In May 2016, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication concerning the antipsychotic drugs, Abilify, Abilify Maintena, and Aristada.
This safety announcement provided the following warning:
The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.
Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. In addition, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.
Since the FDA’s warning, over 800 Abilify lawsuits have been filed against the drug manufacturers, Bristol-Myers Squibb and Otsuka Pharmaceuticals. These cases involve Plaintiffs who used Abilify, then experienced the harmful compulsory behaviors that the FDA warned about in May 2016.
The Plaintiffs argue that the manufacturers of Abilify, Abilify Maintena, and Aristada should have known and warned about the link between their drugs and the harmful, uncontrollable urges. If such warnings had been provided by the drug manufacturers, then the Plaintiffs claim that they would have recognized the causes of such urges and been able to seek medical help before undergoing such devastating losses.
These Abilify cases have been consolidated in the multidistrict litigation (MDL) in the Northern District of Florida. An MDL is often created in order to centralize cases that involve the same defendants and issues.
Three test cases out of this MDL were selected by the involved parties and the judge presiding over the MDL to go to trial in June of this year. However, these cases were recently settled after a successful mediation. According to the Order signed by the MDL judge, once the settlement money is paid by the Defendants and dismissals are signed by the Plaintiffs, the cases will officially be taken off the trial docket.
Often times, the test cases in an MDL — often referred to as “bellwether trials” — will determine rulings for the remaining cases in the MDL. Given that the original cases never went to trial, a new round of test cases will be selected. If the second round of cases is again settled before going to trial, one could predict that the cases remaining in the MDL could also anticipate settlements instead of trial dates.
We will continue to monitor the legal news for updates on the onoging Abilify gambling lawsuits and report significant developments as we are made aware of them.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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