CALIFORNIA: Class action against foreskin product for cancer risk

Foreskin product poses health risk

The Wall Street Journal
March 19, 2014

Hagens Berman: Pharmaceutical Company SkinMedica Selling Misbranded Drug Products as Cosmeceuticals

Consumers today filed a proposed class-action lawsuit against Allergan Inc. (NYSE:AGN) and its pharmaceutical company subsidiary, SkinMedica, claiming that the companies have misbranded and unlawfully marketed Tissue Nutrient Solution (TNS), a skin-care product line containing human growth factors obtained from human foreskin tissue which could increase the risk of cancer and pose other health risks, according to the complaint filed by Hagens Berman Sobol Shapiro LLC.

The lawsuit, filed by consumer-rights law firm Hagens Berman in the U.S. District Court for the Central District of California, claims that for at least the past four years, SkinMedica has failed to disclose significant safety concerns associated with TNS products while marketing the products without appropriate government approval, proper labeling, or adequate safety studies.

"A healthcare company's primary obligation must be to deliver products that are properly tested for safety, and meet all the appropriate regulatory requirements," said Steve Berman, attorney for the plaintiffs and managing partner of Seattle-based Hagens Berman. "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."

"We believe that in SkinMedica's zeal to market its skin care products, it created a serious health risk for those who used TNS products," Berman added.

According to the firm's investigation, SkinMedica's TNS products, which have been sold nationally through doctors' offices and retailers, contain a proprietary mix of "human growth factors" derived from human foreskin tissue. Human growth factors are intended to mobilize, stimulate, or otherwise alter the production of cells, including the ability to initiate cell division, which could stimulate growth of cancerous tumor cells, according to the complaint.

The suit alleges that in marketing their TNS products, Allergan and its subsidiary SkinMedica did not adequately disclose the health risks associated with these growth factors.

SkinMedica's TNS products -- which the company calls "cosmeceuticals" -- did not have government approval and could not be sold lawfully in the U.S. without such approval, something else the company did not disclose to consumers, according to the complaint. The suit alleges that because neither the U.S. Food and Drug Administration nor the California Department of Public Health found TNS products to be safe for their intended use, and because TNS products omit required disclosures relating to safety concerns, the products have been misbranded under both federal laws and parallel state laws.

The lawsuit is a proposed class action based upon California's consumer protection laws, and seeks to represent a class of all persons in the U.S. who purchased SkinMedica's TNS products during the last four years.

Concerned consumers are encouraged to contact Hagens Berman by emailing SkinMedica@hbsslaw.com or calling 206-623-7292.
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