Pradaxa—one of the New Oral Anticoagulants (NOACS)—was created to compete with warfarin, a long-standing blood-thinner used successfully with patients for decades.

Approved by the U.S. Food and Drug Administration (FDA) in 2010, Pradaxa soon became the target of thousands of product liability claims. In its first year on the market, the NOAC was linked to 540 deaths.

Boehringer Ingelheim — the blood-thinning drug’s manufacturer—finally offered a $650 million settlement to resolve over 4,000 cases of Pradaxa litigation in 2014.

It was not the end of the problem for the pharmaceutical developer that had applied for a new drug application allegedly knowing there was no remedy for out-of-control bleeding that could occur. Pradaxa litigation continues to mount with lawyers now filing actions in the State of Connecticut where Boehringer Ingelheim is headquartered.

Presently, the company faces 2,400 cases of Pradaxa litigation in the State of Connecticut Courts. The lawsuits that are part of this massive body of Pradaxa litigation come with similar allegations as the preceding 4,000 settled 2014 cases.

The drug is purportedly connected to dangerous side effects such as bleeding in the brain, gastrointestinal tract and rectal region. These bleeding side effects have been linked to the death of several patients and severe injuries in others.

Pradaxa litigation cases point to the delayed push to get approval for the NOAC’s remedy—Praxbind—as an example of gross negligence and recklessness on the part of the pharmaceutical company.

While Praxbind was supposedly developed around the same time Pradaxa was approved, there was allegedly no effort to seek its approval until late February 2015—a full five years later. Praxbind was approved by the FDA in October of that year.

Pradaxa litigation cases also point to advertising practices surrounding the blood-thinning that were allegedly deceptive. In an effort to set Pradaxa apart from warfarin which requires frequent blood monitoring, dietary changes and more than once-per-day dosing, plaintiffs allege Boehringer Ingelheim built up the NOAC on the basis of its convenience.

Supposedly, there was no need to take it more than once a day, and blood-monitoring and the changing of diet was no longer necessary.

Because filing in the federal MDL isn’t an option any longer, two of four bellwether trials that are part of this state Pradaxa litigation have been completed this year. The first trial was set for March 2018 and was brought by the estate of Mary B. Mary allegedly passed away from an uncontrollable bleeding event affecting her gastrointestinal tract in 2014. She was taking Pradaxa to reduce stroke risk secondary to atrial fibrillation.

The second of the four scheduled bellwether trials concerned Mary Lou G. Mary Lou also took the NOAC to reduce the risks associated with atrial fibrillation. She alleges she suffered a large but unidentified bleeding event in 2014. In these two cases, the jury offered a favorable verdict toward the defendants.

The next two trials are set for September 2018 and February 2019. Parties and attorneys will use the arguments and evidence presented in these four scheduled trials to test the waters for future Pradaxa litigation.