Lawsuit Filed By Estate of Woman Who Bled to Death from Pradaxa
A wrongful death lawsuit has been filed against Boehringer Ingelheim on behalf of a Tennessee woman who bled to death, allegedly due to side effects of Pradaxa.
The Pradaxa lawsuit was filed last month in the U.S. District Court for the Western District of Tennessee by Marlene Wright, on behalf of the Estate of Gertrude Eubanks, who died from internal bleeding on April 4, 2011, just days after she started using the relatively new anticoagulant.
Pradaxa (dabigitran) was introduced by Boehringer Ingelheim in the United States in October 2010, as an alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillation.
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Although the medication was promoted as easier to use than warfarin, because it requires less monitoring, Pradaxa does not have a reversal agent that can be used to quickly stop bleeding problems that may develop. With warfarin, doctors can give patients a dose of vitamin K if bleeding problems occur, but no such antidote is available for Pradaxa users.
According to the complaint (PDF), Eubanks began to bleed internally within days of when she started using Pradaxa. Because there is no antidote available, Wright alleges that Eubanks bled to death from Pradaxa, after her doctors were unable to stop the bleeding.
In recent months, concerns have increased about the Pradaxa bleeding risk, as hundreds of adverse event reports have been filed with the FDA involving hemorrhages and internal bleeding, which have caused many users to bleed to death due to the lack of a reversal agent.
According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of bleeding problems with Pradaxa were reported to the FDA during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin, which was second on the list.
Pradaxa safety investigations are now underway in the U.S. by the FDA, as well as in the European Union and Canada.
A growing number of similar Pradaxa lawsuits have been filed in state and federal courts throughout the United States in recent months. The complaints allege that Boehringer Ingelheim failed to adequately research their medication and promoted the medication as an alternative to the older, safer anticoagulant warfarin, even though they failed to provide adequate warnings about the lack of a reversal agent.
DarleneMay 3, 2012 at 4:22 pm
My husband died on April 12, 2012 the coroner said the cause of death was the cure for his blood clots. The Drug is Taro-Warfarin. So how is it Doctors ask you to poison yourself in hopes of what? Because in less than 4 months after his diagnosis of a serious blood clot that was complained to the Family Doctor for 2 years before it was discovered by another Doctor I lost him and I feel the lack o[Show More]My husband died on April 12, 2012 the coroner said the cause of death was the cure for his blood clots. The Drug is Taro-Warfarin. So how is it Doctors ask you to poison yourself in hopes of what? Because in less than 4 months after his diagnosis of a serious blood clot that was complained to the Family Doctor for 2 years before it was discovered by another Doctor I lost him and I feel the lack of medical attention he received ultimately cost him his life. Lack of care from Doctors and irresponsible communication and scheduling of blood work. My husband suffered greatly for the last 4 months and now I can't even get medical attention because I no longer trust my family Doctor who is the same Doctor my husband had. I would like someone to explain to me why my husband's life did not matter to the family Doctor of course only the family Doctor can answer that and I know that's not going to happen.
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