According to charges in a recent Pradaxa death lawsuit, the defendant’s blood thinner medication caused the plaintiffs’ decedent to suffer fatal injuries. Boehringer Ingelheim Pharmaceuticals designs, markets and manufacturers Pradaxa, a new class of oral anticoagulants that has been associated with uncontrolled bleeding and fatalities in hundreds of patients.
Pradaxa and fatal bleeding risks
Blood thinners like Pradaxa are used to help prevent blood clots (or systemic embolization) and risk of stroke in individuals with atrial fibrillation – a condition where a patient’s heart rhythm is abnormal. Also known by its generic name dabigatran, Pradaxa is a type of direct thrombin inhibitor that was promoted as a superior and more convenient alternative to Warfarin (Coumadin), which required strict dose monitoring and frequent blood tests.
It is believed that patients who suffer from atrial fibrillation are up to six times more inclined to suffer a stroke. Boehringer launched Pradaxa in 2010 after gaining FDA approval, and in the last four years, the medication has been the topic of increasing scrutiny and litigation involving bleeding deaths. The problem with the drug is that it has no proven reversal agent to stop hemorrhaging once it begins.
According to the Institute of Safe Medication Practices (ISMP), the defendant’s blood thinner was tied to more bleeding events and deaths in 2011 than any of the 800 other medications reviewed by the agency. The FDA has been bombarded with thousands of adverse event reports relating to Pradaxa side effects and injury, including more than 500 fatalities. In a drug safety communication posted May 2014, the agency reviewed a recent Medicare study that compared warfarin and Pradaxa in GI bleeding events. Health regulators concluded that “the study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin.”
Accusations in Pradaxa death lawsuit
In this recent wrongful death claim, the plaintiffs are listed as Marie Broekman, Nicholas J. Broekman, Justin Broekman and Aaron Scroggs, individually and on behalf of the decedent, Jonathan Broekman. The civil action is demanding in excess of $75,000 in monetary relief, and was filed in Louisiana district court, but has been transferred to Pradaxa multidistrict litigation, MDL 2385.
The claimants argue that the defendants breached their duty and also failed to exercise reasonable care in the marketing of Pradaxa because they failed to warn that the drug could cause serious injuries and death as suffered by Jonathan Broekman during foreseeable use of the medication. According to the suit, Jonathan Broekman was admitted to the hospital on November 27, 2012 for a cardioversion – a procedure that stabilizes an irregular heartbeat. The next day, he suffered GI bleeding, which could not be stopped by his physicians.
Several blood transfusions were performed, but the decedent coded three times, incurring severe organ damage. It is argued that his untimely death on May 22, 2013 was the direct and proximate result of his excessive bleeding from Pradaxa exposure. His survivors allege that because of taking Pradaxa, the decedent suffered “severe injuries, physical pain, suffering, mental anguish, loss of enjoyment of life, and untimely wrongful death.”
Boehringer sued for negligence and failure to warn
The defendants stand accused of marketing a drug that is inherently dangerous when used for its intended purpose. Since Pradaxa bleeds cannot be quelled by a quick antidote or medical intervention, patients are at extreme risk for permanent injury or life-threatening complications.
In their claim, the plaintiffs are suing on multiple counts including negligent misrepresentation and or fraud, strict liability-failure to warn, design defect, negligence and breach of express warranty. They are also seeking punitive damages against Pradaxa’s manufacturer, in an attempt to punish for their alleged deliberate disregard for consumer safety.
- FDA, Pradaxa (Dabigatran): Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin, http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm397179.htm
- Institute for Safe Medication Practices, How FDA can Help Reduce Dabigatran (Pradaxa) Bleeding Risks, http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=71
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