The son of a New York man is suing Janssen and other drug makers alleging that the anticoagulant caused severe internal bleeding in his father and ultimately led to his death.
According to the lawsuit, Robert R. began using to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation. The lawsuit says he experienced a traumatic rupture of a lower extremity varicosity on Oct. 18, 2015. The internal bleeding led to Robert’s death in his own home.
“As a direct and proximate result of Defendants’ conduct, Decedent, Robert R[], Sr., suffered and incurred harm including severe pain and suffered personal injuries and incurred damages to include severe pain and suffering, medical expenses and other economic and noneconomic damages,” alleges the internal bleeding lawsuit.
Robert’s son alleges that Janssen and other drug makers were aware of the risk presented to patients, but failed to warn them or their doctors when marketing the drug. The lawsuit claims that use of caused Robert to suffer severe and permanent personal injuries, diminished enjoyment in life, additional medical treatment and monitoring before it ultimately caused his death.
According to the internal bleeding lawsuit, drug makers received approval from the Food and Drug Administration for the drug on July 1, 2011.
The FDA approved the use of to reduce the risk of stroke and systemic embolism in patients with nonvalvular 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.
The lawsuit alleges that despite evidence to the contrary, Janssen and other drug companies marketed as a single daily pill that did not require blood monitoring. However, the plaintiff claims that the studies used to promote the drug were flawed and more reliable studies showed that multiple doses and monitoring made safer and more effective.
The internal bleeding lawsuit contends that pharmaceutical companies systematically discarded and ignored evidence that showed a greater incidence of major bleeding events associated with use of . Doctors and patients were not warned about the risks of internal bleeding because of the flawed studies.
“Defendants, who funded and had direct involvement in the design and conduct of the studies, ensured that the studies were not designed to accurately assess differences in bleeding risk between and other anticoagulants, and further ensured that the studies were designed to under-represent the true bleeding risk presented by use,” states the lawsuit.
Instead, alleges the lawsuit, the drug companies emphasized the incorrect and dangerous notion that blood monitoring is not necessary while on . Further, if causes a hemorrhagic complication or internal bleeding, there is no way to reverse the effect. Drug makers failed to warn doctors and patients about this problem as well.
This internal bleeding lawsuit is seeking damages for the additional pain and suffering Robert experienced as a result of taking the drug, as well as the additional medical expenses.
If you or someone you love has been injured by internal bleeding, contact the attorneys at McDonald Worley today. The consultation is free.