KANSAS CITY, Mo. - Tammy Dickinson, United States Attorney for the Western District of Missouri, announced that a Hesston, Kan., man has been indicted by a federal grand jury alongside an Alton, Ill., business owner and his company who were charged earlier this year for distributing more than $3 million worth of foreign Botox and Juvederm in the United States.
Christopher Tozier, 43, of Hesston, was charged in a superseding indictment returned by a federal grand jury in Kansas City, Mo. Today’s indictment replaces an April 3, 2013, indictment that charged Christopher Carstens, 48, of Alton, and his company, Orthopaedic Solutions, Inc., with violations of the Federal Food, Drug and Cosmetic Act.
The federal 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.
Today’s superseding indictment charges Carstens, Orthopaedic Solutions and Tozier together in two counts of smuggling goods into the United States. They allegedly imported foreign Botox into the United States contrary to the prohibition against introducing drugs that were misbranded (because the foreign Botox labeling failed to bear the statement “Rx only”). They allegedly imported Juvederm 3 into the United States contrary to the prohibition against introducing devices that were adulterated (because the foreign versions of Juvederm 3 lacked FDA approval for distribution in the United States).
Tozier is also charged in today’s superseding indictment with one count of smuggling foreign Botox into the United States, two counts of distributing a misbranded drug (foreign Botox) across state lines and one count of distributing an adulterated device (Juvederm 3) across state lines.
Today’s superseding indictment contains several charges that were part of the original indictment. Carstens and Orthopaedic Solutions are charged with one count of mail fraud because they allegedly 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. Carstens and Orthopaedic Solutions are charged with three counts of distributing an adulterated device across state lines. 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.
The 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 for all three defendants and an additional $26,125 from Tozier.
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. Attorneys Jane Pansing Brown and Lucinda S. Woolery. It was investigated by the U.S. Food and Drug Administration, Office of Criminal Investigation.