Paul Tassin  |  August 31, 2016

Category: Legal News

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pradaxaInternal bleeding and Pradaxa have been controversial subjects since the drug was first introduced in 2010. Following a major settlement in 2014, a new wave of Pradaxa lawsuits has begun to grow.

Pradaxa is manufacturer Boehringer Ingelheim’s name for dabigatran. It was approved for sale by the FDA in 2010 as a way to prevent stroke and systemic blood clots in persons with atrial fibrillation.

It’s also approved to treat and prevent pulmonary embolism and deep venous thrombosis.

Pradaxa was the first of three new anticoagulants recently introduced into a market that was dominated for decades by warfarin.

These new drugs were designed to avoid certain drawbacks that were particular to warfarin – drawbacks like dietary restrictions and the need for regular blood testing and dosage adjustment.

Internal Bleeding and Pradaxa

All anticoagulants present a risk of internal bleeding. One natural result of Pradaxa’s anticoagulant effect is that it makes bleeding events more likely and harder to control.

Patients taking Pradaxa have been known to suffer from internal bleeding including brain hemorrhages, gastrointestinal bleeding, and bleeding in the kidneys.

What makes internal bleeding and Pradaxa more controversial – and a point that the plaintiffs in many Pradaxa lawsuits have raised – is that it was introduced to the market with no available antidotes.

So at the time Pradaxa was approved by the FDA, there was no other medication, known as a reversal agent, that could reverse its anticoagulant effect.

Patients who suffered bleeding injuries like hemorrhage or stroke while taking Pradaxa, or who suddenly found themselves in need of emergency surgery, sometimes had to simply wait for their bodies to finish processing the Pradaxa they had already taken.

This lack of a reversal agent was one advantage that warfarin maintained over the new anticoagulants. Warfarin’s anticoagulant effect can be reversed by administering vitamin K.

Although the FDA eventually approved an antidote for Pradaxa in October 2015, the lack of an available antidote for roughly five years left Pradaxa patients exposed to the risk of bleeding events that could not be medically controlled.

Adverse event reports submitted to the FDA in the first six months that Pradaxa was on the market included over 500 reports of internal bleeding or death associated with Pradaxa treatment.

In January 2013, the Institute of Safe Medication Practices compared warfarin and Pradaxa by reviewing thousands of adverse event reports submitted to the FDA.

The ISMP concluded that internal bleeding and Pradaxa are much more likely to result in death than bleeding associated with warfarin.

Pradaxa Litigation Continues After Major Settlement

Legal claims over internal bleeding and Pradaxa snowballed into a wave of thousands of Pradaxa lawsuits.

Plaintiffs generally allege they were not properly warned about the risks of internal bleeding associated with Pradaxa or about the unavailability of an antidote.

In 2014, Boehringer Ingelheim worked out a massive settlement of about 4,000 of these claims, offering a total payout of $650 million, making for an average payout of $175,000.

That settlement addressed only claims that had already been filed. Since then, other plaintiffs continue to come forward with new claims related to internal bleeding and Pradaxa.

In general, Pradaxa lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Pradaxa attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Pradaxa class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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