A company based in Laurel County, Kentucky, named Facial Expressions, has pleaded guilty to receiving misbranded drugs across state lines. The company's owner, Dr. Paula Gill, also admitted guilt to providing false information on a DEA application.
Dr. Gill operated Facial Expressions, which offered treatments using injectable drugs primarily derived from botulinum toxins for reducing skin wrinkles. These prescription drugs' manufacturing and distribution are regulated by the FDA and must be sourced from authorized distributors within the United States. Botulin toxin drugs from unlicensed foreign suppliers are not permitted for use in the U.S.
The plea agreement revealed that between August 2019 and August 2023, Facial Expressions bought botulinum toxin type A drugs intended for sale in Korea and Turkey, unauthorized by the FDA for U.S. use. Several customers experienced side effects from these injections during this period, incurring additional medical costs of at least $24,369.
In addition to the company's plea, Dr. Gill admitted to lying on a DEA form on August 4, 2021. She falsely claimed her dental license had never been suspended when it was actually suspended by the Kentucky Board of Dentistry in October 2010.
"Patients should be able to trust that the clinics they go to for care are operating by the book," stated Acting U.S. Attorney Paul McCaffrey. "When medical providers breach that trust, we will hold them accountable."
"Medical professionals who obtain prescription drugs outside the legitimate supply chain put their unsuspecting patients at significant risk," added Ronald Dawkins, Acting Special Agent in Charge at the FDA Office of Criminal Investigations Metro Washington Field Office.
The guilty plea was announced jointly by McCaffrey, Dawkins, and Phillip J. Burnett Jr., Commissioner of the Kentucky State Police (KSP). The investigation was carried out by the FDA Office of Criminal Investigations and KSP. Assistant U.S. Attorney Brittany Dunn-Pirio is prosecuting the case.
Dr. Gill's sentencing is set for October 16; she could face up to four years in prison and a fine of up to $250,000. However, her sentence will be determined after considering federal guidelines and statutes.
