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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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June 5, 2014: Business Pleads Guilty to $3 Million Scheme to Sell Foreign Versions of Botox

 

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Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release

 

 

For Immediate Release
June 5, 2014

www.justice.gov/usao/mow

United States Attorney

Western District of Missouri

Contact:Don Ledford

Public Affairs

(816) 426-4220

 

 

KANSAS CITY, Mo. - Tammy Dickinson, United States Attorney for the Western District of Missouri, announced that an Alton, Ill., business owner and his company pleaded guilty in federal court today to distributing more than $3 million worth of foreign Botox and Juvederm in the United States.

 

Christopher Carstens, 49, of Alton, and his company, Orthopaedic Solutions, Inc., pleaded guilty before U.S. district Judge Howard F. Sachs to violations of the Federal Food, Drug and Cosmetic Act. Orthopaedic Solutions pleaded guilty to the felony charge of introducing a misbranded drug into interstate commerce. Carstens pleaded guilty to a misdemeanor charge.

 

Carstens and Orthopaedic Solutions pleaded guilty to introducing foreign Botox into interstate commerce (by shipping it across state lines via FedEx) in August 2009. The Botox was not approved by the FDA for distribution in the United States; rather, it was labeled for use in Great Britain. Other Botox was labeled for use in the United Arab Emirates, Bahrain, Kuwait, Lebanon, Oman and Palestine. The foreign Botox was misbranded in that its labeling failed to bear adequate directions for use, failed to bear adequate “black box” warnings and failed to bear the symbol “Rx only.”

 

Carstens admitted that approximately 5,879 units of foreign Botox, Juvederm 2, and Juvederm 3 were distributed by Orthopaedic Solutions to doctors or other health care professionals in the United States between 2008 and 2011, at a retail value of approximately $3,058,183. (Juvederm is a clear, biodegradable gel implant that is injected into the skin to correct wrinkles and folds.)

 

Undercover FDA agents purchased the foreign and mislabeled Botox and Juvederm from Orthopaedic Solutions from June 22, 2009, through Dec. 21, 2010.

 

Under the terms of today’s plea agreement, Orthopaedic Solutions must forfeit $374,476 to the government (with $80,000 due at the time of sentencing and $3,505 paid each month, until paid in full). Carstens must pay a $50,000 fine (with $10,000 due at the time of sentencing and $667 paid each month thereafter until paid in full). A sentencing hearing will be scheduled after the completion of a presentence investigation by the United States Probation Office.

 

This case is being prosecuted by Assistant U.S. Attorneys Jane Pansing Brown and Lucinda S. Woolery. It was investigated by the U.S. Food and Drug Administration, Office of Criminal Investigation.

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This news release, as well as additional information about the office of the United States Attorney for the Western District of Missouri, is available on-line at

 

http://www.justice.gov/usao/mow/index.html

 

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