Pradaxa, also known by its generic name dabigatran, is an anticoagulant drug often used to alleviate the risk of stroke faced by patients with atrial fibrillation.

It’s also used to prevent and treat blood clot-related conditions like pulmonary embolism and deep venous thrombosis in patients who’ve recently undergone surgery, particularly hip or knee replacement surgery.

When blood thinning drug Pradaxa was approved by the FDA in 2010, it was the first anticoagulant to enter a market dominated for decades by warfarin.

Drug companies had sought to develop an alternative to warfarin that would avoid some of warfarin’s drawbacks – particularly the need for dietary restrictions and for regular blood testing.

While Pradaxa does avoid those drawbacks, it can’t avoid the risk common to all blood thinners that they may precipitate episodes of excessive bleeding.

Compounding that risk was the fact that Pradaxa was approved by the FDA even though there was no available antidote on the market.

While an antidote, Praxbind, has since been approved, for about the first five years that Pradaxa was on the market there was no medication available that could reverse its anticoagulant effect.

Within months of Pradaxa’s approval by the FDA, evidence of its associated bleeding risk began to manifest in reports to the FDA’s Adverse Event Reporting System.

Since it became available for use, blood thinning drug Pradaxa has been the subject of over 4,000 reports of adverse events. Of those cases, over 500 ended in the patient’s death.

Studies comparing blood thinning drug Pradaxa to warfarin also showed that Pradaxa led to more frequent episodes of gastrointestinal bleeding. Still, the FDA has declined to take Pradaxa off the market.

Pradaxa Litigation

Patients who feel they weren’t adequately warned about the bleeding risk associated with blood thinning drug Pradaxa began to file Pradaxa lawsuits by the thousands, alleging their episodes of dangerous and even life-threatening bleeding could have been avoided if manufacturer Boehringer Ingelheim had issued a proper warning.

An earlier wave of federal Pradaxa lawsuits ended in a mass settlement in May 2014.

Due to the number of individual claims and the complexity of the medical evidence involved, the federal Judicial Panel on Multidistrict Litigation consolidated a group of existing Pradaxa lawsuits into a single multidistrict litigation, or MDL, to be conducted in a federal court in Illinois.

After that, new Pradaxa lawsuits filed elsewhere in the federal court system were transferred to the Illinois MDL. By May 2014, there were around 4,000 active Pradaxa lawsuits filed, including those filed in state court.

Before these claims began to go to trial, Pradaxa manufacturer Boehringer Ingelheim decided to wrap them all up with a single mass settlement worth $650 million.

New Claims over Blood Thinning Drug Pradaxa

The 2014 mass settlement covered only existing claims. Since then, a new round of litigation has been sprouting up, this time in various state courts.

Plaintiffs who suffered Pradaxa-related bleeding but were not covered by the 2014 settlement still have the option of bringing a new Pradaxa claim.