Pradaxa Lawsuits Filed Over Uncontrolled Bleeding, Death

The number of Pradaxa lawsuits filed in federal district courts throughout the United States is continuing to increase, with at least six complaints filed over the past week involving individuals who suffered uncontrollable bleeding after receiving the medication. 

The product liability complaints were brought against Boehringer Ingelheim in Illinois, Louisiana and Tennessee, alleging that the drug maker failed to adequately warn about the risk of bleeding from Pradaxa, or the lack of a reversal agent that could be used to stop or stabilize bleeding that may occur while using the anticoagulant.

Two of the lawsuits were brought on behalf of the estates of individuals who bled to death after Pradaxa use. According to estimates provided in one of the complaints, at least 500 people in the United States have likely died due to side effects of the anticoagulant, which was just introduced in October 2010 as a new treatment for individuals at risk of stroke due to atrial fibrillation.

One of the wrongful death claims (PDF) was brought on May 14, by the daughter of Ray Herndon Celsor, in the U.S. District Court for the Middle District of Tennessee. The complaint alleges that Celsor was prescribed Pradaxa in March 2011 and suffered severe gastrointestinal bleeding on May 14, which required him to undergo surgery. However, his condition deteriorated and he died due to excessive in May 2011.

The other death lawsuit over Pradaxa (PDF) was filed on behalf of the estate of Bonne Fitzgibbons on May 11, in the U.S. District Court for the Southern District of Illinois. Fitzgibbons was prescribed Pradaxa in August 2011, for treatment of non-valvular atrial fibrillation. She subsequently developed uncontrollable bleeding from Pradaxa, and died in October 2011.

Other recent complaints involving serious, but non-fatal injuries, were brought by Thelma Hawthorne (PDF) of Louisiana, Eva Smith (PDF) of Illinois, Jacqueline Boston (PDF) of Illinois and Carole Richardson (PDF) of Illinois.

Pradaxa (dabigitran) is marketed by Boehringer Ingelheim as an alternative to Coumadin (warfarin). Although the medication has been promoted as superior and easier to use, because it requires less monitoring, Pradaxa does not have a reversal agent that can be used to quickly stop bleeding problems that may develop.  With warfarin, doctors can give patients a dose of vitamin K if bleeding problems occur, but no such antidote is available for Pradaxa users.

In recent months, concerns have increased about the Pradaxa bleeding risk, as hundreds of adverse event reports have been filed with the FDA involving hemorrhages and uncontrollable internal bleeding, which have caused many users to bleed to death due to the lack of a reversal agent.

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of bleeding problems with Pradaxa were reported to the FDA during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin, which was second on the list.

Pradaxa safety investigations are now underway in the U.S. by the FDA, as well as in the European Union and Canada.