Otsuka and Bristol-Meyer Squibb Settle Three Abilify Lawsuits; Global Settlement Agreement to Follow
Japan-based Otsuka Pharmaceuticals and its US partner, Bristol-Meyer Squibb, have settled three Abilify lawsuits that were scheduled to go to trial this summer. The plaintiffs, who suffer from gambling addiction and compulsive behavior disorders, allege that their conditions were caused by taking the antipsychotic medication Abilify (aripiprazole). The three cases represent a total of 808 lawsuits that have been consolidated in multidistrict litigation before U.S. District Judge M. Casey Rodgers. Parties have been ordered to begin the process for reaching a global settlement, which must be established by September 1st.
Judge Rogers has ordered the defendants to pay proceeds to Florida plaintiffs Fanny Lyons, David Viechec, and Jennifer Lilly within 30 days of the settlement. The terms were not disclosed; however, all three plaintiffs will be required to sign releases and an agreement to dismiss their complaints. The first two plaintiffs allege economic losses exceeding $75,000. Lilly's losses were not specified, however, according to her complaint, she is no longer able to engage in employment.
Such trials are usually considered “bellwether trials,” intended to serve as test cases and serve as a guide to lawsuits going forward. However, Judge Rodgers noted that the three cases now settling were chosen because they were filed in the state by Florida plaintiffs. Lilly, Lyons, and Viehcec all filed their cases in the Northern District of Florida in Pensacola, where the multi-district litigation has been established. In an order dated March 13 , Judge Rodgers wrote that the cases “were chosen for convenience” because the local aspect would allow for an accelerated trial schedule. The settlements were reached through mediation.
Last week, Judge Rodgers issued a new order that gives all parties 120 days to finalize an agreement to resolve the remaining cases. The first step, which must be completed by the end of the month, is to define and identify the “no pay” cases that would be ineligible for compensation. After that, the parties will be working with a Settlement Master in order to come up with a mediation process for the cases remaining.
Abilify is a “new generation” neuroleptic medication primarily used to treat schizophrenia; however, physicians have been using it off-label for the treatment of other conditions, including bipolar disorder, depression and autism. Introduced in 2002, sales for Abilify reached $8 billion per year by 2013, eventually becoming the best-selling prescription medication in the US before losing its exclusivity in 2015. It has been linked to an inability to control compulsive behaviors, primarily gambling, shopping, eating, and sex. However, a lawsuit filed in Louisiana in 2014 also alleged that the drug caused an incurable condition known as tardive dyskenisia, which is characterized by uncontrollable muscle spasms.
The drugmakers had issued a warning in Europe about the possible side effect involving impulse control after the FDA had received almost 200 reports of uncontrollable impulse control among patients taking Abilify. However, for reasons that are not altogether clear, no such warning was given in the US until two years later.
The MDL established in Pensacola includes plaintiffs from several other states, including Arizona, California, Delaware New York and Pennsylvania. 50 other Abilify lawsuits are pending in New Jersey, which were scheduled for hearing starting in October.