Patients who suffered a Pradaxa injury still have the option of bringing a claim against the drug’s manufacturer.

Pradaxa is the first of a new generation of anticoagulants that began to enter the market in 2010. For decades, there was only one anticoagulant medication – namely, warfarin, also sold under the brand name Coumadin – that was approved by the FDA to reduce the risk of stroke associated with atrial fibrillation.

While warfarin is effective for that use, patients taking the drug have to submit to certain inconveniences. Regular blood testing and dosage adjustment is necessary to ensure they’re getting the right dose.

And because vitamin K reverses warfarin’s anticoagulant effect, patients must avoid foods that contain significant amounts of that nutrient.

Pradaxa was the first new oral anticoagulant to offer patients an alternative to warfarin. Introduced in 2010, Pradaxa was designed so that patients could take it without submitting to blood testing or dietary restrictions.

Pradaxa Injury Reports

Not long after Pradaxa was introduced, reports of Pradaxa injury began rolling in.

Patients were suffering from injuries involving excessive bleeding, like gastrointestinal bleeds and intracranial hemorrhages – some of which were severe enough to put the patient’s life at risk.

QuarterWatch, a publication that monitors reports of drug-related adverse events filed with the FDA, reported that there were over 500 adverse bleeding events reported in association with Pradaxa treatment in 2011 alone.

Aggravating the risk of excessive bleeding associated with Pradaxa was its lack of an antidote. Warfarin patients don’t face such a problem: in case of bleeding, they can administer vitamin K to counteract warfarin’s anticoagulant effect.

But Pradaxa did not have an antidote available for its first several years on the market. That meant that patients who suffered a Pradaxa injury had no medical way to get Pradaxa’s anticoagulant effect under control.

Pradaxa Litigation

The risk of bleeding associated with Pradaxa became the subject of thousands of products liability lawsuits.

Many patients who ended up with a Pradaxa injury felt the warnings issued by manufacturer Boehringer Ingelheim understated the real risks they were made to face. Some also took issue with the lack of an antidote, arguing that it made Pradaxa an excessively dangerous drug.

Claims in the federal court system became so numerous that a judicial panel consolidated them into a single multidistrict litigation, or MDL, to help process them more efficiently.

In May 2014, Boehringer Ingelheim worked out a mass settlement of thousands of MDL claims. The settlement resolved around 4,000 individual Pradaxa lawsuits for a total price tag of $650 million.

The 2014 settlement covered claims filed at the time of the settlement. However, it also does not preclude new Pradaxa patients from bringing their own new claim.

Attorneys involved in Pradaxa litigation expect there will be a continuing influx of claim in state court now that the federal MDL has been wrapped up. Patients who have suffered a new Pradaxa injury still have the option of bringing their own claims against the manufacturer.