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Boehringer Ingelheim, the manufacturer of blood-thinning drug Pradaxa, was recently fined nearly $1 million because it allegedly lost and destroyed important files. District Judge David Herndon, who is overseeing the coordinated Pradaxa lawsuits currently proceeding in the Southern District of Illinois, required the fine in a recent court order.

Plaintiffs filing claims against Boehringer Ingelheim claim the company failed to provide adequate warnings concerning the risks of excessive bleeding and even death with Pradaxa, and also failed to warn doctors of the lack of any readily available reversal agent.

Defendants Fail to Produce Documents

According to a Bloomberg report, Judge Herndon concluded Boehringer executives acted in bad faith by failing to preserve the documents and files about the drug’s development and marketing. In Case Management Order Number 50, signed December 9, 2013: “Almost since its inception, this litigation has been plagued with discovery problems primarily associated with misconduct on the part of the defendants. The Court is continuously being called upon to address issues relating to untimely, lost, accidentally destroyed, missing, and/or ‘just recently discovered’ evidence.”

The judge goes on to state that the defendants’ justifications for these violations have included the following:

• Placing the blame on others such as third-party vendors or their own employees
• Blaming the defendants’ and/or counsel’s lack of experience in addressing litigation of this size
• Stating they didn’t know until recently that Pradaxa lawsuits would turn into a large nationwide MDL
• Blaming technical issues, such as an accidentally erased hard drive
• Minimizing the violations, stating the documents were not really needed
• Stating the discovery requests are too broad in scope
• Saying they didn’t know about the gaps in their production until September 2013

Excerpts from a September 18, 2013 ruling quote the judge as stating, “I’ve never seen a litigation where the problems are just ongoing and continual, and every month or every week there’s an issue of this failure or that failure and the other failure. It just is astounding.”

Pradaxa Tied with Serious Bleeding Events

Among the materials the defendants allegedly failed to preserve was the custodial file for Professor Thorstein Lehr, a former scientist at the company who was very involved with Pradaxa, but wasn’t identified by the defendants as a source of information. Business-related communications such as text messages were also lost or held back, as was evidence from sales representatives and clinical science consultants.

Pradaxa received FDA approval in October 2010, but since then has been linked with serious bleeding events. In 2011, the FDA received reports of 542 deaths and 3,781 side-effects incidents tied to the drug. Unlike warfarin, the leading anti-coagulant for decades, Pradaxa has no readily available antidote for bleeding emergencies—a fact that the company failed to communicate properly.

The specific amount of the fine against Boehringer Ingelheim was $931,500, or $500 per case. Judge Herndon encouraged the defendants “to respect this Court and comply with its orders.”

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