Archive

November 4, 2013

Johnson & Johnson agreed to pay more than $2.2B to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the FDA and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485M and civil settlements with the federal government and states totaling $1.72B. The allegations were first raised in a qui tam lawsuit filed under the whistleblower provisions of the False Claims Act. DOJ

October 17, 2013

Boston Scientific Corp. agreed to pay $30Mn to settle allegations that, between 2002 and 2005, its Guidant subsidiary knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients. The allegations were first raised in a qui tamlawsuit filed under the whistleblower provisions of the False Claims Act. DOJ

January 20, 2016

Pennsylvania announced a $450,000 consumer protection settlement with CVS Pharmacy, L.L.C. The settlement follows allegations the company violated a 2010 agreement in which it agreed to address concerns related to the sale of expired over the counter drugs, infant formula and dairy products. Agents allegedly reported finding expired products, including infant formula and drugs made for children, at five of the six CVS stores they visited. CVS employees in two cases also allegedly bypassed a register prompt that was designed to prohibit the sale of expired products. PA

January 19, 2016

New Jersey will receive a total of $2.7 million as a result of its participation in a global settlement with Qualitest Pharmaceuticals Inc. that resolves civil allegations the company mislabeled its multivitamin-with-fluoride tablets to indicate they were richer in fluoride than they actually were. Qualitest was the subject of a whistleblower lawsuit filed in 2013 by a Florida dentist who alleged that it unlawfully represented its multivitamin tablets as containing levels of fluoride recommended by the American Dental Association (ADA) when they did not. NJ

December 4, 2015

The New York Attorney General announced the arrest of two individuals for allegedly defrauding the state of more than $3 million. The indictment alleges that the individuals and related companies paid patients not to fill their HIV prescriptions and to forego receiving life-saving medications in return for side payments, as well as with dispensing to patients “diverted” medications obtained from unlicensed vendors. The parties then submitted false claims to Medicaid and the state AIDS Drugs Assistance Program (ADAP), claiming to have dispensed the medications to patients in accordance with state and federal law. NY

December 1, 2015

Athletic apparel company Tommie Copper, Inc. and its founder have agreed to pay $1.35 million to settle FTC charges that they deceptively advertised the company’s copper-infused compression clothing would relieve severe and chronic pain and inflammation caused by arthritis and other diseases. Tommie Copper’s proposed settlement with the FTC also requires the company and its founder and chairman Thomas Kallish to have competent and reliable scientific evidence before making future claims about pain relief, disease treatment, or health benefits. FTC

November 11, 2015

The FTC filed a lawsuit in federal court to stop a dietary supplement marketer from making misleading claims that its product can help treat and even cure people who are addicted to opiates, including prescription pain medications and illegal drugs such as heroin. According to the FTC’s complaint against Sunrise Nutraceuticals, LLC, the company, based in Boca Raton, Florida, deceptively claims that its dietary supplement Elimidrol, a “proprietary blend” of herbs and other compounds, alleviates opiate withdrawal symptoms and increases a user’s likelihood of overcoming opiate addiction. FTC

November 4, 2015

The federal government, District of Columbia, and 48 states, settled claims against AstraZeneca LP and Cephalon, Inc., for a total of $54 million. The settlement resolves allegations that AstraZeneca and Cephalon under-paid drug rebates owed to the states. Under the federal law known as the Medicaid Drug Rebate Program, drug manufacturers must periodically return a portion of the amount paid by state Medicaid programs for the manufacturers’ drugs. The rebate program is designed to ensure that states pay competitive prices for drugs, and is calculated based on a percentage of the average price drug wholesalers pay for the manufacturers’ drugs. This average price, which the manufacturer reports to the federal government, is known as the Average Manufacturer’s Price or “AMP.” The greater the AMP reported by the manufacturer, the greater the rebate the manufacturer must pay. NY; MA; NH

August 18, 2015

Pharmaceutical companies Concordia Pharmaceuticals Inc. and Par Pharmaceutical, Inc. have settled FTC charges that they entered into an unlawful agreement not to compete in the sale of generic versions of Kapvay, a prescription drug used to treat Attention Deficit Hyperactivity Disorder. As part of the settlement, the companies agreed not to enforce the anticompetitive provisions of their agreement, in which Concordia agreed not to sell an authorized generic version of Kapvay in exchange for a share of Par’s revenues. FTC

July 10, 2015

New York reached a $22.4 million settlement with the pharmacy Trinity Homecare LLC, primarily owned by Walgreen Co. The settlement relates to Synagis, an injectable drug for premature infants at risk for Respiratory Syncytial Virus (“RSV”). The drug can cost more than $2,000 per dose. Trinity had its staff try to sell Synagis by directly contacting the families of outpatient premature babies or their doctors, regardless of a patient’s need or if the baby’s current physician wanted it prescribed. According to allegations, initially lodged by a whistleblower hospital physician, Trinity staff improperly obtained babies’ names and other patient information from the hospital’s neo-natal intensive care unit logbooks. The whistleblower also alleged that Trinity misappropriated her name and medical license number on one alleged Synagis prescription for a baby she had never cared for. The Attorney General also conducted an audit and found that Trinity billed Medicaid when the pharmacy had no written prescription or when a purported prescription was invalid, including because it lacked a prescriber’s signature, patient’s name or a date. NY