Whistleblower Lawyers Discuss Settlement in Off-Label Drug Marketing Case
Drug companies are prohibited from marketing drugs for uses beyond those approved by the FDA
/EINPresswire.com/Source (Keller Grover Whistleblower lawyers), San Francisco - Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve criminal and civil charges stemming from the company's promotion of the prescription drug Depakote to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was approved by the Food and Drug Administration (FDA). The settlement is the second largest reported settlement under the False Claims Act. The whistleblowers that brought this matter to light will receive $84 million from the federal share of the settlement amount.
Drug companies are prohibited from marketing drugs for uses beyond those approved by the FDA. The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. Marketing an approved drug for an untested use renders the product misbranded. Abbott pleaded guilty to misbranding Depakote.
In addition to criminal sanctions, Abbott will pay $800 million to the federal government and the states that opt to participate in the agreement, to resolve civil claims that its unlawful marketing and illegal remuneration practices caused false claims to be submitted to government health care programs like Medicare and Medicaid. The civil settlement covers allegations that Abbott made false and misleading statements about the safety and cost-effectiveness of Depakote for unapproved uses. The suit further alleged that Abbott compensated health care professionals to induce them to promote and prescribe Depakote and to improperly influence the content of company-sponsored Continuing Medical Education programs, in violation of the anti-kickback law.
The civil settlement resolves four lawsuits filed under the qui tam, or whistleblower provisions of the False Claims Act. These provisions allow private citizens to bring civil actions on behalf of the United States government and to share in any recovery. The qui tam lawyers at Keller Grover LLP represent whistleblowers in cases alleging fraud against the federal and state governments. Many qui tam matters involve health care fraud. If you believe a company has committed health care fraud, contact the Keller Grover qui tam attorneys at 415.659.9937 or info@kellergrover.com.
/EINPresswire.com/Source (Keller Grover Whistleblower lawyers), San Francisco - Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve criminal and civil charges stemming from the company's promotion of the prescription drug Depakote to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was approved by the Food and Drug Administration (FDA). The settlement is the second largest reported settlement under the False Claims Act. The whistleblowers that brought this matter to light will receive $84 million from the federal share of the settlement amount.
Drug companies are prohibited from marketing drugs for uses beyond those approved by the FDA. The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. Marketing an approved drug for an untested use renders the product misbranded. Abbott pleaded guilty to misbranding Depakote.
In addition to criminal sanctions, Abbott will pay $800 million to the federal government and the states that opt to participate in the agreement, to resolve civil claims that its unlawful marketing and illegal remuneration practices caused false claims to be submitted to government health care programs like Medicare and Medicaid. The civil settlement covers allegations that Abbott made false and misleading statements about the safety and cost-effectiveness of Depakote for unapproved uses. The suit further alleged that Abbott compensated health care professionals to induce them to promote and prescribe Depakote and to improperly influence the content of company-sponsored Continuing Medical Education programs, in violation of the anti-kickback law.
The civil settlement resolves four lawsuits filed under the qui tam, or whistleblower provisions of the False Claims Act. These provisions allow private citizens to bring civil actions on behalf of the United States government and to share in any recovery. The qui tam lawyers at Keller Grover LLP represent whistleblowers in cases alleging fraud against the federal and state governments. Many qui tam matters involve health care fraud. If you believe a company has committed health care fraud, contact the Keller Grover qui tam attorneys at 415.659.9937 or info@kellergrover.com.
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