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Federal Judge Fines Boehringer Ingelheim for Bad Faith in Pradaxa Lawsuits

Boehringer Ingelheim Pharmaceuticals Inc. (BIPI), was fined nearly $1 million for discovery abuse in Pradaxa multidistrict litigation, currently pending in Illinois. U.S. District Judge David R. Herndon, who is overseeing the MDL, said BIPI failing to produce thousands of documents resulted in bad-faith conduct.

BIPI, and its parent company Boehringer Ingelheim International GmbH, cannot explain why they failed to follow a companywide litigation hold to maintain critical documents and communications by June 2012, when they knew Pradaxa would be hit with a rash of product liability lawsuits, noted an order signed by Judge Herndon.

The companies were fined $931,500, after Judge Herndon noted that the court has had to mediate disputes in the case over lost, accidentally destroyed, or “just recently discovered” evidence. Executives for the companies were ordered to be immediately available for depositions in New York or a location convenient for the plaintiffs’ counsel.

Defense withholds evidence in Pradaxa lawsuits

One of the documents the defendants failed to maintain was the custodial file for Professor Thorstein Lehr, formerly a leading scientist at Boehringer, who was very involved in Pradaxa, was not recognized by defense counsel as a possible source of important information.

The defendants kept many other important sources of evidence away from the Pradaxa lawsuits, such as business-related text messages on specific employees’ cellphones, evidence controlled by sales reps, clinical science consultants, medical device liaisons, and a shared network between the companies.

The court imposed a much smaller, $30,000 fine on the defendants in September, and ordered the company to conduct an audit to fix the problems, after the plaintiffs’ steering committee brought its initial sanctions motion. The audit revealed even more misconduct in the actions of the defendants’, revealing a far too selective companywide litigation hold.

Pradaxa bleeding complications

Pradaxa received FDA approval in October 2010, to decrease blood clotting risks in patients with atrial fibrillation not caused by a heart valve problem, but Boehringer has experienced a rise in lawsuits concerning the drug over the past two years.

According to court records, Patients who allege Pradaxa bleeding complications started filing federal lawsuits in March 2012, following a study in the Archives of Internal Medicine tying the drug to an increased risk of heart attack when weighed against other anti-coagulants.

The FDA began investigating Pradaxa in December 2011, saying it would examine whether Pradaxa bleeding side effects transpire more frequently than expected based on clinical trial data from the pre-market approval process of the drug.

In November 2012, the study concluded that Pradaxa bleeding rates were not higher than experienced with new users of warfarin, a long-established drug used to treat atrial fibrillation. The FDA chose not to amend its recommendation regarding the drug.

In July 2013, Judge Herndon refused to dismiss a case in the MDL brought by a Louisiana resident, ruling that the defendant had failed to show its labeling carried the necessary disclosures.

Currently, more than 1,700 lawsuits are pending under Pradaxa bleeding complications MDL 2385. Multidistrict litigation helps the court to conserve resources and maintain consistent rulings in different lawsuits of a similar nature.

  1. FDA, Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events,

  2. U.S. District Court for the Southern District of Illinois, MDL 2385 - Pradaxa (Dabigatran Etexilate) Products Liability Litigation,