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Widow Alleges the Makers of Pradaxa Caused Husband’s Death by Hiding the Drug’s Risks

Filed March 25th, 2014 Laurie

A lawsuit has been filed against Boehringer Ingelheim Pharmaceuticals on behalf of the widow of a man who died from renal failure and intracerebral hemorrhage, allegedly caused by his use of the thrombin inhibitor Pradaxa.

The complaint was filed on March 19 in U.S. District Court in Philadelphia.

James Standish Jr. died on April 10, 2012, after suffering a bilateral cerebellar and left frontal subarachnoid and intraparenchymal hemorrhage. He spent two days at Crozier Chester Medical Center in suburban Philadelphia before succumbing to his injuries, according to PennRecord.com.

James Standish began taking Pradaxa in July 2007 to treat non-valvular atrial fibrillation. Pradaxa is designed to reduce the risk of stroke and systemic embolism in patients who suffer from this heart rhythm disorder. Pradaxa, which was approved by the U.S. Food and Drug Administration (FDA) in the fall of 2010, was touted as a superior treatment to warfarin in preventing stroke and systemic embolism, according to the lawsuit, but Boehringer Ingelheim failed to adequately warn of its dangers, PennRecord.com reported.

In her lawsuit, Nancy L. Standish, James’ wife, alleges the drug makers also failed to warn emergency room physicians, surgeons, and other critical medical care workers that unlike warfarin, there is no antidote to Pradaxa, and therefore no effective means of halting uncontrolled bleeding in patients taking the drug, according to PennRecord.

The lawsuit notes that as of December 31, 2011, the FDA had received more than 500 reports of Pradaxa-linked deaths in the U.S., more than 900 reports of gastrointestinal hemorrhages, more than 300 reports of rectal hemorrhages, and more than 200 reports of cerebrovascular accidents in patients taking the drug, PennRecord.com reported.

Nancy Standish alleges that James Standish and his medical care team were unaware that James would be exposed to the risks of excessive and/or uncontrollable bleeding or other serious health issues associated with Pradaxa because the drug’s makers promoted its safety, effectiveness, and benefits while hiding its risks, according to PennRecord.com.

The lawsuit alleges strict products liability, negligence, negligent misrepresentation and/or fraud, breach of implied and express warranties, negligence per se, and fraudulent concealment. Nancy Standish seeks compensatory damages in excess of $75,000, unspecified punitive damages, damages for pain and suffering, interest, attorneys’ fees and costs, PennRecord.com reported.

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