Bio-Med Plus v. STATE, DEPT. OF HEALTH

915 So. 2d 669, 2005 Fla. App. LEXIS 16640, 2005 WL 2662549
CourtDistrict Court of Appeal of Florida
DecidedOctober 20, 2005
Docket1D05-1761
StatusPublished
Cited by12 cases

This text of 915 So. 2d 669 (Bio-Med Plus v. STATE, DEPT. OF HEALTH) is published on Counsel Stack Legal Research, covering District Court of Appeal of Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bio-Med Plus v. STATE, DEPT. OF HEALTH, 915 So. 2d 669, 2005 Fla. App. LEXIS 16640, 2005 WL 2662549 (Fla. Ct. App. 2005).

Opinion

915 So.2d 669 (2005)

BIO-MED PLUS, INC., Petitioner,
v.
STATE of Florida, DEPARTMENT OF HEALTH, Respondent.

No. 1D05-1761.

District Court of Appeal of Florida, First District.

October 20, 2005.

Sean M. Ellsworth of Ellsworth Law Firm, P.A., Miami Beach, for Petitioner.

Robert P. Daniti, Senior Attorney, Florida Department of Health, Tallahassee, for Respondent.

VAN NORTWICK, J.

Bio-Med Plus, Inc. (Bio-Med), a prescription drug distributor headquartered in Miami, Florida, petitions this court for *670 review of an emergency suspension order (ESO) entered by the Department of Health (Department), respondent, pursuant to which the Department has suspended Bio-Med's permit to distribute plasma-derivative pharmaceuticals.[1] Because the facts alleged in the ESO do not establish an immediate serious danger to the public health, safety or welfare, we grant the petition and quash the ESO.

I.

Bio-Med is a prescription drug distributor with distribution centers in six states and over 125 employees. Since 1996, it has possessed a state permit authorizing it to engage in the wholesale distribution of prescription drugs in or from Florida. Bio-Med is primarily engaged in the buying and selling of plasma-derivative prescription drugs that are used to treat viral diseases and immune and clotting deficiencies, including AIDS and hemophilia. Bio-Med asserts that it is the fourth largest distributor of plasma-derivative pharmaceuticals in the United States and the sole source supplier and distributor of plasma-derivative pharmaceuticals to the Veterans Administration hospitals in the United States.

On March 23, 2005, the United States Attorney in the Southern District of Georgia filed an indictment against Bio-Med charging its principals and affiliates with, among other things, racketeering, racketeering conspiracy, mail and wire fraud, money laundering and conspiracy for various acts allegedly committed between November 1999 and January 2003. The indictment charges that the owners and officers of Bio-Med operated and controlled numerous entities through which they unlawfully obtained prescription drugs which were then fraudulently diverted to Bio-Med and sold in its wholesale distributions. It is also alleged that the affiliated entities, and certain other medical practitioners, fraudulently billed third-party providers for prescription drugs which were not actually dispensed or administered to patients but were diverted to Bio-Med.

Based solely upon the allegations contained within this indictment, the Department issued the ESO charging Bio-Med with several violations of the Florida Drug and Cosmetic Act, chapter 499, Florida Statutes. In the ESO, the Department specifically alleges, based on the allegations in the federal indictment, in pertinent part, as follows:

8. ... 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.
9. ... 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 in s. 499.006, F.S., in violation of s. 499.005(1) and (4), F.S., because the prescription drugs had left the regulatory controls established in federal and state law to protect the safety, integrity, and efficacy of prescription drugs.
*671 10. ... 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.
11. Based on the indictment, 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 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 the 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 therefore presents an unnecessary risk to the unsuspecting consuming public and their prescribing healthcare practitioners.

In the ESO, the Department concludes that:

Bio-Med Plus's continued operation as a prescription drug wholesaler during the pendency 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's pattern of conduct 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.

II.

In our review, we must determine whether the ESO complies with the requirements of section 120.60(6), Florida Statutes (2004), and section 499.066(5), Florida Statutes (2004). See Field v. Dep't of Health, 902 So.2d 893, 894-95 (Fla. 1st DCA 2005). Section 120.60(6) provides that, when the Department "finds that immediate serious danger to the public health, safety or welfare requires emergency suspension, restriction, or limitation of a license ...," the Department

may take such action by any procedure that is fair under the circumstances if:
(a) The procedure provides at least the same procedural protection as is given by other statutes, the State Constitution, or the United States Constitution;
(b) The agency takes only that action necessary to protect the public interest under the emergency procedure; and
(c) The agency states in writing at the time of, or prior to, its action the specific facts and reasons for finding an immediate danger to the public health, safety, or welfare and its reasons for concluding that the procedure used is fair under the circumstances
. . .

Similarly, section 499.066(5), Florida Statutes (2004), provides:

(5) The Department may issue an emergency order immediately suspending or revoking a permit if it determines that any condition in the establishment presents *672 a danger to the public health, safety, and welfare.

"Where, as here, no hearing was held prior to the entry of the emergency order, every element necessary to its validity must appear on the face of the order." Witmer v. Dep't of Bus. and Prof'l Regulation, 631 So.2d 338, 341 (Fla. 4th DCA 1994) (citing Commercial Consultants Corp. v. Dep't of Bus. Regulation, 363 So.2d 1162, 1164 (Fla. 1st DCA 1978)). It is not enough for the ESO merely to allege statutory violations. Robin Hood Group, Inc. v. Fla. Office of Ins. Regulation, 885 So.2d 393, 396 (Fla.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Valls v. Dept. of Health
255 So. 3d 515 (District Court of Appeal of Florida, 2018)
Osakatukei O. Omulepu, M.D. v. State of Florida Department of Health
198 So. 3d 1046 (District Court of Appeal of Florida, 2016)
Zane Paul Webber v. State of Florida, Dept. of Business etc.
198 So. 3d 922 (District Court of Appeal of Florida, 2016)
Burton v. State, Department of Health
116 So. 3d 1285 (District Court of Appeal of Florida, 2013)
Hunter v. Department of Financial Services
111 So. 3d 992 (District Court of Appeal of Florida, 2013)
Nath v. State Department of Health
100 So. 3d 1273 (District Court of Appeal of Florida, 2012)
Kaplan v. State, Department of Health
45 So. 3d 19 (District Court of Appeal of Florida, 2010)
ALLSTATE FLORIDIAN v. Office of Ins. Reg.
981 So. 2d 617 (District Court of Appeal of Florida, 2008)
Henson v. Department of Health
967 So. 2d 404 (District Court of Appeal of Florida, 2007)
Eyemed Vision Care, LLC v. State, Department of Management Services
964 So. 2d 201 (District Court of Appeal of Florida, 2007)
St. Michael's Academy v. State, Dcf
965 So. 2d 169 (District Court of Appeal of Florida, 2007)
Oakcrest Early Education Center v. Dcf
936 So. 2d 1174 (District Court of Appeal of Florida, 2006)

Cite This Page — Counsel Stack

Bluebook (online)
915 So. 2d 669, 2005 Fla. App. LEXIS 16640, 2005 WL 2662549, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bio-med-plus-v-state-dept-of-health-fladistctapp-2005.