Boehringer Ingelheim says that it will pay $650 million to resolve more than 4,000 drug defect cases involving Pradaxa, its anticoagulant. Despite settling, the drug manufacturer is denying any wrongdoing.
Pradaxa has been named in numerous incidents involving excessive bleeding complications. The U.S. Food and Drug Administration has received notice of 12,494 injuries and 1,158 deaths involving Pradaxa users just in the last four years.
The blood-thinning drug was approved in 2010 to prevent strokes in patients suffering from atrial fibrillation. It is supposed to stop the formation of clots. The FDA has also approved Pradaxa to treat pulmonary embolisms and deep vein thrombosis, and the drug is used for off-label purposes that are not FDA-approved.
Many plaintiffs are claiming that Pradaxa was improperly presented as an improvement to Warfarin, another blood thinner. The drug injury lawsuits contend that the manufacturer did not warn users that unlike Warfarin, there is no antidote available to reverse the internal bleeding that can happen from taking Pradaxa. (Warfarin’s antidote is vitamin K.) Plaintiffs believe that Boehringer Ingelheim willfully used deceptive marketing practices that endangered the public, did not reveal the risks involved, and failed to develop proper treatment methods for patients who would experience severe bleeding reactions.
Other claims made against Pradaxa:
• It was presented as a safer drug than Warfarin, even though the risks associated with Pradaxa are the same or greater.
• The manufacturer didn’t warn that the bleeding could prove deadly.
Elderly people seem especially prone to the Pradaxa-related bleeding problems. Pradaxa was touted as the first drug of its type to not require dietary restrictions or regular testing.
A lot of the dangerous drug lawsuits name uncontrollable internal bleeding as a serious side effect of Pradaxa. Other serious side effects linked to Pradaxa include kidney bleeding, internal bleeding, heart attack, brain hemorrhage, gastrointestinal bleeding, and death.
Critics have questioned the clinical trials that were involved in getting FDA approval for Pradaxa. The drug was approved because of the results from RE-Ly, a clinical study that compared the drug to Warfarin. Some experts are saying that the study was flawed.
In Massachusetts, please contact our Boston Pradaxa injury lawyers if you believe that use of this anticoagulant caused injury to you or a loved one. You may have reason to pursue your products liability case against Boehringer Ingelheim and others. For example, depending on the specifics of your case, you also may have grounds to file a Massachusetts medical malpractice case against your prescribing doctor, as well as injury cases against other responsible parties.
Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million, Forbes, May 28, 2014
FDA approves Pradaxa to prevent stroke in people with atrial fibrillation, FDA, October 19, 2010
More Blog Posts:
Pradaxa’s Deadly Side Effects, Drug Injury Lawyers Blog, November 13, 2013
Pradaxa Lawsuit Claims Drug’s Side Effects Caused Woman to Bleed to Death, Boston Injury Lawyers Blog, April 30, 2012
FDA Cuts Sleep Aid Dosage in Half among Side Effect Concerns, Drug Injury Lawyers Blog, May 27, 2014
Altman & Altman, LLP is a dangerous drug law firm based in Massachusetts. Our Boston drug defect lawyers would like to offer you a free case assessment.