Pradaxa Internal Bleeding Problem Lawsuit Allegations Update; Resource4thePeople Reports FDA and New Study also Warn of Possible Heart Attacks
San Diego, CA (PRWEB) July 26, 2013 -- http://www.resource4thepeople.com/defectivedrugs/pradaxa-lawsuits.html
Resource4thePeople is today announcing its latest update for consumers who are following the progress of lawsuits alleging that the use of the popular blood thinner Pradaxa may cause internal bleeding problems.
The first item of interest is that the number of cases of Pradaxa lawsuits alleging serious bleeding problems that have been consolidated in federal court have climbed to at least 1,133 as of July 10, 2013, according to federal court records.*
Resource4thePeople notes that this figure is nearly twice the number of such lawsuits from the last posting of figures on May 15 in the multidistrict litigation in the U.S. District Court, Southern District of Illinois.**
“These figures show that more and more consumers are coming forth with allegations that they have suffered devastating health problems that they attribute to their use of the blood-thinner Pradaxa,” said Resource4thePeople.
“This correlates with the increasing number of inquiries that we have been receiving from consumers who have been inquiring about their rights to seek compensation over serious bleeding allegations attributed to the use of Pradaxa.”
Resource4thePeople also is reporting that its national team of attorneys will continue to offer free consultations to consumers who are attempting to learn what legal options they may have involving allegations of Pradaxa bleeding problems.
“In addition to these free consultations we will continue to provide consumers with updates about the progress of the Pradaxa litigation and important developments from medical studies and the U.S. Food and Drug Administration in connection with the medication,” said Resource4thePeople.
Another important news development is the recently announced result of an important medical research study presented July 1, 2013 at the Congress of the International Society on Thrombosis and Haemostasis.***
Physicians attending the congress in The Netherlands were told that a study that involved over 23,000 patients showed that those taking Pradaxa (dabigaltran etexilate) as a blood thinner were at as high of 45% increased risk of suffering a heart attack than other patients.
Here was the conclusion of the study as presented to the congress:
“This meta-analysis of RCTs (randomized control trials) provides robust evidence that DE (dabigaltran etexilate) is associated with a significantly increased risk of MI (myrocardial infarction), especially at high dose (150mg bid). No firm conclusion can be taken with the lower DE dose (110mg bid) because of the limited number of studies included in this meta-analysis.
“Health care professionals and regulators should consider appropriate strategy to prevent such serious adverse drug reactions. The limitation of the use of DE in patients at high risk or suffering from coronary heart disease, the concomitant use of aspirin or switching to a FXa inhibitor should be carefully considered.”
Resource4thePeople notes that this finding comes just several months after 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.”
Resource4thePeople is aware of the growing concern from consumers over health concerns that have been raised about the use of Pradaxa and is continuing to accept cases involving Pradaxa allegations.
“Consumers should know that there may be time limits affecting their eligibility to seek compensation in such cases and we urge them to contact us as soon as possible to preserve all legal options,” said Resource4thePeople.
The federal judge in the Southern District of Illinois overseeing these consolidated cases involving Pradaxa lawsuits filed across the country is U.S. District Court Judge David R. Herndon. The court file in the multidistrict litigation sums up 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. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.”
Judge Herndon has scheduled a series of bellwether, or test trials in the litigation that will begin later this year.
The plaintiffs are seeking compensation for the medical costs and other expenses they allege they have incurred as a result of using Pradaxa to protect against strokes and heart attacks, according to the court file.
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."
Sources:
*PML 7/10/13; jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-July-10-2013.pdf
**MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, U.S. District Court, Southern District of Illinois
***http://eventure-online.com/eventure/publicAbstractView.do?id=215979&congressId=6839
****http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333209.htm
***** http://www.bloomberg.com/news/2012-12-11/boehringer-sued-by-hundreds-over-bleeding-tied-to-pradaxa.html
Bill Callahan, iLawSuit, 858 602-2749, [email protected]
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