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Pradaxa Lawsuit Update (MDL 2385): Internal Company Documents Recently Unsealed in MDL, as Reported by The New York Times

The New York Times reports that numerous documents have been made public in the Pradaxa® Multidistrict Litigation entitled In re: Pradaxa® (Dabigatran Etexilate) Products Liability Litigation (MDL 2385, Case No. 12-md-2385) pending in the United States District Court for the Southern District of Illinois.

The New York Times provides: “Many of the documents released by Chief Judge David R. Herndon of the United States District Court in East St. Louis, which included emails, memos and internal presentations, centered on whether a coming research paper would undercut one of Pradaxa®’s main selling points: that it does not require regular blood tests to ensure it’s working.” The author also notes that the newly unsealed documents demonstrate that “[t]he makers of the blood-thinning drug Pradaxa® were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether.”

Some may wonder why the issue of testing is thought to be so critical; however, testing is a critical issue for Pradaxa® when considering its race to gain market share from warfarin, a generic blood-thinning medication that has been used for decades and requires frequent blood testing which many patients consider a nuisance. As a result, Pradaxa® would set itself apart from the competing drug warfarin by not requiring testing, while claiming to be as good – or better – at preventing strokes in patients with atrial fibrillation.

The importance of the issue is clear from the unsealed internal documents demonstrating that Boehringer Ingelheim employees “openly fretted when it appeared that the results of the research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from monitoring of their blood. A certain segment of the patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.” A draft version of the paper detailed that keeping patients within a certain blood-level range would help prevent strokes and bleeding; however, Boehringer Ingelheim employees questioned this paper’s conclusion since it would make it “extremely difficult” for the company to defend its position to regulators that testing was not required, while “undermining” the company’s efforts to compete with other blood thinning medications on the market. However, the internal documents demonstrate that some Boehringer Ingelheim employees were of the opinion that the paper addressed serious concerns that doctors were raising in their clinical settings. In particular, Dr. Andreas Clemens, a company leader, stated: “The world is crying for this information – but the tricky part is that we have to tailor the messages smart”.

On February 4, 2014, Dr. Reilly’s paper was published in the Journal of the American College of Cardiology (JACC). Although many of the conclusions in the draft version of the paper remain, the references to a patient’s optimal blood-level range no longer appear in the final, published article.

As reported by The New York Times, Pradaxa® was approved in the United States by the Food and Drug Administration (FDA) for the use of Stroke Prevention in Atrial Fibrillation (SPAF) in October 2010. Since the time of its approval, it has brought in more than $2 billion in US sales for the German company Boehringer Ingelheim. In particular, Pradaxa® has been prescribed to approximately 850,000 patients – and linked to more than 1,000 deaths.

Schlichter, Bogard & Denton, LLP are leaders in the national Pradaxa® Multidistrict Litigation (MDL 2385) against the manufacturers of Pradaxa®. Partner Roger Denton has been appointed by Chief Judge Herndon to serve as Plaintiffs’ Co-Lead Counsel in the Pradaxa® MDL.

Roger Denton and the Pharmaceutical Litigation Department at Schlichter, Bogard & Denton, LLP represent clients nationwide who have suffered serious and fatal injuries as a result of using the blood thinning medication Pradaxa®. Anyone who took Pradaxa® and suffered a severe internal bleeding event, such as gastrointestinal internal bleeding, may be eligible to file a federal case in the Pradaxa® MDL. The attorneys at Schlichter, Bogard & Denton, LLP are offering a free case review with no further obligation to those who have been injured, or those who lost loved ones, after suffering severe internal bleeding events after using Pradaxa®. If you or a loved one has suffered injuries after using the blood thinning medication Pradaxa®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

Schlichter, Bogard & Denton, LLP also welcomes the opportunity to work with other attorneys on these types of cases cases. Schlichter, Bogard & Denton, LLP is available to either handle these cases or work as co-counsel, so other attorneys with Pradaxa® cases are invited to contact an attorney at the firm to explore this opportunity.


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