Boehringer to Pay $931,000 Fine Over Lost Pradaxa Files

Boehringer Ingelheim GmbH, the German family-owned drugmaker, withheld or failed to preserve “countless” files sought by patients suing over the company’s blood thinner Pradaxa and must pay a fine of almost $1 million, a judge ruled.

U.S. District Judge David Herndon in East St. Louis, Illinois, who’s overseeing more than 1,700 consolidated lawsuits over claims that Pradaxa caused excessive and sometimes fatal bleeding, concluded that Boehringer executives acted “in bad faith” by failing to ensure that documents and files about the drug’s development and marketing were preserved.

“The wrongs here are egregious,” Herndon said in yesterday’s ruling. “The gross inadequacy” of the company’s efforts to safeguard the documents justified a sanction of more than $931,000 against Boehringer, the judge said.

Boehringer is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. Herndon set the first consolidated case for trial in August. Other cases are in state courts in Delaware, California, Connecticut and Illinois.

“Boehringer Ingelheim has acknowledged that we have had unintentional and unexpected problems with discovery in this litigation,” Mary Lewis, a U.S.-based spokeswoman for the Ingelheim, Germany-based company, said in an e-mailed statement.

Documents Produced

“We do not believe these problems have prevented the plaintiffs from obtaining access to a very wide range of documents regarding Pradaxa, including the central science, safety and regulatory documents regarding the medicine,” she said.

Patients and their families alleged that Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths.

Pradaxa has generated more than $1 billion in sales worldwide for Boehringer, the world’s biggest family-owned drugmaker. Researchers have found it more effective at preventing strokes than older competitors, including Bristol-Myers Squibb Co.’s Coumadin.

Consumers’ lawyers contend that Boehringer officials marketed the drug as superior to existing blood thinners when they knew its performance was not better than similar medicines.

Pradaxa has been linked to more than 500 U.S. deaths over a two-year period, and Boehringer faces claims that it sold the drug knowing the medicine could cause bleed-outs among some patients, according to a federal panel that tracks consolidated cases.

FDA Approval

The U.S. Food and Drug Administration approved Pradaxa in 2010 as a safe and effective alternative to 58-year-old Coumadin, a brand of warfarin, for preventing strokes caused by blood clots.

Concerns that Pradaxa was unsafe surfaced soon after U.S. doctors began prescribing it. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011.

Patients say Boehringer should have forced employees to preserve documents about the drug’s development and the company’s marketing plan. An effective “litigation hold” should have been placed on documents, patients’ lawyers said.

The company can’t produce files of a high-level scientist involved in developing Prada’s or documents by consultants who worked on the marketing plan, patients’ lawyers alleged in court filings. The company also failed to order employees to save phone messages about their work on the medicine, they added.

‘Burdensome’ Requests

Boehringer said it has made 32 million pages of material about the drug available to the plaintiffs and has been bombarded with “overly burdensome” document requests by patients’ lawyers, according to court filings. The company also argued that many of the documents sought by the plaintiffs’ attorneys are not relevant to the claims at issue.

In his 51-page ruling, Herndon said he was forced to deal with claims that Boehringer was improperly withholding documents from the inception of the case consolidation in 2012. Pradaxa suits filed in federal court across the country were gathered before Herndon for pretrial information exchanges.

Boehringer officials “made misrepresentations” about their efforts to preserve documents and failed to take obvious steps to preserve files and other records, the judge said.

Boehringer executives “failed to ensure the auto-delete feature of their employee cellphones, company owned and personal, was disengaged for the purpose of preserving text messages,” Herndon said. This move “allowed countless records to be destroyed.”

More Sanctions

Along with the fine, Boehringer executives must turn over files sought by patients’ attorneys that are in their possession or officially inform the court that they are “unable to comply with the order,” the judge said. Herndon said he may consider additional sanctions against the drugmaker over the missing files.

The case is In re Pradaxa Products Liability Litigation, 12-MD-02385, U.S. District Court, Southern District of Illinois (East St. Louis).

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