Fo1E-05: 2:152M: DOR PHARMAT, SE2 CE Siz 828 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, BUREAU OF STATEWIDE PHARMACEUTICAL SERVICES, Petitioner, v. CASE NO.: 2005- BIO-MED PLUS, INC., a Florida corporation, together with MARTIN J. BRADLEY, OR., MARTIN J. BRADLEY, III, and STEPHEN B. GETZ, in their corporate and individual capacities, Respondents. AMDINISTRATIVE COMPLAINT YOU ARE HEREBY NOTIFIED that the State of Florida, Department of Health, through its Bureau of Statewide Pharmaceutical Services issues this administrative complaint against Bio-Med Plus, Inc. to suspend its permit, permit number: 22:00813 as a Florida prescription drug wholesaler, until the conclusion after all appeals of the case of United States v. Bio-Med Plus, Inc., et al., pending before the U.S. District Court, Southern District of Georgia, Savannah Division, or to deny renewal and revoke such permit. Additionally, the department seeks an administrative fine of $5,000 per day per violation alleged herein, or any other penalty authorized by law against each of the respondents, Bio-Med Plus, Inc., Martin J. 3 15-C53 2:'52M:90H PHARMAC. SCS CE :G2z S267 Bradley, Jr., Martin J. Bradley, III, and Stephen 3. Getz. In support of the intended final agency action the bureau states that: 1. The Department of Health (hereinafter “the Department”), through the Bureau of Statewide Pharmaceutical Services (‘the Bureau”) is the state agency charged with regulating the wholesale distribution of prescription drugs from, in or into the State.of Florida pursuant to Chapter 499, Florida Statutes, ("F.S.”). 2. Section 499.066(5), Florida Statutes, empowers the Secretary of the Department of Health (hereinafter, “the Secretary”) to issue an emergency order immediately suspending a permit (hereinafter referred to as an “BSO”) if it is determined that any condition in the establishment presents a Ganger to the public health, safety, and welfare, in accordance with Section 120,60(6), F.S. The Secretary issued such an order suspending the prescription drug wholesaler permit, permit number 22:00823, of Bio-Med Plus, Inc., by ESO dated April 14, 2005, and rendered April 15, 2005, which ESO has been stayed by the Florida First District Court of Appeal pending argument on the merits. 3. Bio-Med Plus, Inc., a Florida corporation, whose principle place of business is located at 6855 S.W. 81° Street, Miami, Florida 33143-7707, is permitted by the bureau under the Florida Drug and Cosmetic Act, Chapter 499, F.S., (“the Act") as 2o0f 11 7-28-05; 2:18PM;ND0OH SRARMACY SFT CICE ;S°2 S267 ; . a prescription drug wholesaler with permit number 22:00813. The expiration date of permit number 22:00813 is May 31, 2005; however, Bio-Med Plus, fInc., timely submitted an application to renew prescription drug wholesaler permit number 22:00813. 4, Martin J. Bradley, Jr., Martin J. Bradley, fil and Stephen B. Getz are all officers, directors and owners (shareholders) of Bio-Med Plus, Inc., each of whom is also responsible individually as well as in their corporate capacity for the conduct alleged herein as violations of the Act. 5. On or about March 23, 2005, The United States of America, by and through a United States Attorney, filed an indictment (hereinafter referred to as "the Indictment") in the United States District Court for the Southern District of Georgia, Savannah Division against Bio-Med Plus, Inc.j it's owners and officers Martin J. Bradley, III, Martin J. Bradley, Jr., and Stephen B. Getz; et. al. A copy of the Indictment is attached hereto and made a part of this administrative complaint (the “Complaint”). 6. Relevant to this Complaint, the Indictment alleges Bradley III and Bradley Jr., owned, operated and controlled numerous entities through which they unlawfully obtained prescription drugs, which prescription drugs were diverted to Bio-Med Plus and then sold by Bio-Med Plus in wholesale distributions. In particular, the Indictment alleges that Bio- 3 of tL "1H El REST F-1S-C053; 2:152M;DOF FHARMAC. SEF OICE :SL2 53 Med Plus obtained prescription drugs, such as IV-G and other prescription drugs, from Infustat, a closed pharmacy and from medical practitioners. Infustat and other medical practitioners billed third party providers for prescription drugs not actually dispensed or administered to patients and distributed these prescription drugs to Bio-Med Plus. Infustat also acquixed prescription drugs as a member of a group purchasing organization at preferential pricing because the prescription drugs were limited to "own use" restrictions, i.e., use on or for Infustat's patients and not for further distribution. However, according to the Indictment Bio-Med then obtained these preferentially priced prescription drugs from Infustat, which if proven constitutes violations of the Act, in particular section 499,005(1), (3), (4), (14) and (21) (a), F. S. Moreover, neither Infustat nor the medical practitioners were permitted under the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, or otherwise authorized to sell or distribute prescription drugs to Bio-Med Plus. 7. Relevant to this Complaint, the Indictment further alleges Stephen B. Getz, an officer in Bio-Med Plus, participated in the fraudulent purchase of prescription drugs, specifically IVIG (intravenous immune-globulin), which were sold or otherwise distributed by Bio-Med Plus in wholesale 4o0f 11 PR1S-05; 2:18PM; DOR PHARMAT, shh FOr Ar 6 . :G5P hae? distributions, which if proven constitute violations of the Act, in particular section 499.005(1), (3), (4), (14) and (23), F. S. 8. Relevant to this Complaint, the Indictment also alleges that Martin J. Bradley IIIf, Martin J. Bradley dr., and Bio-Mead Plus created sales invoices from other entities, for some of the pharmaceuticals [prescription @rugs} uniawfully obtained in paragraphs 5 and 6 in an effort to conceal their fraudulent activity with respect to the unlawful sources of these prescription drugs. If proven these acts constitute violations of section 499.005(1), (3), (4), (14) and (23), F. S. 9. Based on the conditions described in paragraphs 6 and 7, Bio-Med Plus engaged in fraud, deceit, misrepresentation and subterfuge in the acquisition of prescription drugs for resale in violation of s. 499.005, (23), F. S. 10. Based on the conditions described in paragraphs 6 and 7, Bio-Med Plus acquired prescription drugs from persons not authorized under the Florida Drug and Cosmetic Act, Chapter 499, F.s., to distribute prescription drugs to Bio-Med Plus. As a result, Bio-Med Plus acquired and resold or otherwise distributed prescription drugs that were adulterated, as defined ins. 499.006, F.S., in violation of s. 499.005(1), (3) and (4), F.S., because the prescription drugs nad left the regulatory controls established in federal and state law to protect the safety, integrity, and efficacy of prescription drugs. Sof il v7 7-15-06: 2:15PM;DOH PHARMAC. SERY CE :322 5267 1 11. Based on the conditions described in paragraph 8, Bio- Med Plus failed to maintain records that truthfully reflect its acquisition of prescription drugs as required by ss. 499.001- 499.081 and the rules adopted under those sections in violation of s. 499.005(18), F. S. 12. Independent of the Indictment, Bio-Med Plus, Inc., has engaged in a continuous course of conduct in violation of the Act from November, 2001 until October, 2002 whereby it obtained, held for resale and resold, cr otherwise distributed wholesale, adulterated prescription drugs as follows. The prescription drugs that Intermed, a prescription drug wholesaler in Savannah, Georgia sold to Bio-Med Plus via invoices documenting such sales for the above-referenced period of time all came from Medpoint, a Florida prescription drug wholesaler not permitted to wholesale such drugs to Intermed in the state of Georgia. As such, under the Act as it existed at that time, such drugs were adulterated. Respondents acquisition of such drugs and subsequent resale or other wholesale distribution of such drugs constitute violations by each of Respondent of section 499.005(1), (3), {4) and (14), F. S. 13. Based on all of the above allegations, Bio-Med Plus is a danger to the public health, safety and welfare and has engaged in a persistent pattern of conduct demonstrating its unwillingness to abide by the Laws of the State of Florida that 6of 11 T#15-C5; 2:15PM;0CH PHARMACY SEP “ICE :Q@f2 52367 } pertain to the regulation of the wholesale distribution of prescription drugs in that: (a) Bio-Med Plus knowingly purchased or otherwise acquired and distributed over $40 millions of dollars worth of adulterated prescription drugs on numerous occasions as set forth herein, (b) Bio-Med Plus engaged in schemes to create documentation to conceal the actual source of ‘he prescription drugs Bio-Med Plus acquired and resold or otherwise distributed, and (c) The prescription drugs that Bio-Med Plus sold or otherwise distributed left the regulated channels for the lawful distribution of prescription drugs in this country and in Florida, thereby jeopardizing the integrity of these prescription drugs. Bio-Med Plus' actions alleged herein with respect to its operation as a prescription drug wholesaler present an unnecessary risk to the unsuspecting consuming public and their prescribing healthcare practitioners. 43. Bio-Med Plus' continued operation as a prescription drug wholesaler during the pendancy of the criminal case arising from the Indictment constitutes an immediate and serious danger to the health, safety and welfare of the public. Based on the allegations in the Indictment, Bio-Med Plus' pattern of conduct 7of ll 7-15-08; 2:15PN;0CH PHARMAC, SES e!CE S25 over a significant duration of time as a prescription drug wholesaler presents an unacceptable risk of injury to the frail and seriously ill consuming public and their prescribing practitioners. 14. Pursuant to section 499.067(1)(b)4, F.S. (which cross- references section 499.012(5)}, the department is authorized to suspend, deny renewal, or revoke the prescription drug wholesaler permit of Bio-~Med Plus, Inc., and impose an administrative fine of $5,C00 per day per violation, or impose any other penalty authorized by law against each of the named respondents in that: a. Bio-Med Plus' past experience in distributing prescription drugs poses a public health risk (see Section 499.012(5)(f), F.S.), b. Bio-Med Plus is affiliated directly through ownership and control with persons whose business operations are or have been detrimental to the public health (see section 499.012(5)(g), F.S.), and c. Bio-Med Plus, as well as the three named respondent-owners or officers of Bio-Med Plus have been charged with a felony in federal court and the disposition of those charges is pending (see Section 499.012(5) (i), F.S.). 8efll 7-15-28; 2:15PM;00CH PHARMACY SERYICE 3922 S367 d. Each of the Respondents has engaged in acquiring for resale, and reselling or otherwise distributing wholesale, adulterated prescription drugs in violation of section 499.005(1), (3), (4) and (14), F. Ss. 15. On learning of the Indictment the bureau initiated a comprehensive investigation under the Act of the Respondents. That investigation is ongoing. The bureau, therefore, reserves the right to amend this Complaint during the pendancy of the investigation and the pendancy of this proceeding to add allegations to this Complaint consistent with che evidence obtained from its continuing investigation of the Respondents. 16. Respondents have the right to request an administrative hearing pursuant to sections 120.569 and 120.57, F. S., if respondents wish to challenge the intended agency action as stated in this complaint. Such proceedings are governed by sections 120.569 and 120.57, F. S., and Fla. Admin. Code Rules 28-106 and 28-107. Requests for a hearing, whether with or without disputed issues of material fact, must comply with Fla. Admin. Code Rule 28-107.004. a. As such each respondent has the -szight to be represented by counsel or other qualified representative, at respondent’s expense; to present evidence and argument; to call and cross-examine witnesses and to have subpoena and subpoena 9 of 11 duces tecum issued on behalf of respondent if a hearing is requested. b. A petition for an administrative hearing must be I writing and must be received by the Agency Clerk for the Department within twenty-one (21) days from the receipt of this complaint. The address of the Agency Clerk is 4032 Bald Cypress way, Bin# A02, Tallahassee, FL 32399-1703. The facsimile numper for the Agency Clerk is 850-410-1448. c. Mediation is not available as an alternative remedy. d. A respondent’s failure to submit a petition for a hearing within 21 days from the receipt of this complaint and notice will constitute a waiver of that respondent's right to an administrative hearing under Fla. Admin. Code Rule 28-106.111 and this complaint shall become a final order as to that respondent. e. Should this complaint and notice become a final order, a party who is adversely affected by it is entitled to judicial review pursuant to section 120.68, F. S. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of a Petition for Review in accordance with Rule 9.100, Florida Rules of Appellate Procedure, with the Department of Health and a second copy of the petition accompanied by a filing fee 10 of 11 prescribed by law with the District Court of Appeal within thirty (30) days of the rendition of the final order (the date this complaint is filed with the Agency Clerk). 17. I HEREBY CERTIFY that a true and correct copy of the above and foregoing Administrative Complaint has been furnished by OVERNIGHT DELIVERY to Martin J. Bradley, III, as the CEO, President and Registered Agent of Bio-Med Plus, to 6855 S.w. &1%¢ h Street, Miami, Florida 33143-7707, on this gt day of Du ne, 2005. R.PH., CHIEF eau of/Statewide Pharmaceutical Services 818-A Mahan Drive Tallahassee, Florida 32308 (850) 922-5190 Copies also furnished to: Sam Powers, Senior Attorney Agency Clerk Department of Health 40052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-0700 (850) 245-4005; (850) 413-8743~-FAX Sean Ellsworth, Esquire 404 Washington Avenue, Suite 75) Miami Beach, FL 33139 Robert P. Daniti, Esquire DOH Senior Attorney, FBIN 0191599 Florida Department of Health 4052 Bald Cypress Way, Bin # A0Q2 Tallahassee, FL 32399-1703 llofll rial

Docket for Case No: 05-002584