In an attempt to escape a wrongful death lawsuit, Boehringer Ingelheim told a federal court that Pradaxa warnings were adequate.

The blood thinner maker urged U.S. District Judge William Young to grant its motion for summary judgment in a holdover case from the multidistrict litigation involving the alleged wrongful death of a retired doctor, Zhensheng L.

Zhensheng died in November 2012 after suffering irreversible brain bleeding following a fall.

His doctors attributed the uncontrollable internal bleeding to his use of Pradaxa, which Zhensheng began taking in 2011, just five months after the drug was FDA approved, to lower the risk of stroke due to his atrial fibrillation.

Drug Maker Says Pradaxa Warnings Adequate

The Pradaxa wrongful death lawsuit is set to commence next month, but Boehringer Ingelheim is attempting to have it dismissed, maintaining Pradaxa warnings about internal bleeding and the potential for death were adequately provided in the drug’s labeling.

Zhenseng’s family claims, however, that Pradaxa warnings fell short in telling patients and the medical community that there was no antidote to reverse the anticoagulation effects of the blood thinner – and that disabling, life-threatening complications could ensue.

Zhenseng’s family has provided an expert’s affidavit that takes issues with the adequacy of Pradaxa warnings.

However, Boehringer Ingelheim challenges the claims raised by the affidavit and the lawsuit, stating they failed to create a genuine dispute about material facts and that the claims are preempted by federal law.

Additionally, the blood thinner maker says that Pradaxa warnings were very clear about the potentially fatal or life-threatening internal bleeding risks.

Boehringer Ingelheim settled thousands of Pradaxa lawsuits in 2014 to the tune of $650 million.  However, due to the date the Zhenseng died, the family was unable to participate in the settlement.

What is Praxada?

Pradaxa is a blood thinner approved by the FDA in 2010 for patients with irregular heartbeat. When introduced, it was celebrated as the first replacement of the decades-old drug warfarin, the leading stroke-prevention pill — but one that requires weekly exams and calls for dietary restrictions.

Pradaxa, by contrast, required fewer doctor check-ups and did not make patients eat selectively.

Beyond that, warfarin’s side effects include brain hemorrhages and other types of internal bleeding. Pradaxa stepped into the lucrative market as an easier, safer alternative.

The new drug was launched by German drug maker Boehringer Ingelheim, one of the largest pharmaceutical companies in the world.

Boehringer spent $464 million in 2011 to promote Pradaxa, including direct-to-consumer advertising. During the same period, the company’s sales topped $1 billion.

However, just one year after approving Pradaxa, the FDA received reports of nearly 3,800 adverse effects and 542 deaths associated with the blood thinner.

In fact, Pradaxa adverse reports and deaths surpassed all other monitored drugs, prompting the FDA to issue a safety announcement about reports of serious bleeding events in patients taking the drug.

Filing a Pradaxa Lawsuit

Pradaxa patients who experienced severe injury from treatment may be eligible to file a Pradaxa lawsuit against Boehringer Ingelheim. Those who experienced a family death may also be eligible to file a Pradaxa lawsuit for their loss.

Individuals who wish to file a Pradaxa lawsuit should speak with a knowledgeable attorney as soon as possible. An attorney can help answer questions and discuss legal options to move forward with a Pradaxa lawsuit.

The Pradaxa Wrongful Death Lawsuit is Case No. 14-cv-13234-WGY in the U.S. District Court for the District of Massachusetts.