FALL RIVER, Mass.--(BUSINESS WIRE)--Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announces that Rikki Carlson of Fall River, Massachusetts, has filed a personal injury lawsuit against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd., and Otsuka America Pharmaceutical, Inc. (“Defendants”) for damages suffered as a direct and proximate result of Defendants’ wrongful conduct in connection with the development, design, testing, labeling, packaging, promoting, advertising, marketing, distribution, and selling of the blockbuster prescription drug Abilify.
“I have suffered devastating financial damages as a result of my Abilify use. Abilify stole my life for several years,” said Ms. Carlson. “Had the defendants been honest and forthcoming about Abilify’s side effects, my life would not have been destroyed by compulsive gambling -- a behavior I had never experienced before I started taking Abilify. The compulsive gambling also negatively affected my family members and my relationships with them.”
Abilify is an atypical anti-psychotic prescription medicine manufactured by Defendant Otsuka Pharmaceutical Co., Ltd. and marketed in the U.S. by Defendants Bristol-Myers Squibb and Otsuka America Pharmaceutical, Inc. Abilify was first introduced to the market in the United States in or around 2002 and is one of the nation’s top-selling drugs, with billions of dollars in sales per year. Prescribed for treatment of depression, bipolar disorder I, and schizophrenia, more than 8.8 million Abilify prescriptions were written in 2014 alone.
Devastating Harm From Compulsive Gambling and Other Compulsive Behaviors
The Complaint alleges that Abilify harmed Ms. Carlson by causing compulsive behaviors including compulsive gambling, shopping, and binge eating, causing her substantial financial, mental, and physical damages. Ms. Carlson began taking Abilify in or around December 2010, began compulsively gambling and shopping shortly thereafter, and stopped compulsively gambling and shopping soon after she ceased taking Abilify in March 2016. While taking Abilify, Ms. Carlson also experienced compulsive eating habits that resulted in substantial weight gain. These urges to binge eat ceased when she discontinued her use of Abilify.
As further maintained in the Complaint, as a direct result of her Abilify use, Ms. Carlson suffered monetary losses in excess of $40,000, loss of financial stability, substantial weight gain, and other mental, physical, and economic losses. Ms. Carlson’s complaint alleges that the impact of Abilify on her brain constitutes a physical injury, and that as a result of her Abilify use, she has suffered, and will continue to suffer, neuropsychiatric and physical injury, emotional distress, harm, and economic loss.
Marked Differences Outside the U.S. Where Abilify Drug Labels Had Strong Warnings
While Abilify labeling in Europe has warned patients and physicians about the risk of “pathological gambling” since 2012, Defendants did not warn or inform Abilify users or prescribers in the United States about the risk of compulsive gambling or other compulsive behaviors prior to 2016. On May 3, 2016, the FDA announced that warnings regarding “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex” would be added to the Abilify label in the U.S. 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.
As alleged in Ms. Carlson’s Complaint, Defendants unjustly profited at the expense of patient safety and full disclosure to the medical community by failing to include language about gambling in the United States labeling and by failing to otherwise warn the public and the medical community about Abilify’s association with gambling, despite a duty to do so. The Complaint notes that as a result, Defendants have made significantly more revenue from Abilify sales in the United States compared to Europe.
Rikki Carlson noted, “If I’d lived in Europe where there were prominent warnings about Abilify being linked to compulsive behavior, this would never have happened. It is hard to believe that doctors and patients outside the U.S. were alerted to Abilify’s gambling risks while those risks stayed undisclosed in America.”
Abilify Injury Complaint Also Alleges Negligent Misrepresentation and Fraudulent Concealment
Compulsive gambling is a major psychiatric disorder. The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders lists gambling disorder under the category Substance-Related and Addictive Disorders to reflect evidence that gambling behaviors activate or are activated by reward systems similar to those activated by drugs of abuse, and produce some of the same symptoms.
Lexi Hazam, Ms. Carlson’s attorney, notes,” Numerous case reports have been published in the medical literature linking Abilify to compulsive behavior, and numerous adverse event reports to the FDA also reported such behaviors in patients taking the drug. Despite these reports, Defendants did not warn of the risks in the U.S.”
The FDA issued a letter dated April 17, 2015 finding Abilify promotional material “false or misleading because it makes misleading claims and presentations about the drug.” The FDA found the material “misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or MDD when this has not been demonstrated.”
More from Ms. Hazam: “Defendants have invested millions of dollars in teams of pharmaceutical sales representatives who visit and contact members of the U.S. medical community, including prescribing doctors, purporting to ‘educate’ them about Abilify. We allege that these sales representatives did not notify prescribers that Abilify is associated with compulsive gambling, pathological gambling, or gambling addiction. Nor did any of the millions upon millions of dollars of ‘Direct-to-Consumer’ Abilify advertising in the United States make any mention that Abilify is linked to these problems.”
Abilify the Top-Seller in the U.S., But Only 7th World-Wide
The Complaint further alleges that as a result of Defendants’ misleading U.S. promotional campaigns, Abilify occupies the top sales position for a prescription drug in the United States.
The lawsuit was filed on July 25, 2016 in federal court in the District of Massachusetts and alleges claims of Strict Liability, Breach of Express Warranty, Breach of Implied Warranty, Negligence, Negligence Per Se, Negligent Misrepresentation, and Fraudulent Concealment, and seeks costs of treatment for Ms. Carlson’s injuries caused by Abilify, damages for her neuropsychiatric, mental, physical, and economic pain and suffering, damages for her mental and emotional anguish, and punitive damages.
Legal Resources for Abilify Patients and their Families
Answers to common questions on Abilify injuries and legal resources for affected patients and their families can be found on Lieff Cabraser's Abilify Gambling Addiction web page.
If you or a family member have suffered losses from compulsive gambling you think may be linked to Abilify use please complete our Abilify Gambling Addiction injury contact form to reach out to an experienced injury lawyer at Lieff Cabraser or call us toll-free at 1 800 541-7358. There is no charge or obligation for our review of your case.
About Lieff Cabraser
Recognized as “one of the nation’s premier plaintiffs’ firms” by The American Lawyer, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-five attorney law firm with offices in San Francisco, New York, Nashville, and Seattle. Our firm has successfully represented thousands of patients across America in individual lawsuits over the injuries they suffered from defective prescription drugs. U.S. News and Best Lawyers have named Lieff Cabraser as their 2016 “Law Firm of the Year” for representing plaintiffs in class actions and mass torts.
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