The Multidistrict Litigation (“MDL”) for Pradaxa involving thousands of Pradaxa lawsuits that allege the blood thinner caused patients to suffer life-threatening and uncontrollable internal hemorrhaging is presently pending before Chief Judge David R. Herndon for the United States District Court for the Southern District of Illinois.
Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals, is an anticoagulant used mainly as a blood thinner for patients who are at risk for stroke or atrial fibrillation. Pradaxa is an oral alternative to warfarin to reduce the risk of stroke in patients with AFib not caused by a heart valve problem. However, unlike warfarin, there is no antidote to reverse the blood-thinning effects of Pradaxa.
Judge Herndon has granted a request by the Plaintiffs to unseal dozens of documents that Boehringer Ingelheim had designated as confidential. Boehringer Ingelheim asserted that the documents in question contained “nonpublic internal communications” that included sensitive proprietary business information. In an Order issued on January 29, 2014, Judge Herndon unsealed the 85 documents, after finding that Boehringer had not sufficiently explained why it had marked them as confidential.
Many of the documents ordered to be produced by Judge Herndon included emails, memos and internal presentations, centered on whether a research paper would undercut one of Pradaxa’s selling points that it does not require regular blood tests to ensure it is effective.
A research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from blood testing. However, internal documents show that some of Pradaxa’s employees were concerned about the marketing implications of the study.
Generally, testing is a critical issue because Pradaxa wanted to gain market share from warfarin, a drug that has been the standard treatment for preventing blood clots and strokes. Many patients viewed warfarin as an annoyance because it requires frequent blood tests and careful attention to other drugs and diet.
There are currently more than 2,100 Pradaxa lawsuits pending in the MDL. All of the lawsuits accuse Boehringer of failing to provide adequate warnings about the risk of Pradaxa bleeding, including the lack of an antidote. What effect will these documents ultimately have on the litigation? Time will tell.