The first of four Pradaxa injury lawsuits scheduled for early trial dates in the Southern District of Illinois have been delayed. U.S. District Judge David R. Herndon deferred the start date by about one month and created a new order for the cases to be heard by juries.
The bellwether trials were originally scheduled to begin between August 2014 and February 2015. A pretrial order issued on March 5 noted the new case order and start dates.
Jury selections for plaintiff Suzanne Mackiewicz will begin on September 8, with the trial expected to begin on September 15. Mackiewicz filed the wrongful death claim on behalf of her father, Malachy Higgins.
The case of plaintiff Georgia Primus will be addressed in the second bellwether trial, scheduled to begin on December 1, 2014. The third bellwether trial, set to begin on February 17, 1015, is based on a wrongful death claim filed by plaintiff Adalaine Nancy Kohn, on behalf of her husband. Finally, the fourth bellwether trial is scheduled to begin on March 23, 2015, centered on a claim filed by Helen Jean and John Edwards Hawkins.
All cases involve similar allegations of uncontrolled Pradaxa bleeding causing patients to suffer severe and sometimes fatal bleeding incidents. Plaintiffs claim they did not receive sufficient warning of the potentially fatal bleeding events and doctors were not provided with an adequate reversal agent to stop the blood thinning effects of the drug.
MDL 2385 was established in August 2012, under the direction of U.S. District Judge David R. Herndon, in the Southern District of Illinois. Approximately 2,000 Pradaxa injury lawsuits are currently pending against manufacturer Boehringer Ingelheim.
Pradaxa bleeding risk
Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. It is categorized as an anticoagulant, a substance that prevents coagulation of blood. Pradaxa is the first new treatment alternative to warfarin (Coumadin), in almost 60 years.
Studies have suggested that although the chances of bleeding may be similar with Pradaxa and warfarin, the former may pose a more serious risk, as hemorrhages are typically more difficult to stop. Warfarin can be easily reversed with a dose of vitamin K and plasma, but there is no reversal agent for Pradaxa.
FDA issues statement on Pradaxa
Pradaxa received FDA approval in October 2010. During the time period of October 2010 through the end of March 2011, approximately 272,119 prescriptions were written for the drug in the United States. During this time period, 932 “serious adverse event” Medwatch reports were filed with the FDA. This included at least 120 deaths and more than 500 reports of severe, life-threatening bleeding.
After evaluating new information on the risk of serious bleeding events associated with Pradaxa and warfarin, the FDA issued the following statement on November 2, 2012:
“The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa,” the statement read. “FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.”
Resources
Resources
- U.S. District Court for the Southern District of Illinois, MDL 2385 - Pradaxa (Dabigatran Etexilate) Products Liability Litigation http://www.ilsd.uscourts.gov/mdl/mdl2385.aspx
- U.S. District Court for the Southern District of Illinois, MDL 2385 – Case Management Order Number 60 http://www.ilsd.uscourts.gov/Documents/MDL2385/CMO60.pdf
- U.S. Food and Drug Administration, Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm282820.htm