In 2014 the German drug manufacturer Boehringer Ingelheim spent $650 million to settle some 4,000 Pradaxa lawsuits. Plaintiffs stated that in 2011 the anti-coagulant had contributed to 540 deaths and several other injuries due to uncontrolled bleeding that could not be stopped. It was in fact the leading cause of adverse event reports registered that year for tracked drugs. The hemorrhaging included rectal, esophageal 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 benefit is that Pradaxa does not need the regular blood monitoring required by individuals utilizing wafarin.
Pradaxa lawsuits asserted that Boehringer Ingelheim failed to notify and misled both doctors and patients about the side effects associated with the drug. Plaintiffs alleged that Pradaxa’s labels failed to provide warnings regarding potential gastrointestinal bleeding, especially in patients with gastrointestinal problems in addition to the risk of bleeding in elderly patients and other at-risk populations. The suits contended that before the approval of Praxbind the company also failed to warn that there was not a quick acting antidote. Boehringer Ingelheim didn’t admit to wrong doing in the earlier Pradaxa lawsuits and potential plaintiffs may still file claims. Potentially successful claims will almost certainly relate to injuries suffered before Boehringer Ingelheim updated warning on Pradaxa labeling and Praxbind has been approved to be used.
Multidistrict Litigation in Pradaxa Lawsuits
In August 2012 most of the Pradaxa lawsuits were united in a single case under Multidistrict Litigation (MDL) in federal court in the Southern District of Illinois.
Lawsuits from around the country may be combined in a single courtroom and Judge in multidistrict litigation in order to combine and simplify pretrial discovery. If the cases are not settled or ignored the presiding judge and parties involved may select one or more representatives’ case to litigate. These “bellwether” cases offer advice to other plaintiffs about if and how to continue. The remaining cases will then be returned to their home jurisdictions for lawsuit. The lawsutis in this case 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.