Drugs From Unapproved Sources
A recent spate of out of the channel drug cases are being brought in federal criminal court and recently a conviction resulted in a Medical Board of California Accusation being filed against a California doctor.
The Accusation reads:
On November 22, 2022,.Respondent pled guilty to Count One of the Indictment, Receipt in Interstate Commerce of Adulterated and Misbranded Drugs and Devices, in violation of 21 U.S.C. sections 33l(c), 333(a)(l), as a misdemeanor. In her signed plea agreement, Respondent admitted the following:
“From at least April 1, 2016, until no earlier than June 3, 2020, I obtained and injected
patients with prescription drugs and devices that were not the subject of an FDA biologics
license, drug approval, or Class III device approval, from foreign sources, primarily by ordering
the drugs and devices over the phone and internet. I took steps to conceal this conduct from
patients, Allergan and the FDA.”
We are aware of other instances where drugs obtained from foreign sources (e.g. Turkey, India) were used instead of the same brand name from approved sources. This had led to investigations of not only individual doctors but larger institutions as well.
In the recent case, the doctor’s practice purchased at least $270,951 in products from illegitimate suppliers, and that her practice received at least 1,069,880 in revenue from services rendered in connection with these products. What is not discussed is the difference in profit receiving goods from established channels vs. the illegal channels. Federal documents indicate that the chemnicals were purchased for “around 40% of Allergan’s price—yet charged patients the same price that she did
when selling legitimate, FDA-approved Allergan products.”
The doctor admitted that the botulinum toxin drugs received by her practice came from online sources. She admitted that the injectable hyaluronic acid devices received by her practice were adulterated and misbranded. Again, the Medical Board Accusation does not specify how they were “adulterated”.
Interestingly, the Accusation does not indicate that any patient was harmed. However, the “no harm no foul” adage obviously does not apply. The Department of Justice issued a press release about her arrest.
Of interest is the Government’s sentencing memorandum in the criminal case which describes in detail what was done. It states in small part”
Contrary to these requirements, from at least April 1, 2016, until June 3, 2020, Clark’s
administrative staff, at Clark’s explicit direction, obtained products purporting to be “Botox” and
“Juvederm” from online “pharmacies” that were not authorized to sell these products in the United
States.” The entire brief can be found here.
What we found troubling in the brief was the fact that the attorney was essentially accused of wrongdoing and targeted in the sentencing brief. It says in part:
What’s more, following xxx’s indictment, xxx civil attorney, xxx —who entered
the guilty plea on behalf of the xxx M.D., Medical Corporation—began sending emails to the
upset patients who had written xxx directly. In those emails, xxx made representations about the
substances that patients were injected with. “It is my understanding,” he wrote K.F., for instance, “that
the Botox that was administered to you was manufactured by Allergan, and although not authorized for
sale in the U.S., is identical to the Botox that Allergan does sell in the U.S. except that it came through a
different distribution chain.” US-254640. But the fundamental problem is that Mr. xxx could not
possibly know that the product (which cannot be called “Botox”) injected into K.F. was “manufactured”
by Allergan or that it was “identical” to the lawful product. That’s the whole problem with buying from
what he euphemistically calls the “different distribution chain.” And emails like this only echo and
indeed amplify xxx original conduct: xxx assured xxx’s patients that the product they received
was safe and what it purported to be—even as he acknowledged, at the same time, that these products
were acquired in defiance of the very laws that serve to ensure safety and genuineness.
We don’t know the details but the civil attorney who entered the plea was somehow injected into the case and that is a painful reality of high stakes litigation – anything you say as a defendant and anything expressed by others, including attorneys can be used against you! The attorney in the above case was a tremendously well qualified and accomplished lawyer – and yet even he could not escape personal criticism. This is an increasingly troubling failure of our justice system (both civil and criminal) and the U.S. government is not the main violator of the long established rule of civility. In civil lawsuits the guns are frequently turned individually against the lawyers. But bottom line, the main target is the doctor.
The takeaway is this. Any criminal charge carries the potential for Medical Board license consequences. Any criminal charge related to the practice of medicine is the kiss of death to the practice. The case some time ago of Dr. XYZ resulted in a conviction against his practice not Dr. XYZ as the individual physician. However, to achieve this goal he had to provide information relating other people who participated in the conduct.
Note: There are two primary sources of Board Accusations. Internal and external Internal often arise from Medical Executive Committee (MEC) actions or complaints by nurses or medical staff members. External are often policy driven and arise from drug prescribing (sometimes reported by pharmacies) or as ancillary damage when a physician services or equipment provider is investigated and those doing business with that larger entity are “discovered”.
If you are charged with a crime and need assistance Call Daniel Horowitz at (925) 291-5388.
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