Three separate lawsuits have been filed in New York at the end of May by plaintiffs who suffered irreversible excessive bleeding after taking an allegedly defective blood thinner. Plaintiffs in the lawsuits maintained that Bristol-Myers Squibb Co. and Pfizer Inc., misrepresented the safety of the anticoagulant including failing to disclose that there was no available reversal agent or antidote to Eliquis, the drug in question, in case of an extreme bleeding event, reports Law360.
“Upon information and belief, defendants concealed and failed to completely disclose their knowledge that Eliquis was associated with or could cause life-threatening bleeding in specific patient populations, and failed to fully identify and convey the risks of use of Eliquis at the same time as other blood-thinning agents, such as aspirin,” according to the complaint.
Dubious Approval of Eliquis
The plaintiffs maintain that the U.S. Food and Drug Administration (FDA) approved Eliquis mostly based on a clinical trial called Aristotle, which was allegedly conducted by “incompetent and untrustworthy” individuals in China. The testing agents were accused of fraud for not reporting a death that occurred during the study, not following up with subjects, making dispensing errors where some subjects never even received the drug, falsifying records and, overall poor quality control, according to Law360.
When the drug manufacturers began to promote Eliquis in the United States, its label did not reveal the lack of an antidote that, for example, the traditional anticoagulant Coumadin (warfarin) has. Bristol-Myers and Pfizer set out on an “aggressive marketing campaign” for the treatment and claimed that with Eliquis, patients’ blood levels do not need to be monitored, their diets do not need to be restricted, unlike with Coumadin, and all patients could take an established dose of the treatment, according to the complaint.
National law firm Parker Waichman LLP has extensive experience and success representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.
Eliquis Lawsuit Allegations
“In the course of these direct-to-consumer advertisements, defendants, overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Eliquis, and that such irreversibility would have life-threatening and fatal consequences” the lawsuit claimed. The plaintiffs maintain, that even after the drug manufacturers became aware of “serious hemorrhaging” in patients, they did not disclose all the details of the Aristotle study.
Plaintiffs are seeking compensatory, economic and punitive damages, prejudgment and post-judgment interest, and costs, Law360 reports.
Previous Eliquis Litigation
A lawsuit filed in 2016 against Bristol-Myers Squibb and Pfizer involved a woman from Louisiana who died allegedly from the use of Eliquis. An addition to the use of Eliquis (apixaban) that was approved by the FDA in 2012, was the treatment of atrial fibrillation. Eliquis was then used to prevent blood clots and stroke, but there were reports of potential serious side effects such as brain bleeding, gastrointestinal bleeding, and severe pain.
Eliquis belongs to the “new generation” of blood thinners that includes Pradaxa (dabigatran) and Xarelto (revaroxoban). These drugs have led to thousands of product liability lawsuits against the manufacturers. The plaintiffs are alleging that these drugs were manufactured and sold and the dangers were not revealed to alert users that a reversal agent for these newer medications did not exist at the time.
In another case, a couple filed an Eliquis uncontrollable bleeding lawsuit, alleging that the blood thinning medication prescribed to treat the wife’s atrial fibrillation, had put her in danger with internal bleeding complications. When the wife with the atrial fibrillation condition consulted with her physician about her treatment options, they chose Eliquis on the basis of the marketing materials that were presented by the pharmaceutical companies.
These newer drugs were initially prescribed for knee or hip replacements and for deep vein thrombosis (blood clots in the veins of the legs). Their purpose was to prevent blood clots from forming and to keep blood blowing smoothly, according to WebMD. Side effects, however, began to emerge including: back pain, bleeding gums, headache, bloody stools, difficulty breathing or swallowing, internal bleeding, pulmonary embolism, heart attack, stroke, and brain hemorrhage, the Mayo Clinic reports.