Following the formation of the pharmaceutical Pradaxa multidistrict litigation (MDL 2385) in late 2012, there have been more than 640 new federal claims filed. The majority of plaintiffs are alleging that the blood thinner has caused them internal bleeding and other potentially life-threatening side effects.
Dabigatran, better known as Pradaxa, marketed by Boehringer Ingelheim, is an anti-coagulant prescribed to millions of patients since its release in 2010. Now patients are coming forward with claims of life-threatening and other serious side effects.
An FDA MedWatch report states that Pradaxa caused at least 542 known deaths in 2011, the year after it was introduced to the public. Other reports include more than 2,350 cases of internal hemorrhaging, 644 strokes and almost 300 cases of acute renal failure. The most often cited side affects patients are claiming were caused by Pradaxa include gastrointestinal bleeding, brain hemorrhage, stroke, and heart attack.
The maker of Pradaxa, Boehringer Ingelheim, has been accused of concealment of risk, negligence, and strict product liability. The company has also been accused of failing to establish an internal bleeding protocol, failing to warn consumers of the high risks associated with taking Pradaxa, and failing to adequately research the medication’s safety and proper dosage.
Pradaxa has been a popular substitute for Warfarin, an anti-coagulant on the market for more than 50 years. Warfarin also increases the risk of internal bleeding, but the bleeding can be stopped with vitamin K. Pradaxa does not have a comparable antidote and there is no standard method to measure its anticoagulant effects.
Pradaxa lawsuits were consolidated in August 2012 to allow multiple litigants; four bellwether trials are scheduled for August 2014. Meanwhile, Pradaxa is still on the market and is considered a viable treatment option for those who need an anticoagulant. Anticoagulants are designed to reduce blood clotting or prevent blood clots. Anticoagulants are commonly prescribed to treat superficial venous thrombosis (SVT), deep vein clots, and deep venous thrombosis DVT. Anticoagulants are also commonly given when there is a risk of stroke.
As of April 2013, the label for Pradaxa contains a boxed warning which advises that discontinuing the medication may increase the risk of stroke.
If you or a loved one has been prescribed Pradaxa and have had any incidences of an adverse reaction, your experience should be immediately reported to the FDA.
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