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Allergan and SkinMedica Face Class Action over Potential NouriCel Cancer Risk

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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.
The case is Josette Ruhnke v. SkinMedica Inc., et al, case number 8:2014-cv-00420, in the U.S. District Court for the Central District of California.

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Reader Comments

Posted by

on
This law suite was dismissed

Posted by

on
The lawsuit is a joke - they just want money from the company! The product has been around for 16 years, it's very safe. Ironic that this lawsuit happened right when SkinMedica was bought by Allergan and Allergan has some of the deepest pockets in the pharmaceutical industry.

Posted by

on
I just purchased this product a few months ago and I absolutely love it, but honestly, I am going to stop using it. Nothing is worth a cancer risk!

Posted by

on
I have been using the TNS products for months, and have noticed great improvement in the texture and brightness of my skin. They wete recommended and purchased at a very reputable plastic surgeon.
Should I stop?

Posted by

on
I started using otters skin brightening and retinal 0.5
My skin got darker and looks sun burn
Should I stop using it?

Posted by

on
I have been using several skin medica products for well over a year....Including TNS
Should I stop using them?

Posted by

on
I use their products for exfoliation and the retinol. I am new to the type of skin care products. Should I stop use or is it only the TNS that is a problem?

Posted by

on
I use skin medica recovery complex twice a day and see great results. Is it not a good product?

Posted by

on
I have been using the TNS serum for a little over a year but never heard of there being a problem and I havent had any issues yet.. Should I stop using the product?

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