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Pradaxa Gastrointestinal Bleeding Lawsuit Filed

Plaintiff Joseph Dasaro has filed a Pradaxa gastrointestinal bleeding lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim International GmbH, for personal injuries and wrongful death suffered after the death of his mother, Rose Dasaro, which he alleges was caused by her use of the blood thinner medicine.

The case was filed on June 19, 2013 in the U.S. District Court in the Southern District of Illinois (East St. Louis). The lawsuit will join the Pradaxa products liability litigation currently pending under MDL 2385. Chief Judge David R. Herndon is overseeing the litigation, which currently includes more than 1,600 cases.

Patient experienced gastrointestinal bleeding

Pradaxa is a blood thinning medication used to reduce the risk of stroke and blood clots in patients with atrial fibrillation (AFib) not caused by a heart valve condition. Rose Dasaro was prescribed Pradaxa in February 2011, for long-term maintenance of AFib, a condition causing an irregular and often rapid heart rate that frequently causes poor blood flow to the body. According to the complaint, Rose Dasaro suffered Pradaxa gastrointestinal bleeding on June 22, 2011 and died as a result of her injuries, which the plaintiffs allege is a direct result of her use of the drug.

The patient and her physician were unaware of the increased risk of gastrointestinal bleeding and bleeding events in general in those taking Pradaxa, especially with aging patients and those with a prior history of gastrointestinal issues. The plaintiff claims had the patient and her physician been aware of the dangerous Pradaxa side effects, she would have been prescribed a safer alternative product.

Pradaxa gastrointestinal bleeding risk

Pradaxa was approved by the FDA on October 19, 2010. It was the first treatment alternative available to Coumadin in nearly 60 years, states the claim. On December 7, 2011 the FDA began an investigation into the serious bleeding events associated with Pradaxa. They issued a statement saying the, “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa [RE-LY trial].”

The claim notes that an FDA analysis showed that patients using Pradaxa demonstrated a higher rate of life-threatening bleeding events than the strokes of systemic emboli the drug was prescribed to prevent. This suggests Pradaxa poses an extreme risk for patients and poses no benefits, alleges the claim.

According to the claim, in November 2011, defendants confirmed at least 260 fatal bleeding events in patients taking Pradaxa were reported between March 2011 and October 2011. The exact number of Pradaxa related deaths remains unknown.

Pradaxa side effects lawsuit claims

The plaintiff is suing the defendants on six counts, including failure to warn; design defect, marketing defect, and manufacturing defect; negligence; negligent misrepresentation and/or fraud; fraudulent concealment; and punitive damages. The Pradaxa gastrointestinal bleeding lawsuit states that “defendants owed a duty to the medical community and consumers, including plaintiff’s decedent and plaintiff’s decedent’s physicians, to provide accurate and complete information regarding Pradaxa,” and alleges they are to blame for of Rose Dasaro’s death. The plaintiff is seeking both economic and non-economic damages from the defendants.