Bleeding causes man to sue Pradaxa maker for failing to warn of risks

By Michelle Keahey, East Texas Bureau | Aug 31, 2012

TYLER -  After experiencing rectal bleeding and a gastrointestinal bleed, a Henderson County man has filed a lawsuit against the manufacturers of the prescription drug used to thin his blood.

Charles Smith filed suit against the makers of Pradaxa -- Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim Pharma GMBH & Co. KG, Boehringer Ingelheim International GMBH and Bidachem S.P.A. -- on Aug 17 in the Eastern District of Texas, Tyler Division.

Approved by the Food and Drug Administration in October 2010, Pradaxa is a direct thrombin inhibitor that is used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillations.  Prior to FDA approval, the drug warfarin was the only anticoagulation available in the U.S. for reducing the risk of stroke and systemic embolism.

According to the lawsuit, there is no effective agent to reverse the anticoagulation effects of Pradaxa and, therefore, no effective means to treat and stabilize Pradaxa patients who are experiencing uncontrolled bleeding.

Smith was prescribed Pradaxa in November 2010 for use a blood thinner.  In December 2010, Smith was taken to the emergency room at Presbyterian Hospital of Kaufman for rectal bleeding. He was diagnosed with an acute lower gastrointestinal bleed.

Smith states he was unaware of the increased risk of developing life-threatening injuries associated with the drug.

The defendants are accused of strict liability, failure to warn, design defect, negligence, negligent misrepresentation, fraud, breach of express and implied warranty, fraudulent concealment, deceptive trade practices and gross negligence.

The plaintiff is asking for an award of damages for medical expenses, conscious physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings and earning capacity, loss of companionship and society, interest, exemplary damages, attorney’s fees and court costs.

Smith is represented by Ryan L. Thompson and Mikal C. Watts of Watts Guerra Craft LLP in San Antonio; and Brian J. Perkins of Foote, Meyers, Mielke & Flowers in Saint Charles, Ill.

A jury trial is requested.

U.S. District Judge Michael H. Schneider is assigned to the case.

Case No. 6:12-cv-00541

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