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 Booth Samuels at
1-866-515-8880 or at booths@pittmandutton.com
for a free consultation.
