News Feature | March 21, 2014

Consumers Claim SkinMedica Misbranding Drugs As "Cosmeceuticals"

By Liisa Vexler

SkinMedica and its parent company Allergan Inc. are the defendants in a proposed class action lawsuit filed by consumers claiming that the company has misbranded and mismarketed its line of Tissue Nutrient Solution (TNS) products as cosmeceuticals rather drug products. The line of skincare products contains human growth factors harvested from the tissue of human foreskins. The law firm representing the plaintiff group, Hagens Berman Sobol Shapiro LLC, claims that these ingredients have been shown to increase cancer risk and other health risks in some populations.

There are two main complaints in the lawsuit filed in U.S. District Court for the Central District of California. The plaintiffs indicate that over the course of at least four years, SkinMedica, has marketed its TNS product without obligatory government approvals, labeling, or adequate clinical data for safety. The lawsuit also claims that the company did not disclose the safety concerns related to its TNS product.

Steve Berman, a managing partner at Hagens Berman, noted, “A healthcare company’s primary obligation must be to deliver products that are properly tested for safety, and meet all the appropriate regulatory requirements. In this case, we intend to show that SkinMedica and Allergan skirted laws that required them to disclose the significant safety concerns at issue and the lack of regulatory approval.”

Investigators for the law firm found that SkinMedica’s TNS products contain human growth factors obtained from the tissue of human foreskins. The lawsuit indicates that human growth factors are known to engage, stimulate, or change cell production. This includes changing the way cells initiate division, thus potentially stimulating cancer tumor cell growth. These risks were not adequately communicated to consumers, according to the lawsuit.

Since neither the FDA or the California Department of Public Health approved the TNS products for use, nor did SkinMedica disclose the risks associated with the human growth factors contained in the products, the line of products are misbranded according to federal and state law consumer protection laws.

The proposed lawsuit is a class action open to anyone who purchased the TNS products within the last four years. For more information, consumers can contact Hagens Berman at SkinMedica@hbsslaw.com or 206-623-7292.