Archive

December 8, 2016

New York and 41 other states announced a $19.5 million multistate agreement with Bristol-Myers Squibb (“BMS”) arising from alleged improper marketing and promotion of the drug Abilify. Abilify is one of several second-generation antipsychotic prescription drugs, commonly referred to as “atypical antipsychotics,” that were originally used to treat schizophrenia. New York alleged that BMS improperly promoted Abilify for pediatric use and for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease. In fact, in 2006, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. The complaint further alleged that BMS violated state consumer protection laws by misrepresenting and minimizing risks of the drug including metabolic and weight gain side effects and by misrepresenting the findings of scientific studies. NY, GA

November 21, 2016

Georgia 41 other states filed an amended antitrust lawsuit against the makers of Suboxone, a prescription drug used to treat opioid addiction, over allegations that the companies engaged in a scheme to block generic competitors and cause purchasers to pay artificially high prices. Reckitt Benckiser Pharmaceuticals, now known as Indivior, is accused of conspiring with MonoSol Rx to switch Suboxone from a tablet version to a film (that dissolves in the mouth) in order to prevent or delay generic alternatives and maintain monopoly profits. According to the lawsuit, when Reckitt introduced Suboxone in 2002 (in tablet form), it had exclusivity protection that lasted for seven years, meaning no generic version could enter the market during that time. Before that period ended, however, Reckitt worked with MonoSol Rx to create a new version of Suboxone – a dissolvable film, similar in size to a breath strip. Over time, Reckitt allegedly converted the market away from the tablet to the film through marketing, price adjustments, and other methods. GA

November 8, 2016

Niurka Fernandez and her son Roberto Alvarez were sentenced to 120 months and 30 months in prison, respectively, for their roles in spearheading a $9.5 million health care fraud conspiracy that targeted Medicare Part D.  In addition, Fernandez and Alvarez were ordered to pay respectively $9.5 million and $1.5 million in restitution and to forfeit the same amounts.  As part of her guilty plea, Fernandez admitted she co-owned and operated several pharmacies in the Miami area, including Calan Pharmacy & Discount Service LLC and Bertyann Corp. (doing business as Best Pharmacy), for the purpose of submitting false and fraudulent claims through Medicare Part D by paying kickbacks to Medicare beneficiaries and patient recruiters for prescriptions that were medically unnecessary.  DOJ

October 17, 2016

Ohio-based nursing home pharmacy Omnicare, Inc. agreed to pay roughly $28 million to resolve charges of violating the False Claims Act by soliciting and receiving kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promoting the prescription drug, Depakote, for nursing home patients.  The settlement follows the May 2012 settlement under which Abbott agreed to pay $1.5 billion to resolve Abbott’s liability under the False Claims Act for, among other things, alleged kickbacks to nursing home pharmacies, including Omnicare and PharMerica Corp.  In October 2015, PharMerica agreed to pay $9.25 million to settle its role in the alleged scheme.  The allegations underlying this settlement as well as the prior Abbott and PharMerica settlements originated in two whistleblower lawsuits filed 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 $3 million from the proceeds of this settlement.  Whistleblower Insider

October 13, 2016

Twenty-nine defendants who sold Auravie, Dellure, LéOR Skincare, and Miracle Face Kit branded skincare products have agreed to court orders with the FTC or had default orders entered against them. Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said “these defendants tricked people into paying for skin care products and abused the credit card system to extend their scheme.” The agency’s original complaint, filed in June 2015, charged seven individuals and 15 companies with selling their skincare products through false advertisements for “risk-free trials.” According to the FTC, the defendants convinced consumers to provide their credit card information, purportedly to pay nominal shipping fees. However, the defendants allegedly used consumers’ credit card information to impose unauthorized recurring monthly charges of up to $97.88 per month for unordered products. FTC

September 20, 2016

New York announced the sentencing of licensed pharmacist Glenn Schabel, 55, of Melville, and his company, Glenn Schabel, Inc. in connection with a nation-wide scheme to sell diverted HIV medication to unsuspecting New Yorkers. Schabel was sentenced to 2-6 years in prison, and forfeited $5,456,267 to the New York State Medicaid Program. This sentencing is part of the Attorney General’s Medicaid Fraud Control Unit’s (“MFCU”) “Operation Black-Market Meds” investigation. NY

September 14, 2016

Healthmark Investment Trust, partial owner of Florida-based compound pharmacy QMedRx, agreed to pay $7.75 million to resolve allegations QMedRx violated the False Claims Act by billing the federal healthcare programs for prescriptions tainted within the meaning of the Anti-Kickback Statute.  The government is still pursuing penalties and fines from other owners and participants within QMedRx.  DOJ (MDFL)

September 9, 2016

Dmitriy V. Melnik, the owner and operator of Candy Color Lenses, a major online retailer of colored contact lenses, pleaded guilty to importing counterfeit and misbranded contact lenses from suppliers in Asia and then selling them over the internet without a prescription to tens of thousands of customers around the country.  According to the plea agreement, Melnik imported large quantities of colored contact lenses from China and South Korea that he knew were counterfeit and/or unauthorized by the FDA and many of which bore labels with counterfeit trademarks for Ciba Vision FreshLook COLORBLENDS, which are manufactured by Novartis International AG.  Melnik admitted that some of the contact lenses he sold were contaminated with potentially hazardous bacteria.  DOJ

July 18, 2016

Bristol-Myers Squibb agreed to a $30 million settlement to resolve allegations of unlawful kickbacks to physicians in the marketing of Pravachol and other drugs.  The claims were made in a whistleblower suit filed under the California Insurance Frauds Prevention Act by three former Bristol-Myers sales representatives, who will receive a share of the settlement.  CA

July 15, 2016

A Minnesota federal court entered a permanent injunction against Kwong Tung Foods Inc. (dba Canton Foods) to prevent the distribution of adulterated noodles and sprouts.  The government charged the company with violating the Food, Drug and Cosmetic Act by preparing and packaging the company's food products under insanitary conditions.  DOJ