Bay Area Physician Charged In Alleged Scheme To Buy And Inject Misbranded Or Adultered Botox And Juvederm Substitutes
Physician allegedly ordered foreign product substitutes with intent to defraud and mislead patients
SAN FRANCISCO – A federal grand jury handed down an indictment charging Lindsay Marie Clark with receiving, offering, and delivering misbranded drugs and misbranded and adulterated devices, in a scheme to buy at a discount and inject into patients products lacking FDA approval, announced Acting United States Attorney Stephanie M. Hinds and Lisa L. Malinowski, Special Agent in Charge of the Food and Drug Administration (FDA) Office of Criminal Investigations, Los Angeles Field Office.
The indictment, filed April 1, 2021, and unsealed earlier today, alleges that Clark, 44, of San Francisco, is a California physician, with practices in San Francisco and San Mateo, who specialized in procedures that use injectable drugs and devices for cosmetic or aesthetic purposes. The indictment explains that federal law regulates the manufacture, labeling, distribution, and administration of biologics, drugs, and devices shipped or received in interstate commerce. The law forbids, as a felony, the receipt and delivery of misbranded or adulterated products with intent to defraud and mislead. Regulated products include drugs such as injectable botulinum toxin and devices such as injectable hyaluronic acid dermal fillers. Under Congress’s regulatory scheme, the FDA approved the use of Botox®, the brand name of a drug derived from Botulinum Toxin Type A. In addition, the FDA approved the use of dermal fillers made from hyaluronic acid, as Class III medical devices, under the name Juvederm® and related names.
According to the indictment, from at least April 2016 until no earlier than February 2020, Clark obtained drugs and devices, represented by sellers to be foreign versions of Botox® and Juvederm®, that were not the subjects of FDA approval. Clark allegedly obtained these products from sources abroad, primarily by ordering the drugs and devices over the phone and internet. The indictment alleges that Clark purchased at least $270,951 worth of products from these foreign online “pharmacies” and “depots,” and obtained revenue from services rendered in connection with these products, perhaps more than $1,069,880.
The indictment alleges that Clark instructed staff to conceal the true identity, name, and source of these products from patients. The indictment also alleges that Clark had patients sign misleading “consent” forms that referred only to products approved by the FDA, rather than informing patients that they were receiving unlicensed and unapproved products. The indictment further alleges that Clark charged patients the same price for the “Botox” and “Juvederm” products whether the products were FDA-licensed and approved, or unlicensed and unapproved.
“Health care professionals who dispense and administer misbranded and adulterated prescription drugs and devices of unknown origin put the health of their patients at significant risk,” said Special Agent in Charge Lisa L. Malinowski, FDA Office of Criminal Investigations Los Angeles Field Office. “We will continue to pursue and bring to justice those who choose to subvert the safeguards of the legitimate drug and device regulatory regime and supply chain and jeopardize the public health.”
Clark is charged with receipt in interstate commerce of a drug that is misbranded, and a device that is adulterated and misbranded, and the delivery or proffered delivery thereof for pay or otherwise, with intent to defraud and mislead, in violation of 21 U.S.C. §§ 331(c), 333(a)(2). If convicted, she faces a maximum penalty of three years in prison and a maximum fine of $10,000. However, any sentence following conviction would be imposed by the court only after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.
Clark made an initial appearance today in federal court before the United States Magistrate Judge Jacqueline Scott Corley. She remains out of custody on bond. Her next scheduled appearance is for a status conference before Senior District Judge Susan Illston on June 4, 2021.
The charges contained in the indictment are mere allegations. As in any criminal case, the defendant is presumed innocent unless and until proven guilty in a court of law.
Assistant U.S. Attorney Joseph Tartakovsky is prosecuting this case with assistance from Laurie Worthen. The prosecution is a result of an investigation by the FDA’s Office of Criminal Investigations.