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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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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

August 18, 2017

Illinois announced a $4.45 million settlement with the pharmaceutical company Insys Therapeutics Inc. (Insys) for deceptively marketing and selling a highly addictive opioid drug for an array of treatments that were not approved by the Food And Drug Administration (FDA). The settlement resolves Madigan’s 2016 lawsuit against Insys for its sale of Subsys, which is significantly more powerful than morphine and intended exclusively for the treatment of breakthrough cancer pain. Madigan alleged Insys deceptively promoted and sold Subsys to treat a wide variety of pain, such as back and neck pain, even though the drug was not approved for those uses. IL

July 26, 2017

Washington recovered nearly $750,000 in Medicaid reimbursement this week from pharmaceutical company Celgene Corporation for promoting medications to treat conditions they were not approved for, including certain types of cancer. The company is also accused of paying kickbacks to doctors for prescribing the medications and helping them change billing codes to ensure Medicaid would pay for their use. Off-label marketing, fraudulent billing and providing kickbacks to doctors are all violations of the Medicaid False Claims Act. WA

Celgene to Pay $280M to Resolve Fraud Allegations

Posted  07/26/17
By the C|C Whistleblower Lawyer Team Pharmaceutical manufacturer Celgene Corp. agreed to pay $280 million to settle claims that it illegally promoted two cancer drugs, Thalomid and Revlimid, for unapproved uses. The case was filed by a former Celgene sales representative under the False Claims Act, which allows individuals to sue to recover government dollars and share in any recovery. The New York Times reports...

July 24, 2017

New Jersey-based pharmaceutical manufacturer Celgene Corp. agreed to pay $280 million to settle charges of violating the False Claims Act by promoting two cancer treatment drugs -- Thalomid and Revlimid -- for uses not approved by the FDA.  The allegations included the use of false and misleading statements about the drugs, and paying kickbacks to physicians to induce them to prescribe the drugs.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by former Celgene sales manager Beverly Brown.  She will receive a yet-to-be-determined whistleblower award from the proceeds of the government's recovery.  DOJ (CDCA)

June 6, 2016

Genentech Inc. and OSI Pharmaceuticals LLC agreed to pay $67 million to resolve charges they violated federal and state False Claims Act by making misleading statements about the effectiveness of the cancer drug Tarceva.  According to the government, Genentech and OSI made misleading representations to physicians and other health care providers about the effectiveness of Tarceva when there was little evidence to show that Tarceva was effective to treat those patients unless they also (i) had never smoked or (ii) had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.  The allegations originated in a whistleblower lawsuit filed by former Genentech employee Brian Shields under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of approximately $10 million out of the proceeds of the government’s recovery.  Whistleblower Insider GA, MA, OH

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