Pradaxa, one of the newer generation of anticoagulant drugs on the market, was approved by the Food and Drug Administration (FDA) in 2010. Boehringer Ingelheim, the blood-thinning drug’s developer and manufacturer, allegedly failed to disclose to the FDA that Pradaxa deaths occurred more frequently after it was release to the market than they did in premarket clinical studies.

Eventually, a Pradaxa antidote was developed that was fast-tracked out of necessity through the clearance process with the FDA. That antidote is known as Praxbind and was not available until October 2015, allowing the anticoagulant to be on the market a full five years without relief for uncontrolled bleeding episodes.

This lengthy time period allowed for the pharmaceutical company to rake in profits while consumers risked loss of life unaware.

Pradaxa was marketed like many drugs in this “newer generation” of anti-coagulants to compete with warfarin, a blood-thinning medication that has been in use successfully for decades.

The marketing campaigns centered on what supposedly made Pradaxa different from warfarin – the lack of need to monitor blood levels and to make dietary changes during treatment.

Thousands of Pradaxa deaths and personal injury lawsuits were filed against Boehringer Ingelheim not long after its appearance on the market. In August 2012, a multidistrict litigation (MDL) was set up in federal court to handle these claims. This MDL eventually drew around 4,000 Pradaxa lawsuits.

Boehringer Ingelheim, the defendant, resisted the plaintiffs’ efforts to obtain documents from them. The result of this failure on their part was a hefty fine – nearly $1 million for abusing the discovery process. As political and public pressure mounted, the defendant decided to settle without the case going to trial.

The amount of the settlement for the thousands of Pradaxa deaths and personal injury lawsuits joined together was $650 million. The settlement was agreed upon in May 2014, and each complainant averaged a take home award in compensatory damages of $162,500. After the settlement, more litigants have come forward against Boehringer Ingelheim and continue to do so.

Pradaxa is often prescribed, like its tried and true counterpart warfarin, for patients with a short-term risk of blood clots such as total knee or hip arthroscopy patients. It is also prescribed for people who, for some reason, release clots from their lower extremities that can travel to the heart or lungs causing heart attack or respiratory arrest.

The syndromes are known as Deep Vein Thrombosis (DVT) and, when clots reach the lungs, Pulmonary Embolism (PE). Pradaxa is also prescribed for individuals with a diagnosis of atrial fibrillation which carries with it a higher risk of stroke.