SkinMedica TNS Advanced Serum Lawsuit: Claims and Outcome

The SkinMedica TNS lawsuit was a 2014 California class action alleging that SkinMedica and its parent company Allergan sold TNS skin care products containing human growth factors that could pose cancer risks and were illegally marketed as cosmetics rather than FDA-approved drugs. Filed in the U.S. District Court for the Central District of California as Ruhnke et al. v. SkinMedica, Inc. and Allergan, Inc., the case ran for nearly four years before ending in a private settlement in early 2018.¹² No class was ever certified, and the settlement terms were not made public.

The Products at the Center of the Case

SkinMedica sold a line of moisturizers, eye creams, body lotions, and serums under the “Tissue Nutrient System,” or TNS, brand. Their signature ingredient was a proprietary blend called NouriCel-MD, made of human growth factors derived from a line of dermal fibroblasts that originated in neonatal foreskin tissue.¹ SkinMedica described these growth factors as proteins that regulate cellular growth and skin cell activity. Allergan acquired SkinMedica in December 2012, and the TNS line became part of one of the world’s largest medical aesthetics companies.

What the Plaintiffs Alleged

Josette Ruhnke filed the complaint on March 19, 2014, represented by attorney Lee M. Gordon of Hagens Berman Sobol Shapiro. The proposed class covered consumers who had bought TNS products in the four years before filing, and the suit sought punitive damages and an injunction barring further sales without full safety disclosures.¹³

Cancer and Safety Risk Claims

The complaint argued that growth factors are believed to contribute to the growth of tumor cells or other abnormalities because their core function is to mobilize, stimulate, and initiate cell division.¹ An amended complaint specifically identified KGF-1, a growth factor in TNS products, as being linked to certain cancers including breast cancer.⁴

The plaintiffs drew a comparison with REGRANEX Gel, an FDA-approved topical product containing a growth factor that carries a “black box warning” about increased mortality related to malignancy. Their argument: if an approved growth factor product requires that kind of warning, TNS products should not be sold with no comparable disclosure, particularly since the FDA had never evaluated them for safety.⁴ The complaint did not point to reported cases of TNS users developing cancer; its cancer allegations rested on the biology of growth factors and the analogy to REGRANEX.

Misbranding as Cosmetics Rather Than Drugs

The second major line of attack was regulatory. Under federal and California law, a product intended to affect the structure or function of the body is a drug. Because the growth factors in TNS products were designed to alter cell production and initiate cell division in the skin, the plaintiffs argued they met that definition and should have gone through FDA drug approval.⁴ The complaint went further, suggesting that because the growth factors were proteins derived from human sources and isolated through biotechnology, the products might qualify as “biologics” requiring a Biologics License Application.

SkinMedica’s own stated position, according to the complaint, was that its products were “intended to meet the FDA’s definition of cosmetic products but are not intended to be drug products.”⁴ The plaintiffs said SkinMedica marketed the products as “cosmeceuticals,” a term implying both cosmetic and pharmaceutical properties, while simultaneously claiming no drug approval was needed.

Undisclosed Ingredients

The amended complaint also alleged that TNS products contained additional biological ingredients not disclosed to consumers, including bovine albumin derived from cow blood, cytokines, matrix proteins, and soluble collagen.⁴ The plaintiffs said the labels failed to identify the relative amounts of growth factors or these ingredients, and that the products lacked the required warning: “WARNING—THE SAFETY OF THIS PRODUCT HAS NOT BEEN DETERMINED.”

Legal Claims

The complaint pleaded five causes of action under California law:

Violations of the Sherman Food, Drug, and Cosmetics Law, for selling unapproved, misbranded, and falsely labeled drug products.
Unfair competition, under Business and Professions Code sections 17200 and following.
Violations of the Consumers Legal Remedies Act, under Civil Code sections 1750 and following.
False advertising, under Business and Professions Code sections 17500 and following.
Deceit, under Civil Code sections 1709–1710.⁴

Steve Berman, the managing partner at Hagens Berman, said at the time of filing that the firm intended “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.”³

How the Case Ended

The case moved slowly. SkinMedica moved to dismiss in June 2014, the plaintiffs filed an amended complaint in February 2015, and in May 2015 the court stayed the case pending a Ninth Circuit appeal in Jones v. ConAgra Foods, Inc. that was expected to clarify class certification standards. The Jones appeal was voluntarily dismissed in August 2017, and the Ruhnke stay was lifted.⁵

The ending itself is described slightly differently by the two available sources. Court records tracked by Truth in Advertising show the action was “voluntarily dismissed with prejudice” in January 2018, with the reasons undisclosed.⁵ Allergan’s own reporting, as noted by Mealey’s Litigation Report, stated that the company and SkinMedica settled the “purported class action lawsuit” on February 16, 2018, “ahead of class motion.”² Those accounts fit a common pattern in class action litigation: the parties reach a private settlement, and the plaintiff then voluntarily dismisses the case with prejudice, meaning it cannot be refiled. The settlement amount and terms were not publicly disclosed. No class was ever formally certified, and no class-wide payout was made. If you purchased TNS products during the class period, there is no public settlement fund to claim against.

What Happened to TNS Products After the Lawsuit

SkinMedica kept selling TNS products after the litigation ended and later reformulated the line. TNS Advanced+ Serum replaced the earlier TNS Essential Serum, using a dual-chamber delivery system and what SkinMedica describes as a “next-generation growth factor blend” with over 450 identified growth factors, up from 380 in the prior version.⁶ The ingredient list still prominently features “Human Fibroblast Conditioned Media,” the same category of foreskin-derived growth factor material at the center of the lawsuit.

The reformulation made the proteins colorless and odorless, removing the fragrances previously used to mask the protein smell. The new formula contains 40% fewer ingredients overall and adds botanical extracts including chlorella, grape flower, and apple fruit extracts. The product won an Allure Breakthrough Award in 2019 and retails for $295. SkinMedica is now managed under AbbVie, which acquired Allergan in 2020.⁶

1
Courthouse News Service. Class Claims Skin Cream Could Cause Tumors
2
Mealeys. Allergan Reports It Settled TNS Cosmeceuticals Case Ahead of Class Motion
3
Clinical Leader. Consumers Claim SkinMedica Misbranding Drugs as Cosmeceuticals
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Truth in Advertising. Ruhnke v. SkinMedica Third Amended Complaint
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Truth in Advertising. SkinMedica’s TNS Products
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SkinMedica. TNS Advanced+ Serum