The estate of a Texas woman is suing the makers of alleging the drug caused serious and dangerous side effects including life-threatening gastrointestinal bleeding that ultimately led to her death.
According to the lawsuit, Edith M. began using at the beginning of 2014. The lawsuit says she experienced gastrointestinal bleeding on March 10, 2015 leading to hospitalizations and extensive medical treatment. The bleeding eventually caused her death, alleges the wrongful death lawsuit, and the drug makers were aware of the risks, but failed to warn patients and doctors when marketing .
is 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, to reduce the risk of recurrence of DVT and/or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery.
It is made by Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc., both defendants in this wrongful death lawsuit..
The drug was put on the market in 2011 and marketed as a single daily pill that did not require blood monitoring, unlike its competitors. However, the drug makers used flawed and unreliable research to get the drug on the market, says the wrongful death lawsuit.
The lawsuit alleges that when the makers of marketed the drug for use in patients undergoing hip and knee replacement surgery, the studies they conducted were flawed and the companies negligent. The lawsuit notes that the Food and Drug Administration cited the drug makers for systematically discarding medical records that did not support the use of the drug, conducting unauthorized unblinding and falsification.
According to the wrongful death lawsuit, the drug makers released the drug based on unreliable studies that failed to account for the life-threatening side effects that lead to Edith’s death.
“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,” alleges the lawsuit. “The single dose and no blood testing requirements or dietary constraints are marked by Defendants as the ‘ Difference.’ However, ’s clinical studies show that is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”
The wrongful death lawsuit claims the drug makers were aware of the need to monitor patients on the drug, but “failed to disclose this vital health information to patients, doctors and the FDA.”
“Importantly, ’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects, unlike warfarin,” the lawsuit states.
This wrongful death lawsuit is seeking damages for Edith’s death, as well as for medical expenses, physical and mental pain and anguish, diminished enjoyment of life, hospitalization, and loss of earnings.
If someone you loved died after taking , filing an wrongful death lawsuit may help recover some of the financial and emotional hardships you’ve suffered.. Contact the attorneys at McDonald Worley today for a FREE case evaluation.