A woman is suing Boehringer Ingelheim over the atrial fibrillation drug Pradaxa, which is allegedly responsible for the death of her husband after causing renal failure and brain bleeding. The lawsuit, which was filed in the U.S. District Court in Philadelphia, alleges that the drug maker failed to properly warn about the risks, specifically that there can be uncontrollable bleeding/hemorrhaging in Pradaxa users.
Nancy L. Standish says that her husband, James Standish Jr., had started taking Pradaxa for his his non-valvular atrial fibrillation in July 2007. He died on April 10, 2012 after suffering from bilateral cerebellar and left frontal subarachnoid and intraparenchymal hemorrhage.
Pradaxa was approved for sale in the US in 2010. In its short time on the market, it has raised a number of safety concerns and lawsuits, mostly over bleeding injuries. Mrs. Standish’s lawsuit is one of many to point out that Pradaxa was touted as superior to an older drug called warfarin, another anti-coagulation medication. However, unlike warfarin, if a Pradaxa patient suffers from hemorrhaging there is no remedy to reverse the bleeding. The lawsuit alleges that Boehringer Ingelheim failed to warn doctors and users about this risk.
According to the lawsuit, the U.S. Food and Drug Administration (FDA) received over 500 reports of Pradaxa-related deaths 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 Mr. Standish came to harm because of the misleading and inaccurate claims the manufacturer made about Pradaxa. It is alleged that if he and his doctors had known how serious the risks were, he would not have taken the drug. 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.