An Illinois federal judge has ordered Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) to pay nearly $1 million as sanctions for discovery abuses in multidistrict litigation (MDL) involving its oral anticoagulant Pradaxa. U.S. District Judge David R. Herndon found that the drugmaker’s failure to produce thousands of documents amounted to bad-faith conduct. BIPI, along with German parent Boehringer Ingelheim International GmbH, can’t explain away their failure to enact a companywide litigation hold to preserve critical documents and communications by June 2012, when they knew a wave of product liability lawsuits over Pradaxa was inevitable, according to an order signed by Judge Herndon.
Noting that the court has repeatedly been asked to referee disputes in the case regarding “lost,” “accidentally destroyed” or “just recently discovered” evidence, Judge Herndon fined the companies $931,500 and ordered them to immediately make executives available for depositions in New York or another convenient locale for the Plaintiffs’ lawyers. Judge Herndon wrote:
The fine imposed today will not impact the defendants’ profit margins, but hopefully together with the potential future actions the court may be forced to take … the defendants will understand once and for all time compliance with the court’s orders is not an optional part of litigation strategy.
Among the materials that the court faulted the defendants for failing to preserve was the custodial file for Professor Thorstein Lehr, a former top scientist at Boehringher who was deeply involved with Pradaxa, but wasn’t even identified by the Defendants as a potential source of relevant information. The court’s order said that business-related text messages on certain employees’ cellphones were also lost or held back, as was evidence controlled by the Defendants’ sales representatives, clinical science consultants and medical science liaisons. A shared network between the companies — known as “G Drive” — was also plagued by production issues, according to the order.
The steering committee for the Plaintiffs brought its initial sanctions motion in September, prompting the court to impose a relatively small fine — just under $30,000 — and to order Boehringer to conduct an audit to fix the problems. However, the audit revealed even more “gaps” in the Defendants’ production and showed that their purported companywide litigation hold had been far too selective, according to the court’s order. Judge Herndon, in his order, wrote:
[T]he court relied on the presumption that the defendants were preserving all relevant documents of every description. It only came to light recently that such was not the case.
In the past two years, Boehringer has faced mounting litigation tied to the drug, which won U.S. Food and Drug Administration (FDA) approval in October 2010 to reduce clotting risks in patients with atrial fibrillation not caused by a heart valve problem. Drug users who claim they experienced bleeding events and other injuries began filing federal lawsuits as early as March 2012, after a study in the Archives of Internal Medicine linked Pradaxa with an increased risk of heart attack compared with other anti-coagulants.
The FDA launched an inquiry into Pradaxa in December 2011, saying it would investigate whether reports of bleeding in patients taking the drug are occurring more commonly than would be expected based on clinical trial data from its premarket approval process. However, the agency concluded in November 2012 that bleeding rates for new Pradaxa users “do not appear to be higher than bleeding rates associated with new use of warfarin,” a pre-existing drug widely used to treat atrial fibrillation. The FDA said it would not alter its recommendation regarding Pradaxa. In July, Judge Herndon refused to dismiss one case in the MDL, brought by Louisiana resident Mark Jackson, ruling the drugmaker hadn’t shown its labeling carried the necessary disclosures.
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