Oct 18 2006 9:07 OCT-18-2886 9:83 FL DEPT OF HEALTH 856 488 1855 P.@2/26 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 2005-00180 HELEN T. DONATELLI, M.D., RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Helen T. Donatelli, M.D., and in support thereof alleges: 1. Petitioner 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 62701. Oct 18 2006 9:07 1855 P.@3/26 OCT-18-2886 9:83 FL DEPT OF HEALTH 858 488 3. Respondent's address of record is 4000 Island Boulevard, #2207, Aventura, Florida 33160. 4. Respondent is board certified in emergency 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(9)(1)(B) and (C), intended for use in the diagnosis, cure, mitigation, treatrnent, 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 Health 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 Toxin Type A is marketed and labeled for this new indication as BOTOX® J APSU\Medical\DLANE\Donatelli\AC 2005-00180.doc 2 Oct 18 2006 9:07 _ @ 468 1855 a4" OCT-18-2886 &9:a4 FL DEPT OF HEALTH 85 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 Costridium Lotulinum. Once in the bady, the toxin binds to nerve endings at the point where the nerves join muscles. 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. 8. Onor about December 1, 2004, while investigating the genesis J. APSU\MedicalDLANE\Donatelli AC 2005-00180.doc 3 Oct 18 2006 9:07 OCT-18-2886 89:84 FL DEPT OF HEALTH 854 488 1655 P8526 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 application for approval as an Investigational New Drug because the JAPSU\Medical\ DIANE\Donatelli\AC 2005-00180.doc 4 Oct 18 2006 9:08 oo OCT-18-2886 89:84 FL DEPT OF HEALTH 858 488 18! Stabilized Botulinum Toxin Type A is marketed “for research Purposes only, P6265 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: Date of Product Quantity | Price | Invoice 8/4/03 | Stabilized Botulinum | 2 vials $1,500 Neurotoxin Type A: 500 IU (5.0 ng) _ | | 11/13/03 Stabilized Botulinum 3 vials $2,000 Neurotoxin Type A: 500 IU (5.0 ng) [78/04 ~——~T Stabilized Botulinum 13 vials | $2,000 Neurotoxin Type A: 500 IU (5.0 ng) 2/23/04 Stabilized Botulinum [2 vials | $2,000 Neurotoxin Type A: 500 IU (5.0 ng) L 3/31/04 Stabilized Botulinum | 2 vials $1,900 Neurotoxin Type A: » 500 IU (5.0 ng) 4 Total 10 vials | $9,400 “| In accordance with Mr, Livdahi’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 purposes only. Not for human use.” JAPSU\Medical\DIANE\Donatelli\AC 2005-00 180.doc 3 Oct 18 2006 9:08 1855 Par 7/26 OCT-18-2886 &9:a4 FL DEPT OF HEALTH 858 488 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 7, 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, she stated that she ordered the TRI product after attending a seminar organized by PowderZ, Incorporated, at which Dr. Bach McComb made a presentation promoting its use. 15. Respondent stated that she had used the product on herself, friends, and relatives as if it were Botox®. Respondent stated that she did not maintain any records associated with the administration of this drug, and she did not charge for the administration of the drug. 16. Respondent claims she did not use the first order of Stabilized Botulinum Toxin Type A because it was not frozen when it arrived. By her own admission, Respondent administered the balance of the Stabilized Botulinum Toxin Type A, and she had none in her possession at the time of the inspection, J -A\PSU\Medical\DLANE\Donatel IAC 2005-001 80.doc 6 OCT-18-2886 69:65 Oct 18 2006 9:08 FL DEPT OF HEALTH 856 488 1855 P8726 17. Chapter 499, Florida Statutes, is called the Florida Drug and Cosmetic Act. (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. According to Section 499.002, Florida Statutes 18, Administering or dispensing an unapproved drug is inherently dangerous as there is 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 ho mechanism for quality assurance, processes, and effective, or adulterated and hazardous. Outside of the parameters of lawful regulatory there is no mechanism to ascertain whether a product is safe J: APSU\Medical\ DIANE\Donatelli\AC 2005-001 80.doe Members of the public Oct 18 2006 9:09 ° 856 488 1855 P9726 cannot protect themselves from such dangers as hidden defects in OCT-18-2886 9:85 FL DEPT OF HEALTH pharmaceutical products. 19. 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. 20. Another serious shortcoming caused by the lack of FDA approval is the failure of adequate labeling. The lack of approved labeling 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 J APSU\Medical\DLANE\DonatelliAC 2005-00180.dac 3 Oct 18 2006 9:09 488 1855 P1826 OCT-18-2886 9:85 FL DEPT OF HEALTH 858 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. , 21. As stated in Section 499.002(1), Florida 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, 22. 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. 23. 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 can ascertain whether an entity is licensed to manufacture or distribute a drug in the JAPSU\Medical\DIANE\Donatelli\AC 2005-00180.doc 9 Oct 18 2006 9:09 T OF HEALTH 856 488 1855 P.11/26 FL DEP State of Florida, Thus, an exercise of due diligence would have revealed OCT-18-2886 &9'86 that the TRY product described herein was not FDA approved, or even pending approval, and that TRI was not a licensed pharmaceutical wholesaler, pharmacy, or distributor, 24. 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 Shé 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. 25. 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; (c) Intended to affect the structure or any function of the body of humans or other animals; or (d) Intended for use aS a component of any article Specified in paragraph (a), paragraph (b), or Paragraph (c), but does not include devices or their components, Parts, or accessories. J ‘APSU\Medieai\DLANB\Donatelli\AC 2005-00180.doc 10 Oct 18 2006 9:10 P1226 OCT-18-2886 &9'86 FL DEPT OF HEALTH 856 488 1855 The definition of “drug” under 21 U.S.C. § 321 is the same in all material respects. 26. 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), arid 21 U.S.C. § 321. 27. Botulinum Toxin Type Ais a “legend drug” under Florida law. 28. 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 29. Petitioner realleges and _ incorporates Paragraphs one (1) through twenty-eight (28) as if fully set forth herein, 30. Section 458.331(1)(g), Florida Statutes (2003)(2004), subjects a doctor to discipline for “[flailing to perform any statutory or legal obligation placed upon a licensed physician.” JAPSU\Medical\DIANE\Donatelli\ AC 2005-00180.doc 11 OCT-18-2886 89:66 FL DEPT OF HEALTH Oct 18 2006 9:10 31. 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. 32. Section 499.023, Florida Statutes (2003)(2004), places a Statutory or legal obligation upon Respondent to refrain from selling, offering for sale, halding for sale, manufacturing, repackaging, distributing, 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, 33. Based on the foregoing, Respondent violated Section 499.023, Florida Statutes (2003)(2004), and, consequently, Section 458.331(1)(g), 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. JAPSU\MedicalDIANE\Donatelli\ AC 2005-00180.doc 12 856 488 1855 P.13/26 Oct 18 2006 9:10 856 488 1855 P.14/26 OCT-18-2886 &9'86 FL DEPT OF HEALTH COUNT TWO 34. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) and paragraph thirty (30) as if fully set forth in this count. 35. 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. 36. Section 21 U.S.C. § 355 places a Statutory or legal obligation upon Respondent to refrain from introducing or delivering a new drug into interstate commerce, unless there is an effective FDA approval. 37. 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 34 U.S.C, § 355. COUNT THREE 38. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) and Paragraph thirty (30) as if fully set forth in JAPSU\Medical\DLANE\Donatelli AC 2005-00180.doe 13 Oct 18 2006 9:10 PT OF HEALTH 856 488 1855 P.15/26 FL Di OCT-18-2886 9a? this count. 39. 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. 40. Section 499.005(1), Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent. 41. 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. 42. 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 by a person not authorized under federal or State law to do so (TRI). IAPSU\Medical\DLAN} E\Donatelli\AC 2005-00] 80.doc 14 Oct 18 2006 9:11 PT OF HEALTH 856 488 1855 P1626 FL DEI COUNT FOUR OCT-18-2886 9a? 43. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) and Paragraph thirty (30) as if fully set forth in this count. 44. 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. 45. Section 499.005(3), Florida Statutes (2003)(2004), Places a statutory or legal obligation upon Respondent. 46. Based on the foregoing, Respondent Violated Section 499.005(3), Florida Statutes (2003)(2004), and, consequently, Section 458.331(1)(g), Florida Statutes (2003)(2004), 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 a person not authorized under federal or state law to do $0 (TRI) and he delivered the drug to patients for pay, COUNT FIVE 47. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) and Paragraph thirty (30) as if fully set forth in J APSU\Medical\DIANE\Donatelli AC 2005-00180.doc 15 06 Sit Oct 18 20 858 486 1855 P.d?/26 FL DEPT OF HEALTH OCT-18-2886 9a? this count. 48. Section 499.005(14), Florida Statutes (2003)(2004), makes unlawful: The purchase or receipt of a legend drug from a “Person that is not aut orized under this chapter to distribute legend drugs to that purchaser or recipient, 49. Section 499.005(14), Florida Statutes (2003)(2004), places a Statutory or legal obligation upon Respondent to refrain from Purchasing or receiving a legend drug from a Person that is not authorized under Chapter 499 to distribute a legend drug to him. 50. Based on the foregoing, Respondent Violated Section 499.005(14), Florida Statutes (2003)(2004), and consequently Section 458.331(1)(q), 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 51. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) as if fully set forth in this count. 22. Section 458.331(1)(m), Florida Statutes (2003)(2004), subjects a doctor to discipline for: I “PSU Medical DLANE\Donatelli\AC 2005-00180.doc 16 OCT-18-2886 9:88 53. states: 54. Oct 18 2006 9:11 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 physician by name and professional title who is or are responsibie 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 FL DEPT OF HEALTH results; test results; records of drugs prescribed, - dispensed, or administered; and reports of consultations and hospitalizations. 856 488 1855 P.18/26 Rule 64B8-9.003(3), Florida Administrative Code (2003)(2004), 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. Respondent failed to document in patient charts whether he administered Botox® or the unapproved Stabilized Botulinum Neurotoxin Type A. JAPSU\MedicaNDIANE\Donatelli\ AC 2005-001 80-doc Oct 18 2006 9:12 219426 OCT-18-2886 9:88 FL DEPT OF HEALTH 856 488 1855 Pil 29. Based on the foregoing, Respondent violated Section 498.331(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 26. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) as if fully set forth in this count. 97. 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 5. 768.13. 58. Respondent prescribed, dispensed, administered, injected, mixed, or otherwise prepared the Stabilized Botulinum Neurotoxin Type A, an Unapproved product, without notifying the patient, making it impossible for the patient to authorize such treatment. 59. 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. JAPSU\MedicaNDLANE\DonatellNAC 2005-00180.doe 18 Oct 18 2006 9:12 - 856 488 1855 P. 28a T-18-2886 89:88 FL DEPT OF HEALTH ocT-18- : COUNT EIGHT 60. Petitioner realleges and incorporates Paragraphs one (1) through twenty-eight (28) as if fully set forth in this count. 61. Section 458.331(1)(q), Florida Statutes (2003)(2004), subjects a doctor to discipline for: Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlied substance, other than in the course of the physician's professional practice. For the Purpeses of- this: Paragraph, it shall be legally presumed that prescribing, dispensing, and is not in the course of the physician's Professional Practice, without regard to his or her intent. 62. 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. 63. Based on the foregoing, Respondent violated Section JAPSU\Medical DLANE\Donatelli AC 2005-00180.doc 19 18 2006 69:12 vet 856 488 1855 P2126 OCT-18-2886 &9:a9 FL DEPT OF HEALTH 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 64. Petitioner realleges: and incorporates Paragraphs one (1) through twenty-eight (28) as if fully set forth in this count. 65. Section 458.331(1)(t), Florida Statutes (2003)(2004), subjects @ 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, 66. 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. 67. 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 JAPSU\Medical\DIANE\DonatelliVAC 2005-001 80.doc 20 OCT-18-2886 89:89 Oct 18 2006 9:12 EPT OF HEALTH 856 488 1855 P. 22/26 FL Dl 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 fees billed-or collected, remedial education and/or any other relief that the Board deems appropriate, SIGNED this_25*” day of Eebrunve , 2005. John O. Agwunobi, M.D., M.B.A., M.P.H. Secretary, Department of Health Diane K. Kiesling Attorney Supervisor PILED cement Unt . a press Way-Bin C- DEPARTMENT OF Maat Tallahassee, Florida 32399-3265 CLERK KS Nae Florida Bar # 0233285 DATE, D°Q3B-O (850) 414-8126 ee: (850) 414-1989 fax DKK/dkk Reviewed and approved Py: Cae (initials) 2 [7/57 (date) PCP: Fe br 25 2005 PCP Members: pad Ashiar M.D(Chalrpuem), Mark Avila, MD. and John Beebe J APSU\Medica\DIANE\Donatelli\ AC 2005-00180.doe 21 Oct 18 2006 9:13 23/26 OCT-18-2886 &9:a9 FL DEPT OF HEALTH 856 488 1855 P23. Helen T. Donatelli, M.D., DOH Case No. 2005-00180 NOTICE OF RIGHTS Respondent has the right 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\MedicaNDLANE\Donateli\AC 2005-00180.doe 22

Docket for Case No: 06-004099PL