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A 79-year-old man has filed a lawsuit accusing Janssen Research and Development LLC, Johnson & Johnson and Bayer of concealing the risk of uncontrollable bleeding that is associated with the drug.
“This is an action for damages suffered by Plaintiff as a direct and proximate result of the Defendant’s negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and/or sale of the pharmaceutical product ,” plaintiff Preston W. says in the lawsuit.
What Is ?
, also known as rivaroxaban, is an anticoagulant medication intended to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. may also be prescribed to reduce the risk of recurrence of DVT and/or PE, and to prevent DVT in patients who will be having hip or knee replacement surgery.
was introduced as an alternative to warfarin (Coumadin), an anticoagulant that has been used to prevent stroke and systemic embolism for 60 years. Unlike warfarin, patients taking are not required to have periodic blood tests, and they do not have to limit their diet.
“Importantly, there is no antidote to , unlike Warfarin,” the lawsuit asserts. “Therefore, in the event of hemorrhagic complications, there is no available reversal agent.”
The original U.S. label reportedly did not warn about this lack of antidote to stop bleeding. The only mention of the lack of antidote was included in the overdosage section.
Lawsuit Says Defendants Concealed Bleeding Risk
According to the lawsuit, Preston was prescribed in October 2016 to prevent atrial fibrillation. He says he used the drug from approximately Oct. 14, 2016 through Nov. 2, 2016, when he suffered a gastrointestinal bleed followed by a life-threatening, irreversible bleed that was allegedly caused by .
In addition to the life-threatening bleeding, Preston says he also suffered other severe and permanent personal injuries, physical pain, mental anguish, diminished enjoyment of life, shortened life expenses, loss of earnings, and medical expenses.
Preston claims the defendants concealed the bleeding risk from the U.S. Food and Drug Administration (FDA), the medical community and the general public. He says the defendants failed to perform sufficient testing of on humans during the clinical trials.
“As a result of the foregoing acts and omissions, the Plaintiff was caused to suffer serious and dangerous side effects including inter alia life-threatening bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life,” the lawsuit alleges.
Did You Suffer Bleeding Complications After Taking ?
Preston is not the first patient to take legal action after allegedly suffering life-threatening complications from the blood thinner. Other bleeding lawsuits have been consolidated in multidistrict litigation titled In re: (Rivaroxaban) Products Liability Litigation, which is currently pending in Louisiana federal court.
If you took and experienced uncontrollable bleeding or other severe complications, you may be able to file a lawsuit to seek compensation for your injuries. Contact the injury lawyers at McDonald Worley for a FREE case evaluation to find out if you qualify.