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November 14, 2016

Nurse Who Operated Spa in Laguna Niguel Agrees to Plead Guilty to Illegally Dispensing Botox Not Approved for Use in United States

Filed under: California Defense Attorney — fayarfa @ 12:09 am

SANTA ANA, California – A registered nurse who owned and operated a day spa in Laguna Niguel has agreed to plead guilty to a federal charge related to the illegal distribution of Botox that was not approved for use in the United States.

Bridget “Gigi” Goddard, 50, of Dana Point, who owned Pure Indulgence Skin Rejuvenation in Laguna Niguel, has agreed to plead guilty to one count of receipt and delivery of a misbranded drug, a crime that carries a statutory maximum penalty of three years in federal prison.

Federal prosecutors today filed a criminal information against Goddard, as well as a plea agreement in which she agrees to plead guilty to the felony offense.

“Drugs and medical devices are regulated to protect the American public,” said United States Attorney Eileen M. Decker. “Those who circumvent those regulations pose a very real risk to patients who could be subject to unsafe products that can do serious harm.”

All Botox products approved for distribution in the United States by the United States Food and Drug Administration are manufactured by Allergan and must be administered under the supervision of a licensed physician. Goddard admitted in her plea agreement that, over the course of several years, she ordered Botox over the internet from Canadian companies that sold unapproved drugs to customers in the United States. (One of those companies, SB Medical Inc., pleaded guilty in federal court in Alexandria, Virginia, and was ordered to pay a $45 million fine and to forfeit $30 million for smuggle misbranded pharmaceuticals into the United States.) The Botox that Goddard purchased had been manufactured for distribution in foreign nations such as Turkey and was not approved by the FDA for distribution in the United States.

In April 2016, Goddard offered to administer Botox to a person she thought was a Pure Indulgence customer, but who in fact was an undercover agent with the FDA. Goddard told the undercover agent that the undercover agent did not need to be examined by a physician before the Botox injections were administered, and Goddard knowingly misled the agent as to whether the Botox was approved for use in the United States.

“Consumers rely on FDA oversight to ensure that the drugs they take are safe and effective. When criminals attempt to distribute unapproved drugs in the U.S. marketplace, they put the public’s health at risk,” said Lisa Malinowski, Special Agent in Charge, FDA Office of Criminal Investigations. “Our office will continue to pursue and bring to justice those who would jeopardize the health and safety of the public.”

Goddard has agreed to make her first appearance in this case in United States District Court in Santa Ana on December 12.

The investigation into Goddard was conducted by FDA’s Office of Criminal Investigation. The case is being prosecuted by Assistant United States Attorney Scott D. Tenley of the Santa Ana branch office.

USAO - California, Central Updated November 10, 2016

Central District of California DOJ / 16-279 / November 10, 2016

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