“With global settlement talks now in place less than a week later”
By Mark A. York (May 3, 2018)
Will Abilify MDL Settle By September 15, 2018?
- Abilify Products Liability Litigation – MDL No. 2734
- Master Docket: 3:16-md-2734
- Judge M. Casey Rodgers, US District Court ND of Florida
(Mass Tort Nexus Media) The first pool of three bellwether trial plaintiffs have settled just before trials started in the Abilify MDL 2734 in front of Judge Casey Rodgers earlier this week, see Abilify Settlement Order Re First Bellwether Trial Pool Cases Entered April 28, 2018 (www.masstortnexus.com), related to the antipsychotic drug Abilify. The plaintiffs claimed after being prescribed the drug, Abilify made them gamble compulsively. All three cases were settled against the drug makers Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, for undisclosed amounts. The three Florida residents’ cases were scheduled for trial starting in June as bellwether trials, for case information see the Mass Tort Nexus Abilify briefcase, ABILIFY-MDL-2734-USDC-MDL-Florida (Briefcases/Drugs).
The Abilify multidistrict litigation includes 808 cases, as of April 16, and as of May 2, 2018 there is a Global Settllement Order in place, see Abilify MDL 2734 Global Settlement Order No. 1 Entered May 2, 2018, where Judge Rodgers gave the parties 120 days to finalize a framework of a global settlement, including a first phase outline of what will be classified as “no pay” cases, with these cases to be identified within 14 days of the global order or by May 16, 2018. Upon identification of the no pay cases, they will be removed from the MDL.
Also of note is language in the April 28th settlement order for the three bellwether trials, is a requirement that defendants must pay the settlement proceeds to plaintiffs, who in turn must execute full release and then, within 10 days, parties must file a stipulation of dismissal. Judge Casey has ordered the three cases to remain on the trial docket until the stipulated dismissals are filed. This appears to be another federal judge asserting direct control over the often lengthy and drawn out settlement talks in MDL’s across the country. Judges are now moving cases toward settlement or setting them for trial, pursuant to the JPML rules of civil procedure outline.
The Abilify litigation is against defendants Japanese drugmaker Otsuka and Britsol-Myers Squibb, which marketed the drug in the U.S. until 2013 and related to plaintiffs being prescribed Abilify, an anti-psychotic medication commonly prescribed to treat a variety of mental disorders, which caused impulse control problems in users. The two primary impulse control claims are “impulsive gambling” and “uncontrollable sexual urges” with several plaintiffs claiming to have lost millions of dollars in gambling sprees brought on after consuming Abilify, while never having gambled before. The other control issue is “inability to control sexual urges or engaging in sexual promiscuity” resulting in ruined personal relationships and adverse health conditions, as well as related financial consequences.
Aripiprazole is available under the brand names Abilify, Abilify Maintena, Aristada, and also as generics. A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature in the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002 identified a total of 184 case reports in which there was an association between aripiprazole use and impulse-control problems.
May 5, 2016 FDA Drug Safety Notice: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
ABILIFY (aripiprazole) – FDA: Adverse Reactions
Seizures/Convulsions. 5.10 Potential for Cognitive and Motor Impairment. 5.11 Body Temperature Regulation. 5.12 Suicide. 5.13 Dysphagia. 6. ADVERSE REACTIONS. 6.1. Clinical Trials Experience. 6.2. Postmarketing Experience. 7. DRUG INTERACTIONS. 7.1. Drugs Having Clinically Important Interactions with Abilify.
THE ABILIFY MDL
On October 3, 2016, the JPML consolidated pretrial proceedings for In Re: Abilify (Aripiprazole) Products Liability Litigation, MDL No. 2734, in the US district Court Northern district of Florida. The transferred actions share factual issues arising from allegations that Abilify (aripirazole), an atypical anti-psychotic medication commonly prescribed to treat a variety of mental disorders, can cause impulse control problems in users. All the actions involve factual questions of whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.
These cases were assigned to the Honorable M. Casey Rodgers for coordinated discovery and pretrial matters.
Abilify Linked to Compulsive Behaviors
Details of the three Abilify settlements were not made public. But include payment by the defendants to the plaintiffs, as well as apparently opening the door for a full global settlement of the remaining 800 plus cases.
Introduced in 2002, Abilify became a blockbuster drug, generating nearly $8 billion a year by 2013. The following year, it was the top-selling drug in the U.S. Sales fell in 2015 when the first generic versions of the drug were approved.
The drug is prescribed to treat psychiatric conditions including bipolar disorder, schizophrenia and major depression.
Off-label uses include anxiety disorders, dementia and post-traumatic stress disorder. The drug has been linked to severe, compulsive behaviors, mainly gambling, sex and shopping.
Gambling Warning Added in 2016
About a week before the settlement was reached, the plaintiffs sought a court order allowing them to secure documents from Otsuka regarding Rexulti, the drug that was introduced when Abilify’s patent expired.
Plaintiffs argued in court filings that Rexulti had the same mechanism of action. The company didn’t begin to warn that Rexulti could cause compulsive gambling until January of this year. That warning was added to the Abilify label in the U.S. in August 2016.
The cases that settled are plaintiffs, Jennifer Lilly, David Viechec and Fanny Lyons.
Lyons’ lawsuit was scheduled to start trial June 18. According to court filings, she began taking Abilify around January 2009 and soon began compulsive gambling. She stopped taking the drug in January 2014 and stopped gambling soon after that. She claims to have lost more than $75,000.
Viechec was scheduled to have his case heard by a jury beginning Aug. 6. According to court filings, he was prescribed Abilify for bipolar symptoms from 2012 until late 2016. He also claimed to have lost more than $75,000 from gambling, which stopped after he stopped taking the drug.
Lilly’s case was scheduled to start trial on Aug. 27. According to her lawsuit, she took Abilify from 2003 to 2016. Her lawsuit claims unspecified gambling and other losses, including the loss of the ability to earn money.
The settlement of the three initial trials and entry of a global settlement order less than a week later seems to point to a decision by Bristol Myers and Otsuka that perhaps settling now versus waiting until adverse material and testimony come out at trial is the prudent legal strategy at this point.
Congratulations to Judge Casey for putting a timer on the settlement discussions and directing legal traffic in his MDL docket.