New Litigation Risks Possible From Pending Allergan V. Athena Case
This article was originally published in The Rose Sheet
Lower court decisions identifying Athena Cosmetics, Inc.'s RevitaLash products as unapproved drugs that compete unfairly against Allergan's Latisse drug could have broader legal implications for the cosmetics industry if the Supreme Court denies the firm's request for review. Already beleaguered by false-advertising class actions on the tails of FDA warning letters, firms could be at further risk of being hit with opportunistic lawsuits if it's left to federal courts to determine products' intended use and regulatory status.
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FDA cites Reviva for unapproved drug claims on eight of its products marketed as cosmetics. Included among targeted claims are familiar statements about collagen production, inflammation reduction and other benefits the agency views as structure/function effects. A number of the claims onceivably could be allowed under the revised "cosmetic" definition proposed by the Cosmetic Modernization Amendments of 2015.
Companies targeted with class actions should avail themselves of every opportunity to contest plaintiff claims throughout the process, attorneys emphasized in a recent Council for Responsible Nutrition webinar. Fear of having to pay out exorbitant damages often compels firms to settle when they may have other options, they suggested, urging companies to consider "the long view."
Following the recommendation of Solicitor General Donald Verrilli, the Supreme Court has declined to review Allergan v. Athena Cosmetics, a case examining if the Federal Food, Drug and Cosmetic Act preempts an unfair competition claim in California characterizing Athena's RevitaLash products as unapproved drugs. Athena predicts a "torrent of novel and disruptive litigation" could ensue.