In October of 2010 the FDA approved Pradaxa®, an oral anti-coagulate, used to treat patients with atrial fibrillation. Pradaxa® is associated with an increase in the rate of gastrointestinal bleeding despite the overall lower rates of bleeding at other sites. A trend of higher bleeding risk was seen with advancing age. This risk was under-estimated in clinical trials giving rise to suspicions that the Phase III test results were not adequately reported and that the warning concerning the impact of gastrointestinal bleeds was diluted. There is no antidote for patients who begin to bleed while on Pradaxa.
The Pradaxa® Litigation Group educates members about Pradaxa®, including its risks, benefits, and alternatives. The Litigation Group provides members with work product and other documents to make their prosecution of these claims easier and less costly.
The Pradaxa® Litigation Group member benefits include a Group Document Library, list server, and education programs.
This Litigation Group was formed in 2012.