Houston Car Accident Lawyers
The makers of , Janssen, Johnson & Johnson, and Bayer, were hit with a lawsuit alleging that the drug caused rectal bleeding.
The plaintiff, Louisiana resident Leon M., alleges in his lawsuit that he took as directed from Sept. 2, 2015 until Oct. 2, 2016 for the treatment of atrial fibrillation. However, he had to stop on Oct. 2 because he allegedly experienced rectal bleeding from , among other severe injuries.
“Plaintiff’s injuries required him to undergo numerous blood transfusions and hospitalization at multiple hospitals,” alleges the lawsuit.
According to the lawsuit, has been associated with severe bleeding events, including rectal bleeding from use in the plaintiff’s case.
“Specifically, Plaintiff suffered various injuries, serious physical pain and suffering, financial expenses for hospitalization and medical care, among other damages, as a direct result of his use of ,” states the lawsuit.
The plaintiff claims the drug makers that produced obtained approval based on flawed research that was conducted in a negligent manner.
One year after the drug was approved by the Food and Drug Administration (FDA) in 2011, says the plaintiff, more than 1,000 reports of -associated serious adverse events were submitted to the agency. Sadly, by the end of the fiscal year those reports had doubled and included more than 65 deaths.
“In fact, FDA Official Action Indicated (‘OA’)-rated inspections in 2009 disclosed rampant violations including, ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization,’” alleges the rectal bleeding from lawsuit.
Despite the problems with the research and continuing serious event reports, alleges the lawsuit, is still often prescribed “for use as an oral anticoagulant, the primary purposes of which are to reduce the risk of stroke and systemic embolism in patients” after hip or knee replacement surgery.
According to the lawsuit, drug makers failed to warn doctors and patients about the risk of severe bleeding events, including rectal bleeding from .
Frustratingly, a safe alternative to exists, says the lawsuit. Warfarin has been the approved treatment for decades, but the drug makers marketed as a more convenient alternative. is marketed as simpler, requiring only a single daily dosing and making blood monitoring unnecessary.
However, drug makers relied on flawed studies to make their marketing claims, putting patients at risk for their marketing scheme, alleges the lawsuit.
“espite life-threatening bleeding findings in a clinical trial and other clinical evidence, Defendants failed to adequately conduct complete and proper testing of prior to filing their New Drug Application for ,” alleges the plaintiff, stating that this failure caused his rectal bleeding from .
“Plaintiff suffered various injuries, serious physical pain and suffering, financial expenses for hospitalization and medical care, among other damages, as a direct result of his use of ,” alleges the lawsuit.
“Defendants made, distributed, marketed, and sold without adequate warning to Plaintiff or his prescribing physician or that was associated with and/or could cause life-threatening bleeding, presented a risk of life-threatening bleeding in patients who used it, and that Defendants had not adequately conducted complete and proper testing and studies of with regard to severe side-effects, specifically life-threatening bleeding.”
If you or a loved one have suffered rectal bleeding from , contact an experienced attorney at McDonald Worley to help receive compensation for your additional medical expenses. The case evaluation is FREE, call today.