A Mississippi woman has filed a Xarelto lawsuit, alleging that the blood thinner caused her to suffer a serious gastrointestinal bleeding event.
Plaintiff Kimberly A. says she took Xarelto from July 2013 to October 2014 and that after she started taking Xarelto she suffered a serious bleeding complication in her intestines.
Kimberly now attributes that gastrointestinal bleed to the Xarelto she took around that time.
Janssen Pharmaceuticals Inc., its parent company Johnson & Johnson Co., Bayer Healthcare Pharmaceuticals Inc., and their related companies are all named as defendants in the Xarelto lawsuit. Kimberly alleges that all these companies had a hand in the development, manufacturing, marketing or distribution of Xarelto.
Also known by its generic name rivaroxaban, Xarelto is among the new generation of anticoagulant medications introduced just within the last few years.
Before these new generation blood thinners appeared, Warfarin had been the go-to blood thinner for several decades.
Xarelto’s manufacturers promoted the new drug as having certain advantages over Warfarin, such as a once-a-day dosing schedule and no need for continuous blood tests.
Xarelto Clinical Trials
Kimberly cites one clinical study in particular, the ROCKET AF study, that had been part of the basis for the Food and Drug Administration’s (FDA) approval of Xarelto as treatment to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation.
While the ROCKET AF study found that Xarelto was “non-inferior” to Warfarin when used for that purpose, it also found that gastrointestinal bleeds occurred more frequently in patients who used Xarelto than in those who used Warfarin.
The Xarelto bleeding lawsuit accuses the defendants of cherry-picking information from the ROCKET AF and other studies in developing their promotional materials for Xarelto. She says those promotional materials failed to mention the risk of gastrointestinal bleeds and other adverse events revealed by those studies.
Kimberly also challenges the defendants’ marketing of Xarelto as not needing regular blood monitoring. The defendants had asserted this point as an advantage Xarelto had over Warfarin, which requires regular blood testing and dosage adjustment to keep the dosage correct.
Kimberly says in her Xarelto lawsuit that the results of the clinical trials showed that Xarelto was safer when administered in conjunction with regular blood monitoring.
Likewise, Kimberly challenges the manufacturers’ once-daily dosing scheme. She cites comments attributed to FDA reviewers who questioned that dosing scheme, noting that blood level studies showed peaks and dips that the reviewers said could have been eliminated by twice-daily dosing.
Kimberly argues that encouraging taking Xarelto on a once-daily dosing schedule and without ongoing blood monitoring increases the risk of major, life-threatening Xarelto bleeding events like the one she suffered.
Kimberly also notes that at the end of fiscal 2012, Xarelto’s first year on the market, the FDA received 2,081 reports of serious adverse events associated with Xarelto. Of these events, 151 reportedly resulted in the patient’s death.
Similar reports arose in Germany. The Xarelto lawsuit states that in the first eight months of 2013, German regulators received 968 reports of adverse events related to Xarelto, 72 of which resulted in death.
Kimberly says the defendants neither alerted the public or the medical community about these reports, nor did they perform any additional investigations into the safety of Xarelto.
Kimberly’s individual Xarelto lawsuit is part of the Xarelto multidistrict litigation centralized in Louisiana.
The Xarelto Multidistrict Litigation is In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Xarelto attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Xarelto class action lawsuit is best for you. [In general, Xarelto lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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If you or a loved one took Xarelto (rivaroxaban) and suffered injuries such as uncontrollable internal bleeding, gastrointestinal bleeding, hemorrhaging, deep vein thrombosis or pulmonary embolism, you may have a legal claim. See if you qualify by filling out the short form below.
An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.
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