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The makers of the , a drug used to reduce the risk of stroke in hip and knee replacement patients, were hit with a lawsuit alleging the drug caused unintended major bleeding.
Plaintiff Isabel L. alleges in her lawsuit that she was prescribed in October of 2013. According to Isabel, several days later she was admitted to the hospital with stroke symptoms. After being discharged from the hospital, Isabel says that she was again admitted in November for anemia and bleeding. She went to the hospital again in January for bleeding and another time in September for shortness of breath in September and was ultimately diagnosed with severe anemia.
According to the complaint, Isabel was on until her hospital stay in September. Isabel alleges caused her health problems that lead to “severe pain and suffering, medical expenses, and other economic and non-economic damages.”
Isabel alleges that was approved by the federal Food and Drug Administration in July of 2011 for the prophylaxis of DVT and PE in patients undergoing hip or knee replacement surgery; however, according to Isabel, the clinical trials showed a greater incidence with of major bleeding events.
Isabel says that severe bleeding events occurred even though individuals with high risk of bleeding were excluded from the studies and the drug maker’s “failures to report significant adverse events and falsifications of adverse event documentation.”
According to the complaint, the makers of marketed the drug as more convenient than the alternative, warfarin, because patients do not have to take blood tests or limit their diet. But, says Isabel, the drug maker’s “promotional materials have failed to … highlight the increased risk of major internal bleeding, among other serious bleeding concerns.
“The term ‘major bleeding’ as used in the record studies was defined as ‘bleeding that was fatal, that involved a critical organ, or that required reoperation or clinically overt bleeding outside the surgical site,” the lawsuit states.
Isabel alleges that the companies that funded the clinical trials had a financial interest in the outcome of the trials and “ensured that the studies were not designed to accurately assess difference 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.”
The lawsuit alleges that the FDA warned the drug makers that they were overstating the effectiveness of the drug and minimizing the risks associated with it in a letter sent in June 2013.
In the course of its advertising campaign, including direct-to-consumer advertisements, the drug makers “overstated the efficacy of , misleadingly suggested that no blood monitoring was required, failed to adequately disclose to patients that there is no antidote for and that such irreversibility could have permanently disabling, life-threatening, and fatal consequences.”
According to the blood thinner lawsuit, by the end of June in 2012, there were over 1,000 reports of -associated serious adverse events, including 65 deaths. Isabel alleges that the drug makers made millions off the drug and their false advertising campaign in the meantime and failed to adequately respond to the complaints.
Isabel alleges the makers of , including Janssen Research and Development, Johnson & Johnson, and Bayer, negligently manufactured and marketed the drug as well as sent the drug to market in an unsafe condition. Isabel says, as a result, she and others suffered serious and dangerous side effects including life-threatening bleeding as well as other severe permanent injuries.
Isabel is seeking damages, including reimbursement of hospital expenses along with attorneys’ fees.
The Lawsuit is Isabel L. v. Janssen Research & Development, LLC., et. al., Case No. 2:17-cv03777 in the U.S. District Court of the Eastern District of Louisiana.
Note: McDonald Worley did not represent the plaintiff in this lawsuit.