REGULATORY INTELLIGENCE YEAR-END REPORT - 2022 Health Policy Tracking Service - Issue Briefs Pharmaceuticals and Medical Devices Business Practices This Issue Brief was written by David J. Steiner, J.D., a contributing writer and member of the Ohio bar. 12/19/2022 |. Introduction Indiana-based Bayer Corporation, and its related entities, Bayer HealthCare Pharmaceuticals Inc., Bayer HealthCare LLC and Bayer AG, have agreed to pay $40 million to resolve alleged violations of the False Claims Act in connection with the drugs Trasylol, Arvelo, and Baycol. The Department of Justice recently announced that pharmaceutical company Biogen Inc. has agreed to pay $900 million to settle allegations that it caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe Biogen drugs. New Hampshire Attorney General recently announced a settlement with Janssen Pharmaceuticals/Johnson & Johnson to settle the state's opioid claims against the company. The company has agreed to pay $40.5 million, of which $31.5 million will be used for opioid abatement purposes. Philips RS North America LLC (formerly known as Respironics Inc.), a manufacturer of durable medical equipment (DME), has agreed to pay over $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to DME suppliers. A federal jury recently convicted a California woman for a health care fraud and prescription drug diversion scheme involving two Southern California pharmacies. CVS Health recently announced today that it has agreed in principle to a financial resolution designed to substantially resolve all opioid lawsuits and claims against the company by states, political subdivisions (such as counties and cities) and tribes in the United States. New York governor Kathy Hochul recently announced the completion of an $8.6 million expansion of Pine Pharmaceuticals LLC's manufacturing plant in the Town of Tonawanda. ll. Legal Actions And Settlements Texas AG Secures $63 Million Statewide Opioid Settlement With Endo Pharmaceuticals Texas Attorney General Ken Paxton recently announced a $63 million statewide opioid settlement with Endo Pharmaceuticals, Inc. The agreement will largely track the terms of the Global Prescription Opioid Litigation Settlement Agreement that was announced on July 23, 2021. Pursuant to the settlement, Endo will pay $63 million into the Texas State Qualified Settlement Fund, without any requirement that the global deal first be finalized, and without any rebates or reductions to the payment amount. This is the third statewide opioid settlement Attorney General Paxton has secured for Texas. In addition to the funds from Endo, Johnson & Johnson and McKinsey, Texas is also expected to receive up to $1.2 billion from distributors in the coming months. 'This settlement is the result of my office aggressively working to hold opioid manufacturers accountable for their deceptive marketing of highly-addictive pain pills, which spurred an epidemic and left victims and families with unimaginable consequences," Attorney General Paxton said. 'This settlement is a necessary step in the right direction, and we will continue to fight to heal our state from this devastating crisis." [FN2] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. New York AG Announces $200 Million Settlement with opioid manufacturer Allergan Finance, LLC New York Attorney General Letitia James recently announced a $200 million settlement agreement with opioid manufacturer Allergan Finance, LLC and its affiliates. The agreement resolves claims brought by Attorney General James for the company's role in helping to fuel the opioid epidemic and requires the company to make full payment of the $200 million by mid-2022 if certain conditions are met, over $150 million of which will go towards opioid abatement. Since June 2021, Attorney General James has negotiated to settlements amounting to $1.7 billion to combat the opioid epidemic. The recently announced agreement also makes enforceable a bar stopping Allergan and all of its subsidiaries, predecessors, and successors from selling opioids in New York and acknowledges Allergan's prior exit from the opioid business. As a result of this settlement agreement, Allergan will be removed from New York's ongoing opioid trial, currently underway in Suffolk County State Supreme Court. According to Attorney General James, 'For more than two decades, opioids have wreaked havoc on New Yorkers and Americans across the nation - causing pain, addiction, and death." James also noted that, 'Our ongoing trial has been about the role companies like Allergan and its predecessors played in helping grow this epidemic, profiting while Americans suffered. But today's agreement keeps Allergan out of the opioid business for the next decade and has the company paying as much as $200 million. We've now negotiated up to $1.7 billion for critical opioid treatment, prevention, and education programs. While no amount of money will ever make up for the thousands who lost their lives or became addicted to opioids across our state, these funds will be used to prevent future devastation." According to the terms of the agreement, Allergan will be prohibited from promoting opioids or opioid products through sales representatives, sponsorships, financial support, or any other means. The company will also be prohibited from providing financial incentives to its sales and marketing employees for the sale of these products. Allergan also agreed to not, directly or indirectly, provide financial support or in-kind support to any third party that primarily engages in conduct that promotes opioids or opioid products. Allergan will not be allowed to use, assist, or employ any third party to engage in any activity that Allergan itself would be prohibited from engaging in pursuant to today's agreement. Furthermore, Allergan will be prohibited from lobbying federal, state, or local legislative or regulatory authorities about opioids or opioid products. Finally, Allergan will have to make additional information about opioids and opioid products more accessible to the public, including to patients, health care providers, and others. Allergan will share its clinical data with a third-party data center or platform owner to allow researchers qualified under the program to access the company's propriety data under the terms of the project. Today's agreement would additionally resolve lawsuits against Allergan by Nassau and Suffolk counties if the county legislatures approve the agreement. In the meantime, Attorney General James filed a motion to remove Allergan from New York's opioid trial. [FNS] AG Garland Issues Statement On Court's Decision To Invalidate The Purdue Pharma Bankruptcy Plan United States Attorney General Merrick B. Garland issued the following statement regarding the U.S. District Court's decision to invalidate the Purdue Pharma bankruptcy plan related to the nationwide opioid settlement: We are pleased with the District Court's decision invalidating the Purdue Pharma bankruptcy plan. The bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family. The department remains committed to opioid abatement efforts and supporting victims of opioid abuse." [FN4] Collegium Pharmaceutical Ends Face-to-Face Marketing For Its Opioid Product to Massachusetts Doctors And Will Pay $185,000 To State Massachusetts Attorney General Maura Healey recently announced that drug maker Collegium Pharmaceutical, Inc. has agreed to pay $185,000 and to stop marketing its opioids through in-person detailing of Massachusetts prescribers and speaker programs with health care professionals. The settlement resolves allegations of unfair and deceptive practices. The assurance of discontinuance, recently filed in Suffolk Superior Court, is the result of an investigation by Healey's Office of Collegium Pharmaceutical, Inc.'s alleged deceptive marketing of its opioid product, Xtampza ER. According to the Attorney General's Office, Collegium sales representatives misled doctors about the potential risks of the drug by marketing it as a safe and responsible alternative to other opioids, even though Xtampza has the same active ingredient (oxycodone) as other drugs like Oxycontin. Attorney General Healey stated that, 'Drug companies should not be going into doctors' offices deceptively marketing addictive drugs as we work to combat a growing opioid epidemic in our state. Our resolution with Collegium will put an end to these marketing tactics and provide much-needed resources for treatment and recovery." THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. The Attorney General's investigation found that Collegium sales representatives arranged face-to-face meetings with physicians and other health care professionals and promoted Xtampza more than 5,000 times since May 2016. Collegium allegedly misled Massachusetts doctors about Xtampza's risks and appropriate uses by deceptively marketing it as a safer and more responsible choice than other opioids and improperly marketing it to treat acute pain. Sales representative also allegedly implied that Xtampza's abuse-deterrent properties made it less subject to diversion than the drug OxyContin. Prior to 2018, Collegium also marketed its drug through sponsored 'Speaker Programs" at which a physician or other health care professional made a speech or presentation to other health care professionals about the drug. Collegium ceased in-person detailing about Xtampza in Massachusetts, effective December 1, 2021 and ended its Speaker Programs in Massachusetts in 2018. Under the recent agreement, Collegium will not resume speaker programs and in-person detailing tactics to promote Xtampza in Massachusetts. The agreement further requires Collegium to publicly disclose important information online about the doses of its opioids that are sold each quarter, in Massachusetts and the entire nation, to provide real-time information that can be used by policymakers, advocates, and journalists monitoring the opioid epidemic. The agreement also includes a $185,000 payment to the Commonwealth, the majority of which will go towards the state's Local Consumer Aid Fund, the Municipal Naloxone Bulk Purchase Trust Fund, and the Opioid Recovery and Remediation Fund. [FNS] Mississippi Pharmacist Sentenced To Five Years For Participating In Prescription Kickback Scheme A Mississippi pharmacist was recently sentenced to five years in prison in the Southern District of Mississippi for a multimillion- dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary prescriptions. The conduct resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal health care programs. According to court documents, David 'Jason" Rutland, 42, of Bolton, a pharmacist and co-owner of compounding pharmacies, schemed to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications. TRICARE is the health care program for uniformed service members, retirees and their families. Rutland adjusted prescription formulas to ensure the highest reimbursement without regard to efficacy. He solicited recruiters to procure prescriptions for high-margin compounded medications and paid those recruiters commissions based on the percentage of reimbursements paid by pharmacy benefit managers and health care benefit programs, including commissions on claims reimbursed by TRICARE. Rutland also routinely and systematically waived and/or reduced copayments to be paid by beneficiaries and members, including utilizing a purported copayment assistance program to falsely make it appear as if his pharmacy and its affiliate compounding pharmacies had been collecting copayments, among other things. Rutland pleaded guilty on July 20, 2021, to conspiracy to defraud the United States and solicit, receive, offer and pay illegal kickbacks. In addition to the term of imprisonment, Rutland was ordered to pay restitution and forfeit all assets traced to his ill-gotten profits. Participating entities in the case included the Justice Department's Criminal Division, U.S. Attorney Darren J. LaMarca for the Southern District of Mississippi, Assistant Director Luis Quesada of the FBI's Criminal Investigative Division, Special Agent in Charge Jermicha Fomby of the FBI's Jackson Field Office, and Special Agent in Charge Cyndy Bruce of the Department of Defense Office of Inspector General's Defense Criminal Investigative Service (DoD OIG-DCIS) Southeast Field Office. The FBI Jackson Field Office and DoD OIG-DCIS are also investigating the case. [FN6] Cardinal Health Settles False Claims Act Allegations For Over $13 Million Relating To Alleged Upfront Discounts To Physician Practice Customers Ohio-based pharmaceutical distributor, Cardinal Health, Inc., recently agreed to pay $13,125,000 to resolve allegations that it violated the False Claims Act by paying 'upfront discounts" to its physician practice customers, in violation of the federal Anti-Kickback Statute. The Anti-Kickback Statute prohibits pharmaceutical distributors from offering or paying any compensation to induce physicians to purchase drugs for use on Medicare patients. When a pharmaceutical distributor sells drugs to a physician practice for administration in an outpatient setting, the distributor may legally offer commercially available discounts to its customers under certain circumstances permitted by the Office of Inspector General for the Department of Health and Human Services (HHS-OIG). HHS-OIG has advised that upfront discount arrangements present significant kickback concerns unless they are tied to specific purchases and that distributors maintain appropriate controls to ensure that discounts are clawed back if the purchaser ultimately does not purchase enough product to earn the discount. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. According to facts that the company has acknowledged in the settlement agreement, Cardinal Health, Inc. failed to meet these requirements because the upfront discounts it provided to its customers were not attributable to identifiable sales or were purported rebates which Cardinal Health's customers had not actually earned. 'Cardinal Health recruited new customers by offering and paying cash bonuses in violation of the Anti-Kickback Statute and False Claims Act. Kickback schemes, such as this one, have the potential to pervert clinical decision-making and are detrimental to our federal health care system and taxpayers," said United States Attorney Rachael S. Rollins. 'We commend Cardinal Health for resolving this matter cooperatively." 'Pharmaceutical distributors are expected to play by the rules and not engage in illegal arrangements," said Phillip M. Coyne, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services. 'Working with our law enforcement partners, we will continue to investigate kickback schemes that threaten the integrity of our federal health care system, no matter how those schemes are disguised." 'Cardinal Health thought it hit upon a surefire moneymaker by paying kickbacks to doctors, which cost health benefit programs millions of dollars in potentially fraudulent claims," said Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. 'Anyone involved in, or entertaining, similar activity should know that health care fraud is a priority for the FBI, and we will pursue anyone trying to profit from this country's vital health care system." The False Claims Act settlements resolve allegations originally brought in lawsuits filed by whistleblowers under the qui tam provisions of the False Claims Act, which allow private parties to bring suit on behalf of the government and to share in any recovery. The relators in this case will receive approximately $2.6 million of the recovery. [FN7] Mississippi Pharmacist Sentenced To Five Years In Prison In Kickback Case A Mississippi pharmacist was recently sentenced to five years in prison in the Southern District of Mississippi for a multimillion- dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary prescriptions. The conduct resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal health care programs. According to court documents, David 'Jason" Rutland, 42, of Bolton, a pharmacist and co-owner of compounding pharmacies, schemed to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications. TRICARE is the health care program for uniformed service members, retirees and their families. Rutland adjusted prescription formulas to ensure the highest reimbursement without regard to efficacy. He solicited recruiters to procure prescriptions for high-margin compounded medications and paid those recruiters commissions based on the percentage of reimbursements paid by pharmacy benefit managers and health care benefit programs, including commissions on claims reimbursed by TRICARE. Rutland also routinely and systematically waived and/or reduced copayments to be paid by beneficiaries and members, including utilizing a purported copayment assistance program to falsely make it appear as if his pharmacy and its affiliate compounding pharmacies had been collecting copayments. Rutland pleaded guilty on July 20, 2021, to conspiracy to defraud the United States and solicit, receive, offer and pay illegal kickbacks. In addition to the term of imprisonment, Rutland was ordered to pay restitution and forfeit all assets traced to his ill-gotten gains. [FNS] Texas Announces Opioid Settlement With Teva Pharmaceuticals Texas Attorney General Ken Paxton announced a recent opioid settlement of $225 million with Teva Pharmaceutical Industries. According to Paxton, 'This agreement is not only another win for Texas, but a major step in the right direction to help people overcome opioid addiction." He also noted that, 'Pharmaceutical companies must be held accountable for their role in this devastating epidemic. These resources will be used to fund recovery initiatives that will help countless Texans." As part of the settlement, Teva will also provide $75 million worth of the medication Narcan, which is a lifesaving intervention for opioid overdoses. Narcan can reverse the frequently fatal effects of illegal street drugs such as fentanyl and heroin, as well as most prescription opioid pain relievers. This settlement will provide resources to local law enforcement and the medical personnel who are fighting the opioid epidemic in Texas communities. [FNS] Consultant Firm Settles False Claims Act Allegations Relating To Alleged Kickbacks Stuart, Florida-based Medicare reimbursement consultant Ted Albin and his wholly-owned consulting and billing firm Grapevine Billing and Consulting Services Inc. (Grapevine) have agreed to pay $50,000 to resolve allegations that they violated the False Claims Act. This settlement resolves allegations that Albin and Grapevine caused the submission of false claims to Medicare because of kickbacks to Medicare beneficiaries and because patients were ineligible to receive glucometers. The settlement is based on the United States' analysis of financial disclosures made by Grapevine. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. 'Consultants must abide by federal requirements when providing Medicare billing advice," said Acting Assistant Attorney General Brian M. Boynton for the Justice Department's Civil Division. 'We will continue to protect the integrity of federal health insurance programs by pursuing individuals or entities responsible for the submission of false or fraudulent claims, including those who cause such claims to be submitted." In its complaint, the United States alleged that, from 2008 until 2017, Albin and Grapevine provided consulting services to now-defunct diabetic testing supplier Arriva Medical LLC (Arriva), its parent Alere Inc. (Alere), and starting in January 2018, Abbott Laboratories (Abbott), after Abbott acquired Arriva and Alere in October 2017. From at least 2009 until 2011, Albin, through Grapevine, allegedly served effectively as the Head of Reimbursement at Arriva, overseeing Arriva's reimbursement department, developing Arriva's policies for the collection of beneficiary copayment obligations, and submitting claims to Medicare on Arriva's behalf for diabetic testing supplies. The United States alleged that, as consultants to Arriva, from April 2010 until the end of 2016, Albin and Grapevine knowingly caused the submission of claims to Medicare that were tainted by the payment of kickbacks to Medicare beneficiaries in the form of (i) free or 'no cost" glucometers, or (ii) the routine waiver of beneficiary copayment obligations. The United States also alleged that Albin and Grapevine knowingly caused the submission of claims to Medicare for glucometers on behalf of beneficiaries who were not eligible to seek reimbursement because they had received a meter paid for by Medicare within the previous five years. The United States produced sworn testimony from Albin in the litigation in which he admitted that, as a reimbursement consultant for Arriva, Albin personally: (1) would 'write off customer co-payments" because 'I could tell someone on my team "Yes, write this off," (2) engaged in such write-offs 'probably every week," (3) engaged in 'mass write-offs of denials by Medicare" for ineligible meters, (4) created Arriva's 'routine policy not to send a bill for customers who owed less than $5," and (5) 'came up with the policy" of 'courtesy adjustments' in the form of copayment waivers in response to customer complaints about their Medicare coinsurance obligations. The litigation resolved by this settlement originally included claims against Arriva and Alere that were brought under the qui tam or whistleblower provisions of the False Claims Act by Gregory Goodman, a former employee in Arriva's Antioch, Tennessee call center. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The act also permits the United States to intervene and take over the litigation of a qui tam action, as the United States did here. In August 2021, Arriva and Alere agreed to pay $160 million to resolve the claims against them. The United States also previously settled for $1 million claims against Arriva's founders, David Wallace and Timothy Stocksdale, for their alleged part in the scheme. The litigation is currently captioned United States v. Albin, et al., Case No. 3:13-cv-00760 (M.D. Tenn.). 'The resolution of this matter brings about the conclusion of a lengthy and protracted investigation and litigation in which the United States sought and received substantial penalties and damages as a result of allegations of False Claims Act violations," said U.S. Attorney Mark H. Wildasin for the Middle District of Tennessee. 'Il commend the legal team and investigators for working diligently to preserve the integrity of our federal healthcare programs." 'Those who provide advice to health care providers about Medicare billing must do so with integrity," said Special Agent in Charge Tamala E. Miles of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). 'Working with our law enforcement partners, we will continue to investigate those who cause fraudulent claims to be submitted to federal health care programs." [FN10] GlaxoSmithKline Announces Settlement Between ViiV Healthcare And Gilead Sciences, Inc. Resolving Litigation Relating To HIV Patents GlaxoSmithKline plc (GSK) recently announced that ViiV Healthcare, a global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi, and Gilead Sciences, Inc. (Gilead) concerning ViiV Healthcare's patents relating to dolutegravir. Dolutegravir is an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus (HIV). ViiV Healthcare, GSK and Shionogi alleged that Gilead's Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir. As a result of the settlement, patent infringement cases in the US, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada will be discontinued. ViiV Healthcare, GSK, Shionogi and Gilead have entered into a global settlement agreement and a patent license agreement under which Gilead has been granted a worldwide license to certain ViiV Healthcare patents relating to dolutegravir and a covenant not to enforce any patents controlled by ViiV Healthcare, GSK or Shionogi against Gilead in connection with any past or future claims of infringement relating to Biktarvy. ViiV Healthcare, GSK and Shionogi have also agreed not to enforce their patents against any future product containing bictegravir, to the extent that the patent enforcement relates to the bictegravir component of the product. Under the terms of the global settlement and licensing agreement, Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare, which is expected in the first quarter of 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy ($6.09 billion in 2020) and in respect of the bictegravir component of any other future bictegravir-containing products sold in the US. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. These royalties will be payable by Gilead to ViiV Healthcare from February 1, 2022 until the expiration of ViiV Healthcare's U.S. Patent No. 8,129,385 on October 5, 2027. Gilead's obligation to pay royalties does not extend into any period of regulatory pediatric exclusivity, if awarded. Regulatory pediatric exclusivity would extend the period of exclusivity after the expiration of the "385 patent by six months from October 5, 2027 to April 5, 2028, N11) Connecticut AG Announces $6 Billion Settlement With Sackler Family And Purdue Pharma Connecticut Attorney General William Tong recently announced that Purdue Pharma and the Sackler family will pay $6 billion to victims, survivors, and states for their alleged role in the opicid epidemic. This newly announced amount is 40 percent more than the previously vacated settlement appealed by Connecticut. As part of the agreement, the Sackler family must apologize and allow institutions to remove the Sackler name from buildings and scholarships. Connecticut will receive approximately $95 million from the settlement which will be used to fund opioid treatment and prevention. The agreement authorizes Connecticut to use a portion of the settlement funds to establish an Opioid Survivors Trust to directly aid survivors and victims of the opioid epidemic. The settlement keeps intact provisions of the Purdue bankruptcy plan forcing the company to be dissolved or sold by 2024 and banning the Sacklers from the opioid business in the United States and around the globe. The initial bankruptcy plan required Purdue and the Sacklers to make public over 30 million documents. The settlement announced today forces disclosure of additional records previously withheld as privileged legal advice. The recent announcement pertains to a civil settlement. Neither this agreement nor the prior bankruptcy plan releases the Sacklers from any potential future criminal liability. The settlement is the product of a court-ordered mediation, which began on January 3, 2022 under Judge Shelley C. Chapman. The mediation was extended three times by the Bankruptcy Court and included dozens of in-person and telephonic negotiation sessions. Settlement highlights include: * The Sackler families must pay $6 billion to the states-$1.675 billion and nearly 40 percent more than the initial bankruptcy plan. The final payments are spread over 18 years, with larger payments frontloaded so that State will receive more money, sooner as compared to the previous bankruptcy plan. ¢ The Sackler families must apologize for their role in the opioid epidemic, and to the victims whose lives have been devastated. ¢ The Sackler family must allow institutions to remove the family name from buildings, scholarships, and fellowships. ¢ Responding to Connecticut's demand, mediator Judge Shelley C. Chapman strongly urged the Bankruptcy Court to require the Sacklers to participate in a public hearing where victims and their survivors would be given an opportunity to directly address the family. ¢ Purdue must make public additional documents previously withheld as privileged legal advice, including legal advice regarding advocacy before Congress, the promotion, sale, and distribution of Purdue opioids, structure of the Purdue Compliance Department and its monitoring and abuse deterrence systems, and documents regarding recommendations from McKinsey & Company, Razorfish, and Publicis related to the sale and marketing of opioids. * The settlement is conditioned upon approval by the bankruptcy court, on the Second Circuit's reversal of the District Court's order, and consummation of the bankruptcy plan. Attorney General Tong noted that, 'Five months ago, Connecticut said no to a Purdue bankruptcy plan that allowed the Sackler family to purchase lifetime legal immunity without so much as an apology. After months of negotiation and consultation with victims and their families, Connecticut has forced Purdue Pharma and the Sacklers to pay a $6 billion settlement and apologize in dollars, words, and actions. Connecticut will use its $95 million share to save lives through opioid treatment and prevention, and | will push to establish a Connecticut Opioid Survivors Trust to provide direct relief to victims and their families." Tong also stated that, 'But this fight has never been about the money. After years of lies and denial, the Sackler family must now directly apologize for the pain they have caused. They must reckon face-to-face with the survivors of their reckless greed at a public hearing. Museums and universities may now scrub the tarnished Sackler name from their walls-ensuring this family is remembered throughout history for their callous disdain for human suffering and nothing else. This settlement is both significant and insufficient- constrained by the inadequacies of our federal bankruptcy code. But Connecticut cannot stall this process indefinitely as victims and our sister states await a resolution. This settlement resolves our claims against Purdue and the Sacklers, but we are not done fighting for justice against the addiction industry and against our broken bankruptcy code." Connecticut first filed suit against Purdue and individual members of the Sackler family in 2018, alleging that the company and family peddled a series of falsehoods to push patients toward its opioids, reaping massive profits while opioid addiction skyrocketed. Connecticut expanded and amended that suit in 2019 to add additional defendants and allegations, including the fraudulent transfer of hundreds of millions of dollars from Purdue Pharma to the Sacklers to shield their wealth from accountability. Purdue Pharma filed for bankruptcy in September 2019. In 2021, the bankruptcy court approved an inadequate Purdue bankruptcy plan that granted a lifetime legal shield to the Sackler family, unlawfully blocking states like Connecticut from pursuing claims against THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. the family. The plan required the Sackler family to pay $4.3 billion over nine years to the states, municipalities and plaintiffs that sued the company. California, Connecticut, Delaware, Maryland, Oregon, Rhode Island, Vermont, Washington, and the District of Columbia objected to and ultimately appealed the plan. The United States Trustee, an arm of the Department of Justice, also appealed. In December 2021, the U.S. District Court vacated the Purdue bankruptcy order, agreeing with the non-consenting states that the bankruptcy court lacked authority to force states to release their claims against the Sackler family. Purdue has appealed to the United States Court of Appeals for the Second Circuit, and that appeal will proceed. Should the case be heard by the U.S. Supreme Court, Connecticut reserves its right to continue its fight against non-consensual non-debtor releases. Attorney General Tong testified last year before the House Judiciary Subcommittee on Antitrust, Commercial, and Administrative Law in support of reforms to bankruptcy laws that would prohibit non-bankrupt individuals and businesses from using loopholes in the bankruptcy code to evade accountability. N11 South Carolina Health System Settles Controlled Substances Act Allegations For $1 Million The U.S. Attorney's Office of the District of South Carolina recently announced that Prisma Health Midlands ('Prisma") has agreed to pay $1 million to resolve allegations that it committed recordkeeping and dispensing violations of the Controlled Substances Act (CSA). These requirements are designed to prevent the diversion of controlled substances. This civil settlement includes a memorandum of agreement and is the culmination of a joint Drug Enforcement Administration (DEA) and U.S. Attorney's Office investigation that began in November of 2018 when two Prisma patients were arrested for distributing drugs, some of which, the United States alleges, they were able to receive through Prisma's pharmacy. This is the largest settlement involving allegations of CSA violations in the state of South Carolina. 'Pharmacists must comply with their responsibilities to issue controlled substances only for legitimate medical purposes and in the usual course of their professional practice," said U.S. Attorney Corey F. Ellis. 'When pharmacists ignore or disregard red flags, their actions allow controlled substance prescriptions to be diverted for illegitimate and dangerous purposes." 'The mission of DEA's Division of Diversion Control is to prevent, detect and investigate the diversion of controlled pharmaceuticals," said Robert J. Murphy, the Special Agent in Charge of the DEA Atlanta Field Division. 'In this case, DEA Diversion Investigators did an outstanding job of uncovering recordkeeping discrepancies for the controlled substances Prisma purchased, maintained and dispensed. The DEA and the U.S. Attomey's Office are committed to making sure healthcare providers are abiding by these important mandates." The United States alleges that Prisma failed to notify the DEA within one business day regarding thefts or significant losses of controlled substances over a three-year time period. As a DEA registrant, Prisma has certain recordkeeping and reporting obligations and one of these is to promptly notify the DEA whenever a theft or significant loss occurs. The United States also claims that Prisma violated the CSA by filling prescriptions that were not issued for a legitimate medical purpose for two patients who have now pleaded guilty to federal drug distribution charges. The conduct outlined in the settlement agreement is alleged, and the agreement does not constitute an admission of liability by Prisma. A main objective of the CSA is controlling illegitimate traffic of controlled substances. To prevent the diversion of controlled substances, the CSA regulates persons, companies and other entities that manufacture, distribute, and dispense controlled substances. [FN13} Rhode Island Settles Opioid Claims With Teva And Allergan For $28.5 Million Rhode Island Attorney General Peter F. Neronha recently announced settlements with drug manufacturers Teva and Allergan for $28.5 million, as well as one million Naloxone sprays to Rhode Island over the next 10 years, free of charge. Rhode Island will also receive 67,000 30-pill bottles of the treatment drug Suboxone in various doses over the next 10 years at no cost, raising the combined settlement value to approximately $107 million to combat the opioid epidemic. The agreements resolve claims brought by the Office for the companies' roles in helping to fuel the opioid epidemic. Over the past year, Attorney General Neronha has negotiated a total of more than $250 million for opioid treatment, rescue, prevention, and recovery in Rhode Island. This recent agreement also resolves Rhode Island's claims against the last remaining opioid defendant in Rhode Island's principal opioid litigation. 'While no amount of money will ever be enough to undo the harm suffered by Rhode Islanders throughout the ongoing opioid epidemic, these additional recoveries will further support public health efforts to respond to the challenges brought on by this epidemic, which have grown much worse during the Covid-19 pandemic," said Attorney General Neronha. 'And now, with the agreement of Teva to supply the state with enough Naloxone to meet the projected demand, at no cost for the next 10 years, we can use these hard-gained monetary recoveries for other purposes. City and town leaders have been important partners in this litigation, and | look forward to working with them to deliver these additional resources to the people they serve." Settlement highlights include: * Teva and Allergan will pay Rhode Island a combined $28.5 million over 13 years, $21 million from Teva and $7.5 million from Allergan. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ Municipalities will have the same opportunity to share in this recovery under the Memorandum of Understanding between the State and cities and towns, which provides that 20% of the cash recoveries will go to cities and towns that join the agreement. ¢ Payments are front-loaded to ensure monetary relief to Rhode Island as quickly as possible. * A total of $12 million will be paid within 60 days of the settlement. * Rhode Island will receive more than half of its cash recovery from Teva ? $13 million ? within one year of the settlement. ¢ Rhode Island will receive its full recovery from Allergan within six years, at $1.25 million per year. ¢ Cities and towns will have an opportunity to receive their share of funds upfront by joining the settlement within 60 days. * Teva has also committed to supply Rhode Island with supplies of Naloxone and Suboxone that are sufficient to meet the State's projected needs for the next 10 years, according to Rhode Island health officials. * Teva will supply 50,000 kits of Naloxone (100,000 nasal sprays) per year for 10 years, medication valued at $62.5 million. Naloxone is a lifesaving intervention that can reverse the often-fatal effects of an overdose. * Teva will supply Suboxone medication valued at $16 million over 10 years. Suboxone is a medication used to treat opioid use disorder. *N"4! Alabama Announces $276 Million In Settlements with Opioid Manufacturers And Distributor Alabama Attorney General Steve Marshall recently announced that the state has reached settlements with two pharmaceutical manufacturers and one pharmaceutical distributor totaling approximately $276 million to resolve the state's claims against them for their alleged role in exacerbating the opioid crisis in Alabama. Attorney General Marshall commented on the settlement, noting that, 'These three settlement agreements affirm my decision to decline participation in the national opioid settlements, which did not adequately acknowledge the unique harm that Alabamians have endured and would have redirected millions of dollars to bigger states that experienced a less severe impact." The settlements include: - Endo Pharmaceutical: The State of Alabama and its subdivisions will receive $25 million this year in a lump-sum payment. By comparison, two similarly populated states and their subdivisions settled with Endo for 26% and 35% of the total that Alabama was able to secure. Pursuant to an agreement between the State and its litigating subdivisions, the State will receive $15 million, less attorneys' fees, and its litigating subdivisions will receive $10 million. - Johnson & Johnson: The State of Alabama and its subdivisions will receive $70.3 million this year in a lump-sum payment. While the State would have received this same amount in the national settlement, it would have been paid out over nine years. The settlement funds will be split 50/50 between the State and its subdivisions. - McKesson: The State of Alabama and its subdivisions will receive $141 million over nine years. Under the national settlement, the State would have received only $115.8 million, paid out over eighteen years. The settlement funds will be split 50/50 between the State and its subdivisions. Pursuant to the terms of each agreement, the settlement funds are to be used to remediate the harms caused by the opioid crisis in Alabama. The state government's share of each settlement will be deposited directly into the state's General Fund. As the Alabama Legislature works to determine the best uses of this funding, appropriators will be reviewing the work done by the Alabama Opioid Overdose and Addiction Council to determine the State's greatest needs. Attorney General Marshall stated that, '| am grateful to each member of the Alabama Opioid Overdose and Addiction Council who has put in the time and energy to provide our legislators with a roadmap as they make critical decisions about the use of this money. We envisioned and developed a State plan long before there was any funding to make it a reality, and | am pleased that we can finally put our plan to good use." In addition to the funding for remediation, Alabama recovered approximately $40 million in attorneys' fees and costs for the State and its subdivisions. The State has remaining claims against opioid manufacturers Purdue Pharma, Mallinckrodt, and Insys in each of their respective bankruptcy cases. Attorney General Marshall also noted that, 'Having encountered the utter darkness of the opioid crisis at my own doorstep, this is one of my most meaningful accomplishments as your Attorney General." [FN15] West Virginia Announces $99 Million Opioid Settlement With Janssen Pharmaceuticals West Virginia Attorney General Patrick Morrisey has announced that his office has reached a $99 million settlement with Janssen Pharmaceuticals, an opioid drug manufacturer group of companies involved in a current trial in Kanawha County, West Virginia Circuit Court. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. This amount is more than double Janssen's national settlement proposal of $48 million. Under the terms of the settlement, West Virginia will receive a $99 million lump sum payment within 45 days of approval by the state's political subdivisions. The settlement funds are intended to be under the terms of the West Virginia First Memorandum of Understanding (MOU), which is an agreement with cities and counties on how future settlement dollars would be used to combat the opioid crisis. The state's counties and cities are currently in the process of approving the West Virginia First MOU. West Virginia filed two separate lawsuits in 2019, claiming that the defendants concealed misconduct, mischaracterized, and failed to disclose the serious risk of addiction. The lawsuits also claim that the companies overstated the benefits of chronic opioid therapy and promoted higher dosage amounts without disclosing their greater risks. One lawsuit is against the Janssen companies, and one is against the Teva and Allergan related group of companies. The state's attorney general alleges that the manufacturers' conduct violated the state's Consumer Credit and Protection Act and caused a public nuisance. Attorney General Morrisey commented on the lawsuits, noting that, 'This settlement will provide significant help to those affected the most by the opioid crisis in West Virginia. We are still arguing our case in court involving Teva and Allergan and my office is steadfast in holding everyone in the pharmaceutical supply chain accountable for their actions in causing this scourge in West Virginia. Morrisey also stated that, 'I've always said that at the end of the day, through our office's opioid work, West Virginia will have the highest per capita settlement results in the nation fighting for our people. It was absolutely the correct decision to proceed to trial and double the amount of relief we can provide to our citizens." The trial against the non-Janssen defendants will continue until resolution or a judgment. [FN16] Washington State Announces $518 Million Settlement With Three Opioid Manufacturers Washington Attorney General Bob Ferguson recently announced a resolution-in-principle with three drug companies valued at approximately $518 million, most of which will be used to help the state combat the opioid epidemic. The Washington Attorney General's trial against McKesson Corp., Cardinal Health Inc., and AmerisourceBergen Drug Corp. began in King County Superior Court on November 15, 2021, which was over two years after Ferguson filed a lawsuit against the three large corporations for allegedly helping to fuel the opioid epidemic. As a result the recently announced resolution, the three opioid distributors will pay a total of $518 million, of which more than $476 million will be directed toward addressing the opioid epidemic. Ferguson rejected a national settlement between the three opioid distributors in order to take these entities to trial and obtained an additional $46 million. According to Ferguson, 'We could have joined the overwhelming majority of states and settled with the largest opioid distributors, but we chose to fight them in court instead." Attorney General Ferguson also noted that, "That decision to take them to court will result in significant additional resources for Washington to combat the opioid epidemic. These resources will increase prevention efforts and help Washingtonians in need, including providing necessary wrap-around services for those experiencing homelessness as a result of their substance abuse disorder. This is a historic resolution - one of the largest in state history. We forced these companies to stand trial for their conduct. Washingtonians will receive approximately one half billion dollars to combat the opioid epidemic - including $46 million more than Washington would have received if we had accepted the national settlement last year." This is the second time Ferguson's rejection of a national settlement led to more money for the state. In March 2022, Ferguson announced that Washington will receive $183 million to address the opioid crisis as a result of his office leading the challenge to the Purdue bankruptcy plan, which was $113 million more than Washington would have received under the original deal. As part of his strategy of rejecting national settlements and choosing to litigate, Ferguson also declined to settle with Johnson & Johnson last year. The Washington Attorney General's Office has a trial scheduled against opioid manufacturer Johnson & Johnson in September. Ferguson's legal team is conducting multiple ongoing investigations into conduct by other entities that helped fuel the epidemic. The recently announced settlement is not final until all litigating Washington jurisdictions and at least 90% of non-litigating jurisdictions with populations over 10,000 agree to its terms, and the King County Superior Court judge approves. This is similar to the structure of the national resolution. If approved, Washington state will receive $518 million. These resources will be paid out over a period of 17 years. This is the same time period for payment as the national settlement that virtually every attorney general agreed to earlier this year. More than $476 million must be used to combat the opioid epidemic through a range of approved strategies. These strategies are consistent with the state's Opioid Response Plan. Approved strategies for addressing the opioid epidemic include: ¢ Improving and expanding treatment for opioid use disorder; ¢ Supporting individuals in treatment and recovery, including providing comprehensive wrap-around services to individuals with opioid use disorder, including housing, transportation, education, job placement, job training or childcare; THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ Addressing the needs of pregnant women and their families, including those with babies with neonatal disorder; ¢ Preventing opioid misuse, overprescribing and overdoses through, among other strategies, school-based and youth-focused programs, public education campaigns, increased availability and distribution of naloxone and other drugs that treat overdoses, additional training and enhancements to the prescription drug monitoring program; and ¢ Supporting first responders. The remainder will cover the costs of litigation, including direct trial expenses of more than $10 million, and approximately $11 million for legal expenses of all litigating local governments. Local governments can allocate additional resources for legal expenses if they choose. Ferguson's lawsuit against McKesson, Cardinal Health, and AmerisourceBergen alleged that the three companies made billions of dollars feeding the opioid epidemic, shipping huge amounts of oxycodone, fentanyl, hydrocodone and other prescription opioids into the state even when they knew or should have known those drugs were likely to end up in the hands of drug dealers and those suffering from substance use disorder. Opioid distributors are legally required to monitor the size and frequency of prescription opioid orders to identify suspicious orders that could be diverted into the illegal drug market. Distributors are required to stop these suspicious shipments and report them to the federal Drug Enforcement Agency (DEA). Instead, McKesson, Cardinal Health, and AmerisourceBergen faced repeated actions from the DEA for continuously failing to stop and report suspicious opioid shipments, paying hundreds of millions in fines for their failure to follow the rules. Prescriptions and sales of opioids in Washington increased by over 500% between 1997 and 2011. In 2011, at the peak of overall sales in Washington, over 112 million daily doses of all prescription opicids were dispensed in the state, which is enough for a 16-day supply for every woman, man, and child in Washington. In 2015, there were eight counties with more prescriptions than population, led by Asotin County, with nearly 1 ? prescriptions per person. The other counties were Clallam, Grays Harbor, Columbia, Garfield, Pend Oreille, Lewis, and Benton. In 2008, there were 16 counties with more prescriptions than people. Ferguson claimed that McKesson, Cardinal Health, and AmerisourceBergen violated the law by filling thousands of suspicious orders in Washington state without adequately identifying them or reporting them. [FN17] Idaho To Receive $119 Million In Opioid Settlement With Cardinal Health, McKesson, AmerisourceBergen, And Johnson & Johnson Idaho Governor Brad Little and Attorney General Lawrence Wasden recently announced the final court approval of a $26 billion opioid agreement with the nation's three major pharmaceutical distributors ? Cardinal Health, McKesson, and AmerisourceBergen ? and Johnson & Johnson. Idaho will receive $119 million. This settlement is the second largest consumer settlement in state history after the 1998 national tobacco settlement. A judge in Ada County recently approved the settlement. All of Idaho's 44 counties, 24 municipalities, and seven health districts have signed on the agreement. Based on the full participation of eligible Idaho entities, the state will receive the full share of the money available to it. Idaho could receive its first settlement payment in the next several weeks. 'Opioid and substance misuse is one of America's ? and Idaho's ? growing problems. Idaho has made significant strides in recent years in combatting the opioid crisis, and the culmination of our legal action against opioid manufacturers ? led by Attorney General Wasden and his team ? now offers additional resources. Altogether, our investments and activities will turn the tide on the opioid crisis. Our coordination and focused efforts will bring about better education and prevention, more effective alternatives for pain, improved treatment options, and coordinated and enhanced mental health resources," Governor Little said. The Attorney General's Consumer Protection Division led Idaho's involvement in the settlement. Negotiations took three years. A total of 49 states signed on to the agreement, which resolves more than 4,000 claims of state and local government across the country. Attorney General Wasden continues to litigate against other opioid manufacturers as well as the Sackler family, owners of Purdue Pharma. According to Wasden, 'This settlement holds some of those most responsible for the opioid crisis accountable and provides significant funding for treatment, recovery and prevention in Idaho." Wasden also noted that, 'These funds will be a huge asset to our state as it continues its recovery from the opioid crisis. | want to thank Governor Little and members of the Legislature for working closely with my office to ensure that these funds will help us move forward toward a healthier future for Idaho citizens. | also want to thank participating counties and cities, as well as the members of my team who worked so hard to execute this incredibly important settlement." All funds must be spent on opioid remediation programs. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -10- Under the Idaho Opioid Settlement Intrastate Allocation Agreement, opioid settlement funds will be divided with 40-percent going directly to participating counties and cities and 20-percent to regional public health districts. The remaining 40-percent will be allocated to the State-Directed Opioid Settlement Fund to be appropriated by the Idaho legislature based on recommendations by the Idaho Behavioral Health Council. As part of the settlement, certain special districts were identified in each participating state based on the size of the population they serve. The special districts who participated in the settlements are North Ada County Fire & Rescue, Eagle Fire, Star Fire, Shelley Firth Fire, Nampa Fire Protection District, Middleton Fire, Kootenai Health, Madison County Fire, Meridian Rural Fire Protection District, Whitney Fire, Kuna Rural Fire, Blackfoot Snake River Fire District, Central Fire Protection District, Kootenai County Fire & Rescue, Northern Lakes Fire Protection, Moscow Fire, Bonneville County Fire Protection District #1, Caldwell Rural Fire, Twin Falls Rural Fire, North Bannock Fire, North Cassia Fire, Minidoka County Fire, Gem County Fire Prot. #1, West Ada School District and Boise School District. In addition to the paying the agreed upon funds, Cardinal, McKesson, and AmerisourceBergen will: - Establish a centralized independent clearinghouse to provide all three distributors and state regulators with aggregated data and analytics about where drugs are going and how often, eliminating blind spots in the current systems used by distributors; - Use data-driven systems to detect suspicious opioid orders from customer pharmacies; - Terminate customer pharmacies' ability to receive shipments, and report those companies to state regulators, when they show certain signs of diversion. - Prohibit shipping of and report suspicious opioid orders; - Prohibit sales staff from influencing decisions related to identifying suspicious opioid orders; and - Require senior corporate officials to engage in regular oversight of anti-diversion efforts. Johnson & Johnson is required to: - Stop selling opioids; - Not fund or provide grants to third parties for promoting opioids; - Not lobby on activities related to opioids; and - Share clinical trial data under the Yale University Open Data Access Project. [FN'18] Tennessee Doctor Barred From Prescribing Certain Controlled Substances United States Attorney Mark H. Wildasin for the Middle District of Tennessee recently announced a settlement reached with David Florence, D.O., a Manchester, Tennessee physician who agreed to be barred from prescribing Schedule II and the vast majority of Schedule III controlled substances. Pursuant to the Consent Judgment and Permanent Injunction, Florence is permanently enjoined from issuing prescriptions for any controlled substances under Schedules II and III of the Controlled Substances Act, with limited exceptions for buprenorphine products as allowed by Tennessee law, testosterone, and two migraine medications. Florence also agreed not to order or store any controlled substances, and not to prescribe to himself, any immediate family members, fellow employees, or significant others. In March 2016, the United States filed a civil complaint in intervention, alleging violations of the Controlled Substances Act and the False Claims Act, against Florence and other defendants. As to Florence, the United States alleged that he prescribed controlled substances that had no legitimate medical purpose and failed to properly supervise mid-level practitioners. The United States previously obtained settlements that resulted in the dismissal of its claims against all other defendants named in its complaint in intervention. N19] West Virginia Announces $162 Million Opioid Settlement With Drug Makers Teva And Allergan West Virginia Attorney General Patrick Morrisey recently announced that his office has reached a $161,531,000 settlement with prescription drug manufacturers Teva and Allergan. Throughout the trial, which began on April 4, 2022, the Attorney General and his Office's lawyers have alleged that the manufacturers helped fuel the opioid epidemic in West Virginia by engaging in strategic campaigns to deceive prescribers and misrepresent the risks and benefits of opioid painkillers. It's been a long trial and, as we have said from the very beginning, we are looking for accountability," Attorney General Morrisey stated. He further noted that, 'This settlement, along with other settlements we will receive from other cases, will provide significant help to those affected the most by the opioid crisis in West Virginia. I've always said that at the end of the day, through our Office's opioid work, West Virginia will have the highest per capita settlement results in the nation fighting for our people." In making its case, the State presented 54 witnesses and approximately 630 documents into evidence in a span of six weeks. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -11- According to the settlement, West Virginia will receive payments totaling more than $134,531 ,000 in cash over the length of the agreement provided that the State has received approval from its political subdivisions. Teva, as part of the settlement, will also supply West Virginia with $27 million worth of Narcan. The monies from the settlement will be distributed under the terms of the West Virginia First Memorandum of Understanding. Announced in mid-February 2022, the MOU is an agreement with cities and counties on how future settlement dollars would be used to abate the opioid crisis throughout the state. It contains a comprehensive plan intended to abate the problems caused by the volume of opioids that was sold in West Virginia. The State's counties and cities are in the process of approving the West Virginia First MOU. The Attorney General will also work with the Legislature to gain support behind certain provisions of the MOU. The lawsuit against Teva and Allergen was filed in 2019 in Boone County Circuit Court. It alleged that the defendants concealed misconduct, mischaracterized, and failed to disclose the serious risk of addiction, overstated the benefits of chronic opioid therapy, and promoted higher dosage amounts without disclosing inherently greater risks. The State had also sued Janssen Pharmaceuticals, Inc., an opioid drug manufacturer family of companies. West Virginia and Janssen announced a $99 million settlement on April 18, 2022. The overall amounts currently secured from opioid manufacturers and related parties is: McKinsey $10,000,000 Endo $26,000,000 Johnson & Johnson $99,000,000 Teva, Allergan $161 ,531,000 Total Settlements: $296,531,000 N°! Oklahoma Reaches $250 Million Settlement With Opioid Distributers McKesson, Cardinal, and AmerisourceBergen Oklahoma Attorney General John O'Connor recently announced a settlement with three opioid distributors: McKesson, Cardinal, and AmerisourceBergen. This settlement will bring over $250 million to Oklahoma to combat the opioid epidemic that has significantly affected the state. 'Many Oklahoma families have been ravaged and lives have been lost by opioid addictions and overdoses," said Attorney General O'Connor. 'Money cannot possibly heal those wounds or bring back our loved ones. The funds we are recovering will be used to prevent and treat addictions to opioids." The Attorney General's Office filed suit against these companies 'to hold them accountable for their role in creating and fueling the nationwide opioid epidemic." Attorney General O'Connor previously rejected a national settlement with these distributors that would have resulted in less money for Oklahoma With these funds, Oklahoma has now recovered over $680 million, less the attorneys' fees and costs related to the opioid crisis. 'lam pleased that the state and many local governments were able to work together to arrive at this settlement amount," said Attorney General O'Connor. 'This settlement is still subject to approval by the decision-makers in the cities and counties." According to Attorney General O'Connor, this settlement will bring the following benefits to Oklahoma: * More than $250 million to be shared by the State and the cities and counties within Oklahoma-a higher per-capita recovery than the amount recovered by many other states, in recognition of the outsized impact the opioid crisis has had on Oklahoma. * Recovered money for cities and counties who filed lawsuits against the Distributors, and for many others which did not file lawsuits. Funding for cities and counties will be allocated to those areas that need help most. ¢ Saved the State millions of dollars in attorneys' fees and expenses. The Distributors have agreed to reimburse the State for millions of dollars of attorneys' fees that would otherwise be paid directly from the recovery the State receives for abatement. And both the outside counsel for the State and counsel for Oklahoma's cities and counties have agreed to reduce their overall fees and expenses, saving the State considerable money, and reserving more to address the opioid epidemic. ¢ Obtained significant injunctive relief that requires the Distributors to take action to prevent drug diversion going forward, including establishing a clearinghouse that consolidates data from all three distributors that can be used by state regulators to prevent diversion of prescription opioids. ¢ Ensured that this settlement will be overseen and administered in Oklahoma, by Oklahoma state courts and Oklahoma judges, rather than federal courts located in other states. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -12- ¢ Guaranteed that no less than 85% of the total amount recovered from the Distributors will go to abating the opioid epidemic in Oklahoma. N21) Nevada AG Announces Multistate $244 million Settlement With Mallinckrodt For Alleged False Claims Act Violations Nevada Attorney General Aaron Ford recently announced a $233.7 million settlement with Mallinckrodt ARD, LLC (formerly known as Questcor Pharmaceuticals, Inc.), a U.S. subsidiary of the Irish pharmaceutical company Mallinckrodt plc (collectively Mallinckrodt). The settlement, joined by all 50 states, Washington, D.C., Puerto Rico and the federal government, will be paid over a period of seven years. In total, Nevada will receive $1,703,095 from the settlement. 'My office will not stop going after those who would seek to defraud our state and our healthcare and Medicaid system," said AG Ford. '| would like to thank the office's Medicaid Fraud Control Unit for the vital work they do ? this is just the latest win they have delivered for the state of Nevada." The settlement resolves allegations that from Jan. 1, 2013, through June 30, 2020, Mallinckrodt knowingly underpaid Medicaid rebates due for its drug H.P. Acthar Gel (Acthar). The government alleges that Mallinckrodt's conduct violated the Federal False Claims Act and the Nevada False Claims Act, and that it resulted in the submission of false claims to the Nevada Medicaid program. Under the Medicaid Drug Rebate Program, when a manufacturer increases the price of a drug faster than the rate of inflation, it must pay the Medicaid program a per-unit rebate of the difference between the drug's current price and the price of the drug if it had gone up at the general rate of inflation since either 1990 or the year the drug first came to market, whichever is later. However, the government alleges that Mallinckrodt (and its predecessor Questcor) began paying rebates for Acthar in 2013 as if Acthar was a new drug rather than a drug that was first introduced in 1952. The government alleges this practice meant the companies ignored all pre-2013 price increases when calculating and paying Medicaid rebates for Acthar from 2013 until 2020. Specifically, the government alleges that Acthar's price had already risen to over $28,000 per vial by 2013. As such, ignoring all pre-2013 price increases for Medicaid rebate purposes significantly lowered Medicaid rebate payments for Acthar. Under the settlement agreement, Mallinckrodt admitted that Acthar was not a new drug as of 2013 but rather was approved by the FDA and marketed prior to 1990. Mallinckrodt agreed to correct Acthar's base date AMP and that it will not change the date in the future. A team from the National Association of Medicaid Fraud Control Units participated in the litigation and conducted settlement negotiations on behalf of the states. The team included representatives from the Offices of the Attorneys General for the states of California, Florida, Massachusetts, Michigan, Nevada, New York, Texas, and Wisconsin. The Nevada Medicaid Fraud Control Unit receives 75% of its funding from the U.S. Department of Health and Human Services under a grant award. The remaining 25% is funded by the State of Nevada. [FN22] Pharmacy Enters Into Deferred Prosecution And Civil Settlement Agreements With Federal Government Relating To Fraudulent Claims For Anti-Overdose Drug Florida-based Solera Specialty Pharmacy has entered into a deferred prosecution agreement and has agreed, along with its Chief Executive Officer (CEO), to pay a $1.31 million civil settlement to resolve allegations that it submitted fraudulent claims to Medicare for Evzio, a high-priced drug used in rapid reversal of opioid overdoses. According to the admissions of Solera and its CEO Nicholas Saraniti in the civil agreement, and Solera's additional admissions in the criminal agreement, the pharmacy dispensed Evzio from January 2017 to May 2018. During that time, Evzio was the highest-priced version of naloxone on the market and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio. Solera completed Evzio prior authorization forms in place of the prescribing physicians, including instances in which Solera staff signed the forms without the physician's authorization and listed Solera's contact information as if it were the physician's. Furthermore, Solera submitted Evzio prior authorization forms that contained false clinical information to secure approval for the drug. Solera also waived Medicare beneficiary co-payment obligations for Evzio on numerous occasions without analyzing whether the patient had a genuine financial hardship. Solera entered into a deferred prosecution agreement in connection with a criminal information charging the pharmacy with one count of health care fraud. Solera and its CEO, Saraniti, also entered into a civil settlement agreement and will pay the government $1.31 million to resolve claims under the False Claims Act. 'Taxpayers deserve honesty and integrity from those who profit from federal health care programs," said United States Attorney Rachael S. Rollins. 'This resolution will provide oversight to correct behavior and prevent it from happening again." 'Pharmacies, like all Medicare providers, must submit accurate claims," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department's Civil Division. 'This settlement demonstrates the department's continuing commitment to preventing submissions of false claims by entities at all levels of the health care delivery chain." THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -13- In connection with the settlement, Solera and Saraniti entered into a three-year Integrity Agreement (IA) with the U.S. Department of Health and Human Services Office of Inspector General. The IA requires, among other things, that Solera implement measures designed to ensure that its submission of claims for pharmaceutical products complies with applicable law relating to prior authorizations and collection of beneficiary co-payment obligations. In addition, the IA requires reviews by an independent review organization. 'The submission of truthful and accurate documentation by all parties involved in the delivery of health care goods or services is essential to the integrity of federal health care programs. This includes pharmacies that submit claims for pharmaceutical products," said Special Agent in Charge Phillip M. Coyne of the Department of Health and Human Services Office of Inspector General (HHS- OIG). 'Along with our law enforcement partners, HHS-OIG is committed to preventing fraud in Medicare and other taxpayer-funded health care programs." 'Today's settlement resolves serious allegations that Solera submitted false and fraudulent claims to Medicare for their own financial gain, pilfering funds from a program intended to help those truly in need, while going behind the backs of prescribing physicians to secure approval for this expensive anti-overdose drug," said Joseph R. Bonavolonta, Special Agent in Charge of the FBI Boston Division. Bonavolonta further noted that, 'This is not a victimless crime-health care fraud is a crime against all of us who contribute hard earned income and taxes into the system. The FBI will continue to work with our law enforcement partners to ensure those who willingly defraud the American people are held accountable." The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by a former employee of kal?o Inc., the manufacturer of Evzio. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. In 2021, the department announced settlements with kal?o for $12.7 million and with other pharmacies for $1 million relating to the submission of false claims for Evzio. 24 New York AG Asks Court To Vacate Dismissal Of Teva Parent Company From Opioid Lawsuit New York Attorney General Letitia James recently took action in an attempt to further hold Teva Pharmaceutical Industries, Ltd. (the Israel-based parent company of Teva Pharmaceuticals USA) accountable for its alleged role in the opioid crisis. In a motion by order to show cause, Attorney General James outlined how Teva Pharmaceutical Industries, Ltd. (Teva Parent) allegedly made significant and intentional misrepresentations to the Office of the Attorney General (OAG) and the court about its involvement with Teva Pharmaceuticals USA (Teva USA) and role in the opioids industry in the United States in order to evade legal action and accountability. New evidence uncovered by OAG allegedly shows that, despite sworn testimony provided to the court that Teva Parent transacted no business in the United States, held no property in the United States, and had no role in its American opioids business, Teva Parent was a primary decision maker for its American subsidiary, maintained property and employees in the country, and exerted control over its finances. James also argues that Teva Parent used a complex web of shell corporations to transfer significant funds out of Teva USA and into offshore accounts it owns and control. Attorney General James argues that, for these reasons, the court should vacate its previous dismissal of Teva Parent from OAG's opioid litigation to allow OAG an opportunity to examine Teva Parent's real role in the opioid crisis and whether it compromises Teva USA's ability to pay New York state by improperly transferring billions of dollars out of the company. The OAG is seeking further discovery into Teva USA to ensure that any forthcoming judgment stemming from a December 2021 jury decision that found Teva USA harmed New Yorkers and violated the state's public nuisance laws will be paid. '| made a promise to New Yorkers that we would do everything in our power to hold drug manufacturers and distributors accountable for their role in the opioid crisis that has devastated our communities," said Attorney General James. 'By making misrepresentations to escape our reach, Teva Pharmaceuticals underestimated our commitment to securing justice for the people of New York. We have already been successful in demonstrating the harm that Teva USA and others inflicted on New Yorkers, but this new evidence shows an even greater disregard for the pain and destruction that that this company fueled. No amount of money will ease the trauma of those impacted by this crisis, but we will continue to stand up to Big Pharma and ensure they pay New Yorkers for the damage they caused." [FN24] Teva Agrees To $4.25 Billion Opioid Settlement With Several States; More Details To Be Announced In Future lowa Attorney General Tom Miller recently announced that he, as well as several states, have reached an agreement in principle on key financial terms with opioid maker Teva, which would provide up to $4.25 billion to participating states and local governments. While critical details of the settlement remain the subject of ongoing negotiations, Teva disclosed the agreement Tuesday ahead of its earnings announcement Wednesday. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -14- 'This is another major step in addressing the opioids crisis," Miller said, noting that lowa was a leading state in negotiating the agreement with Teva. 'We expect these funds to make a significant difference in preventing fatal overdoses and treating opioid addiction disorder." Teva, an Israel-based drug manufacturer, makes Actiq and Fentora, which are branded fentanyl products for cancer pain, and a number of generic opioids, including oxycodone. States alleged that Teva: * promoted potent, rapid-onset fentanyl products for use by non-cancer patients; ¢ deceptively marketed opioids by downplaying the risk of addiction and overstating their benefits, including encouraging the idea that signs of addiction are actually 'pseudoaddiction" treated by prescribing more opioids; and ¢ failed to comply with suspicious order monitoring requirements along with its distributor, Anda. The parties have agreed on the following financial terms: * Teva will pay a maximum of $4.25 billion in cash over 13 years. This figure includes amounts Teva has already agreed to pay under settlements with individual States, funds for participating States and subdivisions, and the $240 million of cash in lieu of product described below. * As part of the financial term, Teva will provide up to $1.2 billion in generic naloxone (valued at Wholesale Acquisition Cost or WAC) over a 10-year period or $240 million of cash in lieu of product, at each State's election. Naloxone is used to counteract overdoses. ¢ The settlement will build on the existing framework that states and subdivisions have created through other recent opioid settlements. * A final settlement remains contingent on agreement on critical business practice changes and transparency requirements. 'Leading a coalition of states to hold accountable the manufacturers of opioids is a priority for our office, which is why | have directed substantial resources toward this effort," Miller said. 'We are dedicated to ensuring that help is available to lowans who are victims of the opioid epidemic." The negotiations are being led by the following states: California, Illinois, lowa, Massachusetts, New York, North Carolina, Pennsylvania, Tennessee, Texas, Vermont, Virginia, and Wisconsin. Although New York is among the 12 states that negotiated this proposed settlement framework, Teva and New York are still engaged in further negotiations. [FN25] FTC Approves Final Order Resolving Charges Relating To Competition For Development and Marketing of Steroid Injectable Drug Following a public comment period, the Federal Trade Commission (FTC) has approved a final order settling charges that Hikma Pharmaceuticals plc's $375 million acquisition of Custopharm, Inc. likely would have harmed competition in the market for the corticosteroid drug triamcinolone acetonide, or TCA, which treats severe skin conditions, allergies, and inflammation Only Custopharm and a few other companies now make this drug. First announced in April 2022, the FTC's complaint alleged that, with this acquisition, Hikma was likely to stop developing its own TCA product, threatening competition in the TCA market. The consent order removes any incentive for Hikma to terminate or delay marketing the TCA product it has under development, by requiring that Custopharm's parent company retain and transfer Custopharm's TCA assets to another one of its subsidiaries, Long Grove Pharmaceuticals, LLC. Historically, the entry of additional generic pharmaceutical competitors has led to lower drug prices. The consent order also requires Long Grove to maintain the competitive viability of the retained TCA assets going forward. And it requires Hikma to seek Commission approval for future TCA-related acquisitions. The Commission vote to approve the final order was 5-0. 'Hikma's acquisition of Custopharm's TCA business could have caused significant harm for patients who use TCA to treat severe skin conditions, allergies, and inflammation," said Holly Vedova, Director of the FTC's Bureau of Competition. Ms. Vedova further noted that, 'Only three competitors now market this drug. The FDA recently approved marketing of Custopharm's TCA product, while Hikma has an injectable TCA product in development. The FTC's action ensures that Hikma still has the incentive to bring its TCA product to market, which will benefit consumers." Hikma is a multinational pharmaceutical company with U.S. headquarters in Berkeley Heights, NJ. It manufactures branded and generic products, including generic injectables. Custopharm develops mostly generic injectable drugs and it relies on contract manufacturers to produce them. [FN26] [FN27] State AGs Settle Opioid Claims With Endo Connecticut Attorney General William Tong has reached an agreement in principle with opioid maker Endo International plc and its lenders that would provide up to $450 million to participating states and local governments, ban promotion of Endo's opioids, and require Endo to turn over millions of documents related to its alleged role in the opioid crisis for publication in a public online archive. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -15- The agreement in principle with Endo, which recently filed for Chapter 11 bankruptcy protection in the Souther District of New York, resolves allegations that Endo boosted opioid sales using deceptive marketing that downplayed the risk of addiction and overstated the benefits. Endo, an Ireland-based drugmaker with its U.S. headquarters in Malvern, Pennsylvania, makes generic and branded opioids, including Percocet and Endocet, and also made Opana ER, which was withdrawn from the market in 2017. The states allege that Endo falsely promoted the benefits of Opana ER's so-called abuse-deterrent formulation, which did nothing to deter oral abuse and led to deadly outbreaks of Hepatitis and HIV due to its widespread abuse via injection. 'Endo falsely peddled its opioids as abuse-deterrent with deadly consequences. They downplayed risks, overpromoted benefits, and reaped profits while people suffered and died. Our settlement forces Endo to pay $450 million to states across the country to support treatment and prevention, bans the marketing of their opioids forever, and forces disclosure of millions of documents," said Attorney General Tong. 'One by one, we are taking on every player in the addiction industry and holding them accountable for the lives they destroyed." The resolution, which is contingent on final documentation and Bankruptcy Court approval, includes the following terms: - Requires payment of $450 million in cash over 10 years to participating states and subdivisions. - Requires Endo to turn over its opioid-related documents for publication online in a public document archive and pay $2.75 million for archival expenses. - Bans the marketing of Endo's opioids forever. The negotiations are being led by the following states: Maine, Massachusetts, New Hampshire, Pennsylvania, Tennessee, Vermont, and Virginia. The settlement is also joined by the attorneys general of Arizona, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Illinois, Indiana, lowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Rhode Island, South Carolina, South Dakota, Utah, Washington, Wisconsin, Wyoming, and the U.S. Virgin Islands. [FN28] Essilor Settles False Claims Act Case For $16.4 Million Texas based Essilor International, Essilor of America Inc., Essilor Laboratories of America Inc. and Essilor Instruments USA ('Essilor') have agreed to pay $16.4 million to resolve allegations that the company violated the False Claims Act by causing claims to be submitted to Medicare and Medicaid that resulted from violations of the Anti-Kickback Statute. Essilor manufactures, markets, and distributes optical lenses and equipment used to produce optical lenses. The United States alleged that, between January 1, 2011 and December 31, 2016, Essilor knowingly and willfully offered or paid remuneration to eye care providers, such as optometrists and ophthalmologists, to induce those providers to order and purchase Essilor products for their patients, including Medicare and Medicaid beneficiaries, in violation of the Anti-Kickback Statute. The Anti-Kickback Statute prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, and other federally-funded programs. The statute is intended to ensure that medical providers' judgments are not compromised by improper financial incentives. In connection with the settlement, Essilor entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG. The CIA requires, among other things, that Essilor hire an independent review organization to review its systems, policies, processes, and procedures for ensuring that any discounts, rebates, or other reductions in price offered to providers comply with the Anti-Kickback Statute. The CIA also requires Essilor to implement a new written review and approval process to ensure all existing and new discount arrangements comply with the Anti-Kickback Statute. The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by former Essilor district sales managers, who will receive a portion of the recovery. 'When medical equipment manufacturers provide kickbacks to referring providers, it can compromise the integrity of medical decision- making," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department's Civil Division. 'The department will continue to pursue violations of the Anti-Kickback Statute to ensure that patient care is not influenced by improper financial incentives." 'The Anti-Kickback Statute was designed to ensure doctors make medical decisions with only their patients' best interests in mind," said U.S. Attorney Chad Meacham of the Northern District of Texas. 'We are pleased to see Essilor taking financial responsibility for their conduct." 'Our healthcare system is predicated on providers making decisions solely in the best interest of the patient," said U.S. Attorney Jacquelin Romero of the Eastern District of Pennsylvania. 'Kickbacks threaten to corrupt that decision-making. The U.S. Attorney's Office stands ready to pursue anyone who fails to abide by the rules that ensure our system functions as it should." THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -16- 'Kickback schemes can impact medical judgment, eroding the trust of both patients and taxpayers," said Lisa M. Re, Acting Chief Counsel at the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). 'Essilor's Corporate Integrity Agreement is intended to establish policies and practices so it complies with the Anti-Kickback Statute moving forward. " [FN28}] Biogen Settles False Claims Act Kickback Allegations Relating To MS Drugs For $900 million The Department of Justice recently announced that pharmaceutical company Biogen Inc. (Biogen), based in Cambridge, Massachusetts, has agreed to pay $900 million to settle allegations that it caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe Biogen drugs. The settlement resolves a lawsuit filed and litigated by former Biogen employee Michael Bawduniak against Biogen under the qui tam, or whistleblower, provisions of the federal False Claims Act, which permit a private party (known as a relator) to file a lawsuit on behalf of the United States and receive a portion of any recovery. The United States may intervene in the action or, as in this case, the relator may proceed with the lawsuit. In his lawsuit filed in the District of Massachusetts, Bawduniak alleged that Biogen paid kickbacks to physicians to induce them to prescribe the company's multiple sclerosis drugs. According to the relator's complaint, from Jan. 1, 2009, through March 18, 2014, Biogen offered and paid remuneration, including in the form of speaker honoraria, speaker training fees, consulting fees and meals, to health care professionals who spoke at or attended Biogen's speaker programs, speaker training meetings or consultant programs to induce them to prescribe the drugs Avonex, Tysabri and Tecfidera, in violation of the Anti-Kickback Statute. Under the terms of the settlement, Biogen will pay $843,805,187 to the United States and $56,194,813 to 15 states. Bawduniak will receive approximately 29.6% of the federal proceeds from the settlement. According to Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department's Civil Division, 'The relator diligently pursued this matter on behalf of the United States for over seven years. The settlement announced today underscores the critical role that whistleblowers play in complementing the United States' use of the False Claims Act to combat fraud affecting federal health care programs." 'We thank Mr. Bawduniak for uncovering this behavior and bringing it to light," said U.S. Attorney Rachael S. Rollins for the District of Massachusetts. 'This matter is an important example of the vital role that whistleblowers and their attorneys can play in protecting our nation's public health care programs. " [FN3O] Bayer Settles False Claims Act Lawsuits Involving Alleged Kickbacks And Off Label Marketing for $40 Million Indiana-based Bayer Corporation, and its related entities, Bayer HealthCare Pharmaceuticals Inc., Bayer HealthCare LLC and Bayer AG (collectively 'Bayer'), have agreed to pay $40 million to resolve alleged violations of the False Claims Act in connection with the drugs Trasylol, Avelox, and Baycol. The settlement addressed two whistleblower lawsuits filed and pursued by a former employee of Bayer who worked in its marketing department. The employee, Ms. Simpson, alleged that Bayer paid kickbacks to hospitals and physicians to induce them to utilize the drugs Trasylol and Avelox, and also marketed these drugs for off-label uses that were not reasonable and necessary. Simpson also alleged that Bayer downplayed the safety risks of Trasylol. The lawsuit alleged that, as a result of this conduct, Bayer caused the submission of false claims to the Medicare and Medicaid Programs and violated the laws of 20 states and the District of Columbia. Trasylol is a drug used to control bleeding in certain heart surgeries. Avelox is an antibiotic approved to treat certain strains of bacteria. Simpson filed a second lawsuit relating to Bayer's statin drug Baycol, which was later transferred to the District of Minnesota. That lawsuit alleged that Bayer knew about, but downplayed, Baycol's risks of causing rhabdomyolysis. The lawsuit also alleged that Bayer misrepresented the efficacy of Baycol when compared to other statins and fraudulently induced the Defense Logistics Agency to renew certain contracts relating to Baycol. Subsequently, Trasylol and Baycol were withdrawn from the market for safety reasons. Under the terms of the settlement, Bayer will pay $38,860,555 to the United States and $1,139,445 to the 20 states and the District of Columbia. Simpson will receive approximately $11 million from the proceeds of the settlement. 'Simpson diligently pursued this matter for almost two decades," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Department of Justice's Civil Division. 'Today's recovery highlights the critical role that whistleblowers play in the effective use of the False Claims Act to combat fraud in federal healthcare programs." 'We recognize Simpson for her perseverance with this matter," said U.S. Attorney Andrew M. Luger for the District of Minnesota. 'We are pleased we were able to work with the parties to facilitate this resolution and help bring this longstanding matter to a close." 'As alleged in the complaints, Bayer ? one of the largest pharmaceutical companies in the world ? engaged in a series of unlawful acts, including paying kickbacks to doctors and hospitals, marketing them off-label, and downplaying their safety risks," said U.S. Attorney Philip R. Sellinger for the District of New Jersey. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -17- Sellinger further noted that, 'This resolution should send a message to the pharmaceutical industry that such conduct undermines the integrity of federal health care programs and jeopardizes patient safety. This settlement reflects the importance of the whistleblower's role in litigating False Claims Act actions on behalf of the United States, and we thank Ms. Simpson and her counsel for stepping forward and pursuing this case to conclusion.' N91] New Hampshire Announces $40.5 million Opioid Settlement With Janssen Pharmaceuticals/Johnson & Johnson New Hampshire Attorney General John M. Formella recently announced a settlement with Janssen Pharmaceuticals/Johnson & Johnson to settle the state's opioid claims against the company. The company has agreed to pay $40.5 million, of which $31.5 million will be used for opioid abatement purposes. 'As part of our continued efforts to battle the opioid epidemic, New Hampshire is a leader in ensuring that the companies who played a role in perpetuating this crisis are held accountable for their actions,' said Governor Chris Sununu. Governor Sununu further noted that, 'This resolution provides a positive step forward in ensuring these devastating business practices are not repeated, and that resources are allocated to help stem the tide of the opioid crisis. | thank the Department of Justice for their work on this case.' Under the terms of the settlement agreement, Johnson & Johnson will make a single payment of $39.605 million to the State and pay approximately $900,000 in attorneys' fees to counsel for the counties, cities and towns that filed opioid lawsuits against Johnson & Johnson prior to September 1, 2019. The State will receive $31.5 million, after payment of litigation costs and fees to its outside counsel. Under state law, all of the $31.5 million must be used for opioid abatement purposes, with $4,725,000 of that amount being paid to the 23 counties, cities, and towns that filed opioid lawsuits prior to September 1, 2019. The remaining funds will be deposited into the Opioid Abatement Trust Fund and used in accordance with RSA 126-A:83-86. The settlement requires releases by the 23 litigating subdivisions and 18 primary non-litigating cities and towns for the agreement to be final. The settlement also contains injunctive terms that imposes on Johnson & Johnson a ban on the selling and manufacturing of opioids, a ban on the promotion of opioids or opioid products, and a ban on prescription savings programs, as well as lobbying restrictions, and contains stringent enforcement provisions. In 2018, the Attorney General filed a complaint against Janssen Pharmaceuticals and Ortho-McNeil-Janssen Pharmaceuticals. Both companies are wholly owned subsidiaries of Johnson & Johnson. In its complaint, the State alleged that Johnson & Johnson aggressively marketed their opioids to prescribers and patients in New Hampshire and misrepresented that their opioids were safer than other alternatives. The state also alleged that the defendants disseminated misleading statements about opioids, that they promoted the false concept of pseudo addiction, and that they misrepresented that their opioids were rarely addictive when used for chronic pain. Furthermore, the state claimed that Johnson & Johnson's marketing targeted particularly vulnerable populations within New Hampshire, such as the elderly, even though opioid use among the elderly carries a heightened risk of overdose, injury, and death. The State further alleged that Johnson & Johnson's opioid activities were a substantial factor in creating a public nuisance in New Hampshire that contributed to the opioid crisis. State Attorney General John Formella noted that, 'New Hampshire has been devastated by the opioid crisis, and we continue to deal with the impacts of that crisis today.' Formella also noted that, 'Today's settlement continues our efforts to hold opioid companies accountable for their role in creating this epidemic, and this settlement represents another successful push to get more resources for New Hampshire to align with the disproportionate impact that this crisis has had on our State. | thank Deputy Attorney General James Boffetti for leading our efforts in this case, and all those who assisted the State in this effort.' The State's trial against Johnson & Johnson was scheduled to begin on September 7, 2022 in Merrimack County Superior Court. The State decided not to join an earlier national settlement with Johnson & Johnson because the opioid crisis in New Hampshire was particularly severe, and also because New Hampshire had already devoted significant litigation resources at the time the national settlement was announced. The terms of the national settlement were significantly less favorable to New Hampshire as compared to the settlement the Attorney General has announced, which will be paid in full in one payment. The national settlement would have resulted in being paid over nine years. [FN32] Philips Subsidiary To Pay Over $24 Million To Settle False Claims Lawsuit Relating To Sales Of Respiratory Equipment Philips RS North America LLC (formerly known as Respironics Inc.), a manufacturer of durable medical equipment (DME) based in Pittsburgh, Pennsylvania, has agreed to pay over $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to DME suppliers. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -18- The affected programs were Medicare, Medicaid, and TRICARE, which is the health care program for active military and their families. The settlement resolves allegations that Respironics caused DME suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment that were false because Respironics provided illegal inducements to the DME suppliers. Respironics allegedly gave the DME suppliers physician prescribing data free of charge that could assist their marketing efforts to physicians. 'Paying illegal remuneration to induce patient referrals undermines the integrity of our nation's health care system," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department's Civil Division. 'To ensure that the goods and services received by federal health care program patients are determined by their health care needs, rather than the financial interests of third parties, we will pursue any individual or entity that violates the prohibition on paying kickbacks, including DME manufacturers." The settlement provides that Respironics will pay $22.62 million to the United States, and in addition, will pay $2.13 million to the various states as a result of the impact of Respironics' conduct on their Medicaid programs, pursuant to the terms of separate settlement agreements that Respironics has, or will enter into, with those states. In addition to the civil settlement, Respironics entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG. The CIA requires Respironics to implement and maintain a robust compliance program that includes, among other things, review of arrangements with referral sources and monitoring of Respironics' sales force. The CIA also requires Respironics to retain an independent monitor, selected by the OIG, to assess the effectiveness of Respironics' compliance systems. [FN33] Jury Convicts California Woman For Health Care Fraud And Prescription Diversion Scheme A federal jury recently convicted a California woman for a health care fraud and prescription drug diversion scheme involving two Southern California pharmacies. According to court documents and evidence presented at trial, Irina Sadovsky, 53, of Calabasas, the owner and pharmacist-in-charge of Five Star RX doing business as Five Star Pharmacy (Five Star Pharmacy) and Ultimate Pharmacy Inc. (Ultimate Pharmacy), engaged in a health care fraud and black market prescription drug diversion conspiracy that began in or around September 2016, and continued through in or around April 2017. Sadovsky submitted claims to Medicaid of California (Medi-Cal) and Medicare for prescription drugs that were never dispensed to beneficiaries but rather were provided to co-conspirators to sell on the black market. Sadovsky's co-conspirators created fraudulent prescriptions, either by writing the prescriptions themselves or by paying kickbacks to marketers with access to patients and prescribers. Sadovsky recommended the combinations of prescription drugs to be written, checked the eligibility of the patients for reimbursement, and fraudulently submitted claims to Medi-Cal and Medicare. Sadovsky was convicted of conspiracy to commit health care fraud and conspiracy to engage in the unlicensed wholesale distribution of prescription drugs. She is scheduled to be sentenced on February 3, 2023 and faces a maximum penalty of 10 years in prison for the health care fraud conspiracy, and five years in prison for the unlicensed distribution conspiracy. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors. Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department's Criminal Division; U.S. Attorney Martin Estrada for the Central District of California; Assistant Director in Charge Donald Alway of the FBI Los Angeles Field Office; and Special Agent in Charge Timothy B. DeFrancesca of the Department of Health and Human Services, Office of Inspector General (HHS-OIG) made the announcement. The FBI and HHS-OIG investigated the case, which was brought as part of the Los Angeles Strike Force, supervised by the Criminal Division's Fraud Section and the U.S. Attorney's Office for the Central District of Califomia. The California Department of Justice provided valuable assistance. The Fraud Section leads the Criminal Division's efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, comprised of 15 strike forces operating in 24 federal districts, has charged more than 4,200 defendants who collectively have billed the Medicare program for more than $19 billion. [FNS4] New York Doctor Pleads Guilty To Illegal Distribution Of Over 100,000 Oxycodone Pills Damian Williams, the United States Attorney for the Southern District of New York, recently announced that Marc Laruelle pled guilty to one count of distributing Oxycodone, among other narcotics, without a legitimate medical purpose while acting outside the usual course of professional practice. Laruelle pled guilty before U.S. District Judge Denis L. Cote. U.S. Attorney Damian Williams stated that, 'Marc Laruelle abused his medical license and violated the oath of his profession when he prescribed more than 100,000 doses of a highly potent and addictive opioid without a legitimate medical need. As this case makes clear, we will aggressively prosecute physicians who are contributing to the national opioid crisis. Laruelle now awaits sentencing for his crime." According to the Indictment, Laruelle's plea agreement, and statements made in Court: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -19- ¢ Between in or about September 2016 up to and including in or about October 2021, Marc Laruelle, a licensed doctor specializing in psychiatry, prescribed more than 100,000 doses of Oxycodone without a legitimate medical purpose outside of the usual course of professional practice. Oxycodone is a highly potent and addictive opioid that commands high prices in the black market because of demand by drug abusers. Laruelle often prescribed Oxycodone in combination with Xanax (alprazolam) and/or Adderall (amphetamine), controlled substances that are themselves frequently abused and resold illicitly. ¢ Laruelle failed to perform proper physical examinations or medical tests prior to prescribing Oxycodone to his patients. Laruelle also charged patients as much as $800 per prescription and prescribed large amounts of Oxycodone with the understanding that the quantity would be resold in the black market. Laruelle, 65, of Yonkers, New York, pled guilty to one count of distributing Oxycodone, Amphetamines, and Xanax, which carries a maximum sentence of 20 years in prison. The statutory maximum sentence is prescribed by Congress. Laruelle is scheduled to be sentenced by Judge Cote on January 26, 2023. Mr. Williams praised the work of the Organized Crime Drug Enforcement Task Force ('(OCDETF") New York Strike Force for their support and assistance in this matter. The OCDETF New York Strike Force is a crime-fighting unit comprising federal, state, and local law enforcement agencies supported by the Organized Crime Drug Enforcement Task Force and the New York/New Jersey High Intensity Drug Trafficking Area. The Strike Force is affiliated with the DEA's New York Division and includes agents and officers of the DEA, New York City Police Department, New York State Police, Homeland Security Investigations, U.S. Internal Revenue Service Criminal Investigation Division, Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Customs and Border Protection, U.S. Secret Service, U.S. Marshals Service, New York National Guard, Clarkstown Police Department, U.S. Coast Guard, Port Washington Police Department, and New York State Department of Corrections and Community Supervision. Mr. Williams also thanked the New York State Department of Health Bureau of Narcotic Enforcement for their assistance in this case. [FN35] CVS Health Settles Mostly All State And Local Opioid Lawsuits For $5 Billion CVS Health recently announced today that it has agreed in principle to a financial resolution designed to substantially resolve all opioid lawsuits and claims against the company by states, political subdivisions (such as counties and cities) and tribes in the United States. If all conditions are satisfied and the non-monetary terms (which still must be determined) are finalized, CVS Health has agreed it will pay approximately $5 billion ($4.9 billion to states and political subdivisions and approximately $130 million to tribes) over the next ten years beginning in 2023, depending on the number of governmental entities that agree to join the settlement. The agreement would fully resolve claims dating back over 10 years and is not an admission of any liability or wrongdoing. CVS Health states that it will continue to defend against any litigation that the final agreement does not resolve. 'We are pleased to resolve these longstanding claims and putting them behind us is in the best interest of all parties, as well as our customers, colleagues and shareholders," said Thomas Moriarty, Chief Policy Officer and General Counsel, CVS Health. 'We are committed to working with states, municipalities and tribes, and will continue our own important initiatives to help reduce the illegitimate use of prescription opioids." CVS states in a press release that the company has undertaken numerous initiatives to fight opioid abuse, including: ¢ Significant investments in technology and procedures to support its pharmacists in exercising their professional obligations. ¢ Innovative, comprehensive, and industry-leading policies, procedures and controls relating to the dispensing of controlled substances. * Effective educational programs on prescription drug misuse that have reached 1.8 million teens and parents. * Rollout of more than 4,750 safe medication disposal units in stores and local police departments across the country, which to date have collected more than 4.5 million pounds of unused medication. « Installation of time delay safes in more than 7,650 pharmacies across 45 states and Washington, DC to help deter opioid robberies. ¢ Nationwide access in CVS Pharmacy locations to life-saving opioid overdose reversal medication. The timing of cash settlement payments will be spread over multiple years to allow 'the company to continue to invest in its strategic priorities. " [FN36] Ill. General News USC White Paper Addresses Industry Tactics That Unnecessarily Increase Drug Prices A recent University of Southern California (USC) Schaeffer Center white paper highlights tactics used by intermediaries in the pharmaceutical distribution system, including pharmacy benefit managers (PBMs) and insurers, that are costing patients, employers, and the government billions for wnat should be inexpensive medicines. Erin Trish, co-director of the USC Schaeffer Center, noted that, 'Generics are overlooked when we talk about drug pricing issues in this country, but the same lack of transparency that is causing outrage over high and rising spending on branded drugs is also creating THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -20- issues in the generic drug space. If you filled a prescription for a generic medicine recently, there is a good chance you overpaid, and PBMs and other intermediaries are making record profits." Trish and coauthors Karen Van Nuys and Robert Popovian suggest that policymakers can reduce overpayments for generic drugs by: * encouraging transparency in transactions across the distribution chain; and * encouraging competition and deterring anticompetitive practices in the sale and distribution of generic drugs. The researchers also discussed three strategies used by PBMs and insurers that potentially lead to overpayment of generics: ¢ Copay Clawbacks ? Copayments paid by commercially insured patients can exceed the cost of the drug. Any overpayment- or clawback-is pocketed by PBMs, who have used contract clauses that prohibit pharmacists from advising patients when their prescription can be purchased with cash for less than their copay. ¢ Spread Pricing ? The PBM reimburses the pharmacy one price when a beneficiary fills a prescription while charging the health plan a higher price, and then pocketing the difference or 'spread." Neither the pharmacy nor the health plan knows what the other side was paid or charged, allowing PBMs to pocket profits in some cases. * Profit-Oriented Formulary Designs ? PBMs may prioritize branded drugs over lower-priced generic versions because the branded medicine comes with lucrative manufacturer rebates, a portion of which they may keep. The researchers suggested several policy solutions to increase competition and deter bad practices, including restricting rebate contracting that drives PBMs to prefer brands over generics and using fixed fees per transaction rather than fees determined as a share of a drug's price. The researchers also recommended increasing competition in the PBM market and using business models that commit to price transparency. Employers and the government should also have audit rights that allow them to review PBM transactions and prices. [FN37] New York Governor Announces Completion Of Expansion Of Plant For Drug Outsourcing Company New York governor Kathy Hochul recently announced the completion of an $8.6 million expansion of Pine Pharmaceuticals LLC's manufacturing plant in the Town of Tonawanda. The drug outsourcing company tripled the size of its facility at Riverview Solar Technology Park following the company's significant growth in the past three years. The expansion has allowed Pine to add almost 90 new, full-time permanent employees, doubling its initial projections and overall full-time permanent workforce. Empire State Development has agreed to support this project with up to $650,000 in performance-based Excelsior Jobs Program tax credits. 'Manufacturing is part of New York's legacy, and our state is home to some of the best engineers, developers, and scientists in the world,' Governor Hochul said. 'Pine Pharmaceuticals investment in Western New York will help fill a critical need for U.S. manufactured drugs, retain and create much-needed jobs, and continue to boost our state's economic growth.' Pine Pharmaceuticals is a family-owned business that has experienced significant growth and success in Western New York. The company provides pharmaceutical compounding, including specialized sterile formulations serving ophthalmologists, retinal specialists, hospitals, ambulatory surgery centers, medical practices and clinics. The company uses technology and industry-leading quality assurance practices and addresses drug shortages by working with hospitals, clinics, medical practices and physician offices to provide sterile compounded pharmaceuticals. Pine Pharmaceuticals invested $8.6 million for the 50,000-square-foot addition to the existing state-of-the-art facility. The firm also benefits from low-cost power awards from the New York Power Authority. Empire State Development President, CEO and Commissioner Hope Knight said, 'The health care industry is a growing sector in the Western New York economy, and with support from Governor Hochul, businesses like Pine Pharmaceuticals are creating more high- quality jobs for local workers. The company's move to triple the size of its facility, while adding 40 full-time jobs, reminds us that our recovery from Covid-19 is well underway.' Alfonse Muto, Owner of Pine Pharmaceuticals said, 'We are so grateful for the support New York State has shown us during our expansion process. We are proud to be leading the charge right here in Western New York by creating dozens of new jobs and providing essential pharmaceuticals that will dramatically improve patient care across the country.' The new single-story addition to the sterile compounding facility includes warehousing, quality, and manufacturing space. Other significant investment includes I|SO-certified cleanrooms and manufacturing equipment. The company will use the additional space to produce IV bags and other complex products, as well as for inspection, packaging, labeling and storage. The entire building was designed from the ground up to comply with the FDA's Current Good Manufacturing Practice (CGMP). State Senator Sean Ryan noted that, 'Pine Pharmaceuticals' expansion is a great example of how supporting the growth of local businesses helps move our regional economy forward. | commend the company's leadership team for their decision to expand their » [FN38] operations right here in Western New York and bring dozens of new jobs to the Town of Tonawanda. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . "Paxton Secures $63 Million Statewide Opioid Settlement," December 23, 2021, available at: https:/Avww.texasattorneygeneral.gov/ news/releases/paxton-secures-63-million-statewide-opioid-settlement [FN3] . 'Attomey General James Delivers Up to $200 Million to Help New York Combat Opioid Crisis, Allergan Agrees Not to Sell Opioids," December 8, 2021, available at: https://ag.ny.gov/press-release/2021/attorney-general-james-delivers-200-million-help-new-york- combat-opioid-crisis [FN4] . "Statement from Attorney General Merrick B. Garland Regarding Purdue Pharma Bankruptcy," December 16, 2022, available at: https:/Avww justice.gov/opa/pr/statement-attorney-general-merrick-b-garland-regarding-purdue-pharma-bankruptcy [FN5] . 'Drug Company Ends Face-to-Face Marketing For Its Opioid Product to Massachusetts Doctors in AG Settlement," December 16, 2021, available at: https:/Awww.mass.gov/news/drug-company-ends-face-to-face-marketing-for-its-opioid-product-to-massachusetts- doctors-in-ag-settlement [FN6] . 'Pharmacist Sentenced for $180 Million Health Care Fraud Scheme," January 26, 2022, available at: https://www.justice.gov/opa/pr/pharmacist-sentenced-180-million-health-care-fraud-scheme [FN7] . "Cardinal Health Agrees to Pay More than $13 Million to Resolve Allegations that it Paid Kickbacks to Physicians," January 31, 2022, available at: https:/Awww justice.gov/usao-ma/pr/cardinal-health-agrees-pay-more-13-million-resolve-allegations-it-paid-kickbacks [FN8] . 'Pharmacist Sentenced for $180 Million Health Care Fraud Scheme," January 26, 2022, available at: https:/Avww.justice.gov/opa/pr/ pharmacist-sentenced-180-million-health-care-fraud-scheme [FN9] . 'Paxton Reaches Another Opioid Settle?ment for Texas; $225 Million Against Teva," February 7, 2022, available at: https:// www.texasattorneygeneral.gov/news/releases/paxton-reaches-another-opioid-settlement-texas-225-million-against-teva [FN10] . "Florida-Based Medicare Reimbursement Consultant Resolves Litigation for Allegedly Causing False Diabetic Supply Claims to Medicare," February 14, 2022, available at: https://Awww.justice.gov/opa/pr/florida-based-medicare-reimbursement-consultant-resolves- litigation-allegedly-causing-false [FN11] . "GSK announces settlement between ViiV Healthcare and Gilead Sciences, Inc. resolving litigation relating to Biktarvy and ViiV's dolutegravir patents and entry into a patent licence agreement," February 1, 2022, available at: https:/Avww.gsk.com/en-gb/media/press-releases/gsk-announces-settlement-between-viiv-healthcare-and-gilead-sciences/ [FN12] . "Attorney General Tong Compels Purdue Pharma and Sackler Family to Pay $6 Billion to Victims, Survivors and States," March 3, 2022, available at: https://portal.ct.gov/AG/Press-Releases/2022-Press-Releases/AG-Tong-Compels-Purdue-and-Sacklers-to-Pay-Six- Billion-to-Victims-Survivors-and-States [FN13] . 'Prisma Health Midlands to Pay $1 Million to Resolve Alleged Controlled Substance Act Violations," April 5, 2022, available at: https:// www .justice.gov/usao-sc/pr/prisma-health-midlands-pay-1-million-resolve-alleged-controlled-substance-act-violations THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- [FN14] . "Attorney General announces additional opioid settlements valued at more than $100 million against manufacturers Teva and Allergan," March 21, 2022, available at: https://riag.ri.gov/press-releases/attorney-general-announces-additional-opioid-settlements- valued-more-100-million [FN15] . 'Attomey General Steve Marshall Announces $276 Million in State of Alabama Settlements with Opioid Manufacturers, Distributor," April 19, 2022, available at: https:/Avww.alabamaag.gov/newsviewer/e000276a-e01 1-4c6e-8d33-472bc01 fcc31 [FN16] . WDN, "Attorney general announces $99 million settlement with Janssen Pharmaceuticals More Than Doubles National Settlement Amount for West Virginia," April 20, 2022, available at: https:/Avvdn.com/31849/ [FN17] . 'AG Ferguson: Opioid distributors to pay $518 million to Washington," May 3, 2022, available at: https:/Awww.atg.wa.gov/news/news- releases/ag-ferguson-opioid-distributors-pay-51 8-million-washington [FN18] . 'Idaho to Receive Nearly $120 Million to Fight the Opioid Crisis," May 13, 2022, available at: https:/Avww.ag.idaho.gov/newsroom/idaho-to-receive-nearly-120-million-to-fight-the-opicid-crisis/ [FN19] . 'Manchester Physician Barred From Prescribing Certain Controlled Substances," May 18, 2022, available at: https:/Avww.justice.gov/ usao-mdtn/pr/manchester-physician-barred-prescribing-certain-controlled-substances [FN20] . "Attorney General Morrisey Announces Record-Breaking $161.5-Plus Million Settlement with Teva and Allergan," May 25, 2022, available at: https://mailchi.mp/a92a675984be/wva-agannounces-record-breaking-1615-plus-million-settlement-with-teva-and- allergan-712141?e=b243bea835 [FN21] . "Oklahoma Reaches Historic Settlement with Three Opioid Distributors," June 27, 2022, available at: https:/Awww.oag.ok.gov/articles/ oklahoma-reaches-historic-settlement-three-opioid-distributors [FN22] . "Attorney General Ford Announces Settlement with Mallinckrodt ARD Pharmaceutical Company for Fraudulent Medicaid Claims," June 16, 2022, available at: https://ag.nv.gov/News/PR/2022/ Attorney_General_Ford_Announces_Settlement_with_Mallinckrodt_ARD_Pharmaceutical_Company_for_Fraudulent_Medicaid_Claims/ [FN23] . 'Pharmacy Agrees to Enter into Deferred Prosecution and Civil Settlement Agreements in Connection with Fraudulent Claims for Anti- Overdose Drug," July 13, 2022, available at: https:/Awww justice.gov/usao-ma/pr/pharmacy-agrees-enter-deferred-prosecution-and-civil-settlement-agreements-connection [FN24] . 'Attorney General James Uncovers Evidence That Teva Pharmaceuticals Lied to Evade Accountability for Opioid Crisis in New York," July 11, 2022, available at: https://ag.ny.gov/press-release/2022/attorney-general-james-uncovers-evidence-teva-pharmaceuticals-lied- evade [FN25] . "Opioids maker Teva agrees to $4.25 billion settlement," July 26, 2022, available at: https:/Avww.iowaattorneygeneral.gov/newsroom/ opioids-maker-teva-agrees-to-425-billion-settlement [FN26] . "FTC Approves Final Order Preserving Competition for Development and Marketing of Steroid Injectable Drug," July 14, 2022, available at: https:/Awww.ftc.gov/news-events/news/press-releases/2022/07/ftc-approves-final-order-preserving-competition- development-marketing-steroid-injectable-drug THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -23- [FN27] . 'Federal Trade Commission Preserves Competition for Development and Marketing of Steroid Injectable Drug," April 19, 2022, available at: https://Awww .ftc.gov/news-events/news/press-releases/2022/04/federal-trade-commission-preserves-competition- development-marketing-steroid-injectable-drug [FN28] . "State Attorneys General Reach $450 Million Nationwide Settlement as Part of Opioid Maker Endo's Bankruptcy," August 17, 2022, available at: https://portal.ct.gov/AG/Press-Releases/2022-Press-Releases/State-AGs-Reach-450-Million-Settlement-With-Endo [FN29] . 'Essilor Agrees to Pay $16.4 Million to Resolve Alleged False Claims Act Liability for Paying Kickbacks," August 23, 2022, available at: https:/Avww justice.gov/opa/pr/essilor-agrees-pay-164-million-resolve-alleged-false-claims-act-liability-paying-kickbacks [FN30] . "Biogen Inc. Agrees to Pay $900 Million to Settle Allegations Related to Improper Physician Payments," September 26, 2022, available at: https:/Awww justice.gov/opa/pr/biogen-inc-agrees-pay-900-million-settle-allegations-related-improper-physician-payments [FN31] . "Bayer to Pay $40 Million to Resolve the Alleged Use of Kickbacks and False Statements Relating to Three Drugs," September 2, 2022, available at: https:/Awww.justice.gov/opa/pr/bayer-pay-40-million-resolve-alleged-use-kickbacks-and-false-statements-relating- three-drugs [FN32] . 'Attomey General Reaches $40.5 Million Settlement with Johnson & Johnson To Settle Opioid Claims," September 1, 2022, available at: https:/Avww.doj.nh.gov/news/2022/2022901 -opioid-settlement.htm [FN33] . "Philips Subsidiary to Pay Over $24 Million for Alleged False Claims Caused by Respironics for Respiratory-Related Medical Equipment," September 1, 2022, available at: https:/Avww.justice.gov/opa/pr/philips-subsidiary-pay-over-24-million-alleged-false-claims- caused-respironics-respiratory [FN34] . 'Pharmacist Convicted for Health Care Fraud and Black-Market Prescription Drug Diversion Scheme," October 17, 2022, available at: https:/Avww justice.gov/opa/pr/pharmacist-convicted-health-care-fraud-and-black-market-prescription-drug-diversion-scheme [FN35] . 'Yonkers Doctor Pleads Guilty To Illegal Distribution Of More Than 100,000 Oxycodone Pills," October 19, 2022, available at: https:// www .justice.gov/usao-sdny/pr/yonkers-doctor-pleads-guilty-illegal-distribution-more-100000-oxycodone-pills [FN36] . "CVS Health reaches agreement in principle for global opioid settlement," November 2, 2022, available at: https:/Avww.cvshealth.com/ news-and-insights/press-releases/cvs-health-reaches-agreement-in-principle-for-global-opioid [FN37] . "Schaeffer White Paper Highlights Failures in Generic Drug Market That Cost Patients," May 31, 2022, available at: https:// healthpolicy.usc.edu/article/paper-highlights-failures-in-the-generic-drug-market-that-are-costing-patients/ [FN38] . "Governor Hochul Announces Completion of $8.6 Million Expansion of Pharmaceutical Plant in Tonawanda," September 19, 2022, available at: https:/Awww.governor.ny.gov/news/governor-hochul-announces-completion-86-million-expansion-pharmaceutical-plant- tonawanda Produced by Thomson Reuters Accelus Regulatory Intelligence 27-Jun-2023 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24-