PHILADELPHIA – Seventeen Pennsylvania plaintiffs have sued Bristol Myers-Squibb and Otsuka Pharmaceutical over anti-psychotic prescription medication Abilify, claiming that taking the drug caused them to develop compulsive behaviors such as addictions to gambling, shopping, binge eating and sex.
The plaintiffs collectively filed suit in the Philadelphia County Court of Common Pleas on Aug. 15 against Bristol Myers-Squibb Company and Otsuka America Pharmaceutical, Inc., plus Otsuka Pharmaceutical Co., Ltd. (all c/o CT Corporation System) of Plantation, Fla. and Baltimore, Md., respectively.
According to the lawsuit, Abilify was first introduced in the United States in the fall of 2002 as an anti-psychotic medication discovered by Otsuka Pharmaceutical Co., Ltd., used to treat schizophrenia, bipolar disorder, depression and autism spectrum disorders.
A decade later in 2012, the European Medicines Agency required labeling for the drug in Europe to carry a special warning regarding its users developing gambling addictions, regardless of whether or not they had a prior history of gambling. In 2015, Canadian regulators found a link between Abilify use and pathological gambling or hyper-sexuality.
However, the suit claims that despite these warnings in Europe and Canada, the U.S. labeling for Abilify did not contain warnings of any kind until January 2016. At that time, when the patent for Abilify expired in the United States, pathological gambling was added only to the Postmarketing Experience section of the label, and the plaintiffs alleged the defendants “failed to make mention of gambling in the patient medication guide, a source of information likely viewed by physicians and patients.”
“On May 3, 2016, the FDA issued a warning that Abilify was associated with ‘compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.’ The FDA recommended that doctors ‘make patients and caregivers aware of the risk of these uncontrollable urges,’ ‘closely monitor’ patients, and consider reducing or stopping Abilify if compulsivity emerges,” the suit states.
On the possibility of Abilify one day becoming a mass tort series in the Philadelphia County Court of Common Pleas’s Complex Litigation Center, and if a certain number of cases need to be filed against a certain drug or entity before being assigned that designation, CLC Director Stanley Thompson said that there was “not a specific, magic number.”
“Based on past decisions, there has to be significant number. In the past, at least 50 to 100 or more were filed before a mass tort program was created. It is important to note, it is not just the actual number of cases, but projected numbers. The number/projected number of cases is just one consideration,” Thompson stated.
The litigation alleges the defendant pharmaceutical companies knew or should have known that Abilify can cause a number of compulsive behaviors to manifest in its users due to its role in activating dopamine, a neurotransmitter which helps regulate the brain’s reward and pleasure centers.
“From 2005 to 2013, an FDA report showed that Abilify accounted for at least 54 reports of compulsive or impulsive behavior problems, including 30 reports of compulsive gambling, 12 reports of impulsive behavior, nine reports of hyper-sexuality, and three reports of compulsive shopping,” the lawsuit says.
Furthermore, the lawsuit claims the defendants have invested millions of dollars in teams of pharmaceutical sales representatives who visit and contact members of the medical community, including prescribing doctors to “educate” them about Abilify – but at the same time, do not convey information about its risks to patients.
“Defendants have made payments to doctors to promote Abilify. From August 2013 to December 2014, $10.6 million in payments relating to Abilify were made to 21,155 physicians in the United States. To date, defendants have not adequately notified or warned patients, the medical community, or prescribers in the United States that Abilify causes, is linked to, and is associated with compulsive gambling, pathological gambling, or gambling addiction,” the suit reads.
As the plaintiffs claim the defendants concealed information about the compulsive addiction side effects related to Abilify until January 2016, the plaintiffs believe they could not have reasonably known of such wrongdoing until then and want the discovery rule to be applied, in tolling the running of the statute of limitations until that time.
This Philadelphia lawsuit comes after the defendant pharmaceutical companies individually settled three bellwether lawsuits from a multi-district litigation connected to Abilify earlier this year in the U.S. District Court for the Northern District of Florida, which alleged the drug caused the same compulsive behaviors. All three cases were settled for undisclosed sums.
Per an order from U.S. District Court Judge M. Casey Rodgers, the same defendants have until Sept. 1 to devise a way to settle more than 800 fellow cases in that same federal multi-district litigation revolving around Abilify.
For counts of strict liability (design, manufacturing and warning), breach of express warranty, breach of implied warranty, negligence, negligent misrepresentation and fraudulent concealment, the plaintiffs are seeking actual damages incidental to the purchase and ingestion of Abilify in an amount to be determined at trial; costs of treatment for injuries caused by Abilify; damages for neuropsychiatric, mental, physical, and economic pain and suffering; damages for mental and emotional anguish; pre-judgment and post-judgment interest; punitive damages; costs and expenses of this litigation; reasonable attorney’s fees and costs as provided by law; and such further relief as this Court deems necessary, just and proper, in addition to a trial by jury.
The plaintiffs are Deborah Tucci, Charles Gilbert, Rebecca Fitzgerald, Gilda Garvin, Renaldo Scott, Dennis S. Barr and Darla Barnes of Philadelphia, Christopher Jack Cooper of Sewickley, Samantha Conway of Exeter, Melissa Hoey of Coalport, Bernadette Mealia of Warminster, Loretta Foote of Reading, Rebecca McBride of Peach Bottom, Emmy Vandenberg of Gladwyne, Richard Perry of Prospect Park, Edward P. Gryskevicz of Shavertown and Anne Ferrara of Drexel Hill.
They are represented by James Douglas Barger of Aylstock Witkin Kreis Overholt in Pensacola, Fla.
Philadelphia County Court of Common Pleas case 180801181
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com