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What is Pradaxa?

Pradaxa is a medication that was designed to prevent strokes in patients who suffer from atrial fibrillation, an irregular heartbeat condition common among the elderly. It works by inhibiting the enzyme that is responsible for clotting blood. However, sometimes it works too well. When a patient who is using a drug like Pradaxa suffers a serious bleeding event, their blood fails to clot and can sometimes lead to the patient bleeding to death.

As a result of these side-effects, many Pradaxa lawsuits have been and still are being filed. There has been at least one major Pradaxa settlement. More may be on the way.

Pradaxa was first approved for use in the U.S. in October 2010, but it is not purely a domestic issue. The FDA is not the only entity concerned with internal bleeding deaths. European regulators have recommended that patients who are about to start a Pradaxa regimen should first have their kidneys checked. Individuals with weakened kidneys have a higher risk of suffering internal bleeding.

Japanese regulators required manufacturer Boehringer Ingelheim to issue a strong warning to physicians regarding the potentially deadly bleeding caused by the use of Pradaxa.

Pradaxa Linked to Complications

Thousands who have been prescribed and taken Pradaxa to prevent strokes are reporting deadly side effects.

Pradaxa Lawsuit Claims

  • Pradaxa caused severe bleeding
  • Pradaxa inadequately warned patients about the drug’s life-threatening risks

Pradaxa Side Effects

  • Unusual bruising or bleeding
  • Red or black tarry stools
  • Pink or brown urine
  • Vomit that resembles coffee grounds or blood
  • Coughing up blood
  • Lethargy
  • Headaches
  • Frequent nosebleeds
  • Joint pain or swelling

Who is at Risk

  • Patients 75 years old or older
  • Patients with existing kidney problems
  • Patients with stomach bleeding or ulcers
  • Patients taking other blood thinners

Pradaxa Lawsuit

The blood thinner drug has been blamed for thousands of injuries and hundreds of deaths. In 2011, the FDA received 3,781 reports of adverse events and 542 deaths associated with Pradaxa use. The manufacturer of Pradaxa, Boehringer Ingelheim, is being sued by family members of affected patients claiming that the company used deceptive marketing methods to promote the drug and failed to adequately warn patients of the potentially deadly side effects.

Trials for Pradaxa lawsuits are still ongoing with tentative dates that are subject to change. There are still an estimated 3,000 cases filed throughout the United States and around 2,600 of these cases are pending in the MDL in Connecticut State Court.

2010

Research studies found bleeding events in the Randomized Evaluation of Long Term Anticoagulant Therapy trial with Dabigatran Etexilate trial data. This resulted in a required update to Pradaxa’s medication label.

2011

The FDA reviewed data from post-market studies of severe bleeding events to determine if these events were occurring more frequently than expected.

August 2012

Around 4,000 Pradaxa lawsuits were consolidated in MDL with the Connecticut State Court.

2013

Boehringer Ingelheim added a black box warning for Pradaxa to warn patients about the risks of prematurely discontinuing the medication and the increased risk of spinal hematomas.

2014

The FDA issued a safety communication that warns patients about the increased risk of gastrointestinal bleeding linked to Pradaxa.

May 2014

Boehringer Ingelheim agrees to pay $650 million to resolve most of the 4,000 lawsuits claiming that its drug, Pradaxa, caused severe health problems.

May 2014

The manufacturer Boehringer Ingelheim announced that over 4,000 Pradaxa lawsuits would be settled. Thousands of patients explained that the drug led directly to a life of pain and suffering. Over $650 million was owed to the claimants. Despite the massive Pradaxa settlement, the terms exempted the manufacturer from any wrongdoing. The company continues to stand behind its drugs.

April 2017

The FDA granted tentative approval to drugmaker Glenmark to sell a generic form of the drug Pradaxa.

May 2017

Several plaintiffs filed a lawsuit against Boehringer Ingelheim Pharmaceuticals Inc. and several others in the San Francisco County Superior Court. The complaint alleges negligence for failing to warn consumers of the dangerous side effects.

June 2017

A Pradaxa lawsuit was filed by the family of a deceased man. The family is suing Boehringer Ingelheim Pharmaceuticals Inc. after the death of their family member in November 2012, who was using the anticoagulant, Pradaxa.

July 2017

The final results of a Pradaxa reversal agent showed that Praxbind was able to completely and successfully reverse the effects of the anticoagulant Pradaxa. The authors reported that there were no serious adverse safety signals related to the reversal agent observed in the study.

October 2018

Boehringer Ingelheim pays a settlement of $1.2 million to the family of a woman who died while taking Pradaxa. This would be the first verdict to be awarded to a consumer alleging injuries from the drug.

May 2019

An 81-year-old man from New York was awarded $542,465 and punitive damages in a lawsuit against Boehringer Ingelheim claiming that the man suffered severe bleeding after taking Pradaxa.

Updates

References

RxList. “Pradaxa“RxList, Accessed April 29, 2019.

FDA. “FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin”, U.S. Food & Drug Administration, . Accessed April 29, 2019.

Boehringer Ingelheim. “Boehringer Ingelheim announces comprehensive settlement of U.S. Pradaxa® (dabigatran etexilate mesylate) litigation”, Boehringer Ingelheim, Accessed April 29, 2019.

Ron Meneo. “Pradaxa Lawsuits”, Consumer Safety, Accessed April 29, 2019.

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