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BMJ Investigation Shows Boehringer Ingelheim Withheld Critical Safety Information on Pradaxa®

Roger Denton of Schlichter, Bogard & Denton, LLP reports that the manufacturers of the blood thinning medication Pradaxa® withheld from regulators critical evidence on how monitoring drug plasma levels could have improved the drug’s safety, according to a recent BMJ Investigation.

Roger DentonA recent article published in the British Medical Journal (BMJ) on July 23, 2014 details that the BMJ conducted an investigation and found that recommendations for use of Pradaxa® (dabigatran) could be flawed because Boehringer Ingelheim, the Germany-based manufacturer, failed to reveal to federal regulators important analyses demonstrating that monitoring anticoagulant activity and making appropriate dosing adjustments accordingly could have prevented major bleeds.

The article provides that internal company documents disclosed in 2011 during the Pradaxa® Multidistrict Litigation (MDL 2385, Case No. 12-md-2385)—which resulted in a $650 Million settlement for those injured by the drug—showed that major bleeding events could have been reduced by 30-40%. Internal company documents also exposed that the evidence used to promulgate guidelines in recommending Pradaxa® in the U.S., Europe, and Canada was incomplete. Boehringer Ingelheim stated that it had not shared this information with either doctors or regulators because the analyses did not provide a reliable prediction of patient outcomes. However, internal company emails released during the Pradaxa® Multidistrict Litigation reflected the sentiment that the company did not want these conclusions to be known. One Boehringer employee commented on the analyses stating, “This may not be a onetime test and could result in a more complex message (regular monitoring) and a weaker value proposition.”

Pradaxa® was approved in the United States by the U.S. Food and Drug Administration (FDA) in October 2010 to lower the chance of stroke in individuals with non-valvular atrial fibrillation (AF). In December 2011, the FDA initiated a formal investigation to determine whether the excessive bleeding in patients ingesting Pradaxa® occurred more commonly than would be expected. One study published by The Journal of the American College of Cardiology in March 2012 concluded that patients using Pradaxa® experience a significant increase in the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.

In May 2014, the Plaintiffs’ Steering Committee, appointed by The Honorable Chief Judge David R. Herndon to negotiate the settlement on behalf of all plaintiffs in the Pradaxa® MDL, and Boehringer Ingelheim Pharmaceuticals, Inc. (and affiliates) negotiated a settlement program in the amount of $650 Million to resolve approximately 4,000 Pradaxa® claims. Roger Denton of Schlichter, Bogard & Denton served as Co-Lead Counsel on the Plaintiffs’ Steering Committee (PSC) and a Lead Negotiator in the national Pradaxa® Multidistrict Litigation.

Schlichter, Bogard & Denton, LLP is a unique law firm that has held numerous leadership positions in national litigations involving dangerous pharmaceutical medications and unsafe medical devices, including but not limited to: In re: Pradaxa® (Dabigatran Etexilate) Products Liability (MDL 2385, Case No. 12-md-2385, S.D. Ill.), In re: Testosterone Replacement Therapy Products Liability Litigation (MDL 2545, Case No. 14-md-2545, N.D. Ill.), In re: Yasmin® and Yaz® (Drospirenone) Marketing and Sales Practices and Products Liability Litigation (MDL 2100, Case No. 09-md-2100, S.D. Ill.), In re: NuvaRing® Products Liability Litigation (MDL 1964, Case No. 08-md-1964, E.D. Mo.), In re: Gadolinium-Based Contrast Products Liability Litigation (MDL 1909, Case No. 08-md-50000, N.D. Ohio), and In re: Ortho Evra® Products Liability Litigation (MDL 1742, Case No. 06-md-40000, N.D. Ohio).

The Pharmaceuticals and Medical Litigation Department at Schlichter, Bogard & Denton aggressively represent clients who allege to have suffered injuries as a result of dangerous pharmaceutical medications and unsafe medical devices. The attorneys at Schlichter, Bogard & Denton, LLP who represent such victims include Roger Denton, Kristine Kraft, Beth Wilkins Flieger, Ashley Brittain Landers, and Tara Rocque. With hard work, creative thinking, and strong trial skills, we have earned an outstanding nationwide reputation by representing thousands of individuals who have suffered serious and life-threatening injuries, or even death.

If you or a loved one has suffered serious injuries after using pharmaceutical medications or medical devices, 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. Schlichter, Bogard & Denton, LLP is available to either handle these cases or work as co-counsel, so other attorneys with these types of cases are invited to contact an attorney at the firm to explore this opportunity.

 

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