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(USGovernment-News.Com, June 26, 2014 ) New York, NY -- The Pradaxa side effect lawyers at Alonso Krangle LLP, an experienced law firm focused on fighting for the rights of victims injured by harmful drugs, report that Boehringer Ingelheim has agreed to pay $650 million to settle approximately 4,000 Pradaxa lawsuits pending in federal and state courts across the United States. In announcing the settlement on May 28, 2014, Desiree Ralls-Morrison, Boehringer Ingelheim’s senior vice president and general counsel, stated in a news release that the company is not admitting to any wrongdoing but decided to settle the claims to “avoid the distraction and uncertainty of lengthy litigation.” Court records indicate that over 2,400 Pradaxa lawsuits have been filed in multidistrict litigation (MDL) in the U.S. District Court, Southern District of Illinois on behalf of plaintiffs who allege that they suffered severe internal bleeding or hemorrhaging while using the prescription blood thinner. (In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385) The Pradaxa lawsuits further allege that Boehringer Ingelheim failed to warn about an increased risk of excessive or uncontrollable bleeding with Pradaxa, and the lack of an effective antidote to reverse the bleeding.
[ca.finance.yahoo.com/news/boehringer-ingelheim-announces-comprehensive-settlement-120000411.html, May 28, 2014]
Reuters reported that a plaintiffs’ lawyer believed the Pradaxa victims would receive their compensation within a year. According to the Reuters news report, the compensation would vary with each plaintiff and would be based on the severity and nature of the alleged injury. In its news release, Boehringer Ingelheim stated that it expects most, if not all, of the plaintiffs will accept the settlement.
[reuters.com/article/2014/05/28/us-boehringer-lawsuit-idUSKBN0E81BL20140528?feedType=RSS, May 28, 2014]
Pradaxa, generically known as dabigatran etexilate, was approved by the U.S. Food & Drug Administration (FDA) in 2010 as an oral anticoagulant that reduces strokes and blood clots among patients with atrial fibrillation. Pradaxa was promoted as a superior alternative to warfarin, a blood thinner which also goes by the brand name, “Coumadin.” In December 2011, the FDA warned Pradaxa patients that the blood thinner could possibly increase their risk for bleeding events. While blood thinners pose a risk of serious internal bleeding, warfarin bleeding can be treated by administering vitamin K. There is no readily available antidote for Pradaxa bleeding. After Praxada complaints continued, the FDA commissioned a study based on information from over 134,000 Medicare patients 65 and older, comparing Pradaxa to warfarin. The FDA study found that new Pradaxa users had a lower risk of having clot-related strokes, bleeding in the brain and death, but a higher risk of having major gastrointestinal bleeding than those who used warfarin. Research also found the risk of a heart attack was similar for both Praxdaxa and warfarin. In a May 13, 2014, safety alert, the FDA announced that the latest study was consistent with the clinical trial results that led the agency to clear Pradaxa for sale in 2010. As a result, the FDA concluded Pradaxa has a “favorable benefit to risk profile” and it would not make changes to Pradaxa’s current label or recommendations for use.
[fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm282820.htm, December 7, 2011]
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm, May 13, 2014]
According to court documents in the Pradaxa MDL, Boehringer Ingelheim conducted its own study of the blood thinner. The company’s study found that different patients had different absorption rates of Pradaxa. Some patients were not getting the stroke prevention benefits because they were not absorbing enough of Pradaxa while others were at a greater risk of having severe bleeding episodes because they were absorbing too much of the blood thinner. Court documents also indicate that the first belllwether Pradaxa MDL trial is scheduled for the September 2014. It is not clear whether that trial will proceed due to the recent settlement announcement.
If you or someone you love has suffered any injuries or complications due to the use of Pradaxa or some other potentially dangerous drug, you may be able to file a lawsuit to seek compensation from Boehringer Ingelheim, the maker of that drug. Alonso Krangle LLP offers free lawsuit evaluations to prospective plaintiffs. To learn more about obtaining the justice you deserve, please contact the experienced product liability lawyers at Alonso Krangle LLP by filling out our online form or calling 1-800-403-6191 or visit www.fightforvictims.com.
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