False Claims Act

  • May 8, 2012
    Guest Post

    By Reuben Guttman and Traci Buschner. Mr. Guttman is a Senior Fellow and Adjunct Professor at the Emory Law School Center for Advocacy and Dispute Resolution, and a partner at the firm of Grant & Eisenhofer where he heads the firm's whistleblower practice. He is a founder of the website, Whistleblowerlaws. Ms. Buschner is a Senior Counsel with Grant & Eisenhofer. Mr. Guttman and Ms. Buschner were lead counsel for the lead whistleblower, Meredith McCoyd, in U.S. ex rel. McCoyd v. Abbott Labs.


    Abbott Labs has agreed to pay $1.6 billion dollars to settle criminal and civil allegations that it engaged in the unlawful marketing of its anti-epileptic drug Depakote.

    The settlement arose out of a False Claims Act (FCA) case filed in the fall of 2007.  Whistleblower or "Relator" Meredith McCoyd, alleged that the company marketed Depakote to elderly nursing home patients and to children for purposes that had not been approved by the Food and Drug Administration (FDA).  Ms. McCoyd also alleged that Abbott made misrepresentations about the safety and efficacy of the drug and paid kickbacks to doctors and others.

    This case was not just about lost government dollars. It was about a company that placed money over medicine by marketing unlawfully to vulnerable patient populations. And we still don't know what the long-term consequences are for those patients who took Depakote as a result of marketing improprieties.

    Unfortunately, Abbott is not the first pharmaceutical company to face allegations of unlawful marketing tactics. Astra Zeneca, Johnson & Johnson and Pfizer have all paid hefty fines following allegations of marketing derelictions.

  • October 18, 2011
    Guest Post

    By Reuben Guttman and Oderah Nwaeze. Reuben Guttman is a Director at the firm of Grant & Eisenhofer and heads the firm's False Claims Act litigation group. He is a Senior Fellow and Adjunct Professor at the Emory Law School Center of Advocacy and Dispute Resolution. Oderah Nwaeze is member of the Grant & Eisenhofer False Claims Act Litigation Group, and a 2011 graduate of Emory Law School.


    Buried in President Obama’s healthcare reform law, the Patient Protection and Affordable Care Act (PPACA), is a measure called the Physician Payments Sunshine Provision or the “Disclosure Law.” This law requires the public disclosure of payments made to doctors by pharmaceutical and medical device manufacturers.  Since even small gifts can compromise a doctor’s objectivity, a patient should know whether his physician has received money and/or gifts from drug or device companies.  Recent civil prosecutions of the pharmaceutical and medical device industries under the False Claims Act (FCA), resulting in pharmaceutical giants paying millions of dollars to resolve allegations that they paid kickbacks in order to induce the writing of prescriptions, demonstrates that the transparency required by this law is long overdue.

    The FCA allows private citizens with knowledge of a fraud on the government to bring suit in the name of the government. Whistleblower cases brought under the FCA against some of the world's largest pharmaceutical companies have surfaced allegations and information raising real concerns that illegal marketing schemes including off label marketing -- or marketing a drug for purposes outside its indication -- and kickbacks in form of payments made to doctors under the guise of research studies -- have caused billions of dollars of prescriptions to be written for drugs that are not needed or that may actually cause injury or illness with additional costs for treatment further burdening our nation's health care system. Within the last five years alone, Pfizer, AstraZeneca, Boston Scientific, Eli Lilly, and Biovail paid a combined total of $4.3 billion to settle claims of unlawful marketing.  Although Pfizer's share was a record $2.3 billion, the company posted revenues of more than $171 billion for the drugs that were illegally marketed. To a large degree, these settlements -- even with the huge monetary sanctions -- only serve to highlight problems rather than fully address them.     

  • April 20, 2011
    Guest Post

    By Reuben Guttman.  Mr. Guttman, a partner at the law firm of Grant & Eisenhofer, heads the firm's whistleblower practice and is founder of the website Whistleblowerlaws, which helps individuals using the False Claims Act to seek compliance with environmental, affirmative action, wage and hour, and "Buy American" requirements. It was cited as an authority by the Chamber of Commerce in its brief in Schindler Elevator Corp. v. U.S. ex rel. Kirk, which is pending before the U.S. Supreme Court.


    As the fate of a government shutdown last week was teetering over budget cuts of between $20-$40 billion, I could not help remind myself that only last year the Deputy Attorney General of the United States estimated that Medicare-Medicaid fraud alone costs the government up to $60 billion.

    Of course, this figure does not even account for precious healthcare dollars spent to treat injuries caused by misbranded drugs and defective medical devices. Taking into account over-billing by defense contractors in Iraq and Afghanistan, the for profit colleges whose degrees are not worth the tuition financed with government grants, the construction contracts designed to create good paying jobs but whose workers are not being paid prevailing wages, or the large scale procurements made under the Buy American Act where the goods are actually manufactured abroad, and the government has either wasted a massive amount of money or the money has been spent in ways that will not bring anticipated returns. Worse yet, as in the case of misbranded drugs, taxpayers may also face physical injury or illness.

    Unfortunately, instead of jail time or debarment, fraudsters are often rewarded with more government business. Even when they pay fines, the fines are so disproportionally small that they amount to a fee for the license to break the law. Consider the government’s $2.3 billion dollar settlement with Pfizer in 2009, which encompassed a pattern of alleged wrongdoing including misbranding of a drug for pediatric use. The combined civil and criminal penalty seemed large but actually paled in comparison to the $171 billion that the drug giant pulled in from sales of the pharmaceuticals encompassed by the complaint during the damage period.

  • November 23, 2009
    Guest Post

    By Martin Magnusson, an associate at Day Pitney LLP.

    The False Claims Act allows private citizens to prosecute fraud on behalf of the federal government. It dates back to the 1860s, when Congress passed the act to address fraud on the part of government contractors who supplied the Union Army during the Civil War.

    Liability under the False Claims Act is robust: Damages are trebled, civil penalties are assessed for each violation, and the whistleblower can recover his or her attorney's fees. Because the whistleblower also shares 15 to 30 percent of the government's recovery, the False Claims Act is a powerful incentive for whistleblowers to step forward with inside information about fraud and abuse in government contracts. The financial incentives that underlie the False Claims Act, though, are generally reserved for whistleblowers with nonpublic information about fraud in government contracts. The so-called "public-disclosure bar" prevents non-whistleblower plaintiffs from bringing opportunistic suits based on information that is already public knowledge.

    But the exact parameters of the public-disclosure bar are unclear and have divided federal courts. This term, the United States Supreme Court will resolve this issue in Graham County Soil & Water Conservation District v. United States ex rel. Wilson.