A lawsuit alleges that an Iowa woman developed anemia after taking .
According to the lawsuit, Rebecca Williams, took from March 11, 2013 until June 26, 2013 and also from Oct. 13, 2013 until Dec. 26, 2015. The plaintiff says she developed and suffered from anemia from on May 13, 2014.
The lawsuit alleges that the “Plaintiff suffered various injuries, serious physical pain and suffering, medical, hospital and surgical expenses as a direct result of the use of .”
Jassen and other pharmaceutical companies were “in the business of and did design, research, manufacture, test, advertise, promote, market, sell, and distribute the drug for use as an oral anticoagulant, the primary purposes of which are to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, to treat DVT and 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 defendant drug makers spent millions aggressively marketing the drug, but failed to properly identify and warn doctors and patients about the risk of anemia from , among other dangers.
” is the second most prescribed drug for treatment of atrial fibrillation, behind only Coumadin (warfarin), and achieved blockbuster status with sales of approximately $2 billion dollars in 2013,” points out the lawsuit.
Although the Food and Drug Administration approved use of the drug, after numerous complaints were filed, the agency reviewed the studies the drug makers used to support approval of . According to the lawsuit, the FDA found “rampant violations including, ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.'”
Additionally, a safe drug for preventing the problems is meant to treat exists, says the complaint. The safe treatment, Coumadin, also known as warfarin, is more labor intensive for the patient, requiring blood monitoring and limitations to patients’ diets.
“Defendants’ aggressive and misrepresentative marketing of a ‘ Difference’ lead to an explosion in sales,” alleges the lawsuit. “The ‘ Difference,’ i.e., was once a day dosing without blood monitoring. In fact, the ‘ Difference’ was nothing more than a marketing campaign based on flawed science.”
The lawsuit alleges that was pushed on the public as a next generation improvement on the safe treatment because it does not require blood monitoring or changes in diet, according to the drug makers. But, says the plaintiff, the drug maker’s own research showed that is safer and more effective if taken twice a day and when there is blood monitoring.
Another big problem is that unlike warfarin, there is no antidote to problems caused by , alleges the lawsuit.
Instead of addressing these problems, alleges the anemia from lawsuit, drug makers instigated a direct-to-consumer marketing campaign. “In the course of these DTC advertisements, Defendants overstated the efficacy of with respect to preventing stroke and systemic embolism, failed to disclose the need for dose adjustments, failed to disclose the need for blood monitoring, and failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of , and, that such irreversibility could have permanently disabling, life-threatening and fatal consequences,” alleges the plaintiff.
If you or a loved one has suffered anemia from or any other side effect, consider contacting an experienced McDonald Worley attorney to protect your legal rights.Disclaimer: McDonald Worley is not representing the plaintiff in this lawsuit.