Defective Products

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 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 6, 2016

New Jersey-based Pharmaceutical Innovations Inc. pleaded guilty to criminal charges and resolved a civil lawsuit arising from the company’s distribution of ultrasound gel contaminated with bacteria.  In addition to placing the company on two years probation, the court ordered the company to pay a criminal fine of $50,000 and to forfeit an additional $50,000 – the approximate value of the adulterated gel.  DOJ

July 6, 2016

The U.S. District Court for the Southern District of Alabama entered a consent decree of permanent injunction against BEK Catering LLC (dba Floppers Foods LLC) to prevent the distribution of adulterated and misbranded seafood products.  DOJ

June 6, 2016

Genentech Inc. and OSI Pharmaceuticals LLC agreed to pay $67 million to resolve charges they violated federal and state False Claims Act by making misleading statements about the effectiveness of the cancer drug Tarceva.  According to the government, Genentech and OSI made misleading representations to physicians and other health care providers about the effectiveness of Tarceva when there was little evidence to show that Tarceva was effective to treat those patients unless they also (i) had never smoked or (ii) had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.  The allegations originated in a whistleblower lawsuit filed by former Genentech employee Brian Shields under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of approximately $10 million out of the proceeds of the government’s recovery.  Whistleblower Insider GA, MA, OH

December 16, 2015

Qualitest Pharmaceuticals, the company’s corporate shell, Vintage Pharmaceuticals, its parent Endo Pharmaceuticals, and seven of their affiliates, agreed to pay $39 million to 48 states and the federal government to settle charges they violated federal and state False Claims Acts by selling understrength chewable fluoride tablets.  As part of the settlement, Qualitest admitted the drug labeling for its chewable fluoride tablets represented fluoride amounts in line with guidelines of the American Dental Association and the American Academy of Pediatrics when in reality it used less than half of these represented amounts.  The allegations were first raised in a whistleblower lawsuit brought Dr. Stephan Porter under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of roughly $4.71 million from the proceeds of the government’s recovery.  Whistleblower Insider, NY, NH

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

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