At least 10 patients have suffered injuries due to treatment with Chinese products
KANSAS CIT. A Kansas man, who was the former owner of a Kansas City medical spa, has been convicted in federal court of providing illegal treatments to his patients, many of whom have suffered adverse effects from foreign products, according to the US attorney.
Richard B. Smith III, 47, of Shawnee, Kansas, was sentenced by US 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 receiving misbranded drugs (foreign and unapproved Botox) and delivering them for a fee with intent to defraud or mislead, and to receiving adulterated devices (Juvederm Ultra 3) and delivering them for a fee with intent to defraud or mislead.
Smith owned and operated Tap and Blade, headquartered at 7208 Wornall Road, Suite 206, in Kansas City. Tap and Blade offered medical services, such as prescription drug injections, including Botox, and prescription devices to enhance facial features, including Juvederm Ultra 3. Tap and Blade also offered cosmetic services, such as microblading, eyebrow shading, and fresh sculpting. Smith was Tap and Blade’s sole employee and performed all of the procedures offered at the clinic.
The U.S. Food and Drug Administration’s Office of Criminal Investigations began investigating Tap and Blade in December 2020 based on reports that multiple patients suffered injuries after receiving treatment at Tap and Blade. Officers executed a search warrant at Tap and Blade on April 7, 2021 and found boxes of Juvederm Ultra 3 and three syringes filled with Botox.
Smith admitted to obtaining Botox and Juvederm Ultra 3 on the Internet and without a prescription from a website in China. Smith bought the products from Alibaba.com because foreign products were significantly cheaper, which allowed him to lower costs than his competitors and led him to acquire more customers. Smith knew that the drugs and devices he was injecting into his patients were illegal.
Smith admitted that he never told his patients that he was using foreign drugs and devices that hadn’t been approved by the FDA. Smith estimated that he treated about 50-60 clients. Smith has treated at least 10 patients who suffered physical injuries after being treated with Juvederm Ultra 3.
For example, according to court documents, one patient told investigators that the treatment was very painful and she immediately injured her lip. She went to the emergency room due to severe pain and blisters on her upper lip and was treated by a plastic surgeon. Another patient told investigators she has a permanent scar from Smith’s treatments.
Even after Smith learned of patients suffering adverse reactions to his procedures, he continued to inject the same way using the same types of illegal products.
During the more than three years that Tap and Blade operated, from January 1, 2018 to April 30, 2021, there was never a physician associated with the spa, nor a physician supervising procedures. Smith admitted that he knew his patients should see a doctor before receiving treatment and that he told them there was a doctor on staff. Smith has consistently misrepresented his qualifications to patients. He told patients that he was a registered nurse or had a nursing degree and that he was licensed to perform the procedures. These lies enabled him to gain the trust of his clients which enabled him to commit these crimes which ultimately resulted in several people getting injured.
Smith has not attended any training on how to properly administer the products. Before opening Tap and Blade, Smith injected fruit with honeydew, fake heads, and fake skins.
The FDA approval of Botox restricts the drug to be used under the supervision of a licensed professional, so it is a prescription drug. Smith admitted that the foreign, unapproved Botox he purchased for use at his spa was mislabeled because it didn’t carry proper instructions for use.
After being injected beneath the skin’s surface, Juvederm adds volume and lift to smooth wrinkles and creases. 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. FDA approval for Juvederm products restricts their use under the supervision of a licensed professional, therefore they are prescription-only devices. Juvederm Ultra 3 is not legal for distribution in the United States due to lack of FDA approval.
Smith was convicted in 2011 of one attempted possession of gamma-butyrolactone (GBL) with intent to produce gamma-hydroxybutyric acid (GHB), and three counts of possession of GBL with intent to produce GHB. He was sentenced to five years in federal prison without parole. During the investigation of that case, it was determined that Smith, as a representative of Schindler Elevator, purchased four 30-gallon drums of GBL from Barton Solvents, Inc. in Kansas City, Kan., between October 5, 2006 and December 3, 2007. Smith falsely claimed that the GBL was to be used for cleaning and degreasing purposes, when in fact, Smith obtained the GBL with the intent of converting it to GHB. On October 8, 2007, a woman who was living with and dating Smith died of a drug overdose. GHB was a 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.
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