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October 29, 2015

Warner Chilcott US Sales LLC, a subsidiary of pharmaceutical manufacturer Warner Chilcott PLC, agreed to plead guilty to a felony charge of health care fraud as part of a global settlement in which Warner Chilcott agreed to pay $125 million to resolve its criminal and civil liability arising from illegally marketing the drugs Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace and Loestrin in violation of the False Claims Act and Anti-Kickback Statute.  Specifically, the government charged that between 2009 and 2013, Warner Chilcott paid physicians to induce them to prescribe Warner Chilcott drugs.  The government also alleged that Warner Chilcott employees submitted false or misleading prior authorization requests and other coverage requests to federal health care programs for the osteoporosis medications Atelvia and Actonel.  The government further claimed that Warner Chilcott employees were instructed by members of the company’s management team to make unsubstantiated superiority claims when marketing the drug Actonel.  The allegations first arose in a whistleblower lawsuit by two former Warner Chilcott sales representatives filed under the qui tam provisions of the False Claims Act.  The whistleblowers will receive a whistleblower award of approximately $22.9 million from the federal share of the civil recovery.  Whistleblower Insider

October 8, 2015

Evelio Fernandez Penaranda, owner of Miami-based Naranja Pharmacy Inc., was sentenced to 46 months in prison and to pay $1,876,241 in restitution for his role in the submission of more than $1.8 million in fraudulent claims to Medicare.  According to his guilty plea, Naranja Pharmacy submitted fraudulent claims to Medicare for prescription drugs not prescribed by physicians, not medically necessary and not provided to Medicare beneficiaries. DOJ

October 7, 2015

Kentucky-based nursing home pharmacy PharMerica Corp. agreed to pay $9.25 million to resolve allegations it violated the False Claims Act by soliciting and receiving kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promoting the anti-epileptic prescription drug Depakote for nursing home patients.  The settlement is part of the continuing fallout of the $1.5 billion settlement Abbott entered into with the government in May 2012 to resolve Abbott’s liability under the False Claims Act for alleged kickbacks to nursing home pharmacies, including PharMerica.  The settlement partially resolves allegations raised in two whistleblower lawsuits brought by former Abbott employees Richard Spetter and Meredith McCoyd under the qui tam provisions of the False Claims Act.  Ms. McCoyd will receive a whistleblower award of $1 million from the federal share of the settlement amount. Whistleblower Insider

September 3, 2015

Genzyme Corporation, a wholly-owned biotechnology subsidiary of French pharmaceutical company Sanofi, agreed to resolve criminal charges it violated the Food, Drug and Cosmetic Act with regard to the unlawful distribution of the surgical device Seprafilm.  As part of the agreement, Genzyme agreed to admit to the facts underlying the charges and pay a monetary penalty of $32,587,439.  Whistleblower Insider

September 1, 2015

Discount department store chain KMART Corp., which operates approximately 780 in-store pharmacies throughout the US, agreed to pay $1.4 million to resolve allegations it violated the False Claims Act by using drug manufacturer coupons and gasoline discounts as improper Medicare beneficiary inducements.  According to the government, Kmart improperly influenced the decisions of Medicare beneficiaries to bring their prescriptions to Kmart pharmacies by permitting them to use drug manufacturer coupons to reduce or eliminate prescription co-pays that they otherwise would be obligated to pay, and by also offering them varying levels of discounts on the purchase of gasoline at participating gas stations.  The allegations originated in a whistleblower lawsuit filed by former Kmart pharmacist Joshua Leighr under the qui tam provisions of the False Claims Act.  Leighr will receive a whistleblower award of approximately $248,500.  DOJ

August 7, 2015

Tamara Esponda, owner of Miami-based Biomax Pharmacy, pleaded guilty to submitting almost $1.6 million in fraudulent claims to Medicare.  Specifically, Esponda admitted that Biomax Pharmacy submitted fraudulent claims to Medicare for prescription drugs not prescribed by physicians, not medically necessary, not purchased by Biomax Pharmacy and not provided to Medicare beneficiaries.  DOJ

August 3, 2015

Rouzbeh Javaherian, owner of Los Angeles-based Westaid Pharmacy and Medical Supply, was sentenced to 18 months in prison and to pay $644,060 in restitution for his role in a fraud scheme involving the Medicare Part D prescription drug program.  Specifically, Javaherian paid illegal cash kickbacks to Medicare beneficiaries to induce them to submit their prescriptions to Westaid.  Javaherian then filled some of those prescriptions, but also submitted false claims to Medicare Part D plan sponsors for prescriptions that he did not actually fill.  DOJ

July 24, 2015

California oncologist Dr. Neelesh Bangalore has paid $736,000 to settle allegations that he improperly billed Medicare, Medicaid, and Tricare for certain chemotherapy drugs purchased from an unlicensed foreign pharmaceutical distributor, Warwick Healthcare Solutions Inc., also known as Richards Pharma, a former United Kingdom-based drug distributer that did not have a license to distribute drugs in the United States.  DOJ

July 23, 2015

Evelio Fernandez Penaranda, owner of Miami-area pharmacy Naranja Pharmacy Inc., pleaded guilty for his role in the submission of more than $1.8 million in fraudulent claims to Medicare.  Specifically, Penaranda admitted submitting fraudulent claims to Medicare for prescription drugs not prescribed by physicians, not medically necessary and not provided to Medicare beneficiaries.  DOJ

July 1, 2015

The U.S. District Court for the District of New Jersey entered a consent decree of permanent injunction against Acino Products LLC and its president, Ravi Deshpande, to prevent the distribution of unapproved and misbranded drugs.  Specifically, the injunction involves hydrocortisone acetate suppositories under the brand names Rectacort-HC and GRx HiCort 25 and government charges these suppositories are not approved by the FDA and are misbranded because they do not bear adequate directions for use as required by law.  DOJ
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