The Joplin Globe, Joplin, MO

Business

May 7, 2012

Abbott Laboratories to pay $1.6 billion to settle Depakote claims

CHICAGO — Abbott Laboratories will pay $1.6 billion to settle federal and state claims that it improperly marketed the neurologic medication Depakote for off-label uses, the company said Monday.

Abbott will pay $800 million to resolve civil allegations split among federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters, the North Chicago-based company said.

Abbott said in previous filings with the Securities and Exchange Commission that it had earmarked $1.5 billion for a potential settlement.

Under terms of the settlement, Abbott has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. The company also will be restricted from marketing the drug for off-label uses.

Abbott, which plans to spin off its legacy drug business into a separate, publicly traded firm called AbbVie later this year, said certain compliance measures and certification requirements will transfer to the new company.

Depakote, an anti-seizure and mood-stabilizing drug, is approved by the Food and Drug Administration to treat epilepsy, bipolar disorder and migraine prevention. Lawsuits filed by four groups of whistle-blowers alleged Abbott marketed the drug for off-label uses, including for treatment of schizophrenia, agitated dementia and autism. The Department of Justice intervened in those suits to determine whether the company’s marketing of the drug violated civil and criminal laws, including fraudulently charging Medicare and Medicaid.

Those lawsuits alleged that Abbott encouraged and trained its salespeople to market Depakote off-label to nursing-home directors, geriatric doctors and other long-term care providers. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug to boost sales, according to the whistle-blower suits, which were filed in federal courts in Illinois, Virginia and the District of Columbia.

Though doctors are allowed to prescribe drugs “off-label,” as the practice is known, companies are prohibited from marketing them to treat conditions not approved by the FDA.

The FDA approved Depakote in 1983 to treat certain seizures in adults and children over age 10. Since then, the drug has been approved to treatment of other types of seizures, manic episodes of bipolar disorder and the prevention of migraine headaches.

The FDA, which has ramped up its investigation of off-label drug marketing, has induced several large settlements from other drugmakers in recent years.

In November, GlaxoSmithKline PLC said it would pay the U.S. government $3 billion to settle civil and criminal charges for illegal marketing of diabetes drug Avandia and others. In 2009, Pfizer Inc. paid $2.3 billion for similar allegations about its painkiller Bextra, and Eli Lilly & Co. settled for $1.4 billion the same year for Zyprexa, used to treat schizophrenia.

 

1
Text Only
Business
  • Express Scripts expansion could mean 1,500 jobs

    The nation’s largest company that manages pharmacy benefits is opening a new office building in St. Louis County as part of an expansion expected to add 1,500 jobs over the next few years.

    July 28, 2014

  • 5 things to know about coal trade, global warming

    As the Obama administration weans the U.S. off polluting fuels blamed for global warming, energy companies have been sending more of America’s unwanted energy leftovers to other parts of the world where they could create even more pollution.

    July 28, 2014

  • US rig count up 12 to 1,883

    Oilfield services company Baker Hughes Inc. says the number of rigs exploring for oil and natural gas in the U.S. rose 12 this week to 1,883.

    July 25, 2014

  • Business Visa, Amazon pull stock market lower

    Disappointing news on the American consumer, reflected in the results of retail giant Amazon and credit card processor Visa, dragged down the stock market Friday, putting two major indexes on course for a weekly loss.

    July 25, 2014 1 Photo

  • Aviations Bad Week.jpg Very bad week: Airline disasters come in a cluster

    Nearly 300 passengers perish when their plane is shot out of the sky. Airlines suspend flights to Israel’s largest airport after rocket attacks.

    July 24, 2014 1 Photo

  • Dave Ramsey: Keep hands off the 529 money

    Should we use money from our son's 529 plan for college to pay off debt?

    July 24, 2014

  • New Jersey sues over Florida pizza shop logo

    The New Jersey Turnpike Authority wants a Florida pizza shop to pay a big toll for using a logo similar to the Garden State Parkway’s green and yellow signs.

    July 24, 2014

  • Laclede Group gets nod to buy Alabama company

    The Alabama Public Service Commission this week voted to approve the acquisition of Alabama Gas Corp. by The Laclede Group from Energen Corp.

    July 24, 2014

  • France: Air Algerie flight vanishes over N Mali

    An Air Algerie flight carrying 116 people from Burkina Faso to Algeria’s capital disappeared from radar early Thursday over northern Mali after heavy rains were reported, according to the plane’s owner and government officials in France and Burkina Faso.

    July 24, 2014

  • Business US stocks rise as investors weigh earnings

    Stocks mostly rose in early trading Thursday as several big companies across industries reported second-quarter earnings, including Facebook, Ford and equipment maker Caterpillar.

    July 24, 2014 1 Photo

Poll

A new provision by the U.S. Department of Agriculture allows qualifying districts with high percentages of students on food assistance to allow all students to eat free breakfasts and lunches. Would you agree with this provision?

Yes
No
     View Results
Facebook
Twitter Updates
Follow us on twitter
NDN Video
Kerry: Humanitarian Cease-fire Efforts Continue Raw: Corruption Trial Begins for Former Va Gov. The Carbon Trap: US Exports Global Warming UN Security Council Calls for Gaza Cease-fire Traditional African Dishes Teach Healthy Eating 13 Struck by Lightning on Calif. Beach Baseball Hall of Famers Inducted Israel, Hamas Trade Fire Despite Truce in Gaza Italy's Nibali Set to Win First Tour De France Raw: Shipwrecked Concordia Completes Last Voyage Raw: Sea Turtle Hatchlings Emerge From Nest Raw: Massive Dust Storm Covers Phoenix 12-hour Cease-fire in Gaza Fighting Begins Raw: Bolivian Dancers Attempt to Break Record Raw: Israel, Palestine Supporters Rally in US Raw: Air Algerie Flight 5017 Wreckage Virginia Governor Tours Tornado Aftermath Judge Faces Heat Over Offer to Help Migrant Kids Kangaroo Goes Missing in Oklahoma More M17 Bodies Return, Sanctions on Russia Grow