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A Lawsuit Alleges Predaxa Caused Uncontrollable Bleeding and Death

The family of a patient who had been prescribed Predaxa and died chose to file a Pradaxa lawsuit. According to the lawsuit, the victim died of internal bleeding. The bleeding was uncontrollable in the brain after taking the blood thinning drug. The case was filed in the Superior Court in San Francisco County on June 27, 2012. In it they assert they were unaware of the risk of dangerous Pradaxa side effects when their family member began taking the drug to treat non-valvular atrial fibrillation.

This is not the first involving the death of a patient using Pradaxa. In September 2011, New Zealand reported the deaths of five elderly patients who took the drug. 14 possible Pradaxa-related deaths have been reported in Japan and there have been as many as 260 reports of death resulting from Pradaxa use worldwide.

A patient and physician unaware of Pradaxa risks

Cornelia Caton, the deceased, began taking Pradaxa to treat atrial fibrillation in March, 2011. At the time neither Caton nor her physicians were aware of the risks of Pradaxa side effects. On March 22, 2011, Caton developed bleeding in the brain and was hospitalized for 10 days. On April 2, 2011, Caton died from her internal bleeding. The lawsuit was filed on her behalf by her husband and daughter, claiming her death was directly related to side effects from taking Pradaxa.

Worldwide Pradaxa side effects reported

Recently the Institute for Safe Medicine Practices released a report citing statistics showing more than 3,700 reports of serious Pradaxa side effects have been reported to the FDA since the drug went on the market in 2010. Many of those complaints involved death. Others reported kidney failure, hemorrhage and stroke.

The plaintiffs are seeking general and punitive damages of an unspecified amount and in their complaint cited product liability, negligence, fraud, false advertising, violation of consumer legal remedies, breach of warranty, strict liability and wrongful death.

Pradaxa touted as a better alternative to warfarin

To treat patients diagnosed with atrial fibrillation as a means to prevent blood clots, Pradaxa was first approved by the FDA in October, 2010. Pradaxa manufacturer Boehringer Ingelheim touts Pradaxa as an alternative to warfarin with the claim that Pradaxa is easier to use and more effective than older blood-thinning medication. Unlike warfarin, however, Pradaxa doesn’t have an available antidote if bleeding occurs while the patient is taking the drug. warfarin patients can be given doses of vitamin K to reverse the effects of the drug and stop bleeding. Without an antidote to reverse Pradaxa, uncontrollable bleeding—as is alleged in the case of the plaintiff—can develop.


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