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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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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.  According to qui tam relator Brian McCormick of Ross Feller Casey LLP, 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.  USAO EDPA

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

September 13, 2019

Medical device manufacturer Avalign Technologies, Inc. and its subsidiary Instrumed International, Inc., will pay $9.5 million to resolve allegations that the companies unlawfully marketed devices not properly approved by the FDA for use in spinal surgeries, circumcisions, and other medical procedures, with knowledge that the devices did not have the required FDA approvals.  The allegations were originally made in False Claims Act action brought by a whistleblower.  USAO SDNY

Question of the Week — Is the use of public nuisance law against J&J for its role in the opioid crisis appropriate?

Posted  08/29/19
The landmark $572M opioid verdict in Oklahoma against Johnson & Johnson stemmed from a single claim: “public nuisance” under state law.  Other cases against opioid manufacturers, including whistleblower cases, involve claims for fraud, unlawful marketing, improper prescriptions, kickbacks, violating the Controlled Substances Act by failing to report suspicious purchases, and even flooding the black market.  But...

June 5, 2019

Opioid manufacturer Insys Therapeutics will pay $225 million to resolve federal criminal and civil claims against it regarding the unlawful marketing of its drug Subsys, including the payment of kickbacks to providers through sham "speaker programs" that rewarded practitioners who increased their Subsys prescribing, as well as jobs for prescribers' relatives and friends, and lavish meals and entertainment.  $195 million of the settlement will be paid to resolve False Claim Act allegations in five separate whistleblower lawsuits in which the government intervened in 2018; the whistleblower reward shares have not yet been determined.  To resolve the criminal claims, Insys will pay $2 million and forfeit $28 million; its operating subsidiary will plead guilty to wire fraud and related charges.  In addition, Insys entered into a five-year Corporate Integrity Agreement and a five-year deferred prosecution agreement. Previously, five former Insys executives were convicted of racketeering in connection with Subsys marketing.  DOJ; USAO Mass

Question of the Week — Should the CEO Be Held Accountable?: Lessons from the Insys verdict.

Posted  05/10/19
By Jessica T. Moore
Handcuffed business-leader walking through jail.
In a shocking first, a federal jury has convicted an opioid-company CEO and other top executives of a criminal racketeering conspiracy. Insys founder and chairman John Kapoor and four other executives bribed doctors to overprescribe a highly addictive fentanyl painkiller, and ran a phony call-center to defraud insurance companies into paying for the expensive drug. Although the company itself had already paid over...
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