Jon Campisi Mar. 21, 2014, 7:17am


The widow of a man who died from renal failure and intracerebral

hemorrhage allegedly tied to his use of the medication Pradaxa has filed a federal wrongful death complaint against the makers of the drug.

Nancy L. Standish is suing Boehringer Ingelheim Pharmaceuticals over the death of her husband, James Standish, Jr., who died on April 10, 2012, after suffering a bilateral cerebellar and left frontal subarachnoid and intraparenchymal hemorrhage.

The injuries led James Standish to spend two days in Crozier Chester Medical Center in suburban Philadelphia before he ultimately passed away, the suit claims.

James Standish, the complaint states, had been taking Pradaxa since July 2007 for treatment of non-valvular atrial fibrillation.

The medication is a direct thrombin inhibitor that is designed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, which is a heart rhythm disorder.

Pradaxa, which received Food and Drug Administration approval in the fall of 2010, was promoted as being more effective than a drug called warfarin in preventing stroke and systemic embolism, the lawsuit states, but in reality the makers of the drug failed to properly warn of its dangers.

The defendants, the suit says, also failed to warn emergency room physicians, surgeons and other critical care medical professionals than unlike generally-known measures taken to treat and stabilize bleeding in users of warafin, there is no effective agent to reverse the anticoagulation effects of Pradaxa, and therefore no effective means to stabilize patients who experience uncontrolled bleeding while taking Pradaxa.

The complaint says that as of Dec. 31, 2011, the FDA has received more than 500 reports of deaths of people in the United States linked to Pradaxa.

There have additionally been more than 900 reports of gastrointestinal hemorrhages, more than 300 reports of rectal hemorrhages, and more than 200 reports of cerebrovascular accidents suffered by Americans associated with Pradaxa use, according to the lawsuit.

As a result of the defendants’ claims regarding the effectiveness, safety and benefits of Pradaxa, the plaintiff’s husband and his doctors were unaware that the man would have been exposed to the risks of excessive and/or uncontrollable bleeding and other health issues associated with the medication, the complaint states.

The suit contains counts of strict products liability, negligence, negligent misrepresentation and/or fraud, breach of implied and express warranties, negligence per se, and fraudulent concealment.

The plaintiff says she has incurred medical, funeral and estate expenses relating to the death of her husband.

She seeks compensatory damages in excess of $75,000, unspecified punitive damages, damages for pain and suffering, interest, attorneys’ fees and costs.

The complaint was filed in U.S. District Court in Philadelphia on March 19 by attorney Michael M. Weinkowitz of the firm Levin, Fishbein Sedran & Berman.

 

The federal case number is 2:14-cv-01627-ER.

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