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New York Pradaxa Lawsuit Lawyer
Pradaxa is a drug prescribed for the prevention of strokes in atrial fibrillation patients. Unfortunately, Pradaxa has been linked to thousands of adverse events resulting from side effects as well as over 1,000 deaths. Patients taking the anticoagulant have been known to literally bleed to death from a minor cut. If you are taking Pradaxa, you need to be aware of the potential side effects.
Taking Pradaxa? Have You Suffered From:
- Coughing up blood
- Joint swelling
- Joint pain
- Abdominal/stomach pain
- Upset stomach
- Frequent nosebleeds
- Unusual bleeding/bruising
- Brown/pink urine
- Black/red tarry stools
- Swelling and weakness of lower legs, hands, feet, arms, ankles
- Vomiting that resembles coffee grounds or blood
- Skin rash
If so, we understand how frightening it is to be taking a drug you thought would help you, only to discover later that it could not only cause you great harm, but result in your death. Sobo & Sobo L.L.P. has won personal injury settlements for thousands of New York victims and we are here to help. Talk to us, we want to hear your story.
Pradaxa Concerns Surface
Dabigatran Etexilate Mesylate, otherwise known as Pradaxa, was approved by the FDA (U.S. Food and Drug Administration) in 2010 for the prevention of strokes in atrial fibrillation patients. By 2012, over 725,000 Americans were taking Pradaxa. In 2015, the FDA expanded its approval of Pradaxa for use in preventing venous thromboembolism for individuals who have had hip and knee replacement surgery.
Since its introduction, it has been linked to thousands of adverse events and well as over 1,000 deaths. The number of lawsuits being filed is phenomenal – close to 4,000 which have since been consolidated into a multi-district litigation (MDL). In May of 2014 Pradaxa’s maker, German pharmaceutical company Boehringer Ingelheim, paid $650 million to settle the MDL suits.
The FDA is not alone in its concerns. European regulators recommend patients starting Pradaxa to have their kidneys checked as those with weakened kidneys have a higher risk of internal bleeding. Japanese regulators mandated that Boehringer Ingelheim must issue a strong warning to doctors relating to the potentially deadly bleeding caused by Pradaxa.
Pradaxa Warnings and Label Updates
2010: Researchers discover additional bleeding events in the Randomized Evaluation of Long Term Anticoagulant Therapy trial With Dabigatran Etexilate (RE-LY) trial data, resulting in an update to Pradaxa’s drug label
2011: FDA determines such incidents were more frequent than expected.
2013: Boehringer Ingelheim adds black box warning about risks of prematurely discontinuing drug, increased risk of spinal hematomas in some individuals
2014: FDA issues safety communication stating Pradaxa caused a higher risk of gastrointestinal bleeding than warfarin
2015: FDA expanded approval of Pradaxa for preventing venous thromboembolism
An Antibody Is Approved
Then in 2015, the FDA approved Praxbind (idarucizumab), an antibody that reverses the effects of Pradaxa.
This indicates that for five years, Boehringer Ingelheim marketed an anticoagulant that had no antidote in situations where a patient was hemorrhaging.
With alternative anti-coagulant Warfarin, a severe bleeding event could be stopped by Vitamin K. Other modern anticoagulants, such as Eliquis and Xarelto, do not as of yet, have approved antidotes.
Pradaxa has never taken off the market since despite the fact there was no way to reverse the effects of the drug until 2015. Although it appears that the antidote for Pradaxa does successfully reverse the effects of the drug, there are no studies indicating whether or not the antidote has possible risks and side effects.
You Have A Right To Be Compensated
There are a number of arguments for plaintiffs to pursue if filing a lawsuit against Pradaxa’s manufacturer.
These arguments include:
- Boehringer Ingelheim should have known about the higher risk of gastrointestinal bleeding and should have warned doctors and consumers
- The manufacturing and marketing of the drug violated regulatory requirements because they did not properly warn about the high risks associated with the drug
- The drug makes committed a breach of warranty in producing and promoting a dangerous drug and is, therefore, was negligent.
While another round of Pradaxa MDL litigation started in 2014, in 2017 a judge recommended shutting down the MDL process. This does not mean that if you have taken this blood thinner and have suffered dangerous side effects or a severe bleeding episode, you should not pursue your case. It is important that you connect with an attorney to discuss filing a lawsuit.
Defective drug and personal injury lawsuits can be extremely complex so speaking to an experienced lawyer can help you avoid potential pitfalls. Drug companies make billions of dollars and spend as much as they need to protect company earnings and maintain the status quo. You deserve to be compensated for your injuries and Sobo & Sobo wants to help you hold these pharmaceutical companies accountable.
Help For Your Defective Drug Case
The attorneys at Sobo & Sobo are personal injury law leaders who are dedicated to using their years of experience to help. Take the time to learn about your legal rights, call Sobo & Sobo at 855-468-7626 as soon as possible. During your initial consultation, we listen to your story and help you make informed decisions about how to proceed.
We understand it is a difficult time and want to be there on every step of your journey through the defective drug litigation process. Our prompt action, in partnership with you, could make a difference in the outcome of your case. We would be honored to hear your story and look forward to taking the next step toward Winning Together.