A new lawsuit filed in Louisiana argues that a Tennessee resident not only sustained severe injuries from use of , but that her death was ultimately caused by the gastrointestinal bleeding side effect brought about by use of the medication.
The lawsuit was filed approximately six years after was introduction in the U.S. is part of a family of medications known as “New Oral Anticoagulants.” These medications, including other versions like Pradaxa and Eliquis, were intended to replace the popular warfarin, a blood-thinning medication on the market for more than six decades at the time. Warfarin was often chosen by doctors to prevent stroke and systemic embolism.
FDA approval was given to the makers of in 2011 to prevent deep vein thrombosis and pulmonary embolism in patients going through knee or hip replacement surgeries. Patient reports were followed by medical studies that identified that patients faced a much higher risk of severe internal bleeding events when taking , but the drug was still approved for use in the U.S.
Claims Behind the Latest Lawsuit
Research has found that the use of without dose adjustment, blood monitoring, and twice a day dosing could lead to life-threatening bleeding events. Doctors prescribing the medicine to their patients, according to the lawsuit, were never warned about the risks. Doctors needed to balance the dosage of to ensure that the blood was thinned to an appropriate level to minimize risks of a stroke but not so much that the patient was in jeopardy of a life-threatening bleed.
One major distinction between and the predecessor drug used by most doctors, warfarin, is that an antidote was available for warfarin. Despite the fact that comes with life-threatening risks for patients, an antidote was not available to doctors to be able to stop the development of the side effects quickly and effectively.
The FDA received more than 1,000 adverse event reports linked to usage of between the drug’s approval and June of 2012. The newest lawsuit aims to hold manufacturers accountable for an array of problems, including not disclosing the need for dose adjustments, failing to disclose the need about blood monitoring and twice daily dosing, and improper labeling, among other issues.
The number of adverse event reports and lawsuits have been on the rise in recent years, as more injured patients and surviving family members of those who died from severe bleeding incidents begin to share their stories and take action. As with other allegedly dangerous drugs, those who have suffered injuries may be eligible to file a defective drug lawsuit to hold the manufacturer accountable and to receive compensation..
The lawyers at McDonald Worley are currently evaluating claims from patients and family members who have lost loved ones because of complications – if you believe you need legal insight about your eligibility to file a lawsuit, call for a free consultation today.