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JOSEPHINE KIMBALL vs DEPARTMENT OF HEALTH, 03-002807F (2003)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Jul. 28, 2003 Number: 03-002807F Latest Update: Mar. 23, 2005

The Issue The issues for consideration in this case are whether the Petitioner, Josephine Kimball, is entitled to an award of attorney fees from Respondent, Department of Health, as provided in Section 120.595, Florida Statutes (2003), and, if so, in what amount.

Findings Of Fact Based on the oral and documentary evidence presented at hearing and on the entire record of this proceeding, the following Findings of Fact are made. The Department, through its Bureau of Statewide Pharmaceutical Services (formerly the Bureau of Pharmacy Services), is the state agency responsible for administering and enforcing the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (1997), which includes the regulation of the manufacture, promotion, and distribution of prescription drugs. The Department initiated an Administrative Complaint in August 1993 (1993 Administrative Complaint) while in the middle of an investigation and after participating in a federal and state force of agencies that executed a search and seizure of the business establishment and of the home of James T. Kimball and his wife, Josephine Kimball, both of which were located in Wesley Chapel, Florida. The Kimballs' business establishment was located at 29949 State Road 54 West in Wesley Chapel, Florida ("business establishment" or "29949 State Road 54 West"). The search and seizure took place on May 12, 1993, pursuant to federal warrants. The 1993 Administrative Complaint was issued to Discovery Experimental and Development, Inc. ("DEDI"), located at 29949 State Road 54 West and related to that company's alleged sale of drugs that were not approved by the Federal Drug Administration (FDA). After the 1993 Administrative Complaint was filed, the Department continued to investigate the activities of DEDI. Deborah Orr (Agent Orr) began working for the Department as a drug agent and investigator on or about 1993 and was assigned to investigate the underlying case until the case culminated. During the investigation, Agent Orr and other Department agents, investigators, and officials reviewed documents and other evidence seized during the search of the business establishment and the home of the Kimballs that tied both James and Josephine Kimball to several corporations that appeared to be connected to the manufacture and sale of certain unapproved drugs. Among the documents found and seized from the Kimballs' home, pursuant to the 1993 warrant and reviewed by Agent Orr, was the financial statement of James and Josephine Kimball dated April 14, 1992. According to that document, James and Josephine Kimball were 90-percent owners of DEDI, which "develops pharmaceuticals and chemicals for manufacturing" and had an assessed value of $1,000,000; James and Josephine Kimball were 90-percent owners of ASTAK, Inc. ("ASTAK"), a company that "manufactures custom order vitamins"; James T. Kimball was a 100-percent owner of Discovery Experimental and Development, Mexico N.A. (DEDI of Mexico), a company that "manufacture[s] pharmaceuticals" and ships to 12 countries; and James and Josephine Kimball were 83-percent owners of Discovery Tour Wholesalers, Inc. (Tours), which owned the real property located at 29949 State Road 54 West. The Department's investigation indicated that several companies controlled by the Kimballs had separate and distinct functions related to the unlawful drug enterprise. For example, it appeared that one company manufactured the unlawful drugs, another took and filled orders from customers for the unlawful drugs, and another put out promotional information and literature about the unlawful drugs. During the investigation, the Department determined that most of the corporations involved in the unlawful drug enterprise had common ownership and operated from 29949 State Road 54 West. The Department's investigation revealed that Josephine Kimball provided administrative and secretarial services, as well as "consultant services," for several corporations owned by her husband, James T. Kimball, and/or owned jointly by Mr. and Mrs. Kimball that were alleged and found to have been involved in unlawful drug activities. Prior to 1997, Agent Orr received and reviewed several checks written to Tours by companies operating out of the 29949 State Road 54 West location, specifically DEDI and ASTAK, both of which were involved in the manufacture and distribution of drugs that were not approved by the FDA. From a review of these checks, it appeared that Mrs. Kimball, in her individual capacity or in connection with her role at Tours, had signature authority on those corporate bank accounts because some of the checks written to Tours by DEDI and by ASTAK, on their respective bank accounts, were actually signed by Josephine Kimball. During the course of the Department's investigation, Agent Orr obtained and reviewed a letter and check which indicated that Josephine Kimball ordered and/or purchased self-inking signature stamps for "personal checks" for "R.R. Riot" and "R.C. Brown." The letter, which effectively placed the order for the self-inking signature stamps, was signed by Josephine Kimball, as the representative of "Discovery," and requested that the self-inking stamps be mailed to "Discovery, 29949 S.R. 54 West, Wesley Chapel, Florida." Moreover, the self-inking stamps were paid for by check on the account of DEDI and bore the facsimile signature of "R.C. Brown" and the hand- written signature of Josephine Kimball. The R.R. Riot and the R.C. Brown signature stamps were connected to DEDI of Mexico and B & B Freight Forwarding, Inc. (B & B Freight), respectively. According to documents reviewed by the Department, the "R.R. Riot" signature stamp was used to establish a bank account for DEDI of Mexico. A resolution, executed by James T. Kimball, as secretary of DEDI of Mexico, authorized the bank at which that company's account was established, to honor all checks or drafts or other orders of payment drawn on the DEDI of Mexico account that bore or purported to bear only the facsimile signature of R.R. Riot. The self-inking stamp for R.C. Brown was to include the facsimile signature of "R.C. Brown" and the following: B & B Freight Forwarding Pay to Order of Dis. Exp .& Dev. Inc. For Deposit Only Lloyd's Bank Acct. #12032151 During its investigation, the Department obtained bottles of liquid deprenyl from an individual in South Carolina who had ordered the product from Discovery of Mexico, c/o B & B Freight Forwarding" at 29949 State Road 54 West. Both DEDI of Mexico and B & B Freight, which were Respondents in the underlying proceedings and alleged to have manufactured, sold, or otherwise distributed drugs that were not approved by the FDA, in violation of Chapter 499, Florida Statutes (1997). In that proceeding, B & B Freight was determined to have violated the provisions of Chapter 499, Florida Statutes (1997), as alleged in the Administrative Complaint. Prior to issuance of the 1997 Administrative Complaint, Agent Orr wrote a report of her findings based on her multi-year investigation and sent them to her supervisor, who forwarded the report to Jerry Hill, R. Ph., Bureau Chief of the Department's Bureau of Statewide Pharmaceutical Services. Mr. Hill reviewed Agent Orr's report and other information and evidence obtained during the investigation. He also talked to some of the Department agents and/or investigators who participated in the investigation at various times during the years the investigation was on-going. Based on his review of Agent Orr's report and related information and evidence, Mr. Hill believed there were several companies involved in promoting and/or advertising, manufacturing, and distributing prescription drugs that were not approved by the FDA. The specific unapproved drugs were selegiline citrate (deprenyl) and some silvicidal products, some of which had been found during inspections of the premises at 29949 State Road 54 West prior to issuance of the 1997 Administrative Complaint. After reviewing all of the information and documents provided to him, Mr. Hill believed that some of the companies were more involved in the illegal drug operation than others. However, he also believed that all of the principals had some involvement in the illegal activity. A review of the documentation, particularly certain checks, provided to Mr. Hill indicated that Josephine Kimball had full signature authority on the checking accounts of several of the corporations that the Department determined were involved in the illegal drug activity. Based on checks seized pursuant to the federal search warrants, Mr. Hill determined that checks from DEDI, written to Tours for consulting fees, were signed by Mrs. Kimball. There was also documentation that Mrs. Kimball signed checks from ASTAK that were written to Tours. Based on the information and evidence Mr. Hill had received, he believed that the corporations that were engaging in the illegal drug activities involved two principal natural persons, James and Josephine Kimball. Mr. Hill believed that he had sufficient evidence to tie Josephine Kimball and several of the companies, including DEDI, DEDI of Mexico, ASTAK, and Tours, together. Given the companies' common ownership, and Josephine Kimball's involvement in those companies, Mr. Hill was concerned that if the Department did not prosecute all the entities and individuals involved in the operation, the illegal activity would continue and the unapproved drugs would get into commerce. After careful consideration of all the information and evidence provided to him by Department investigators, agents, and other Department officials familiar with and involved in the investigation, Mr. Hill concluded that Josephine Kimball participated in the illegal drug enterprise and was, therefore, in violation of Chapter 499, Florida Statutes (1997). The Department expanded its administrative enforcement action in the underlying case by the Administrative Complaint dated June 24, 1997, based on its on-going investigation of illegal activities taking place at the 29949 State Road 54 West. Mr. Hill, on behalf of the Department, issued the 1997 Administrative Complaint, and that case was later assigned DOAH Case No. 97-3836. Pursuant to a Delegation of Authority dated February 19, 1997, Mr. Hill was authorized to initiate and pursue to conclusion any legal or administrative action authorized by Chapter 499, Florida Statutes (1997). In the underlying administrative proceeding, after taking and considering testimony and documentary evidence, the Administrative Law Judge issued a Recommended Order finding that the Department failed to prove the allegations against Josephine Kimball by clear and convincing evidence and recommending that the charges against her be dismissed. However, the Recommended Order made no finding that the Department participated in the underlying proceeding against Petitioner for an improper purpose. With regard to the corporate Respondents in the underlying proceeding, the Recommended Order found that Discovery Distributing, Inc., DEDI, ASTAK, and B & B Freight, violated the provisions of Chapter 499, Florida Statutes (1997), as alleged in the underlying proceeding and recommended that those Respondents be fined a total of more than $3.5 million dollars for the violations. The Department adopted the Recommended Order in the underlying proceeding in its Final Order. In this proceeding, Petitioner asserted that the Department brought the underlying proceeding against her for "personal" reasons. In support of this assertion, Petitioner presented the testimony of one witness, Petitioner's adult daughter, Toni Kimball, who was also a Respondent in the underlying proceeding. Toni Kimball testified that at some point, Agent Orr and/or counsel for the Department told her that the Department took the underlying action against Josephine Kimball because of Mrs. Kimball's relationship with James T. Kimball and that the case was "no longer business," but was "personal." Ms. Kimball's testimony is not credible or persuasive and is, therefore, rejected. Clearly, at the time the Department initiated the underlying proceeding and participated in that proceeding, there was sufficient evidence of Josephine Kimball's connection and involvement with the companies engaged in the illegal drug activities to bring and pursue the administrative action against her. At the final hearing in the underlying proceeding, there was voluminous evidence that appeared to tie Petitioner to the corporate Respondents found to have engaged in the illegal drug activity with which they were charged and that implicated her in some of these activities. Josephine Kimball and Tours, a company she operated, was represented by Elliot Dunn, Esquire, in the underlying proceeding, including and through the final hearing. Mr. Dunn withdrew from the case prior to Petitioner's filing her Proposed Recommended Order. Mr. Dunn did not testify at this proceeding and no time records related to his representation of Josephine Kimball or any of the other Petitioners in the underlying proceeding were available for review, inspection, or consideration. Josephine Kimball did not pay Mr. Dunn for the legal services that he provided. Instead, he was paid by ASTAK, one of the nonprevailing parties in the underlying proceeding and, later, by Strictly Supplements. There was never a contract between Josephine Kimball and Mr. Dunn that defined the terms and conditions of Mr. Dunn's legal representation on behalf of Josephine Kimball. However, during the time Mr. Dunn represented Josephine Kimball, he was in-house counsel for ASTAK and/or DEDI, a job for which his annual salary was about $52,000. Petitioner's expert witness opined that a reasonable hourly rate for an attorney representing each of the Petitioners, including Josephine Kimball was $175 to $350. Petitioner's expert did not form an opinion as to the total number of hours reasonably spent by Mr. Dunn representing Josephine Kimball in the underlying proceeding. Rather, the expert testified that he utilized Rule Regulating Florida Bar 4-1.5, which deals with the reasonableness of fees. Based on the factors in that Rule, Petitioner's expert opined that reasonable attorney's fees incurred by Josephine Kimball in the defense of the underlying case are $50,000, assuming the hourly rate of $175. Rolando J. Santiago, Esquire, provided legal services to Josephine Kimball in the post-hearing phase of the underlying proceeding. Specifically, Mr. Santiago reviewed the case file and the record in the underlying case and prepared the Proposed Recommended Order and related pleadings for Josephine Kimball. Mr. Santiago's hourly rate is $175 and he spent 92 hours providing legal services to Josephine Kimball in the underlying proceeding. Therefore, Mr. Santiago's fee for the legal work he performed for Josephine Kimball is $16,100. In light of the findings and conclusions reached in this Recommended Order, no findings are made or necessary regarding issues related to the reasonableness of the attorney's fees, the quality of the evidence presented on that issue or any other issues related to attorney's fees.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner Josephine Kimball's Petition for Attorney Fees and Costs be DISMISSED. DONE AND ENTERED this 25th day of January, 2005, in Tallahassee, Leon County, Florida. S CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of January, 2005.

Florida Laws (2) 120.57120.595
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UNIVERSITY OF FLORIDA vs. GARY P. HOWLAND, 79-002267 (1979)
Division of Administrative Hearings, Florida Number: 79-002267 Latest Update: Oct. 14, 1980

The Issue The issue posed for decision herein is whether or not the Respondent, Gary Howland, engaged in conduct, which will be set forth hereinafter in detail, which is sufficient to warrant the Petitioner's suspension of this employment without pay in accordance with the rules of Petitioner as set forth in Chapter 6C-5.27, Florida Administrative Code.

Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying the documentary evidence received and the entire record compiled herein, the following relevant facts are found. Respondent, Gary P. Howland, was employed by Petitioner in the Institute of Food and Agricultural Sciences as a visiting associate research scientist through an appointment which ended, by its terms, on June 30, 1979. On August 30, 1978, Respondent was charged with a felony, to-wit: unlawful possession and sale of a controlled substance in violation of Section 893.13(1)(a)(1), Florida Statutes. During September of 1978, Petitioner learned that Respondent was arrested and charged with the unlawful delivery and possession of a controlled substance. Petitioner immediately took steps to suspend and ultimately terminate Respondent's appointment. On September 26, 1978, Respondent was suspended from his position without pay. On October 11, 1978, Respondent challenged Petitioner's action in suspending him without pay and through an option exercised by Respondent, the matter was referred to the Academic Freedom and Tenure Committee on February 13, 1979. 2/ On May 10, 1979, Respondent filed a motion to dismiss the complaint which was then pending before the Academic Freedom and Tenure Committee. Pursuant to a consideration of Respondent's motion to dismiss the charges filed before the Academic Freedom and Tenure Committee (Committee), a decision was entered by that Committee recommending that Respondent's motion to dismiss be granted based on a determination that the University did not follow certain procedural safeguards. Specifically, the Committee recommended that: The matter not be sent to a plenary hearing; That the President determine that the suspension was unlawful; That Respondent be awarded back pay through June 30, 1979; and The President direct that Respondent's employment record show that he was not terminated for cause and that his suspen- sion was unlawful. By letter dated November 2, 1979, Respondent was advised by Petitioner's President, Robert Q. Marston, that the recommendation of the Committee was being rejected and the matter was transferred to the Division of Administrative Hearings pursuant to Section 120.57(1), Florida Statutes. 3/ Lee Cowart has been employed by the Alachua County Sheriff's Office for approximately three (3) years. During times material in 1978, he worked as an undercover agent in the Drugs and Narcotics section of the Sheriff's Office. On April 21, 1978, Officer Cowart met Respondent at the Main Street Lounge in Gainesville, Florida, and discussed the use, sale and purchase of four grams of cocaine for the agreed-upon price of three hundred dollars ($300.00). Officer Cowart observed the transaction via a visual surveillance of Respondent from a van. Officer Cowart paid Respondent three hundred dollars ($300.00) and took delivery of the substance, had it analyzed by the U.S. Department of Justice Drug Enforcement Administration, which analysis revealed that of 3.8 grams received, 29 percent thereof was cocaine hydrochloride. (Petitioner's Exhibit 1.) Officer Coward is trained as a field agent and has field tested approximately two hundred (200) samples of unlawful drugs during his career of employment with the Alachua County Sheriff's Office. Officer Cowart performed a field test of the substance delivered by Respondent, which test proved positive. Dr. F.A. Wood, Dean of Research, Food and Agricultural Sciences, was familiar with Respondent's tenure of employment at the University. Respondent joined the staff of the University during 1978 as a temporary appointee for a one-year term. Respondent was paid from funds received through a NASA grant. Pursuant to the terms of Respondent's appointment at the University, he did not earn tenure. Dean Wood considered Respondent's temporary suspension and decided that based on the evidence presented to him, that Respondent's suspension be made permanent. In making this decision, Dean Wood relied on the information gathered by the Vice President and the Academic Freedom and Tenure Committee. (Testimony of Dr. Wood.)

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby, RECOMMENDED: That the Petitioner's suspension of Respondent without pay on September 26, 1978, be SUSTAINED. RECOMMENDED this 18th day of September, 1980, in Tallahassee, Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of September, 1980.

Florida Laws (3) 120.5783.13893.13
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BOARD OF MEDICAL EXAMINERS vs. NEWELL JEROME GRIFFITH, 80-002093 (1980)
Division of Administrative Hearings, Florida Number: 80-002093 Latest Update: Mar. 13, 1981

Findings Of Fact Respondent Newell Jerome Griffith is a licensed physician and, at all times pertinent to this proceeding, was engaged in the practice of medicine at Winter Haven, Florida. (Testimony of Respondent) During the period 1979-1980, Respondent's investigator, Lawrence E. Dodd, Jr., conducted routine audits of pharmacies in the Winter Haven area. The purpose of his audits was to review prescriptions for controlled substances in order to determine if irregularities had taken place in the prescribing and dispensing of such substances by pharmacists and physicians. During the course of these audits, Dodd found that Respondent had issued a large number of prescriptions in preceding years for various controlled substances which fell into the category of Schedule II under Chapter 893, Florida Statutes. The prescriptions in questions were prescribed for and obtained by Gerald Cooney, Annette Groover, and Peggy Moore. (Testimony of Dodd, Petitioner's Exhibits 1- 9) The following facts relate to each of the above named individuals: Gerald Cooney Respondent has treated Gerald Cooney as a patient since approximately 1974. Medical records reflect that Respondent treated Cooney for a medullary sponge kidney or similar chronic urinary infection, and acute and chronic recurrent infection of the left knee area which originally had been caused by a bicycle injury and was aggravated by shrapnel wounds in the same area during wartime service in 1970. Since that time, he has had multiple problems with his left leg requiring hospitalizations and has had a chronic recurrent cellulitis. Be has never had full use of the extremity since that time and has had recurrent swelling and extreme pain requiring narcotics. To alleviate the pain, Respondent prescribed both oral and injectable Dilaudid. In 1977, Respondent referred Cooney to the University of Florida College of Medicine regarding his renal difficulty. On April 1, 1977, Respondent wrote the Chief, Division of Urology, at the College that Cooney continues to require, and receive oral Dilaudid in amounts greater than I am comfortable with, but see no alternative to prescribing." On April 7, 1977, the Division Chief wrote Respondent that he had been unable to find any reason for Cooney's protracted pain requiring narcotics. In July 1978, Cooney was admitted to the Veteran's Hospital in Tampa for urinary tract infection and underwent a cystoscopy. The patient was discharged with instructions to return to Respondent for treatment of his "narcotic dependency." Respondent's office notes on February 19, 1979, stated that Cooney had been taking from 14 to 24 Dilaudid tablets daily and was able to make a reduction in dosage for a day or two, but then exacerbation of all illnesses recurred. The medical records further reflect a letter written by Respondent on August 17, 1979, "To Concerned Treating Physician or Physicians" which stated that Respondent had been treating Cooney for Dilaudid abuse which had come about because of symptoms associated with his left knee and urinary problems. In September of 1978, Cooney was again admitted to a Veteran's Hospital for a urinary tract infection, sponge kidney, and Dilaudid addiction. The attending physician noted that since Cooney's dependency had not been treated by his private doctor in Winter Haven, after his last discharge, it was decided that it should be treated at that time by withdrawing Dilaudid. Cooney, however, disagreed and was discharged to be treated at a drug center in Orlando. He did not seek such treatment but obtained further prescriptions for Dilaudid from Respondent. During the period November 1976 to June 1979, Respondent prescribed over 12,500 tablets of Dilaudid 4 mg for Cooney. Additionally, Dilaudid was prescribed in injectable form in the amount of 2 mg./cc. 14 x 20 vials. Between July and December 1979, Respondent prescribed over 2500 tablets of Dilaudid 4 mg, and 24 tablets of Dilaudid 2 mg. Between December 1979 and January 1981, Respondent issued prescriptions to Cooney for almost 7500 tablets of Dilaudid 4 mg, and a prescription for 20 1 cc ampules of injectable Dilaudid. Dilaudid is a Schedule II controlled substance listed under Chapter 893, Florida Statutes. It is customarily used for pain and has addictive qualities. Respondent is of the opinion that there was no alternative to the treatment which he gave to Cooney. He recognized that the patient was addicted to Dilaudid and attempted to assist him with detoxification in 1976. At one time, Cooney was taking as many as 20 tablets per day and, although Respondent limited him to between 16 to 20 tablets per day, he acknowledged that this amount was excessive. Respondent had prescribed other drugs for the patient, but he had allergic reactions to them. (Testimony of Dodd, Deatsch, Respondent, Petitioner's Exhibits 5, 6, 9, Respondent's Exhibit 1) Annette Groover Annette Groover has been a patient of Respondent's for over 26 years and was once employed by him as a nurse's assistant and receptionist. During this period, Respondent treated her for severe migraine headaches and seizure disorder. During the course of treatment, Respondent referred the patient to neurologist for consultation at various times who placed her on anticonvulsive medication. Respondent had prescribed Talwin for the patient's headaches, but in 1970 he became aware that she had used the drug excessively and for feelings of depression at times rather than for headache relief. In September 1979, Respondent's office notes reflect that Groover had been using a Variety of medications including Talwin, and that she had revealed that if she did not take the drug "her legs start to tremble, nose starts running, and I get jittery." Respondent thereafter counseled the patient regarding drug habituation and she thereafter was successful in withdrawal from Talwin. He then placed her on a regime of injectable Demerol because other drugs did not provide headache relief. In 1977, a consulting neurologist examined the patient and characterized her headaches as a chronic problem which was most likely related to tension. Between November and June 1979, Respondent prescribed for the patient more than 1850 cc. of injectable Demerol, 50 mg./cc. In addition, 12 tablets of 50 mg. Demerol and 100 tablets of Dexedrin Sulphate, 5 mg., were prescribed. Between July 1980, and November 1980, Respondent prescribed 66 2 cc. vials of Demerol, 100 mg./cc. Although Respondent's patient records do not reflect that Respondent examined Mrs. Groover between October 7, 1977 and March 23, 1978, he issued 29 prescriptions for injectable Demerol to her during that period. Respondent maintained at the hearing that his treatment of Mrs. Groover was legitimate and that she has never shown any withdrawal symptoms during periods of several weeks when she has gone without the drug. Mrs. Groover's husband is a medical technician in the Naval Reserve and normally administers her Demerol injections. Although she has tried other drugs, most of them have conflicted with her seizure problem and Demerol does not affect her in that manner. Demerol is a Schedule II controlled substance under Chapter 893, Florida Statutes. It is a central nervous system depressant which relieves pain, but is addictive. (Testimony of Respondent, Groover, Dodd, Deatsch, Petitioner's Exhibits 1-2, 7) Mary E. (Peggy) Moore Mrs. Moore is a legal secretary who has been a patient of Respondent for over 20 years. Respondent has treated her primarily for diabetes and pancreatitis. Over a number of years, she was hospitalized several time after referrals by Respondent to gastroenterology specialists. Demerol was prescribed both by Respondent and specialists to control the pancreatitis attacks. Her medical records reflect that she has been subject to episodes of hypoglycemia-- insulin reaction, usually complicated by epigastric pain and vomiting. In December 1979, after Mrs. Moore had been admitted to the Winter Haven Hospital for insulin reaction, the gastroenterologist who treated her stated in his report that the patient takes an appropriate amount of properly monitored narcotics in the form of Demerol at intervals of one to three months when experiencing pain from pancreatitis. Respondent also prescribed Quaaludes for Mrs. Groover in order that she could sleep because she had been under extreme pressure and stress. She took two tablets at night off and on for two to three years. She needed Demerol in the past at particular times when she had pancreatitis attacks. In 1980, Respondent referred her to Emory University Diagnostic Clinic and it was discovered that diabetic neuropathy was causing pain rather than pancreatitis. She is not taking Demerol at the present time and no longer suffers from her former attacks. During the period when she took Demerol, her daughter who was a registered nurse administered the injections and later her husband performed this task. On one occasion in 1978, her Demerol supply was stolen when she was on a trip. During the period when she was using Demerol, her husband destroyed any that she did not use between attacks. Respondent testified at the hearing that Demerol did become a problem with her before she went to Emory University Clinic, but she has not used it since that time. Demerol is a Schedule II controlled substance under Chapter 893, Florida Statutes. Quaaludes are a sedative and also a Schedule II controlled substance which is suitable periodically for sleep, but the patient is subject to rapid tolerance of the drug. One-half tablet of 300 mg Quaalude is usually sufficient for infrequent users. Mrs. Moore terminated the use of Quaaludes in the summer of 1980. Respondent's medical records concerning Mrs. Moore reflect that he did not examine her during the period May 9, 1979 and October 1, 1979, but continued to issue prescriptions to her for Demerol and Quaalude. Between December 1976 to June 1979, Respondent prescribed for Mrs. Moore in excess of 1400 cc. of injectable Demerol, 50 mm./cc., and 1900 tablets of 300 mg. Qualudes. Between July 1979 through December 1979, he prescribed 400 tablets of Quaalude,300 mg., 277 cc. of Demerol 50 mg./cc., and 230 cc. of Demerol, 100 mg./cc. Between July and November 1980, Respondent prescribed 101 cc. of Demerol, 50 mg./cc., 46 cc of Demerol 100 mg./cc., and 172 cc. of Demerol, 75 mg./cc. (Testimony of Dodd, Deatsch, Respondent, Moore, Petitioner's Exhibits 3-4, 8, Respondent's Exhibit 2) In the opinion of physicians who are experts in the field of drug treatment and internal medicine who reviewed the medical records of Gerald Cooney, Annette Groover, and Peggy Moore, Respondent exercised poor judgment in prescribing known addictive medicine in excessive amounts for prolonged periods to those patients, without properly monitoring their course of treatment. They therefore are of the opinion that Respondent failed to treat those patients in conformity with recognized acceptable standards of medical practice. Specifically, they based their opinions in the case of Cooney upon the fact that Respondent was aware of the patient's addiction to Dilaudid, yet prescribed inordinate amounts of the drug over an extended period of time without taking definitive action to either cut off the patient's supply or to change the medication. A normal dose of Dilaudid would be from four to six 4 mg. tablets a day and never should exceed 12 or 14 during limited time periods for acute pain. Respondent's dosage of 16 to 20 tablets per day on a continuing basis resulted in perpetuation of the patient's addiction. As to Annette Groover's case, the expert testimony reflects the opinion that since the Respondent was aware of the patient's former dependency upon Talwin, he should have prescribed other addictive drugs, such as Demerol, in limited amounts and attempt to use non-addictive medication for the patient's migraine headaches, particularly where, as here, they result from periods of tension. They also are of the opinion that the use of Demerol by the patient reflects a pattern of abuse, but not necessarily addiction. Further, a patient with a history of drug abuse should not have been permitted to administer Demerol by injection at her home, but should have been required to have such treatment administered by a nurse or at a hospital emergency room. The basis of the expert opinion in the case of Peggy Moore is that Respondent prescribed excessive amounts of Demerol and Quaalude for the patient without adequate monitoring of the need for such drugs, and that he permitted home administration rather than at his office, or a hospital site in spite of his expressed concern over the possibility that the patient may have been abusing the use of such drugs. The above opinions are confirmed by the evidence and accepted as a basis for this finding of fact. Other opinions expressed by the expert witnesses during the course of their testimony are not considered to be supported by the evidence. (Testimony of Deatsch, Davenport) Dr. John Smythe, a Winter Haven physician who has known the Respondent for a period of 27 years, is of the opinion that although Respondent's treatment of the patients in question was perhaps "unorthodox," he was dealing with severe chronic patients and perhaps showed too much compassion in prescribing greater drug amounts than he (Smythe) might have prescribed under similar circumstances. Respondent's reputation in the Winter Haven medical community is that of an intelligent, sincere, and conscientious physician who does not hesitate to refer patients to specialists as necessary. (Testimony of Smythe) Dr. William T. Steele, a Winter Haven physician who has known Respondent since the latter has practiced in Winter Haven, is of the opinion that he is an outstanding physician with high moral character who conducts his practice as well as any physician in the community. (Testimony of Steele)

Recommendation That Petitioner suspend Respondent's privilege to prescribe Schedule II controlled substances as defined by Chapter 893, Florida Statutes, for a period of one year, but that the suspension be stayed and Respondent be placed on probation for a like period under appropriate terms and supervision established by the Board to protect the public against inappropriate prescribing of controlled substances. DONE and ENTERED this 13th day of March, 1981, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of March, 1981. COPIES FURNISHED: Deborah J. Miller, Esquire Assistant General Counsel Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Robert A. Pyle, Esquire Post Office Box 557 Lake Alfred, Florida 33850

USC (1) 21 USC 823 Florida Laws (2) 458.331893.05
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HARMONY ENVIRONMENTAL, INC. vs DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION, DRUGS, DEVICES AND COSMETICS PROGRAM, 14-005334RU (2014)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Apr. 08, 2015 Number: 14-005334RU Latest Update: Jan. 29, 2016

The Issue Whether Petitioner has been substantially affected by agency statements made by Respondent, and, if so, whether the statements violate section 120.54(1)(a), Florida Statutes?

Findings Of Fact Petitioner, Harmony Environmental (Harmony), is duly- licensed as a Universal Waste Transporter Facility (UWTF) with the Florida Department of Environmental Protection (FDEP), holding EPA ID No. FLR000202424. Additionally, Harmony is registered as a Hazardous Waste Transporter by FDEP as well as the U.S. Department of Transportation (USDOT); a Used Oil Handler by FDEP; a Biomedical Waste Transporter by the Florida Department of Health; and as a Waste Transporter by Broward and Miami-Dade counties. Respondent is the state department charged with regulating drugs, devices, and cosmetics pursuant to section 20.165 and chapter 499, Florida Statutes. Respondent does not have jurisdiction over the permitting of universal waste transporters or over Florida Administrative Code Chapter 62-730. Respondent has not issued any permits or licenses to Petitioner. On May 20, 2014, Respondent’s Inspector Dr. Tram Vu inspected Petitioner. The Entry Notice and On-Site Inspection Report was included as an exhibit to the Petition filed in this matter. It makes reference to the “inspection” by Dr. Vu as one, “conducted under Ch. 499.051, F.S., and Rule 61N-1.019, F.A.C., to assess firm’s activities and compliance.” Respondent admitted the May 20th inspection was conducted under the authority cited in the report. On July 16 and 17, 2014, Dr. Vu again inspected Petitioner. A number of photographs were taken during the inspection. The photographs depict two large white containers referred to in the Petition and at the hearing as “yard super sacks.” Inspector Vu testified that the yard super sacks were sealed and that none of the “prescription drugs” photographed were found outside of the sealed Universal Pharmaceutical Waste (UPW) containers. Dr. Vu subsequently requested Petitioner to “voluntarily” quarantine the super sacks and a black tote, and a voluntary quarantine form was prepared and executed. The voluntary quarantine form states that it is “an alternative to the Florida Department of Business and Professional Regulation (‘DBPR’) removing some or all of the products for examination and sampling pursuant to Section 499.065(2), Florida Statutes.” Respondent issued a Notice of Intent to Deny (NOID) to Petitioner on August 18, 2014, regarding its application for a restricted drug distributor/destruction permit. The NOID concluded that Petitioner acted as a restricted drug distributor/destruction establishment without a license. The NOID cited rule 61N-1.023(4), which provides that such a permit is required for a person to take possession in Florida of a prescription drug for the purpose of arranging for its destruction. When asked by Petitioner in an interrogatory, “Are there any facts or circumstances that would cause the DDC to consider that a prescription drug has become UPW and no longer subject to its authority? If so, state or identify each and every such fact or circumstance.” Respondent answered, “No. The term ‘UPW’ is a term that is within the jurisdiction of another Florida state agency, the Department of Environmental Protection (DEP). A prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” Reginald Dixon, the Director of the Division of Drugs, Devices, and Cosmetics (DDC), acknowledged that in his two years as Director, Respondent’s chapter 61N-1 has not contained any definition that addresses the difference between viable drugs and non-viable drugs and that it contains no reference to UPW. Mr. Dixon further acknowledged that chapter 61N-1 does not contain the statement that “[a] prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” He further acknowledged that he is not aware of any federal or Florida law, rule, or regulation that provides the same or similar statement; and that chapter 61N-1 does not contain any definition or explanation as to how the change or alteration that may render the active ingredient inactive takes place. Respondent’s policy that a drug continues to be a prescription drug until its nature is altered or changed so that the active ingredient that makes it a prescription drug is no longer active applies not only to Petitioner. Such policy would apply to other entities engaged in a similar business, as well as to pharmacies, drug wholesalers, and hospitals when considering how to legally dispose of prescription drugs. Respondent takes the position that the UPW rule “is not a rule that belongs to DBPR” (Hr’g Tr. 62); that Respondent “does not have any jurisdiction over the DEP rules” (Hr’g Tr. 75); and that Respondent does “not look at the DEP rules to determine or use their determination of whether or not a drug is viable . . . or nonviable” (Hr’g Tr. 75). “To the extent that [the UPW] rule talks about viable and nonviable pharmaceuticals, that’s not something within our jurisdiction and we don’t deal with it” (Hr’g Tr. 78). Respondent admitted that it is important for regulated entities to know when the agency considered that a drug is no longer under its jurisdiction. Respondent also admitted that if other regulations exist that do not call prescription drugs “prescription drugs” anymore, but instead call them “solid waste, universal pharmaceutical waste or hazardous waste,” those statutes and regulations may “possibly” have a bearing on chapter 499 and chapter 61N-1. In response to Petitioner’s Request for Admissions, Respondent claimed to be “without knowledge” of whether the hazardous waste program under the Federal Resource Conservation Recovery Act (RCRA) established a “cradle to grave” system for controlling hazardous waste; and whether pursuant to 40 C.F.R. § 272.501, the Federal EPA approved the hazardous waste management program administered by the FDEP pursuant to chapter 403, Florida Statutes. Moreover, Respondent was “without knowledge” of whether the U.S. Food and Drug Administration (FDA) does not regulate drugs that have been discarded as hazardous or pharmaceutical waste; and that the FDA does not regulate generators or handlers of hazardous or pharmaceutical waste. Respondent also claimed to be “without knowledge” that some UPW is generated by hospitals during surgical procedures when a vial containing a standard dose of medication is not fully used because of the patient’s size or condition, with the unused dose “wasted” by placing it in a sealed, properly labeled UPW container; that hospitals that dispose of non-controlled and non-viable drugs in a properly labeled UPW container pursuant to rule 62-730.186, do not routinely create a list or inventory of the drugs being wasted or placed in the container that includes the name of the manufacturer, the name of the drug, the quantity, lot number, expiration date, or any combination of these elements; and that hospitals wasting non-viable controlled substances maintain a log that identifies the name and quantity of the controlled substance wasted, but not the manufacturer, the lot number, or the expiration date; and that such controlled substance log complies with DEA regulations as well as chapter 893, Florida Statutes. Mr. Dixon testified that the act of disposing of the unused portion of a prescription drug in a UPW container at a hospital that also contains sharps, broken glass, tissue, and bloody gauzes could constitute the adulteration of that prescription drug. Further, Mr. Dixon testified that when hospitals dispose of drugs in UPW containers they are “possibly” adulterating drugs, and when Petitioner picks up the UPW container, Petitioner may likewise “possibly” be holding adulterated drugs. Petitioner’s witness, Michelle Chambers, was accepted as an expert witness on UPW and related regulations, both state and federal. Although unpaid for her work due to being the spouse of Petitioner’s owner, she is the compliance coordinator, bookkeeper, and registered agent for Petitioner. Mrs. Chambers trains drug wholesalers how to manage their UPW by directing them to “utilize a return if they can get credit for the drug, but that once a drug becomes waste it falls under the guidelines of UPW and those drug wholesalers need to create a separate area that can handle UPW containers.” When discussing the process of sending UPW to a reverse distributor regulated by Respondent, Mrs. Chambers referred to the FDEP’s pharmaceutical waste guidelines, which state: Only pharmaceuticals with a reasonable expectation of credit can be sent to a reverse distributor. Drop pills, non- credible items, formulated mixtures, items with patient’s names, and raw chemicals cannot be sent to a reverse distributor for credit; thereafter, a waste determination is required and the decision must be made to manage this waste as hazardous waste or UPW waste. Mrs. Chambers stated she had knowledge of unexpired drugs, still in the original packaging that were declared waste by the wholesaler. She asserted that drug wholesalers abandoned or discarded the unexpired drugs in their original packaging because “they couldn’t send it back to a reverse distributor to get credit. There was just no value to it, whatsoever, so they decided to make that waste determination that this is waste, UPW.” Mrs. Chambers stated that UPW labels are attached to UPW containers in Petitioner’s facility, according to the FDEP rule regarding UPW. These labels represent the characteristics of the hazardous waste and other waste inside those containers. Some of the notations on the label refer to a substance, material, or a chemical product that is a prescription drug. She also testified that several documents may be created in the UPW process, such as a hazardous-waste manifest and a bill of lading. In records that a UPW handler is expected to maintain under FDEP rules, a UPW handler is not required to have those records contain the name of the drugs that are in the UPW containers, the manufacturer’s information, or the expiration date of the drugs in the UPW container. She asserted that Petitioner could not reasonably create inventories of all the drugs inside a UPW container because “some of the labels have been poured on by other elements within the container; some are unidentifiable; some are broken . . . it would be very difficult to create an inventory.” Based upon her audits of more than 200 hospitals, Mrs. Chambers stated that if a hospital has a procedure to put non-viable drugs in a UPW container, it is because they are trained to do so. She testified that no hospital she has ever audited has ever kept records that include drug names, manufacturers, or expiration dates for anything they have placed in the UPW containers. Petitioner picks up these containers and brings them to its facility. A UPW handler can add waste to the container, as well as consolidate those containers. Mrs. Chambers also discussed consumer packaging under rule 62-730.186(4)(a), which states: “Consumer packaging” means the packaging that surrounds and encloses a container, in a form intended or suitable for a healthcare or retail venue, or rejected during the manufacture process as long as it is enclosed in its bottle, jar, tube, ampoule, or package for final distribution to a healthcare or retail venue. Further, UPW handlers can conduct activities, including disassembling packages containing several pharmaceuticals into individual pharmaceuticals from consumer packaging. In her experience in the auditing of hospitals for UPW, as well as with Petitioner, Mrs. Chambers stated that controlled substances are put into UPW containers from time to time, yet Petitioner has never been cited or received a notice of violation from the DEA regarding the possession of a controlled substance. To her knowledge, the DEA has never notified any UPW handler in Florida of any violations for possessing controlled substances. Dr. Vu conducts inspections and investigations pursuant to chapter 499, specifically investigating unlicensed activities as well as inspecting facilities that are attempting to obtain a DDC permit. Dr. Vu was tendered and accepted as an expert in pharmacy and conducting inspections for Respondent pursuant to chapter 499. She testified that during her inspection of Petitioner on July 14, 2014, she pulled drugs from UPW containers to inspect them. She admitted there were no prescription drugs outside the UPW containers on Petitioner’s premises. She stated that Petitioner’s agents or employees volunteered to open the UPW containers for her inspection. The scant evidence Dr. Vu relied upon that Petitioner had any controlled substances on the premises was based upon documents she obtained from a third party as well as from Petitioner. She admitted there was no evidence of controlled substances on Petitioner’s premises. While Dr. Vu stated she is able to recognize prescription drugs when she sees them, she is not able to recognize UPW since she is “not trained in universal pharmaceutical waste.” She also stated she is not able to recognize a non-viable drug when she sees it. Dr. Vu has received no training from Respondent on the opening of UPW containers, and even though she has not been trained in UPW rules and definitions, she strongly asserted that Petitioner “[c]learly was in possession of prescription drugs,” and that Petitioner had no permit or authorization to possess prescription drugs. When asked about her understanding of when a prescription drug ceases to be a prescription drug, she replied that “a prescription drug is always a prescription drug unless it’s inactivated or loses its drug ability –- characteristics.” Dr. Vu noted that this understanding is not stated in chapter 61N-1 or chapter 499. David Laven, another drug inspector for Respondent, was tendered and accepted as an expert in pharmacy and issues related to the inspection for Respondent under chapter 499. He testified that Petitioner is not allowed to possess prescription drugs without a DDC permit. On cross-examination, however, he admitted he had not read the rule on UPW, has no knowledge of EPA rules and requirements, and that he is not trained to recognize a non-viable drug. He testified that he considers a prescription drug that is discarded in a UPW container still to be a prescription drug because “there’s still a possibility, depending on how that drug has been disposed of, the container may be partially full –- it can be a full container sometimes. Drugs are thrown in a container for a number of reasons, doesn’t necessarily mean that the drug is no longer viable or can be used in any way.” Regarding the definition of prescription drugs, Mr. Laven stated that “[a] drug is no longer viable or useable if it’s out of date, it’s been damaged in some way, compromised, mis-branded, [or] adulterated.” On October 6, 2014, Petitioner sent a Notice of Unadopted Rules letter to Respondent, stating that the conduct and statements set forth above constitute unpromulgated rules and that, according to section 120.595(4)(b), Florida Statutes, they have 30 days to begin proposed rulemaking in order to rectify the actions and statements made. Respondent did not begin proposed rulemaking in that 30-day period. Respondent presented no evidence or testimony to establish that rulemaking was not feasible or practicable.

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BOARD OF PHARMACY vs. MICHAEL HORNSTEIN, 80-000554 (1980)
Division of Administrative Hearings, Florida Number: 80-000554 Latest Update: Nov. 22, 1991

The Issue The issues posed for decision herein are whether or not the Respondent, Michael Hornstein, registered pharmacist, individually and as owner/operator of Rolette Drugs, Inc., d/b/a Curtiss Pharmacy, has engaged in conduct which will be set forth hereinafter in detail which warrants disciplinary action by the Board of Pharmacy. 1/

Findings Of Fact Based upon my observation of the witness and his demeanor while testifying, the arguments of counsel and the entire record compiled herein, the following relevant facts are found. Michael Hornstein is a registered pharmacist and is the owner/operator (licensee) of Rolette Drugs, Inc., d/b/a Curtiss Pharmacy. Pursuant to a Complaint and Notice to Show Cause filed December 20, 1979, 2/ against Respondent, individually and as owner/operator of Curtiss Pharmacy, the subject administrative hearing was convened to consider allegations that the Respondent, as alleged in the Complaint and Notice to Show Cause, permitted the keeping of improper records, in that he failed to maintain current and accurate records of scheduled controlled substances during the period January 1 through November 30. Pursuant to information furnished by the Drug Enforcement Administration (DEA) in Miami, Florida, a drug accountability audit was performed at Curtiss Pharmacy covering the period January 1 through November 30. The subject audit covered the controlled drugs, Quaalude, Dilaudid, Biphetamine, Tuinal and Desoxyn. Vernon K. Bell, the investigative supervisor for Region V investigative services (Miami, Florida), conducted the drug accountability audit of Curtiss Pharmacy by conducting an on-site review and reconciliation of Respondent's scheduled drug purchases and prescription files respecting the subject drugs. Investigator Bell started the audit period with a beginning inventory for the subject drugs of zero, making no allowances for drugs the Respondent had on hand on January 1. Investigator Bell also allowed Respondent a credit for those scheduled drugs claimed to have been lost due to thefts and robberies. Respondent introduced records which revealed that as a result of robberies of the pharmacy on February 5 and September 26, approximately two hundred (200) Biphetamine capsules and three hundred (300) Quaalude tablets were taken. Examination of the drug accountability report reveals that during the audit period, from total purchases of approximately ten thousand six hundred (10,600) Quaalude 300 mg tablets, Respondent was short approximately eight thousand six hundred nine (8,609) tablets when the drug report was completed for the audit period on December 7 by Investigator Bell. For the scheduled drug, Dilaudid four mg tablets, of total purchases of one thousand four hundred (1,400) tablets, Respondent was short one thousand two hundred eighty (1,280) tablets as of the audit period ending November 30. Biphetamine 20 mg capsules were short approximately one thousand six hundred fourteen (1,614) tablets from total purchases of two thousand three hundred (2,300) tablets during the audit period. Allowing for adjustments, there is still an outstanding shortage of approximately one thousand three hundred fourteen (1,314) Biphetamine capsules. Of total purchases of two thousand (2,000) Tuinal three gram capsules, Respondent's records revealed a shortage of approximately one thousand eight hundred sixty-four (1,864) capsules. Finally, of seven hundred (700) Desoxyn 15 mg tablets, Respondent's records reflect a shortage of six hundred forty (640) tablets. (Petitioner's Exhibit 1 and testimony of Vernon K. Bell.) 3/ RESPONDENT'S DEFENSE Respondent introduced exhibits which substantiated that Respondent's pharmacy was robbed on at least two occasions and police incident reports were completed, as well as DEA controlled drug loss forms to substantiate Respondent's claimed loss for the subject drugs, Biphetamine and Quaalude. Allowances were made herein for the claimed losses. (Respondent's Composite Exhibits 1 through 5.) Thereafter, Respondent invoked the Fifth Amendment privilege based on the claimed pendency of other criminal litigation. Respondent also allowed that the instant administrative proceedings herein should have been abated based on the pending or imminent criminal proceedings involving the subject drug losses by DEA. Respondent requested leave to supplement the record at such time as immunity is granted or jeopardy is removed when the related criminal proceedings have been terminated. This request was considered and denied based on the undersigned's conclusion that the Petitioner is authorized and is in fact duty bound to proceed as the regulating agency charged with protecting the public. See Schwartz v. Florida Board of Pharmacy, 302 So.2d 423 (1DCA 1974), cert. denied, 314 So.2d 151 (,Fla. 1975). Finally, Respondent questioned the accuracy of the audit based on the adjustments made when the police incident and DEA 106 forms were presented. Respondent also claimed that there was a possibility that there should be an additional downward adjustment of approximately nine hundred (900) Quaalude tablets. 4/

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Respondent's license to practice pharmacy and permit to operate a pharmacy in this State be SUSPENDED FOR A PERIOD OF TWO (2) YEARS. RECOMMENDED this 16th day of July, 1980, in Tallahassee, Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675

Florida Laws (3) 120.57465.023893.07
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DEPARTMENT OF LAW ENFORCEMENT, CRIMINAL JUSTICE STANDARDS AND TRAINING COMMISSION vs. CHARLES RAMSEY, 89-000098 (1989)
Division of Administrative Hearings, Florida Number: 89-000098 Latest Update: Apr. 28, 1989

The Issue The issue is whether the certificate issued to Mr. Ramsey by the Criminal Justice Standards and Training Commission should be revoked for his failure to maintain good moral character through the use of cocaine.

Findings Of Fact Charles Ramsey was issued a certificate on October 2, 1981, by the Criminal Justice Standards and Training Commission, number 19-81-502-01, as a correctional officer. On April 12, 1988, Mr. Ramsey went to the Mount Sinai Medical Center for Industrial Medicine at 4300 Alton Road, Miami Beach, Florida 33140. The overall purpose of the visit was not clear, but as a part of his activities at the Center, Ramsey provided urine specimen for analysis. Before providing the specimen, Ramsey had disrobed, was wearing a hospital gown, and was escorted to a bathroom at the site, where he was given two marked specimen bottles. The first bottle was for the main sample, the second for any overflow if Mr. Ramsey's urine donation was greater than the size of the first bottle. Each bottle was a 60 ml. pharmaceutical round bottle. The specimen bottles had his name on them, a bar code identifying the bottles as bottles from an employee of the Metro-Dade Law Enforcement Department, and the unique specimen number of 117270. At that time, Mr. Ramsey initialed the information on the bottle acknowledging that it was correct. After he exited the bathroom and delivered the urine bottle it was sealed with evidence tape by the technician at Mount Sinai, Sonia Abreu, and was placed in a locked cabinet. The cabinet was opened with a key belonging to the courier for the Toxicology Testing Service of Miami, Florida. The urine was kept under lock and key until it was removed and brought to the screening room at Toxicology Testing Service. The technician there broke the seal and dispensed a sample into an automated clinical analyzer which performed an EMIT screen test on 3 ml. of urine. That test showed the presence of cocaine metabolites, i.e., substances left in the body after cocaine has been ingested and been processed by the metabolic action of the body. Based on this initial positive screening test result, another 3 ml. of the sample was used to perform the screening test again. When the screening test again was positive for cocaine metabolites, a more specific test for the presence of cocaine metabolites was performed by Dr. Terry Hall, who holds his doctorate in chemistry, and has specialized in forensic toxicology. The test was performed using a gas chromatograph and a mass spectrometer. The study showed the presence of methylecganine in the urine, which is a cocaine metabolite. The concentration of the methylecganire in the sample was such that it is likely that Mr. Ramsey used cocaine within the previous two weeks. Exposure to trace amounts of cocaine, such as from airborne cocaine which might be inhaled while measuring cocaine seized as part of a drug arrest, could not have yielded the high level of methylecganine found in Mr. Ramsey's urine. The level of metabolite is such that Mr. Ramsey would have had to ingest approximately 10 grams of cocaine.

Recommendation Based upon the foregoing, it is RECOMMENDED that the certificate held by Charles Ramsey be revoked for failure to maintain good moral character. DONE and ENTERED this 28th day of April, 1989, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 1989. COPIES FURNISHED: Joseph S. White, Esquire Florida Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 Charles Ramsey 1064 Northwest 61st Street Miami, Florida 33127 Daryl McLaughlin, Executive Director Florida Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 Jeffrey Long, Director Criminal Justice Standards and Training Commission

Florida Laws (4) 120.57893.13943.13943.1395 Florida Administrative Code (2) 11B-27.001111B-27.00225
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JOHN MARSHALL BRUMLEY vs DEPARTMENT OF REVENUE, 89-006841 (1989)
Division of Administrative Hearings, Florida Filed:Miami, Florida Dec. 13, 1989 Number: 89-006841 Latest Update: May 21, 1990

Findings Of Fact Based upon the record evidence, the following Findings of Facts are made: Idaliza Roman is employed by Respondent as a Collections Specialist II. She is assigned to Respondent's Plantation, Florida office. As part of her job responsibilities, she issues assessments against persons suspected of having engaged in illicit drug activity made taxable by Section 212.0505, Florida Statutes. On October 13, 1989, Roman issued such an assessment against Petitioner. She also issued and filed a tax warrant based on the assessment. The assessment alleged that, on or about August 16, 1989, Petitioner had engaged in a taxable transaction involving 27 kilograms of cocaine. In making this allegation, Roman relied exclusively upon information she had gleaned from a probable cause affidavit contained in a court file, as well as a laboratory report and a property room receipt. She conducted no further investigation into the matter before issuing the assessment. The probable cause affidavit upon which Roman relied reflected that Petitioner had been arrested on August 16, 1989, for a cocaine-related offense. It did not reveal, however, when the alleged offense had been committed. Roman assumed, erroneously, that it had been committed on or about the date of Petitioner's arrest. The arrest actually had been for an offense, involving substantially less than 27 kilograms of cocaine, that Petitioner had allegedly committed in January, 1989. The authorities had no information that Petitioner had been involved in any illicit, drug-related activity on or about August 16, 1989. On April 3, 1990, Roman discovered that the October 13, 1989, assessment against Petitioner and the tax warrant she had issued based on the assessment were incorrect. She thereupon issued and filed a "corrected" tax warrant.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that a final order be issued sustaining Petitioner's challenge to the October 13, 1989, jeopardy assessment issued against him and rescinding the assessment. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 21st day of May, 1990. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of May, 1990.

Florida Laws (5) 120.68212.1272.011893.02893.03
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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs KENNETH M. LOOMIS, 01-003074PL (2001)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Aug. 02, 2001 Number: 01-003074PL Latest Update: Dec. 26, 2024
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BOARD OF PHARMACY vs RALPH SHUTTERLY, 95-002139 (1995)
Division of Administrative Hearings, Florida Filed:Sarasota, Florida May 05, 1995 Number: 95-002139 Latest Update: Jun. 05, 1996

The Issue The issue in this case is whether Respondent is guilty of being convicted or found guilty of a crime directly relating to the ability to practice pharmacy or the practice of pharmacy and, if so, what penalty should be imposed.

Findings Of Fact Respondent received his license to practice pharmacy in Pennsylvania in 1962. He has been continuously licensed in Florida since December 31, 1973, through March 28, 1995, when his Florida license was suspended by emergency order of the Board of Pharmacy for the reasons set forth below. His Florida license number was PS0013841. Respondent has not previously been disciplined. Respondent has been employed for many years with a large pharmacy chain. Over the years, he was promoted into positions of increasing managerial responsibility. At one point, he was in charge of the operations of over 25 stores. Sometime prior to the incidents described below, Respondent's responsibilities were reduced, evidently due to corporate restructuring. At the same time, his wife of 15 years had an affair. Respondent suffered other stresses, including a homicide involving someone in a close relationship. Respondent was ill-equipped to deal with these setbacks. He was a hard- working, intense person with no emotional outlets. Two prior marriages had failed in part due to Respondent's lack of emotional insight. Respondent has long defined his role in relationships almost entirely in terms of his income- earning ability. Unable to deal with the stress, Respondent one night picked up a streetwalker in Bradenton and paid her to have sex with him. Respondent identified himself to her. A sexual relationship ensued. The woman had a child, and they lived in squalor. Respondent' initial sexual impulse toward the woman yielded to an impulse by Respondent to rescue the mother and child and serve as their savior or hero. The woman made increasing demands of Respondent. Several times, Respondent tried to end the relationship, but the woman threatened to disclose the relationship to Respondent's wife and employer. Respondent informed her that he had no more money to give her, but she continued her demands. Eventually, Respondent began to steal from the pharmacy store at which he worked. At first, he stole boxes of cigarettes. Later, he stole prescription drugs, including various Schedule III and IV controlled substances. The drugs contained codeine, and Respondent knew that the woman was selling the drugs on the street. At least one of the drugs was popular among drug abusers. About a year after meeting the woman, Respondent was caught in the act of stealing drugs in the early-morning hours at the store. He immediately made a full confession and was prosecuted by federal authorities for the controlled substances and by state authorities for the cigarettes and other miscellaneous merchandise. In Count I of the federal indictment, Respondent was charged with a violation of 21 U.S.C. 846 by knowingly and intentionally combining, conspiring, confederating, and agreeing with the woman and other persons to possess with intent to distribute acetaminophen with codeine and hydrocodone bitartrate, which are Schedule III controlled substances, and diazepam and alprazolam, which are Schedule IV controlled substances. A Schedule III controlled substance has a potential for abuse less than substances contained in Schedules I and II and has a currently accepted medical use in treatment in the United States. Abuse of a Schedule III controlled substance may lead to moderate or low physical dependence or high psychological dependence. A Schedule IV controlled substance has a potential for abuse less than substances contained in Schedules I, II, and III and has a currently accepted medical use in treatment in the United States. Abuse of a Schedule IV controlled substance may lead to limited physical or psychological dependence. Respondent pleaded guilty to Count I, which carried a maximum sentence of five years, fine of $250,000, and probation of three years, as well as restitution. The United States noted Respondent's acceptance of responsibility as a factor in mitigation. In the plea agreement, Respondent acknowledged that he began diverting controlled substances, once or twice a week, in September 1993. He had been caught and arrested in April 1994. On February 24, 1995, The United States District Court entered a judgment adjudicating Respondent guilty of Count I, placing him on six months' house arrest, placing him on five years' probation, and ordering restitution to the pharmacy chain of $10,574.84 for the diverted controlled substances. The judge stated her desire that Respondent continue to work as a pharmacist in order to pay for what he had stolen. Respondent's conviction directly relates to his ability to practice pharmacy or to the practice of pharmacy. At the time of Respondent's arrest, the pharmacy chain had fired him. Following the arrest but before the conviction, Respondent worked as a pharmacist for a corporation that supplies licensed replacement pharmacists on a short-term or indefinite basis. Primarily assigned to one client working with terminally ill patients, Respondent was valued as a pharmacist by the clients and his employer for the six months that he was so employed. Respondent's employment as a licensed pharmacist ended when the Board of Pharmacy issued an emergency order suspending his license on March 28, 1995. Respondent has since attempted to find employment, but he has found none. His ability to make restitution has been impeded, although he has made some payments. Respondent has received private psychological counselling since October 1994. The psychologist's diagnosis was that Respondent was suffering from an adjustment reaction with depressed mood. Helping Respondent to analyze his past mistakes and equip himself to deal with stress, the psychologist opines that it is very unlikely that Respondent would repeat this behavior and would not represent a threat to the public safety, health, or welfare if he were to continue practicing pharmacy. Respondent has participated in the PRN since August 1994. The impaired practitioner program typically serves licensees who are unable to practice due to mental illness, substance abuse, or physical disability. The program has determined that Respondent suffers from no chemical dependency, sexual disorder, or psychiatric illness. Rather, at the time of the criminal behaviors, Respondent was under extreme stress. However, the director of the program testified that Respondent is progressing very well, free of all illness, and gaining insight into his difficulties so that he can now express his feelings and handle his stresses. The director also opines that Respondent would not pose a threat to public safety, health, or welfare if he were to continue practicing pharmacy. Respondent has entered into a five-year contract with the PRN. The program monitors Respondent for a lifetime. If at anytime the director were to determine that Respondent is not progressing, such as by failing to renew a contract when asked to do so by the program, the director would file a complaint with Petitioner. It has been almost two years since Respondent began diverting controlled substances to the prostitute and almost a year and one-half since he was caught. This relatively recent behavior was not isolated, but lasted six months. Respondent was caught and did not turn himself in. Respondent's behavior harmed himself, his family and friends, and his employer, which spends considerable resources to develop public trust and employee morale, both of which were damaged by Respondent's actions. Respondent's behavior also harmed the woman, whose squalid circumstances were worsened by Respondent's "generosity." And his criminal behavior threatened the safety, health, and welfare of numerous persons who purchased the controlled substances that Respondent had stolen and given to the woman. On the other hand, Respondent poses no risk to the public. This is the opinion of two mental-health professionals working closely with Respondent. Also, Respondent did not steal controlled substances while working for six months as a temporary pharmacist and while under considerable stress from the criminal prosecutions. Although Respondent did not turn himself in, he did confess immediately and completely. As a practical matter, his ability to make restitution is dependent on his ability to practice pharmacy. Respondent and Petitioner each present numerous final orders of the Board of Pharmacy evidencing past penalties. Petitioner's final orders include Newman, Case No. 94- 20465 (five years' suspension and $2000 fine for state conviction for sale, purchase, or delivery of Schedule IV controlled substance; and Dunayer, Case No. 07300 (revocation for shortage of over 500,000 dosage units of many of the same codeine- containing drugs). Respondent's final orders include Feldman, Case No. 92- 07313 (three years' suspension, retroactive 14 months to when licensee was ordered by court to surrender license, three years' probation, and $3000 fine for federal conviction for distributing and dispensing outside course of professional practice of pharmacy--although some of the same codeine-containing drugs were involved, it appears that considerably greater quantities may have been involved); Swoy, Case No. 93-11716 (two years' suspension, of which 22 months were stayed and several years' probation for state conviction of delivery of one of the same codeine-containing drugs--quantity unclear); and Levine, Case No. 92-04729 (two years' suspension that was stayed and four years' probation for state conviction of impaired practitioner for theft from pharmacy of relatively small quantities of Schedule II controlled substances).

Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Pharmacy enter a final order finding Respondent guilty of violating Section 465.016(1)(f), suspending his license for one year from the date of the emergency suspension, imposing a $3000 fine to be paid within 90 days after the end of the suspension, and placing Respondent on probation for a period of five years. ENTERED on August 8, 1995, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings on August 8, 1995. COPIES FURNISHED: John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792 Nancy M. Snurkowski Agency for Health Care Administration 1940 North Monroe St., Suite 60 Tallahassee, FL 32399-0792 Salvatore A. Carpino 8001 North Dale Mabry Hwy. Suite 301-A Tampa, FL 33614

USC (1) 21 U.S.C 846 Florida Laws (2) 120.57465.016
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