Sanctions Imposed on Boehringer Ingelheim for Pradaxa Discovery Abuses

Boehringer Ingelheim has been ordered by a federal judge to pay expenses associated with plaintiffs’ attorneys renting office space in Amsterdam during depositions in the Pradaxa lawsuits, as a sanction for the drug maker acting in bad faith during the discovery phase of the litigation and withholding or destroying important evidence.  

More than 2,000 product liability lawsuits have been filed against Boehringer Ingelheim throughout the federal court system by individuals who allege that the drug maker failed to adequately warn about the risk of serious and potentially life threatening injuries associated with uncontrollable bleeding on Pradaxa.

All federal complaints have been centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois for coordinated handling as part of an MDL, or multidistrict litigation.

On March 13, Judge Herndon issued a case management order (PDF) that imposed new sanctions against Boehringer Ingelheim, requiring the defendant to pay expenses incurred by plaintiff attorneys while they take depositions of employees of the drug maker.

In December, Judge Herndon fined the Germany-based company nearly $1 million for acting in bad faith and also ordered the company to send a number of its employees to the U.S. for deposition as part of the Pradaxa discovery process. However, the Seventh Court of Appeals overturned part of that order earlier this year, saying Judge Herndon had overstepped his bounds in forcing the employees to fly to the U.S. However, the financial sanctions were upheld.

Since attorneys representing plaintiffs in the litigation will now have to travel to Europe to conduct the depositions, Judge Herndon has ordered Boehringer Ingelheim to pick up the tab for those depositions, requiring the company to pay for plaintiff attorneys to rent sufficient office space in Amsterdam, the capital city of the Kingdom of the Netherlands. The order also requires the company to reimburse the costs of court reporters, videographers and interpreters the plaintiffs’ attorneys use while in Europe retroactively from December 9, 2013 until at least August.

The parties estimate that about 50 Boehringer Ingelheim employees will be deposed.

The judge rejected calls by plaintiffs’ attorneys to increase the previous fine to $20 million, but noted that Boehringer Ingelheim may face more sanctions in the course of the litigation. He also did not order the company to pay for the plaintiffs’ attorneys travel expenses.

Pradaxa Litigation

A small group of cases pending before Judge Herndon are being prepared for early Pradaxa trial dates, known as “bellwether” cases, which are expected to begin in September 2014.

All of the lawsuits contain similar allegations that the manufacturer failed to adequately warn consumers and the medical community about the potential bleeding side effects of Pradaxa, as well as the lack of an antidote that would allow doctors to stop the blood thinning effects of the medication. As a result, many doctors did not have a plan for counteracting the drug.

Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was approved by the FDA in October 2010. It was the first member of a new class of medications that are promoted as superior alternatives to warfarin, also known by the brand name Coumadin, for stroke prevention. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.

Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa was promoted as easier to use, because it requires less monitoring by the doctor during treatment, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.

Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.

There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced in October 2010.

During the first full year the drug was on the market in the United States, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.

These early Pradaxa trials are being closely watched by lawyers involved in the litigation, as they may help gauge how juries will respond to certain evidence and testimony that is likely to be similar to what is offered in other cases. Following a series of four trials, if Pradaxa settlement agreements are not reached to resolve a large portion of the cases, Judge Herndon may be remanding hundreds of cases back to U.S. District Courts throughout the country for individual trial dates.