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Pradaxa Lawsuit Filed by Georgia Couple

The controversial anticoagulant Pradaxa is at the center of yet more allegations of life-threatening  bleeding events. In a Pradaxa lawsuit filed last month in the U.S. District Court for the Northern District of Georgia, a married couple from Forsyth County, GA, claim that Boehringer Ingelheim, the company behind the product, failed to adequately warn them of the risks associated with the drug. The case is a tag-along action to the multidistrict litigation proceedings (MDL no. 2385).

The male plaintiff was first prescribed Pradaxa in August 2011, as a treatment for atrial fibrillation. Three months later, he suffered an uncontrollable bleeding event, a life-threatening condition that required hospitalization for four days.

The facts of the lawsuit closely resemble a number of similar cases alleging serious – and sometimes fatal – internal bleeding episodes caused by the blood-thinner. Multiple  independent studies on Pradaxa uncontrollable bleeding events have been cited in lawsuits filed throughout the country. Boehringer Ingelheim is accused of falsely marketing their product as a safer alternative to rival anticoagulants.

Pradaxa uncontrollable bleeding risks

In a multi-million dollar marketing campaign, the company claimed Pradaxa was preferable to warfarin, a decades-old blood-thinner with a relatively small number of associated deaths, thanks largely to the availability of an antidote in case if internal bleeding – something which Pradaxa lacks.

A number of studies indicate that Boehringer Ingelheim’s claims are unfounded. Figures show that the risk of severe internal bleeding with Pradaxa is 1.6%, compared with 1.1% for warfarin. In 2011, health regulators in New Zealand issued a warning stating that Pradaxa carries a greater risk of severe, uncontrollable bleeding than warfarin. The study looked at 10,000 New Zealanders treated with Pradaxa. Severe internal bleeding was experienced by 78 people, with 55 of those requiring hospitalization, and 10 dying of their injuries.

Pradaxa also linked to heart attacks

Uncontrollable bleeding is not the only serious Pradaxa side effect reported by patients.

In a study presented at the 2013 Congress of the International Society on Thrombosis and Haemostasis, Pradaxa was shown to increase the risk of heart attack by as much as 70%. In another piece of research, published in the Journal of the American College of Cardiology, it was claimed that Pradaxa could increase the risk of heart attack by 48%.

The risk was shown to be greater as the dosage increased, indicating causal link between heart attacks and Pradaxa.

Hundreds of adverse event reports filed with FDA

Pradaxa has been linked to more than 500 deaths in the U.S. A review conducted by The Institute for Safe Medication Practices (ISMP) showed it generated 956 adverse event reports in 2012, including 178 fatalities. According to the ISMP, the death rate associated with Pradaxa is five times higher than with warfarin.

There are more than 200 Pradaxa lawsuits pending, most of which allege uncontrollable bleeding events caused by the medication. The MDL was established to consolidate cases for pretrial proceedings, avoid conflicting rulings and to serve the convenience of defendants, plaintiffs and witnesses. It is being presided over by District Judge David R. Herndon.