By Christina Spicer  |  February 11, 2014

Category: Legal News

Pradaxa Side Effects LawsuitOn Jan. 29, 2014, a federal judge granted a motion to unseal 85 “confidential” documents relating to the blood thinning medication Pradaxa, which is at the center of hundreds of product liability and wrongful death lawsuits pending in multidistrict litigation (MDL).

Pradaxa, manufactured by Boehringer Ingelheim, is a blood thinning medication approved by the U.S. Food & Drug Administration (FDA) in 2010. The drug has recently been linked to significant complications, including excessive bleeding. Numerous people have filed lawsuits against the drug maker and the cases were consolidated in May 2013. The first trial in the Pradaxa MDL is scheduled to begin in September 2014. The ability to file a Pradaxa lawsuit and seek damages for complications related to internal bleeding and hemorrhaging from the drug is still available.

“Confidential” Pradaxa Lawsuit Documents Unsealed

In their motion to de-designate the “confidential” label on 85 documents, the plaintiffs’ steering committee asserted that more than 93 percent of the documents produced by the defendants, Boehringer Ingelheim International GmbH and Boehringer Ingelheim Pharmaceuticals Inc., had been designated either “confidential” or “highly confidential” in the second amended case management order. The steering committee argued that such conduct violates the amended case management order and the public’s right to an open court system.

The Court granted the plaintiffs’ motion and found that Boehringer had not sufficiently established that the confidentiality designations were proper.

The amended case management order employs a two-tiered designation system for “Confidential Information” and “Highly Confidential Information.” The plaintiffs’ steering committee asserted that Boehringer lacked good cause to designate the Pradaxa documents as either confidential or highly confidential. Per the case management order, the burden of proof fell to Boehringer to demonstrate that their designation of the Pradaxa documents in question as “confidential” and/or “highly confidential” was proper.

In November 2013, in response to a letter from the plaintiffs’ steering committee challenging the confidentiality designations of 86 documents, Boehringer asserted that the challenged documents were “internal,” “non-public,” and/or contained proprietary information in their response that consisted of “a four paragraph cover letter and a table listing the documents, along with brief boilerplate bullet points as to the basis for each designation.”

Boehringer did de-designate one document in response to the steering committee’s challenge. The steering committee brought the matter to the Court per the case management order concerning the remaining 85 documents. In the decision issued Jan. 29, the Court noted that in response to plaintiffs’ steering committee’s motion, “[Boehringer] contends that the Challenged Documents’ designations are appropriate, but devotes very little attention to the actual content of the documents.”

Boehringer also asserted that the steering committee challenged the confidentiality designations in an effort to use “selective and out-of-context document leaks to try this case in the press.” Further, Boerhinger argued that the documents were non-public internal communications consisting of sensitive proprietary business information and that enforcement of the confidentiality designations were necessary to prevent a trial by media and/or protect the public.

The Court found that Boehringer’s “non-specific arguments” did not sufficiently establish that the confidentiality designations are proper as required by the case management order. The Court did allow Boehringer to provide redacted copies of “German Custodial Documents.”

The Pradaxa MDL is In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the Southern District of Illinois.

Join the Pradaxa MDL with a Free Legal Review

If you or someone you love has experienced internal bleeding after taking Pradaxa, you could qualify to file a Pradaxa lawsuit. To learn more about your options, visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. Once you submit your information, a Pradaxa lawyer will review your claim to determine whether you qualify to join a class action lawsuit.

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