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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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September 2, 2022

Bayer Corporation, together with its subsidiaries, will pay $40 million to settle claims initiated by a whistleblower alleging that the pharmaceutical manufacturer violated the False Claims Act by engaging in off-label marketing, unlawful kickbacks, and misreporting of safety risks with respect to its drugs Trasylol, Avelox, and Baycol.  The whistleblower, former Bayer marketing employee Laurie Simpson, will receive approximately $11 million from the settlement.  DOJ; USAO MN; USAO NJ

August 3, 2022

Dunn Meadow LLC dba Dunn Meadow Pharmacy, pleaded guilty to illegally distributing prescription fentanyl and paying kickbacks to healthcare providers, in violation of the False Claims Act and the Controlled Substances Act. From 2015 through 2019, Dunn Meadow filled prescriptions not written for a legitimate medical purpose, including those for patients exhibiting suspicious drug-seeking behavior (i.e., requesting prescriptions be sent to suspicious or inappropriate locations including hotels, casinos, and elementary schools). These actions caused a $4.5 million loss to the federal government. Dunn Meadow will pay up to $50 million over the next five years to resolve its civil liability if it generates future revenue. USAO NJ

July 29, 2022

Allergan will pay up to $2.27 billion to settle allegations they deceptively marketed opioids by downplaying the risks of opioid addiction and instead touting exaggerated benefits from the drugs. Rather than encouraging alternative treatments, Allergan encouraged doctors to prescribe more opioids, and failed to maintain effective controls to prevent diversion of opioids. This settlement involves multiple states, excluding New York, which settled separately with Allergan. VA OAG

May 24, 2022

Dr. Roger Wang will pay over $1 million for violations of the False Claims Act committed by charging Medicare for non-FDA-approved drugs and associated services. Dr. Wang, a rheumatology specialist, injected his patients with drugs like Synvisc, Synvisc One, or Orthovisc—vicosupplements used to treat osteoarthritis pain—that were not FDA-approved for distribution in the US, and therefore not billable to Medicare. USAO NDCA

Therakos Settlement Keeps Private Equity in DOJ’s Crosshairs for FCA Liability

Posted  12/4/20
durable medical equipment fraud whistleblower
On November 19th the United States Department of Justice (“DOJ”) announced an $11.5 million settlement involving the alleged promotion of two drug-device systems for unapproved uses by Therakos, Inc.  The action was initiated by a whistleblower under the qui tam provisions of the False Claims Act. The settling defendants included Johnson & Johnson subsidiary Medical Device Business Services, Inc. and The Gores...

November 19, 2020

Johnson & Johnson (J&J) subsidiary Medical Device Business Services, Inc. (MDBS) has agreed to pay $10 million to settle allegations that a former J&J subsidiary, Therakos, Inc., promoted two medical devices for unapproved uses in pediatric patients.  A second entity, The Gores Group (TGG), agreed to pay $1.5 million to settle allegations of continuing to promote the devices for unapproved uses after it acquired Therakos in 2012.  In an action initiated by a whistleblower, the government alleged that between 2006 and 2015, Therakos improperly promoted its extracorporeal photopheresis (ECP) systems, used to treat cutaneous T-cell lymphoma, for use in children despite the fact that no ECP devices had been approved for that population.  In so doing, Therakos allegedly caused false claims to be submitted to Medicaid, the Federal Employee Health Benefits Program, and TRICARE, in violation of the False Claims Act.  The total settlement funds were divided between federal and state governments.  USAO EDPA; CA

September 21, 2020

Neurosurgical Care LLC, its medical director Sagi Kuznits, and its practice director Pnina Kuznits, will pay over $1 million to resolve claims that they overbilled Medicare, TRICARE, and the Federal Employees Health Benefits Program, for the implantation of neuro-stimulators.  Defendants improperly billed the non-surgical application of P-Stim and Stivax devices as surgical procedures, and improperly billed for the application of an eVox device which was not approved for Medicare reimbursement.  USAO ED PA

Top Ten State Healthcare and Financial Fraud Recoveries of 2019

Posted  01/30/20
mount-rushmore-and-state-flags
Here at Constantine Cannon, our attorneys represent whistleblowers reporting a wide variety of healthcare fraud and financial fraud, including government contract fraud, unlawful kickbacks, tax evasion, and more. While such wrongful conduct often violates federal laws, state governments are also important enforcement authorities. For whistleblowers, state enforcement can offer additional opportunities.  New York,...

Catch of the Week: Avanir Pharmaceuticals

Posted  09/27/19
doctor-on-phone
Our Catch of the Week goes to Avanir Pharmaceuticals, manufacturer of Nuedexta, for allegedly paying kickbacks to physicians and engaging in false and misleading marketing tactics.  Avanir allegedly marketed Nuedexta in long-term care facilities and targeted their sales tactics to encourage doctors to prescribe the drug to dementia patients for off-label uses. The pharma company agreed to pay over $108 million in...

September 26, 2019

Pharmaceutical manufacturer Avanir Pharmaceuticals will pay approximately $116 million to resolve civil and criminal charges related to its marketing of Nuedextra for off-label purposes and payment of kickbacks to prescribers and others.  The government alleged that Avanir marketed Nuedextra to long-term care facilities, suggesting that it could be used as an alternative to anti-psychotics for dementia patients, even though Nuedextra had only been approved by the FDA for treatment of particular symptoms secondary to a neurologic disease or brain injury.  In addition, Avanir provided certain physicians and other healthcare professionals with unlawful remuneration in the form of money, honoraria, travel, and food to induce them to write prescriptions for Nuedexta. The civil settlement for $103 million, which includes a five-year corporate integrity agreement, resolves whistleblower actions brought under federal and state False Claims Acts by former Avanir employees Kevin Manieri, Duane Arnold, and Mark Shipman.  Manieri will receive $12.4 million, and Arnold and Shipman will receive $5.4 million. In addition to the civil settlement, Avanir will pay a criminal penalty of $7.8 million, forfeit $5.1 million, and enter into a deferred prosecution agreement admitting to payment of kickbacks and requiring cooperation in ongoing in ongoing criminal investigations of individuals involved in marketing and prescribing Nuedextra.  Indictments against four individuals, including former Avanir employees and one of the top prescribers of Nuedexta in the country, were announced, charging the individuals with conspiracy to solicit, receive, offer and pay health care kickbacks.  DOJ
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