2020 Significant Settlements
JUSTINE E. LENEHAN*
This chapter summarizes a selection of significant settlements in 2020 between members of the food and drug industry and the U.S. Food and Drug Administration (FDA) alongside the U.S. Department of Justice (DOJ). The enforcement authority of FDA and DOJ includes both civil penalties and criminal prosecution.
Consistent with prior years, a majority of these settlements arise from DOJ’s use of the False Claims Act (FCA), which imposes liability on persons and companies who defraud governmental programs and contracts. In 2020, the federal government recovered $2.2 billion in FCA judgements and settlements, nearly $1.9 billion (86%) of which came from health care and life sciences companies. Total recoveries amount to roughly $64 billion since Congress overhauled the FCA in 1986 in order to encourage whistleblower complaints. Whistleblower, or qui tam, actions continued to be a driving force behind DOJ enforcement activity, with 672 whistleblower suits filed in 2020 (as compared to 250 cases filed by the government) resulting in DOJ recovering nearly $1.7 billion from these and earlier filed suits and $309 million awarded to relators for their role.
Notably, however, the 2020 recovery marked a ten-year low, decreasing 27% from the $3.08 billion recovered in 2019. This marked reduction in FCA recoveries in 2020 arguably reflects the impact of the novel coronavirus (COVID-19) pandemic that unavoidably slowed the pace of litigation nationwide and likely does not signal a decrease in DOJ’s efforts to investigate and litigate alleged fraud against the government. In fact, the number of new matters initiated in 2020 increased over 17% from 2019.
Further, the two stimulus bills enacted during the pandemic, both of which commit the federal government to spend or make available trillions of dollars, have the potential to be a catalyst for increased FCA enforcement for months and years to come. Historically, an increase in fraud-related investigations and prosecutions follows implementation of federal programs directed at crisis relief. For example, following the 2008 financial crisis, Congress enacted The Emergency Economic Stabilization Act of 2008, which established financial relief programs (such as the Troubled Asset Relief Program, commonly known as TARP) and established new mechanisms for oversight of the programs, very similar to the oversight mechanisms incorporated within the recent legislation passed in response to the COVID-19 pandemic. To date, more than $11 billion has been recovered as a result of TARP-related fraud enforcement. It is likely that similar heightened attention to fraud investigation and prosecution will result here. Even prior to enactment of the CARES Act, then-Attorney General William Barr directed every U.S. Attorney’s Office to prioritize the investigation and prosecution of all criminal conduct related to the COVID-19 pandemic, and then-Deputy Attorney General Jeffrey Rosen directed each U.S. Attorney to appoint a Coronavirus Fraud Coordinator for their federal judicial district. We have already seen activity by DOJ and United States Attorneys’ Offices prosecuting entities and individuals for fraudulent receipt of federal funds and activity related to products that impermissibly purport to treat, diagnose, and/or prevent COVID-19.
While we can expect FCA enforcement related to the COVID-19 pandemic to play a significant role in DOJ activity, DOJ will also continue to prioritize existing efforts related to opioid abuse, protection of elderly patients and seniors, electronic health records, telehealth schemes, and cybersecurity.
This chapter reviews some of the key FCA settlements and other representative settlements and consent decrees between the food and drug industry and the government in 2020.
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation (Novartis) agreed to pay more than $642 million in two separate settlements relating to (1) the company’s alleged illegal use of three foundations as conduits to cover copayments of Medicare patients taking two of Novartis’s drugs (Gilenya, for treatment of relapsing forms of multiple sclerosis, and Afinitor, a treatment for progressive neuroendocrine tumors and a second-line treatment for advanced renal cell carcinoma (RCC)); and (2) the company’s alleged kickback payments to doctors.
The government alleged that, on numerous instances, Novartis gave money to co-pay foundations under the guise of charitable payments when, in fact, Novartis directed these funds through the foundations to patients taking the company’s drugs. In effect, Novartis’s payments to these foundations operated as kickback schemes. For instance, upon learning that it would be the only donor to an RCC copay assistance fund operated by a charitable donation, Novartis allegedly informed the foundation that it would be willing to donate only if the eligibility definition was narrowed to ensure that a greater amount of the copay assistance would support patients taking Afinitor. Novartis agreed to pay $51.25 million to resolve these allegations.
Further, to resolve FCA claims that Novartis paid kickbacks to doctors to induce prescription of the company’s drugs Lotrel, Valtuma, Starlix, Tekturna, Tekturna HCT, Tekamlo, Diovan, Diovan HCT, Exforge, and Exforge HCT, the company agreed to: (1) pay over $591 million in settlements; (2) forfeit $38.4 million in proceeds; and (3) adhere to strict limitations on any future speaker programs. Novartis also agreed to pay an additional $48 million to resolve state Medicaid claims. The government alleged that Novartis hosted thousands of speaker programs and related events purported to provide educational content when, in reality, such events operated only as a means to bribe doctors.
Novartis also entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG) that requires Novartis to, among other things: (1) significantly reduce the number of paid speaker programs and the amounts spent on such programs; (2) hold such programs only in a virtual format and only under limited circumstances; (3) implement measures in order to promote independent from any patient assistance programs; and (4) cooperate in monitoring of its operations.
Gilead Sciences, Inc.
Gilead Sciences, Inc. (Gilead) agreed to pay $97 million to resolve allegations that the company illegally used a non-profit foundation as a conduit to cover copayments of Medicare patients taking Gilead’s drug, Letairis, for pulmonary arterial hypertension. Similar to Novartis’s alleged activities described above, Gilead claimed to make charitable donations to a foundation but, according to the government, covered copays only for its own drug. Specifically, Gilead utilized data received from the foundation that detailed the amount the foundation spent on Letairis; Gilead used this data to determine its contributions to the foundation and set at an amount sufficient only to cover the copays of its own patients.
As reported in last year’s edition of Top Food and Drug Cases and announced by DOJ in July 2019, Reckitt Benckiser Group plc, former parent company to Indivior Solutions (Indivior), agreed to pay $1.4 billion as part of a settlement related to its sales and marketing of Suboxone, an opioid addiction treatment drug. Following that resolution, Indivior and its parent companies have now agreed to pay nearly $600 million to resolve criminal and civil liability associated with its marketing of Suboxone. Specifically, Indivior or its parent companies must pay: (1) $289 million in criminal fines, forfeiture, and restitution; (2) $300 million in civil payments to the federal government and participating states; and (3) $10 million for allegations that it violated the Federal Trade Commission Act. The total recovery related to sale and marketing of Suboxone now reaches more than $2 billion—DOJ’s largest recovery involving an opioid.
Indivior pleaded guilty to a one-count felony charge and admitted to making false statements to the Massachusetts Medicaid program (MassHealth) to promote Suboxone Film. Specifically, Indivior sent false data to MassHealth indicating that Suboxone Film had the lowest rate of accidental pediatric exposure. The former CEO of Indivior’s parent company (Indivior plc), Shaun Thaxter, also pleaded guilty to a one-count misdemeanor charge related to these activities. This resolution of the criminal investigation totals $289 million and includes a criminal fine, forfeiture, and restitution. The plea agreement further requires that: (1) Indivior disband its Suboxone sales force and not reinstate it; (2) Indivior’s CEO personally certify on an annual basis that during the prior year (a) Indivior was in compliance with the Federal Food, Drug, and Cosmetic Act and did not commit healthcare fraud or (b) list all non-compliant activity and the steps taken to remedy this activity; and (3) Indivior refrain from using data obtained from surveys from healthcare providers for marketing, sales, and promotional purposes, among other things.
Indivior’s parent companies have agreed to pay $300 million to resolve claims that the marketing of Suboxone caused submission of false claims to government healthcare programs. This includes roughly $209.3 million to the federal government and $90.7 million to participating states. Specifically, the government alleged that Indivior companies knowingly (1) promoted Suboxone to physicians who wrote prescriptions for illegitimate medical purposes and were often diverted, among other things; (2) promoted Suboxone to physicians and state Medicaid agencies using false and misleading claims that the product was less susceptible to diversion, abuse, and accidental pediatric exposure as compared to competitive products; and (3) submitted a petition to FDA claiming that the Suboxone Tablet was discontinued due to safety concerns in an effort to delay the entry of generic competition.
Indivior also entered into a five-year CIA with the HHS-OIG subjecting the company to accountability and auditing requirements. For instance, top executives and the Board of Directors must certify compliance with an annual risk assessment to be undertaken by Indivior, and an independent reviewer must conduct multi-faced audits.
Lastly, under a separate agreement with the Federal Trade Commission, Indivior has agreed, among other things, to pay $10 million to resolve allegations that it violated the Federal Trade Commission Act by impeding competition from generic equivalents of Suboxone.
Pentax Medical Company
Pentax Medical Company (Pentax) agreed to pay $43 million to resolve criminal charges arising out of the company’s shipment of four types of endoscope products without FDA-cleared instructions for use and due to the company’s failure to file timely adverse event reports. Specifically, Pentax must pay a $40 million criminal fine and forfeit $3 million. Pentax also entered into a three-year deferred prosecution agreement pursuant to which the company must comply with certain reform and enhanced compliance requirements.
Pentax admitted that it deliberately chose not to use revised FDA-cleared instructions related to cleaning of its medical products for fear that doing so would negatively impact sales. Further, Pentax admitted that, on two separate occasions, it failed to file timely adverse event reports after learning that numerous patients had been infected with serious bacteria following treatment with endoscopes that had been used on other infected patients.
As part of the deferred prosecution agreement, Pentax must conduct audits of its current instructions for use and adverse event report reporting procedures to ensure compliance with FDA requirements. Further, Pentax must enhance its compliance training and maintain an effective compliance program; certifications to this effect must be made annually by Pentax’s president, as well as the president of Pentax’s parent company and its board of directors.
ResMed Corp. (ResMed) agreed to pay more than $37.5 million to resolve civil allegations that the company violated the FCA by paying kickbacks to durable medical equipment suppliers, sleep labs, and other health care providers in order to induce patient referrals. This settlement resolves five qui tam lawsuits in which the whistleblowers will collectively receive $6.2 million of the settlement.
ResMed’s activities included provision of: free patient outreach services that enabled suppliers to order resupplies for sleep apnea patients, free and below-cost sleep apnea masks and machines to sleep labs, fully guaranteed interest-free loans in connection with the purchase of ResMed equipment, and non-sleep specialist physicians free home sleep testing devices.
ResMed also entered into a CIA with the HHS-OIG requiring that ResMed implement additional controls regarding its product pricing and sales and that the company monitor its arrangements with referral sources.
Practice Fusion, Inc.
Practice Fusion Inc. (Practice Fusion) agreed to pay $145 million to resolve criminal and civil liability arising out of the company’s electronic health records (EHR) software. Notably, this marks the first criminal action against an EHR vendor. Medical professionals rely upon patient data and unbiased medical information contained in EHR software to properly advise patients. However, the government alleged that Practice Fusion received kickbacks from pharmaceutical manufacturers in exchange for implementing clinical decision support (CDS) alerts in its software that were designed to increase prescription of their products.
With respect to its criminal liability, Practice Fusion admitted to soliciting and receiving kickbacks from various pharmaceutical manufacturers in exchange for use of its EHR software to influence physician prescribing of opioid drug products. Specifically, Practice Fusion allowed companies to influence the development, implementation, and design of CDS alerts, including when a prescriber may receive an alert and what the alert would say. Practice Fusion also entered into a deferred prosecution agreement with the U.S. Attorney’s Office for the District of Vermont pursuant to which the company must invest heavily in compliance overhauls and commit to stringent oversight and transparency, pay a criminal fine of $25.3 million dollars, and forfeit proceeds of nearly $1 million.
Practice Fusion agreed to pay $118.6 million to the federal government and to states in order to resolve civil allegations that it accepted kickbacks and knowingly caused users of the EHR software (healthcare providers) to submit false claims for federal incentive payments by misrepresenting the capabilities and certifications of its EHR software.
Oklahoma Center for Orthopaedic and Multi-Specialty Surgery
The Oklahoma Center for Orthopaedic and Multi-Specialty Surgery (OCOM), its part-owner and management company, USP OKC, Inc. and USP OKC Manager, Inc. (collectively, USP), an Oklahoma City-based physician group, Southwest Orthopaedic Specialists, PLLC (SOS), and two SOS physicians agreed to pay $72.3 million to resolve allegations in connection with improper relationships between OCOM and SOS, resulting in the submission of false claims in violations of the FCA and Oklahoma Medicaid False Claims Act. Specifically, USP agreed to pay $60.86 million to the United States, $5 million to the State of Oklahoma, and $206,000 to the State of Texas. SOS and two of its physicians agreed to pay $5.7 million to the United States and over $495,000 to the State of Oklahoma.
The government alleged that, for over a decade, OCOM and USP gave improper remuneration to SOS and certain physicians in exchange for patient referrals. This remuneration took the form of: free or below-fair market value office space, employees, and supplies; above-market compensation for services provided by SOS; equity buyback provisions and payments to certain physicians in excess of fair market value; and preferential investment opportunities for the provision of anesthesia services at OCOM. As a result of this activity, claims were submitted to the Medicare, Medicaid, and TRICARE programs for illegally referred patients. The government further alleged that USP impermissibly provided preferential investment opportunities to physicians at four surgery facilities in Texas.
OCOM and SOS also each entered into five-year CIAs with the HHS-OIG. Under these agreements, OCOM and SOS will maintain compliance programs and hire an independent reviewer to assess arrangements that their respective entities enter into. Further, key executives must make compliance-related certifications in order to increase individual accountability.
Universal Health Services
Universal Health Services, Inc., UHS of Delaware, Inc. (together, UHS), and a UHS facility, Turning Point Care Center, LLC (Turning Point), agreed to pay a combined total of $122 million to resolve alleged FCA violations for (1) billing for medically unnecessary inpatient behavioral health services; (2) failing to provide adequate and appropriate services; and (3) paying illegal inducements to federal healthcare beneficiaries.
Specifically, UHS agreed to pay to the United States and to participating states a total of $117 million; the federal government will receive roughly $88 million of these funds, with roughly $29 million being returned to individual states. The government alleged that, for over a decade, UHS facilities admitted patients who were not eligible for inpatient or residential treatment and failed to properly discharge admitted patients who no longer needed inpatient care. Further, UHS facilities billed for services not rendered; billed for improper and excessive lengths of stay; failed to provide adequate staffing, training and/or supervision of staff; and improperly used physical and chemical restraints and seclusion. UHS also allegedly failed to provide care consistent with federal and state regulations, such as failing to update individual assessments and treatment plans, failing to provide adequate discharge planning, and failing to provide required therapy services.
On behalf of its inpatient acute and residential behavior health facilities, UHS entered into a five-year CIA with the HHS-OIG pursuant to which an independent monitor selected by OIG will assess and report back on UHS’ Behavior Health Division’s patient care protections. An independent reviewer must also assess UHS’ inpatient behavior health claims to federal health care programs on an annual basis.
Separately, Turning Point agreed to pay the United States and the State of Georgia $5 million in connection with allegations that, for over a decade, it provided free or discounted transportation services to induce Medicare and Medicaid beneficiaries to seek treatment at its facilities.
This settlement resolves nineteen qui tam lawsuits in which the whistleblowers will collectively receive almost $17 million of the settlements. The alleged conduct by UHS and Turning Point was viewed as especially predatory in that it affected vulnerable populations—those seeking care for additional and other behavioral health needs.
Blue Bell Creameries L.P.
Ice cream manufacturer Blue Bell Creameries L.P. (Blue Bell) agreed to pay $19.35 million to resolve criminal and civil liability arising from claims that the company shipped contaminated products linked to a 2015 listeriosis outbreak. Blue Bell’s former president was also charged in connection with covering up the incident.
On more than one instance, state officials notified Blue Bell that certain of its ice cream products were contaminated with Listeria monocytogenes (L. mono); however, Blue Bell surreptitiously removed certain contaminated product from the market but failed to recall the products or issue any formal communication to consumers until roughly one month later, following multiple hospitalizations. Around this same time, FDA inspections also revealed sanitation issues at two Blue Bell facilities.
This resolution included: (1) a $17.25 million criminal fine and forfeiture pursuant to a plea agreement in which Blue Bell pled guilty to two misdemeanor counts of distributing adulterated ice cream product; and (2) a $2.1 million civil settlement to resolve allegations that the products were manufactured under insanitary conditions and sold to federal facilities. This settlement amount is the second largest ever related to a food safety matter.
Mississippi Department of Health Services
The Mississippi Department of Health Services (MDHS) agreed to pay $5 million to resolve allegations that its administration of the U.S. Department of Agriculture’s (USDA) Supplemental Nutrition Assistance Program (SNAP) violated the FCA. Under SNAP, USDA provides eligible low-income individuals and families with financial assistance to purchase food. The federal government funds SNAP but relies on the states to determine an applicant’s eligibility for benefits, to administer those benefits, and to perform quality control on eligibility decisions. USDA reimburses states for a portion of administrative expenses incurred in administering SNAP and awards performance bonuses to states with the lowest and most improved error rates.
The allegations stemmed primarily from concerns that third-party consultants weakened the integrity of the SNAP quality control process. Specifically, MDHS engaged a consultant, Julie Osnes Consulting, LLC (Osnes Consulting), to provide advice designed to lower its quality control error rate. The government alleged that Osnes Consulting’s recommendations created bias, resulting in MDHS’ submission of false quality control data to USDA and its receipt of undeserved performance bonuses.
This settlement represents the sixth settlement with a state agency for manipulating its SNAP quality control findings, following settlements in Virginia, Wisconsin, Texas, Louisiana, and Alaska. Inclusive of this settlement with MDHS, the United States has recovered over $41 million in connection with this investigation.
The 2020 settlements illustrate FDA’s and DOJ’s commitment to food and drug safety, even in the face of a global pandemic.
The FCA operates as the government’s primary civil tool to rectify false claims of federal funds. With the availability of trillions of dollars of federal relief funds in response to COVID-19, we may expect to see an abrupt increase in the number of new investigations and/or recovery figures in the coming years. However, whether DOJ will re-align any areas of focus to those particularly implicated by our behavioral changes in response to COVID-19 (think, increases in the use of telehealth medicine and resulting cybersecurity concerns) remains to be seen.
* Justine E. Lenehan is an associate at Kleinfeld, Kaplan & Becker LLP. She advises and represents pharmaceutical, food, dietary supplement, cosmetic, tobacco product, and medical device companies on regulatory and advertising law matters.
 U.S. Dep’t of Justice, Fraud Statistics—Overview (Dec. 2020), https://www.justice.gov/opa/press-release/file/1354316/download.
 Id.; Press Release, U.S. Dep’t of Justice, Justice Department Recovers Over $2.2 Billion from False Claims Act Cases in Fiscal Year 2020 (Jan. 14, 2021), https://www.justice.gov/opa/pr/justice-department-recovers-over-22-billion-false-claims-act-cases-fiscal-year-2020.
 U.S. Dep’t of Justice, supra note 1.
 Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), Pub. L. No. 116-136 (2020); American Rescue Plan Act of 2021, Pub. L. No. 117-2 (2021).
 Pub. L. No. 110-343 (2008).
 Letter from the Special Inspector General, Office of the Special Inspector General for the Troubled Asset Relief Program, SIGTARP’s Quarterly Report (October 1, 2020–December 31, 2020), https://www.sigtarp.gov/sites/sigtarp/files/2021-01/SIGTARP_First_Quarter_Letter_2021.pdf.
 Memorandum from the Attorney General, Office of Att’y Gen., U.S. Dep’t of Justice, COVID-19 – Department of Justice Priorities (March 16, 2020), https://www.justice.gov/archives/ag/page/file/1258676/download; Press Release, U.S. Dep’t of Justice, Attorney General William P. Barr Urges American Public to Report COVID-19 Fraud (March 20, 2020), https://www.justice.gov/opa/pr/attorney-general-william-p-barr-urges-american-public-report-covid-19-fraud.
 See, e.g., Press Release, U.S. Dep’t of Justice, Justice Department Takes Action Against COVID-19 Fraud (March 26, 2021), https://www.justice.gov/opa/pr/justice-department-takes-action-against-covid-19-fraud.
 See U.S. Dep’t of Justice, Acting Assistant Attorney General Brian M. Boynton Delivers Remarks at the Federal Bar Association Qui Tam Conference (Feb. 17, 2021), https://www.justice.gov/opa/speech/acting-assistant-attorney-general-brian-m-boynton-delivers-remarks-federal-bar.
 Press Release, U.S. Dep’t of Justice, Novartis Pays Over $642 Million to Settle Allegations of Improper Payments to Patients and Physicians (July 1, 2020), https://www.justice.gov/opa/pr/novartis-pays-over-642-million-settle-allegations-improper-payments-patients-and-physicians. Similar to a component of the DOJ’s settlement with Novartis, numerous other settlements in 2020 resolved alleged FCA violations related to pharmaceutical companies impermissibly making kickback payments, disguised as charitable contributions, to cover patients’ copayments. See e.g., Press Release, U.S. Dep’t of Justice, Patient Services Inc. Agrees to Pay $3 Million for Allegedly Serving as a Conduit for Pharmaceutical companies to Illegally Pay Patient Copayments (Jan. 21, 2020), https://www.justice.gov/opa/pr/patient-services-inc-agrees-pay-3-million-allegedly-serving-conduit-pharmaceutical-companies; Press Release, U.S. Dep’t of Justice, Biogen Agrees To Pay $22 Million To Resolve Alleged False Claims Act Liability For Paying Kickbacks (Dec. 17, 2020), https://www.justice.gov/opa/pr/biogen-agrees-pay-22-million-resolve-alleged-false-claims-act-liability-paying-kickbacks; Press Release, U.S. Dep’t of Justice, United States Files False Claims Act Complaint Against Drug Maker Teva Pharmaceuticals Alleging Illegal Kickbacks (Aug. 18, 2020), https://www.justice.gov/opa/pr/united-states-files-false-claims-act-complaint-against-drug-maker-teva-pharmaceuticals.
 Press Release, U.S. Dep’t of Justice, Gilead Agrees to Pay $97 Million to Resolve Alleged False Claims Act Liability for Paying Kickbacks (September 23, 2020), https://www.justice.gov/usao-ma/pr/gilead-agrees-pay-97-million-resolve-allegations-it-paid-kickbacks-through-co-pay.
 Press Release, U.S. Dep’t of Justice, Indivior Solutions Pleads Guilty To Felony Charge And Indivior Entities Agree To Pay $600 Million To Resolve Criminal And Civil Investigations As Part Of DOJ’s Largest Opioid Resolution (July 24, 2020), https://www.justice.gov/opa/pr/indivior-solutions-pleads-guilty-felony-charge-and-indivior-entities-agree-pay-600-million.
 Press Release, U.S. Dep’t of Justice, Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation Concerning Misbranded Endoscopes (April 7, 2020), https://www.justice.gov/opa/pr/pentax-medical-company-agrees-pay-43-million-resolve-criminal-investigation-concerning.
 Press Release, U.S. Dep’t of Justice, Resmed Corp. to Pay the United States $37.5 Million for Allegedly Causing False Claims Related to the Sale of Equipment for Sleep Apnea and Other Sleep-Related Disorders (January 15, 2020), https://www.justice.gov/opa/pr/resmed-corp-pay-united-states-375-million-allegedly-causing-false-claims-related-sale.
 Press Release, U.S. Dep’t of Justice, Electronic Health Records Vendor to Pay $145 Million to Resolve Criminal and Civil Investigations (January 27, 2020), https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0.
 Press Release, U.S. Dep’t of Justice, Oklahoma City Hospital, Management Company, And Physician Group to Pay $72.3 Million To Settle Federal And State False Claims Act Allegations Arising From Improper Payments To Referring Physicians (July 8, 2020), https://www.justice.gov/opa/pr/oklahoma-city-hospital-management-company-and-physician-group-pay-723-million-settle-federal.
 Press Release, U.S. Dep’t of Justice, Universal Health Services, Inc. and Related Entities To Pay $122 Million To Settle False Claims Act Allegations Relating To Medically Unnecessary Inpatient Behavioral Health Services And Illegal Kickbacks (July 10, 2020), https://www.justice.gov/opa/pr/universal-health-services-inc-and-related-entities-pay-122-million-settle-false-claims-act.
 Press Release, U.S. Dep’t of Justice, Blue Bell Creameries Agreed to Plead Guilty and Pay $19.35 Million for Ice Cream Listeria Contamination – Former Company President Charged (May 1, 2020), https://www.justice.gov/opa/pr/blue-bell-creameries-agrees-plead-guilty-and-pay-1935-million-ice-cream-listeria.
 Press Release, U.S. Dep’t of Justice, Mississippi Department of Health Services Agrees to Pay $5 Million to Resolve False Claims Act Liability in Connection with SNAP Quality Control (June 2, 2020), https://www.justice.gov/opa/pr/mississippi-department-health-services-agrees-pay-5-million-resolve-false-claims-act.