L. Standish, says that her husband James Standish Jr. died on April 10, 2012 after suffering from bilateral cerebellar and left frontal subarachnoid and intraparenchymal hemorrhage. Mr. Standish had been taking Pradaxa since July 2007 for his non-valvular atrial fibrillation.
When Pradaxa was first introduced, it was promoted as being superior to an older drug called warfarin. However, unlike warfarin there is no cure to stop internal bleeding once it starts in Pradaxa users. Standish’s lawsuit alleges that the drug makers failed to the properly warn the public and healthcare professionals about this deadly side effect.
More than 500 reports of Pradaxa-related deaths were reported to the U.S. Food and Drug Administration (FDA) as of December 31, 2011. Additionally, there have been 900 reports of gastrointestinal bleeding, 300 reports of rectal bleeding and over 200 reports of cerebrovascular accidents associated with the use of Pradaxa, the lawsuit says.
The lawsuit alleges that because of the inaccurate and misleading claims about Pradaxa, Mr. Standish and his doctors did not know how serious the risks were and that uncontrollable bleeding could occur. Mrs. Standish is suing for counts of strict products liability, negligence, negligent misrepresentation and/or fraud, breach of implied and express warranties, negligence per se, and fraudulent concealment. The death of her husband has led to medical, funeral and estate expenses as well, she said.