51 Attorneys General Reach Consumer Protection Settlement with Boehringer Ingelheim Pharmaceuticals, Inc. Concerning Off-Label Promotion of Four Prescription Drugs

Delaware and the attorneys general of 49 other states and the District of Columbia have reached a settlement with Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”) regarding alleged off-label marketing and deceptive and misleading representations made in BIPI’s promotion of four of its prescription drugs: Micardis®, Aggrenox®, Atrovent®, and Combivent®.

The settlement resolves allegations that BIPI engaged in a course of trade or commerce that constitutes unfair, deceptive, or misleading practices, by making misrepresentations about the above-mentioned prescription drugs and by representing that the prescription drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that they did not have.

Specifically, the States allege BIPI: (1) misrepresented that its antiplatelet drug, Aggrenox®, was effective for many conditions “below the neck,” such as heart attacks and congestive heart failure, and that it was superior to Plavix® without evidence to substantiate that claim; (2) misrepresented that Micardis® protected patients from early morning strokes and heart attacks and treated metabolic syndrome; (3) misrepresented that Combivent® could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); and (4) falsely stated that Atrovent® and Combivent® could be used at doses that exceeded the maximum dosage recommendation in the product labeling and that they were essential for treatment of COPD.

The settlement requires BIPI to ensure that its marketing and promotional practices do not unlawfully promote these prescription drug products. Specifically, BIPI will:

  • Limit product sampling of the four drugs to health care providers whose clinical practice is consistent with the product labeling;
  • Refrain from offering financial incentives for sales that may indicate off-label use of any of the four drugs;
  • Ensure clinically relevant information is provided in an unbiased manner that is distinct from promotional materials; and
  • Provide that requests for off-label information regarding any of the four drugs are referred to BIPI’s Medical Division.

The settlement also requires BIPI to make payments to the states and the District Columbia that brought the case. For Delaware, about $137,000 will go into the state’s Consumer Protection Fund, which pays for the Delaware Department of Justice’s work on consumer fraud and deceptive trade practice matters and other consumer-oriented investigations and legal actions.

Deputy Attorney General Gina Schoenberg led Delaware’s efforts on this matter, with assistance from Consumer Protection Director Christian Douglas Wright and Deputy Attorney General James Vadakin.

Leader of Downstate Organized Crime Enterprise Convicted Of Two Murders

Also, Wilmington man faces life in prison after murder conviction; Former nonprofit executive sentenced to prison for stealing donations

Steven Kellam, the leader of a violent crime network that operated in Sussex and Kent counties, was convicted on several felony charges including 2 counts of Murder First Degree, and will spend the rest of his life in prison when sentenced later this year. A Superior Court jury convicted Kellam, 37, of Seaford, on charges of 2 counts of Murder First Degree, 1 count of Organized Crime and Racketeering, 27 counts of Possession of a Firearm During the Commission of a Felony, 3 counts of Conspiracy Second Degree, 1 count of Conspiracy First Degree, 3 counts of Home Invasion, 2 counts of Robbery First Degree, 2 counts of Assault Second Degree, 1 count of Assault Third Degree, 2 counts of Attempted Robbery First Degree, and 1 count of Wearing a Disguise During the Commission of a Felony. In addition to several other crimes, Kellam along with Richard Robinson, Rhamir Waples, Shamir Stratton and Carlton Gibbs were found to be involved in a January 2014 home invasion robbery on Harmon’s Hill Road in Millsboro, during which Cletis Nelson and William Hopkins were shot and killed. The criminal enterprise was brought down in the summer of 2015 by a joint investigation by the Delaware State Police and the Delaware Department of Justice, called Operation “In the House.” Kellam’s case was the last to be resolved of those involved in the January 2014 incident. In addition to Kellam’s conviction:

  • Richard Robinson pled guilty in December 2016 to Murder Second Degree, Organized Crime and Racketeering, 2 counts of Possession of a Firearm During the Commission of a Felony, 1 count of Conspiracy First Degree, and 1 count of Burglary First Degree.
  • Rhamir Waples was convicted by a jury in March 2017 of 2 counts of Murder First Degree, 15 counts of Possession of a Firearm During the Commission of a Felony, 1 count of Home Invasion, 2 counts of Robbery First Degree, and 1 count of Conspiracy Second Degree.
  • Shamir Stratton pled guilty in December 2016 to Home Invasion, Possession of a Firearm During the Commission of a Felony, Robbery First Degree, and Conspiracy Second Degree.
  • Carlton Gibbs pled guilty in May 2017 to Robbery Second Degree.

Deputy Attorneys General Chris Hutchison and Martin Cosgrove prosecuted the case. The original release with details on Operation “In The House” can be found here. Department of Justice has worked with Delaware State Police and other agencies over the past few years in bringing down similar criminal enterprises as part of other joint investigations including: “Operation Golden Horseshoe” in August 2017 related to a drug trafficking operation in Sussex County; Operation Duck Hunt” in May 2016 involving heroin trafficking and money laundering in Kent and Sussex counties; and “Operation Son Sun” which resulted in guilty adjudications for all 46 defendants tied to Delaware’s largest heroin trafficking organization. DOJ prosecutors have also successfully prosecuted multiple members of the Touch Money Gang (TMG), Only My Brothers (OMB) and the Shoot to Kill (STK) criminal gangs.

A 40-year-old Wilmington man will spend the rest of his life in prison for the 2015 fatal shooting of another man in the city. A Superior Court jury convicted Damian Thomas of Murder First Degree, Possession of a Firearm During the Commission of a Felony, Possession of a Firearm by a Person Prohibited, and Carrying a Concealed Deadly Weapon. In April 2015, 38-year-old Deshannon Reid was on the phone while sitting with his mother on his porch in the unit block of West 27th Street when Thomas came up and tried to talk to him. The two men argued when Reid told Thomas to leave him alone, prompting Thomas get a gun from a nearby apartment, return, and use it shoot Reid. Thomas fled after the shooting and was arrested in Cherry Hill, New Jersey in July 2016. A judge will sentence Thomas to life in prison in November. Deputy Attorneys General Annemarie Puit and Eric Zubrow prosecuted the case, with assistance from social worker Donna Lindsey, investigator John Ciritella, paralegals Stacey Coupe and Jamie Prater, and administrative specialist Evelyn Davis.

Eric Harris, the former executive director of Sojourners’ Place in Wilmington, will spend 7 years in prison for stealing from the non-profit organization. The 51-year-old Harris pled guilty in Superior Court in April 2017 to Theft over $100,000, Act of Intimidation, and Forgery Second Degree. Starting in fall 2013, Harris began stealing donation checks sent to Sojourners Place totaling $189,947, depositing them into a bank account he had set up in the charity’s name without its authorization. Harris then withdrew those funds as cash or charged the account for personal expenses. A Superior Court judge sentenced Harris to a total of 35 years in prison, of which he will serve 7 years, followed by 6 months of either home confinement or work release, then 1 year of probation. Harris was ordered to have no contact with Sojourners’ Place or its employees, and not to handle any funds for any future employer. Harris must also pay restitution to Sojourners’ Place and its insurance carrier. During the sentencing hearing, the judge expressed the magnitude of the impact that this economic crime had on the community, and the good, charitable work done by Sojourners’ Place. Deputy Attorneys General Stephen McDonald and Thomas Brown of the DOJ Consumer Protection Unit prosecuted the case. Detective Michael Hayman of the Wilmington Police led the criminal investigation.

Deputy Attorney General Jenna Milecki secured a prison sentence for a 33-year-old Middletown man who sexually abused a child. Daniel Alvarez pled guilty in July to one count of Rape Third Degree and one count of Attempted Unlawful Sexual Contact First Degree in connection with his repeated abuse of a child throughout 2014. A Superior Court judge sentenced Alvarez to 11 years in prison, followed by 6 months of either home confinement or work release, then 4 years of probation. Alvarez must also register as a Tier 3 sex offender. DOJ social worker Claudia Melton assisted with the case.

A 34-year-old New Castle man will face at least 10 years in prison for raping a child. Gemiyale Adkins pled guilty to one count of Rape Second Degree and one count of Rape Fourth Degree in Superior Court. During the late summer of 2016, Adkins sexually assaulted a young child. When sentenced by a Superior Court judge in November, Adkins faces a minimum mandatory prison sentence of 10 years, and will be required to register as a Tier 3 sex offender. Deputy Attorney General Jenna Milecki prosecuted the case with assistance from social worker Claudia Melton.

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.

Attorney General Denn Confirms Delaware’s Involvement In Ongoing National Opioid Investigation and Begins Steps for Independent State Investigation

In response to a Wall Street Journal article describing a national coalition of Attorneys General investigating whether manufacturers have engaged in unlawful or deceptive practices in the marketing and sale of opioids, Attorney General Denn confirmed Thursday that the Delaware Department of Justice is actively participating in this investigation.

Attorney General Denn also announced that his office will issue an invitation to private law firms to submit competitive bids to be appointed as special counsel for the Department of Justice to conduct further investigation regarding opioid manufacturers for violation of Delaware state law in the sale and marketing of opioids. The detailed Request for Proposal requires that the work be done on a contingency fee basis so it would not involve the use of state funds.

The national coalition of Attorneys General is examining what role manufacturers of opioid drugs may have played in creating or prolonging the nation’s opioid epidemic. The coalition of Attorneys General is using its investigative tools, including subpoenas for documents and testimony, to determine the appropriate course of action. The national coalition of state Attorneys General is not disclosing the specific companies that are the current subjects of its investigation, which has been underway for some time.

The Request for Proposal for private firms to investigate possible claims may result, if the facts and law provided a legal basis, in a separate lawsuit brought by and in Delaware. The RFP contains detailed provisions to ensure fairness, competitiveness, and transparency in the retention of a law firm, and appropriate state control over any decision to initiate litigation and the conduct of any litigation that is initiated. The RFP is expected to be posted at bids.delaware.gov and attorneygeneral.delaware.gov by the end of next week.

“These efforts to hold manufacturers of opioids financially responsible where the law allows are an important part of our overall effort to improve prevention and treatment of substance abuse,” Attorney General Denn said. “If our investigations reveal that the manufacturers of these products violated Delaware law, we will seek to have them help pay for the fight to end the epidemic.”

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.