In 2014 the German drug manufacturer Boehringer Ingelheim spent $650 million to settle some 4,000 Pradaxa lawsuits. Plaintiffs claimed that in 2011 the anti-coagulant had led to 540 deaths and numerous other injuries due to uncontrolled bleeding that could not be easily stopped. It was in fact the leading cause of adverse event reports filed in that year for monitored drugs The hemorrhaging included gastrointestinal, rectal and brain bleeding. It was not until late 2015 that the FDA approved Praxbind as a fast-acting Pradaxa antidote. The FDA had approved Pradaxa as an alternative to the blood thinning drug wafarin in 2010. A principal advantage is that Pradaxa does not require the frequent blood monitoring required by patients using wafarin.
Pradaxa lawsuits claimed that Boehringer Ingelheim failed to inform and misled both doctors and patients about the risks associated with the drug. Plaintiffs alleged that Pradaxa’s labels failed to provide warnings about possible gastrointestinal bleeding, specifically in patients with gastrointestinal issues as well as the risk of bleeding in older patients and other at-risk populations. The suits contended that prior to the approval of Praxbind the company also failed to warn that there was then not a fast acting antidote.
Boehringer Ingelheim did not admit to wrong doing in the earlier Pradaxa lawsuits and potential plaintiffs may still file claims. Potentially successful claims will most likely relate to injuries suffered before Boehringer Ingelheim updated warning on Pradaxa labeling and Praxbind was approved for use.
Multidistrict Litigation in Pradaxa Lawsuits
In August 2012 most of the Pradaxa lawsuits were combined in a single case under Multidistrict Litigation (MDL) in federal court in the Southern District of Illinois.
Cases from around the country may be combined in a single court and judge in multidistrict litigation in order to combine and simplify pretrial discovery. If the cases are not settled or dismissed the presiding judge and parties involved may choose one or more representatives case to litigate. These “bellwether” cases offer guidance to other plaintiffs about if and how to continue. The remaining cases will then be returned to their home jurisdictions for litigation. The cases in this instance were settled prior to the litigation of four bellwether trials.
Pradaxa is used to reduce the risk of stroke and blood clots in people suffering from atrial fibrillation. It is also used to treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) and reduce the risk of them occurring again.