Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Fax Number: Subject: Type: Fax MAR-11-200@5 13:52 AHCAZLEGAL MEDICAL 858 414 1989 P.@3 ~ ro oa : STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 2005-00229 STEPHEN CHIARELLO, M.D., on eat ps RESPONDENT. O 2 O49 | F L- ve COMES NOW, Petitioner, Department of Health, by and through Its ot undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Stephen Chiarello, and in support thereof alleges: 1. Patitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed physician within the state of Florida, having been issued license number ME 34901. Received Event (Event Succeeded) Date: Pages: Sender: Time: 1:55 PM 8 as Duration: 7 min 53 sec 850 414 1989 Company: 9893 AHCA/LEGAL MEDICAL 858 414 1 11-2 153 MAR-11-28@85 13:5 mM 3. Respondent's address of record is 200 Doctors Drive, Panama City, Florida 32405-4559, 4. Respondent is board certified in dermatology and internal medicine. - 5. Botox®, which contains Botulinum Toxin Type A, is a legend drug, which requires a physician’s Prescription for use or administration. Botulinum Toxin Type A is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g)(1)(B) and (C), intended for use in the diagnosis, Cure, mitigation, treatment, or prevention of disease in man, or to affect the structure or the function of the body of man, and biologic, as defined in section 361(i) of the Public Heath Service Act, 42 U.S.C. § 262, and Section 499.003(17)(b) and (c), Florida Statutes (2003)(2004), On December 9, 1991, the FDA approved BOTOX®, a Botulinum Toxin Type A drug manufactured by Allergan of Irvine, California, for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck Pain associated with cervical dystonia and the treatment of strabismus and blepharospasm associated with dystonia. On April 12, 2002, the FDA approved a supplement to the Botulinum Toxin Type A license application for treatment of glabellular lines, commonly referred to as wrinkles. Under this approval, Botulinum JAPSU\Medical\DIANE\Chiarello\AC 2005-00229.doc 2 P.@4 Received Event (Event Succeeded) Time: 1:55 PM : 05 Page 8 m Duration: 7 min 53 sec ages: Sender: 850 414 1989 Company: nhiant os Few nee 1-2005 13:53 AHCA’LEGAL MEDICAL a58 414 1989 P M “o~ oN Toxin Type A is marketed and labeled for this new indication as BOTOX® and BOTOX@COSMETIC manufactured by Allergan. No other manufacturers have been approved by the FDA to produce or distribute Botulinum Toxin Type A as a drug in the United States, 6. Botulinum Toxin Type A is a neurotoxin produced by the Clostridium botulinum bacterium, the same bacterium that causes botulism. Abuse or overdose of Botulinum Toxin Type A can cause botulism. 7. Botulism is a muscle-paralyzing disease caused by a toxin made by a bacterium called Clostridium botulinum. Once in the body, the toxin binds to nerve endings at the point where the nerves join muscies. This prevents the nerves from signaling the muscles to contract. The result is weakness and paralysis that descends from the cranium down, affecting, among other things, the muscles that regulate breathing. Respiratory dysfunction often follows from the respiratory paralysis. Recovery can be extremely slow. Assuming the patient receives proper care to ensure continued breathing, recovery occurs only when the affected nerves grow new endings, a process that can take several months, although the length of time varies greatly from case to case. In rare cases, botulism can be fatal. JAPSU\MedicafDIANE\Chiarelio\AC 2005-00229. doc 3 Received Event (Event Succeeded) ime: ‘55 PM Date: 3/11/2005 Time: 1 56 Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Fax Number: Subject: Type: Fax MAR-11-2685 13:53 AHCA”LEGAL MEDICAL oa. oN 8. On or about December 1, 2004, while investigating the genesis of four cases of botulism that had drawn national attention, the FDA executed a search warrant on Advanced Integrated Medical Center, Inc., (Advanced Integrated). Pursuant to the warrant, the FDA seized advertisements from Toxin Research International, Inc. (TRI), which advertised Botulinum Neurotoxin Type A for sale at a price of $1,250.00 for one 500-unit vial or $2,000.00 for two 500-unit vials, The advertisement included a notation under the TRI logo, which read, “For Research Purposes Only Not for Human Use.” 9. On or about December 29, 2004, the Department received communication from the FDA that it had executed a search warrant on TRI, P.O. Box 89357, Tucson, Arizona, a company advertising and distributing “Stabilized Botulinum Neurotoxin Type A” to physicians around the country. 10. TRI does not have a permit to Operate as a prescription drug manufacturer, pharmacy, prescription drug distributor, or pharmaceutical wholesaler in Florida. 11, In a statement to FDA Investigators, Chad Livdahl, principal Owner, Operator, and president of TRI, said that TRI is not registered with the FDA and has not filed a New Drug Application for its product or an JAPSU\ Media DTANE\Chrerelto\AC 2005-00229.doc 4 rey 858 414 1989 P.@6 Received Event (Event Succeeded) Date: Pages: Sender: F 1 Time: 1:55 PM oe Duration: 7 min 53 sec ns Company: a a 858 414 1989 =P. a7 CAL " ~ 154 AHCA/LEGAL MEDI MAR-11-2885 13 ae ~ application for approval as an Investigational New Drug because the Stabilized Botulinum Toxin Type A is marketed “for research Purposes only, not for human use,” 12. During the execution of the search warrant, the FDA recovered files from TRI Computers containing invoices of purchasers of the Stabilized Botulinum Neurotoxin Type A. Respondent was among these Purchasers, with the following purchases: Quantity I vial Stabilized Botulinum Neurotoxin Type A: 500 IU 5.0 ni Stabilized Botulinum Neurotoxin Type A: 500 IU 2 vials $2,000 Stabilized 2 vials Botulinum Neurotoxin Type A: 500 Iu $1,900 In accordance with Mr. Livdahl's Statement, each invoice Respondent received stated “For research Purposes only, not for human use.” In addition, the Standard label on the vials from TRI indicated, “For research J: APSU\Medical\DLANE\Chiarello\ AC 2005-00229.doc 5 Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Foy Aliimbar: Cuhiané- . MAR-11-2885 13:54 AHCA/LEGAL MEDICAL , 858 414 1989 P.28 a . . purposes only. Not for human use.” 13. Because Botulinum Neurotoxin Type A is the active ingredient in Botox®, and because Botox® is the only FDA approved form of the Botulinum Toxin Type A, on or about January 10, 2005, investigators from the Department inspected Respondent's office to ascertain how Respondent was using the Stabilized Botulinum Neurotoxin Type A. 14. When investigators interviewed Respondent, he stated that he “réceived an adveéitisement from TRI, and he believed TRI was a legitimate company offering botulinum at a reduced price. He further stated that he received the Stabilized Botulinum Toxin Type A in a concentrated form and diluted it for use. 15. Respondent admitted that he had used the product on patients as if it were Botox®. Respondent stated the patient records did not reflect whether a patient received Botox® or Stabilized Botulinum Neurotoxin Type A, but he did not use Botox® during the time period in which he ordered the TRI product. 16. Respondent had no remaining Stabilized Botulinum Neurotoxin Type A from TRI. Respondent stated that he had destroyed two or three Vials of Stabilized Botulinum Toxin Type A that he had purchased from TRI. By his admission, from on or about May 20, 2004, through January 7, JAPSU\MedicalNDLANE\Chiarello\AC 2005-00229.doc 6 Received Event (Event Succeeded) Time: 1:55 PM Date: 3/11/2005 Duration: 7 min 53 sec Pages: 28 Company: Sender: 850 414 1989 Shine 858 414 1989 her: IEDICAL ™ Num 11-2ees 1354 BALES M ~ 2005, Respondent treated 28 Patients for wrinkles using the Stabilized Botulinum Neurotoxin Type A. 17. By his admission, Respondent did not denote in patient records that he was using the TRI product, nor did he inform his patients that he Was using anything other than Botox®. 18. Respondent and two members of his staff indicated that he discontinued use of the Stabilized Botulinum Neurotoxin Type A when the four cases of severe complications associated with the use of unapproved botulinum toxin were published in the national media. 19. Chapter 499, Florida Statutes, is called the Florida Drug and Cosmetic Act, According to Section 499.002, Florida Statutes (2003)(2004), the Purpose of the act is to: (1) Safeguard the Public health and promote the public welfare by Protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics, (2) Provide uniform legislation to be administered SO far as practicable in conformity with the Provisions of, and regulations issued under the authority of, the Federal Food, Drug, and Cosmetic Act and that portion of the Federal Trade Commission Act which expressly prohibits the false advertisement of drugs, devices, and cosmetics. (3) Promote thereby uniformity of such state and federal laws, and their administration and enforcement, throughout the United States. I APSU\MedicaNDIANE\Chiarello\AC 2005-00229.doe 9 P.@9g Received Event (Event Succeeded) Time: 1:55 PM Date: 3/11/2005 Duration: 7 min 53 sec Pages: 28 Company: Sender: 890 414 1989 Sih 850 414 1989 P10 Numher- . MEDICAL ~~ WMAR-11-2005 13:54 Bead LEGAL ~ 20. Administering or dispensing an unapproved drug is inherentiy dangerous as there js no mechanism for inspection or verification of product contents, efficacy, or safety. Similarly, purchasing drugs from an unlicensed source is inherently dangerous as there is no mechanism for quality assurance. Outside of the parameters of lawful regulatory Processes, there is no mechanism to ascertain whether a product is safe ~and- effective,—or -adulterated “and hazardous: Members of ‘the public cannot protect themselves from such dangers as hidden defects in pharmaceutical products, 21. FDA approval is Critical to establish the safety and efficacy of a new drug. Biologic Products, such as the botulinum toxin at issue herein, must be approved by the FDA by a biologic license application (“BLA”). Without FDA approval, then, there is no assurance that the product has been appropriately tested for use on humans, or that the manufacturing process conforms to current good manufacturing Practice. The purity, potency, stability, and Sterility characteristics of the product may vary batch by batch. 22. Another serious shortcoming caused by the lack of FDA approval is the failure of adequate labeling. The lack of approved labeling FAPSU\Medical\DLANE\Chiarctlo\AC 2005-00229.doc 8 10 Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Fax Number: Subject: Type: Fax MAR-11-2885 13:55 BuCALEGAL MEDICAL . 85@ 414 1989 P.1i for the TRI product constituted a serious danger to the patients to whom the drug was administered. The labeling contained no directions for use in human beings. There was heightened potential for Injection of excessive amounts of toxin because the safe and effective dose of the TRI product was unknown. The units of measurement of Botox® were specific to Allergan, and the testing method used by Allergan for assaying the potency of its finished product was proprietary. Thus, one unit of the TRI product was not equivalent to one unit of Botox®. As there was no established safe and effective dose of botulinum toxin distinct from Botox®, and the TRI product was not equivalent to Botox® unit for unit, there was no established safe and effective dosage of the TRI product. Without an established safe and effective dosage, the risk of overdose was increased. This risk was a foreseeable risk Inherent in utilizing a drug that was not FDA approved. 23. As stated in Section 499.002(1), Horida Statutes (2003)(2004), Chapter 499, Florida Statutes, is a public welfare statute. The regulatory provisions of the Florida Food and Drug Act under Chapter 499, Florida Statutes (2003)(2004), and the Federal Food, Drug, and Cosmetic Act under 21 U.S.C, § 301, et seq., are strict liability statutes. JADSU\Modical\DIAND\Chiarello\AC 2005-00229.dos 9 11 Received Event (Event Succeeded) Time: 1:55 PM Page 2 Duration: 7 min 53 sec Pages: 28 Company: reneer come ies MEDICAL 85@ 414 1989 P.12 , : GAL | MAR-11~28@5 13:55 preence ~ 24. While doctors cannot be guarantors of the safety or efficacy of drugs they administer, inject, or dispense to their patients, doctors have a Statutory or legal obligation to their patients to abide by the laws regulating the distribution of those drugs. 25. The FDA approval status of a drug is readily ascertainable to a physician. Upon approval of a drug, the FDA adds the drug to its published list of approved products, and that list is available to the public. -Similarly, ‘through the -exercise ‘of due’ diligence; “a ‘doctor cari ascertain whether an entity is licensed to manufacture or distribute a drug in the State of Florida, Thus, an exercise of due diligence would have revealed that the TRI product described herein was not FDA approved, or even pending approval, and that TRI was not a licensed pharmaceutical wholesaler, pharmacy, or distributor, 26. Under the strict liability regulatory provisions of the Federal Food, Drug, and Cosmetic Act, and the Florida Food and Drug Act, it is the affirmative duty of a doctor to know whether a drug is FDA approved and to know that the source from which he or she obtained the drug is licensed to distribute the drug to him or her Prior to, and as a condition of, administering, injecting, or distributing that drug to a patient. JAPSU\MedicalNDLANE\Chiarello\AC 2003-00229.doc 10 12 Received Event (Event Succeeded) Time: 1:55 PM Date: a Duration: 7 min 53 sec Pages: Company: Sender: 850 414 1989 Guhiart aso 414 1989 P.43 For a ent 12005 13:55 AHCA/LEGAL MEDICAL ~ oN 47. Section 499.003(17), Florida Statutes (2003)(2004), defines “drug” as an article that is: (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or Prevention of disease in humans or other animals; (Cc) Intended to affect the structure or any function of the body of humans or other animals; or (d) Intended for use as @ component of any article Specified in paragraph (a), paragraph (b), or paragraph (€), but does not include devices or their components, parts, or accessories. The definition of “drug” under 21 U.S.C. § 321 is the same in all material respects. 28. Because Stabilized Botulinum Neurotoxin Type A is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals, or to affect the Structure or the function of the body of humans or other animals, it is a drug within the meaning of Section 499.003(17), Florida Statutes (2003)(2004), and 21 U.S.C, § 321. 29. Botulinum Toxin Type A is a “legend drug” under Florida law. J: ‘APSU\Medical\DIANE\Chiarello\AC 2005-00229, doc ql 13 Received Event (Event Succeeded) ime: ‘55 PM Date: 3/11/2005 Time: 1 55 Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Snuhiact _ .14 Few nee 12005 13:56 | PHCA/LEGAL MEDICAL a 858 414 1989 P.t 30. The Stabilized Botulinum Neurotoxin Type A that Respondent purchased from TRI does not have an approved and effective application under Section 505 of the Federal Food, Drug, and Cosmetic Act, and is a “new drug” under Section 499.023, Florida Statutes (2003)(2004), and under 21 U.S.C. § 355. ) COUNT ONE 31. Petitioner realleges and incorporates Paragraphs one (1) through thirty (30) as if fully set forth herein. 32. Section 458.331(1)(g), Florida Statutes (2003)(2004), subjects @ doctor to discipline for “[flailing to perform any statutory or legal obligation placed upon a licensed physician.” 33. Section 499.023, Florida Statutes (2003)(2004), states: 499.023 New drugs; sale, manufacture, repackaging, distribution.— A person may not sell, offer for sale, hold for sale, manufacture, repackage, distribute, or give away any new drug unless an approved application has become effective under s. 505 of the federal act or unless otherwise permitted by the Secretary of the United States Department of Health and Human Services for shipment in interstate commerce. 34. Section 499.023, Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent to refrain from Selling, Offering for sale, holding for sale, manufacturing, repackaging, distributing, 12 J APSU\MedicaNDLANE\Chiarello\ac 2005-00229.doo Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Fax Number: Subject: Type: Fax MAR-11-2885 13:56 ; JPHCA/LEGAL MEDICAL ; @52 414 1989 P.1S or giving away a new drug that has no approved application under s. 505 of the federal Food, Drug, and Cosmetic Act or that is not otherwise permitted by the Secretary of the United States Department of Health and Human Services for shipment in interstate commerce. 35. Based on the foregoing, Respondent violated Section 499.023, Florida Statutes (2003)(2004), and, consequently, Section 458.331(1)(Q), Florida Statutes (2003)(2004), when he sold, offered for sale, held for sale, manufactured, repackaged, distributed, or gave away the TRI product, Stabilized Botulinum Neurotoxin Type A, a new drug with no approved and effective application under Section 505 of the Federal Food, Drug, and Cosmetic Act. COUNT TWO 36. Petitioner realleges and Incorporates paragraphs one (1) through thirty (30) and paragraph thirty-two (32) as If fully set forth in this count. 37. Similarly, under 21 U.S.C. § 355, the Federal Food, Drug, and Cosmetic Act prohibits a person from introducing or delivering a new drug into interstate commerce, unless there is an effective FDA approval for the drug. 38. Section 21 U.S.C. § 355 places a statutory or Icgal obligation JNPSU\Modical\DLANE\Chiarello\AC 2005-00229.doc Is Received Event (Event Succeeded) Date: Pages: Sender: 3/11/2005 Time: 1:55 PM 28 Duration: 7 min 53 sec 850 414 1989 Company: " MAR-11-2085 13:56 | PHCA/LEGAL MEDICAL ~ 858 414 1989 upon Respondent to refrain from introducing or delivering a new drug into interstate commerce, unless there is an effective FDA approval. 39. Based on the foregoing, Respondent violated Section 458.331(1)(g), Florida Statutes (2003)(2004), by administering, dispensing, or injecting the TRI product, Stabilized Botulinum Neurotoxin Type A, into many patients, thereby placing a new drug with no approved and effective application under Section 505 of the Federal Food, Drug, and Cosmetic Act-into-interstate commerce, in violation of 21 U.S.C. § 355. COUNT THREE 40. Petitioner realleges and incorporates paragraphs one (1) through thirty (30) and paragraph thirty-two (32) as if fully set forth in this count. 41. Under Section 499.005(1), Florida Statutes (2003)(2004), it is unlawful to perform or cause the performance of the following acts: The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use. 42. Section 499.005(1), Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent. }APSU\Medical\DLANE\Chiarello\AC 2005-00229.doc 14 16 P.16 Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min §3 sec Sender: 850 414 1989 Company: Few eR 11-2005 13:56 , PHCA/LEGAL MEDICAL Sunines: ~ 858 414 1989 1 43. Under Section 499.006(10), Florida Statutes (2003)(2004), a drug or device is deemed to be adulterated if it is a legend drug that has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. 44. Based on the foregoing, Respondent violated Section 499.005(1), Florida Statutes (2003)(2004), and, consequently, Section 458.331(1)(g), Florida Statutes (2003)(2004), by manufacturing, repackaging, Selling, delivering, or holding or offering for sale a drug (the unapproved TRI product, Stabilized Botulinum Neurotoxin Type A) that was adulterated because it had been purchased, held, sold or distributed bya person not authorized under federal or state law to do so (TRI). COUNT FOUR 45. Petitioner realleges and incorporates paragraphs one (1) through thirty (30) and paragraph thirty-two (32) as if fully set forth in this count. 46. Under Section 499.005(3), Florida Statutes (2003)(2004), it is unlawful to perform or cause the performance of the following acts: The receipt of any drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of such drug, device, or cosmetic, for pay or otherwise. IAPSU Medical DIANE\Chiarello\AC 2005-00229.doc 15 P. 17 Received Event (Event Succeeded) Date: Pages: Sender: Fax Number: 3/11/2005 Time: 1:55 PM 28 Duration: 7 min 53 sec 850 414 1989 Company: Subject: Type: Fax a MAR-11-20@85 13:57 858 414 1989 AHCA’LEGAL MEDICAL 47, Section 499.005(3), Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent. 48. Based on the foregoing, Respondent violated Section 499,005(3), Florida Statutes (2003)(2004), and, consequently, Section 458.331(1){g), Florida Statutes (2003X2004), by receiving a drug (the unapproved TRI product, Stabilized Botulinum Neurotoxin Type A) that had been adulterated because it had been Purchased, held, sold, or distributed by @ person not authorized under federal or state law to do so (TRI) and he delivered the drug to patients for pay. COUNT FIVE 49. Petitioner realleges and incorporates Paragraphs one (1) through thirty (30) and Paragraph thirty-two (32) as if fully set forth in this count. 50. Section 499.005(14), Florida Statutes (2003)(2004), makes unlawful: The purchase or receipt of a legend drug from a Person that is not authorized under this chapter to distribute legend drugs to that purchaser or recipient. 51, Section 499.005(14), Florida Statutes (2003)(2004), places a statutory or legal Obligation upon Respondent to refrain from purchasing or JAPSU\MedicaNDIANE\Chauretin\ AC 2003-00229.doc 16 Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Fax Number: Subject: Type: Fax ; MAR-11-28@85 13:57 AHCA’LEGAL MEDICAL ay 858 414 1989 P.19 receiving a legend drug from a person that is not authorized under Chapter 499 to distribute a legend drug to him. 52. Based on the foregoing, Respondent violated Section 499.005(14), Florida Statutes (2003)(2004), and consequently Section 458.331(1)(g), Florida Statutes (2003)(2004), when he purchased and received a legend drug (the unapproved Stabilized Botulinum Neurotoxin Type A) from TRI, an entity not licensed in Florida to distribute legend drugs. COUNT SIX 53. Petitioner realleges and incorporates paragraphs one (1) through thirty (30) as if fully set forth in this count. 54. Section 458,331(1)(m), Florida Statutes (2003)(2004), subjects a doctor to disciptine for: Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physidan by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations. JAPSU Medical DIANE huaretlo\Ac 7904-00229. doc VW Received Event (Event Succeeded) Date: Pages: Sender: MAR-11-2885 13:57 3/11/2005 Time: 1:55 PM 28 Duration: 7 min 53 sec Company: 850 414 1989 AHCA/LEGAL MEDICAL ~ 858 414 1989 55. Rule 64B8-9,003(3), Florida Administrative Code (2003)(2004), states: The medical record shall contain — sufficient information to identify the patient, Support the diagnosis, justify the treatment and ‘document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs Prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient. 56. Respondent failed to document in patient charts whether he administered Botox® or the unapproved Stabilized Botulinum Neurotoxin Type A. 57. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2003)(2004), by failing to note in patient charts whether he administered Botox® or the unapproved Stabilized Botulinum Neurotoxin Type A, as further required by Rule 64B8-9.003(3), Florida Administrative Code. COUNT SEVEN 58, Petitioner realleges and incorporates paragraphs one (1) through thirty (30) as if fully set forth in this count. JAPSU\Medical\ DIANE\Chiarelio\AC 2005-00229.doe 1a 20 P.2@ Received Event (Event Succeeded) Time: 1:55 PM Date: eo 1/2008 Duration: 7 min 53 sec Pages: ompany: Sender: 850 414 1989 canoer SQ 414 1989 PL Fax NA 12005 13:58 AHCA“LEGAL MEDICAL 8 T ~ oo. oN 59. Section 458.331(1)(p), Florida Statutes (2003)(2004), subjects a doctor to discipline for: Performing professional services which have not been duly authorized by the patient or client, or his or her legal representative, except as provided in s. 743.064, S. 766.103, or s. 768.13. 60. Respondent prescribed, dispensed, administered, injected, mixed, or otherwise prepared the Stabilized Botulinum Neurotoxin Type A, an unapproved product, without notifying the patient, making it impossibie for the patient to authorize such treatment. 61. Based on the foregoing, Respondent violated Section 458.331(1)(p), Florida Statutes (2003)(2004), by performing professional services which were not duly authorized by the patient or client, or his or her legal representative. COUNT EIGHT 62. Petitioner realleges and incorporates Paragraphs one (1) through thirty (30) as if fully set forth in this count. 63. Section 458.331(1)(q), Florida Statutes (2003)(2004), subjects @ doctor to discipline for: Prescribing, dispensing, administering, mixing, or otherwise Preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the Purposes of this paragraph, it shall be legally J ‘APSU\Medical\DIANE\Chiarelio\ AC 2005-00229.doc Received Event (Event Succeeded) Time: 1:55 PM Date: 3/11/2005 Duration: 7 min 53 sec Pages: 28 Company: Sender: 850 414 1989 Subiect: Q50 414 1989 = P.22 Fax Nine 41-2005 13:58 AHCA/LEGAL MEDICAL T . os oN - presumed that prescribing, dispensing, administering, mixing, or otherwise Preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's Professional practice, without regard to his or her intent. 64. Prescribing, dispensing, administering, injecting, mixing, or otherwise preparing an unapproved drug obtained from an unlicensed source is illegal and is inappropriate and outside the course of a physician‘s professional practice, Respondent dispensed, administered, injected, mixed or otherwise prepared a legend drug, the unapproved Stabilized Botulinum Neurotoxin Type A, obtained from an unapproved source, inappropriately and outside the course of his Professional practice, 65. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2003)(2004), by prescribing, dispensing, administering, injecting, mixing, or otherwise Preparing an unapproved drug obtained from an unlicensed source inappropriately and outside the course of his professional practice. COUNT NINE 66. Petitioner realleges and incorporates Paragraphs one (1) through thirty (30) as if fully set forth in this count. Be APSU\Medical\DLANE\Chiarello\AC 2005-00229. doc 20 22 Received Event (Event Succeeded) Time: 1:55 PM Date: 3/11/2005 Duration: 7 min 53 sec Pages: 28 Company: Sender: 850 414 1989 Suhiect- 858 414 1989 n° DICAL Fax Number” 2005 13:58 BHCAYLEGAL ME! 1 o~ 67. Section 458.331(1)(t), Florida Statutes (2003)(2004), subjects a physician to discipline for failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. 68. By administering, injecting, or dispensing the unapproved TRI product to many patients, Respondent has failed to meet the applicable Standard of care which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances, 69. Based on the foregoing, Respondent violated Section 458.331(1)(t), Florida Statutes (2003)(2004), by failing to Practice Medicine with that level of Care, skill, and treatment which is recognized by a reasonably prudent similar Physician as being acceptable under similar Conditions and circumstances. WHEREFORE, the Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: Permanent revocation or Suspension of Respondent's license, restriction of Practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of J ‘APSU\MedicaNDLANE\Chiarello\ AC 2005-00229.doc 2] Received Event (Event Succeeded) Date: 3/11/2005 Time: 1:55 PM Pages: 28 Duration: 7 min 53 sec Sender: 850 414 1989 Company: Fax Number: Suhbiect- MAR-11-28@05 13:58 AHCA-LEGAL MEDICAL 858 414 1989 P.24 1 oN fees bi i billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this _257* day of Cid Ae ne , 2005 John O. Agwunobi, M.D M.B , M.D., M.B.A., M.P.H. Secretary, Department of Health FILED 4052 Bald Cypress Way-Bin C-65 DEPARTMENT OF DEPUN Or HEATH Tallahassee, Florida 32399-3265 ae-\ }ekaoum, Florida Bar # 0233285 mare D250 (850) 414-8126 (850) 414-1989 fax DKK/dkk Reviewed : ini and approved DY: Ole (initials) 5 {telex (date) PCP: Fe br, 25, 2005 PCP Members: 4 4 ers: Mund Ashkar; MD( Chairperson), Mark Ayila, MD, amd John Beebe J: APSU\MedieallDIANE\ChiarellolAC 2005-00229. doc 22 24 Received Event (Event Succeeded) Time: 1:55 PM Date: 3/11/2005 Duration: 7 min 53 sec Pages: 28 Company: Sender: 890 414 1989 Shine 850 414 1989.25 Fax Numher- : AHCA/LEGAL MEDICAL MAR-11-2085 13:59 nHCF 1 o~ Stephen Chiarello, M.D., DOH Case No. 2005-00229 NOTICE OF RIGHTS Respondent has the tight to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested, NOTICE REGARDING ASSESSMENT OF COSTS - —-~- ~ Respondent is Placed on notice that Petitioner has incurred Costs related to the investigation and Prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and Prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. J APSU\Medical\DIANE\Chiarello\AC 2005-00229 doc 23 25

Docket for Case No: 05-000951PL