08/08/12–In this recent Praxdaxa Lawsuit action filed against the designers, marketers, and manufacturers of the pharmaceutical drug Pradaxa, Plaintiffs have pointed to many inadequacies in the drug’s warning label as an important factor in the alleged liability asserted against the Defendants for the internal bleeding suffered by Plaintiff Khaleel Elahee. Plaintiffs state that the failure of Defendants to adequately warn consumers of the serious risks involved with the use of Pradaxa directly contributed to the injuries that Mr. Elahee faced in 2011.
The complaint states that the original warning for Pradaxa was inadequate for a host of reasons. The original warning label did not mention, among other things, that there is no means to reverse the anticoagulation effects of Pradaxa; that there is a need to assess renal functioning prior to starting Pradaxa use; and that use of Pradaxa can significantly increase the risk of gastrointestinal and other bleeding. Although the label was modified in March 2011, Plaintiffs allege that it was still inadequate because the severity of the bleeding risks associated with use of Pradaxa was not addressed. In November of 2011 the label was modified to include warnings about the need to monitor kidney function before and during Pradaxa use. In January and April of 2012 the label was modified again, but Plaintiffs still allege that the warning label was inadequate in informing users of all of the risks related to internal bleeding.
The complaint goes on to describe a timeline of events that occurred in other countries in relation to marketing and distribution of Dabigatran (named Pradaxa in the U.S.). It states that due to these international developments as well as reports of bleeding in the U.S., Defendants knew or should have known of the bleeding risks (such as that suffered by Plaintiff) that all users of Pradaxa have a high risk of experiencing. Plaintiffs also allege that had doctors or Plaintiff Khaleel Elahee been aware of the risks through a proper warning label, that Mr. Elahee would not have taken Pradaxa and would therefore not have suffered his injuries in the first place.