On May 11, 2012, the law firm of Searcy Denney filed a Pradaxa lawsuit against Boehringer Ingelheim through its local counsel in St. Louis in the federal court for East St. Louis, Illinois. This case was filed on behalf of a 68 year old Grafton, Illinois resident who suffered a significant GI bleed in late 2011 with related kidney failure. The patient had been on Pradaxa for only 8 days prior to suffering this serious drug-induced injury.
This is one of only a handful of cases that have been filed so far in state courts and federal courts in Connecticut, Kentucky, Tennessee, Louisiana, Illinois, and Oklahoma. It is anticipated that hundreds of additional cases will be filed in the coming months in state and federal court around the country, as the drug has now been associated with more than 3,000 adverse events including hundreds of bleeding-related deaths.
Pradaxa has been on the market in the United States for less than two years and has been under a cloud of suspicion since shortly after its introduction. The drug is supposed to be given to patients with atrial fibrillation that is not attributable to valvular heart disease. The drug has been promoted as having numerous benefits over Coumadin or warfarin therapy, which has been used by patients for decades as an anti-coagulant.
The manufacturers of Pradaxa (also known as dabigatran) have aggressively promoted its convenience for patients, as patients who are on Coumadin must have their INR levels checked on a regular basis. Warfarin and Coumadin are also associated with various drug and food interactions.
However, the marketing campaign for Pradaxa failed to provide proper information to patients and their doctors about the significant risks associated with use of the drug, including the lack of an antidote for its anti-clotting properties, the increased incidence for GI bleeds and other bleeding episodes experienced by patients, the fact that the drug may cause irritation and actually initiate GI bleeds, that older patients and those with impaired renal function may develop toxic levels of the drug in their bodies due to poor clearance by the kidneys, and that the approval of the drug by the FDA was based on a single study of questionable reliability.