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A lawsuit alleges that an Indiana man suffered a stroke and ultimately died after taking .
According to the lawsuit, Santiago A. was prescribed , but suffered a hemorrhagic stroke after taking the drug and ultimately died. The drug is an anticoagulant, and the lawsuit alleges that it caused the plaintiff’s bleeding death.
“The primary purposes of are to reduce the risk of stroke and systemic embolism in patients with non- valvular atrial fibrillation, to treat Deep Vein Thrombosis (‘DVT’) and Pulmonary Embolism (‘PE’), to reduce the risk of recurrence of DVT and/or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery,” states the lawsuit.
The lawsuit alleges that the drug makers, Janssen Pharmaceuticals and Bayer Pharma were either aware of the increased risk of hemorrhagic stroke and bleeding death, or should have been aware of the risk. The drug makers had a duty to warn the plaintiff and his doctors about the risk of a bleeding death before they prescribed the drug. Instead, says the lawsuit, the companies spent millions on the aggressive and misrepresentative marketing of the drug.
According to the lawsuit, the introduction of by the drug makers for use in patients with knee or hip replacement surgery was based on flawed studies that were conducted negligently.
“In fact, FDA Official Action Indicated (‘OAI’)—rated inspections in 2009 disclosed rampant violations including, ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties randomization,’” alleges the bleeding death lawsuit.
The lawsuit states the FDA found that one study regarding the use of was so flawed that its results had to be discarded.
Further, alleges the lawsuit, an established safe treatment for preventing stroke and bleeding death exists. Coumadin, also known as warfarin, has been in use for 60 years; however, warfarin requires blood monitoring and limitations to patients’ diets.
Drug makers marketed as a single daily dose pill that does not require blood monitoring or changes in diet; however, alleges the lawsuit, research shows that is safer and more effective if taken twice a day and when there is blood monitoring.
“The use of without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” alleges the bleeding death lawsuit.
“Physicians using have to be able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event,” the complaint continues. “The Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors and the FDA.”
Further, there is no antidote to stroke and other causes of bleeding deaths, says the lawsuit. But there are antidotes to problems caused by warfarin, if necessary – a factor glossed over by the drug makers in marketing the drug to patients and doctors.
If your loved one experienced a bleeding death, you and your family may be entitled to compensation. Contact the experienced attorneys at McDonald Worley today for a FREE case review.