More Than 2,000 Plaintiffs Join Pradaxa MDL Over Bleeding Problems

Boehringer Ingelheim, the makers of the anticoagulant drug Pradaxa, is now facing over 2,000 Pradaxa lawsuits filed by patients severely injured by the blood thinning medication. These patients say that the drug caused them to experience serious Pradaxa side effects, and some loved ones have joined, citing that the drug was fatal.

All of these 2,000+ Pradaxa lawsuits were filed in the United States, although the very first Pradaxa complaint was covered in a German media outlet. However, during this massive Pradaxa multidistrict litigation (MDL), the makers of the drug have remained adamant that the amount of “bleeding events” are right on par with what was expected when managing clinical trials. On the other hand, doctors began noting that they had zero control over excessive bleeding when patients were given Pradaxa. In some cases, “bleeding out” couldn’t be stopped. Unlike warfarin, the other main anticoagulant on the market, there’s no antidote for Pradaxa.

At the core of the Pradaxa MDL is the assertion that the company didn’t properly warn the medical community, patients or consumers about the full Pradaxa bleeding side effects. The plaintiffs also claim that they weren’t warned that there was no antidote. Patients allege that they didn’t know their doctors had no control over the excessive bleeding, leading to issues when physicians may have unintentionally made decisions that exacerbated the side effect.

Pradaxa has been facing these lawsuits since the summer of 2012, when they were first consolidated in Illinois by U.S. District Judge David Herndon. When there are so many similar complaints, an MDL can centralize and streamline the process. Bellwether trials are scheduled to begin from August 2014 to February 2015, and these will decide how juries are most likely to respond to key testimony and evidence. It’s a benchmark for both parties, and a time when a better grasp will be had on what’s likely to come. By joining an MDL, victims can enjoy a faster resolution while still getting their own trial by jury. However, double discovery is avoided since basic facts, such as the history of the drug and related research, don’t have to be showcased over and over again.

Judge Herndon stated during the initial discovery phase that the makers of the drug acted in bad faith. He says that they intentionally withheld documents or destroyed them when the documents were relevant to the MDL. In December 2013, Judge Herndon stated that the company must be sanctioned almost $1 million since the company allegedly didn’t maintain the records of employees who were involved with the development and marketing of the drug. Additionally, the company might be hit with even more fines over similar actions, and juries will be advised to consider these bad faith moves during the litigation.

Other important documents that were released revealed that the company had updated conclusions on a more recent study. The judge discerned that the company had an idea that patients might need more medical monitoring than originally suggested, solely because of potential bleedouts. This assertion was in opposition to some of the company’s previous marketing points, which stated that Pradaxa patients needed no monitoring. This was a big selling point since medical monitoring requires extra time and money. The documents also suggested that the company did indeed have data showing that people may metabolize the drug differently.

Inner Turmoil

The documents that have been released show that a number of employees were worried about the research findings from clinical program director Paul Reilly. His research suggested that patients shouldn’t be aware of the Pradaxa complications. The findings were recently published in the Journal of the American College of Cardiology. In the documents, it’s also suggested that the research would harm the marketing efforts for Pradaxa. At the same time, other employees were adamant that the findings should be made public (but done in a “smart” way so that Pradaxa was still profitable).

According to records, in the first year that Pradaxa was available, the Institute for Safe Medication Practices discovered that a number of Pradaxa complications were present, and there were actually more Pradaxa complications than there were from all other drugs the group monitored. In 2011 alone, the U.S. Food and Drug Administration (FDA) received nearly 4,000 reports of Pradaxa injuries including 542 deaths and 2,367 reports of hemorrhaging.

The Pradaxa MDL is In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

Join the Pradaxa MDL & Seek Compensation

Did you or a loved one suffer from Pradaxa side effects? If so, you may qualify for a Pradaxa legal claim and might deserve compensation. To find out more, visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. Once your information is received, an attorney will be in touch with you if you have a case for a free Pradaxa claim review.