Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
April 3, 2013
United States Attorney's Office
Western District of Missouri
Contact: Don Ledford
KANSAS CITY, Mo. - Tammy Dickinson, United States Attorney for the Western District of Missouri, announced that an Alton, Ill., business owner was indicted by a federal grand jury today for distributing more than $3 million worth of foreign Botox and Juvederm in the United States.
Christopher Carstens, 47, of Alton, and his company, Orthopaedic Solutions, Inc., were charged in a nine-count indictment returned by a federal grand jury in Kansas City for violations of the Federal Food, Drug and Cosmetic Act.
Today's indictment alleges that Carstens and Orthopaedic Solutions distributed approximately 5,879 units of a foreign version of the prescription drug Botox and a foreign version of the prescription device Juvederm through their sales representatives 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.
Carstens and Orthopaedic Solutions are charged with one count of mail fraud because they executed their scheme by distributing foreign Botox (which the FDA had not approved for distribution in the United States) via FedEx and attempted to hide their fraudulent scheme from doctors and health care professionals. Carstens and Orthopaedic Solutions are charged with one count of distributing an unapproved new drug across state lines because they had not received approval to import or distribute the foreign version of Botox in the United States. Carstens and Orthopaedic Solutions are charged with one count of distributing a misbranded drug across state lines because the foreign Botox labeling failed to bear the statement "Rx only."
Carstens and Orthopaedic Solutions are charged with three counts of distributing an adulterated device across state lines because the foreign versions of Juvederm lacked FDA approval for distribution in the United States. Carstens and Orthopaedic Solutions are charged with three counts of distributing a misbranded device across state lines because the Juvederm 3 labeling failed to bear adequate directions for use or appropriate warnings.
Today's indictment also contains a forfeiture count, which would require Carstens and Orthopaedic Solutions to forfeit to the government any property derived from the proceeds of the scheme, including a money judgment of $3,058,183.
Dickinson cautioned that the charges contained in this indictment are simply accusations, and not evidence of guilt. Evidence supporting the charges must be presented to a federal trial jury, whose duty is to determine guilt or innocence.
This case is being prosecuted by Assistant U.S. Attorney Jane Pansing Brown. It was investigated by the U.S. Food and Drug Administration, Office of Criminal Investigation.