Man Calls for Pradaxa Fatal Bleeding Warning

CHICAGO (CN) - More than 500 people bled to death last year because of inadequate warnings from the maker of Pradaxa, a blockbuster drug to reduce the risk of stroke, a man claims in Federal Court.

Arthur Gabriel says he was hospitalized with a sever hematoma six months after he was prescribed Pradaxa in 2011. Treatment included surgery and a blood transfusion, according to the complaint against Boehringer Ingelheim Pharmaceuticals, its parent company Boehringer Ingelheim International, and Bidachem S.P.A.

The Food and Drug Administration approved Pradaxa in 2010 to reduce the risk of stroke and embolism in patients with cardiac arrhythmia.

Unlike the generic anticoagulant warfarin, Pradaxa does not require patients to follow dietary restrictions or undergo regular blood tests, Gabriel says.

Armed with FDA approval, Boehringer spent $464 million marketing Pradaxa, including direct-to-consumer advertising and 1.5 million "detailing sessions" for medical practitioners, according to the complaint. Boehringer allegedly told doctors and consumers that Pradaxa was more effective than warfarin at reducing strokes.

But Gabriel says the drugmaker failed to warn consumers that "there is no agent to reverse the anticoagulation effects of Pradaxa and that if serious bleeding occurs, it may be irreversible, permanently disabling, and life-threatening."

"From October 2010 until the end of March 2011, approximately 272,119 prescriptions for Pradaxa were written in the United States," according to the complaint. "During that same period, there were 932 Pradaxa-associated 'Serious Adverse Event' (SAE) Medwatch reports filed with the U.S. Food and Drug Administration, including at least 120 deaths and over 500 reports of severe, life-threatening bleeding.

"From April 1 until the end of June 2011, there were an additional 856 Pradaxa-associated SAE Medwatch reports filed with the U.S. Food and Drug Administration including at least 117 deaths and over 510 reports of severe, life-threatening bleeding."

By the end of 2011, Pradaxa sales surpassed $1 billion, achieving "blockbuster" sales status, the complaint claims.

At the same time, "as of December 31, 2011, the U.S. Food and Drug Administration received over 500 reports of deaths of people in the U.S. linked to Pradaxa which, at that point, had been available in the U.S. for approximately 14 months," Gabriel says. "In addition, there were over 900 reports of gastrointestinal hemorrhages, over 300 reports of rectal hemorrhages, and over 200 reports of cerebrovascular accidents suffered by U.S. citizens associated with Pradaxa."

Boehringer allegedly failed to include a boxed or a bolded warning about serious bleeding side-effects associated with Pradaxa.

"In their 'Medication Guide' intended for distribution to patients to whom Pradaxa has been prescribed, defendants failed to disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Pradaxa and that if serious bleeding occurs, such irreversibility could have permanently disabling, life-threatening or fatal consequences," the complaint states.

Gabriel seeks punitive damages for strict liability, negligence, negligence misrepresentation, breach of warranty and fraudulent concealment.

He is represented by Brian Perkins with Foote, Meyers, Mielke & Flowers in St. Charles.

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit