An atrial fibrillation patient who took Pradaxa has filed an uncontrollable bleeding lawsuit against the drug’s manufacturer over his ensuing Pradaxa side effects.

In February 2013, plaintiff John S. of Louisiana was prescribed Pradaxa for his atrial fibrillation so that he could receive cardioversion. A month later, he reported to the hospital with symptoms of gastrointestinal bleeding, the Pradaxa lawsuit claims.

Treatment required the transfusion of five packets of blood, and his doctor recommended he stop using Pradaxa. Based on that instance of adverse Pradaxa side effects, John is now filing this Pradaxa bleeding lawsuit against the drug’s manufacturer Boehringer Ingelheim Pharmaceuticals.

Pradaxa Bleeding Risk

Pradaxa, also known by its generic name dabigatran, is an anticoagulant medication used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It works by inhibiting the action of an enzyme that makes blood clot.

When the FDA approved Pradaxa in October 2010, it was the first new anticoagulant medication to be approved in over 50 years. Before then, the only drug approved for that particular treatment was warfarin (also sold under the brand name Coumadin). Pradaxa offers an advantage over warfarin in that it does not require the same ongoing monitoring of blood levels and adjustments of dosage. Boehringer also promoted Pradaxa as being more effective than warfarin.

The differences led to big profits for Boehringer: in its first three years on the market, Pradaxa was prescribed about 6.2 million times to 934,000 patients in the United States. During fiscal year 2011, Pradaxa sales topped $1 billion.

However, Pradaxa does have one major drawback that warfarin does not. All anticoagulants create a risk of excessive bleeding by preventing normal blood clotting. Pradaxa is unlike warfarin in that when such excessive bleeding occurs, there is no complementary medication, known as a reversal agent, that can stop the bleeding.

This tendency to cause uncontrollable, excessive bleeding resulted in thousands of Severe Adverse Event reports filed with the FDA over Pradaxa bleeding, including hundreds of reports of cases that ended in patient death. Pradaxa has received similar negative attention from healthcare authorities in Canada, Japan and New Zealand.

John’s Pradaxa lawsuit alleges Boehringer failed to warn him and his physician about the risk of uncontrollable, life-threatening bleeding and the lack of a reversal agent. He argues that Boehringer’s labeling and marketing for Pradaxa overstated the safety and efficacy of the drug while understating its risks. He states he was unaware of the risk of excessive bleeding when he took Pradaxa, and if he had been so aware he would not have taken it.

John’s Pradaxa lawsuit is charging the drug maker with claims of strict products liability (for defective design, manufacture, or marketing), negligence, misrepresentation or fraud, and breach of warranty.

John seeks compensation for medical expenses, pain and suffering, and attorneys’ fees. John also seeks punitive damages against Boehringer based on the alleged intentional nature of its conduct.

This Pradaxa Bleeding Lawsuit is Case no. 6:15-cv-1071, filed in the U.S. Court for the Western District of Louisiana.