Pradaxa Lawsuit News: Boehringer Ingelheim Reports Possible Antidote Found To Reverse Effects Of Pradaxa, The Oliver Law Group Reports
Chicago IL (PRWEB) October 02, 2014 -- With almost 2,500 Pradaxa lawsuits pending litigation in the U.S. District Court, Southern District of Illinois, Boehringer Ingelheim, the makers of Pradaxa, announced that a potential antidote to its blood thinner medication is in its final phase of testing. The company said it is investigating “idarucizumab” as a reversal agent to Pradaxa (dabigatran), which currently does not have an antidote to uncontrolled bleeding. According to Boehringer Ingelheim, the third phase of the “Re-Verse Ad” testing is underway in more than 200 locations in 30 countries. There are currently no test sites in the United States actively recruiting participants for the clinical trial. The test involves using idarucizumab on patients who are taking Pradaxa and have uncontrolled bleeding or require emergency surgery or procedures. Boehringer Ingelheim said that data from the first phase of a randomized, double-blind, placebo-controlled study of 145 healthy males showed that idarucizumab was able to immediately reverse and sustain the anticoagulation induced in the participants by Pradaxa. (In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385)
[us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2014/06-26-14-boehringer-ingelheim-investigational-antidote-pradaxa-dabigatran-etexilate-mesylate-fda-breakthrough-therapy-designation.html, June 26, 2014]
In June, Boehringer Ingelheim announced that the U.S. Food & Drug Administration (FDA) has given idarucizumab a “breakthrough therapy designation” which will help to accelerate the approval process for the drug. In July 2012, the FDA signed the Food and Drug Administration Safety and Innovation Act (FDASIA) which provided a new designation for drugs called, “Breakthrough Therapy Designation.” According to the FDA, a breakthrough therapy is a drug that can treat a serious or life-threatening disease or condition by itself or in combination with other drugs if preliminary clinical evidence shows that the drug may demonstrate substantial improvement over existing therapies. The FDASIA allows the FDA to speed up the development and review process of a breakthrough therapy drug.
[fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm, September 10, 2014]
[us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2014/06-26-14-boehringer-ingelheim-investigational-antidote-pradaxa-dabigatran-etexilate-mesylate-fda-breakthrough-therapy-designation.html, June 26, 2014]
Pradaxa was approved by the FDA in 2010 to reduce the risk of stroke and blood clots in people with atrial fibrillation (irregular heart beats) not caused by a heart valve problem. About a year after the blood thinner was approved, the FDA began receiving complaints about Pradaxa and the major bleeding events associated with using the oral anticoagulant. A study by the Institute for Safe Medication Practices (ISMP), a non-profit organization that monitors adverse effects reports filed with the FDA, found that Pradaxa received the most complaints than any other prescription medication in 2011 and 2012. According to the ISMP study, the FDA received 1,158 reports of Pradaxa deaths and 12,494 Pradaxa reports of serious injuries since the federal agency approved the blood thinner medication in 2010. The 13, 652 adverse events reports officially made Pradaxa the most complained-about prescription medication in the U.S., the ISMP reported.
[wxyz.com/web/wxyz/money/consumer/pradaxa-lawsuit, February 25, 2014]
Court documents further confirm complaints about major bleeding episodes allegedly resulting from taking Pradaxa. As of September 15th there have been 2,479 Pradaxa bleeding side-effects lawsuits filed in the U.S. District Court, Southern District of Illinois, where the complaints have been consolidated for pretrial proceedings. (In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385) Boehringer Ingelheim is named as a defendant in the complaints that allege that patients who were prescribed Pradaxa allegedly experienced uncontrolled bleeding, and in some cases died, because Pradaxa does not have an antidote to reverse the effects of the blood thinner. The Pradaxa lawsuits also purport that Boehringer Ingelheim claim Pradaxa is safe and effective to use but did not warn emergency room physicians, primary care doctors and their patients that Pradaxa does not have an antidote to stop bleeding, and therefore there is no effective means to treat and stablize patients who experience major bleeding events while using the blood thinner medication.The first federal jury trial in MDL 2385 had been scheduled for September 2014, however, in May, Boehringer Ingelheim announced that it would pay $650 million to resolve approximately 4,000 Pradaxa lawsuits pending in state and federal courts. After the company’s announcement, U.S. District Judge David R. Herndon halted all pretrial proceedings in MDL 2385.
[jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-September-15-2014.pdf, September 15, 2014]
[ca.finance.yahoo.com/news/boehringer-ingelheim-announces-comprehensive-settlement-120000411.html, May 28, 2014]
The Oliver Law Group is offering free Pradaxa lawsuit reviews to individuals who allegedly suffered serious internal bleeding due to their use of the medication. Free legal evaluations are also being offered to families of patients who allegedly died as a result of Pradaxa bleeding. To learn more about filing a Pradaxa lawsuit, please contact our office by calling 800-939-7878 today.
About The Oliver Law Group P.C. And Filing A Pradaxa Lawsuit
Oliver Law Group P.C. is a different kind of law firm. One that focuses on the needs of the injured first. A compassionate law firm dedicated to fighting for the rights of victims and their families, and doing everything necessary to ensure those rights.
The experience of a large firm. The 1-on-1 dedication of a small firm. A reputation built on trust.
Experience. Dedication. Trust. Oliver Law Group P.C.
If you would like to learn more about filing a Pradaxa lawsuit, turn to the law firm with the Experience, Dedication, and Trust you deserve. Contact the Oliver Law Group P.C. for your free case review by calling toll free 800-939-7878 today or visiting http://www.legalactionnow.com.
Alyson Oliver, The Oliver Law Group, http://www.legalactionnow.com, +1 800-939-7878, [email protected]
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