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Pharma Fraud

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Another Clinical Trial Fraud Success for Government Enforcement: Bring on the Clinical Trial Fraud Whistleblowers

Posted  12/11/24
colorful drugs
On December 10, the Department of Justice (DOJ) announced the latest clinical trial fraud enforcement success with the conviction of two chief executives for lying to investors about the supposed promise of an investigational drug called leronlimab their companies were promoting to treat HIV and COVID-19.  It follows two recent Securities and Exchange (SEC) actions against biopharma companies and their executives for...

Walgreens to Pay $106.8M to Settle Whistleblower Case Alleging it Billed the Government for Prescriptions it Did Not Dispense

Posted  09/17/24

Walgreens has agreed to pay $106.8 million to settle false claims allegations that between 2009 and 2020 it billed government healthcare programs, including Medicare and Medicaid, for prescriptions that it never dispensed because they were not picked up by patients. The government alleged that Walgreens received tens of millions of dollars to which it was not entitled for prescriptions that it never actually provided...

Rite Aid Settles Allegations Over Improper Opioid Dispensing

Posted  07/16/24
doctor in laboratory

Rite Aid Corporation, one of the biggest names in the retail pharmacy industry, has reached a settlement following allegations of improper practices related to opioid dispensing. This settlement, announced by the U.S. Department of Justice, involves a total payment of $7.5 million to resolve claims under the False Claims Act  and Controlled Substances Act (CSA). 

From 2014 to 2019, Rite Aid allegedly dispensed...

Catch of the Week - Endo Health Solutions

Posted  03/1/24
spilt pills
This week's Department of Justice (DOJ) Catch of the Week goes to Endo Health Solutions.  Yesterday (February 29), the now-bankrupt pharmaceutical company agreed to pay up to $465 million over 10 years to settle criminal and civil charges relating to its sales and marketing of the opioid drug Opana.  Endo voluntarily withdrew the drug from the market in 2017. This bankruptcy-negotiated payout flows from a...

February 1, 2024

Hikma Pharmaceauticals has reached a settlement in principle with multiple states for $150 million following allegations that the opioid manufacturer failed to monitor and report suspicious orders.  From the settlement proceeds, $115 million will be paid in cash, while the remaining $35 million will be allocated toward opioid addiction treatment medications.  CA AG; NC AG; VA AG

December 21, 2023

Ultragenyx Pharmaceutical, Inc., maker of Crysvita, will pay $6 million for violating the False Claims Act. Crysvita is prescribed to treat a rare inherited blood disorder, which may require a genetic test to definitively diagnose. To induce purchases and referrals, Ultragenyx paid a laboratory to conduct genetic tests at no cost to healthcare providers or patients, and then provide the results reports to Ultragenyx. Ultragenyx then used the positive test results reports to target healthcare providers for Crysvita sales. Internally, Ultragenyx referred to this kickback scheme as their "sponsored" testing program. The program was exposed via a qui tam whistleblower, who will receive $1.07 million of the $6.7 million recovery. DOJ

December 21, 2023

Armando Herrera was sentenced to 51 months in prison for distributing at least $16.7 million worth of adulterated and misbranded prescription HIV drugs. Herrera and his co-conspirators operated companies in four states, creating false documentation to then pass off the drugs as legitimately acquired, and then sold to unwitting pharmaceutical suppliers who, in turn, sold them to unsuspecting HIV patients. DOJ

November 16, 2023

A Florida man who was the Chief Compliance Officer of pharmacy holding company A1C Holdings LLC has been ordered to pay $21.7 million in restitution for his role in a $50 million fraud scheme against Medicare.  Pharmacies associated with Steven King and his co-conspirators allegedly secured prescriptions and refills for medically unnecessary lidocaine and diabetic testing supplies, and took steps to avoid oversight by registering as brick-and-mortar pharmacies, concealing their ownership, and shipping expensive prescriptions without patient authorization.  DOJ

November 6, 2023

Drogueria Betances LLC will pay $12 million and will make extensive compliance and reporting improvements as required under a consent decree, for its failures to report suspicious orders and make required reports to the DEA. One of Puerto Rico's largest pharmaceutical drugs distributors, Betances failed to report to the DEA hundreds of "suspicious orders" for fentanyl and oxycodone from 2016 through at least June 2019. Additionally, from May 2017 to July 2018, Betances failed to report to the DEA all of the more than 7.8 million dosage units of Schedule II opioids distributed, committed hundreds of recordkeeping violations, filled orders placed with defective order forms, and gave inaccurate shipping or delivery information to the DEA. DOJ

October 30, 2023

Nostrum Laboratories Inc. and its founder, Nirmal Mulye, Ph.D., have agreed to pay up to $50 million, with a minimum of $3.8 million, to resolve allegations of defrauding Medicaid in connection with one of their drugs.  As part of the settlement, Nostrum and Mulye admitted that they knowingly failed to pay required drug rebates to Medicaid, in violation of the False Claims Act, despite being notified by CMS that they should do so.  DOJ
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