|[March 19, 2014]
Hagens Berman: Pharmaceutical Company SkinMedica Selling Misbranded Drug Products as Cosmeceuticals
SEATTLE --(Business Wire)--
Consumers today filed a proposed class-action lawsuit against Allergan
Inc. (NYSE:AGN (News - Alert)) and its pharmaceutical company subsidiary, SkinMedica,
claiming that the companies have misbranded and unlawfully marketed
Tissue Nutrient Solution (TNS (News - Alert)), 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,"
According to the firm's investigation, SkinMedica's TNS products, which
have been sold nationally through doctors' offices and retailers,
contain a propietary 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.
Additional information about the suit is available at http://www.hbsslaw.com/cases-and-investigations/cases/SkinMedica.
Hagens Berman Sobol Shapiro LLP is a consumer-rights, class-action law
firm with offices in nine cities. The firm has been named to the
National Law Journal's Plaintiffs' Hot List seven times. More about the
law firm and its successes can be found at www.hbsslaw.com.
The firm's class-action law blog is located at www.classactionlawtoday.com.
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