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A federal judge has ruled that during the discovery phase of the Pradaxa litigation, plaintiffs may obtain documents and other materials involving the marketing practices of Boehringer Ingelheim, including information about illegal promotions for medications that are not involved in the lawsuits.
In an order (PDF) issued January 18, U.S. District Judge David R. Herndon rejected a request filed by the drug maker for a protective order in response to discovery requests that seek information regarding any lawsuits that claimed Boehringer Ingelheim engaged in off-label marketing of medications for uses that were not approved by the FDA or alleged that the drug maker paid “kick backs” to doctors to encourage them to prescribe their products.
Plaintiffs have sought documents, names of employees and other materials involved in a whistleblower lawsuit filed by a former employee against Boehringer Ingelheim, involving the marketing of Aggrenox, Atrovent, Combivent and Micradis between 2001 and 2008. The case ended in a settlement agreement last year for illegal promotion of the medications, with Boehringer Ingelheim agreeing to enter a “Corporate Integrity Agreement.”
Boehringer Ingelheim filed a motion for a protective order, arguing that the requested information was not relevant to the claims raised in the Pradaxa lawsuits, which involve allegations that the drug maker failed to provide adequate warnings about the potential side effects of the anticoagulant, including the risk of uncontrollable bleeding.
The drug maker also argued that the discovery request was unduely burdensome and would delay the expeditious advancement of the Pradaxa litigation, which has an aggressive trial schedule, with the first cases expected to reach a jury in August 2014.
“The fact that the (whistleblower lawsuit) involved drugs other than Pradaxa does not make the information irrelevant for purposes of discovery,” wrote Judge Herndon the order. “It is entirely possible that the marketing policies and strategies at issue in the (whistleblower) action extended to (Boehringer Ingelheim)’s marketing of Pradaxa. Thus, the plaintiffs inquiry into those marketing practices and the individuals involved in those marketing practices appears to be reasonably calculated to lead to dsicovery of admissible evidence and is an appropriate subject of discovery.”
Judge Herndon cautioned that the evidence obtained will not necessarily turn out to be admissible in court. He also dismissed Boehringer Ingelheim claims that finding and turning over the documents would be overly burdensome.
Plaintiffs’ attorneys have indicated that the information may establish a pattern of actions by Boehringer that show that the company may have engaged in illegal marketing of Pradaxa.
Pradaxa Lawsuits Filed Over Bleeding Side Effects
Pradaxa (dabigitran) is an anticoagulant that was introduced by Boehringer Ingelheim in October 2010 for prevention of strokes in patients with atrial fibrillation.
The medication has been promoted as a superior alternative to warfarin (Coumadin), because it is easier to take and requires less monitoring. However, while users of warfarin can be given a dose of vitamin K to quickly stop any bleeding problems that may develop while taking the older medications, no such antidote or reversal agent is available to stop Pradaxa bleeding problems.
About 200 complaints have been filed against Boehringer Ingelheim in the federal court system, with the litigation centralized before Judge Herndon as part of an MDL, or multidistrict litigation. Judge Herndon has established a case management plan where a handful of cases are being prepared for early trial dates, which are expected to go to trial in August 2014. Judge Herndon has also ordered the parties to meet every month starting in August 2013, to discuss potential Pradaxa settlement agreements.