A Rhode Island consumer has filed suit against several pharmaceutical companies for damages attributed to using Xarelto between 2011 and the present.
Daniel Hernandez sued Janssen Research & Development, LLC, Janssen Ortho, LLC, a subsidiary of Johnson & Johnson, Janssen Pharmaceuticals, Inc., Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, Bayer Corp., Bayer Healthcare AG and Bayer AG on Feb. 5 in St. Clair County Circuit Court.
The defendants manufacture and distribute Xarelto as an anti-coagulant medication intended to reduce the risk of stroke, embolism and other disorders, throughout Illinois, according to the filing.
Hernandez states that the defendants received a warning letter from the FDA on June 6, 2013 requesting them to cease product promotion. According to the complaint, more than 1,000 reports were filed regarding Xarelto-related cases, including at least 65 deaths.
The suit states that there exists no antidote to Xarelto in the event of hemorrhagic complications. Alleging that the defendants failed to fully research the medication’s safety, provide warning to consumers or advise physicians of risks, and knowingly failed to disclose knowledge of serious side effects, the plaintiff alleges fraud, negligence, breach of warranty and deception.
Citing product liability, and distress, he is seeking damages in excess of $50,000, plus attorneys’ fees and costs.
John Driscoll of St. Louis represents the plaintiff.
A spokesperson for Janssen Global Services responded to the report of the lawsuit with the following statement:
"Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots," said Kristina Chang.
"After more than three years on the U.S. market, and more than 2 million patients prescribed in the U.S. to date, the benefit-risk profile of Xarelto remains favorable and consistent with the clinical trials. All anticoagulants, or blood thinners, carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks.
"Blood thinners are important and potentially life-saving medicines that should be taken by patients as prescribed by a doctor and should not be discontinued without a discussion with a doctor. We will continue to defend against the claims raised in this litigation."
In addition to the Hernandez case, Driscoll filed similar complaints on behalf of Vickie Ballinger of Illinois, Carl Edens of West Virginia and Lovell Hoover of Texas.
Hernandez - St. Clair County Circuit Court case number: 15-L-58
Ballinger - St. Clair County Circuit Court case number: 15-L-81
Edens - St. Clair County Circuit Court case number: 15-L-77
Hoover - St. Clair County Circuit Court case number: 15-L-72