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Off-Label and Unapproved Use

This archive displays posts tagged as relevant to off-label marketing and prescribing of pharmaceuticals and medical devices. You may also be interested in our pages:

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July 18, 2018

AngioDynamics, a New York-based medical device manufacturer, will pay $12.5M to settle allegations that it caused healthcare providers to submit false claims to Medicare and Medicaid. $11.5M of settlement resolves allegations that the aggressively marketed an unapproved drug delivery device, the LC Bead, with false and misleading statements. The remaining $1M resolved allegations that the company sold a device that was approved to collapse malfunctioning superficial veins to collapse malfunctioning perforator veins, also using false and misleading statements. The LC Bead-related fraud was brought to light by a whistleblower who will receive an award of $2.3M. DOJ

April 23, 2018

Three individuals who fraudulently marketed and sold light-emitting medical devices as a cure-all to consumers were sentenced as follows: Robert “Larry” Lytle, the leader of the scheme, was sentenced to 12 years in prison; Ronald D. Weir Jr. was sentenced to 24 months; and Irina Kossovskaia was sentenced to 15 months. Lytle and his co-conspirators marketed and distributed QLaser devices to mostly elderly consumers by falsely claiming they could safely and effectively treat a panoply of medical conditions at home, including cancer, emphysema, diabetes, autism, HIV, and heart disease. DOJ

Three Sentenced To Prison For Fraudulent Sales of Laser Devices to Seniors

Posted  04/24/18
Three individuals were sentenced to prison for their fraudulent marketing and sale of light-emitting medical devices to elderly consumers.  Robert “Larry” Lytle, the leader of the scheme, was sentenced to 12 years in prison; Ronald D. Weir Jr. was sentenced to 24 months in prison; and Irina Kossovskaia was sentenced to 15 months in prison.  See DOJ Press Release. As part of his guilty plea, Lytle admitted...

December 12, 2017

Med-Fast Pharmacy, Inc. agreed to pay roughly $2.7 million to resolve both criminal and civil charges of violating the False Claims Act relating to the conduct of Iserve Technologies, Inc., a company co-located with and operated out of Med-Fast, filling prescriptions for nursing homes with recycled unused drugs that were commingled with drug stocks on hand at Med-Fast’s Institutional Pharmacy. The settlement also resolves allegations that Med-Fast sought Medicare and Medicaid reimbursement for the retail-packaged version of diabetes testing strips while actually supplying patients with cheaper mail-order-packaged version of the same strips. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act. The whistleblower will receive a yet-to-be-determined award from the proceeds of the government's recovery. DOJ (WDPA)

December 20th, 2017

California announced a $13.5 million multistate settlement with pharmaceutical company Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) for its deceptive and misleading representation and off-label marketing of its prescription drugs. California will receive $857,000. The settlement resolves allegations that BIPI misled the public about the uses and efficacy of prescription drugs, including Micardis, Aggrenox, Atrovent, and Combivent. The settlement comes after a multistate investigation found that BIPI engaged in deceptive practices. BIPI represented that its prescription drugs had sponsorship, approval, characteristics, ingredients, uses and benefits that they did not have. For example, BIPI engaged in off-label marketing and promoted its drugs to treat life-threatening conditions, such as heart attacks, congestive heart failure, and strokes, without evidence to substantiate their claims. CA

October 4, 2017

Med-Fast Pharmacy, Inc. and its owner Douglas Kaleugher agreed to pay roughly $2.7 million to settle charges of violating the False Claims Act by distributing and submitting claims to Medicare for medication that it had either recycled from long-term care facilities serviced by its institutional pharmacy, or that otherwise differed from the medications identified as part of the claims submitted to the government.  The government further alleged the company sought reimbursement for the retail-packaged version of diabetes testing strips, while actually supplying patients with cheaper mail-order-packaged version of the same strips.  The allegations originated in two whistleblower lawsuits filed under the qui tam provisions of the False Claims Act.  The whistleblowers will receive an award from the proceeds of the government's recovery. DOJ (WDPA)

September 22, 2017

Aegerion Pharmaceuticals Inc., the Massachusetts-based subsidiary of Novelion Therapeutics Inc., agreed to plead guilty to charges relating to its prescription drug Juxtapid.  Specifically, Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy.  Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising out of violations of the False Claims Act and Federal Food, Drug, and Cosmetic Act.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Aegerion former employees Michele Clarke, Tricia Mullins, and Kristi Winge.  They will receive a whistleblower award of $4.7 million from the proceeds of the government's recovery. DOJ

September 5, 2017

Novo Nordisk Inc. agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza.  The New Jersey based pharmaceutical manufacturer is a subsidiary of Denmark’s Novo Nordisk A/S.  At the time of Victoza’s FDA approval in 2010, the FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. Under the REMS, Novo Nordisk was required to disclose to physicians the potential risk. If it failed to comply with these disclosure requirements, including requirements to communicate accurate risk information, the drug would be considered misbranded under the law.  According to the government, Novo Nordisk failed to comply with the REMS requirements, providing information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant.  The allegations originated in several whistleblower lawsuits filed under the qui tam provisions of the False Claims Act. The whistleblowers who brought these actions will receive a yet-to-be-determined whistleblower award from the proceeds of the government’s recovery. Whistleblower Insider

September 5, 2017

Novo Nordisk, Inc. has agreed to $1.1 million to resolve claims that its diabetes drug Victoza was unlawfully promoted for off-label use in violation of the California Insurance Frauds Prevention Act.  The claims were brought in a whistleblower action under that act filed by former Novo Nordisk researcher Peter Dastous, who will receive a share of the settlement.  CA
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