Lawsuits have been filed against Boehringer Ingelheim, alleging patients suffered side effects, some fatal, as a result of using Pradaxa. Among the alleged side effects is a risk of uncontrollable bleeding. The lawsuits also allege that Pradaxa was marketed as being a better drug than warfarin, even though there is an antidote to uncontrollable bleeding linked to warfarin.As of February 25, 2014, there were approximately 2,300 lawsuits filed in federal courts against Boehringer Ingelheim.
Pradaxa lawsuits filed in federal courts have been consolidated for pretrial information exchanges.
The first of four bellwether trials in Pradaxa litigation has reportedly been scheduled to begin on September 8, 2014. The three remaining bellwether trials are set for December 1, 2014, February 17, 2015 and March 23, 2015.
Lawsuits have also been filed in state courts in California, Connecticut, Delaware and Illinois.
A report by WXYZ News suggests that Pradaxa is the most complained about drug in the US.
A report by the Institute for Safe Medicine Practices (ISMP) notes that Pradaxa was linked to 1,158 deaths in the US from the time it was approved to the end of 2012 and 7,387 serious injuries.
Allegations have been raised that Boehringer Ingelheim conducted a study showing an increased risk of death due to bleeding in patients who used Pradaxa but did not share those results with the FDA.
The lawsuit is In re Pradaxa Products Liability Litigation, 12-MD-02385, US District Court, Southern District of Illinois.