License Revocation of Jerome N. Lentini, M.D.
Stephen Barrett, M.D.
In 2008, the Oregon Medical Board revoked the medical license of Jerome Lentini, M.D., who owned and operated the "A Younger You Medical Center" in Salem and Tigard, Oregon. As noted below, the board objected to three things they considered to be unprofessional or disreputable conduct.
- In treating patients who thought they were receiving BOTOX® Cosmetic injections, he substituted products that were not FDA-approved.
- He prescribed and dispensed human growth hormone (HGH) for "anti-aging" purposes, which is illegal as well as medically improper. Among other things, he falsely told patients that the injections would stop, slow, and/or reverse the aging process.
- He performed mesotherapy, which entailed injections of vitamins and others substances that he improperly advertised would help them lose weight, dissolve fat, and reduce "cellulite."
For using the unapproved BOTOX-substitutes, Lentini was convicted of criminal misbranding with intent to defraud patients and was ordered to spend 18 months in prison and pay restitution of $330,307 to more than 800 patients.
OREGON MEDICAL BOARD
STATE OF OREGON
In the matter of
JEROME NICHOLAS LENTINI, MD
HISTORY OF THE CASE
On January 25, 2007, the Oregon Medical Board (Board) issued a Complaint and Notice of Proposed Disciplinary Action to Jerome Nicholas Lentini, MD. The Board proposed to take disciplinary action against Dr. Lentini for violations of the Medical Practice Act, ORS 677.190. Dr. Lentini, who voluntarily withdrew from the practice of medicine in January 2005, pursuant to an Interim Stipulated Order, requested a hearing on the proposed discipline. On May 18, 2007, the Board referred the matter to the Office of Administrative Hearings (OAR).
The hearing was held on November 29 and 30, 2007, at the Board's office in Portland, Oregon. Alison Greene Webster, from the OAH, presided as the Administrative Law Judge (ALJ). The Board was represented by Warren Foote, Assistant Attorney General. Dr. Lentini appeared without counsel.
The following witnesses testified for the Board: Dr. Lentini, David Michael Cook, MD, Sandra Flint, Special Agent for the Federal Bureau of Investigation (FBI), and Mei-Mei Wang, Board Investigator. Dr. Lentini also testified on his own behalf.
On December 20, 2007, the Office of Administrative Hearings received the written transcript of the proceeding.1 The record closed on that date.
1The transcript of hearing was prepared in two sections. Transcript 1 (tr. 1) refers to the proceedings on November 29, 2007, and transcript 2 (tr. 2) refers to the proceedings on November 30, 2007.
1. Whether Dr. Lentini engaged in unprofessional or dishonorable conduct under ORS 677.190(1)(a), as defined by ORS 677.188(4)(a).
2. Whether Dr. Lentini obtained any fee by fraud or misrepresentation in violation of ORS 677.190(4).
3. Whether Dr. Lentini was convicted of an offense punishable by incarceration in a Department of Corrections institution or federal prison in violation of DRS 677.190(6).
4. Whether Dr. Lentini made false or misleading statements regarding the skill, value or efficacy of the medicine, treatment or remedy he prescribed or administered in the treatment of any disease or condition of the human body or mind, in violation of ORS 677.190(9).
5. Whether Dr. Lentini committed gross negligence or repeated negligence in the practice of medicine. ORS 677.190(14).
6. If Dr. Lentini violated provisions of the Medical Practice Act, what is the appropriate sanction?
Board Exhibits Al through A17 were admitted at hearing without objection.
FINDINGS OF FACT
1. Jerome Nicholas Lentini, MD, was first licensed to practice medicine in Oregon in 1999. When he came to Oregon, he practiced emergency medicine. Prior to moving to Oregon, Dr. Lentini practiced emergency and cosmetic medicine in Florida. (Ex. A13 at 7-8.)
2. In approximately February 2003, Dr. Lentini opened a medical clinic in Salem, Oregon, known as "A Younger You Medical Center." The clinic provided a variety of cosmetic and anti-aging treatments and aesthetic services. In January 2004, Dr. Lentini purchased another clinic in Tigard, Oregon, to perform the same cosmetic and anti-aging services. Dr. Lentini purchased the Tigard clinic from Steven Gabriel Moos, MD, who was at the time facing criminal charges in Oregon and revocation of his medical license. Dr. Lentini purchased the hard assets from Dr. Moos' clinic, as well as Dr. Moos' patient database. (Tr. 1 at 8; tr. 2 at 12-13; test. of Lentini.)
3. Dr. Lentini ran both clinics with the assistance of his then-girlfriend, Cathryn Lyn Garcia, a registered nurse, who was licensed by the Oregon State Board of Nursing. Ms. Garcia was Dr. Lentini's employee. She was also his patient. Dr. Lentini occasionally filled prescriptions for Ms. Garcia and injected her face with various botulinum toxin type A products. (Tr. 1 at 15-16,24-27; test. of Lentini.)
4. When Dr. Lentini first opened his Salem clinic, he was using BOTOX® Cosmetic, the only botulinum toxin type A product approved by the Food and Drug Administration (FDA) for removing facial wrinkles. BOTOX® Cosmetic is a registered trademark of Allergan, Inc., a pharmaceutical company in California, (Tr. I at 13 -14, 21.) At a certain point, when Allergan increased the price of the product, Dr. Lentini began importing BOTOX® Cosmetic from Italy and Spain. (Tr. 2 at 18,22; test. of Lentini.)
5. In approximately March 2003, Dr. Lentini attended a conference in Arizona, sponsored by Toxin Research International (TRI), a company that was manufacturing and marketing another botulinum toxin type A product, Botulinum NeuroToxin Type A, known as "TRI-toxin." A physician from Kentucky who spoke at the conference represented that TRI-toxin was designed to compete with BOTOX® Cosmetic. (Tr. at 16-18; test. of Lentini.) Unlike BOTOX® Cosmetic, however, TRI-toxin was not an FDA-approved product. (Ex. A15 at 2.)
6. A few months after he attended the conference, Dr. Lentini purchased TRl-toxin for use in his clinic. TRI-toxin was less expensive than BOTOX® Cosmetic. In approximately November 2003, Dr. Lentini began using TRI-toxin on patients in lieu of BOTOX® Cosmetic. (Tr. 2 at 41-42; test of Lentini; tr. 1 at 129-31; test. of Flint.)
7. Dr. Lentini continued to represent on advertisements and marketing brochures for his "A Younger You" clinics that he was using BOTOX®. (Exs. A15 and A17.) Through at least mid-2004, Dr. Lentini used a Patient Consent form for patients seeking treatment of facial lines that provided, in pertinent part, as follows:
Jerome N. Lentini, MDPC
Patient Consent Form
BOTOX® botulinum toxin type A
Patient Name: ___________________________
Chart #:______________________ Date: ____________________
To the patient: Being fully informed about your condition and treatment will help you make the decision whether or not to undergo BOTOX® Cosmetic treatment. The disclosure is not meant to alarm you; it is simply an effort to better inform you so that you may give or withhold your consent for this treatment.
I have requested that Dr. Jerome N. Lentini, MD attempt to improve my facial lines with BOTOX® Cosmetic. This is the Allergan Inc. trademark for botulinum toxin type A. These injections have been used for more than a decade to improve spasm of the muscles around the eye, to correct double vision due to muscle imbalance as well as numerous other uses. BOTOX® Cosmetic is now approved by the FDA to improve the appearance of vertical lines between the brows. A few tiny injections of BOTOX® Cosmetic relax overactive muscles and soften those vertical lines. Injections in other areas to improve the appearance of facial lines have been reported in the literature, but the FDA has not approved those uses. The results of BOTOX® Cosmetic are usually dramatic, although the practice of medicine is not an exact science and no guarantees can be or have been made concerning expected results. _ __Patient Initials
* * *
Patient's Signature: ____________________ Date: _____________
Physician's Signature: ____________________Date: _____________
(Ex. Al at 3 L)
8. With the exception of only two or three patients, Dr. Lentini did not advise his patients when he began using TRI-toxin in place of BOTOX® Cosmetic to treat facial wrinkles. Dr. Lentini treated several hundred patients at his Salem and Tigard clinics with TRI-toxin, when these patients believed they were receiving injections of the FDA-approved BOTOX®. (Tr. 1 at 13-15,21-22,28; test. of Lentini.)
9. Dr. Lentini received vials of TRI-toxin containing the following warning on the label:
"For Research Purposes Only. Not For Human Use." The warning was written vertically on the side of each of the vial's label, in black ink with a yellow background. (Ex. A15 at 2; Ex. A16; tr. 1 at 134-35; test. of Flint.)
10. By mid-2004, Dr. Lentini became dissatisfied with the results his patients were getting with TRl-toxin. Around that same time, he became aware of another botulinum toxin type A product being manufactured by the Shandong BioResearch Institute in China under the name "Refinex." Dr. Lentini received favorable information about Refinex from a physician in Istanbul, Turkey, named Abdul Omarjee. Dr. Lentini learned, among other things, that Refinex used gelatin rather than albumin as a binding agent, which reportedly caused fewer side effects and longer results from the toxin. Sometime after July 2004, Dr. Lentini began importing Refinex from South America and then Istanbul, Turkey, for use in treating his patients' facial wrinkles. (Tr. 1 at 18-20; test. of Lentini.)
11. Like TRI-toxin, Refinex was not approved by the FDA for use on humans. (Tr. at I at 19-21; test. of Lentini.)
12. Dr. Lentini continued to represent in advertisements and marketing brochures that he was using BOTOX®. In late 2004, he sent out a "Holiday Special" postcard to patients on his mailing list offering 10 percent off BOTOX® treatments. (Ex. A1FAlllll5.)
13. Dr. Lentini did not advise his patients when used Refinex in place of BOTOX® to treat facial wrinkles. Most patients believed they were receiving BOTOX® treatments.2 (Tr. I at 21-22,30-32; test. of Lentini.)
2Dr. Lentini's nurse, Ms. Garcia, and the other clinic employees who received anti-wrinkle injections from Dr. Lentini knew that he was using TRI-toxin and/or Refinex instead of BOTOX®. (Tr. 1 at 22, 67; test. of Lentini.) At some point, Dr. Lentini also advised two or three other patients that he was using a "new" or "different brand" of BOTOX®, which he believed was actually a better product. These patients did not seem concerned about the change, and just asked that they be given the best, yet less expensive product. (Tr. at 21-22; test of Lentini.),
14. In 2004, when Dr. Lentini opened "A Younger You" clinic in Tigard, he inherited many of Dr. Moos's patients. Some of these patients were receiving hormone therapy, more specifically, Human Growth Hormone (HGH) injections from Dr. Moos. These patients asked Dr. Lentini to continue with the HGH treatments. Dr. Lentini had routine blood work done on these patients, including a determination of their insulin-like growth factor 1 (IGF 1) level. If the patient's IGF I was below, or in the low range of normal for the patient's age, Dr. Lentini would offer HGH therapy. (Tr. 1 at 49-57; test. of Lentini.)
15. Dr. Lentini used a Patient Consent form for patients seeking evaluation and treatment for "Hormone Balancing Therapy." The six page Consent form provided, in part, as follows:
Consent for the Evaluation and Treatment for Hormone Balancing Therapy. I authorize and give my consent to Jerome N. Lentini, M.D. and such other physicians, associates, technicians, pharmacists, and well as any other healthcare personnel of "A Younger You" for the evaluation and treatment of my aging process by the administration of hormones, other pharmaceutical interventional therapies and dietary supplements, and any other non-described here-to-fore described interventional therapeutic agents in this document. The goal and possible benefits of this therapy is to try and stop/slow and/or reverse my aging process, through hormone balancing, control of oxidative stress and other clinically significant therapeutic agents.
I fully understand that the medical diagnosis of "deficiency and insufficiency" do not apply to my case because such diagnosis may require tests to establish much lower levels, and as such my levels could be considered normal under that standard.
* * * Jerome N. Lentini, MD will prescribe these medications at physiologic dosages designed to accomplish physiologic levels of hormones/medications/ vitamins/herbs/minerals in my blood stream. Our goal is to achieve physiologic levels that are set to that of a 20 year old person . . . and would be within the "normal" or "average" blood concentrations for that group. At physiological blood levels, there is not expected to be any significant risks/adverse reactions . . . as long as the full medical disclosure is achieved from the patient . . . during the total time of therapy.
Prescription And Non-Prescription Hormones: And Other Suggested or Prescribed Therapies:
Human Growth Hormone (HGH) - Somatotropin
A prescription hormone, given by hypodermic injection or transdermal infusion. This is the primary and essential anti-aging hormone that affects cellular growth and metabolism. HGH is the main and most popular hormone in use throughout the world. It has multiple benefits. There are thousands of confirmatory research papers extolling the benefits of HGH in setting back the aging process. Our target is to obtain the growth and development hormone levels of a thirty year old and above.
Adverse reactions at or above therapeutic levels include, transient high blood sugar (hyperglycemia), development of antibodies to HGH, localized joint pain and water retention and carpal tunnel syndrome. These side effects are dose related and are usually eliminated by adjusting the dosage.
(Ex. A14 at 27-32.)
16. Patient B, a 49-year-old woman, came to Dr. Lentini's clinic in late 2004 asking for hormone replacement therapy. Patient B's lab work indicated that she had an IGF 1 factor of 133, which was within the normal range of 94 to 252 for her age group. (Ex. A14 at 8.) Dr. Lentini put her on daily HGH injections, with the goal of increasing her IGF 1 level to 250, the high end of the normal range for a 49 year old. Dr. Lentini prescribed Patient B with one unit (approximately 1/15th of a vial) of HGH per day, which she was to inject herself (Tr. 1 at 78-85; test. of Lentini.) Patient B paid Dr. Lentini approximately $250 per vial, or about $500 per month for her HGH therapy. (Tr. 2 at 24-25; test. of Lentini.)
17. The FDA has approved the use of growth hormones for adults only under certain circumstances. That use, however, is subject to strict medical guidelines. The guidelines set standards for the diagnosis and therapy of growth hormone deficiency in adults. They establish that growth hormone therapy is indicated only where the patient has a confirmed diagnosis of growth hormone deficiency. (Tr. 1 at 91-92; test. of Cook.)
18. The distribution of human growth hormone is also regulated by federal statute, 21 U.S.C. §333(e). Under this statute, it is a felony to knowingly distribute human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services. (Ex. A6.)
19. Dr. Lentini was unaware of the strict guidelines for use of HGH or the provisions of 21 U.S.C. §333(e) when he prescribed HGH to patients. (Tr. 2 at 7; test. of Lentini.)
20. In prescribing HGH to adults, the standard of care demands that the patient have a growth hormone deficiency, a diagnosis that is confirmed by stimulation test or evidence of a traumatic brain injury affecting the pituitary, or evidence of pituitary disease and loss of function. There are no approved applications or indications for using HGH for anti-aging, fat reduction or sleep improvement purposes in adult patients. (Tr. 1 at 94; test. of Cook.)
21. The dosage of HGH that Dr. Lentini prescribed for Patient B, an injection of one unit per day, served to replace and displace the growth hormone her body was already producing (approximately 250 micrograms per day), but it was insufficient to increase her IGF 1 level. Therefore, while this HGH therapy was not causing Patient B any harm per se, it was also not necessary or efficacious. (Tr. 1 at 97-99; test. of Cook.)
22. Dr. Cook is a professor of medicine at Oregon Health Sciences University in Portland, Oregon, and he is the chief of the endocrinology, diabetes and clinical nutrition department. He has served as a co-chairman in writing the American Association of Clinical Endocrinologist's medical guidelines for use of growth hormones in clinical practice. (Tr. 1 at 89-90.) In Dr. Cook's opinion, the Informed Consent form about hormone replacement therapy that Dr. Lentini used with Patient B and other patients did not adequately address the risks associated with HGH therapy. (Tr. 1 at 99-100.) In addition, in Dr. Cook's opinion, Dr. Lentini did not conform to well-recognized standards of practice when he prescribed HGH to Patient B and others. (Tr. 1 at 102; test. of Cook.)
23. Other services and treatments offered by Dr. Lentini's "A Younger You" clinics included a minimally invasive face lifting procedure called "FeatherLift" or "Threadlift," lip and facial line fillers using Restylane, Juvederrn or Perlane, and an alleged fat-dissolving process called "mesotherapy.' In a mailer from later 2004, Dr. Lentini advertised "Certified in Mesotherapy for: Fat Dissolving, Body Sculpting & Cellulite." (Exs. A15 and AI7.)
24. Mesotherapy involves the injection of plant extracts, vitamins and medications under the skin to be absorbed into the mesodermal layer. It is touted as an alternative to liposuction. (Ex. A7.) Mesotherapy is not approved by the FDA and, in May 2007, the American Society for Aesthetic Plastic Surgery released a patient safety warning advising against the use of such treatment. Although there have been media reports and advertising claiming that mesotherapy is a safe and effective way to eliminate unwanted body fat, there have been no published peer-reviewed scientific reports of properly performed studies to confirm the safety and/or efficacy. (Ex. AI0.)
25. Dr. Lentini went to a conference on mesotherapy in 2004. He also reviewed information from the drug company that sold Lipostabil, the plant extract, vitamin and medication cocktail that he injected into the patient in performing mesotherapy. Based on this information, Dr. Lentini believed that mesotherapy was effective. He, or his nurse, Ms. Garcia, did mesotherapy on only a few patients, however, and according to Dr. Lentini, those patients seemed satisfied with the results. (Tr. 1 at 37-41; test. of Lentini.)
26. In May 2004, Board Investigator Mei-Mei Wang and Oregon State Board of Nursing Investigator Marilyn Iverson went to Dr. Lentini's Tigard clinic in an undercover capacity for a free consultation. The Board had received a complaint about improper medical care regarding the clinic's use of Lipostabil, so Wang and Iverson went to investigate. They met with Dr. Lentini and his nurse, Ms. Garcia. They discussed mesotherapy and soft-tissue fillers, antiwrinkle injections and chemical peels. (Tr. 193-96; test. of Wang.)
27. Ms. Wang told Dr. Lentini and Ms. Garcia that she was getting married that summer, and she wanted to "freshen up" and look good for the big event. She also mentioned that she had had a baby, and was hoping to get down to her pre-pregnancy size of a 2 or 4 by the time of the wedding. With regard to mesotherapy, Dr. Lentini advised Ms. Wang that it had been done for many years in Europe, that it started in France and people all over the country were doing it. He explained that the treatment involved a series of injections. Ms. Wang asked about the side effects. She was told that there were very few, maybe some slight swelling and pain at the injection sites. She also was told that she could have the treatment to reduce fat on her hips, butt and triceps. (Tr. 1 at 197-98; test. of Wang.)
28. With regard to soft tissue fillers, Ms. Wang was advised that the soft tissue fillers (Restylane, Juvederm and Perlane), could be used on her face to make it look smoother. Ms. Garcia mentioned to Ms. Wang that Restylane was FDA approved, but the gels, Juvedenn and Perlane, were not yet approved. Ms. Wang also asked about the BOTOX® treatments listed in the clinic's cosmetic services brochure. Ms. Garcia did not advise Ms. Wang that the clinic was using a product other than BOTOX® by Allergan. (Tr. I at 201-02; test. of Wang.)
29. Dr. Lentini also sold "Super Packs," at his clinics, which were marketed as an antiaging product. These packets of "nutraceuticals' included daily doses of vitamins, co-enzyme Q, rose hips, flax seed and anti-oxidants, among other things. (Tr. 1 at 44-49; test. of Lentini.)
30. In late December 2004, after the media reported that some people in Florida had become critically ill after being injected with non-FDA approved botulinum toxin, the Board received a tip that Dr. Lentini had been using non-FDA approved botulinum toxin products in place of BOTOX® Cosmetic. The Board passed information on to the FBI, and both the FBI and the Board began investigating the matter. In early January 2005, the FBI obtained a warrant and searched both of Dr. Lentini's clinics and his home in Salem. (Tr. 1 at 129-148; test. of Flint; tr. 1 at 202-08; test. of Wang.)
31. In July 2005, Dr. Lentini was indicted in the United States District Court for the District of Oregon and charged with mail fraud, wire fraud and misbranding drugs, in connection with purchase and use of TRI-toxin and Refinex on his patients. (Ex. A2.) In December 2006, Dr. Lentini pled guilty to one felony charge of Misbranding a Drug (Tri-toxin) in violation of 21 U.S.C. §§ 331(k) and 333(a)(2); 18 U.S.C. §2. The remaining counts were dismissed. Dr. Lentini was convicted of the felony offense, and sentenced to 18 months at the federal Bureau of Prisons at Sheridan Camp in Sheridan, Oregon. He was also ordered to pay restitution to identified victims in the amount of $330,306.76. (Ex. A3.)
32. Dr. Lentini began serving his prison term in late January 2007. He is scheduled to be released in July 2008. (Ex. A3.)
CONCLUSIONS OF LAW
1. Dr. Lentini engaged in unprofessional or dishonorable conduct under ORS 677.190(1)(a), as defined by ORS 677.188(4)(a).
2. Dr. Lentini obtained fees by fraud or misrepresentation in violation of ORS 677.190(4).
3. Dr. Lentini was convicted of an offense punishable by incarceration in a federal prison in violation ofORS 677.190(6).
4. Dr. Lentini made false or misleading statements regarding the skill, value or efficacy of the medicine, treatment or remedy he prescribed or administered in the treatment of any disease or condition of the human body or mind, in violation of ORS 677.190(9).
5. Dr. Lentini committed gross negligence or repeated negligence in the practice of medicine. ORS 677.190(14).
6. The appropriate sanction for Dr. Lentini's violations of the Medical Practice Act is revocation of his license to practice medicine.
"The burden of presenting evidence to support a fact or position in a contested case rests on the proponent of the fact or position." ORS 183.450(2). Here, the Board has the burden of proving its allegations, and Dr. Lentini has the burden of proving any affirmative defenses. Gallant v. Board of Medical Examiners, 159 Or App 175, 183 (1999). See also, Harris v. SAIF, 292 Or 683, 690 (1982) (general rule regarding allocation of burden of proof is that the burden is on the proponent of the fact or position.); and Cook v. Employment Div., 47 Or App 437 (1980) (in the absence of legislation adopting a different standard, the standard in administrative hearings is preponderance of the evidence).
The Board is authorized by ORS 677.190 to suspend or revoke the license of a physician to practice medicine for any of several delineated reasons. In this case, the Board sought to revoke Dr. Lentini's license. It based its action on the following statutory provisions:
(1)(a) Unprofessional or dishonorable conduct.
(4) Obtaining any fee by fraud or misrepresentation.
6) Conviction of any offense punishable by incarceration in a Department of Corrections institution or in a federal prison * * *.
(9) Making false statements that the licensee knows, or with the exercise of reasonable care should know, are false or misleading, regarding skill or the efficacy or value of medicine, treatment or remedy prescribed or administered by the licensee or at the direction of the licensee in the treatment of any disease or other condition of the human body or mind.
* * *
(14) Gross negligence or repeated negligence in the practice of medicine or podiatry.
The Board's allegations of misconduct focus primarily on four aspects of Dr. Lentini's cosmetic medicine practice: (1) His use of non-FDA approved botulinum toxin type A products (TRl-toxin and Refinex) to treat patients' facial wrinkles, and his misrepresentations to patients that they were receiving BOTOX® Cosmetic by Allergan, Inc.; (2) his use of HGH for patients' life enhancement purposes, and his marketing HGH therapy as a way to slow or reverse the aging process; (3) his advertising of mesotherapy as a safe and effective fat loss treatment, and his use of that treatment on patients; and (4) his marketing of "Super Packs" of vitamins as antiaging products.
Each alleged violation will be addressed in tum.
1. Unprofessional or dishonorable conduct
The definition of "unprofessional or dishonorable conduct" is set out at ORS 677.188(4):
Unprofessional or dishonorable conduct' means conduct unbecoming a person licensed to practice medicine or podiatry, or detrimental to the best interests of the public, and includes:
(a) Any conduct or practice contrary to recognized standards of ethics of the medical or podiatric profession or any conduct or practice which does or might constitute a danger to the health or safety of a patient or the public or any conduct, practice or condition which does or might impair a physician's or podiatric physician and surgeon's ability to safely and skillfully to practice medicine or podiatry;
(b) Willful performance of any surgical or medical treatment which is contrary to acceptable medical standards; and
(c) Willful and repeated ordering or performance of unnecessary laboratory tests or radiologic studies; administration of unnecessary treatment; employment of outmoded, unproved or unscientific treatments; failure to obtain consultations when failing to do so is not consistent with the standard of care; or otherwise utilizing medical service for diagnosis or treatment which is or may be considered inappropriate or unnecessary.
The Board alleged that Dr. Lentini engaged in unprofessional or dishonorable conduct when he: (a) injected patients with TRI-toxin and Refinex in lieu of BOTOX® Cosmetic without informing these patients of the switch; (b) prescribed and dispensed HGH to patients, including Patient B; and (c) performed mesotherapy on patients.
a. Use of Non-FDA approved botulinus toxin type A. The record clearly demonstrates that by injecting patients with TRI-toxin and Refinex, non-FDA approved botulinum toxin type A products, and representing to those patients that they were receiving BOTOX®, the FDA product from Allergan Inc., Dr. Lentini engaged in unprofessional or dishonorable conduct. First, it is obviously unethical to mislead patients, i.e., to advertise, or to identify on the patient consent form, one particular product, and then use a different product on the patient. It is also unethical to fail to advise patients that the particular product they are receiving has not been approved by the FDA.
Dr. Lentini asserts that he did not know that TRl-toxin and Refinex were not FDA-botulinum approved products, but this contention is untenable. Dr. Lentini knew that the FDA had approved BOTOX® Cosmetic which is Allergan Inc.'s brand of botulinum toxin type A, for use on wrinkles. He knew that a product had to be approved by the FDA to be used on humans. He attended a conference touting TRl-toxin as a competitor to Allergan's BOTOX®, but he later received vials of the product labeled "For Research Purposes Only. Not for Human Use." As a physician, Dr. Lentini had an obligation read the label warnings on the product he was using. He also had an obligation to determine whether TRI-toxin was FDA-approved for use on humans.
With regard to the Refinex, Dr. Lentini's information source and contact was a physician in Istanbul, Turkey. Dr. Lentini knew the product was being manufactured in China, and he imported it into this country via South America or Turkey. He knew the product was somewhat different than BOTOX®, because it had gelatin rather than albumin as a binding agent. Given these circumstances, Dr. Lentini simply had no rational basis to believe or expect that this product was approved by the FDA to treat facial wrinkles.
Aside from the ethical issues, Dr. Lentini's use of TRI-toxin and Refinex also constituted a potential danger to the health and safety of his patients, as these products were not approved for human use in the United States. Thus, this violation has been proven.
b. Use of HGH. The record further demonstrates that Dr. Lentini engaged in unprofessional or dishonorable conduct in prescribing and dispensing HGH to patients, including Patient B. It is contrary to acceptable medical standards to use HGH for life enhancement purposes, as opposed to the treatment of disease with a confirmed diagnosis of adult growth hormone deficiency or other recognized medical condition. It is also a federal crime to prescribe HGH for purposes other than treatment of a disease or recognized medical condition. 21 U.S.C. §333(e)(1).
In addition to being illegal and contrary to the acceptable medical standards, Dr. Lentini's use of HGH on Patient B was also medically unnecessary and ineffective. The Board's expert, Dr. Cook, explained the dosage of HGH that Dr. Lentini prescribed for Patient B (1 unit per day) did nothing but replace and displace the growth hormone her body was already producing. This amount was not enough to cause harm to her, but it was also insufficient to increase her IGF 1 level. Thus, Patient B paid several hundred dollars for a treatment that was illegal and that provided no benefit to her.
c. Mesotherapy. Dr. Lentini offered mesotherapy to patients as a way to lose weight, dissolve fat and reduce cellulite. As of May 2007 however, three years after Dr. Lentini offered the treatment, there were still no peer-reviewed, scientific articles confirming the treatment's safety and efficacy. The promotion and use of this unproven treatment on clinic patients constitutes unprofessional or dishonorable conduct as defined by ORS 677.188(4}.
2. Obtaining a fee by fraud or misrepresentation
Pursuant to ORS 677.190(4), the Board is authorized to discipline a physician for "obtaining any fee by fraud or misrepresentation." As set forth above, Dr. Lentini misled his patients about the anti-wrinkle injections he was using. He advertised and informed patients that he was using BOTOX®, when he was instead using other, non-FDA approved botulinum toxin type A products. Dr. Lentini treated several hundred patients with these non-FDA approved products and, collectively, these patients paid him more than $300,000 for such treatments. Thus, the Board has established repeated incidents in which Dr. Lentini obtained a fee by fraud or misrepresentation in violation of this provision.
Dr. Lentini also charged patients for mesotherapy, promising fat loss and cellulite reduction, when such treatments were scientifically unproven. Furthermore, as discussed above, he charged patients for HGH therapy, promising to stop or reverse the patient's aging process, when the dosage he prescribed did nothing to increase the patient's growth hormone level.
3. Conviction of an offense punishable by incarceration
As set out above, ORS 677.190(6) authorizes the Board to suspend or revoke the licensee for "Conviction of any offense punishable by incarceration in a Department of Corrections institution or in a federal prison, subject to ORS 670.280."3
3DRS 670.280 requires, in essence, that the conduct giving rise to the conviction be substantially related to the licensee's fitness and ability to engage in the activity for which the license is required. The statute provides, in part, as follows:
(2) Except as provided in DRS 342.143 or 342.175, a licensing board, commission or agency may not deny, suspend or revoke an occupational or professional license solely for the reason that the applicant or licensee has been convicted of a crime, but it may consider the relationship of the facts which support the conviction and all intervening circumstances to the specific occupational or professional standards in determining the fitness of the person to receive or hold the license.
(3) A licensing board, commission or agency may deny an occupational or professional license or impose discipline on a licensee based on conduct that is not undertaken directly in the course of the licensed activity, but that is substantially related to the fitness and ability of the applicant or licensee to engage in the activity for which the license is required, In determining whether the conduct is substantially related to the fitness and ability of the applicant or licensee to engage in the activity for which the license is required, the licensing board, commission or agency shall consider the relationship of the facts with respect to the conduct and all intervening circumstances to the specific occupational or professional standards.
Dr. Lentini pled guilty to, and was convicted of, the felony offense of Misbranding a Drug With Intent to Defraud Patients, 18 U.S.C. §2 and 21 felony U.S.C. §§ 331(k) and 333(a)(2). The conduct giving rise to this conviction was undertaken in the course of Dr. Lentini's medical practice, and the offense is punishable by incarceration in a federal prison. As a result of his conviction, Dr. Lentini is currently serving an 18-month sentence at the Sheridan Camp in Sheridan, Oregon. Thus, the Board has a basis to revoke Dr. Lentini's license under this provision as well.
4. Making false statements
Another basis for revoking a physician's license is set out at ORS 677.190(9), as follows:
Making statements that the licensee knows, or with the exercise of reasonable care should know, are false or misleading, regarding skill or the efficacy or value of the medicine, treatment or remedy prescribed or administered by the licensee or at the direction of the licensee in the treatment of any disease or other condition of the human body or mind.
The Board's counsel asserted at the hearing that Dr. Lentini violated this provision when he failed to advise his patients that he was using TRl-toxin and Refinex in place of BOTOX®, when he represented that HGH therapy can stop or reverse the aging process, and when he asserted that mesotherapy was a safe and effective way to rid one's body of unwanted fat.
The evidence demonstrates that Dr. Lentini led many patients to believe he was using BOTOX® when in fact he was using other, non-FDA approved botulinum toxin type A products. The evidence also shows that, for the few patients he did advise about the alternate product, he led them to believe it was the same thing, yet better than original. This was misleading information, because neither TRl-toxin or Refinex were approved by the FDA for use in treating facial wrinkles.
With regard to HGH, Dr. Lentini represented that the therapy could "stop/slow and/or reverse" the patient's aging process. Dr. Lentini should have known this was false or misleading information, as there are no approved applications or indications for using HGH for anti-aging purposes. Growth hormone therapy is appropriate only where the patient has a confirmed diagnosis of growth hormone deficiency.
In addition, Dr. Lentini charged patients for mesotherapy, promising fat loss and cellulite reduction, when such treatments were scientifically unproven. He also sold vitamin "Super Packs," which he claimed promoted health and longevity, when the benefits of these vitamin packets have not been scientifically proven. Given these findings, the Board has established that Dr. Lentini violated ORS 677.190(9) as well.
5. Gross or repeated negligence
Finally, the Board alleged that Dr. Lentini was grossly or repeatedly negligent in the practice of medicine at his two clinics. Negligence is defined as "the failure to exercise the standard of care that a reasonably prudent person would have exercised in a similar situation." Black's Law Dictionary 1 056 (7th ed 1999). Although the statutes governing the Board do not specifically define "negligence," the dictionary definition is consistent with the standard set out in ORS 677.095(1).4
4"(1) A physician or podiatric physician and surgeon licensed to practice medicine or podiatry by the Oregon Medical Board for the state of Oregon has the duty to use that degree of care, skill and diligence that is used by ordinarily careful physicians or podiatric physicians and surgeons in the same or similar circumstances in the community of the physician or podiatric physician and surgeon or a Similar community." DRS 677.095(1).
The record demonstrates that Dr. Lentini fell below the standard of care in using non-FDA approved botulinum toxin type A products on his patients in lieu of BOTOX® Cosmetic. A reasonably prudent physician would have confirmed whether the products injected into patients were FDA approved. A reasonably prudent physician would have informed patients about the specific product being used, and not misled patients to believe they were receiving BOTOX®. A reasonably prudent physician would also have heeded the warning on the TRI-toxin label, and not used this product on human patients.
The record also establishes that Dr. Lentini fell below the standard of care in prescribing HGH to his patients, including Patient B. Dr. Lentini was unfamiliar with the approved federal guidelines for use of growth hormones for adults, and he failed to adequately discuss with his patients the risks and side effects associated with HGH therapy. Dr. Lentini further failed to conduct proper testing on patients to determine whether the patient needed such treatment. His conduct in this regard also constitutes gross or repeated negligence.
Dr. Lentini has committed multiple violations of the Medical Practice Act, as set forth above. Under ORS 677.205, the Board is authorized to discipline licensees who have committed such violations. As it is entitled to do under ORS 677.205(2), the Board sought to revoke Dr. Lentini's license based on the violations established in this case.
Given both the nature and the number of violations established, the AU found that revocation is warranted and appropriate. The evidence shows that Dr. Lentini's misconduct goes wen beyond the felony criminal act for which he was convicted, i.e., misbranding a drug with intent to defraud patients. He put patients at risk by using non-FDA approved botulinum toxin type A products, and by being unfamiliar with the standard of care and the law for prescribing HGH. The AU further recommended that, in accordance with the Board's authority under ORS 677.205(2), Dr. Lentini be assessed the costs associated with this disciplinary proceeding.5 The Board adopts these findings and recommendations.
4In Adams v. Board of Medical Examiners, 170 Or App I (2000), the court held that "costs of the disciplinary proceeding" as set forth in DRS 677.205 (2)(f) properly included the cost of hearing officer, expert witness fees, cost of court reporter and cost of Board counsel.
1. The Board revokes Dr. Lentini's medical license.
2. After the passage of two years, if and when Dr. Lentini applies for an Oregon medical license, he must first demonstrate that his medical skills, knowledge and judgment are current and meet the community standards.
3. Dr. Lentini is assessed the costs associated with this disciplinary proceeding. The assessed costs shall be paid within 90-days from the date the Board issues its "Bill of Costs."
DATED this 11th day of April 2008.
OREGON MEDICAL BOARD
State of Oregon
PATRICIA L. SMITH
Right to Judicial Review
NOTICE: You are entitled to judicial review of this Order. Judicial review may be obtained by filing a petition for review with the Oregon Court of Appeals within 60 days after the final order is served upon you. See ORS 183.482. If this Order was personally delivered to you, the date of service is the day it was mailed, not the day you received it. If you do not file a petition for judicial review within the 60 days time period, you will lose your right to appeal.
This page was posted on March 16, 2015.