Despite settling a large number of Pradaxa lawsuits, drug manufacturer Boehringer Ingelhiem is expected to face a second wave of claims over Pradaxa internal bleeding complications.

Pradaxa, known generically as dabigatran, is the first of a new generation of anticoagulant medications that were designed to avoid some of the drawbacks associated with the older anticoagulant warfarin.

These drugs were designed so that users would not need to undergo the regular blood testing and dosage adjustments that warfarin patients must submit to.

They are now in widespread use – particularly among patients with atrial fibrillation, who use anticoagulants to reduce their risk of stroke and other blood clot-related injuries.

But just like with other anticoagulant medications, patients using Pradaxa face a risk of developing Pradaxa internal bleeding complications.

By their nature, these drugs tend to make bleeding injuries more likely to happen and harder to get under control.

Raising the stakes associated with that risk is the fact that at the time Pradaxa was introduced to the market, there was no antidote available that could counter its anticoagulant effect.

Unlike with warfarin, which could be counteracted by administering vitamin K, Pradaxa had the potential to cause bleeding that could not be controlled with other medication.

Litigation Begins over Pradaxa Internal Bleeding Complications

Not long after Pradaxa was put on the market, reports of excessive Pradaxa bleeding injuries emerged.

The FDA received a large number of reports of adverse events that appeared to be related to Pradaxa.

Plaintiffs soon began filing Pradaxa lawsuits taking drug maker Boehringer Ingelheim to task for allegedly failing to warn patients about the potential risks.

In August 2012, the federal Judicial Panel on Multidistrict Litigation created a single multidistrict litigation, or MDL, to handle all federal claims related to Pradaxa internal bleeding complications.

The JPML transferred the first few claims from around the country to the U.S. District Court for the Southern District of Illinois, to be overseen by District Judge David R. Herndon.

The federal court system sometimes used the MDL procedure when a large number of claims allege similar facts and legal theories.

Consolidating these claims into a single procedure allows the court to coordinate pretrial procedures and avoid inconsistent rulings on pretrial matters.

The 2014 Pradaxa Settlement

In May 2014, Boehringer Ingelheim agreed to settle all pending claims in the MDL for a total of $650 million. By that time, the number of claims in the MDL had grown to about 4,000

Since the 2014 settlement, plaintiffs’ lawyers say they plan to continue bringing Pradaxa lawsuits – as more and more patients continue to develop new Pradaxa internal bleeding complications. This “second wave” of Pradaxa lawsuits is expected to be brought in state courts.

But although the federal MDL produced a considerable body of evidence through its massive coordinated discovery process, a decision by Judge Herndon will keep that discovery off-limits to plaintiffs in new Pradaxa lawsuits.

The judge granted Boehringer Ingelheim’s request that all confidential discovery produced in the federal MDL be either destroyed or returned to the company. The company is expected to reproduce these documents on a case-by-case basis as new Pradaxa claims arise.