US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      509 Recalls Helmets Due to Risk of Head Injury

      The recalled helmets fail to provide sufficient protection in the event of a crash, posing a risk of head injury. … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Drug Recalls / Abilify / 43 States and the District of Columbia Settle Abilify Lawsuit

43 States and the District of Columbia Settle Abilify Lawsuit

December 12, 2016 By US Recall News Leave a Comment

On Thursday, Bristol-Myers Squibb agreed to settle a lawsuit including charges from 43 states and the District of Columbia for $19.5 million. The charges brought in the lawsuit concern the marketing of Abilify, an atypical antipsychotic drug produced to treat multiple forms of bipolar, schizophrenia, and Tourette’s disorder.

The Problem With Abilify

Abilify was approved by the US Food and Drug Administration (FDA) in 2002. The drug, marketed and manufactured by Bristol-Myer Squibb in association with Otsuka America Pharmaceutical Inc., was later given a “black box” warning label by the FDA in 2006. However, Bristol-Myer Squibb continued to market Abilify and promoted off-label uses of the drug that were not approved by the FDA, according to the lawsuit.

The lawsuit alleges that Bristol-Myer Squibb downplayed some of the drug’s serious side effects including a higher risk of suicide in children and teens, and an increased mortality rate in elderly dementia patients. Although Abilify has also been associated with several other side-effects, including:

  • Reduced impulse control
  • Twitching of the limbs, eyes, lips, tongue, and lips
  • Nausea
  • Weight gain
  • Blurred vision
  • Feeling of restlessness

Conditions of the Settlement

Along with a $19.5 million payment, the settlement also requires Bristol-Myer Squibb to reform and maintain marketing, sales and disclosure strategies. Specifically, the settlement requires that Bristol-Myer Squibb to:

  • Stop compensating health care providers for attending promotional meetings or other activities regarding Abilify.
  • Refrain from creating scientifically unsupported comparisons between Abilify and other medications or products.
  • Not to allow company staff, who do not have a scientific background, from making opinions about Abilify that may suggest off-label usage.
  • Discontinue providing grants to promote Abilify, including educational grants or any other form of grant.
  • Stop providing samples of Abilify to health care providers whose specialities do not coincide with the FDA-approved label guidelines.
  • Provide clear and accurate risk information when promoting Abilify.
  • Disclose compensation of speakers and consultants related to abilify.
  • Create and maintain records concerning unsolicited requests for off-label information about Abilify, as well as information provided to the requestor.
  • Reform marketing techniques of company sales and marketing staff to ensure the promotion of Abilify for its FDA-approved uses only.

State Responses to the Abilify Lawsuit

Regarding the Abilify class-action, Bristol-Myer Squibb stated, “We have resolved this matter with 42 states and the District of Columbia. The multi-state Consumer Protection Act investigation is a follow-on to the 2007 civil settlement the company reached with the federal government involving Abilify and released 2008 civil Medicaid-focused settlements the company reached with a number of states.”

The company claims no wrongdoing, according to the Associated Press, and states, “We are pleased to put this matter behind us so that we can focus on making transformation medicines for patients battling serious diseases.”

However, many state attorneys voiced their discontent with Bristol-Myer Squibb’s actions leading to the settlement on Thursday. New Jersey Attorney General, Christopher Porrino, stated “When it comes to the marketing of prescription drugs, anyone who makes misleading or unfounded statements, minimizes or fails to disclose associated dangers and aggressively promotes a product for unapproved uses is betraying the public trust and, potentially, putting consumers at risk.”

Another example, Texas Attorney General Ken Paxton stated, “BMS put Texans’ lives at risk when it marketed Abilify for uses not approved by the FDA.” Yet another criticism comes from Michigan Attorney General, Bill Schuette, who stated, “Deceptive medical marketing practices threaten the health and wellbeing of Michigan families. Michigan consumers shouldn’t have to wonder if the drugs prescribed to them by their physician is the right medicine for them.”

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: Abilify

About US Recall News

US Recall News provides recall news and information to the United States general public. Find all of the latest drug, food, products, and vehicle recall news as reported by U.S. government agencies and more.

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

509 Recalls Helmets Due to Risk of Head Injury

July 2, 2025 By The CPSC

SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi

July 2, 2025 By The CPSC

Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard

July 2, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop

July 2, 2025 By The CPSC

Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard

July 2, 2025 By The CPSC

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

iHerb Recalls Bottles and Blister Packs of California Gold Nutrition Iron Supplements Due to Risk of Serious Injury or Death from Child Poisoning; Violation of Federal Standard for Child Resistant Packaging

June 25, 2025 By The CPSC

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • 509 Recalls Helmets Due to Risk of Head Injury
  • SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi
  • Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard
  • DEWALT Recalls Grinder Flap Discs Due to Laceration and Injury Hazards
  • Trane Recalls Gas/Electric Packaged Units Due to Risk of Gas Leak, Fire Hazard
  • Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop
  • Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in