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Page 29 of 33

June 26, 2015

Charlie Chi, the former president and CEO of OtisMed Corporation, was sentenced to two years in prison and to pay a $75,000 fine for intentionally distributing a medical device used in knee replacement surgery after its application for marketing clearance had been rejected by the Food and Drug Administration.  In September 2014, OtisMed, now a subsidiary of Stryker Corporation, was sentenced to a criminal fine of $34.4 million and ordered to pay $5.16 million in criminal forfeiture for this conduct.  In a related civil settlement, OtisMed agreed to pay approximately $41.2 million to resolve its civil liability for submitting false claims to the Medicare, TRICARE, Federal Employees Health Benefits and Medicaid programs.  DOJ

May 20, 2015

Pharmacy benefits manager Medco Health Solutions Inc., a wholly-owned subsidiary of the pharmacy benefit manager Express Scripts Holding Company, agreed to pay $7.9 million to settle allegations it engaged in a kickback scheme in violation of the False Claims Act.  According to the government, Medco solicited remuneration from AstraZeneca in exchange for identifying Nexium as the “sole and exclusive” proton pump inhibitor on certain of Medco’s prescription drug lists known as formularies.  AstraZeneca allegedly compensated Medco in the form of reduced prices on the following AstraZeneca drugs: Prilosec, Toprol XL and Plendil.  In January 2015, the government reached a $7.9 million settlement with AstraZeneca to resolve kickback allegations arising out of the same conduct.  The allegations first arose in a whistleblower lawsuit filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle under the qui tam provisions of the False Claims Act.  They will receive a whistleblower reward from the recovery that has yet to be determined.  DOJ

May 14, 2015

PharMerica Corporation, an organization of long-term care pharmacies that dispense medications to residents of nursing homes and skilled nursing facilities across the country, agreed to pay $31.5 million to settle charges it violated the Controlled Substances Act by dispensing Schedule II controlled drugs without a valid prescription and violated the False Claims Act by submitting false claims to Medicare for these improperly dispensed drugs.  The government’s allegations against PharMerica arose out of whistleblower lawsuit brought by Jennifer Denk, a pharmacist formerly employed by PharMerica, under the qui tam provisions of the False Claims Act.  Ms. Denk will receive a whistleblower award of $4.3 million.  Whistleblower Insider

May 1, 2015

Accredo Health Group, a unit of Express Scripts Holding Co., agreed to pay $60 million to settle False Claims Act and Anti-Kickback Statute charges that the company participated in a kickback scheme with Novartis Pharmaceuticals Corp. involving the prescription drug Exjade.  According to the government, Novartis provided kickbacks, in the form of patient referrals and related benefits, to Accredo in exchange for Accredo recommending refills to Exjade patients.  The government also intervened in a whistleblower lawsuit against Novartis for the same alleged scheme.  The government claims defendants allegedly understated the serious and potentially life-threatening side effects of Exjade when promoting the drug’s benefits to patients. FBI

March 16, 2015

Los Angeles pharmacist Rouzbeh Javaherian pleaded guilty to defrauding the Medicare Part D program through his pharmacy called Emoonah Inc. (d/b/a Westaid Pharmacy and Medical Supply).  Specifically, he paid illegal cash kickbacks to Medicare beneficiaries to induce them to submit their prescriptions to Westaid and he submitted fraudulent claims to Medicare Part D plan sponsors for prescriptions he did not actually fill.  DOJ

March 10, 2015

Johnson & Johnson subsidiary McNeil-PPC Inc. pleaded guilty to selling adulterated infants’ and children’s over-the-counter liquid medicines, including Infants’ and Children’s Tylenol Motrin.  As part of the criminal resolution, McNeil agreed to pay a criminal fine of $20 million and forfeit $5 million.  DOJ

February 24, 2015

Louisiana oncologist Prabhjit S. Purewal agreed to pay $550,000 to settle allegations he defrauded Medicare, Tricare and Medicaid in violation of the False Claims Act by billing for chemotherapy drugs not approved by the FDA.  Dr. Purewal purchased the drugs from UK-based drug distributor Warwick Healthcare Solutions, Inc. (also known as Richard’s Pharma), which did not have a license to distribute drugs in the US.  DOJ

February 13, 2015

Illinois physician Dr. Michael J. Reinstein pleaded guilty to the crime of receiving illegal kickbacks and benefits totaling nearly $600,000 from pharmaceutical manufacturer Teva Pharmaceuticals USA Inc. and its subsidiary IVAX LLC in exchange for regularly prescribing the anti-psychotic drug clozapine to his patients.  Reinstein also agreed to pay $3.79M to settle a parallel civil lawsuit alleging he violated the False Claims Act for causing the submission of false claims to Medicare and Medicaid for the clozapine he prescribed for thousands of elderly and indigent patients in at least 30 Chicago-area nursing homes and other facilities.  In March 2014, Teva Pharmaceuticals and IVAX paid $27.6M million for their role in the kickback scheme. DOJ

February 11, 2015

Delaware-based pharmaceutical manufacturer AstraZeneca LP agreed to pay $7.9M to settle charges it violated the False Claims Act by engaging in an illegal kickback scheme with pharmacy benefit manager Medco Health Solutions.  The government alleged, among other things, that AstraZeneca agreed to provide remuneration to Medco in exchange for Medco maintaining for AstraZeneca’s Nexium drug “sole and exclusive” status on certain Medco formularies and through other marketing activities.  The charges originated with a whistleblower lawsuit filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle under the qui tam provisions of the False Claims Act.  They will collectively receive a whistleblower award of $1,422,000.  Whistleblower Insider

February 3, 2015

Medical device maker Atrium Medical Corporation, Maquet Holding B.V. & Co. KG, Maquet Cardiovascular LLC, and Maquet Cardiopulmonary AG were permanently enjoined from distributing adulterated and misbranded medical devices. According to the government, Atrium — which manufactures medical devices for cardiovascular-related uses, including chest drains, surgical meshes, vascular grafts and stent systems — was not complying with the FDA’s current good manufacturing practice requirements for medical devices which are designed to ensure the devices are safe and effective and otherwise in compliance with the federal Food, Drug and Cosmetic Act. DOJ
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