More Sanctions in Pradaxa Lawsuits Could Be Levied Against Manufacturer

After noting that Boehringer Ingelheim may have withheld negative information about Pradaxa during discovery, the federal judge presiding over hundreds of lawsuits is threatening to sanction the drug maker again for acting in bad faith during the litigation.

Just a week after U.S. District Judge David R. Herndon hit Boehringer Ingelheim with a fine of more than $900,000, a case management order (PDF) was issued by the Court that threatens to fine the company again in regards to the files of Professor Thorstein Lehr; a former company employee and scientist who worked on the development of Pradaxa.

According to the order entered by Judge Herndon on December 18, the drug maker failed to keep crucial files and claims it cannot provide them as the court has required, leaving it open for more fines and other sanctions.

Judge Herndon is currently presiding over more than 1,700 Pradaxa lawsuits filed against Boehringer Ingelheim on behalf of individuals who allege that they suffered severe bleeding problems that doctors were unable to stop or control. In the federal court system, the cases have been centralized for coordinated pretrial proceedings as part of an MDL, or Multidistrict Litigation.

The complaints all involve similar allegations that the drug maker failed to adequately research the medication or warn about the potential side effects of Pradaxa, as well as the lack of a reversal agent that could allow doctors to counteract the blood thinning caused by the anticoagulant.

As part of the coordinated pre-trial proceedings, Judge Herndon has established an aggressive discovery schedule, which calls for the first Pradaxa trials to begin in the second half of next year, with four cases scheduled to go before juries on August 11, 2014, November 3, 2014, January 5, 2015 and February 16, 2014.

These early Pradaxa trials, known as “bellwether” cases, are designed to help the parties gauge how juries may respond to certain facts and testimony that may be offered throughout a large number of similar cases. The outcomes are designed to further Pradaxa settlement negotiations and potentially facilitate a resolution for the litigation.

Boehringer Ingelheim May Have Destroyed, Hid Evidence

On December 9, Judge Herndon hit the company with $931,500 in sanctions for failing to produce or preserve documents important to the litigation. Judge Herndon accused the company of acting in bad faith throughout the litigation and for giving poor excuses for not preserving or turning over the files.

Following a court order to turn over the professor’s relevant files, the company told the court that only his e-mails had been properly maintained. The company reports that Lehr’s laptop, desktop computer and blackberry phone are all gone, but that the company has found his “user share” files, which it previously said were unavailable.

Judge Herndon wrote that the company has provided inaccurate information regarding the data it can provide for Professor Lehr in previous affidavits, suggesting that the company has acted “unreasonably, negligently, willfully, and in bad faith.”

“[T]he Court finds the plaintiffs have presented sufficient evidence to establish [Boehringer Ingelheim] destroyed or failed to preserve Dr. Lehr’s laptop, desktop, and blackberry, in bad faith, for the purpose of hiding adverse information,” Judge Herndon wrote.

He said the sanctions will be decided at the end of the Bellwether Discovery and those being considered in relation to Professor Lehr’s files include the striking of certain affirmative defenses, preventing the company from making certain arguments at trial, deeming certain facts admitted at trial or providing an adverse inference jury instruction, which would mean that the jury will be that the failure to preserve documents may be considered as evidence that the drug maker was protecting itself from legal repercussions.

Pradaxa Bleeding Concerns

Pradadxa (dabigatran) is a relatively new anticoagulant therapy 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 does require less monitoring, 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.

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.