Boehringer Fined Almost $1 Million over Missing Pradaxa Files


boehringer-fined-almost-one-millionGerman drug maker, Boehringer Ingelheim, has been fined nearly $1 million for withholding or failing to preserve “countless” files sought by patients suing the company over its blood thinner, Pradaxa.

U.S. District Judge David Herndon 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, Bloomberg News reports. Judge Herndon is overseeing more than 1,700 consolidated lawsuits involving claims that Pradaxa (dabigatran) caused excessive and, sometimes, fatal bleeding. In his ruling, Judge Herndon described the company’s conduct as “egregious.”

Pradaxa users allege that Boehringer executives knew Pradaxa posed a deadly risk to some consumers when the drug came to market in the United States in October 2010, Bloomberg News reports. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, and this can lead to so-called “bleed-out” deaths.

Pradaxa received U.S. Food and Drug Administration (FDA) approval in 2010 as an alternative to Coumadin (warfarin), which had been in use for more than 50 years to prevent strokes caused by blood clots, according to Bloomberg News. Plaintiff’s lawyers contend that Boehringer marketed the drug as superior to other blood thinners when they knew its performance was not better. Concerns about Pradaxa’s safety arose soon after doctors began prescribing it. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents involving Pradaxa in 2011.

Boehringer is unable to produce files of a high-level scientist involved in developing Pradaxa, or documents from consultants who worked on the marketing plan, patients’ lawyers allege in court filings. The company also failed to order employees to save telephone messages about their work on the medicine, according to Bloomberg News.

In addition to the fine, the judge has ordered the company to turn over the documents sought by the plaintiffs or officially inform the court it cannot comply. Bloomberg News reports that Judge Herndon is considering additional sanctions against the drug maker.