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Description: San Francisco, California criminal law lawyer represented Defendant charged with one misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by receiving and delivering misbranded drugs and misbranded and adulterated devices. Her medical practice, Lindsay Clark, M.D., Medical Corporation, also pleaded guilty to one felony count of receiving and delivering misbranded drugs and misbranded and adulterated devices.
Clark specialized in procedures using injectable drugs and devices for cosmetic purposes. In pleading guilty, Clark admitted that, from 2016 through 2020, she obtained and used with patients prescription drugs and devices that were not the subject of Food and Drug Administration (FDA) licenses or approvals, and that she took steps to conceal this conduct from patients, the FDA, and the authorized corporate distributor of the products. Clark further admitted that she and her practice obtained these products from sources outside of the United States. Specifically, the defendants purchased unapproved and unlicensed injectable botulinum toxin drugs and hyaluronic acid filler devices from online “pharmacies” outside the United States. Clark admitted that she then sold these products to patients, falsely representing the products to be the more expensive, FDA-approved products Botox and Juvederm. Clark’s practice received more than $1,069,880 in connection with the sale and use of misbranded and adulterated products.
“Consumers must have confidence that the prescription drugs and devices they use are authentic and safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work with its law enforcement partners to investigate and prosecute doctors who mislead patients for their own profit.”
“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 Acting Special Agent in Charge Robert M. Iwanicki of the 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 and Lindsay Clark, M.D., Medical Corporation pleaded guilty before District Judge Susan Illston in San Francisco. Sentencing is scheduled for April 7, 2023.
The case is being investigated by the FDA’s Office of Criminal Investigations.
Assistant U.S. Attorneys Joseph Tartakovsky and Kaitlin Paulson for the Northern District of California and Trial Attorney Rachael Doud of the Civil Division’s Consumer Protection Branch are prosecuting this case.
21 U.S.C. §§ 331(c), 333(a)(1) Receipt in interstate commerce of drugs that are misbranded, and devices that are misbranded and adulterated, and the delivery or proffered delivery thereof for pay or otherwise
Outcome: Defendant pled guilty Using Misbranded and Adulterated Products Sold as Botox and Juvederm.