Inspections, Compliance, Enforcement, and Criminal Investigations

December 13, 2013: Owner of Bluegrass Women's Healthcare in Elizabethtown Ordered to Pay Victim's $50,663.31 for Misbranding

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Food and Drug Administration
Office of Criminal Investigations

U.S. Department of Justice Press Release

 

For Immediate Release
December 13, 2013
www.justice.gov/usao/kyw

United States Attorney
Western District of Kentucky

 

LOUISVILLE, Ky. - The owner of Bluegrass Women's Healthcare, located in Elizabethtown, Kentucky was sentenced yesterday, in United States District Court, by United States District Judge John G. Heyburn, to one year probation for a single charge of misbranding, and the corporation, Bluegrass Women's Healthcare, was sentenced and ordered to pay a fine of $25,000 announced David J. Hale, United States Attorney for the Western District of Kentucky. The defendant owner, Canh Jeff Vo was also ordered to pay restitution in the amount of $50,663.31 to victims.

Vo, age 45, of Louisville, Kentucky, was the owner, supervising physician, and president at Bluegrass Women's Healthcare between March 2008 and September 2009 when the violations occurred. Vo offered gynecological and obstetric services to women at Bluegrass Women's Healthcare, including providing forms of birth control. According to the plea agreement, between March 2008 and September 2009, Vo, purchased and inserted into patients, foreign, non-FDA approved (levonorgesteral-releasing intrauterine device). These intrauterine devices or IUDs, were misbranded in that their labeling was not in the English language; and their labeling did not bear adequate directions for use. Vo pleaded guilty to the misdemeanor charge of misbranding on September 6, 2013 and agreed to pay jointly and severally with Bluegrass Women's Healthcare, restitution to the victims.

Also, between March 2008 and September 2009, Bluegrass Women's Healthcare received, brought, and imported into the United States, IUDs, knowing that these were misbranded and unlawfully introduced into interstate commerce from various countries, including from Canada. Defendant VO, as president of Bluegrass Women's Healthcare pleaded guilty, on behalf of the corporation, to the felony charge of smuggling and agreed to pay a $25,000 fine.

This case was prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb, and was investigated by the United States Food and Drug Administration (FDA) Office of Criminal Investigations, the Federal Bureau of Investigation (FBI), and Kentucky Office of the Attorney General Office of Medicaid Fraud and Abuse Control.

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