STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH AND )

REHABILITATIVE SERVICES, )

)

Petitioner, )

)

vs. ) CASE NO. 89-4444

) ARTHRITIS MEDICAL CENTER, INC. ) and DONNA PINORSKY ROTHBLATT, )

)

Respondents. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was conducted in this case on October 30, 1989, in Fort Lauderdale, Florida, before Stuart M. Lerner, a duly designated Hearing Officer of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: John Rodriguez, Esquire

Department of Health and Rehabilitative Services

1317 Winewood Boulevard Building One, Room 304 Tallahassee, Florida 32399-0700

For Respondents: Karen Coolman Amlong, Esquire

Amlong & Amlong, P.A.

101 Northeast Third Avenue, Second Floor Fort Lauderdale, Florida 33301

STATEMENT OF THE ISSUES

1. Whether Respondents committed the offenses described in the administrative complaint?

   
   

2. If so, what penalties should they receive?

PRELIMINARY STATEMENT

On or about July 20, 1989, Petitioner served on Respondents an administrative complaint. The complaint alleged a violation of the provisions of Chapter 499, Florida Statutes, and Chapter 10D-45, Florida Administrative Code, resulting from the refusal, on January 16, 1987, and again on March 13, 1987, to allow Petitioner's inspectors to inspect the premises of the Arthritis Medical Center in Fort Lauderdale, Florida, for the following: "drugs, labels and labeling, review of all records relating to drugs, including receiving documents, shipping documents, purchase orders, purchase requisitions, invoices, and paid receipts." The complaint indicated that Petitioner "intend[ed] to

impose an administrative fine of Ten Thousand Dollars ($10,000.00)" upon Respondents. On August 7, 1989, Respondents filed with Petitioner a written request for a formal hearing on the administrative complaint filed against them. On August 17, 1989, the matter was referred to the Division of Administrative Hearings for the assignment of a Hearing Officer.

At hearing, Petitioner presented the testimony of two witnesses: Richard

1. Grant, head of Petitioner's Pharmacy Program Office; and Greg Jones, a drug inspector supervisor who works in Grant's office. Petitioner also offered into evidence three exhibits: a copy of the complete file of Respondent Arthritis Medical Center, Inc., maintained by the Florida Department of State; the investigative report completed by Jones regarding his attempted inspection of the Arthritis Medical Center on January 16, 1987; and the investigative report completed by Jones regarding his attempted inspection of the Arthritis Medical Center on March 13, 1987. In addition, Petitioner requested that the Hearing Officer take official recognition of the Order of Final Summary Judgment issued by Judge Stanley Marcus of the United States District Court, Southern District of Florida, in Case No. 87-6078-CIV. Petitioner's request was granted. The only evidence elicited by Respondents at hearing was the testimony given through the cross-examination of Petitioner's witnesses.

   
   

   At the close of the hearing, upon being advised that Petitioner would be furnishing him a copy of the transcript, the Hearing Officer announced on the record that post-hearing pleadings had to be filed no later than ten days following the Hearing Officer's receipt of the hearing transcript. The Hearing Officer received a copy of the transcript on November 15, 1989. Neither party timely filed any post-hearing pleading. On December 1, 1989, however, Respondents filed a motion for extension of time to file its proposed recommended order. Because the motion was filed after the deadline for the submission of proposed recommended orders, the motion is hereby DENIED. See Parada Holding Co. v. Sulkin, 126 So.2d 601, 602 (Fla. 3d DCA 1961); Graham v. Thorton, 104 So.2d 95, 96 (Fla. 1st DCA 1958)

   
   

   FINDINGS OF FACT

   
   

   Based on the record evidence, the Hearing Officer makes the following Findings of Fact:

   
   

   1. Richard Grant is the Administrator of the Department of Health and Rehabilitative Services Pharmacy Program Office. His office is responsible for the administration and enforcement of the provisions of Chapter 499, Florida Statutes, relating to drug manufacturing, drug repackaging, drug wholesaling, device manufacturing and cosmetic manufacturing. Among its responsibilities is the issuance of permits to persons and entities engaged in activities over which it has regulatory authority.

      
      

   2. Respondents do not possess such a permit issued by Grant's office.

      
      

   3. In the latter part of 1986, on the basis of a complaint received from the Department of Professional Regulation, Grant directed that an inspection be conducted of a facility operated by Respondent Arthritis Medical Center, Inc.

      
      

   4. An inspection of the facility was attempted on January 16, 1987. Respondent Pinorsky, who is the President of Arthritis Medical Center, Inc., did not allow the inspectors to enter the premises. The inspectors therefore left without conducting an inspection of the premises.

   5. Another inspection of the facility was attempted on March 13, 1987. Again Respondent Pinorsky denied the inspectors entry. Accordingly, no inspection was conducted.

      
      

      CONCLUSIONS OF LAW

      
      

   6. Pursuant to Section 499.004, Florida Statutes, "[t]he Department of Health and Rehabilitative Services is charged with the administration of ss. 499.001-499.081, which sections are designed to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics; and the department is further charged to enforce the provisions of ss. 499.001-499.081 relating to the production, manufacture, repackaging, and distribution of drugs, devices, and cosmetics."

      
      

   7. Among the provisions of Sections 499.001-499.081, Florida Statutes, is that which prohibits "[t]he refusal to permit entry or inspection by the department of factories, warehouses, or establishments in which drugs, devices, or cosmetics are manufactured, processed, repackaged or held." Section 499.005(6), Florida Statutes.

      
      

   8. The Legislature has granted the Department, in Section 499.066, Florida Statutes, the authority to take the following action to enforce this and the other provisions of Section 499.001-499.081, Florida Statutes:

      
      

      The department may revoke or suspend the permit of any drug repackaging, drug wholesaling, or drug, device, or cosmetic manufacturing establishment which is found to have:

      (c) Violated any of the requirements of

      ss. 499.001-499.79 . . . or any of the rules of the department as they relate to drug repackaging, drug wholesaling, or drug, device, or cosmetic manufacturing establishments

      1. Notwithstanding the existence or pursuit of any other remedy, the department may maintain an action in the name of the state for injunction or other process to enforce the provisions of ss. 499.001-499.081 and rules promulgated under such sections.

      2. The department may, pursuant to chapter 120, impose an administrative fine, not to exceed $5,000 per violation per day, for the violation of any provision of ss. 499.001-

         499.081 or rules promulgated under such sections. Each day such violation continues constitutes a separate violation, and each separate violation is subject to a separate fine. All amounts collected pursuant to

         this part shall be deposited into the Florida Drug, Device, and Cosmetic Trust Fund and are hereby appropriated for the use of the department in the administration of this part. In determining the amount of fine to be levied

         for a violation, the following factors shall be considered:

         1. The severity of the violation.

         2. Any actions taken by the permittee to correct the violation or to remedy complaints.

         3. Any previous violations

      3. The department may issue an emergency order immediately suspending or revoking a permit when it determines that any condition in the facility presents a clear and present danger to health.

      
      

   9. In the instant case, the Department seeks to impose upon Respondents an administrative fine of $10,000 for their alleged refusal to permit inspection of the Arthritis Medical Center on January 16, 1987, and March 13, 1987, which, according to the Department, violated the provisions of Section 499.005(6), Florida Statutes, and the Department's rules promulgated thereunder. The evidence adduced at hearing, however, does not establish that the Department has the authority to take such punitive action against Respondents.

      
      

   10. The Department, like other regulatory agencies of the State of Florida, "has only that authority delegated to it by statute." Department of Highway Safety and Motor Vehicles v. German, 451 So.2d. 1013, 1015 (Fla. 3d DCA 1984); see also Section 120.54(15), Florida Statutes, ("nor has any agency authority to establish penalties for violation of a rule unless the Legislature, when establishing a penalty, specifically provides that the penalty applies to rules").

       
       

   11. Section 499.066, Florida Statutes, is the statute which delegates to the Department the authority to impose administrative fines and other penalties for violations of Section 499.005(6), and the rules promulgated thereunder by the Department. A careful examination of Section 499.066 reveals that it authorizes the Department to impose such fines and penalties only upon those who hold a permit or license issued by the Department pursuant to Chapter 499, Florida Statutes. 1/ With respect to violations committed by others, the Department's authority is limited to "maintain[ing] an action in the name of the state for injunction or other process."

       
       

   12. Respondents do not hold a permit or license issued by the Department pursuant to Chapter 499, Florida Statutes. Accordingly, the Department is without authority to fine them or to impose any other penalty for the conduct alleged in the administrative complaint. The instant administrative complaint therefore should be dismissed.

       
       

   13. Furthermore, the record evidence is insufficient to establish that the Arthritis Medical Center is a factory, warehouse or establishment "in which drugs, devices, or cosmetics are manufactured, processed, repackaged, or held." The Department was required to make such a showing at hearing in support of the allegation in the administrative complaint that Respondents engaged in conduct in violation of Section 499.005(6), Florida Statutes. Its failure to prove that Respondents engaged in such conduct provides an additional reason to dismiss the instant administrative complaint.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby

RECOMMENDED that the Department of Health and Rehabilitative Services enter a final order dismissing the instant administrative complaint.

DONE AND ENTERED in Tallahassee, Leon County, Florida, this 4th day of December, 1989.

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 4th day of December, 1989.

ENDNOTE

1/ Particularly revealing in this regard is subsection (4)(b) of Section 499.066, which requires the Department, in determining the amount of the fine to be imposed, to consider "[a]ny actions taken by the permittee to correct the violation or to remedy complaints." (emphasis supplied).

COPIES FURNISHED:

John Rodriguez, Senior Attorney Technical Health Services Department of Health and

Rehabilitative Services 1317 Winewood Boulevard Building One, Room 304

Tallahassee, Florida 32399-0700

Karen Coolman Amlong, Esquire Amlong & Amlong, P.A.

101 Northeast Third Avenue Second Floor

Fort Lauderdale, Florida 33301

1. Power, Agency Clerk Assistant General Counsel Department of Health and

   Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407

   Tallahassee, Florida 32399-0700

   John Miller, Esquire General Counsel Department of Health and

   Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407

   Tallahassee, Florida 32399-0700

   
   

   =================================================================

   AGENCY FINAL ORDER

   =================================================================

   
   

   STATE OF FLORIDA

   DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES

   
   

   DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES,

   
   

   Petitioner,

   
   

   vs. CASE NO.: 89-4444

   
   

   ARTHRITIS MEDICAL CENTER, INC. and DONNA PINORSKY ROTHBLATT,

   
   

   Respondent.

   /

   
   

   FINAL ORDER

   
   

   This cause came on before me for the purpose of issuing a final agency order. The Hearing Officer assigned by the Division of Administrative Hearings (DOAH) in the above-styled case submitted a Recommended Order to the Department of Health and Rehabilitative Services (HRS). A copy of that Recommended Order is attached hereto.

   
   

   RULING ON EXCEPTIONS FILED BY DEPARTMENT

   
   

   Counsel excepts to the Hearing Officer's conclusion that Section 499.066, Florida Statutes (1987) limits the department's authority to impose fines to entities holding a drug or cosmetic permit under Section 499.01. Section 499.066(4), Florida Statutes (1987) authorizes the department to impose a fine for violation of any provision of Sections 499.001 - 499.081 and has no language which provides that only permittees may be fined. Nor does Section 499.066(3) provide the only remedy for violations committed by others (non-permittees).

   Section 499.066(3) merely expands the department's authority to enforce all provisions of Chapter 499 by pursuing an injunction. The only limit is that there must be violation of Chapter 499 or applicable rules.

   
   

   A statute must be interpreted to avoid an unreasonable result if it is open to another interpretation. The Hearing Officer's interpretation of Section 499.066(3) and (4) could lead to an unreasonable result. Department of

   Professional Regulation, Board of Medical Examiners vs. Durrani, 455 So2d 515 (Fla. 1st DCA 1984). Pursuant to the Hearing Officer's interpretation, the department could fine only those who comply with the law by getting a permit (license) before operating a factory, warehouse, or establishment in which drugs are held. The Legislature did not intend that the department's enforcement authority be circumvented by operating such a facility without a permit.

   
   

   Counsel also excepts to the Hearing Officer's conclusion that in order to impose a fine for refusal to allow an inspection, the department must prove that the facility the department was unable to inspect was in fact an establishment where drugs or cosmetics were manufactured, processed, repackaged, or held.

   
   

   Section 499.051, entitled "Inspections and Investigations" reads in pertinent part as follows:

   
   

   1. The agents of the department and the Department of Law Enforcement shall have the authority to inspect, monitor, and investigate all drug and cosmetic wholesalers; drug repackagers; investigational drug programs; and drug, device, or cosmetic manufacturers during business hours for the purposes of enforcing the provisions of Sections 499.001 - 499.79, Chapters 893 and 465, and the rules of the department which relate to the protection of the health, safety, and welfare of the public.

      
      

   2. In addition to the authority set forth in subsection (1), the department and any duly designated officer or employee thereof shall have the right to enter upon and inspect any other facility for the purposes of determining compliance with the provisions of this chapter and rules promulgated thereunder regarding a drug, device, or cosmetic product... (Emphasis added)

Section 499.051, Florida Statutes (Supp. 1988).

In its administrative complaint, the department charged respondent with failure to allow an inspection of its establishment located at 901 S.E. 17th Street, Suite 200, Ft. Lauderdale, Florida, for the purposes of determining compliance with Chapter 499, Florida Statutes, and Rule 10D-45, F.A.C. Respondent is an unlicensed medical center, treating patients with arthritic symptoms (See US District Court, Southern District, 87-6078-CIV, pages 1, 2).

To require the department to prove that respondent conducted certain activities, when an inspection designed to make that determination was denied,

is unreasonable. Certainly, it would be a valid defense for the respondent to show that it was not a factory, warehouse, or establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, or held. The exceptions are granted.

FINDINGS OF FACT

The department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.

CONCLUSIONS OF LAW

The department hereby adopts and incorporates by reference the conclusions of law set forth in the Recommended Order except where inconsistent with the ruling on the exceptions. The Hearing Officer found that on January 16 and March 13, 1987, respondent refused to allow the department to inspect its premises. Thus, the violations alleged in the complaint were established.

Based upon the foregoing, it is

ADJUDGED, that a fine of $10,000.00 be imposed. Said fine shall be paid no later than 30 days from the rendition of this Order.

DONE and ORDERED this 1st day of February, 1990, in Tallahassee, Florida.

Gregory L. Coler Secretary

Department of Health and Rehabilitative Services

by Deputy Secretary for Operations

COPIES FURNISHED:

John Rodriguez, Esquire Interprogram & Development Technical Assistance Office 1317 Winewood Boulevard Building One, Room 100 Tallahassee, Florida 32399-0700

Karen Coolman Amlong, Esquire AMLONG & AMLONG, P. A.

101 Northeast Third Avenue Second Floor

Ft. Lauderdale, Florida 33301

Stuart M. Lerner Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that a copy of the foregoing a sent to the above-named people by U.S. Mail this 6th day of February, 1990.

R. S. Power, Agency Clerk Assistant General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407

Tallahassee, Florida 32399-0700 904/488-2381

NOTICE OF RIGHT TO JUDICIAL REVIEW

A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF HRS, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.

Docket for Case No: 89-004444

Orders for Case No: 89-004444