15-001271RP Dahlia Barnhart, By And Through Her Parent And Natural Guardian, Moriah Barnhart vs. Department Of Health Status: Closed DOAH Final Order on Friday, April 10, 2015.

Summary: Insufficient facts alleged to show Petitioner would be substantially affected by proposed rule; Petitioner failed to amend Petition. Issues regarding negotiated rule committee and SERC were not cognizable. Petition dismissed for lack of standing.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DAHLIA BARNHART, BY AND THROUGH

HER PARENT AND NATURAL GUARDIAN,

MORIAH BARNHART,

Petitioner,

vs. Case No. 15 - 127 1RP

DEPARTMENT OF HEALTH,

Respondent.

_______________________________/

FINAL ORDER OF DISMISSAL

Respondent Department of Health (Respondent or Department )

seeks dismissal of this proposed rule challenge, contending that

Petitioner lacks the requisite standing. After Respondent filed

a motion to dismiss with supporti ng authorities and Petitioner

was given several opportunities to respond and offer

countervailing authorities, an Order was issued granting the

motion to dismiss, without prejudice to Petitioner filing an

amended petition. Petitioner declined to act on th e opportunity

provided. Accordingly, for the reasons set forth below, the

Petition is dismissed, as the factual allegations are

insufficient to show that Petitioner has standing to maintain

this proposed rule challenge.

APPEARANCES

For Petitioner: Ian J . Christensen, Esquire

IJC Law Group, P.A.

1832 University Boulevard, South

Jacksonville, Florida 32216

For Respondent: W illiam Robert Vezina , Esquire

Eduardo S. Lombard, Esquire

Megan S . Reynolds, Esquire

Vezina, Lawrence and Piscitelli, P. A.

413 East Park Avenue

Tallahassee, Florida 32301

PRELIMINARY STATEMENT

On March 11, 2015, Petitioner Dahlia Barnhart, by and

through her parent and natural guardian, Moriah Barnhart

(Petitioner), filed a Petition to Challenge Proposed Rule

64 - 4.002 as [an] Invalid Exercise of Delegated Legislative

Authority (Petition).

The proposed rule challenge was assigned to the undersigned

on March 16, 2015. On March 18, 2015, the final hearing was set

for April 14, 2015, and an Order of Pre - Hearing Instruct ions was

issued establishing accelerated procedures and deadlines,

including shortened discovery deadlines, to comport with the

expedited nature of a proposed rule challenge proceeding.

See generally § 120.56(1) and (2), Fla. Stat. (2014). 1/ The

partie s were directed to initiate any needed discovery

immediately.

On March 19, 2015, Respondent served interrogatories on

Petitioner. The shortened deadline for Petitioner to serve its

written responses, with answers and any objections, was March 24,

2015.

On March 23, 2015, Respondent served its first request for

production on Petitioner. The shortened deadline for Petitioner

to serve its written responses, including any objections, was

March 30, 2015.

On March 26, 2015, Respondent filed two motions: a moti on

to dismiss, which set forth authorities and argument to support

the contention that Petitioner lacks standing; and a motion to

compel answers to interrogatories based on Petitioner ' s failure

to timely serve any written responses to Respondent ' s

interrog atories by the shortened deadline.

In an Order to Petitioner to Show Cause issued on March 26,

2015, Petitioner was directed to show cause by no later than noon

on March 30, 2015, as to why Respondent ' s motion to dismiss

should not be granted. In addition , a telephonic hearing on

pending motions was coordinated with counsel and scheduled for

3:00 p.m. on March 30, 2015.

Petitioner did not submit any written argument or

countervailing authorities to respond to those presented in the

motion to dismiss, as di rected by the Order to Show Cause.

A telephonic motion hearing was held as noticed, and counsel

for both parties participated in the fairly lengthy discussion of

the standing issues raised by Respondent ' s motion to dismiss and

the discovery compliance pr oblem raised by Respondent ' s motion to

compel. At the conclusion of the hearing, the undersigned ruled

that the motion to dismiss would be granted without prejudice and

that the motion to compel would be conditionally granted,

conditioned on Petitioner ta king the opportunity to file an

amend ed petition. Counsel for Petitioner was asked how much time

was needed to amend the Petition to address the deficiencies in

the standing allegations that had been discussed at length, and

counsel ultimately responded t hat three days would be sufficient.

Counsel for Petitioner also indicated that he had written

responses to the interrogatories prepared, but had not served

them yet; counsel claimed that he was waiting because of the

pending motion to dismiss.

It was agre ed that the deadline for Petitioner to file an

amended petition would be April 3, 2015 -- allowing four days

instead of three -- so that if Petitioner chose to file an amended

petition, then Petitioner also would be required to serve

complete answers to Respon dent ' s interrogatories by the April 3,

2015, deadline. In addition, it was noted that if Petitioner

wanted to proceed with the proposed rule challenge, as evidenced

by filing an amended petition and answers to interrogatories by

April 3, 2015, then Petiti oner would also have to address

Respondent ' s document production, which would then be past due.

The rulings announced on March 30, 2015, were reduced to a

written Order Granting Motion to Dismiss, Without Prejudice, and

Conditionally Granting Motion to Compel Interrogatory Answers,

issued on April 1, 2015.

Petitioner chose not to file or serve an amended petition or

answers to interrogatories by the deadline of April 3, 2015, nor

did Petitioner seek an extension of that deadline before it

expired.

O n April 6, 2015, Respondent filed its Motion for Final

Order of Dismissal With Prejudice, asserting that Petitioner must

be deemed to have abandoned the proposed rule challenge by

failing to comply with the deadline established by the foregoing

Order. It is unnecessary to await a response to this motion;

Petitioner has been afforded multiple opportunities to respond to

the arguments and authority presented in Respondent ' s March 26,

2015, motion to dismiss. The relief sought by the April 6, 2015,

motion is appropriate without regard to that motion, as it was

made clear to Petitioner that the proceeding would stand

dismissed if Petitioner did not timely file an amended petition

curing the deficiencies discussed at length in the telephonic

motion hearing. Pe titioner chose, by inaction, to allow for

final dismissal of this action , rather than comply with the Order

requiring an amended petition and answers to discovery.

FINDING S OF FACT

1. On February 6, 2015, Respondent published a notice of

proposed rulema king in the Florida Administrative Register . The

notice set forth the text of six proposed rules to implement the

Compassionate Medical Cannabis Act of 2014 (the Act), chapter

2014 - 157, Laws of Florida, codified as section 381.986, Florida

Statutes. 2/

2 . The Petition is directed to only one of the proposed

rules: proposed Florida Administrative Code R ule 64 - 4.002,

entitled " Initial Application Requirements for Dispensing

Organizations. " As part of the challenge to proposed rule

64 - 4.002, the Petition also " questions " the composition of a

negotiated rulemaking committee used by Respondent to develop the

proposed rules and the adequacy of Respondent ' s Revised Statement

of Regulatory Costs (Revised SERC).

3. Facts related to Petitioner are contained in two

paragraphs, which set forth both factual allegations and

conclusions offered to support Petitioner ' s standing. In their

entirety, t he two paragraphs related to Petitioner provide:

Petitioner is a 4 [ - ] year [ - ] old child living in

the State of Florida who has been diagnosed

with an inoperable brain tumor who is

currently using medical cannabis extracts to

treat her condition. For purposes of this

proceeding, Petitioner can be contacted

through her undersigned counsel.

Petitioner is eligible under the Act and plans

to register with the Office of Compassionate

Use Registry to become a " qualified patient "

for the medical use of low THC cannabis and

thus is " substantially affected " and has

standing to challenge the proposed rule.

Florida Statutes § 120.56(2) (a).

Petition, ¶¶ 4, 5.

4. The Petition does not contain factual allegations

describing any injuries that Petitioner would suffer by

application of the challenged proposed rule if it were adopted.

5. The Petition contains some general allegations o f harm

without an adopted rule because of a " desperate need for access

to low THC cannabis. " The Petition alleges that the Act requires

expedited promulgation of rules, which is imperative because the

" selected applicants will be responsible for ensuring access to

ordered medic ation , with greater risk of public injury if there

is no access to medicine. " (Petition, ¶ 14). In seeming

contradiction, though, the Petition also alleges that " numerous

corporations can now lawfully ship laboratory tested low - THC

cannabis based food product and cosmetics to all 50 States

without a prescription[.] " (Petition, ¶ 21 , footnote omitted ).

Most favorably construed to Petitioner, these allegations suggest

some general harm caused by the delay in getting a rule in place,

but do not suggest harm that would be suffered by Petitioner

( " who is currently using medical cannabis extracts " ) nor harm

caused by application of the proposed rule.

6. The Petition also includes allegations of harm to

potential applicants eligible to become dispensing organizations

caused by an " overly burdensome " application, scoring, and

selection process in the proposed rule. Petitioner alleges that

the burdensome process to select dispensing organizations has " no

reasonable justification given the safety profile of low - THC

cannabis as one of the safest substances known to man and the

urgent need for this medicine for thousands of critically ill

patients. " (Petition, ¶ 16). The Petition complains about " an

unauthorized arbitrary selection commi ttee to choose among

eligible applicants based on a complex and overly burdensome

scoring system[,] " from which the Petition concludes: " Overall,

the proposed rule fails to provide any objective methods to

determine whether an eligible applicant is superi or at growing

low - THC cannabis or filling out a lengthy application. "

(Petition, ¶ 19). Finally, the Petition characterizes the

proposed rule as an " attempt to eliminate applicants ' rights to

challenge the selection by comparative administrative review. "

(Petition, ¶ 21). But the Petition does not allege that

Petitioner is an eligible applicant whose rights allegedly would

be burdened or harmed in these ways.

7. Finally , the Petition raises a general concern about the

proposed rule ' s failure to conside r or address the economic

impact to patients of having to pay for purchases of low - THC

cannabis from dispensing organizations. (Petition, ¶ 22). Here ,

too, the concern is expressed generally and is not attributed to

Petitioner. Although not entirely cle ar, it appears that this

allegation is intended as a criticism of the Revised SERC by

suggesting a " cost " that should have been considered.

CONCLUSIONS OF LAW

8 . The Division of Administrative Hearings has jurisdiction

over the parties and subject matter. §§ 120.56(1) & (2),

120.569, and 120.57, Fla. Stat.

9. Standing to challenge proposed or existing

administrative rules is governed by statute. Section

120.56(1)(a) provides that " [ a ] ny person substantially affected

by a rule or a proposed rule may se ek an administrative

determination of the invalidity of the rule on the ground that

the rule is an invalid exercise of delegated legislative

authority. "

10. Section 120.56(1)(b) sets particular pleading standards

for a petition challenging a proposed rul e, as follows:

The petition seeking an administrative

determination must state with particularity

the provisions alleged to be invalid with

sufficient explanation of the facts or

grounds for the alleged invalidity and facts

sufficient to show . . . that th e person

challenging a proposed rule would be

substantially affected by it .

11. The " substantially affected " test for standing requires

that a proposed rule challenger first allege, and ultimately

prove, facts sufficient to show the challenger will su ffer a real

and sufficiently immediate injury in fact by application of the

proposed rule and that the asserted interest is arguably within

the zone of interest to be protected or regulated. See, e.g. ,

Of f . of Ins. Reg. v. Secure Enters., LLC. , 124 So. 3d 332, 336

(Fla. 1st DCA 2013); Fla. Bd. of Med. v. Fla. Acad. o f Cosmetic

Surgery, Inc. , 808 So. 2d 243, 2 50 (Fla. 1st DCA 2002); Ward v.

Bd. of Tr s. of the Int . Impust Fund , 651 So. 2d 1236,

1237 - 1238 (Fla. 4th DCA 1995); and Fla . Med . Ass ' n, Inc. v. Dep ' t

of Prof ' l Reg. , 426 So. 2d 1112, 1114 (Fla. 1st DCA 1983).

12. The requirement that a petitioner plead a real and

sufficiently immediate injury in fact is not met by allegations

of potential injuries that are speculative, abstract,

conjectural, or h ypothetical. Fla. Med. Ass ' n , 426 So. 2d at

1114 n.4, and 1118. The pleading requirement for the zone of

interest element of the standing test looks to whether the

challenger asserts that the challenged proposed rule encroaches

upon an interest protected by a statute or constitutional right.

Id. at 1117; Ward , 651 So. 2d at 1238.

13. Respondent argues in its motion to dismiss that the

standing case presenting issues most like those here is Florida

Medical Association . At issue in Florida Medical Associ ation was

the standing of various challengers to a proposed rule by the

Board of Optometry " purporting to set standards for the

prescribing of certain drugs by optometrists, and providing

guidelines for the determination of the competence of

optometrists t o use and prescribe drugs in their practice. " Fla.

Med. Ass ' n , 426 So. 2d at 1112 - 1113. The hearing officer

determined that the standing allegations were insufficient and

dismissed the challenges by a licensed Florida physician

specializing in opthalmolo gy, two associations whose members were

medical doctors and opthalmologists, a pharmacist, and a patient

of an optometrist. On appeal, the court reversed as to the

physician and the two associations representing physicians and

opthalmologists, finding tha t standing was established by their

allegations that they would suffer economic injury if the

proposed rule were adopted and that the proposed rule encroached

on their exclusive statutory and property right to use and

prescribe drugs as part of the license d practice of medicine.

However, pertinent here, the court affirmed the dismissal of the

pharmacist and the optometric patient for lack of standing. The

pharmacist alleged concern about getting in trouble for filling

optometrists ' prescriptions for drugs , which was contrary to the

directions of the Board of Pharmacy, or incurring economic loss

if he did not fill those prescriptions. Id. at 1113 n.3. The

court determined: " [W]hile [the pharmacist] may be ' interested '

in whether the rule is valid or inva lid, he has not demonstrated

an injury except in the abstract or speculative sense, which is

not sufficient. " Id. at 1118. The allegations offered to

support the optometric patient ' s standing were that he currently

receives, and would continue to need, e ye care from an

optometrist, but if the proposed rule was adopted, the patient

would either have to stop using an optometrist or hope that he

would not be injured by the optometrist ' s use of drugs, which the

patient believed exceeded the scope of optometri c practice

authorized by the licensing laws. These allegations were

determined insufficient to show an injury in fact, in that the

potential injury was speculative, nonspecific and hypothetical,

lacking in immediacy and reality. The hearing officer noted that

the patient could avoid injury by simply refusing optometric

treatment that involved use of drugs, thereby maintaining the

status quo that existed without the rule. Id. at 1114 n.4. The

court found this reasoning persuasive. Id. at 1118.

14. Resp ondent ' s motion to dismiss contends that similar

reasoning requires a determination that Petitioner lacks

standing. In ruling on the adequacy of the Petition to meet the

threshold pleading requirements to establish Petitioner ' s

standing, the factual alleg ations in the Petition are accepted as

true and are construed in a light favorable to Petitioner.

C onsideration of factual matters has been limited to the four

corners of the Petition and the attachments incorporated as

exhibits thereto. See Altee v. Duva l Cnty. Sch. Bd. , 990 So. 2d

1124, 1129 (Fla. 1st DCA 2008).

15 . When judged by the standards set forth above, the

Petition is insufficient. The factual allegations fail to show

that Petitioner would be substantially affected by proposed rule

64 - 4.002 , i f it were adopted. The Petition does not get past the

first part of the standing test, as it is devoid of factual

allegations showing that Petitioner will suffer a real or

sufficiently immediate injury in fact caused by application of

the proposed rule. T he Petition does not even allege that

Petitioner will suffer potential injuries that are abstract,

hypothetical, conjectural, or speculative, as the optometric

patient and pharmacist did in Florida Medical Association .

16. Indeed, the Petition ' s claim for standing is based

solely on allegations and conclusions that Petitioner ' s condition

renders her " eligible " under the Act and that Petitioner " plans

to register with the " compassionate use registry for medical use

of low - THC cannabis. In other words, in the language of the Act,

the Petition concludes that Petitioner is eligible for " qualified

patient " status. Even if the factual allegations were sufficient

to show that Petitioner is, or is reasonably expected to become,

a " qualified patient " under the Act, that status alone would not

suffice to meet the standing test; the Petition would still have

to plead facts sufficient to meet the injury in fact and zone of

interest tests. But the Petition does not even allege sufficient

facts to support the claim ed status relied on as a predicate for

standing -- that Petitioner is eligible for " qualified patient "

status.

17. Pursuant to the Act, a " qualified patient " is defined

as a resident of Florida who has been added to the compassionate

use registry by a phy sician licensed under chapter s 458 or 459 ,

Florida Statutes, to receive low - THC cannabis from a dispensing

organization. § 381.986(1)(d), Fla. Stat. The Petition alleges

that Petitioner plans to register; although it will not be

possible for Petitioner t o register herself (because only

physicians are permitted to add patients to the registry) ,

construed most favorably to Petitioner, this allegation is

interpreted to mean that Petitioner plans to have a Florida -

licensed physician add her to the registry.

1 8. The Petition fails to allege the factual predicate

necessary to show that Petitioner ' s plans in this regard are

likely or even possible. Section 381.986(2) identifies a very

narrow class of patients for whom a physician can consider this

option. In a ddition, the statute imposes several conditions

precedent that must be met before a physician is permitted to add

a patient to the registry to receive low - THC cannabis from a

dispensing organization. The Petition does not allege facts to

show that these s tatutory requirements are or can be met. The

statute provides:

Effective January 1, 2015, a physician

licensed under chapter 458 or chapter 459 who

has examined and is treating a patient

suffering from cancer or a physical medical

condition that chronical ly produces symptoms

of seizures or severe and persistent muscle

spasms may order for the patient ' s medical

use low - THC cannabis to treat such disease,

disorder, or condition or to alleviate

symptoms of such disease, disorder, or

condition, if no other sat isfactory

alternative treatment options exist for that

patient and all of the following conditions

apply:

(a) The patient is a permanent resident of

this state.

(b) The physician determines that the risks

of ordering low - THC cannabis are reasonable

in light of the potential benefit for that

patient. If a patient is younger than 1 8

years of age, a second physician must concur

with this determination and such

determination must be documented in the

patient ' s medical record.

(c) The physician registers as the orderer

of low - THC cannabis for the named patient on

the compassionate use registry maintained by

the department and updates the registry to

reflect the contents of the order. . . .

(d) The physician maintains a patient

treatment plan that includ es the dose, route

of administration, planned duration, and

monitoring of the patient ' s symptoms and

other indicators of tolerance or reaction to

the low - THC cannabis.

(e) The physician submits the patient

treatment plan quarterly to the University of

Fl orida College of Pharmacy for research on

the safety and efficacy of low - THC cannabis

on patients.

(f) The physician obtains the voluntary

informed consent of the patient or the

patient ' s legal guardian to treatment with

low - THC cannabis after sufficient ly

explaining the current state of knowledge in

the medical community of the effectiveness of

treatment of the patient ' s condition with

low - THC cannabis, the medically acceptable

alternatives, and the potential risks and

side effects.

19. The allegations regarding Petitioner ' s medical

condition are insufficient to describe a condition that would

render Petitioner potentially eligible for a physician ' s order to

receive low - THC cannabis. The Petition alleges that Petitioner

has an inoperable brain tumor, b ut the Petition does not allege

that Petitioner ' s condition falls within the narrow parameters of

the Act, that is, that Petitioner has cancer or that Petitioner ' s

medical condition chronically causes seizures or muscle spasms. 3/

20. Similarly, although t he Petition alleges that

Petitioner is " currently using medical cannabis extracts to treat

her condition [,] " the Petition fails to allege that Petitioner is

being treated by a physician licensed under chapter 458 or

chapter 459, much less that such Florida - licensed treating

physician has made or will make the determinations required by

section 381.986(2), and has complied or will comply with all of

the conditions precedent imposed by that law. Indeed, the very

allegation that Petitioner " is currently using medical cannabis

extracts to treat her condition " is notable by the absence of the

" low - THC " qualifier, which would be the only type of medical

cannabis treatment permitted under the Act.

21. Without factual allegations that answer these questions

and fi ll in these gaps, the Petition ' s conclusion that

" Petitioner is eligible under the Act " cannot be credited nor can

the Petition ' s allegation that Petitioner " plans to register with

the Office of Compassionate Use Registry to become a ' qualified

patient [ . ] ' "

22. " Qualified patient " status, when adequately alleged,

might , hypothetically, be sufficient as part of the predicate for

standing to challenge rules implementing the Act. For example,

as discussed in the telephonic motion hearing, pursuant to the

Ac t, the Department is to authorize " the establishment of five

dispensing organizations to ensure reasonable statewide

accessibility and availability as necessary for patients

registered in the compassionate use registry and who are ordered

low - THC cannabis under this section, one in each of " five

geographic regions, identified generally as northwest Florida,

northeast Florida, central Florida, southeast Florida, and

southwest Florida. § 381.986(5)(b), Fla. Stat. One of the

proposed rules not challenged by Petitioner allocates each

Florida county to one of the five geographic regions. It is

conceivable that a petitioner who could show " qualified patient "

status could sufficiently plead standing to challenge the rule

allocation of counties to the geographic regions, if the claim

was that the allocation was contrary to the statutory designation

of geographic regions, which was intended to protect the

qualified patient ' s interest in reasonable access.

23. Respondent argued that a " qualified patient " could

neve r have standing to challenge proposed rule 64 - 4.002, because

that rule only addresses the application requirements, scoring,

and selection process for dispensing organizations. It is true

that a " qualified patient " would not be directly regulated or

subje ct to the requirements of proposed rule 64 - 4.002. However,

the undersigned is unwilling to conclude, and it is unnecessary

to conclude, that a " qualified patient " could not, as a matter of

law, allege a sufficient injury or protected interest implicated

b y rule 64 - 4.002. Instead, it is concluded only that the

Petition at issue here fails to allege sufficient facts to show

that this Petitioner has standing to challenge proposed rule

64 - 4.002 , for all of the reasons previously stated .

24. While Petitioner was given an opportunity to attempt to

amend the petition to address the deficiencies in the standing

allegations, in two respects, the Petition was not curable.

First, to the extent the Petition sought to challenge the

validity of proposed rule 64 - 4.002 because of Petitioner ' s

" questions " about the composition of the group participating in

negotiated rulemaking to develop the proposed rule language, that

contention must be rejected.

25. Negotiated rulemaking is an approved rule development

procedure int ended for the type of situation the Department was

addressing. Section 120.54(2)(d) provides:

1. An agency may use negotiated rulemaking

in developing and adopting rules. The agency

should consider the use of negotiated

rulemaking when complex rules are being

drafted or strong opposition to the rules is

anticipated. The agency should consider, but

is not limited to considering, whether a

balanced committee of interested persons who

will negotiate in good faith can be

assembled, whether the agency is willing to

support the work of the negotiating

committee, and whether the agency can use the

group c onsensus as the basis for its proposed

rule. Negotiated rulemaking uses a committee

of designated representatives to draft a

mutually acceptable proposed rule.

2. An agency that chooses to use the

negotiated rulemaking process described in

this paragraph shall publish in the Florida

Administrative Register a notice of

negotiated rulemaking that includes a listing

of the representative groups that will be

invited t o participate in the negotiated

rulemaking process. Any person who believes

that his or her interest is not adequately

represented may apply to participate within

30 days after publication of the notice. All

meetings of the negotiating committee shall

be noticed and open to the public pursuant to

the provisions of this chapter. The

negotiating committee shall be chaired by a

neutral facilitator or mediator.

3. The agency ' s decision to use negotiated

rulemaking, its selection of the

representative groups, and approval or denial

of an application to participate in the

negotiated rulemaking process are not agency

action. Nothing in this subparagraph is

intended to affect the rights of an affected

person to challenge a proposed rule developed

under this paragraph in accordance with

s. 120.56(2) .

26. As section 120.54(2)(d)3. m akes clear, the Department ' s

decisions regarding use of the negotiated rulemaking proce ss,

selection of the representative groups, and approval or denial of

individual applications to participate are deemed " not agency

action, " meaning that they are not subject to challenge. While

the use of negotiat ed rulemaking to develop a proposed rule does

not preclude an otherwise proper proposed rule challenge,

Petitioner ' s complaints about that process are not grounds for

challenging the proposed rule.

27. The second area of insufficiency that w ould not have

been curable by amending the Petition i s with respect to the

apparent attempt to question the adequacy of the Department ' s

Revised SERC. An inadequate SERC might be grounds for

challenging a rule as an invalid exercise of delegated statutory

authority, if the argument is that " [t] he rule impos es regulatory

costs on the regulated person, county, or city which could be

reduced by the adoption of less costly alternatives that

substantially accomplish the statutory objectives. "

§ 120.52(8)(f), Fla. Stat. (emphasis added). Where, as here, the

Dep artment prepared a SERC and Revised SERC, then the adequacy of

the Revised SERC is subject to challenge if a lower cost

regulatory alternative was timely submitted and rejected, and the

challenge is lodged by someone who is substantially affected by

the re jection of the offered lower - cost regulatory alternative.

§ 120.541(1)( g ), Fla. Stat.

28. The Petition sets forth no predicate allegations

regarding the grounds in section 120.52(8)(f) or the requirements

in section 120.541 for challeng ing t he adequacy o f a revised

SERC. The only factual allegation raised regarding any " costs "

is the general allegation that the Department did not consider

the economic impact to patients who will have to pay the cost of

purchasing low - THC cannabis fr om dispensing organiza tions. That

allegation does not raise an issue of regulatory costs.

29. Respondent ' s argument in the m otion to d ismiss that

Petitioner lacks standing to challenge the Revised SERC is

correct. Petitioner offered no response to this argument, either

in w riting or in argument in the telephonic motion hearing.

ORDER

Based on the foregoing Findings of Fact and Conclusions of

Law, it is ORDERED that the Petition to Challenge Proposed Rule

64 - 4.002 as Invalid Exercise of Delegated Legislative Authority

is DI SMISSED, with prejudice.

DONE AND ORDERED this 10th day of April , 2015 , in

Tallahassee, Leon County, Florida.

S

ELIZABETH W. MCARTHUR

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 10th day of April , 2015 .

ENDNOTE S

1/ References to Florida Statutes a re to the 2014 codification.

2/ The proposed rules published on February 6, 2015, represent

Respondent ' s second attempt at rulemaking to implement the Act.

The first effort was challenged by several parties (not including

Petitioner) and invalidated by Final Order that was not appealed.

Costa Farms, LLC, et al. v. Dep ' t of Health , Case Nos. 14 - 4296RP,

14 - 4299RP, 14 - 4517RP, & 14 - 4547RP (Fla. DOAH Nov. 14, 2014).

3/ As discussed with counsel for Petitioner in the telephonic

motion hearing, t he omission of additional facts that would bring

Petitioner within the narrow class of potentially eligible

patients would seem easy enough to cure if the additional facts

were true. Counsel for Petitioner was specifically invited to

cure this pleading deficiency by amending the petition, but chose

not to. The undersigned draws no inference from Petitioner ' s

failure to file an amended petition along with interrogatory

answers that it was because of an inability to cure this

particular pleading deficiency. Instead, P etitioner may have

chosen not to proceed with the proposed rule challenge because of

an inability to cure the other pleading deficiencies discussed

herein, because of an unwillingness to comply with the Order

compelling interrogatory answers or bear the co nsequences for

failing to do so , because of an unwillingness to submit to the

other requirements that come with party status in the

administrative litigation Petitioner initiated , or because of

some other reason .

COPIES FURNISHED:

John H. Armstrong, M.D ., F.A.C.S.

State Surgeon General

Department of Health

Bin A00

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

(eServed)

Jennifer A. Tschetter, General Counsel

Department of Health

Bin A02

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

(eSe rved)

Shannon Revels, Agency Clerk

Department of Health

Bin A02

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1703

(eServed)

Ian J. Christensen, Esquire

IJC Law Group, P.A.

1832 University Boulevard, South

Jacksonville, Florida 32216

(eServed)

Edua rdo S. Lombard, Esquire

Vezina, Lawrence and Piscitelli, P.A.

413 East Park Avenue

Tallahassee, Florida 32301

(eServed)

Megan S. Reynolds, Esquire

Vezina, Lawrence and Piscitelli, P.A.

413 East Park Avenue

Tallahassee, Florida 32301

(eServed)

William Ro bert Vezina, Esquire

Vezina, Lawrence & Piscitelli, P.A.

413 East Park Avenue

Tallahassee, Florida 32301

(eServed)

Ernest Reddick, Chief

Department of State

R. A. Gray Building

500 South Bronough Street

Tallahassee, Florida 32399 - 0250

(eServed)

Alexander Nam

Department of State

R. A. Gray Building

500 South Bronough Street

Tallahassee, Florida 32399 - 0250

(eServed)

Ken Plante, Coordinator

Joint Adminstrative Procedures Committee

Room 680, Pepper Building

111 West Madison Street

Tallahassee, Flor ida 32399 - 1400

(eServed)

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is entitled

to judicial review pursuant to section 120.68, Florida Statutes.

Review proceedings are governed by the Florida Rules of Appe llate

Procedure. Such proceedings are commenced by filing the original

notice of administrative appeal with the agency clerk of the

Division of Administrative Hearings within 30 days of rendition

of the order to be reviewed, and a copy of the notice,

acco mpanied by any filing fees prescribed by law, with the clerk

of the District Court of Appeal in the appellate district where

the agency maintains its headquarters or where a party resides or

as otherwise provided by law.