September 6, 2013: Owner of Bluegrass Women's Healthcare in Elizabethtown Guilty of Misbranding and Bluegrass Women's Healthcare Guilty of Smuggling
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
September 6, 2013
United States Attorney
Western District of Kentucky
Contact: Stephanie Collins
Agreed to pay restitution in the amount of $50,663.31
LOUISVILLE, Ky. - The owner of Bluegrass Women's Healthcare, located in Elizabethtown, Kentucky pleaded guilty today, in United States District Court, before U.S. Magistrate Judge James Moyer, to a single charge of misbranding, the corporation pleaded guilty to smuggling, and agreed to pay restitution in the amount of $50,663.31 to victims, announced David J. Hale, United States Attorney for the Western District of Kentucky.
Canh Jeff 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 and agreed to pay jointly and severally with Bluegrass Women's Healthcare, restitution to victims in the amount of $50,663.31.
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.
If convicted at trial, Vo faced a maximum of 1 year in prison, a maximum fine of $1,000 and up to 1 year of supervised release. The corporation faced a maximum fine of $500,000 and up to three years of supervised release.
Vo is scheduled for sentencing before U.S. District Judge John G. Heyburn II, on December 17, 2013, at 1:30 pm, in Louisville. At the time of sentencing, the United States has agreed to drop charges in the superseding indictment.
This case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb, and is being 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.