Pradaxa is a new generation blood thinner that launched in 2010. The first of a new group of alternatives to the traditional clot-buster warfarin, Pradaxa hit the market with great fanfare.

However, after coming into real-world use, reports of dangerous Pradaxa bleeding side effects started to mount.

The new age anticoagulant is prescribed to patients to help prevent strokes in individuals who suffer a condition called atrial fibrillation.

Just after roughly two years on the market, Pradaxa earned manufacturer Boehringer Ingelheim Pharmaceuticals more than $1 billion in sales revenue.

Pradaxa was the first of a new category of anticoagulants. Before Pradaxa, a blood thinner called warfarin (Coumadin) was used for nearly 60 years.

However, according to the U.S. Food and Drug Administration (FDA), roughly 725,000 U.S. patients have used Pradaxa.

Thousands of these patients experienced adverse effects including uncontrollable internal bleeding. A number of Pradaxa lawsuits have been filed from injured patients and families who lost a loved one to Pradaxa side effects.

Pradaxa Complications

In 2011, one year after the new blood thinner came to market, the FDA received 3,781 adverse event reports and 542 deaths associated with Pradaxa use.

The Institute for Safe Medication Practices reported that Pradaxa is linked to more injury and death reports than any of the 800 drugs that it regularly monitors.

The problem with Pradaxa — and the foundation for the most grievous of Pradaxa side effects—is the inability to reverse serious bleeding once it starts. Warfarin, the predecessor of Pradaxa, can be reversed with the use of Vitamin K, which serves as a means to reverse the anti-clotting qualities of warfarin, allowing the blood to resume the clotting necessary to stop uncontrolled bleeding.

Unfortunately, there is no antidote that can reverse the bleeding that Pradaxa can cause, with many patients suffering from fatal rectal, brain, and gastrointestinal bleeding. Many find it shocking that the FDA approved a drug with untreatable fatal side effects.

Overview of Pradaxa Allegations

Pradaxa lawsuits are being filed on the basis that Boehringer Ingelheim Pharmaceuticals used deceptive marketing practices to promote the drug.

Boehringer marketed the drug as a safer and more effective alternative to warfarin. However, evidence suggests that Pradaxa has equal or higher risks of internal bleeding.

Additionally, Pradaxa was misrepresented as a “one-size-fits-all” treatment. Checkups and dosage adjustments were not required in the instructions, as they are with warfarin.

Many claim that Boehringer Ingelheim Pharmaceuticals was negligent by not establishing protocol for treating Pradaxa bleeding episodes.

The company recommends dialysis treatment to help flush the patient’s body of the drug. However, medical professionals assert that dialysis treatment is unrealistic and difficult to tolerate by patients who may be bleeding to death.

It is alleged that the company failed to adequately warn the public of the risks of using Pradaxa. Many believe that Pradaxa was released onto the market prematurely, since there is no option for reversing the potentially deadly effects.

Pradaxa Lawsuit Status

Pradaxa lawsuit claims that were filed in federal court have since been consolidated into a multidistrict litigation (MDL).

In May 2014, Boehringer Ingelheim Pharmaceuticals agreed to settle around 4,000 claims regarding Pradaxa for a total of approximately $650 million. The Pradaxa settlement covers claims in both state and federal courts. In agreeing to the settlement, Boehringer Ingelheim did not admit to any liability.

Although Boehringer Ingelheim Pharmaceuticals agreed to settle thousands of Pradaxa lawsuits, the drug maker is still facing thousands more claims in federal court, alleging that users suffered severe and often fatal bleeding problems after using the controversial anticoagulant.

Nearly 3,000 Pradaxa lawsuits are currently consolidated in a multidistrict litigation known as In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL 2385, in the U.S. District Court for the Southern District of Illinois.