The Plastic Surgery Group LLP, based in Albany, New York, has pled guilty to charges regarding the use and false branding of a cheap Botox substitute – incidents that spanned ten months in 2004 and involved 151 patients. The company faces fines and seven associates of the company, five of them doctors, face fines and up to a year in prison.

The defendants were charged with using a botulinum toxin manufactured by Toxin Research International in Arizona that was not FDA approved and was mislabeled as being Botox, the FDA said in a written statement.

In 2004, the Plastic Surgery Group, by its own admission, injected the knock-off Botox into 151 people who thought they were receiving the genuine product.  The company has pled guilty to a felony count of misbranding drugs and the associates have pled guilty to misdemeanor conduct violations.

In addition to fines, the company has been ordered to pay restitution to the patients. And in light of the verdict, the company released a statement admitting responsibility for the mistake.

E. Stewart Jones, legal counsel for the Plastic Surgery Group, told reporters that though the patients will be repaid in full, their health and safety were never at risk and that Plastic Surgery Group misused the drug not deliberately but genuinely by mistake, believing it to be real Botox.

Sentencing in the case is set for mid-December.

The federal hammer recently swung down on a plastic surgery firm accused of giving its patients a cheap and unsafe Botox substitute.

Individuals associated with the Gastonia, North Carolina location of Southeastern Plastic Surgery have been accused of injecting 41 people with a product that had been deemed for research purposes only – not for human use.

Indictments were filed earlier this month in a federal court.

The court documents say the violations began in 2004 when Southeastern Plastic Surgery purchased 10 vials of the fake Botox product from Toxin Research International, a company located in Arizona.

Chad Livdahl, the 34-year-old president of Toxin Research International Inc. and his wife, 34-year-old Zahra Karim, faced fraud and conspiracy charges and were convicted in 2008. They were sentenced to nine and six years, respectively.

Since then, law enforcement has pursued the companies who knowingly purchased and distributed the faux Botox, including Southeastern Plastic Surgery, which has three clinics throughout North and South Carolina.

According to documents submitted to the court, Southeastern Plastic Surgery used this drug because it was cheaper than Botox and was said to have a longer shelf life. But the firm allegedly altered the drug label and also designed a consent form that inaccurately claimed the drug had been proven safe during clinical trials.

Patients who were injected with the cheaper drug had all signed the consent form, even though they were later made to pay the higher prices associated with Botox. Officially, the firm is being charged for the United States Code violations of altering drug labels and dispensing a drug imitation.

Legal proceedings continue. But the United States Attorney’s office has already asked Southeastern Plastic Surgery to surrender any property that was involved in administering the fake Botox. The U.S. Attorney’s office also requests about $15,000 for the company’s alleged code violations. We’ll keep you updated on this story, as more facts emerge.

All of those stories and more are featured in this week’s newscast. Click the screen below to catch Plastic Surgery News now!

Organizations mentioned in this episode:

• The American Society of Plastic Surgeons
• American College of Obstetricians and Gynecologists
• Dr. Louis Bucky, MD, FACS
• The Official Michael Jackson Site
• Dr. Wallace Goodstein, MD
• Dr. Brett Snyder, MD
• Southeastern Plastic Surgery
• Britney Spears (official site and blog)