Monday, February 3, 2014

Pradaxa Manufacturer hit with Million Dollar fine by Federal Judge for Improperly Withholding Documents

Boehringer Ingelheim GmbH (Boehringer) was hit with almost $1 Million in sanctions for withholding documents requested by Plaintiffs’ attorneys in the Pradaxa MDL.  Boehringer, the German family-owned drugmaker, is the manufacturer of the blood thinner Pradaxa. The allegations against Boehringer over the drug are that Pradaxa® causes excessive internal bleedings which can cause serious complications, including death.
U.S. District Judge David Herndon in East St. Louis, Illinois, who’s overseeing more than 1,700 consolidated lawsuits in the MDL 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. In his 51 page ruling, Judge Herndon stated, “The wrongs here are egregious,” and that he was, “stunned” by their discovery violations. He went on to add that the company’s efforts to safeguard the documents amounted to, “…gross inadequacy”.
In his December 9th ruling, Herndon wrote that he was forced to deal with claims that Boehringer was improperly withholding documents from the inception of the case consolidation in 2012. He characterized Boehringer as acting in, “bad faith”.
The Plaintiffs argued that Boehringer should have forced employees to preserve documents about the drug’s development and the company’s marketing plan. They also argued that Boehringer failed to order employees to save phone messages, including texts, about their work on Pradaxa® which allowed countless records to be destroyed. Such protocol is often referred to as a “litigation hold”; a routine and regulated aspect of the discovery process in federal and state litigation.

Among other malfeasance, Boehringer could not produce files of a high-level scientist involved in developing Pradaxa® or documents by consultants who worked on the marketing plan. The Court’s Order indicates that the files of Professor Thorsten Lehr may be among the evidence that allegedly was destroyed by Boehringer. Court documents describe Professor Lehr as a prominent scientist who played a key role in developing Pradaxa® and who authored a study that initially concluded that Pradaxa®’s safety was related to the therapeutic range of the drug. The Court’s Order explains that Professor Lehr’s desire to publicly disclose the existence of a therapeutic range for Pradaxa® was highly controversial within the company. The order quotes Boehringer employee, Dr. Andreas Clemens, who stated, “The world is crying for this information – but the tricky part is that we have to tailor the messages smart.” The Order further states that, ultimately, Boehringer required that the study be revised to exclude information about therapeutic range.
Judge Herndon ruled that all of these actions justified sanctions amounting to $931,000.

Along with the fine, Boehringer executives must turn over files that are in their possession or officially inform the court that they cannot. Judge Herndon did not leave out the opportunity to levy additional sanctions against the corporation over the missing files.
Plaintiffs allege that Boehringer executives knew Pradaxa® posed a deadly risk when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, Pradaxa® has no antidote to reverse its effects, which can lead to so-called bleed-out deaths. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011.
This is not the first time in this litigation Boehringer has been sanctioned. In a September 18, 2013 Order, the Court sanctioned Boehringer in the amount of $29,540. The Order stated that the Court was a firm believer in progressive discipline, and that Boehringer was required to abide by the discovery rules.
Pittman, Dutton & Hellums, P.C. is currently investigating claims for patients injured by Pradaxa®.  Contact Chris Hellums at 1-866-515-8880 or at for a free consultation.