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A New York man has filed a lawsuit against Janssen Research & Development LLC, Bayer Healthcare Pharmaceuticals and related entities alleging he suffered uncontrolled bleeding.
According to the bleeding lawsuit, plaintiff Robert S. used the oral anticoagulant from approximately June 21, 2013 through September 2013.
Robert says he coughed up blood on Aug. 22, 2013 as a direct result of taking (rivaroxaban).
is primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism and reduce the risk of the recurrence of DVT and PE, and for prophylaxis of DVT for hip and knee surgery patients.
is part of a class of drugs known as New Oral Anticoagulants, or NOACs. NOACs such as , Pradaxa and Eliquis have been marketed as a new alternative to replace warfarin (Coumadin), which has been accepted as a safe treatment for the prevention of stroke and systemic embolism for six decades.
“Defendants market and promote as a single daily dose pill that does not require the need to measure a patient’s blood plasma levels, touting it more convenient than warfarin, and does not limit a patient’s diet,” the lawsuit says. The defendants allegedly market these advantages as the “ Difference.”
The U.S. Food and Drug Administration (FDA) approved on July 1, 2011 after reviewing studies that Robert alleges were “flawed in design and conducted in a negligent manner.”
According to the lawsuit, other studies indicated had a risk of major bleeding that was similar to the bleeding risk posed by warfarin. However, the study reportedly showed that posed a higher risk of bleeding from gastrointestinal sites and bleeding more often required transfusion. Other studies have reportedly found similar gastrointestinal bleeding risks associated with the use of .
Even though the defendants claim that blood monitoring is not necessary with , Robert says that failure to monitor the blood and adjust the dosage of the anticoagulant can lead to significant and life-threatening bleeding events.
Robert alleges the defendants were aware of the risk of potentially life-threatening bleeding and the need for blood monitoring, but they failed to inform doctors, patients and the FDA about this important information.
“Importantly, ’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects, unlike warfarin,” the lawsuit states. “Therefore, in the event of hemorrhagic complications, there is no available reversal agent.” However, the original U.S. label allegedly failed to warn about the lack of bleeding antidote and only included the information in the overdose section.
Despite knowing about the increased risk of potentially life-threatening bleeding events and the availability of safer alternatives, the defendants continue to urge consumers to use without regular blood monitoring, the lawsuit alleges.
Did You Experience Uncontrolled Bleeding?
If you or a loved one experienced uncontrolled gastrointestinal bleeding or other serious bleeding complications after taking , you may have a legal claim.
Contact the drug injury attorneys at McDonald Worley today for a free case evaluation. If you have a case, you may be able to take legal action against the drug’s manufacturers and seek compensation for your medical expenses, pain and suffering, lost wages, and other losses you experienced.