- a) ty STATE OF FLORIDA — ie NO DEPARTMENT OF HEALTH ey : : “yy DEPARTMENT OF HEALTH, 3 through its BUREAU OF ‘ PHARMACY SERVICES, Petitione:, Gase No: vs. (DOH: .01-0-1914) Brazil-US Trading, LLC, a Florida Corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, Respondents. ADMINISTRATIVE COMPLAINT Notice is hereby provided that Petitioner, Department of Health by and through its Bureau of Pharmacy Services (the “bureau”), intends to impose against Respondents, Brazil-US Trading, LLC, (“Brazil-US Trading”), a Florida corporation, as well as Solange E. Benitez-Luz, individually and Jose A. Benitez, individually an administrative fine in the amount of Two hundred seventy-two thousand two hundred fifty dollars ($272,250), pursuant to section 499.066(3), Florida Statutes, and revoke the prescription drug wholesaler permit number 22:01243, that authorizes Brazil-US Trading to operate as a prescription drug wholesaler in Florida. In support of the intended final agency action the bureau states: (1) Petitioner, Department of Health (hereinafter “the Department”), through the Bureau of Pharmacy Services (“the Bureau”), 2818-A Mahan Drive, Tallahassee, Florida, 32308, is the state agency charged with implementing and enforcing the provisions of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (“the Act”), including the regulation of the acquisition and distribution of prescription drugs in, into and from Florida as oe well as the permitting of entities to engage in this activity. The prescription drug wholesaler permit is established under the Act. (2) Brazil-US Trading located at 1355 N.W. 93rd Court, Suite A-102, Miami, Florida, is permitted under the Florida Drug and Cosmetic Act, Chapter 499, F.S., (“the Act”) as a prescription drug wholesa er. P anit number 22:0124% represents, ihe. authority for Brazil-US Trading to engage in the whciesale distribution of prescription drugs:in or from Florida until the permit expires on April 30, 20063, unless sooner suspended or revoked.. An emergency suspension order was issued by the Secretary of the Department of Health on February 18, 2002, to suspend immediately Brazil US-Trading’s prescription drug wholesaler permit 22:01243 pending the final disposition of the allegations in this Complaint. . (3) Solange E. Benitez-Luz is the president of Brazil-US Trading and the spouse of Jose A. Benitez. Solange E. Benitez-Luz is an authorized signature on the business checking account of Brazil-US Trading and signed authorizations for payments for prescription drugs purchased in paragraph (9) of this “Complaint. As a result, Solonge E. Benitez-Luz is responsible for the unlawful prescription drug wholesaling practices of Brazil-US Trading. (4) Jose Andres Benitez is the vice-president of Brazil-US Trading and the brother of Jose Antonio Benitez (“Jose A. Benitez”). Jose Andres Benitez (“Andy Benitez”) is an authorized signature on the business checking account of Brazil-US Trading and signed authorizations for payments for prescription drugs purchased in paragraph (9) of this Complaint. As a result, Andy Benitez is responsible for the unlawful prescription drug wholesaling practices of Brazil-US Trading. : (5) Jose A. Benitez is directly involved in the day-to-day operations of Brazil-US Trading as further alleged in this complaint. (6) On January 11, 2002, an agent of the Bureau conducted an inspection at Proscript Pharmacy Services at 3732 S.W. 64" Ayenue, Davie, Florida immediately after the departure of an employee of Brazil-US Trading had made a delivery of prescription drugs pursuant to a regulated wholesale transaction. Upon physical inspection of the prescription drugs delivered by Brazil-US Trading to Proscript, the agent observed that four containers of Combivir; two containers of Kaletra; one container of Diflucan 100mg; one container of Sustiva 200 mg; ene container of Crixivan 400mg; and three containers of Ziagen 300 mg were missing outserts. ‘An outsert is labeling of the pres criptio.: drug by the manufacturer required! Linder the federal Food, Drug and Cosmetic Act and requlations promulgated ther2urider, that 's attached to the exterior container of a prescription drug but not directly to the label. The outsert contains essential information about the instructions for use, indications, and warnings regarding the drug. The absence of this labeling, prior to a product being dispensed, misbrands a prescription drug under federal law and more specifically, under s. 499.007, Florida Statutes, and Rule 64F- 42.006(1), Florida Administrative Code. (7) The Bureau's agent also noted the labels on the containers of the prescription drugs identified in paragraph (6) showed signs of wear and tear and were very sticky to the touch. As a result, these prescription drugs were also adulterated pursuant to s. 499.006, F.S. (8) Therefore, based on the allegations in paragraphs (6) and (7), Brazil-US Trading distributed prescription drugs that were misbranded and adulterated in violation of s. 499.005(1) and (4), F.S. (9) Records of purchase of prescription drugs by Brazil-US Trading and other documentation provided to the department by or on behalf of Brazil-US Trading demonstrate that during the period July 1, 2001 through November 30, 2001, Brazil-US Trading purchased over $6.9 million worth of prescription drugs from A&s Trading, LLC (“A & J”) at 4614 Wilgrove Mint Hill Road, Mint Hill (Charlotte), N.C. 28227. (10) A & J is required to hold a valid permit as an Out-of-State Prescription Drug Wholesaler as provided by s. 499.012(2)(c), F.S., to engage in the wholesale distribution of prescription drugs prior to selling or physically disfributing any prescription drug to Brazil-US Trading in Florida. A & J, however, is not currently and has not been permitted under Chapter i+ ) 499, F.S., at any time relevant and material to this Complaint, to engage in the wholesale distribution of any prescription drug from, in or into the State of Florida. (11) According to A & J's application for the Wholesale Prescription Drug Distributors license in the state of Norih Carnlina, Jose A. Beriitez, or his orother, is identified as the President of A & J. Jose A. Be tite: and A & J ke o1 hed reason fo believe tha: an application by A &J Trading for an Out-of-State Prescrip ion Wholesa er permit under the Act would be : denied, since the department has revoked a previous permit issued to Triple J Trading to wholesale prescription drugs in Florida, where Jose A. Benitez was an officer and owner. Triple J Trading’s prescription drug wholesaler permit was revoked for several reasons, including the fact that Jose A. Benitez is a convicted felon. In addition, the department responded to correspondence from an attorney representing Brazil-US Trading notifying him that if Jose A. Benitez were an employee or participated in administering or operating any establishment permitted to handle prescription drugs under the Act, the department would seek revocation of that establishment's permit. (12) Brazil-US Trading has also purchased prescription drugs from Two M Enterprise in Wanatah, Indiana. Two M Enterprise is not currently and has not been permitted under Chapter 499, F.S., at any time relevant and material to this Complaint, to engage in the wholesale distribution of any prescription drug from, in or into the State of Florida. Two M Enterprise is required to hold a valid permit as an Out-of-State Prescription Drug Wholesaler as provided by s. 499.012, F.S., to engage in the wholesale distribution of prescription drugs prior to selling or physically distributing any prescription drug to Brazil-US Trading in Florida. (13) | When Brazil-US Trading acquired prescription drugs from either A & J or Two M Enterprise, Brazil-US Trading purchased or received a prescription drug from a person that is not authorized under Chapter 499, F.S., to sell or distribute prescription drugs to it and thereby violated s. 499.005(14), F.S. “. (14) In addition, A & J purchased prescription drugs from several sources in Florida. However, at least four of these sources in Florida, Unimed Medical Center in Hialeah, Millenium Health Center in Miami, Ola’s Pharmacy in Hialeah, and Huffree International Corp, in North Miami, were not permitted to engage ir, the wholesaie distribution of prescription drugs at the tim? of th» transactions. Thetefo e, all of the pescription drags the t Erazl-LS Trading claims to have purcaased from A & J that came from any of these fou scurces were adulterated pursuant to s. 499.096(2) and (3), F.S. (15) Since A & J and Two M Enterprise were not permitted to engage in the wholesale distribution of prescription drugs in or into Florida and some of the prescription drug sources for A & J were not permitted to wholesale prescription drugs to A & J, all prescription drugs that Brazil-US Trading purchased or received from either A & J or Two M Enterprise are adulterated pursuant to s. 499.006(2) and (3), F.S. Therefore Brazil-US Trading has purchased and received adulterated drugs in violation of ss. 499.005(3) and (4), F.S. (16) Furthermore, Brazil-US ‘Trading sold and distributed the prescription drugs it claims to have purchased from A & J and Two M Enterprise, thereby selling and distributing adulterated prescription drugs in violation of ss. 499.005(1), (3), and (4), F.S. (17) By written correspondence dated September 12 and 27, 2001, the Bureau's agent requested shipping records documenting the movement of prescription drugs from A & J to Brazil-US Trading. To date, Brazil-US Trading has not produced to the Bureau any shipping records for the receipt of prescription drugs it allegedly purchased from A & J. Records related to the physical movement of prescription drugs are required to be maintained and produced to the Bureau for inspection under ss. 499.0121(6) and 499.051, F.S., and Rule 64F-12.012, Florida Administrative Code. Brazil-US Trading therefore violated s. 499.005(6) and 499.005(18), F.S. for not maintaining and producing required records related to its prescription drug wholesaling activities. o- (18) “Pedigree papers’ related to the prescription drugs purchased from A & J did not comply with the requirements for pedigree papers contained in s. 499.0121(6)(d), F.S., and Rule 64F-12.012(3), Florida Administrative Code. A pedigree paper is a record required to be provided by a prescription drug wholesaler distributing a prescription drug to another prescription drug w volasaier when \he distribtitin } wholesaler is not tae authorivec distributer of record for the: prescription drug which is the subject of the transaction. The Act requires that this -record trace the sales and movement of the prescription drug back to the manufacturer. The pedigree papers related to the transactions between A & J and Brazil-US Trading were missing the following elements, which is not an all-inclusive list of the deficiencies: the name of the product, the quantity by lot number, the name and address of each owner, and the name and address of each location from. which: the prescription drug was shipped if different from the owner's. (19) A&Jisnotan authorized distributor of record for the prescription drugs sold to Brazil-US Trading and the pedigree papers, as they were, did not disclose the sale of the prescription drugs prior to A & J and the location from which the prescription drugs were shipped if different from the owner’s as required by s. 499.0121(6)(d), F.S., and Rule 64F- 12.012(3), Florida Administrative Code. Therefore, Brazil-US Trading was on notice that the pedigree paper for the prescription drugs purchased from A & J were deficient, placing the safety and integrity of these prescription drugs in question. Brazil-US Trading should have declined the purchase of these prescription drugs pursuant to Rule 64F-12.013(5), Florida Administrative Code. (20) Furthermore, according to an inspection of A & J by the North Carolina Department of Agriculture and Consumer Services, an employee of A & J indicated that A & J had never received or stored prescription drugs at the permitted premises of 4614-J Wilgrove Mint Hill Road. Moreover, according to a sworn statement from an employee of Brazil-US ah ) Trading, Jose A. Benitez would personally bring boxes of ‘prescription drugs into Brazil-US Trading, the source of which has not been documented by Brazil-US Trading. (21) Pedigree papers provided by Brazil-US Trading to its customers purchasing prescription drugs were missing the same elements as identified. in paragraph (18) above. Therefore, Brazil-US' Trading knowingly engaged in fraud and misrepresentation in tha distribution of prescriptio’ crugs ty selling to its customers adultératud drugs anc: p oviding inaccurate and misleading pedigree papers regarding the prescription dtugs sold to customers, a violation of s. 499.005(23), F.S. (22) According to Brazil-US Trading records for the period April 1, 2001 —- September 12, 2001, it sold to OmniMed, a permitted prescription drug wholesaler in Boca Raton, Florida, 168 units of Neupogen 300mg. The pedigree papers supplied by Brazil-US Trading to OmniMed related to these sales indicated the Neupogen 300mg was purchased and came from Global Rx, a permitted prescription drug wholesaler in Miami, Florida. However, records documenting the purchase of prescription drugs from Global Rx for the same time period indicates Brazil-US Trading only purchased 19 units of Neupogen 300mg from Global Rx. Brazil-US Trading therefore provided false and fraudulent pedigree papers to OmniMed related to the sale of Neupogen 300mg and engaged in fraud or misrepresentation in the distribution of a prescription drug in violation of s. 499.005(23), F.S. (23) Brazil-US Trading also provided the pedigree papers and documents related to prescription drug transactions that were provided to customers in paragraphs (21) and (22) to the Bureau in response to a request for records related to its prescription drug wholesaling activities. Therefore, Brazil-US Trading provided the department with false or fraudulent records in violation of s. 499.005(19), F.S. (24) On or about January 11, 2002, Brazil-US Trading possessed in excess of 200 prescription drugs, valued at several hundred, -thousand dollars that were missing the manufacturer's outsert. Furthermore, the labels on these prescription drugs showed signs of wear and were sticky to the touch. Exhibit A is incorporated by reference into this Complaint and lists the specific prescription drugs addressed in this paragraph. Brazil-US Trading was therefore in possession of and holding for sale hundreds of misbranded and adulterated prescription drugs in violation of s. 499.005(1) and (12), F.S. (25) A arescription drug that is m’ss'ng the outsert, shows signs of wear and tear on the label, and has e. sticky latel ind cates he drug, more tikeiy than noi, had previously been dispensed by a pharmacy: and the dispensing labals had been removed for the uniawtul reintroduction of the drug into commerce. On or about January 11, 2002, Brazil-US Trading possessed approximately 8 pints of Ronsonol brand lighter fluid, 2 quarts of denatured alcohol, and a half-gallon of liquid degreaser under the sink inside a cabinet within the drug storage area of the permitted establishment. According to an employee of Brazil-US Trading, these products were used to clean prescription drugs that were sticky. Brazil-US Trading was distributing adulterated prescription drugs and I had the means to distribute prescription drugs that had previously been dispensed by a pharmacy and unlawfully reintroduced into commerce. (26) On or about January 11, 2002 an individual left Brazil-US Trading carrying a blue cooler. The cooler contained the prescription drugs Neupogen and Procrit and Purchase Order #16215 from Brazil US Trading to A & J listing most of the drugs in the cooler. This purchase order totaled $68,878.12. Jose A. Benitez had toid this individual to take the cooler to Benitez’ home. Jose A. Benitez and Brazil-US Trading violated s. 499.005(15), F.S., by transferring prescription drugs to a person not authorized to purchase and possess prescription drugs. Furthermore, s. 499.01 provides that a prescription drug wholesaler may not store prescription drugs at an unpermitted address. The Act and rules adopted thereunder also provide that a prescription drug cannot be stored at a residence, unless the prescription drug is in the possession of the person to whom it was lawlully dispensed. (27) Jose A. Benitez was convicted of a felony in the Southern District of Florida in December 1991 related to a prescription drug. (28) Jose A. Benitez is actively involved in the day-to-day operations of Brazil-US Trading which is evidenced as follows: (a) Jose A. Benitez holds himself out to employees of Brazil-US Trading as a co- owner of Brazil-US Trading and directs these employees regarding the receipt and handling of prescription drugs. ) (0) Jose A. Benitez. has been present .on i:t l:ast two occasions, Septomter 21, 2001 and January. 11, 2002, when tne Bureat! has attempted an inspection of Brazil-US Trading. None of the officers or responsible persons identified by Brazil-US Trading on its application form for the Chapter 499 prescription drug wholesaler permit were present at either of these times. (c) Jose A. Benitez informed the Bureau’s agent on January 11, 2002, that he was a consultant for Brazil-US Trading. (d) Jose A. Benitez persgnally transports prescription drugs from his automobile into Brazil-US Trading. ™ (29) The violations of Chapter 499, F.S., by Brazil-US Trading, Solonge Benitez-Luz, Andy Benitez, and Jose A. Benitez as set forth in this complaint constitute sufficient grounds for DOH to revoke Brazil-US Trading’s prescription drug wholesaler permit and impose an administrative fine of Two hundred seventy-two thousand two hundred fifty dollars ($272,250) or impose any other penalty authorized by Chapter 499, F.S. and Chapter 64F-12, Florida Administrative Code against the Respondents. (30) Rule 64F-12.024 (4), Florida Administrative Code sets the range of the penalty for violations of the Florida Drug and Cosmetic Act, Chapter 499, F.S. Pursuant to that rule the bureau intends to impose the fines and action as noted. {a) The rule authorizes a fine for the purchase or acquisition of a prescription drug from an unauthorized source ranging from $250 to $1,000 per violation per day. Brazil-US Trading claimed purchases of prescription drugs from A & J, but A & J is not permitted to sell ~~ Od prescription drugs to a Florida wholesaler. A & J, also acquired prescription drugs from sources that were not permitted at all to engage in the wholesale distribution of prescription drugs. Furthermore, the physical source of the prescription drugs purchased from A & J has not been identified. Therefore Brazil-US Trading’s purchase of prescription drugs from A & J is a more serious viclation than purchasing a prescription drug irom a source that 's permitted to wholesale presciption drugs in its resident stete and otharwise co np.ies with the regulatory raquirements related to ihe wholesale distribution of prescription drugs, but has not yet obtained an Out-of-State Prescription Drug Wholesaler permit from the State of Florida to wholesale prescription-drugs into this state. Moreover, the prescription drugs purchased by Respondents trom unauthorized sources as alleged in this Complaint are needed by people who are extremely ill, suffering from AIDS, cancer, and other conditions of persons with compromised immune systems. Because the source of millions of dollars worth of prescription drugs wholesaled by Brazil-US Trading is unknown, it warrants the department to impose the upper level of the range of penalty for the violations and enhance the penalty with revocation of the permit that authorizes Brazil-US Trading to wholesale prescription drugs. The bureau intends to fine Respondents $42,500 in for the violations alleged in paragraphs (9), (12), (13), and (15) ($1,000 for each of the 40 invoices from A & J Trading plus $250 for each of the 10 invoices from Two M Enterprises) and revoke permit 22:01243 for this violation. (b) The rule authorizes a fine for the sale or delivery of an adulterated or misbranded prescription drug ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $89,000 for the violations alleged in paragraphs (6) — (8) and (16) ($1,000 for each of the 12 products in paragraph (6) plus $1,000 for the 77 invoices in paragraph (16)) and revoke permit 22:01243 for this violation. (c) The rule authorizes a fine for the failure to maintain records as required ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $41,250 ($250 for each of the following - the 44 ut ) invoices for which no shipping record was provided as alleged in paragraph (17) plus the 44 invoices with pedigree paper deficiencies for purchases alleged in paragraph (19) plus the 77 invoices of sale with pedigree paper deficiencies alleged in paragraphs (21) and (22)) for this ‘violation. (d) The rule authorizes a fine for engaging in misrepreseniation 2r fauclir the dis tribution of a prescription drugs renging frora $500 - $5,000 per viclation ser da / aiid suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $22,000 ($1,000 for the 22 invoices alleged in paragraph (22)) and revoke permit 22:01243 for this violation. (e) The rule authorizes a fine for holding for sale adulterated prescription drugs ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $71,500 ($250 for each of 286 prescription drugs alleged in paragraph (24)) and,revocation of the permit 22:01243 for this violation. (f) The rule authorizes a fine for providing the department with false or fraudulent information ranging from $500 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $5,000 for violation alleged in paragraph (23) and revoke permit 22:01243 for this violation. (g) The rule authorizes a fine for transferring a prescription drug to a person not authorized to possess a prescription drug ranging from $250 - $1,000 per violation per day. The bureau intends to fine Respondents $1,000 for the violation alleged in paragraph (26). (31) Section 499.067(1), F.S., authorizes the department to deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with ss. 499.001-499.081 or chapter 465, chapter 893, or chapter 501, or the rules adopted under any of those sections or chapters. In addition, s. 499.067(3)(c), F.S., authorizes the department to deny, suspend or revoke a permit if the permittee has violated any-provisions of ss. 499.001-499.081 or rules adopted under those sections. Furthermore, s. 499.067(5), F.S., authorizes the department to “deny, suspend, or revoke a permit issued under the Act which authorizes the permittee to purchase prescription drugs, if any owner, officer, employee, or other person who participates in administering or operating the establishment has been found guilty of any violation of ss. 499.001-499.081 ..: any rules adopted under any of those sections or chapters, or any federal ‘or stete rug kiw, regardless of wiether’ the person has been pardoned, had her civil righ’s restored, or had acjudication withheld,” (32) The violations alleged in this complaint evidence a substantial failure to comply and are substantial violations of the Florida Drug.and Cosmetic Act, Chapter 499, Florida Statutes. The unlawful acquisition practices of Brazil-US Trading facilitated the distribution of adulterated and misbranded prescription drugs. Brazil-US Trading poses an additional threat to public health in that it allows Jose A. Benitez to participate in administering or operating Brazil- US Trading. Jose A. Benitez has also been found guilty of violating a federal drug law. Additionally, the purchasing and distribution practices of prescription drugs by Brazil-US Trading present a public health threat and the continued authority to engage in the wholesale distribution of prescription drugs poses a danger and is not in the best interest of the public health, safety and welfare. Finally, the practices of Brazil-US Trading as alleged in this complaint represent a substantial disregard for and an unwillingness to abide by the regulatory scheme regarding the wholesaling of prescription drugs, which undermines the regulatory structure established by federal and state law for the protection of the public health that warrant revocation of the authority to engage in the wholesale distribution of prescription drugs under permit 22:01243. (33) You have the right to request an administrative hearing pursuant to sections 120.569 and 120.57, F.S., if you wish to challenge the imposition of the administrative fine and the intended agency action to revoke permit 22:01231. Such proceedings are governed. by sections 120.569 and 120.57, F.S., and Rules 28-106 and 28-107, Florida Administrative Code. Request for a hearing, formal or informal, myst comply with Rule 28-107.004, Florida Administrative Code. (34) A petition for administrative hearing must be in 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 4052 Bald Cypress Way, BIN # A02, Tallahassee FL. 32399-1703. The Agency Clerk's facsimile number is 850-410-1448. (a) Vediaiion is not available as an alternative remedy. (9) Your failure to submit a petition fer hearing withia 21 days from receipt of this complaint will constitute a waiver of your right io an administrative hearing, under Florida Administrative Code Rule 28-106.111 and this complaint shall become a “final order". (ec) Should this complaint become a final order, a party who is adversely affected by it is entitled to judicial review pursuant to section 120.68, Fla. Stat. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings may be commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Department of Health and a second copy, accompanied by the filing fees required by law, with the Court of Appeal in the appropriate District Court. The notice rriust be filed within 30 days of rendition of the final order. (35) The undersigned certifies that a true copy of this administrative complaint was sent by U.S. Certified Mail, Return Receipt Requested, to Solange E. Benitez-Luz, as the President of Brazil-US Trading, to 1855 N.W. 93rd Court, Suite A-102, Miami, Florida 33172 this _ 4th day of March, 2002. ief of Pharmacy Services 2818-A Mahan Drive Tallahassee, Florida 32308 Telephone: (850) 922-5190 Copy also furnished to: Counsel for Brazil-US Trading, LLC: Joseph R. Buchanan, Esquire; Wampler Buchana Walker, et.al; 900 SunTrust Building; 777 Brickell Avnenue; Miami, Florida 33131 - 13 Craig Brand, Esquire; Ocean Optique Building, 2 N.E. 40" Street, 4" Floor; Miami, Florida 33137. . Counsel for the Department: Robert P. Daniti, Senior Attorney; 4052 Bald Cypress Way, Bin A02; Tallahassee, Florida 32399- 1703; Telephone (850) 245-4005; Facsimile (850) 413 8743; Florida Bar No. 191599 PROPERTY RECEIPT © ME O- DADE POLICE DEPT. M.S DADEPOUGE CASE NO, Page. ot ~ 9111 NW. 25th Street 10 ¢¥8~ FEB INVENTORY NO. , Miami, Florida 33172 - (305) 471-2900 DATE-TIME IMPOUNDED FES | | PROPERTY BUREAU LOCATOR CODE THe L002. OTHER DEPT. PROPERTY LOCATION AND INVENTORY NO. ADDRESS WHERE PROPERTY POUNDED (Give exact location where property was located.) (335 Sos F, 7 FAV. (os T™ PR OONERED BY Esme) ADDRESS =O 4. . Pont. aaabsant STATE _ CA Cana Arres. FEP0 plun RAL $7. AKG Aeon. (VIO S/F RB SWKER wot 7 DOF ESS” STATE” Li S72 ont Pesusiecr” ~~ ()SusPecT~ “Be at ~ . ( STOLEN PROPERTY ZRTRAL EVIOENCE (HOMICIDE PROBATE QO SECURITY STORAGE LOST/FOUND PROPERTY. EVIOENCE OTHER AGENCY OTHER (SPECI Gurrency Only PROPERT HY Proc 4 Ximl Ye nooumts |_| (3 | Goenit brim bo coo wid || lp | Weveoe, tpomes 10xime [ [| * [2] Poert yoeco wits eXime= [OT Puy| Nev Poger Boomes OXime | | a Creer Bonen ok, G 1m L~ | HEREBY ACKNOWLEOGE THAT THE ABOVE WET REPRESENTS ALL PROPERTO ve 'HEREBY ACKNOWLEOGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY IMPOUNI FROM NY POSSESSION AND THAT I HAVE RECEIVED A COPY OF THIS RECEIPT. BY ME IN THE OFFIGIAL PERFORIZANCE OF DUTY AS A DEPUTY SHERIFF / LAW ENFOR QFFICER. : ‘ SS - ° » a _eat es COCR S 2) NAke 3Z ; LEAD GATOR PRINT/SIGN SECTIONAJ! BADG 4 4 fh (PRINT AND SIGN) ae OTS IMPOUNDING OFFICER PRINT/SIGN ~ OISTHICT 6BADG and Evidence Bureau Use Ony vse = PRINT NAME SIGNATURE AND BADGE NO. 9111-N.W. 25th Street Miami, Florida 33172 (305) 471 -2900 | PROPERTY BUREAL | LOCATOR CODE" OTHER DEPT. PROPERTY LOCATION AND INVENTORY NO. « ia es : She BI ed Ornate oe Ee aay et Sec, Spanier OA TO he ROT es oe ~ Pene2., Jose Ae? - milk <9 es Ives ONO. “Ld STOLEN PROPERTY OCOTRIAL EVIDENCE TInoMGIoE POE ate a SECUANY STORAGE STORAGE i LOST/FOUND PROPERTY L) LAS EVIDENCE [JOTHER AGENCY {_) OTHER (SPEC! FEM Tuas Currency Only SeROPER oe ene ze cea_f Zs MUG st a ee a Sa 2] S| Battces/ Zeait| Wo m& Yt | pose ees| Vinee [eg Pil eertre/ prewesecf/atory | | | of Bethe | prostesec Ue - Ww& || ’ Fisleettees| Verimunte | Zoe me] | | nn re Ns | meres Lawistte! 2ZSoa mse ~S eetttes! UYiencert] zso my] | | thi Peete [eceer-c] yoemg | D | HEREBY ACKNOWLEDGE THAT THE ASOVE LIST REPRESENTS ALL PROPERTY IMPOUN UHEREBY ACKNOWLEDGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY TAKEN FROM NY POSSESSION ANO THAT I HAVE RECEIVED A COPY OF THIS RECEIPT. BY ME IN THE OFFICIAL PERFORMANCE OF DUTY AS A DEPUTY SHERIFF / LAW ENFOF : MENT OFFICER, LEAD INVESTIGATOR PRINT/SIGN SECTION/UNIT BAOC (PRINT AND SIGN) IMPOUNDING OFFICER PRINT/SIGN DISTRICT BADC and Evidence Bureay Use PRINT NAME SIGNATURE ANO BADGE NO. DATE AND TIME RECEIVEO DATE AND TIME RECEIVED RECEIVED PRINT NAME RECEIVED PRINT NAME DATE AND TIME RECEIVED {Cont'd on back) . a ~ Page. of. 9111 NW. 25th Street SOYYS~ A PEB INVENTORY NO, ; Miami, Florida 33172 = ; (805) 471 -2900 a QATE-TIMEIMPOUNDED——- PROPERTY BUREAU LOCATOR CODE a HL Tt) of @b- OTHER DEPT. NO, OTHER DEPT. PROPERTY LOCATION AND INVENTORY NO, . FOR PROPERTY ANO EVIDENCE BUREAU USE ONLY ADORESS WHERE PROPERTY IMPOUNDED [Give exact location where property was located.) TYPE OF CASS My, Ger, & Ain on aN EHUOR) . STATE TEL ® — es So —- Qeage. Fiona Rasuaecr — CjSUSPECT dD ben are2. Jose 7 . (J STOLEN PROPERTY’ “RQTRIAL EVIDENCE (JHOMICIDE PROBATE (1) _LOST/FOUNO PROPERTY (@LAB EVIDENCE __- OTHER AGENCY. OTHER (SPEC! ITEM Currency Only Total Face Value Jour ic woran- Model Serial No. - Size > Color + Barret - Itemize currency by denomination) + HEREBY ACKNOWLEDGE THAT THE ASOVE UIST REPRESENTS ALL PROPERTY TAKEN t HEREBY ACKNOWLEDGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY IMPOUN FROM NY POSSESSION AND THAT t HAVE RECEIVED A COPY OF THIS RECEIPT. ea ME IN THE OFFICIAL PERFORMANCE OF DUTY AS A DEPUTY SHERIFF / LAW ENFOF . MENT Of A, i LEAD INVESTIGATOR PRINT/SIGN . SECTION/UNIT BADC {PRINT AND SIGN) TTA EEEEIREEEDE 47-777" PY ‘} IMPOUNDING OFFICER PRINT/SIGN DISTRICT BADE For and Evidence Bureau Use SECEIVED PRINT NAME SIGNATURE AND BADGE NO. REASON [DATE AND TIME RECEIVED PRINT NAME DATE AND TIME RECEIVED AeCeVveD PRINT NAME . | REASON | OATE AND TIME RECEIVEO RECEIVED PRINT NAME REASON DATE AND TIME RECEIVED “nar ne hack! t oo : } PROPERTY.RECEIPT Mt O-DADE POLICE DEPT. M SDADE POUCE CASE NO. - 9111 NW, 25th Street | SOLS S~ Pee 7 Miami, Florida 33172 od. (305) 471-2900 [ PROPERTY BUREN LOCATOR GOGE OTHER DEPT. PROPERTY LOCATION AND INVENTORY NO. FOR PROPERTY AND EVIDENCE BUREAU USE ONLY SIIPE OF Seo on (ZSUBIECT — GysusPect —_ ya ACRES OTES THARRANT Ben Fez. Tite An _ Py, “losr slo ow Ores’ Gno |oves oy “C) STOLEN PROPERTY SSTRIALEVIDENCE - CJHOMICIDE aes ~ __ Q)SECURITY STORAGE 1} LOST/FOUND PROPERTY, 5SLAB EVIDENCE CJOTHER AGENCY () OTHER (SPECI cep : (TEM OESCRIPTION Gurrency Only” PROPERN NO. ou (Article « Brand - Model - Serlat No. ; . Size - Color - Caliber - Barrel - hemize currency by | denomination) | ¢ A | t HEBESY ACKNOWLEDGE THAT THE ABOVE UST REPRESENTS ALL PROPERTY TAKEN 1 HEREBY ACKNOWLEOGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY IMPOUND ESM NY POSSESSION AND THAT | HAVE RECEIVED A COPY OF THIS RECEIPT. BY ME IN THE OFFICIAL PERFORMANCE OF DUTY AS A DEPUTY SHERIFF / LAW ENFORC MENT OFEICER, . . ay So shone se Nore. SD 35% ; Loe G, PRINT/SIGN TONAJ! BADGE (PRINT AND SIGN} tAS : 2. FRIIS OISTHICT BADGE fi | . 4 : t * For Pi and Evidence Bureau Use : RECEIVED PRINT NAME. SKGNATURE AND BADGE NO.] REASON DATE AND TIME RECEIVED PRINT NAME RECEIVED PRINT NAME or | OATE AND TIME RECEIVED - en ee 03/26/02 12:31 FAX 305°°93700 BRAND& FERNANDEZ \ Gos STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS DEPARTMENT OF HEALTH, 7 through its BUREAU OF a PHARMACY SERVICES, a ‘on " Netitioncr, ' wei : DOAH CASE NO. 02- Doh: 01-04914 Braval-US Trading, LLC, a Florida co-p oration, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, Respondents. -_—————————/ RESPONDENTS’ AMENDED ANSWER TO ADMINISTRATIVE COMPLAINT COME NOW the Respondents, Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres, Bennes (improperly referred to in the style as Benetiz), individually, and Jose Antonio. Benitez, individually, by and through his undersigned counsel. and answer ‘ the Administrative Complaint in this cause and say: 1. They admit paragraph 1. 2. They admit paragraph 2; however, they affirmatively state that the validity and finality of the emergency suspension order is under review by the District Court of Appeal of Florida, Third District, Case No. 3D02-601, and is set for oral argument on April 15, 2002.. _ 3. They admit the first and second sentences of paragraph 3; however, they deny that portion of the third sentence of paragraph 3 that alleges unlawful prescription drug wholesaling practices by Brazil-US Trading, LLC, and any resulting responsibility of Solange E. Benitez-Luz therefore. 4. They admit the first and secand sentences of paragraph 3; however, they deny that portion of the third sentence of paragraph 3 that alleges unlawful prescription drug wholesaling practices by EXHIBIT { Ven 03/26/02 12:31 FAX 3055°93700 BRAND& FERNANDEZ \ oe } ‘ DOH, etc. v. Brazil-US Trading, LLC, et al. DOAH Case No. 02- Amended Answer and Affirmative Defenses Page 2 Brazil-US Trading, LLC, and any resulting responsibility of Jose Andres Benitez therefore. ». They deny paragraphs 5, 6, 7, 8, 10, 11, 12,13. 14, 15, 16, 17, 18, 19, 20, 21, 25, 28, 29, anc. 92, and demand strict proof thereof. 3. As to paragraph 9, they admit tha: Brazil-US Trading, LLC, purchased wholesale prescription drugs from A & J Trading, LLC, but deny the allegation of the paragraph as otherwise alleged. 7. Asto paragraph 22, they admit that Brazil-US Trading, LLC, sold 168 Units of Neupogen; however they deny the remaining allegations of the paragraph and demand strict proof thereof. 8. Asto paragraph 23, they admit that Brazil-US Trading, LLC, provided all pedigree papers and documents required by law to the purchasers, however, they deny the remaining allegations of the paragraph and demand strict proof thereof 9. Asto paragraph 24, they admit that Brazil-US Trading, LLC, lawfully possessed certain wholesale prescription drugs, but deny the remaining allegations of the paragraph and demand strict proof thereof. 10. Asto paragraph 24, they admit that Jose Antonio Benitez was convicted of a felony, but deny the remaining allegations of the paragraph and demand strict proof thereof. 11. As to paragraph 30, they admit that Rule 64F-12.024(7), Florida Administrative Code sets forth a range of possible penalties for violations of specific sections of Chapter 499, Florida Statutes, but deny the remaining allegations of the paragraph and demand strict proof thereof. 12. As to paragraph 31, they admit that the subsections of section 499.067, Fla. Stat., speak for themselves, but deny the remaining allegations of ‘the paragraph and demand strict proof thereof. 03/26/02 12:31 FAX 3055793700 BRAND& FERNANDEZ 7 ot DOH, ete. v. Brazil-US Trading, LLC, et al. DOAH Case No. 02- Amended Answer and Affirmative Defenses Page 3 AFFIRMATIVE DEFENSES 13. Asa first affirmative deferse, Respondents allege any transaction between Brazil-US Trading, LLC, and A.& J Trading, LLC, is excepted fron: the rm quirement of A & J Trading, LLC, heing permitted as an out-of-siate prescription drug wholesaler. ' 14. Asa second affirmative defense, Respondents allege that any failure to supply shipping records is the fault of one or more common carriers who are in possession and/or control of such records. 15. Asathird affirmative defense, Respondents allege that any and all wholesale prescription drugs referred to in the Petition were lawfully branded and as represented as to description, quantity, and strength. then 16. Asa fourth affirmative defense, Respondent, Brazil-US Trading, LLC, alleges that the © Florida Statutes and Florida Administrative Code regulations which entitle Petitioner to exercise its authority to revoke this Respondent’s Wholesale Prescription Drug Permit 22:01231 are unconstitutional in that: A. Separate and apart from any prescription drugs, acts and transactions of Respondent alleged by Petitioner to be in violation of §§499.001-499.081, Fla. Stat., and which constitute sufficient grounds for revocation of such Permit, Respondent has lawfully purchased wholesale prescription drugs while said Permit was in fill force and effect; B. Should Wholesale Prescription Drug Permit 22:01231 issued to Respondent remain suspended as a result of the failure of Respondent to prevail in the appeal of the emergency suspension order referred to in paragraph “2" above ind should said Permit ultimately be revoked in 03/26/02 12:31 FAX 3055793700 BRAND& FERNANDEZ 5 é DOH, ete. v. Brazil-US Trading, LLC, et al. DOAH Case No. 02- Amended Answer and Affirmative Defenses Page 4 this preceding and/or as a result of the finality of'a subsequent agency order, and Respondent would be deprived cf the right to possess such wholesale prescription drugs; C. The applicable atures nnd regulations fail to provide and/or authr riz any lewfidl procedure fo: Respondent to sell agd/or otherwise recover the luwiul value of wholesale prescription drugs it lawfully purchased and possessed and/or that it had the lawful right to possess; D. Respondent would be unable to lawfully recover any value of such wholesale prescription drugs; E. Therefore, said statutes and applicable provisions of the Florida Administrative Code constituting a taking of the Respondent's lawful property without due process of law in violation of the Fifth Amendment to the United States Constitution and Article I, Section 9, of the Florida Constitution. 17. Respondents have employed the undersigned counsel and have agreed to pay a reasonable attorney’s fee therefore. WHEREFORE Respondents pray that the Administrative Complaint will be dismissed and a reasonable attorney’s fee and costs be awarded against the Petitioner. / / / CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing brief was served by fax and U.S. Mail on this 2-4 day of March 2002, to: Robert P. Daniti, Esq., Senior Attomey, Dept. 208 03/26/02 12:31 FAX 3055°°3700 BRAND& FERNANDEZ Zoe 4 } ) DOH, etc. v. Brazil-US Trading, LLC, et ab DOAH Case No. 02- Amended Answer and Affirmative Defenses Page 5 of Health, General Counsel’s Office, 4052 Bald Cypress Way, Bin #A02, Tall., Fl 32399-1703. THE LAW OFFICES OF BRAND & FERNANDEZ, PA. Attorneys for Respendents | 2NE. 40 Street, 4° Flour Miami, Florida 33137 Tel. No.: (305) 539-3700 Fax No.: (305) 539-3750 nn 4 CRAIG A. BRAND, ESQUIRE FBN: 896111 The Law Offices of BRAND & FERNANDEZ a . A Professional Association Craig A. Brand, Esquire 2N.E. 40" Street, 4? Foo} Joseph H. Fernandez, Esquire Miami, Florida 33 ISP, _ BrandandFernandez.Gom Manny Pozo, Mecicare C ons altar t Tel. (305) 539-3700 wo 4 D. Belleh umeur, . .ccredit, Consu tant Fax (305) 539-3750 0 1, Hilde Rocrignez, 2.N., C.W.5. Warts. 1-800-44'-5685 ~ Marck 18, 2002 Certified Mail RRR# 7099 2400 C000 52q2 1G235- Agency Clerk Department of Health Bin#A-02 4052 Bald Cypress Way Tallahassee, FI. 32399-1703 Re: Department of Health, through its Bureau of Pharmacy Services, Petitioner, vs. Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, Respondents. DOH: 01-04914 PETITION FOR FORMAL HEARING AND REFERRAL TO ADMINISTRATIVE LAW JUDGE Dear Agency Clerk: COMES NOW the Petitioners (designated as Respondents in the DOH matter referenced above), Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, by and through their undersigned counsel and hereby file this petition for a Formal Hearing and Referral to an Administrative Law Judge, pursuant, and not limited, to §§120.569, 120.57(1), Fla. Stat., and Rules 28-106.201 and 28-107.004, F.A.C., and further state: 1. This petition arises from out of and from an Administrative Complaint issued by the Department of Health, State of Florida, acting through its Bureau of Pharmacy Services (“BPS”), against Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually. The DOH file number is 01- 04914. The Administrative Complaint is attached hereto as Exhibit “A”. a Dept. Of Health, etc. v. Brazil-US Trading, LLC, et al. Letter of March 18, 2002, Requesting Formal Hearing and Referral to Admin. Law Judge Page 2 2. The said Administrative Complaint was mailed to Brazil-US Trading, LLC, a Florida corporation, on March 4, 2002. 3. Although the individuals named in the Administrative Complaint have not formally been served, the undersigned counsel hereby appears on their beha'f, and they jcin in this Petition for Yormal Hearing and Refurra to Ad ninistrative Law Judge. 4. Inits Admi istrative Comiplzint, the BPS seeks to revok2 the Wholesale Prescription Drug Permit 22:01231 issued by it to Brazil-US Trading, LLC, and seeks to fine the corporation as well as all individual Respondents. Thus, the corporation and individuals all have substantial interests that will be affected by the Administrative Complaint. 5. The principal business address of Brazil-US Trading, LLC, is 1355 N.W. 93 Court, Suite A-102, Miami, Miami-Dade County, Florida, and the Permit which BPS seeks to revoke is also issued to Brazil-US Trading, LLC, at that address. The addresses of Solange Luz Benitez and Jose Andres Benitez, improperly named as Benetiz, is 1355 N.W. 93" Court, Suite A-102, Miami, Miami-Dade County, Florida. The address of Jose Anotonio. Benitez is c/o Craig A. Brand, Esq., 2 N.E. 40" Street, Suite 403, Miami, FL 33137. 6. Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, are represented pursuant to Ch. 120, Fla.Stat., by Craig A. Brand, Esq.(F.B.N. 896111), at: 2 N.E. 40" St., Suite 403, Miami, FI. 33137. The telephone number is: (305) 539-3700 and the fax number is (305) 539-3750. Service of any and all communications (oral or in writing) should be made upon Craig A. Brand, Esq., at the designated address. 7. Petitioners attach their Answer and Affirmative Defenses to this Petition for Formal Hearing and Referral to Administrative Law Judge is attached hereto as Exhibit “B”. 8.At this juncture it is uncertain how many witnesses would need to be called. It is expected that the Formal Hearing would last one - two weeks 9. Venue is requested within Miami-Dade County, Florida. WHEREFORE, Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, hereby pray that this petition is accepted and that pursuant to §§120.59, 120.57 and 120.60, Fla. Stat., and Rule 28-107.004, F_A.C., a Formal Hearing before an Administrative Law Judge is granted. Dept. Of Health, etc. v. Brazil-US Trading, LLC, et al. Letter of March 18, 2002, Requesting Formal Hearing and Referral to Admin. Law Judge Page 3 Respectfully Submitted, BRAND & FERNANDEZ, P.A. Craig A. Brand, IEsq. FBN# 896111 CAB:m Encl: 2 cc: Robert P. Daniti, Esq. Senior Attorney Department of Health General Counsel’s Office Bin A02 4052 Bald Cypress Way Tallahassee, FL 32399-1703 ae — —_ STATE OF FLORIDA — : 2 DEPARTMENT OF HEALTH £0, DEPARTMENT OF HEALTH, a e through its BUREAU OF . a PHARMACY SERVICES, ; 2. Petitioner, ‘ Case No: vs. (DOH: 01-04914) Brazil-US Trading, LLC,'a Florida Corporation, Solange E. Benitez-Luz, individually, Jose Andres Benetiz, individually, and Jose Antonio. Benitez, individually, Respondents. ___/ ADMINISTRATIVE COMPLAINT Notice is hereby provided that Petitioner, Department of Health by and through its Bureau of Pharmacy Services (the "bureau”), intends to impose against Respondents, Brazil-US Trading, LLC, (“Brazil-US Trading”), a Florida corporation, as well as Solange E. Benitez-Luz, individually and Jose A. Benitez, individually an administrative fine in the amount of Two hundred seventy-two thousand two hundred fifty dollars ($272,250), pursuant to section 499.066(3), Florida Statutes, and revoke the prescription drug wholesaler permit number 22:01243, that authorizes Brazil-US Trading to operate as a prescription drug wholesaler in Florida. In support of the intended final agency action the bureau states: (1) Petitioner, Department of Health (hereinafter “the Department’), through the Bureau of Pharmacy Services (‘the Bureau”), 2818-A Mahan Drive, Tallahassee, Florida, 32308, is the state agency charged with implementing and enforcing the provisions of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (“the Act”), including the regulation of the acquisition and distribution of prescription drugs in, into and from Florida as - EXHIBIT “A well as the permitting of entities to engage in this activity. The prescription drug wholesaler permit is established under the Act. (2) Brazil-US Trading located at 1355 N.W. 93rd Court, Suite A-102, Miami, Florida, is permitted under the Florida Drug and Cosmetic Act, Chapter 499, F.S., (“the Act’) asa prescription drug wholesaler. Permit number 22:012433 represents the authority for Brazil-US Tr dir g to engage in the wholesale dis:ribi:tion 0’ prescription drugs in or from Florida until the permit expires on April 30, 2003, unless sooner suspended or revoked. An emergency suspension order was issued by the Secretary of the Department of Health on February 18, 2002, to suspend immediately Brazil US-Trading’s prescription drug wholesaler permit 22:01243 pending the final disposition of the allegations in this Complaint. . (3) Solange E. Benitez-Luz is the president of Brazil-US Trading and the spouse of Jose A. Benitez. Solange E. Benitez-Luz is an authorized signature on the business checking account of Brazil-US Trading and signed authorizations for payments for prescription drugs purchased in paragraph (9) of this ‘Complaint. As a result, Solonge E. Benitez-Luz is responsible for the unlawful prescription drug wholesaling practices of Brazil-US Trading. (4) Jose Andres Benitez is the vice-president of Brazil-US Trading and the brother of Jose Antonio Benitez (“Jose A. Benitez”). Jose Andres Benitez (“Andy Benitez”) is an authorized signature on the business checking account of Brazil-US Trading and signed authorizations for payments for prescription drugs purchased in paragraph (9) of this Complaint. As a result, Andy Benitez is responsible for the unlawful prescription drug wholesaling practices of Brazil-US Trading. (5) Jose A. Benitez is directly involved in the day-to-day operations of Brazil-US Trading as further alleged in this complaint. (6) On January 11, 2002, an agent of the Bureau conducted an inspection at Proscript Pharmacy Services at 3732 S.W. 64" Ayenue, Davie, Florida immediately after the departure of an employee of Brazil-US Trading had made a delivery of prescription drugs pursuant to a regulated wholesale transaction. Upon physical inspection of the prescription drugs delivered by Brazil-US Trading to Proscript, the agent observed that four containers of Combivir; two containers of Kaletra; one container of Diflucan 100mg; one container of Sustiva 200 mg; one container of Crixivan 400mg; and three containers of Ziagen 300 mg were missing ouiserts.. Ain ot tsirt is labeling of the presscripticn drug by the manufacturer requ'red ur der the fecleral Food, Cruc and Cosmeiic Act and regulations promulyated tereur der, that ‘s attached to the exterior container of a prescription drug but not directly to the label. The outsert contains essential information about the instructions for use, indications, and warnings regarding the drug. The absence of this labeling, prior to a product being dispensed, misbrands a prescription drug under federal law and more specifically, under s. 499.007, Florida Statutes, and Rule 64F- 12.006(1), Florida Administrative Code. (7) The Bureau’s agent also noted the labels on the containers of the prescription drugs identified in paragraph (6) showed signs of wear and tear and were very sticky to the touch. As a result, these prescription drugs were also adulterated pursuant to s. 499.006, F.S. (8) Therefore, based on the allegations in paragraphs (6) and (7), Brazil-US Trading distributed prescription drugs that were misbranded and adulterated in violation of s. 499.005(1) and (4), F.S. (9) Records of purchase of prescription drugs by Brazil-US Trading and other documentation provided to the department by or on behalf of Brazil-US Trading demonstrate that during the period July 1, 2001 through November 30, 2001, Brazil-US Trading purchased over $6.9 million worth of prescription drugs from A & J Trading, LLC (“A & J”) at 4614 Wilgrove Mint Hill Road, Mint Hill (Charlotte), N.C. 28227. (10) A Miami, Florida 33172 a - (805) 471-2900 PROPERTY BUREAU LOCATOR CODE Page___of. PEB INVENTORY NO. OATE-TIME IMPOUNDED (HE Sib. 32. STATE Tele Was faa? AW Sse 3 Hai wunylec. 7 CTSUSFECT eho a pape eid a 0 STOLEN PROP! : COTRIAL EVIDENCE CIHOMICIDE PROBATE 1 SECURITY STORAGE 7) LOST/FOUND PROPERTY, Oss EVIDENCE CIOTHER AGENCY _- : OTHER (SPECI mrEM DESCRIPTION Currency Only PROPERTY QUANTITY (Article - Brand - Model - Serial + Brand - Model - Serial No. - Size - Color - olor - Caliber - Barrel - Itemize currency by denomination}; s Total Face Value | BUREAU ON. Aft feorne/ Senter] on ma Fe 5 Gol TLES| WisSrewpoAL =s L BettTuEes/ RISPerpoaL = — “7 . Qeole BottLes/ DIF UocKA | Zoe m | HEREBY ACKNOWLEDGE THAT THE ASOVE LIST REPRESENTS ALL PROPERTY TAKEN U HEREBY ACKNOWLEDGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY IMPOUNS FROM NY POSSESSION AND THAT 1 HAVE RECEIVED A COPY OF THIS RECEIPT. BY ME IN THE OFFICIAL PERFORMANCE OF OUTY AS A DEPUTY SHERIFF / LAW ENFORC . MENT OFFICER. me LEAD INVESTIGATOR PRINT/SIGN SECTION/UNIT BAOG: (PRINT AND SIGN) . IMPOUNDING OFFICER PRINT/SIGN DISTHICT BADGE 4 a For Property and Evidence Bureau Use Only RECEIVED PRINT NAME SIGNATURE AND BADGE NO.] REASON DATE AND TIME RECEIVED 2 RECEIVED PRINT NAME REASON DATE AND TIME RECEIVED RECEIVED PRINT NAME REASON | DATE AND TIME RECEIVED RECEIVED PRINT NAME . REASON | DATE AND TIME RECEIVED 4 | RECEIVED PAINT NAME | REASON | DATE AND TIME RECEIVED (Cont'd on back) (305) 471-2900 9111 NW. 25th Street 0) oF jf ai : Miami, Florida 33172 | ___ A044 OTHER DEPT. PROPERTY LOCATION AND INVENTORY NO. FOR PROPERTY AND EVIDENCE BUREAU USE ONLY TYPE OF CASE ADORESS WHERE PROPERTY IMPOUNDED (Give exact location where property was located.) 1358 Aw. > or ! DiSCOVERED BY (Nar AOORFSS ony ST. TE Chee, 4 . 32 Er fa: uae ts : zy Se A O RU: 32 of Bil Mini Aly hs (Ep ISIB 2. ae Tate. - Feoluon dein ise BPE leap [ ae (] STOLEN PROPERTY QQTRIAL EVIDENCE COHOMICIDE PROBATE C SECURITY STORAGE LOST/FOUND PROPERTY OQLAS EVIDENCE. CIJOTHER AGENCY. CJ OTHER (SPECIFY), sul eetrees | erivin | a TEM DESCRIPTION Currency Only PROPERT Ni QUANTITY] {Article - Brand - Model - Serial No, - Size - Color - Caliber - Barrel - itemize currency by denomination) total Face Value BUREAU ON J HEREBY ACKNOWLEDGE THAT ‘THE ABOVE LIST REPRESENTS ALL PROPERTY IMPOUN: BY ME IN THE OFFICIAL PERFORMANCE OF DUTY AS A DEPUTY SHERIFF / LAW ENFOR MENT OFFICER. | HEREBY ACKNOWLEDGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY TAKEN FROM NY POSSESSION AND THAT | HAVE RECEIVED A COPY OF THIS RECEIPT, LEAD INVESTIGATOR PRINT/SIGN + SECTION/UNIT BADG {PRINT AND SIGN) IMPOUNDING OFFICER PRINT/SIGN OISTHICT BADG For Property and Evidence Bureau Use Only S=CEIVED PRINT NAME SIGNATURE AND BADGE NO.| REASON | DATE AND TIME RECEIVED SECENED PRINT NAME REASON | DATE AND TIME RECEIVED RECEIVED PRINT NAME REASON [pre AND TIME RECEIVED RECEIVED PRINT NAME | REASON DATE ANO TIME RECEIVED t RECEIVED PRINT NAME | REASON —t DATE AND TIMF FECENVED PROPERTY.RECEIPT ME of, O-DADE POLICE DEPT. 9111 NW. 25th Street Miami, Florida 33172 (305) 471-2900 _ 3 DADE POUCE GASE NO, SO¥SS~4 Page BEB INVENTORY NO. OATE-TIME IMPOUNDED Lan 2002, BSio pice, $2 SP ag. LULA TY ‘Bex ez. ( STOLEN PROPERTY SSTRIAL EVIDENCE CQHOMICIDE PROBATE C) SECURITY STORAGE 0) _LOST/FOUND PROPERTY 2ILAB EVIDENCE CIOTHER AGENGY OTHER (SPECIFY) | ITEM DESCRIPTION Teuirency Only PROPERTY NO, (Article - Brand - Modet - Seriat No. + Size - Color - Caliber - Barret - Nemize currency by denomination)| ¢ | °'' ; ace Value ¢ BUREAU ONL | HEZESY ACKNOWLEOGE THAT. THE ABOVE LIST REPRESENTS ALL PAOPERTY TAKEN ' HEREBY ACKNOWLEDGE THAT THE ABOVE LIST REPRESENTS ALL PROPERTY IMPOUNDE EOM NY POSSESSION AND THAT | HAVE RECEIVED A COPY OF THIS RECEIPT. 8Y ME IN THE OFFIC) PERFORMANCE OF DUTY AS A OEPUTY SHERIFF / LAW ENFORC: MENT OFE)CER, ese Nor. sD 2x: \ oe: ee wa WS a : ‘AD, VSP @ PRINT/SIGN EETION BADGE: Z ‘ AS of owe aoe IMPRLO. La PRINT AND SIGN) PRINTS DISTRICT BAOGE: “or Property and Evidence Bureau Use Only =CEIVED PRINT NAME, SIGNATURE AND BADGE NO. REASON DATEAND TIME RECEIVED REASON | DATE AND TIME RECEIVED CEWED PRINT NAME CEIVED PRINT NAME DATE ANDO TIME RECEIVED CEIVED PRINT NAME DATE AND TIME RECEIVED SEIVEO PRINT NAME PATE ANIA Tage none STATE OF FLORIDA - ; rm DIVISION OF ADMINISTRATIVE HEARINGS by DEPARTMENT OF HEALTH, an through its BUREAU OF - PHARMACY SERVCES 2 = Petitioner, — . . . my i Ws. DOAH CASE MO. 32- . , Doh: 01-0414 Brazil-US Trading, LUC, a Florida corporation, Solange E. benitez-Luz, individually,; Jose Andres Benetiz, individually, and _- Jose Antonio. Benitez, individually, Respondents. / RESPONDENTS’ ANSWER TO ADMINISTRATIVE COMPLAINT COME NOW the Respondents, Brazil-US Trading, LLC, a Florida corporation, Solange E. Benitez-Luz, individually, Jose Andres Benitez (improperly referred to in the style as Benetiz), individually, and Jose Antonio. Benitez, individually, by and through his undersigned counsel. and answer the Administrative Complaint in this cause and say: 1. They admit paragraph 1. 2. They admit paragraph 2; however, they affirmatively state that the validity and finality of the emergency suspension order is under review by the District Court of Appeal of Florida, Third. District, Case No. 3D02-601, and is set for oral argument on April 15, 2002.. 3. They admit the first and second sentences of paragraph 3; however, they deny that portion of the third sentence of paragraph 3 that alleges unlawful prescription drug wholesaling practices by Brazil-US Trading, LLC, and any resulting responsibility of Solange E. Benitez-Luz therefore. 4. They admit the first and second sentences of paragraph 3; however, they deny that portion of the third sentence of paragraph 3 that alleges unlawful prescription drug wholesaling practices by EXHIBIT 18° DOH, etc. v. Brazil-US Trading, LLC, et al. DOAH Case No. 02- Answer and Affirmative Defenses Page 2 Brazil-US Trading, LLC, and any resulting responsibility of Jose Andres Benitez therefore. 5. They deny faragraphs 5, 6,7, 2, 1C; 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 25, 78, 29, and 32, ard demand strict proof thereof. 6. As to paragraph 9, they admit that Brazil-US Trading, LLC, purchased wholesale Prescription drugs from A & J Trading, LLC, but deny the allegation of the paragraph as otherwise alleged. 7. As to paragraph 22, they admit that Brazil-US Trading, LLC, sold 168 Units of Neupogen; however they deny the remaining allegations of the paragraph and demand strict proof thereof. 8. As to paragraph 23, they admit that Brazil-US Trading, LLC, provided all pewdigree papers and documents required by law to the purchasers; however, they deny the remaining allegations of the paragraph and demand strict proof thereof. 9. As to paragraph 24, they admit that Brazil-US Trading, LLC, lawfully possessed certain wholesale prescription drugs, but deny the remaining allegations of the paragraph and demand strict proof thereof. 10. As to paragraph 24, they admit that Jose Antonio Benitez was convicted of a felony, but deny the remaining allegations of the paragraph and demand strict proof thereof. 11. As to paragraph 30, they admit that Rule 64F-12.024($), Florida Administrative Code sets forth a range of possible penalties for violations of specific sections of Chapter 499, Florida Statutes, but deny the remaining allegations of the paragraph and demand strict proof thereof. 12. As to paragraph 31, they admit that the subsections of section 499.067, Fla. Stat., speak for themselves, but deny the remaining allegations of the paragraph and demand strict proof thereof. DOH, etc. v. Brazil-US Trading, LLC, et al. DOAH Case No. 02- Answer and Affirmative Defenses Page 3 AFFIRMATIVE DEFENSES 13. As a first affirmative Cefense, Respordents ailege any transaction between Braziil-US Ti adiag, LLC, end A é& J Trading, LLC, is exvepted ‘rom the requirement of A & J Trading, LLG, : being permitted as an out-of-state préscription drug whoiesaler. 14. Asa second affirmative defense, Respondents allege that any failure to supply shipping records is the fault of one or more common carriers who are in possession and/or control of such records. 15. Asa third affirmative defense, Respondents allege that any and all wholesale prescription drugs referred to in the Petition were lawfully branded and as represented as to description, quantity, and strength. ro 16. Respondents have employed the undersigned counsel and have agreed to pay areasonable attorney’s fee therefore. WHEREFORE Respondents pray that the Administrative Complaint will be dismissed and a reasonable attorney’s fee and costs be awarded against the Petitioner. / / CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing brief was served by fax and U.S. Mail on this as day of March 2002, to: Robert P. Daniti, Esq., Senior Attomey, Dept. DOH, etc. v. Brazil-US Trading, LLC, et al. DOAH Case No. 02- Answer and Affirmative Defenses Page 4 of Health, General Counsel’s Office, 4052 Bald Cypress Way, Bin #A02, Tall., Fl. 32399-1703. TRE LAW OFFICES OF BRAND & FERNANDES, P.A. Attornevs for Respondents 2 NE. 40% Street, 4° Floor Miami, Florida 33137 Tel. No.: (305) 539-3700 Fax No.: (305) 539-3750 ay. eee ee CRAIG A. BRAND, ESQUIRE FBN: 896111

Docket for Case No: 02-001405

Issue Date	Proceedings
Aug. 04, 2003	Respondents` Response to Order to Show Cause, Seeking Extension of Time to Obtain New Counsel Should the File of the Department of Administrative Hearings be Reopened and Motion to Withdraw s Counsel for Respondents filed.
Oct. 29, 2002	Notice of Unavailability (filed by C. Brand via facsimile).
Oct. 07, 2002	Notice of Unavailability (filed by C. Brand via facsimile).
Sep. 19, 2002	Order on Motion to Reconsider Closing Order issued. (case shall remain closed, without prejudice to the filing of a motion to reopen case file)
Sep. 06, 2002	Status Report of the Department filed.
Sep. 06, 2002	Motion to Reconsider Closing Order filed by Petitioner.
Sep. 04, 2002	Order Closing File issued. CASE CLOSED.
May 16, 2002	Order Granting Continuance and Placing Case in Abeyance issued (parties to advise status by August 16, 2002).
May 15, 2002	Motion for Protective Order Motion for Continuance of Trial (filed by Respondents via facsimile).
May 09, 2002	Respondent`s Motion to Shorten Time for Petitioner`s Response to First Interrogatories to Petitioner and Response to First Request for Production (filed via facsimile).
May 08, 2002	Notice of Taking Deposition Duces Tecum, J. Andres, Brazil-Us Trading, A&J Trading, J. Antonio, S. Benitez-luz (filed via facsimile).
May 01, 2002	Order of Pre-hearing Instructions issued.
May 01, 2002	Notice of Hearing issued (hearing set for June 10 through 14, 2002; 9:00 a.m.; Miami, FL).
Apr. 26, 2002	Respondent`s Response to Initial Order (filed via facsimile).
Apr. 25, 2002	Petitioner`s Response to Initial Order (filed via facsimile).
Apr. 10, 2002	Initial Order issued.
Apr. 09, 2002	Administrative Complaint filed.
Apr. 09, 2002	Amended Petition for Formal Hearing and Referral to Administrative Law Judge Superseding March 18, 2002, Petition filed.
Apr. 09, 2002	Notice (of Agency referral) filed.