Amanda Antell  |  March 3, 2015

Category: Legal News

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heart drugsMissouri plaintiff Judith D. has become the latest in a string of Pradaxa users to sue Boehringer Ingelheim for the injuries she allegedly suffered from a near fatal Pradaxa bleeding event.

Like many patients in America, Judith had been prescribed Pradaxa to treat her atrial fibrillation and to prevent stroke. She started this prescription in February 2011, and stayed on the medication for several months before suffering severe Pradaxa complications, her lawsuit alleges.

According to the Pradaxa lawsuit, on May 28, 2011, the plaintiff woke up vomiting blood and needed immediate medical treatment. It was discovered that the plaintiff was suffering from internal bleeding, which seemed to have worsened because of Pradaxa. While the plaintiff survived this ordeal, she decided to file legal action against Boehringer Ingelheim for failing to warn her about the risk of uncontrollable bleeding caused by Pradaxa.

Where Was the Warning?

Prior to the bleeding incident, Judith claims she was not aware that Pradaxa could cause bleeding injuries or that there was no antidote to stop bleeding in Pradaxa users should it occur.

Additionally, she claims that at no point in time — before or after she was prescribed Pradaxa — did Boehringer provide relevant studies or adequate warnings about these risks. Boehringer also failed to provide adequate language on the drug warning label that described the possibility of Pradaxa bleeding injuries, when these bleeding events are not considered unusual, the Pradaxa lawsuit further alleges.

Judith contends that Boehringer had the civil responsibility to warn patients of all potential Pradaxa side effects, because they are relying on the accuracy of the given information provided on the drug warning label. Judith insists that she never would have used Pradaxa if she had known about the possibility of uncontrollable internal bleeding.

So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug, Judith is suing Boehringer Ingelheim. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

Her Pradaxa lawsuit joins the federal MDL known as: In Re: Pradaxa (Dabigatran Etexilate Products Liability Litigation), MDL No. 2385, in the U.S. District Court of Southern Illinois.

Overview of Pradaxa Complications

Pradaxa was first approved by the FDA on Oct. 19, 2010 to prevent stroke in high-risk patients and for patients suffering with atrial fibrillation.

Pradaxa is manufactured and sold by the German pharmaceutical giant Boehringer Ingelheim, and was the first drug to successfully break into the anticoagulant market since Warfarin.

For generations, Warfarin had been the only choice for patients who needed an anticoagulant. Warfarin, however, required frequent blood monitoring and dose adjustments, along with frequent doctor appointments. These inconveniences had been the best selling points for Pradaxa, which stated that patients only required one constant dose amount and no frequent monitoring.

However, these attributes may have led to the many Pradaxa bleeding injuries that were reported soon after its release. By not seeing their physicians regularly, patients were at a constant risk for fatal bleeding incidents without even realizing it.

Additionally, it was soon discovered that Pradaxa lacked a major safety feature compared to Warfarin, which is a reversal agent for bleeding events. If a Warfarin bleeding event occurred, patients could stop the bleeding by administering vitamin K; as of now, Pradaxa has no such remedy.

From October 2010 to March 2011, approximately 272,119 patients had been prescribed Pradaxa in the United States. During that time, there were 932 injury reports submitted to the FDA, including 120 deaths and 500 reports of severe, life-threatening bleeding injuries.

After receiving these injury report statistics, Boehringer updated the Pradaxa labels in America in March 2011 to mention the possibility of bleeding injuries. However, critics state that the Pradaxa label still lacks adequate warning and still puts patients at risk.

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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