Off-Label and Unapproved Use

November 3, 2022

Teva Pharmaceuticals, Ltd., subsidiary Teva Pharmaceuticals USA, and its affiliates will pay $523 million to New York State for their role in fueling the opioid crisis. Injunctive relief includes a ban on high-dose opioids and prescription savings programs, prohibitions on marketing and funding third parties that promote opioids, restrictions on political lobbying, and monitoring and reporting of off-label use of fentanyl nasal spray products. NYAG

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

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