Delaware, Reckitt Reach Suboxone Settlement

Multi-state settlement resolves allegations of improper marketing and sale of addictive withdrawal treatment

Attorney General Kathy Jennings announced today that Delaware and other states have reached an agreement with pharmaceutical distributor Reckitt Benckiser Group (“Reckitt”) to settle allegations that the company, either directly or through a subsidiary, improperly marketed and otherwise promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds.

Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.

“I’m grateful for the work that our Medicaid Fraud Control Unit does each day to protect consumers and ensure good stewardship of our tax dollars,” said Attorney General Jennings. “The opioid crisis has been one of the deadliest epidemics in Delaware history, and the challenges of recovery cannot be overstated. Appropriate medication can be a vital resource for people facing the considerable challenges of recovery, and we expect companies selling that medication to be fair and honest with consumers and Medicaid alike.”

Reckitt is an English public limited company headquartered in the United Kingdom. Until December 23, 2014, Reckitt’s wholly owned subsidiary Indivior Inc. (then known as Reckitt Benckiser Pharmaceuticals, Inc.) distributed, marketed, and sold Suboxone Sublingual Tablets and Suboxone Sublingual Film in the United States.

The civil settlement resolves allegations that, from 2010 through 2014, Reckitt directly or through its subsidiaries:

  1. Promoted the sale and use of Suboxone to physicians who were writing prescriptions for patients without any counseling or psychosocial support, for uses that were unsafe, ineffective, and medically unnecessary. These practices allegedly made Suboxone susceptible to diversion for uses that lacked a legitimate medical purpose.
  2. Falsely and misleadingly claimed that Suboxone Sublingual Film was less susceptible to diversion and abuse than other buprenorphine products, and that Suboxone Sublingual Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets;
  3. Fraudulently claimed in an FDA petition that it had discontinued manufacturing and selling Suboxone Sublingual Tablet “due to safety concerns” about the drug’s tablet formulation; and
  4. Fraudulently stifled generic competition for various forms of Suboxone in order to improperly control pricing, including pricing to federal health care programs.

Reckitt has agreed to pay a total of $700 million to resolve various civil fraud allegations impacting government health care programs, with $3.08 million going to Medicaid. Delaware’s share of $1.3 million will go to the Division of Medicaid and Medical Assistance within the Department of Health and Social Services.

A National Association of Medicaid Fraud Control Units (“NAMFCU”) Team participated in the investigation and in settlement negotiations. The Team included representatives from the Offices of the Attorneys General for the states of California, Indiana, New York, Ohio, Virginia, and Washington. Director Christina Kontis and Senior Auditor Ellen Yates of the Medicaid Fraud Control Unit handled this matter for Delaware.


Police Chief Pleads Guilty

Other defendants plea to gang activity, weapons, murder, rape, and theft charges

Michael Capriglione, Chief of police for the Town of Newport, has pled guilty to charges stemming from official misconduct. In May 2018, Capriglione ordered the deletion of a surveillance video, which depicted him striking another vehicle in the parking lot of Newport Police Department while driving a departmental vehicle. Capriglione pled guilty to Official Misconduct and Careless Driving and will be sentenced following a pre-sentence investigation by the Court. Deputy Attorney General Sonia Augusthy, director of the DOJ Office of Civil Rights and Public Trust, prosecuted the case, which was investigated by the Delaware State Police and Frank Robinson, on behalf of the DOJ.

An 18-year-old member of the Shoot to Kill (STK) gang pled guilty to gun and gang charges. Deputy Attorney General Mark Denney secured the plea from Chaz Cowan of New Castle to 3 counts of Possession of a Firearm by a Person Prohibited and 1 count each of Illegal Gang Participation, and Non-Compliance with Bond Conditions. In February 2018, Cowan, barred from having a gun because of a felony conviction of Possession of a Firearm by a Juvenile in 2015, appeared in a YouTube music video holding a gun. While out on bail in a few months later, Cowan violated a no contact order with co-defendants and cellular phones in November 2018 when police arrested him during a car stop. Police arrested Cowan again in January 2019 after a search warrant — conducted in response to a number of shootings — turned up firearms as well as pictures of Cowan holding at least two of them. A Superior Court judge immediately sentenced Cowan to 1 year in prison, followed by 6 months of either home confinement or work release, then 1 year of probation.

A man and woman have pled guilty to Murder by Abuse or Neglect First Degree in the 2018 beating death of 15-month-old Chosen Smith. Deputy Attorneys General Jim Kriner and Diana Dunn secured the pleas from Tameke Wright, 23 and Lavar Harris, 38, in Superior Court. The couple were babysitting the child in February 2018 when they drove the child to the hospital and reported that he had fallen off a futon. The child died minutes after arriving at the hospital. Upon examination, it was discovered that the child had abrasions and bruises all over his body as well as abusive head injuries, including a fractured skull. The Medical Examiner ruled the death a homicide as a result of blunt force trauma. Detective Devon Jones of the Wilmington Police Department arrested Wright and Harris the following week. Both defendants face a sentence of 15 years to life in prison when sentenced in June. DOJ paralegal Jayna Quillen and victim services specialist Bettina Jones also participated in the prosecution.

A 55-year-old Dover man is awaiting sentencing for raping a teenager. Tyrone Evans pled no contest in Superior Court to Rape Fourth Degree and Unlawful Sexual Contact Second Degree. In June 2018, Evans exposed himself to the teenager and began having sexual intercourse as the victim slept. A Superior Court judge will sentence Evans in March; there is no minimum prison time but the crimes carry as much as 18 years in prison. Deputy Attorney General Kathleen Dickerson prosecuted the case with assistance from Detective Dale Boney of the Dover Police Department, administrative assistant Penny Mannering, social worker Lorraine Freese, paralegal Sue Balik and investigator LaVincent Harris.

A nurse who worked at Brookdale Assisted Living Center in Hockessin has pled guilty to stealing from a resident of the facility. Deputy Attorney General Lisa Barchi of the DOJ Medicaid Fraud Control Unit (MFCU) secured the plea from Jennifer Wilson, 31, of Wilmington. In October 2018, Wilson went into a resident’s dresser drawer and took $180 and a credit card, which Wilson used to purchase a television. Wilson pled guilty in the Court of Common Pleas to Theft Under $1,500 and was immediately sentenced by a judge to 1 year of probation, ordered to pay $560.94 in restitution, and reported to the Adult Abuse Registry. Wilson was referred to the Division of Professional Regulation where disciplinary action on her nursing license is pending. Corporal Joshua Walther of the Delaware State Police investigated the case with assistance from MFCU chief special investigator Bruce Pinkett.


Prison Sentence for Man Who Beat Nephew With Pipe

Other defendants plead to rape, leaving the scene of a fatal accident, assault, and theft charges

Deputy Attorney General Anna Currier secured a prison sentence for a 60-year-old Wilmington man who pled guilty to beating his nephew with a metal pipe. After an argument, Mark Herring took a 2-foot-long pipe from the basement of a home he resided in along with his nephew, and repeatedly beat him as he slept, causing injuries including skull and facial fractures, as well as brain hemorrhages. In September 2018, Herring pled guilty to Assault First Degree and Possession of a Deadly Weapon During the Commission of a Felony. A Superior Court judge sentenced Herring to 5 years in prison, followed by 2 years of probation. DOJ social worker Jenn Kutney-Soper assisted with this case.

Deputy Attorney General Jenna Milecki secured a guilty plea from a Newark man whose sexual assault of a minor. In May 2017, Liberty Wiggins, 25, had consensual sex with a minor despite his being 24 at the time. Wiggins pled guilty to one count of Rape Fourth Degree and faces up to 15 years in prison when sentenced by a Superior Court judge in May. Wiggins will also have to register as a Tier 3 sex offender. Paralegal Jayna Quillen and social worker Claudia Melton assisted with the case.

A Superior Court judge sentenced a 22-year-old Seaford man for a hit and run accident that claimed the life of a young girl. Dwayne McConnell received an 18-month prison sentence, followed by one year of home confinement then 18 months of probation for the April 2018 accident. McConnell struck 9-year-old Germani Truitt-Handy as she crossed the street after checking her family’s mailbox along German Road in Seaford. In December 2018, McConnell pled guilty to Operation of a Motor Vehicle Causing Death and Leaving the Scene of a Fatal Car Accident. Deputy Attorney General Michael Tipton prosecuted the case.

Two former employees of a day program for adults with intellectual and developmental disabilities pled guilty to Crimes Against a Vulnerable Adult after an incident at the center in Millsboro. Witnessed by several people, in August 2018, Tomika West, 40, of Seaford, and Cherise Hazzard, 28, of Lincoln, restrained a client of the program by pulling her by the ponytail as she tried to leave. A Superior Court judge immediately sentenced both West and Hazzard to 6 months of probation. Both women will be placed on the state’s Adult Abuse Registry. Deputy Attorney General Christina Kontis of the Medicaid Fraud Control Unit prosecuted the case along with Chief Investigator Bruce Pinkett.

A woman and her daughter involved in a fraud scheme pled to charges of Falsifying Business Records and misdemeanor Theft by False Pretense. Medicaid Fraud Control Unit Deputy Attorney General Lisa Barchi secured the pleas from Anna Barnes, 54, and Ann Margaret Johnson, 37, both of Morrisville, PA. For about a year beginning October 2016, Johnson was registered as a Personal Care Attendant with Easter Seals of Delaware and Maryland’s Eastern Shore, allowing her to be paid to care for her mother, Barnes. In 2017, Barnes moved and became a permanent resident of Pennsylvania, and began receiving Pennsylvania Medicaid, but continued signing and submitting timesheets for care to Easter Seals in Delaware. Both women received a sentence of 6 months of probation and were ordered to make restitution to Easter Seals. Barnes, who pled no contest, must repay $1,500 and Johnson, who pled guilty, must repay $516. DOJ special investigator James Armstrong investigated the case with assistance from special investigator Paul Reutter.


Delaware Medicaid Program To Be Reimbursed Almost $900K for Overcharges on EpiPens

The Medicaid Fraud Control Unit of the Delaware Department of Justice will join the United States and other states to settle allegations against Mylan Inc. and its wholly-owned subsidiary, Mylan Specialty L.P. (collectively “Mylan”). The settlement will resolve allegations that Mylan knowingly underpaid rebates owed to the Medicaid program for the drugs EpiPen and EpiPen Jr. (“EpiPen”) dispensed to Medicaid beneficiaries. As part of the settlement, Delaware will receive $899,882 in restitution and other recovery, which will be returned to the Delaware Medicaid program.

The allegations against Mylan were that it was misstating the nature of its EpiPen drug and mischaracterizing the price at which it sold the EpiPen, in order to reduce the amount of rebates that it was required to pay state Medicaid programs.

“This settlement will relieve some of the budget pressure on the state’s Medicaid program in the coming year,” Attorney General Matt Denn said. “We will continue to expand our efforts to work with our law enforcement colleagues to ensure that people do not take advantage of the state’s largest health care program.”

Mylan Specialty owns the exclusive rights to sell EpiPen in the United States and possesses legal title to the New Drug Codes (“NDCs”) for EpiPen. The federal Medicaid Drug Rebate Statute requires participating pharmaceutical manufacturers or NDC holders, such as Mylan, to sign a Rebate Agreement with the Secretary of the United States Department of Health and Human Services as a precondition for obtaining Medicaid coverage for their drugs and to pay quarterly rebates to State Medicaid programs for drugs dispensed to Medicaid beneficiaries. NDC holders are required to provide information to CMS concerning their covered drugs. In particular, they have to advise CMS regarding the classification of a covered drug as an “innovator” or “noninnovator” drug, as the amount of rebates owed varies depending on the drug’s classification. The amount of the rebate also depends on pricing information provided by the manufacturer. For drugs classified as “innovator” drugs, NDC holders must report their “Best Price,” or the lowest price for which it sold a covered drug in a particular quarter.

Specifically, the settlement resolves allegations that from July 29, 2010 to March 31, 2017, Mylan submitted false statements to the Centers for Medicare and Medicaid Services (“CMS”) that incorrectly classified EpiPen as a “noninnovator multiple source” drug, as opposed to a “single source” or “innovator multiple source” drug. Mylan also did not report a Best Price to CMS for EpiPen, which it was required to do for all “single source” and “innovator multiple source” drugs. As a result, Mylan submitted or caused to be submitted false statements to CMS and/or the states relating to EpiPen for Medicaid rebate purposes, and underpaid its EpiPen rebates to the state Medicaid Programs.

Deputy Attorney General Tiphanie Miller and Senior Auditor Ellen Yates worked on the case for Delaware.

The investigation stemmed from two qui tam actions, United States ex rel. sanofi-aventis US LLC v. Mylan Inc., et al. (No. 16-cv-11572-ADB), and United States ex rel. Ven-A-Care of the Florida Keys, Inc. v. Mylan Inc., et al. (No. 17-10140-ADB), pending in the United States District Court for the District of Massachusetts. A qui tam case is one where an individual – known as a relator – claims to have specific knowledge of charges submitted for payment to the local, state or federal governments that are improper under federal or state False Claims Act laws; the federal, state or local government can either intervene in the action and participate with the relator as a plaintiff, or the state can decline to intervene and allow the plaintiff/relator to attempt to recover those losses on behalf of the state.

The total amount Mylan will pay to the United States and the individual states is $465 million.

Any Delawarean who suspects fraudulent billing or other fraud can report Medicaid Fraud by calling the Department of Justice Healthcare Provider Fraud Hotline at (302) 577-5000. Anonymous tips are accepted.


Former High School Employee Pleads Guilty to Sexual Solicitation of a Child

Also, Medicaid Fraud unit prosecutes two health care workers in separate cases.

The former athletic director at McKean High School in the Red Clay School District, Brian Budd, 34, of Columbus, NJ, has pled guilty to Sexual Solicitation of a Child. In July 2016, Budd solicited a 16-year-old student to allow him to engage in prohibited sexual acts. Budd faces up to 15 years in prison when sentenced in Superior Court later this year. Deputy Attorney General Jenna Milecki secured the plea.

Deputy Attorney General Matthew Frawley secured a 15-year prison sentence for 36-year-old Richard Ferry of New Castle for burglarizing a home in July 2016. Ferry broke into a home in the 700 block of Wildel Avenue in Minquadale and stole a firearm. Ferry pled guilty to Burglary Third Degree, Theft of a Firearm, and Possession of a Firearm by a Person Prohibited. Ferry is barred from having a gun because of several previous felony convictions including drug, burglary and identity theft charges. Due to the previous felony convictions, a Superior Court judge sentenced Ferry as a habitual offender on the firearm possession charge and sentenced him to a minimum mandatory 15 years in prison.

A second man involved in a March 2016 Wilmington shooting will spend 9 years in prison. In March 2016, Keenan Mitchell, 22, of Wilmington, was armed and displayed a weapon during an argument he initiated with another man, Michael Boyd, in the 600 block of Jefferson Street in Wilmington. During the course of the argument, Boyd retrieved a firearm from his girlfriend and he and Mitchell exchanged gunfire. Boyd’s girlfriend was struck in the arm as a result. Mitchell pled guilty in December to Assault First Degree and two counts of Possession of a Firearm During the Commission of a Felony. Mitchell was sentenced in Superior Court to 9 years in prison including the completion of the KEY-CREST Program. Deputy Attorney General Phillip Casale secured the sentence against Mitchell. The other man, Boyd, pled guilty in December to Possession of a Firearm by a Person Prohibited, and Possession of Ammunition by a Person Prohibited and was immediately sentenced to 5 years in prison, followed by 6 months of either home confinement or work release, then 18 months of probation.

James Norwalt, 35, Wilmington will go to prison for a home break-in. In August 2016, Norwalt forced his way into a home in the unit block of Gail Road in New Castle. When the woman inside forced him out, Norwalt damaged property by banging on the front door and broke the storm door. Norwalt also threatened to hit the victim and her father with a glass bottle. Norwalt pled guilty in Superior Court to Burglary Second Degree and Menacing in the case prosecuted by Marc Petrucci. Due to several previous felony convictions including assault, burglary, and conspiracy, Norwalt was declared a habitual offender and sentenced to 8 years in prison followed by 6 months of probation. Deputy Attorney General Christina Kontis secured a prison sentence

A 46-year-old Dover woman became the first person convicted for violating the Delaware Prescription Monitoring Act. Michele Staats, former nursing director of Kent Sussex Community Services, was found guilty after a five-day Superior Court bench trial of three felony counts of Unauthorized Access of Prescription Monitoring Information, and one felony count of Making a False Statement. For a 16-month period beginning in January of 2014, Staats, using the login credentials of her employer, accessed the Prescription Monitoring Program information of three people who were not her patients. Staats also made several false statements denying her responsibility to investigators. Established by the legislature in 2010, the goal of the Delaware Prescription Monitoring Act is to help reduce the misuse and diversion of controlled substances while promoting improved professional practice and patient care. Deputy Attorneys General Tiphanie Miller and Laura Najemy prosecuted the case for the DOJ Medicaid Fraud Control Unit.The case was primarily investigated by Agent Ray Hancock of the Delaware State Police Drug Diversion Unit, with assistance from Special Investigators James Armstrong and Patrick Corcoran of the MFCU. Staats will be sentenced in June.

A former personal care attendant with JEVS Human Services pled guilty in Superior Court in relation to improper billing for patient care. Jacqueline Pauls, 63, of Wilmington pled guilty to Misdemeanor Theft. The client Pauls cared for was hospitalized in September 2015, but Pauls continued to submit time sheets detailing work she said she performed for the client for the next seven weeks. Pauls was ordered to pay $1,505 in restitution, to have no contact with JEVS and was sentenced to one year of probation. Special Investigator Paul Reutter investigated the case and Deputy Attorney General Lisa Barchi secured the plea and sentence for the Medicaid Fraud Control Unit.