Abilify: A Well Planned Gamble Now Heading To Rock-Bottom!
Abilify was introduced to the U.S. market in 2002 by Otsuka Pharmaceutical Co. and Bristol-Myers Squibb Company as a drug for treating bipolar disorder, schizophrenia, irritability associated with autism spectrum disorder, and depression. By 2013, Abilify sales crossed $2 billion, making it the biggest seller for the makers. In a small window between April and June 2014, sales of this antipsychotic drug reached a whopping $417 million in the U.S. and $515 million worldwide.
Although the label warned about various other issues and also included a ‘Black Box Warning ‘ for some conditions, there were no safety warnings for at least 14 years in the drug’s U.S. label about pathological gambling or compulsive behaviors. Trouble started brewing while the makers were basking in the success of the highly profitable drug. Complaints and adverse event reports started pouring between 2002 and 2016. Of the complaints filed, the FDA was successful in identifying 184 cases where they could point an association between aripiprazole (the active ingredient in Abilify) use and impulse-control related disorders, they also noted that pathological gambling was the most common with 164 cases. It was in 2016 when the FDA intervened and required the makers to update the label to warn about the compulsive behaviors which included intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.
However, the side-effects had already taken a toll on hundreds culminating in the filing of lawsuits by January 2016, by those who decided to punish the offenders. Negligence and failure to warn allegations Otsuka Pharmaceutical Co. and Bristol-Myers Squibb Company were brought in a number of lawsuits. The main allegations made against the defendants include that they were negligent in creating a drug that was defectively designed and manufactured and they failed to warn the medical community despite being aware of the drug’s alleged tendency for causing compulsive behaviors, taking away their right to make an informed decision.
Due to the growing number of lawsuits in this mass tort, in October 2016, the JPML created an MDL 2734 as agreed that pretrial proceedings should be consolidated so as to coordinate discovery, reduce costs and eliminate the risk of inconsistent rulings. Currently, more than 440 Abilify lawsuits are pending in federal court in Florida, presided by Chief Judge M. Casey Rodger, who is currently considering a motion filed by the plaintiffs to start holding multi-plaintiff trials owing to a large amount of nearly identical evidence, a move opposed by the defendants. The bellwether trials are expected to begin in June 2018. The judge also plans a proposal to start putting claims involving multiple plaintiffs before the same jury in consolidated trials.
A request has been put before the New Jersey Supreme Court for the creation of an MDL to ensure that future cases filed, end up in Bergen County to join the others pending before Superior Court Judge DeLuca. The nine cases filed earlier were consolidated in March 2016, since then the remaining cases and the existing lawsuits have advanced considerably and a bellwether track has been established by the judge; the first trial is expected to begin by the end of 2018. This request is viewed as a fair, more convenient, and cost-effective process.
Numerous trial attorneys across the country are now burdened with the responsibility of proving the fault and bringing justice to those truly affected by the adverse side-effects of this antipsychotic drug. While a few are engaged in collecting damning evidence to prove the compulsive behaviors, the others are keenly analyzing medical summaries and chronology reports prepared by experts, to link the proof of usage to the proof of injury and also identify the missing medical records required to make the case strong. A quality medical record review will help to know the eligibility of the case, and accordingly, attorneys can estimate the worth of the case. It would also help to gauge the future of the case with respect to quality of life, expenses incurred or worth of the legal case or amount of compensation.
The drugmakers may or may not lose money in the ongoing litigation, but they have lost a huge amount by paying over $500 million as penalty and settlement costs to the U.S. government to settle matters related to the off-label use and aggressive marketing.
All eyes are now on the Abilify litigation.
This article was submitted by Neural IT. Neural IT provides cost-effective and timely medical reviews for personal injury, medical malpractice, and mass tort cases. For more information, please visit www.neuralit.com. Email us at [email protected] or call +1-844-NIT-TEAM (648-8326) to learn more about our free trial.