The Federal Trade Commission (“FTC”) sent letters to several law firms and marketing companies, warning them that advertisements soliciting clients for personal injury lawsuits against pharmaceutical manufacturers “may misrepresent the risks associated with the treatment.” In addition, according to the FTC, the ads in question could give consumers the false impression that the drugs have been recalled or cause harm that outweighs their benefits, or constitute some kind of official alert that has been approved by the Food and Drug Administration (“FDA”).
The FTC has the authority to regulate attorney advertising and solicitation under the FTC Act, which prohibits “unfair or deceptive advertising by lawyers.” An additional provision of the FTC Act specifically prohibits “deceptive attorney advertising that has an effect on drug or device sales.” According to an FTC Policy Statement, an advertisement is deceptive “if it is likely to mislead consumers acting reasonably under the circumstances” and if it is material – that is, if the ad is likely to “affect the consumer’s conduct or decisions with regard to a product or service.” In performing this analysis, the FTC will consider the entirety of the ad as opposed to “isolated excerpts,” and “considers the net impression the ad conveys from the perspective of the audience to whom it is directed.”
The FTC letters were directed in particular to ads relating to the diabetes drugs Invokana, Invokamet, Jardiance and Farxiga. Other drugs mentioned in the letters include Abillify, Tasigna, Xarelto, Pradaxa and Nexium. For example, in reference to the diabetes drugs, one ad stated that they are linked to an increased risk of “toe, leg, and foot amputations,” as well as a form of gangrene, and ketoacidosis. The ad concludes with the statement that patients who suffer “serious” side effects after taking these drugs “may be entitled to a cash award.” The FTC notes that these claims may be deceptive as viewers may incorrectly conclude that the FDA has warned of a “substantial risk” of gangrene, when in fact, gangrene is actually a rare side effect. In addition, the FTC notes that the statement about amputation risk suggests that the “risks from taking these medicines outweigh their benefits.” However, the FTC cautioned that “[u]nless you have competent and reliable scientific evidence to support such claims, you should not make them.”
Following a review of the FDA’s Adverse Event Reporting System, the FTC notes that patient harm may have already occurred. Specifically, the FTC determined that the Reporting System “contains reports of consumers who viewed lawsuit ads about the prescribed drugs they were taking, discontinued those medications, and then suffered adverse consequences.”
The FTC concluded the letters strongly encouraging the review of the advertising in question “to ensure that it is not unfair or deceptive,” and further noted that the agency will continue to monitor the situation and “take follow-up action as warranted.” Should the violative ads continue, the FTC can seek a broad range of enforcement options, including imposing civil penalties and seeking injunctive relief.