German drug maker Boehringer Ingelheim continues to face litigation from U.S. consumers over claims that its blood thinning drug Pradaxa causes life-threatening bleeding injuries, despite agreeing to pay $650 million last year to resolve nearly 4,000 Pradaxa lawsuits.

One of the latest Pradaxa lawsuits to be filed comes from New Jersey plaintiff Mildred B., who — like thousands of other plaintiffs — alleges that Boehringer was aware, or reasonably should have been aware, of the dangers associated with Pradaxa.

Pradaxa is an anticoagulant designed to make it harder for patients with atrial fibrillation to form blood clots. This is very useful for patients who are at high-risk for stroke, pulmonary embolism, or other disorders wherein the clotting process can misfire and form a clot inside the body. However, as this Pradaxa lawsuit alleges, blood thinning drugs like Pradaxa may carry risks of their own.

According to her complaint, Mildred states that she took the drug starting in March of 2011 and used it for more than a year without any complications. However, in June of 2014, the plaintiff experienced uncontrollable bleeding that required emergency medical care. Mildred narrowly survived, the Pradaxa lawsuit claims.

Uncontrollable bleeding is the main allegation raised in thousands of Pradaxa lawsuits, which accuse Boehringer of failing to warn patients and the medical community that a bleeding antidote does not exist for Pradaxa, unlike its predecessor drug Warfarin (Coumadin).

The problem, these lawsuits contend, is that Pradaxa was heavily marketed as a new superior alternative to Warfarin without properly informing the public of its risks.

Boehringer agreed to a massive $650 million settlement in 2014 to resolve nearly 4,000 Pradaxa lawsuits filed by patients and their families who claimed the drug maker failed to properly warn them that the drug caused serious and sometimes fatal bleeding that could not easily be reversed.

Pradaxa Marketing on Trial

Older-generation anticoagulants like Warfarin had several drawbacks. They required more doses per day, and regular blood testing. Additionally, since older blood thinners worked by interfering with Vitamin K (normally part of the blood clotting process), patients had to carefully restrict their diets to avoid Vitamin K and interfering with the drug.

These all became marketing points when drug makers debuted a new generation of blood-thinners — Pradaxa, Eliquis and Xarelto — which, according to promotional material, did not require blood testing; they only required a single dose, and required no dietary restrictions.

But alarmingly, newer-generation blood thinners like Pradaxa carry a serious drawback: they do not carry an antidote to stop bleeding in patients taking these drugs.

If patients on Warfarin experience uncontrollable bleeding, doctors could administer a very high dose of Vitamin K, allowing them to form blood clots and stop bleeding. However, newer-generation anticoagulants like Pradaxa have no known reversal agent. Instead, doctors can only treat the symptoms of internal bleeding, providing massive blood transfusions in the hopes that the patient will live long enough to work the Pradaxa out of their system.

Additionally, Pradaxa lawsuits like the one filed by Mildred allege that research strongly suggests that patients taking Pradaxa and other newer blood thinners could benefit from regular blood testing, undermining some of the marketing claims for these newer drugs.

Despite hundreds of reports of alleged Pradaxa bleeding incidents, the drug has generated billions for the drug’s makers. A major factor in this is that Pradaxa is on-patent.

For a set amount of time after a drug is made, the patent holder owns the exclusive rights to the drug, and drug makers do not have to compete against other drug makers. Once this patent expires, drug makers often have to lower their prices, as competing generic brands lower the demand for their drug.

Older blood thinners like Warfarin have expired patents, while newer drugs like Pradaxa are still on-patent, potentially motivating drug companies to market them despite safer, but less profitable drugs.

The Pradaxa lawsuit is Case No. 0539, within the larger MDL In Re: Pradaxa (Dabigatrain Etexilate) Product Liability Litigation, MDL No. 2385, filed in the United Stated District Court for the Southern District of Illinois, East Saint Louis Division.