New York, NY: Allergan Inc' subsidiary SkinMedica Inc, is facing a dangerous drugs class action lawsuit alleging the cosmeceutical company withheld information from consumers regarding its anti-aging creams that contain human foreskin cells, specifically that these creams pose a risk for cancer.
Filed by plaintiff Josette Ruhnke, the complaint alleges that the sale of SkinMedica Inc.' line of "Tissue Nutrient Solution"(TNS) products containing the compound "NouriCel"is illegal, because the products haven't received approval from the U.S. Food and Drug Administration. U.S. District Judge David O. Carter ruled the case can go forward.
According to the complaint, TNS products are marketed for "skin rejuvenation"purposes. However, they contain a proprietary mix of human growth factors that originate from human foreskin tissue. The products are trademarked as NouriCel. The TNS creams have the ability to initiate cell division, which, according to Ruhnke' complaint, are thought to contribute to the growth of tumor cells or other abnormalities.
The complaint, filed in 2013, also claims that, in addition to lacking FDA approval, SkinMedica had not performed required controlled safety studies before marketing TNS products. Judge Carter rejected arguments from SkinMedica that TNS products aren't drugs under the Federal Food, Drug and Cosmetic Act because the growth factors they contain are "naturally occurring."
"kinMedica promotes TNS Products as 'cosmeceuticals' containing a mix of endogenous 'growth factors' for skin rejuvenation. The term 'cosmeceutical' conveys that a product is both a cosmetic and pharmaceutical,"Judge Carter wrote. "A product which occurs naturally or is derived from natural ingredients is capable of regulation as a drug."
Additionally, Judge Carter noted that the creator of NouriCel has stated that more double-blind and controlled studies are needed to confirm the preliminary clinical effects of growth factor products. Judge Carter also cited the fact that the complaint stated that the two FDA-approved products on the market containing human growth factors provide prominent safety warnings the TNS products lack.
"The thrust of defendants' argument is essentially that the evidence does not support plaintiff' claim,"Judge Carter wrote. "Plaintiff' allegations, taken as true, suggest that there are serious safety concerns associated with TNS Products."
Ruhnke is represented by Lee M. Gordon and Steve W. Berman of Hagens Berman Sobol Shapiro LLP.
