Pradaxa Litigation and Bleeding Risks

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Plaintiffs who filed lawsuits over the anticoagulant drug Pradaxa (dabigatran etexilate) allege that they were never informed about the risk of bleeding-related injuries, including gastrointestinal bleeding and bleeding in the brain. Boehringer Ingelheim, the manufacturer of Pradaxa, allegedly failed to warn about the risk of irreversible bleeding with the drug, lawsuits allege.

The U.S. Food and Drug Administration (FDA) approved Pradaxa in 2010 to reduce the risk of blood clot and stroke in patients with atrial fibrillation, an abnormal heart rhythm. The drug was part of a new generation of anticoagulants that offered an alternative warfarin, which requires regular blood monitoring and dietary restrictions. Plaintiffs in the Pradaxa litigation allege that Boehringer Ingelheim marketed the anticoagulant as being superior to warfarin, but failed to warn them or their doctors about the risks.

Up until late last year, there was no antidote to reverse the blood-thinning effects of Pradaxa. This was not the case with warfarin, which can be reversed with vitamin K. Although the purpose of an anticoagulant is to reduce the risk of blood clotting in order to prevent a stroke or heart attack, sometimes it is necessary to reverse these effects to stop hemorrhaging during a medical emergency. Lawsuits filed over Pradaxa allege that plaintiffs were not warned about this caveat. In October 2015, the FDA approved Praxbind (idarucizumab), the first reversal agent that neutralizes the effects of Pradaxa.

A multidistrict litigation (MDL) was created for Pradaxa lawsuits in 2012, consolidating cases in order to make proceedings more efficient. MDLs are established in order to speed up complex litigation; they centralize lawsuits that have similar allegations. The plaintiffs similarly alleged a failure to warn, and also alleged that Pradaxa led to a bleeding-related injury. Alleged injuries included types of brain bleeding and gastrointestinal bleeding. Suits also allege that Pradaxa’s label did not include dosing information based on a patient’s weight between October 2010 and March 2011; the standard one-size-fits-all dose is not effective, and sometimes dangerous, suits allege.

In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle 4,000 lawsuits in the MDL. The average payout was roughly $160,000 per plaintiff. The settlement was not necessarily the end of litigation over the drug, as it does not prevent new plaintiffs from filing lawsuits.

In October 2015, The Neurohospitalist published a paper documenting four cases of intracranial hemorrhage associated with Pradaxa. The authors concluded that intracranial hemorrhages related to Pradaxa use should be managed on a case-by-case basis and stated that “More clinical studies are needed to determine a standardized approach to treat dabigatran-associated intracranial hemorrhage. Institutional protocol development will facilitate safe, efficacious, and timely use of the limited management options.”