Ana Bertha Diaz Hernandez, 47, who is not a physician and did not have any professional licenses in the U.S., was sentenced by a federal judge on March 5, 2018, after pleading guilty to one count of receiving and administering an adulterated and misbranded liquid substance and admitting that she injected the liquid substance into the victim during a body contouring procedure that included buttocks enhancement. As part of the plea agreement, Diaz Hernandez will also pay a $95,000 fine and $30,000 restitution to her victim.
The conviction was the result of a joint investigation conducted by the U.S. Food and Drug Administration (FDA), Office of Criminal Investigations, and Operation Safe Medicine, part of the Health Quality Investigation Unit (HQIU) within the California Department of Consumer Affairs’ Division of Investigation.
In December 2016, the Medical Board of California received a complaint alleging that Diaz Hernandez had injected a victim with an unknown substance during an enhancement procedure. HQIU investigators learned the procedure involved a series of treatments at Diaz Hernandez’s home. During the contouring process, Diaz Hernandez claimed to be a doctor and mislead the victim about the safety of the injections.
Following the procedure, the unknown substance migrated into the victim’s back, hips and legs and she underwent surgery to remove the foreign substance from her body. She was eventually hospitalized due to infections and complications from the procedure and received skin grafts to repair the damage.
HQIU investigators alerted the FDA and HQIU and FDA investigators teamed up to inspect trash from Diaz Hernandez’s home, where they found bottles of Spanish-labeled medical products and empty syringe packaging. Investigators then conducted surveillance on Diaz Hernandez’s home and served a search warrant.
Drugs and medical devices are considered adulterated when they are used for a purpose other than the use they have been approved or cleared for marketing by the FDA. Drugs and medical devices are considered misbranded when their labeling does not have adequate directions and warnings for use under U.S. law or when prescription drugs are dispensed without a written or oral prescription by a licensed medical practitioner.
Diaz Hernandez was arrested in June 2017 and reached a plea agreement with the United States Attorney’s Office in July 2017.
The United States Attorney’s Office news releases can be read HERE.