Two Daughters File Pradaxa Brain Bleed Lawsuit

Two Massachusetts daughters have filed a Pradaxa brain bleed lawsuit against the international pharmaceutical giant, Boehringer Ingelheim, for the wrongful death of their father in November 2012.

The sisters, Li Liu and Dr. Emily Liu, co-administrators of the estate of the deceased, Dr. Zhensheng Liu, M.D. filed the suit on behalf of the estate of Dr. Liu and their mother, Dr. Julia Song, on August 5, 2014, in U.S. District Court in Boston, Massachusetts.

The action pits Boehringer Ingelheim, the manufacturer of the anticoagulant medication, Pradaxa, against plaintiffs who allege that the defendant willfully concealed the “true and significant” risk of death from the deceased Dr. Liu and his physician before he ingested it.

According to the suit, the defendants made deceitful claims regarding the effectiveness, safety, and benefits of Pradaxa while being well aware of the clear risk of excessive and/or uncontrollable bleeding for which there was no antidote or reversal agent.

Pradaxa brain bleed lawsuit

The deceased Dr. Liu was first prescribed Pradaxa for atrial fibrillation on March 31, 2011. On November 25, 2012, Dr. Liu sustained a fall and was transferred to Massachusetts General Hospital’s neurological intensive care unit. He was diagnosed with a subarachnoid hemorrhage along both frontal lobes and along the medial aspect of the left temporal lobe due to the fall.

Dr. Liu continued to experience bleeding in his brain and received fresh frozen plasma and hemodialysis in an attempt to remove the Pradaxa from his system. The efforts failed, and he died on November 29, 2012. All of the attending physicians attribute Dr. Liu’s death to his uncontrollable internal bleeding from Pradaxa.

Boehringer spent $464,000,000 in 2011 on marketing

Pradaxa (dabigatran) was first approved by the FDA in October 2010 for prevention of strokes and blood clots among patients with non-valvular atrial fibrillation (AF). It was the first anticoagulation medicine approved in the U.S. in fifty years for patients with AF and the first new alternative to warfarin (Coumadin) in sixty years. The drug was aggressively promoted against warfarin, the long-time market leader, as a more convenient and effective alternative because it did not require the burdensome monitoring of drug levels in the blood that warfarin mandated. Those taking warfarin had to have their blood tested once or twice weekly in the early stages of treatment to allow for dosage adjustments.

While Pradaxa proved effective at reducing the incidence of strokes in atrial fibrillation patients, its anticoagulant effects were virtually impossible to control. The anticoagulant action of warfarin, on the other hand, could be controlled with doses of Vitamin K.

Shortly after its introduction, the FDA received thousands of adverse event reports on Pradaxa after patients experienced uncontrolled bleeding events, including 580 deaths in the US to date, according to the Institute for Safe Medication Practices.

Plaintiffs demand “full and complete compensation”

The Liu’s Pradaxa lawsuit alleges that the defendant, Boehringer, “overstated the efficacy of Pradaxa with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Pradaxa, and that the irreversibility of the anticoagulation effects of Pradaxa could have permanently disabling, life threatening, or fatal consequences.”And finally, the defendant “failed to provide adequate instructions on how to intervene and/or stabilize a patient who suffers a bleeding incident while taking Pradaxa” which ultimately led to their father’s passing.

The Lius demand they be awarded full and complete compensation from the defendants for their losses and injuries, including punitive damages.

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