San Diego, Ca (PRWEB) October 15, 2013
Resource4thePeople announced today its most current report for consumers who have expressed interest in the ongoing litigation involving state and federal lawsuits alleging that the popular blood thinner Pradaxa may cause internal bleeding problems.
"It has become clear from recent filings and figures released by the federal court system that there has been a significant increase in the number of lawsuits alleging that the use of Pradaxa can cause bleeding problems," said Resource4thePeople.
"Some of these cases, which will be detailed below, involve allegations in which the use of Pradaxa caused deaths, according to the details of these lawsuits. Others include claims of life-threatening bleeding incidents that required significant medical attention."
The main group of federal lawsuits that have been consolidated from cases filed across the country are now organized in what is called a multidistrict litigation under the supervision of a single judge.
In the case of the Pradaxa, allegations, the lawsuits* have been assigned to U.S. District Court Judge David R. Herndon in the Southern District of Illinois.
The latest court figures** show that there are now at least 1,470 cases in the consolidated litigation, according to the U.S. District Panel on Multidistrict Litigation, as of Sept. 11, 2013, the latest reporting period.
"This is the highest number of cases so far in this particular consolidated litigation and we expect these figures to increase as more consumers who may have been affected by these Pradaxa allegations come forward," said Resource4thePeople.
"The increasing number of inquiries that we have been receiving has convinced our nationwide network of attorneys to continue their offer of free consultations to consumers who may be seeking information about their legal rights to compensation."
Resource4thePeople also notes that other cases continue to be filed in state courts across the country, including five recent cases* filed in Illinois where plaintiffs are claiming that relatives either died or suffered serious bleeding problems from the use of Pradaxa.
The Madison-St. Clair Record reported**** Sept. 26, 2013 that "Some of the plaintiffs claim their relatives died within months of taking Pradaxa, while others claim chronic bleeding caused by the drug required them to be given blood transfusions to prevent their deaths."
In another Pradaxa development, the recently published findings of a trial that was conducted to determine whether Pradaxa (dabigatran) is an effective alternative to warfarin in patients with atrial fibrillation was terminated because of a high number of bleeding incidents attributed to Pradaxa.
The results of the study***** were published in the Sept. 1, 2013 edition of the New England Journal of Medicine and involved hundreds of patients with mechanical heart valves who were tested in comparisons of the two popular anticoagulants.
The anticoagulant trial was terminated prematurely after the enrollment of 252 patients because of an excess of thromboembolic and bleeding events among patients in the dabigatran group, according to the published findings.
"In the as-treated analysis, dose adjustment or discontinuation of dabigatran was required in 52 of 162 patients (32%). Ischemic or unspecified stroke occurred in 9 patients (5%) in the dabigatran group and in no patients in the warfarin group; major bleeding occurred in 7 patients (4%) and 2 patients (2%), respectively," the researchers reported. "All patients with major bleeding had pericardial bleeding."
The researchers reached the following conclusion:
"The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk."
Resource4thePeople will continue to provide updates of this and other litigation involving Pradaxa and will continue to review claims from consumers who have not filed lawsuits.
Bloomberg News, in a Dec. 11, 2012 posting, reported****** that Pradaxa “has been linked to more than 500 U.S. deaths over a two-year period.”
Bloomberg also reported that “Concerns about Pradaxa’s safety surfaced soon after U.S. doctors began prescribing it. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011."
Resource4thePeople notes that the FDA issued a Drug Safety Communication warning Dec. 19, 2012 that the medication should not be used in patients with mechanical prosthetic heart valves.*******
Here is a part of that warning:
“The FDA issued a Drug Safety Communication informing healthcare professionals and the public that the anticoagulant Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves.
“The RE-ALIGN clinical trial in Europe was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in warfarin users.”
The court file in the multidistrict litigation* includes a summation of the Pradaxa allegations:
“All the actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking the drug Pradaxa (dabigatran etexilate) and that defendants did not adequately warn prescribing physicians of the risks associated with Pradaxa, including the potential for severe or fatal bleeding, and that there is no reversal agent to counteract the Pradaxa’s anticoagulation effects.”
*MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, U.S. District Court, Southern District of Illinois
*** Case #s 13-L-469, 13-L-470, 13-L-467, 13-L-468, 13-L-466, St. Clair County Circuit Court, Ill.