The former owner of a Kansas City, Mo., medical spa was sentenced in federal court for providing illegal treatments to his patients, several of whom suffered adverse effects from the foreign products.
Richard B. Smith III, 47, of Shawnee, Kansas, was sentenced by U.S. District Judge Howard F. Sachs to two years in federal prison without parole. The court also ordered Smith to pay $18,296 in restitution to his victims.
On July 27, 2022, Smith pleaded guilty to one count of receiving misbranded drugs (foreign and unapproved Botox) and delivering them for pay with the intent to defraud or mislead, and one count of receiving adulterated devices (Juvederm Ultra 3) and delivering them for pay with the intent to defraud or mislead.
Smith owned and operated Tap and Blade, located at 7208 Wornall Road, Suite 206, in Kansas City, Mo. Tap and Blade offered medical services, such as injections of prescription drugs, including Botox, and prescription devices to enhance facial features, including Juvederm Ultra 3. Tap and Blade also offered cosmetic services, such as microblading, brow shading, and cool sculpting. Smith was the only employee of Tap and Blade and performed all the procedures offered at the clinic.
The U.S. Food and Drug Administration, Office of Criminal Investigations began investigating Tap and Blade in December 2020 based on information that multiple patients suffered injuries after receiving treatment at Tap and Blade. Agents executed a search warrant at Tap and Blade on April 7, 2021, and found boxes of Juvederm Ultra 3 as well as three syringes filled with Botox.
Smith admitted that he obtained Botox and Juvederm Ultra 3 over the Internet and without a prescription from a website in China. Smith purchased the products from Alibaba.com because the foreign products were significantly cheaper, which allowed him to lower his cost compared to his competitors and led him to gain more customers. Smith knew the drugs and devices he was injecting into his patients were illegal.
Smith admitted he never told his patients he was using foreign prescription drugs and devices that had not been approved by the FDA. Smith estimated he treated approximately 50 to 60 customers. Smith treated at least 10 patients who suffered a bodily injury after being treated with Juvederm Ultra 3.
For example, according to court documents, one patient told investigators the treatment was very painful and bruised her lip immediately. She went to the emergency room due to severe pain and blistering on her upper lip and was treated by a plastic surgeon. Another patient told investigators she has a permanent scar as a result of Smith’s treatments.
Even after Smith became aware of patients suffering adverse reactions to his procedures, he continued to perform injections in the same manner using the same types of illegal products.
During the more than three years Tap and Blade operated, from Jan. 1, 2018, to April 30, 2021, there was never a medical doctor associated with the spa, nor was there a doctor overseeing procedures. Smith admitted that he knew his patients should have seen a doctor prior to receiving treatment, and that he told them there was a doctor on staff. Smith persistently misrepresented his qualifications to patients. He told patients he was a registered nurse or had a nursing degree, and that he was licensed to perform the procedures. These lies allowed him to gain the trust of his clients, which enabled him to commit these crimes that ultimately led to several individuals suffering an injury.
Smith did not attend any training courses on how to properly administer the products. Prior to opening Tap and Blade, Smith practiced injections on honeydew fruit, fake heads, and fake skins.
The FDA approval of Botox limits the drug to use under the supervision of a licensed practitioner, thus, it is a prescription drug. Smith admitted that the foreign and unapproved Botox he purchased for use at his spa was misbranded because it did not bear adequate directions for use.
Upon being injected beneath the skin’s surface, Juvederm adds volume and lift to smooth wrinkles and folds. Juvederm products are regulated as devices because, when injected, they are intended to reside under the skin and do not achieve their primary intended purpose through chemical action or metabolization. The FDA’s approval for Juvederm products limits them to use under the supervision of a licensed practitioner, thus, they are prescription devices. Juvederm Ultra 3 is not legal for distribution in the United States because it lacks FDA approval.
Smith was convicted in 2011 of one count of attempted possession of gamma-butyrolactone (GBL) with intent to manufacture gamma-hydroxybutyric acid (GHB) and three counts of possession of GBL with intent to manufacture GHB. He was sentenced to five years in federal prison without parole. During the investigation of that case, it was determined that Smith, acting as a representative of Schindler Elevator, purchased four 30-gallon drums of GBL from Barton Solvents, Inc. in Kansas City, Kan., between Oct. 5, 2006, and Dec. 3, 2007. Smith falsely claimed the GBL would be used for cleaning and degreasing purposes, when in reality, Smith obtained the GBL with the intent of converting it to GHB. On Oct. 8, 2007, a woman who lived with and dated Smith died from a drug overdose. GHB was one drug found in her system. The amount of GHB in her system was considered a lethal level of GHB and likely led to her death.
This case was prosecuted by Special Assistant U.S. Attorney Bradley Cooper. It was investigated by the Food and Drug Administration Office of Criminal Investigation.
