As Pradaxa Lawsuits Mount, FDA Announces Plan for Large Scale Assessment Comparing Pradaxa Bleeding Rates to Warfarin.
The Pradaxa lawyers at Wright & Schulte LLC were pleased with news that the U.S. Food & Drug Administration (FDA) has planned a large scale-assessment comparing Pradaxa bleeding rates to those associated with warfarin. The announcement of the study comes as thousands of Pradaxa lawsuits that allege use of the drug caused patients to suffer life-threatening episodes of internal bleeding are moving through U.S. courts, according to Wright & Schulte LLC.
According to a notice posted on an FDA website on December 30, 2013, the new Pradaxa study will examine “selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin. “ The FDA said the goal of the study is to “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation.”
[mini-sentinel.org/assessments/medical_events/details.aspx?ID=219, FDA, Dec. 30, 2013]
Brought to market in 2010, Pradaxa is used to prevent strokes in atrial fibrillation patients. In October, the Institute for Safe Medicine Practices reported that the FDA received just over 3,290 reports of Pradaxa side effects in 2012, more than any other drug it monitors. Most of the reports involved cases of Pradaxa bleeding, including hundreds of fatalities. And while the review found that side effects attributed to warfarin resulted in fatal outcome just 6.5% of the time, Pradaxa adverse events proved fatal in about 18% of the cases, the ISMP said.
[ismp.org/QuarterWatch/pdfs/2012Q4.pdf, ISMP QuarterWatch, Oct. 17, 2013]
According to court documents, at least 2,100 Pradaxa lawsuits have been filed in the U.S. District Court, Southern District of Illinois, where all federally-filed Pradaxa bleeding claims have been consolidated for pretrial proceedings. All of the lawsuits allege that Pradaxa was improperly marketed as a safer alternative to warfarin, a blood thinner that has been on the market for decades. Pradaxa lawsuits further allege that the manufacturer of Pradaxa failed to disclose its risk, particularly the lack of an antidote for Pradaxa bleeding. (In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385)
Court documents indicate that the first bellwether trial in the federal Pradaxa bleeding litigation is scheduled to begin in August 2014. On December 9, 2013, U.S. District Judge David Herndon, who is overseeing the proceeding in the Southern District of Illinois, sanctioned Boehringer Ingelheim and fined the drug maker more than $931,000 for failing to preserve “countless” documents sought by plaintiffs who have filed claims against the company. In a second Order issued December 18th, Judge Herndon stated he was considering additional sanctions against the drug maker, writing that the company had acted “unreasonably, negligently, willfully, and in bad faith,” because it had been unable to provide certain evidence in accordance with an earlier directive of the Court.
Wright & Schulte LLC is already representing plaintiffs in Pradaxa lawsuits that have been filed in the federal multidistrict litigation, and continues to offer free legal consultations to alleged victims of Pradaxa bleeding side effects. For more information on filing a Pradaxa bleeding lawsuit, or to arrange for a free legal consultation, please visit yourlegalhelp.com.
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Pradaxa lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.
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