Boehringer Ordered To Pay $931,000 for Lost Pradaxa Files

German drugmaker Boehringer Ingelheim was found guilty of withholding and/or failing to preserve numerous files which were wanted by Pradaxa bleeding victims who are suing the company for failing to warn about the risks of Pradaxa. As restitution, U.S. District Judge David Herndon has ordered Boehringer to pay a fine of $931,000.

Judge Herndon in St. Louis, Ill. is the overseer of more than 1,700 Pradaxa lawsuits which have been consolidated into multidistrict litigation (MDL). The plaintiffs claim that the drug caused excessive bleeding that sometimes turned fatal.

As a popular blood thinning medication, the purpose of Pradaxa is in fact to thin the blood, but some say that the effects can be over the top and there’s no “cure” for Pradaxa bleeding. Judge Herndon found that the executives of the company acted “in bad faith” when they didn’t ensure that key documents were preserved. These files reportedly included information on how the drug was developed and marketed, and may have been crucial in the upcoming Pradaxa trials.

According to Judge Herndon, “The wrongs here are egregious.” He calls the move (or lack thereof) a “gross inadequacy” and holds Boehringer responsible for keeping such files safe.

This situation happened just as the company is gearing up to tackle the first federal court trial, facing those who say that the Pradaxa bleeding risks were intentionally hidden. The first Pradaxa lawsuit trial is set for August 2014, and there are also cases in other states including California, Connecticut and Delaware.

A spokeswoman for Ingelheim, the U.S. arm of Boehringer, stated in an email: “Boehringer Ingelheim has acknowledged that we have had unintentional and unexpected problems with discovery in this litigation. We do not believe these problems have prevented the plaintiffs from obtaining access to a very wide range of documents regarding Pradaxa, including the central science, safety and regulatory documents regarding the medicine.”

There’s one common thread woven through almost every Pradaxa claim: The plaintiffs allege that the executives of Boehringer had knowledge that the drug could be deadly.

Pradaxa has only been available in the United States since 2010 and, unlike other blood thinners (according to researchers), there’s no antidote available that can reverse the Pradaxa bleeding. Some victims have simply bled out and there was nothing doctors could do.

According to Pradaxa bleeding survivors and/or their heirs, the company had plenty of information about the full Pradaxa complications before the drug was brought to America. However, the plaintiffs allege that perhaps the profits were just to tempting to pass up. Around the globe, Pradaxa has created more than $1 billion in sales for the company, which is also the world’s largest family-owned drugmaker.

The plaintiffs claim that Boehringer intentionally marketed Pradaxa as better than all other blood thinners on the market. However, it’s also been connected to more than 500 deaths in the United States alone during just a two-year time frame. Some critics also say that the drugmaker knew that bleed outs were possible (this information comes from a federal panel charged with tracking the details of class action lawsuit), but that Boehringer moved forward with U.S. marketing and distribution anyway.

The U.S. Food and Drug Administration (FDA) first approved Pradaxa in 2010, claiming that it was both safe and effective as an alternative for the staple Coumadin, which has been in the United States for more than 60 years. A warfarin brand, Coumadin, was the go-to blood thinner of choice for decades until Pradaxa hit the market.

The Beginning of Rumors

It wasn’t long after Pradaxa became available in the United States that murmurings began about the real safety issues. The FDA received 542 reports of death and almost 4,000 reports of non-deadly Pradaxa side effects in 2011 alone. As for patients, they say that the company should have been much stricter when it came to ensuring that employees preserved the documents which have since been lost. Basically, they argue a “litigation hold” should have been put on the documents. Additionally, Boehringer employees allegedly weren’t required to save and store phone messages regarding their work on the drug.

In response, the company said it’s created 32 million pages of material about Pradaxa, which is available to the plaintiffs, but complain that they’ve been buried in “overly burdensome” requests since the claims began. Furthermore, the company says many of the materials requested aren’t even relevant.

However, Judge Herndon disagrees, saying that he’s had to deal with claims that Boehringer was “improperly withholding” files since the Pradaxa litigation began in 2010. He says that the company “failed to ensure the auto-delete feature of their employee cellphones, company owned and personal, was disengaged for the purpose of preserving text messages” which “allowed countless records to be destroyed.”

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

Did Pradaxa Impact You?

If you or a loved one were hurt by Pradaxa, you might have a Pradaxa legal claim and it may not be too late to join a class action lawsuit. Find out more by visiting the Pradaxa Internal Bleeding Class Action Lawsuit Investigation right now. Once your information is received, an attorney will be in touch if you have a case for a free Pradaxa claim review.