SUNNY SIDE CONSULTING, INC
AVENTURA, FLORIDA

Our marketing compliance consultants combine their knowledge of regulations in the medical devices or cosmetics industries best practices to provide sound and practical guidance and proofreading to make sure your marketing and communication meet FDA and FTC regulations. Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them. That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices. These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers. Read more ... Marketing compliance, what does this mean for your company? As enforcement rules get stricter, companies have no choice but to ensure that how and what they are communicating to consumers follows the letter of the law. But in today’s world where control over your marketing messages is not absolute, this is no easy task. Don’t wait for an impending event to make an investment in marketing compliance. Remember that it’s usually consumer complaints that trigger action from regulators. It’s easier and less expensive to get your house in order before the FDA, FTC, FCC or Attorney Generals come knocking. An audit from a regulator is extremely expensive and can be crippling to business growth. Investing upfront in Unapproved products related to the 2012/2013 flu Season   ract lawyers, making these companies targets for litigation on a massive scale. Through advertising, consumer fraud lawyers can amass hundreds or thousands of plaintiffs, providing a springboard for protracted and extremely costly class action litigation. Plaintiffs will allege that consumers were defrauded into purchasing the product because of illegal marketing claims and trumpet those same FDA warning letters as proof that the marketing claims were deceptive under state consumer fraud statutes. Plaintiffs in these cases often seek to recover not only the costs of the product, but also treble, punitive and other damages. The lawsuit, which seeks to certify a nationwide class with a Florida subclass, alleges that the structure/function claims identified in FDA’s warning letter misled the public into purchasing anti-aging products. The named plaintiff piles on, taking issue with products other than those specifically mentioned by FDA. The plaintiff alleges that because “defendants utilize the same marketing schemes and promises for the entire Lancôme anti-aging product line,” the “claims of deceptive and misleading advertising/marketing apply to Defendants’ entire Lancôme anti-aging product line.” The plaintiff seeks disgorgement of profits, restitution and injunctive relief. These companies were hit again on Nov. 5, 2012. See Kallen v. L’Oreal USA, Inc., Case No. 12-9479 (C.D. Cal.). This lawsuit seeks to represent a class of California consumers who allegedly purchased Lancôme’s products and were led to believe that “the products could prevent, reduce, or reverse the signs of aging, including by manipulating biological structures.” In addition to seeking restoration of the monies spent on the products, the plaintiffs seek an order compelling Lancôme to “conduct a corrective advertising campaign.” Avon was next. On Oct. 23, 2012, Avon was hit with a proposed nationwide class action (with a California subclass), alleging that it misrepresented its anti-aging products to consumers. See Trujillo v. Avon Products, Inc., Case No. 12-9084, (C.D. Cal). The plaintiff claims that Avon “disseminat[ed] false and misleading information via television commercials, Internet websites and postings, blast emails, radio media, blogs, video news, releases, advertisements, and the packaging” of the Anew product line, which induced her purchase of the products. The plaintiff seeks disgorgement of profits and restitution, injunctive relief and a corrective advertising campaign. Yet another proposed nationwide class action was filed against Avon in California federal court on Nov. 9, 2012. See Quinta v. Avon Products Inc., Case No. CV12-09629 (C.D. Cal.). Like its predecessor, this lawsuit seeks damages allegedly resulting from purchasers’ reliance on marketing claims regarding the Anew product line. The plaintiff claims that Avon aggressively sought to capitalize on the growing “baby boomer population” by defrauding consumers about the efficacy of its products. The number of lawsuits against cosmetic companies is likely to grow. Numerous plaintiffs’ firms are advertising on a national scale for consumer fraud cases. Sophisticated class action lawyers may also attempt to export this theory to products and companies not covered by FDA’s recent warning letters. Don’t wait for a violation to happen. We can help you contact us now !