strasburg v. state bd. of pharmacy, case no. 2007 … of appeals failed to articulate how the trial...

IN THE SUPREME COURT OF OHIO

SCP, INC. dba STRASBURG PI-IARMACYAndMICHAEL T. DENNIS, R. PH.,AndAMY LYNN FROMAN, R.PH.,

APPELLANTS,

V.

OHIO STATE BOARD OF PHARMACY,

APPELLEE.

On Appeal from the Tuscarawas CountyCourt of Appeals, Fifth Appellate District

Court of AppealsCase No. '2008 AP 10 0063Case No. 2008 AP 10 0064Case No. 2008 AP 10 0065

MEMORANDUM IN SUPPORT OF JURISDICTION OF APPELLANTSSCP, INC., MICHAEL T. DENNIS, R.PH., AND AMY L. FROMAN, R.PII

Scott P. Sandrock (#0015826)(COUNSEL OF RECORD)Jerry R. Krzys (#0078013)Elizabeth Shively Boatwright (#0081264)Brennan, Manna, & Diatnond, LLC75 East Market StreetAkron, Ohio 44308(330) 253-5060Fax No. (330) [email protected]

Richard Cordray (#0038034)Attorney GeneralTracy M. Greuel (#0074067)(COUNSEL OF RECORD)Assistant Attorney General30 E. Broad Street, 26°i FloorColumbus, OH 43215(614) 466-8600Fax No. (866) [email protected]

COUNSEL FOR APPELLANTSSCP, INC., MICHAEL T. DENNIS,R.PI3., AND AMY L. FROMAN, R.PH.

COUNSEL FOR APPELLEEOHIO STATE PHARMACY BOARD

TABLE OF CONTENTS

Page

EXPLANATION OF WHY THIS CASE IS ONE OF PUBLIC OR GREAT GENERALINTEREST AND RAISES A SUBSTANTIAL CONSTITUTIONAL QUESTION ........... 1

STATEMFNI' OF TIIE CASE AND FAC'I'S ................................................:........ 2

ARGUMENT IN SUPPORT OF PROPOSITIONS OF LAW..................................... 7

Proposition of Law No. I: Proving a licensed health professional's non-compliance withstatutory and regulatory requirements is an element that the State must prove by apreponderance of the evidence in an administrative proceeding .................................... 7

Proposition of Law No. II: Due process requires that evidence, accepted at a hearing shouldbe limited to the charges in the notice of hearing and not include issues outside of thecitation .. . . . . . . .. . . . .. . .. . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . ... 11

Proposition of Law No. III: A pharmacist's right to due process is violated when the StateBoard of Pharmacy permits witness testimony regarding documents and summaries ofdocuments without offering the documents into evidence and when the Board admitshearsay involving significant witnesses testimony and the contents of essential documents... 12

Proposition of Law No. IV: Prior to August 30, 2007, the vote of at least five members ofthe State Board of Phannacy was required to constitute a majority decision to revoke thelicense of a pharmacist .................................................................................... 14

Proposition of Law No. V: A court of appeals ens by reweighing the evidence whenconsidering a trial court's affirmation or reversal of an administrative agency's decision andmaking no specific finding regarding how the trial court abused its discretion .................. 14

CON CLUSI ON . . . . . . . . . . . . . . . . . . .. . . .. . . . .. . . . . . .. . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . .. . . . . . . . . . . . . .. . . . . . . ... 15

PROOF OF SERVICE .................................................................................... 16

APPENDIX Appx. Page

Opinion of the Tuscarawas County Court of Appeals(Feb. 10, 2010) ............................................................................................. A 1

Judgment Entry of the Tuscarawas County Court of Appeals(Feb. 10, 2010) ............................................................................................. B 1

Judgment Entry of the Tuscarawas County Court of Common Pleas, SCP, Inc. d/b/aStrasburg v. State Bd. of Pharmacy, Case No. 2007 AA 01 0041, (Sept. 4, 2008) ............... C I

Judgment Entry of the 'I'uscarawas County Court of Common Pleas, Dennis v. State Bd. ofPharmacy, Case No. 2007 AA 01 0042, (Sept. 4, 2008) ............................................. D I

Judgment Entry of the Tuscarawas County Court of Common Pleas, Froman v. State Bd. ofPharmacy, Case No. 2007 AA 01 0055, (Sept. 4, 2008) ............................................. E 1

Order of the State Board of Pharinaey, In the Matter of: StrasburQ Pharmacy, Docket No. D-050719-004, (Jan. 11, 2007) ............................................................................. F I

Order of the State Board of Pharmacy, In the Matter of: Dennis, R.Ph., Docket No.D-050719-005, (Jan. 11, 2007) .......................................................................... G I

Order of the State Board of Pharmacy, In the Matter of: Amy Lymi Froman, R.Ph., DocketNo. D-050719-006, (Jan. 11, 2007) ..................................................................... H 1

EXPLANATION OF WHY THIS CASE IS ONE OF PUBLIC OR GREAT GENERALINTEREST AND RAISES A SUBS'fANTIAL CONSTI'fUTIONAL QUESTION

Due process is required before Ohioans may be deprived of rights and liberties. This case

involves issues of public or great general interest concerning due process protections applicable

in adniinistrative license proceedings. The public, and specifically licensed professionals, have a

great interest in ensuring that agencies comport with due process.

The daiiger posed by unfettered and uncontrolled agencies is illuminated by three

fundamental due process violations in this case: (1) the State Board of Phai-macy ("Board")

revoked or suspended the licenses of SCP, Inc. d/b/a Strasburg Pharmacy, Michael T. Dennis and

Amy L. Froman,t a pliarmacy and its pharmacists, without evidence supporting each element of

the charges; (2) the Board found violations for which Appellants were not charged in the notice;

and (3) the proceedings were so replete with hearsay, innuendos and improprieties that

Appellants were denied their due process rights to fair and impartial hearings.

With respect to the first issue, this Court recently noted in State v. Nucklos that due

process requires the State to prove non-compliance witli statutory or regulatory requirements by

a licensed health professional in a criminal drug trafficking charge. (2009), 121 Ohio St.3d 332.

Essentially, the issue in Nucklos was whether the physician issued prescriptions in a legitimate

patient relationship. In this case, the pharmacists where charged with filling prescriptions issued

by a physician outside of a legitimate patient relationship. Therefore, this case presents a parallel

issue with Nucklos: In administrative license procedures involving a similar charges for filling

prescriptions, is the State reqtured to prove non-compliance with statutory or regulatory

requirements before it revokes or suspends a license for the alleged non-compliance?

' SCP, Inc. d/b/a Strasburg Pharmacy, Michael T. Dennis and A ny L. Froman are referenced herein collectively as"Appellants" and individually as "SCP," "Dennis," and "Froman" respectively.

'The Board claimed Appellants filled prescriptions issued by doctors without legitimate

medical purposes outside the usual course of the physicians' practice. 'The State presented no

evidence shownig the prescriptions were not appropriate for the patients or the non-existence of a

bona fide doctor-patient relationship. The Board denied Appellants due process by revoking or

suspending their licenses without evidence to support the charge in the citations. This Court

should consider whether Nucklos equally applies to agencies to prohibit professional license

suspensions without evidence supporting each element of the charge and set forth due process

standards for administrative license procedures.

The second due process violation is that the Board charged Appellants with one offense

in the Notice and Opportunity for Hearing ("Notice") and imposed sanctions against Appellants'

licenses without finding wrongdoing on the matter cited. Instead, the Board imposed sanctions

based on issues not included in the Notices. Rather than finding Appellants filled prescriptions

witlrout legitimate medical purposes, the Board found they neglected their corresponding

responsibility and duties under regulations not contained in the Notices further violating due

process guarantees. Finally, in fundamentally flawed proceedings, numerous instances of hearsay

and double hearsay involving significant witness testimony and documentary evidence totally

denied even a semblance due process.

In addition to the substantial constitutional questions, this case raises important

procedural issues, such as the appropriate standard of appellate review for agency decisions. The

trial court reversed the Board finding a lack of reliable, probative and substantial evidence.

Altliough this Court has recently addressed the abuse of discretion standard in Bartchy v. State

Bd. of Edu. (2008), 120 Ohio St.3d 205, the Court of Appeals failed to follow the standard of

review and exceeded its role, made its own findings, and substituted its own judgment. The

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Court of Appeals failed to articulate how the trial court's decision was based on "perversity of

will, passion, prejudice, partiality or moral delinquency." Id. at 213.

This case presents a unique series of constitutional and procedural issues of a public and

great general interest involving the constitutional protections due to every Ohioan, and provides

an opportunity to define due process paraineters required for fair administrative proceedings.

STATEMENT OF THE CASE AND FACTS

This case involves the Board's revocation of SCP's and Dennis's licenses and suspension

of Froman's license on January 11, 2007, which were reversed by the Tuscarawas County Court

of Common Pleas and reinstated by the Fifth District Court of Appeals. The events central to

this case began in 2003. At that time, Dennis and Froman worked as pharmacists at SCP.

A. Professional Pain Management of Ohio (PPMO)

In early 2003, Dr. DeHaas opened PPMO, a pain management clinic. DeHaas visited

local pharmacies, including SCP, to explain he was opening a clinic for intractable pain care and

treatment. DeHaas provided SCP a verbal and written explanation of his pain management

approach, which included personal evaluation and pain medication as warranted. DeHaas furtlier

explained: his practice was relocating from Soutlieni Ohio; he called in prescriptions to avoid

forgery or alteration; many former patients would likely seek treatment at his new office; and

many of his patients were not insured and had limited financial resources. DeHaas requested

price quotes from pharmacies, including SCP, for his commonly prescribed pain medications

because of his patients' limited resources. Dennis contacted the State Medical Board to confirm

that DeHaas was a licensed physician in good standing, and Appellants began to fill PPMO

prescriptions. At all times, Appellants reviewed patient profiles, talked to patients about their

medical conditions, and checked patient identification when filling PPMO prescriptions.

3

In May 2003, Dennis purchased SCP and applied to transfer the pharmacy license. In the

process, Dennis called David Gallagher ("Gallaglier"), a Board agent, explained SCP was

receiving a high volume of PPMO prescriptions, and asked if the Board knew anything about

PPMO. While other pharmacies gave Gallagher similar information and he advised them not to

lill PPMO prescriptions, he told Dennis he was not aware of any problems with PPMO.

As PPMO prescription volume grew, Dennis again verified DeHaas's license status with

the Medical Board. Demiis also contacted the Board to explain PPMO prescription volume was

increasing and that SCP verified the prescriptions with the physicians. Gallagher again withheld

inforination that he was invesfigating PPMO, told Appellants to use their own professional

judgment when filling prescriptions, and said he did not have any information about PPMO.

On December 1, 2003, multiple Board agents visited SCP unannounced and seized

records for the PPMO investigation. Appellants fully cooperated, provided accurate records for

each prescription and every pill dispensed, and submitted to interviews. Appellants offered to

immediately cease tilling PPMO prescriptions, but the agents threatened criminal obstruction of

justice charges if they stopped. Within weeks, Board agents seized PPMO's records closing the

practice. SCP and other area pharmacies filled PPMO prescriptions until the day it was closed.

B. Board Citation

Nineteen months later, the Board issued Notices to Appellants listing PPMO

prescriptions and making the sole claim that Appellants filled the prescriptions "when not for a

legitimate medical purpose issued by a prescriber acting in the usual course of his professional

practice." Importantly, the Notices did not assert charges of any otlier misconduct.

The Notices are an example of the State's inappropriate conduct and how Appellant's due

process rights were violated. The Notices were 359 pages long and listed numerous

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prescriptions, but only a fraction of the prescriptions were actually challenged. The State was

obviously and inappropriately attempting to condemn Appellants through innuendo from

prescription volume alone and not evidence.

C. Board Hearings

Appellants requested a hearing on the Notices, which was not held until the following

year in Novernber and Deceniber 2006, sixteen months later. At the hearing, the State presented

only two witnesses. Gallagher, a Board agent who is not a pharmacist or physician, testified over

objection regarding his conversations with and the opinions of other pharmacists. Robert

Kubasak ("Kubasalc"), a pharmacist, testified that every single.PPMO prescription was improper

despite acknowledging: (a) he was not a physician; (b) he had not reviewed a single medical

record; (c) he was not competent to determine if patients had medical conditions for which pain

medication was appropriate; and (d) he was not aware of Appellants' steps to investigate PPMO

and the precautions that Appellants took before filling prescriptions.

The State presented no medical records and no medical testimony showing PPMO issued

the prescriptions without legitimatc medical purposes outside of a bona fide doctor-patient

relationship. The State instead focused solely on prescription volume without evidence that any

particular patient lacked a medical condition requiring pain medication. Further, although

dozens of pharmacists at numerous pharmacies filled PPMO prescriptions, the State could not

explain why it limited enforcement to pharmacists at independent phannacies while taking no

action against pharmacists at large retail pharmacies such as Wal-Mart, Rite Aid or CVS.

It is undisputed that every single tablet Appellants dispensed was accounted for, every

dispensed prescription was on file, and Appellants recorded every patient transaction. Further,

5

the record contains the precautions Appellants took before filling PPMO prescriptions, including

talking with patients, PPMO, other pharmacists, the Medical Board, aud the Board.

D. Board Decision

Over three years after the Board visited SCP in its PPMO investigation, on January 11,

2007, the Board revoked SCP's and Dennis' licenses and suspended Froman's license with no

finding that even a single prescription lacked a legitimate medical purpose.' Appx. F 5, G 5, H 5.

The Board concluded Appellants "shirked" their responsibilities under O.A.C. 4729-5-18, 4729-

5-20, 4729-5-22, and 4731-21-02 (although the Notices made no such charges). Appx. F 4, G 4,

H 4. Even though Appellants were not charged with these offenses, the Board found Dennis and

Frotnan guilty of gross immorality, unprofessional conduct, and willfully violating, conspiring to

violate, attempting to violate, or aiding and abetting the violation provisions of R.C. Chapters

2925 and 3719. Appx. G 4,114.

E. Trial Court Decision

Appellants appealed to the Tuscarawas County Court of Common Pleas which reversed

and vacated the Board's decisions on September 4, 2008. The trial court found the State's only

two witnesses' testimony was not reliable, probative and substantial. It discredited the State's

expert's testimony because he did not review medical charts; he was unaware whether any

patient had chronic pain; he offered opinions beyond his expertise based on incomplete

information; he relied on facts not in evidence; and he was never made aware of Appellants'

actions regarding PPMO. Appx. C 10, D 10, B 10. The trial court also discredited Gallagher's

testimony because he was not qualified to determine if a prescription should be filled. Appx. C

10-11, D 10-11, E 10-11. Therefore, the court held the State did not prove Appellants filled any

2 Dennis' license was revoked by a split four to three decision. Appx. at G-5.

6

prescriptions that lacked a legitimate medical purpose or that. Appellants knew or should have

known a prescription was illegitimate. Appx. C 11, D 11, E 11.

F. Court of Appeals Decision

The Board appealed to the Fifth District Court of Appeals, which reversed and reinstated

the Board' decision on February 10, 2010. While the Court of Appeals cited the abuse of

discretion standard of review, it failed to explain how the trial court's decision demonstrated a

perversity of will, passion, prejudice, partiality or moral delinquency. Further, the Court of

Appeals failed to consider the impact of Nucklos or the State's burden to prove the health

professional's non-compliance with O.A.C. 4729-5-30. Rather, it appears to have concluded

that, even tliough Appellants were cited under O.A.C. 4729-5-30, the State had no obligation to

prove Appellants filled prescriptions that lacked legitimate medical purposes-an element o1'the

regulation, when it stated that medical testimony is unnecessary to establish that a prescription

was not issued for a legitimate medical purpose. Appx. A 20, n.5. The Court of Appeals

exceeded its role and substituted its judgment for that of the trial court.

ARGUMENT IN SUPPORT OF PROPOSITIONS OF LAW

Proposition of Law No. 1: Proving a licensed health professional's non-compliancewith statutory and regulatory requirements is an element the State must prove by apreponderance of the evidence in an administrative proceeding.

In Nucklos, this Court addressed the State's burden to convict a licensed health

professional for crinuiial drtig trafficking. 121 Ohio St.3d 332. A physician was charged with

drug trafficking under R.C. 2925.03(A). Id. at 333. T'he primary issue was the meaning of R.C.

2925.03(B)(1), which provides that criminal drug trafficking "does not apply to a licensed health

professional who complies with applicable statutory or regulatory requirements." Id. at 332.

Stated another way, the issue was "whether or not a physician acting in the course of the bona

7

fide treatment of patients... [was] an affirmative defense." State v. Nucklos (2007), 171 Ohio

App. 3d 38, 46. The trial court instructed the jury that compliance with statutory and regulatory

requirements was an affirmative defense and the physician was convicted. Nucklos, 121 Ohio

St.3d at 333.

After the Second District reversed, iii part, based upon the jury instruction, this Court

explained "[t]he state has the burden of establishing all material elements of a crime" and the

"Due Process Clause protects the accused against conviction except upon proof beyond a

reasonable doubt of every fact necessary to constitute the crime with which [the accused] is

charged." Id. at 334, emphasis in original. Since statutory and regulatory compliance was not an

affirmative defense, this Court affirmed the Second District and held a`9icensed health

professional's noncompliance with statutory or regulatory requireinents is an element of

trafficking in drugs that the state must prove beyond a reasonable doubt." Id. at 332. Basically,

the State had to prove that the physician issued the prescriptions outside of the bona fide

treatment of patients.

Due process protections extend beyond criminal proceedings and apply as well to

administrative proceedings revoking a professional license. Black v. State Bd. of Psychology

(2005), 160 Ohio App.3d 91, 94. When an administrative agency revokes or suspends a

professional license or certification, "fundamental notions of fairness dictate that the proof

offered must be able to withstand at least a minimum of judicial scrutiny." In re Sarver (1990),

70 Ohio App.3d 471, 479. As in Nucldos, in administrative license revocation proceedings, due

process mandates that the State produce evidence to support each "required element of the

charged violation" in order for the decision to be "supported by reliable, probative, and

substantial evidence." In re Sarver, 70 Ohio App.3d at 479.

8

In this case, the Notices alleged that Appellants "sold...controlled substances to...

patients when not for a legitimate medical purpose" in violation of O.A.C. 4729-5-30. O.A.C.

4729-5-30(A) states: "A prescription, to be valid, must be issued for a legitimate medical

purpose by an individual prescriber acting in the usual course of his/her professional practice... "3

The Board had to establish: (1) a prescription was not issued for legitimate medical purposes in

the usual course of bona fide patient treatment; and (2) Appellauts knew it was not legitimate but

still filled the prescription.

The Board made no finding that any prescription was issued without legitimate medical

purposes. Rather, it focused on Appellants' corresponding responsibility, the fact that patients

lacked insurance, and prescription volume to find they should have known not to fill PPMO

prescriptions without actual proof that even a single prescription was illegitirnate. The Board

bootstrapped the "no legitimate medical purpose element" to prescription volume without a

scintilla of evidence. (The State's expert even admitted the State had no such evidence).

Recognizing this error, the trial court held the Board "did not tneet its burden of proof on the

issue of whether the prescriptions issued by Dr. Dellaas at PPMO were for a legitimate medical

purpose." Appx. C 11, D 11, E 11.

Contrary to this Court's holding in Nucklos that the State had to prove each element, the

Court of Appeals adopted the Board's constitutionally deficient rationale that "[t]he vohime of

prescriptions filled for a single medical practice, as well as the prices charged ... support the

Board's conclusions that [Appellants] knew that the prescriptions were not issued for a

legitimate medical purpose."4 Appx. A 20. The Court of, appeals cited cases froni other

jurisdictions for the proposition that medical testimony was unnecessary to prove a prescription

'21 U.S.C. 1306.04(A) is nearly identical to O.A.C. 4729-5-30, so this brief only discusses O.A.C. 4729-5-30.

° As previously discussed, the Board made no finding that auy prescription lacked a legitimate medical puipose.

9

had no legitimate niedical purpose and was ontside bona frde professional treatment. Appx. A

20, n.5. However, the cases that the Court of Appeals cited are clearly not applicable to

Appellants. For example, in United States v. Hayes, the volume of drugs per patient was

massive. The pharmacist filled 347 separate prescriptions for just one patient in a two month

period,5 this patient lived with the doctor and sold drugs, the doctor was an alcoholic, the

phai-enacist had a supply of prescription forms he gave to patients for the doctor to sign, and the

doctor testified that he had no legitimate patients. (5th Cir. 1979), 595 F.2d 258, 263.

The trial court recognized that this case is not one where medical evidence is not

required. Appx. C 10-12, D 10-12, D 10-12. No patient files were introduced, the State's expert

did not review any patient files, and no patients or PPMO physicians testified. The Board

permanently revoked SCP's and Dennis' licenses and suspended Froman's license despite a

complete absence of any evidence that even a single prescription lacked a legitimate niedical

purpose-an element required to prove non-cornpliance with O.A.C. 4729-5-30. As due process

required evidence to support each element of the charge, the State was required to present

evidence that the prescriptions lacked legitimate medical purposes. Without such evidence, the

Board's decision and the Court of Appeals' Opinion reinstating the Board's decision violated

Appellants' right to due process. Nucklos, 121 Ohio St.3d at 334; In re Sarver, 70 Ohio App.3d

at 479.

Appellants requests this Court to reverse the Court of Appeals and clarify that the State

was required to prove the prescriptions lacked legitimate medical purposes by a preponderance

of the evidence to establish a violation of O.A.C. 4729-5-30. Nucklos, 121 Ohio St.3d at 334.

5 In this case, the Notices indicate that Appellauts filled one prescription per patient per month.

10

Proposition of Law No. Il: Due process requires that evidence accepted at a hearingshould be limited to the charges in the notice of hearing and not include issuesoutside of the citation.

Due process requires notice and a hearing in an administrative proceeding "which

revokes an individual's license to practice a profession." Black, 160 Ohio App.3d at 94. The

notice must be "reasonably calculated, under the circumstances, to apprise interested parties of

the pendency of the action" (Mullane v. Cent. Hanover Bank & Trust Co. (1950), 339 U.S. 306,

314) and must provide "a reasonable opportunity to know the claims of the opposnig party."

Gonzales v. United States (1955), 348 U.S. 407, 414, n.5. Ohio courts have stated that due

process requires that notice apprise the individual of the "subject matter• of the hearing." State ex

rel. LTV Steel Co. v. Industrial Comm'n. of Ohio (1995), 102 Ohio App.3d 100, 104, emphasis

in original. "Without specific, actual notice" that an issue will be addressed, an individual does

not have "an adequate opportunity to prepare evidence or develop arguments on his behalf." Id.

Under R.C. 119.07, notice must include "the charges or other reasons for the proposed

action, [and] the law or rule directly involved." Deficient notice "invalidate[s] any order entered

pursuant to the hearing." R.C. 119.07. R.C. 119.07 is clear: If a licensed professional is charged

with violating one section of the Revised Code "of which he is not found guilty, a finding of the

[administrative agency] suspending such [professional] for alleged violation of another section of

such law upon which he was not charged is not in conformity with [R.C. 119.07]...and such

order of suspension is invalid." Ohio Motor Vehicle Dealers' & Salesman's Licensing Bd. v.

Memphis Auto Sales (1957), 103 Ohio App. 347, Syllabus T3.

In this case, the Notices failed to comply with due process and R.C. 119.07. Appellants

were cliarged with selling controlled substances to specified "patients when not for a legitimate

medical purpose issued by a prescriber acting in the usual course of his professional practice" in

11

violation of O.A.C. 4729-5-30. The Board, however, did not find Appellants filled prescriptions

that were not for legitimate medical purposes. Instead, it found they violated their duty to

exercise a corresponding responsibility (an allegation not contained in the Notices) by failing to

take steps required by O.A.C. 4729-5-18, 4729-5-20, 4729-5-22, and 4731-21-02 (regulations

not included in the Notices) that would have permitted them to recognize "red flags" (facts not

included in the Notices and standards not defined in any regulation) and stop filling PPMO

prescriptions. The Court of Appeals compotwded the constitutional and statutory deficiencies by

referencing newsletters and other matters not in evidence. Since the Notices were deficient, the

Board's decisions are void under R.C. 119.07 and the Court of Appeals should be reversed.

Proposition of Law No. II[: A pharmacist's right to due process is violated when theState Board of Pharmacy permits witness testimony regarding documents andsummaries of documents without offering the documents into evidence and whenthe Board admits hearsay involving significant witnesses testimony and the contentsof essential documents.

Due process requires "`that where governmental action seriously injures an individual,

and the reasonableness of the action depends on fact findings, the evidence used to prove the

Government's case must be disclosed to the individual so that he has an opportunity to show that

it is unhue."' In re Kralick (1995), 101 Ohio App.3d 232, 237, quoting Greene v. McElroy

(1959), 360 U.S. 474, 496. Based upon this principal, it has been held that the State Medical

Board denied a physician due process where the State's expertwas permitted to testify regarding

records not introduced into evidence, and the physician did not have an opportunity to review the

records and cross-examine the expert regarding his reliance on the records, Id.

In this case, the State apparently provided a box of iiivestigative records to its expert.

The expert formulated his opinions from the records and surmnaries were created from them.

The expert testimony and summaries were admitted into evidence over Appellants' objections

12

even though the box of records were not introduced into evidence, and Appellants were not

provided an opportunity to review the records and cross-examine the expert regarding his

reliance on them. The trial court recognized this error when it noted that the State's expert relied

on materials not admitted into evidence. Appx. C 10, D 10, E 10. "I'he Court of Appeals,

however, erred by completely ignoring this issue and reinstating the Board's decision.

Similarly, the Court of Appeals failed to consider that the record was replete with hearsay

and double hearsay. '1'he hearsay rule is relaxed in administrative proceedings, but an agency's

"discretion to consider hearsay evidence cannot be exercised in an arbitrary manner." Haley v.

Ohio State Dental Bd. (2nd Dist. 1982), 7 Ohio App.3d 1, 6. Erdelhohn v. Ohio State Bd. of

Phannac involved a case where, "if hearsay [was] not permitted before the pharmacy board,

then none of the charges [would have] been proven." (1987), 38 Ohio Misc.2d 1, 3. "The hearsay

involved the testimony of significant witnesses and the contents of essential documents." Id. at 4.

Based upon "[t]he virtually exclusive use of hearsay and inferences thereon," the trial court

concluded that the pharmacy board's consideration of hearsay was arbitrary. Id.

In this case, Gallagher was permitted to testify about multiple hearsay statements from

other pharmacists to claim that Appellants should have ceased filling PPMO prescriptions. He

ignored the fact that dozens of other pharmacists continued to fill PPMO prescriptions and no

action was taken against them. The State's expert testified entirely based on hearsay statements

and documents not in evidence to opine that Appellants should have stopped filling PPMO

prescriptions. Witliout the hearsay evidence, there would have had no evidence at all show

whether Appellants should or should not have ceased filling PPMO prescriptions, especially

since they eontinued to fill PPMO prescriptions after the Board threatened criminal prosecution

13

if they stopped filling PPMO prescriptions. The Board acted arbitrarily in admitting the hearsay

and the Court of Appeals erred by reinstating the Board's decision.

Proposition of Law No. IV: Prior to August 30, 2007, the vote of at least fivemembers of the State Board of Pharmacy was required to constitute a majoritydecision to revoke the license of a pharmacist.

At the time of the hearing in 2006, R.C. 4729.17 provided that any finding or order of a

member or members of the board "shall be deemed to be the order of said board wlien approved

and confirmed by a majority of' the board" The Board is comprised of nine members, eight

licensed pharmacists and one member of the public. R.C. 4729.02. In Abukhali v. Ohio State

Bd. of Pharmacy, the Board voted in a four to three split decision to revoke a pharmacist's

licensc. 8th Dist. No. 86129, 2006 Ohio 176. One member abstained and the president did not

vote because the president "does not vote on matters unless there is a tie in the vote." ld. at ¶18,

citing R.C. 4729.03. Since the Board was conrprised of nine nrembers, the court reversed

because "it is patently clear that a majority constitutes at least five members" Id.

Similarly, the Board's Dennis decision was a four to three split decision with one

member and the president not voting. The Board failed to follow its own hearing procedures by

revoking Dennis' license without a majority vote. Accordingly, the Board violated Dennis' riglit

to procedural due process and the Court of Appeals erred in reinstating the decision.

Proposition of Law No. V: A court of appeals errs by reweighing the evidence whenconsidering a trial court's affirmation or reversal of an administrative agency'sdecision and making no specific finding regarding how the trial court abused itsdiscretion.

'fhis Court has addressed an appellate court's role in an administrative appeal, which "is

more limited than that of a trial court reviewing the sanre order." Bartchy v. State Bd. of Edu.

(2008), 120 Ohio St.3d 205, 212. An appellate court is not charged with reexamining the

evidence; it "is to determine only if the trial court has abused its discretion." Id. "An abuse of

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discretion implies not merely error of judgment, but perversity of will, passion, prejudice,

partiality, or moral delinquency." Id, at 213. "[W]hen much of the evidence and factors for

consideration offered by each side are questionable, inconsequential, and in dispute" a trial court

is "justified in either affinning or reversing the order of the state board." Id. at 225. In such case,

"[i]t is not the role of an appellate court...to reweigh the evidence." Id.

In this case, the Court of Appeals exceeded its limited duty to review the trial court's

decision for an abuse of discretion. The Court of Appeals recognized that the trial court made

factual determinations based upon the record. Further, it is clear the Court of Appeals did not

find that the trial court relied upon matters that were not in the record. The Court of Appeals'

neither discussed the trial court's rationale for discrediting the testimony of the State's witnesses,

nor how the trial court showed perversity of will, passion, prejudice, partiality or moral

delinquency. The Court of Appeals simply disagreed with the trial court's review of the evidence

and substituted its judgment for that of the trial court based upon its own de novo review of the

record in ten pages of its Decision. Appx. A 3-13. For this reason, the Court of Appeals'

decision should be reversed.

CONCLUSION

For the reasons discussed above, this case involves matters of public and great general

interest and substantial constitutional questions. "I'he Appellants request that this Court accept

jurisdiction in this case so that the important issues presented will be reviewed on the merits.

Respectfullyr s

OUNSEL FOR APPELLANTS,SCP, INC., MICHAEL T'. DENNIS, R.PH.AND AMY L. FROMAN, R.PII.

15

PROOF OF SERVICE

I certify that a copy of the foregoing was sent by ordinary U.S. mail to counsel forAppellee, Richard Cordray, Attorney General, and Tracy M. Greuel, Assistant Attorney General,30 E. Broad Street, 26`h Floor, Columbus, OH 43215 on March-c;, 29)0.

.7

.COUNSEL FOR APPELLANTS,SCP, INC., MICHAEL T. DENNIS, R.PH.,AND AMY L. FROMAN, R. PH.

1':\Sandrock\Dennis, Miohael\Sta[e Pharmacy Board Issue\Supreme ConttAppeal\Mernornndutn in Support of Jurisdiction(filcd).doc

16

COURT OF APPEALSTUSCARAWAS COUNTY, OHIOFIFTH APPELLATE DISTRICT

SCP, INC. dba STRASBURG . JUDGES:PHARMACY,And : Hon. W. Scott Gwin , P.J.MICHAEL T. DENNIS, R. PH., . Hon. Julie A. Edwards, J.And . Hon. Patricia A. Delaney, J.AMY LYNN FROMAN, R. PH.,

Plaintiffs-Appeilees : Case Nos. 2008 AP 10 0063,2008 AP 10 0064 and 2008 AP 10 0065

-vs-

OHIO STATE BOARD OF PHARMACYDefendant-Appellant

OPINION

CHARACTER OF PROCEEDING: Administrative Appeals from theTuscarawas County Court of CommonPleas Case Nos.2007-AA-01-0041, 2007-AA-01-0042 and2007-AA-01-0055

JUDGMENT: ^, FfLED^th District Court of App"ERSEDTuscarawas Co., Ohio

DATE OF JUDGMENT ENTRY:

APPEARANCES:FFB 10 2010

ROCKNE W. CLARKE

For Appellees SCP and DennTsiP rk of Courts For Appellant:

SCOTT P. SANDROCK75 East Market StreetAkron, Ohio 44308

For Appellee Froman:DOUGLAS E. GRAFF604 East Rich StreetColumbus, Ohio 43215

RICHARD CORDRAYAttorney General of OhioSALLY ANN STEUKAssistant Attorney General77 South High Street, Room 1702Columbus, Ohio

Appx. A-1

Tuscarawas Cty. App. Case Nos. 2008 AP 10 63, 2008 AP 10 64, & 2008 AP 10 65 2

Delaney, J.

{11} Appellant Ohio State Board of Pharmacy ("Board") appeals three

judgment entries of the Tuscarawas County Court of Common Pleas, all filed on

September 4, 2008, which reversed and vacated the Board's disciplinary action taken

against the pharmaceutical licensure of Appellees SCP, Inc., dba, Strasburg Pharmacy

(Case No. 2008 AP 10 0063), Michael T. Dennis, R.Ph. (Case No. 2008 AP 10 0064)

and Amy Lynn Froman, R. Ph. (Case No. 2008 AP 10 0065).

{¶2} Because the three cases involve the same facts and the identical

assignments of error, they shall be addressed together.

STATEMENT OF THE FACTS AND CASE

{'(I3} Michael Dennis is the owner and responsible pharmacist at Strasburg

Pharmacy, a small independent pharmacy located in Strasburg, Ohio. Amy Lynn

Froman is a staff pharmacist at Strasburg Pharmacy. Strasburg Pharmacy is a

Terminal Distributor of dangerous drugs under the supervision of Dennis. Dennis,

Froman and Strasburg Pharmacy were duly licensed by the Board pursuant to R.C.

Chapter 4729, which governs the practice of pharmacy in the State of Ohio.'

{¶4} On July 19, 2005, the Board issued separate Notices of Opportunity for

Hearing to Appellees. Each Notice was 359 pages long, consisting of 1510 paragraphs

alleging wrongdoing. Paragraphs 1 through 755 of the Notice alleged that each

Appellee: "did...knowingly sell, conspire to sell, andlor aid and abet the sale of a

controlled substance when the conduct was not in accordance with Chapter 3719.,

4729., and 4731. of the Ohio Revised Code, to wit: [Appellees] sold the following

' In addition to the statutes, a pharmacist's responsibilities are detailed in regulations found in OhioAdministrative Code ("OAC") Chapter 4729-5 and the Board's Compliance Bulletins.

Appx. A-2


controlled substances to [the listed patients] when not for a legitimate medical purpose

issued by a prescriber acting in the usual course of his professional practice and in

compliance with the administrative code rules addressing pain management and

violating Rule 4729-5-30 of the Ohio Administrative Code and 21 CFR 1306.04. Similar

violations were alleged in Paragraphs 756 through 1510 of the Notices, except the

charges in these paragraphs involved dangerous drugs.

{¶5} An administrative hearing on the charges commenced on November 6,

2006 before the Board. At the beginning of the hearing, the State, without objection,

orally requested the removal of thirty-two paragraphs from each Notice. The motion was

granted by the Board.

t16} The following evidence was adduced at the hearing, which was held over

four days.

(¶7) At the hearing, David Gallagher, a compliance agent with the Ohio State

Board of Pharmacy, testified that in February of 2003 he began receiving reports from

several retail pharmacists in Tuscarawas County about unusual prescription drug

activity. Agent Gallagher testified that he leamed from the pharmacists that in late

2002, a Dr. Edward DeHaas came to New Philadelphia and opened a pain clinic known

as Professional Pain Management of Ohio ("PPMO"). The clinic was located near the

off-ramps for Interstate 77. Prior to opening the clinic, Dr. DeHaas sent out mass

mailings in Kentucky, West Virginia, and Ohio announcing his opening. He also visited

area pharmacies to introduce himself and provided the pharmacy with a letter explaining

the nature of his practice. The letter states, "most of our patients come to us as a last

resort, with chronic pain which has not responded to surgical intervention, physical

Appx. A-3


therapy, or other forms of treatment." Previously, Dr. DeHaas operated a pain

management clinic along the Ohio River.

{¶8} Agent Gallagher testified that between mid and late February of 2003, he

started receiving telephone calls complaining about PPMO and Dr. DeHaas's

prescriptions. According to Agent Gallagher, four of the calls came from area

pharmacies in New Philadelphia indicating, "they were concerned about the practice,

the fact that the practice was presenting so many prescriptions for patients who were

receiving all the same type of medications, hydrocodone 10 products and carisoprodot

350 milligrams. They were upset or concemed that the patients were coming in groups,

multiple patients in the same vehicles, they were concerned because these patients

were coming from such long distances in these vehicles, from the Kentucky, West

Virginia area, is what I was told. And they wanted to make me aware of these concerns

and what they were seeing and that they wanted - I think maybe one or two may have

said something about getting - that I need to look into it. These were red flags that they

were bringing up to me. Some of them even addressed it in that way." Hearing

Transcript ("T.") at 31.

{¶9} As a result of his surveillance of the pain clinic, Agent Gallagher learned

that customers of the clinic were predominately going to two different pharmacies, one

of them being Strasburg Pharmacy, which was a 20-minute drive north of PPMO, just

off Interstate 77.

{¶10} Agent Gallagher testified that he went to Strasburg Pharmacy on

December 1, 2003 to gather prescription data on prescriptions from PPMO. When he

arrived, approximately 20 PPMO patients were waiting in line for prescriptions. Fie

Appx. A-4


found on the front counter area numerous bottles of pre-packaged hydrocodone 10mg

(also known as Lortab or Lorcet), an opioid derivative pain reliever, and carisoporodal

350mg (also known as Soma or Vicodin), a muscle relaxer, and "an incredible large

stock supply" of the drugs. T. at 46, State's Exhibit 6. He discovered that the pharmacy

had filled quite a few of the PPMO prescriptions, and had created pre-printed

prescription blanks in order to make it quicker to dispense PPMO drug orders that were

being telephoned in by PPMO doctors. T. at 58.

{911} Upon reviewing the pharmacy records, Agent Gallagher testified that there

were upward of 1,800 PPMO patients that received prescriptions from Strasburg

Pharmacy. He discovered that the vast majority of patients were coming from Kentucky

(1700 patients) and West Virginia (88 patients) and traveling 8 to 12 hours round-trip for

their prescriptions. Appellees began filling PPMO prescriptions in March with 31

prescriptions and increasing each month thereafter to 3,308 prescriptions in October. in

less than nine months, the pharmacy had dispensed in excess of 900,000 doses of

hydocodone 10mg and in excess of 400,000 carisoprodol 350mg doses.

{112} Exhibit 21, which was compiled from data from the Drug Enforcement

Administration, showed that, in 2003, Strasburg Pharmacy was the largest retail

purchaser of hydrocodone 10mg tablets in the State of Ohio, with 984,600 dosage

products.

{¶13) Agent Gallagher testified that the total profit after wholesale costs made

by the pharmacy to be in excess of $380,000 for the hydrocodone and carisoprodal

prescriptions. T. at 65.

Appx. A-5


{¶14) When asked why the citation issued to Appellees only contained

approximately 730 patients, Agent Gallagher responded as follows:

{115) "THE WITNESS: I was asked to use the profiles of individuals that met a

a duration of therapy that's talked about as being beyond, or for a period of time of 12

weeks; that is talked about in the Medical Board's Intractable Pain Rule," T. at 62.2

{¶16) Agent Gallagher was questioned about the four different pharmacies that

contacted him in February of 2003 with concems about PPMO. Notarized written

statements from the area pharmacists were admitted as State's Exhibits 2, 3, 4 and 5.

Ted Nussbaum with Discount Drug Mart, in his statement (Exhibit 2) stated that he had

concerns over numerous patients asking for specific color or tablets Discount Drug had

and stated that he "felt this was a sure sign of problems because drug seekers or sellers

usually know what they are looking for." He also voiced concerns over the fact that the

patients were coming a long way. Nussbaum stated that he told Dr. DeHaas that he

would have to handwrite his prescriptions in the proper formal rather than call them in

and that Dr. DeHaas gave him a hard time.

{¶17) Brad White, a pharmacist with the Medicine Shoppe, staled in his

notarized statement (Exhibit 3) that he was concerned that all of PPMO patients were

receiving the exact same drugs in the same strength and under the same directions;

that they were from out of state and that he was repeatedly asked by patients for the

' By way of background, intractable or chronic pain is defined as "a state of pain that is determined, afterreasonable medical efforts have been made to relieve the pain or cure its cause, to have a cause forwhich no treatment or cure is possible or for which none has been found. R.C. 4731.052(A). The staternedical board t as established standards and procedures to be followed by physicians in the diagnosisand treatment of intractable pain, including standards for prescribing dangerous drugs in amounts andcombinations that may not be appropriate when treating other medical conditions. R.C. 4731.052(8).These standards are more fully discussed later in this Opiriiori.

Appx. A-6


"blues." He also noted that he observed more than one patient arrive in the same car.

The Medicine Shoppe only filled 15 prescriptions before refusing to fill any more.

{118} Janine O'Neill, also a pharmacist with the Medicine Shoppe, stated in her

notarized statement (Exhibit 4) that shortly after she began filling PPMO prescriptions

she noticed that two of Dr. DeHaas's patients were from Kentucky and rode together in

the same car and getting the same two medications filled (Lorocet and Soma). She

stated: "This is when I expressed to Brad (pharmacy mgr) that something isn't right and

did not feel comfortable filling his prescriptions. Then more prescriptions came in from

patients with KY addresses and that was it for me. Brad called the Board with his

concerns and we stopped filling his prescriptions."

{¶19} Dana Coutts, a pharmacist at Wal-Mart, was the first pharmacist to contact

Agent Gallagher in February, 2003. Her concerns were detailed in a notarized

statement to the Board (Exhibit 5) and Agent Gallagher summarized those as follows:

{¶20} "THE WITNESS: One of the things that stood with her was that they were

frequently calling the doctor's office to try and get diagnoses and understand what was

causing the doctor's office to prescribe these drugs for these individual patients. She

stated that they were also getting, as detailed as possible, patient histories and, as a

result, the patients were getting very upset that they were being questioned and talked

to, or asked any questions. And she also stated that she had argued with Dr. DeHaas

(sic) on the telephone. '"* She did talk eariy on, in February, about the patients

coming in groups, primarily the same type of red-flag complaints. The one that stood

out at the time to me was she - her contact, just like Pharmacist Nussbaum, that they

Appx. A-7


had contacted the Doctor and run into a less than - a situation where the Doctor didn't

want to listen to them."

{¶21} Gallagher also established that although the Board has compliance

agents who review pharmacists' records, drug storage, and files, these agents are not

pharmacists3 and therefore lack the power to decide whether there is a legitimate

purpose for a given prescription. T. at 148, 151-152. Accordingly, the Board relies

upon voluntary compliance from pharmacists.

{¶22} Appellee Dennis was interviewed by the Board's compliance agents at the

Strasburg Pharmacy on December 1, 2003 and the interview was audio taped,

transcribed and admifted as State's Exhibit 11. Pursuant to R.C. 4729.19, a pharmacist

"shall cooperate with federal, state, and local government investigations and shall

divulge all information when requested by a government agency." During his interview,

Dennis indicated that all the pre-packaged Lorcet and Soma was for Dr. DeHaas's

patients and that was done to get PPMO patients, who seemed to come in a "surge,"

out of the store quicker because they were shoplifting. Dennis Transcript ("D.T.") at 22-

23. Dennis also stated he was raising the prices on PPMO prescriptions by $10 to $20

to "get some of them not to come here" and provided written notice of the price

increases to the customers on November 1 st. D.T. at 23-24, 41. He noted the majority

paid cash and since none of the PPMO patients ever had any questions about their

prescriptions, the pharmacists did not offer to counsel them. Furthermore, Dennis

stated that if a patient refuses counseling, the store failed to document it, which Dennis

recognized was a legal requirement. Almost all PPMO customers used generic, as

3 Agent Gallagher has been employed as a Board compliance agent for 14 years and formerly was apolice officer for Jackson Township, Stark County for 9 years.

Appx. A-8


opposed to name brand, and knew and requested certain color pills such as blue and

green, which Dennis noted on the patient prescription and profile. D.T. at 37-38.

{¶23} Dennis stated he did research into pain management and felt that Dr.

DeHaas's treatment followed the Medical Board's preference for treatment of intractable

pain, which he understood to be pain that can't be cured and which may not have a

specific cause. D.T. at 43-44. However, he did not consider PPMO customers to be

intractable pain patients. Id. He further stated that 100% of Dr. DeHaas's patients

received either hydrocodone or Soma or both and that these customers accounted for

approximately 50% of the pharmacy's prescriptions prior to the notice of the price

increase. He noted it was "odd" that a single person would pay for two or three people's

prescriptions and asked Dr. DeHaas about it, who explained that these patients have a

"handler." He stated it was very rare for other doctors to write prescriptions for Lorcet or

Soma. D.T. at 77. Dennis stated that the pain treatment regime by Dr. DeHaas was all

the same, only the doses varied, he thought, according to the patient's size and their

level of pain. D.T. at 80. He understood that ihese patients did not have much money

and couldn't afford more expensive medicine and got the feeling that Dr. DeHaas was

trying to keep the price affordable with using something he thought would work.

{¶24} Furthermore, Dennis stated he had not experienced other pain

management centers prescribing all the same drug nor had he ever worked at a

pharmacy were he prepared vials of prescription drugs beforehand. D.T. at 103-104.

He also told the investigators that Froman, who worked about 26 hours a week at the

pharmacy, did not indicate to him that she had any major concems or problems with

filling PPMO prescriptions. D.T. at 121.

Appx. A-9

Tuscarawas Cty. App. Case Nos. 2008 AP 10 63, 2008 AP 1064, & 2008 AP 10 65 10

{¶25} At the hearing, Agent Gallagher testified that he also spoke with Froman

on December 4, 2003 and audiotaped the interview, which was transcribed and

admitted at the hearing. State's Exhibit 12. Froman stated that Dr. DeHaas visited the

pharmacy and others to get the lowest price for his poor patients and subsequently told

her the pharmacy was the lowest. However, she revealed that the mark-up charged to

PPMO patients was "quite gouging," for example the markup for Soma was $26.50,

compared to the store's usual $10 over cost, and she "wouldn't do that to my normal

customers." Froman Transcript at 14-18.

{¶26} PPMO was closed down on December 16, 2003, after the execution of a

search warrant.

{¶27} At the Board's administrative hearing, Robert Kubasak, a registered

pharmacist with the State of Ohio who owns two pharmacies, testified as an expert on

behalf of the State. He testified that has been a licensed pharmacist since 1973 and

was qualified as an expert in the area of pharmacy. Kubasak testified that he was

asked by the Board to review records and material involving Strasburg Pharmacy and

Appellees. He testified that he was given a printout of all the prescriptions for the year

2003 as well as patient profiles.

{¶28} According to Kubasak, pharmacists are not required to fill the prescriptions

submitted to them. T. at 305. Rather, they must determine whether a prescription

should be filled in light of any contraindications for the drug and whether there is a

legitimate medical purpose for its use. Id. at 292, 305. The "corresponding

responsibility" is discussed in various newsletters issued by the Board that set forth

dispensing guidelines to assist pharmacists in exercising their professional judgment as

Appx. A-10


to whether a prescription should be filled. Moreover, absent a legitimate medical reason

for its use, a prescription is a"false" prescription and a pharmacist dispensing such a

purported prescription is subject to the penalties of law. See, OAC 4729-5-30.

{¶29} The regulatory scheme reflects that pharmacists are the last safety check

before a drug reaches a customer, and they therefore have the ultimate responsibility in

determining that there is a legitimate purpose for the medication. Specifically, Kubasak

discussed patients being treated for intractable pain. He discussed the State Medical

Board regulation, OAC 1731-21-02, which governs the utilization of prescription drugs

for the treatment of intractable pain. The regulation requires an individualized treatment

plan with prescription drug therapy plan "tailored to the individual medical needs of each

patient." ld. He also stated a pharmacist would know that the intractable pain regulation

requires an individualized treatment plan. T. at 291. Kubasak opined that PPMO was

not in compliance with this regulation because 80 to 90 percent of PPMO patients were

receiving the exact same medications for long-term use and the dosages were

escalating, not decreasing. T. at 289-290.

{¶30} Kubasak further explained that a pharmacist must follow OAC regulations

which requires a pharmacist to: (1) obtain patient data and drug therapy record for a

patient profile, OAC 1729-5-18; (2) review that patient profile prior to dispensing any

prescription for the purpose of identifying over-utilization or abuse/misuse, OAC 1729-5-

20; and (3) personally offer to provide the service of counseling for any prescription,

new or refill, and when counseling is refused, the pharmacists shall ensure the refusal is

documented in the patient's or caregiver's presence, OAC 1729-5-22.

Appx. A-11


{¶31} In this case, Kubasak opined the Appellees failed to exercise their

professional judgment as follows:

{132} "The sheer volume of numbers; the patients traveling long distances,

everybody getting the same medication. Unbelievable that everybody would get the

same medication. Patients paying for it with large dollar amounts; handlers coming in,

people coming in to handle them or bring them into the pharmacy. Again, the distances

are just, that bothers me immensely." T. at 306.

{¶33} He further stated:

{¶34} "My conclusion was that they both, Froman and Pharmacist Dennis, not

only deviated from acceptable standards of practice, but that they continuously and

repeatedly did so by continuing to dispense the prescriptions on a daily basis to Dr.

DeHaas. If there's any kind of professional judgment, if there's any kind of professional

judgment, if they had thought of anything or even looked at this, it would have lead any

reasonable pharmacist to conclude that these were not for a legitimate medical

purpose. And that they should have questioned every prescription that came in. I think

they both failed to fulfill their Corresponding Responsibility as pharmacists. And as far

as that goes, they totally failed to do it. That is my opinion. " T. at 308.

{¶35} Both Dennis and Froman testified at the hearing that they never refused to

fill any PPMO prescriptions because Dr. DeHaas was a licensed physician in good

standing and it appeared to them that his treatment was consistent with the intractable

pain rule based upon information provided by Dr_ DeHaas. Dennis further testified that

the store profits from PPMO business went to pay down his business and personal

Appx. A-12

Tuscarawas Cty. App. Case Nos. 2008 AP 10 63, 2008 AP 10 64, & 2008 AP 1065 13

loans, and purchase store stock. Appellees did not present any expert testimony on

their behalf.

{¶36} Pursuant to separate Orders mailed on January 11, 2007, the Board

revoked the terminal distributor license of Strasburg Pharmacy, but suspended the

revocation provided there are no similar violations within the next year; permanently

revoked Dennis' pharmacist license and suspended Froman's pharmacist license for a

period of three years.

{¶37} In the Orders, the Board stated, in relevant part, as follows:

{¶38} "The Board is cognizant that both rule 4729-5-21 (formerly embodied in

rule 4729-5-30) of the Ohio Administrative Code and Section 1306.04 of Title 21 of the

Code of Federal Regulations state that a pharmacist has a corresponding responsibility

with the prescriber to ensure that a prescription is issued for a legitimate medical

purpose by a licensed prescriber in the usual course of professional practice. This is

axiomatic in the pharmacy profession. This means that a pharmacist must review every

prescription for legitimacy and must then make a professional judgment on whether or

not to fill the prescription. Every pharmacist is accountable to this Board and to society

for what he knew or should have known due to professional training, experience,

licensure, and continuing pharmacy education in pharmacy law. Obviously, the

dispensing pharmacist need not review the prescriber's patient chart; rather, the

required judgment to be exercised must be based upon the pharmacist's extensive

knowledge and training in drug therapy, the pharmacist's knowledge of the patient

(obtained through profile information required by rule 4729-5-18 of the Ohio

Administrative Code, a review of that profile as required by rule 4729-5-20 of the Ohio

Appx. A-13


Administrative Code, and other discussions with the patient pursuant to rule 4729-5-22

of the Ohio Administrative Code), and the pharmacist's knowledge of the prescriber's

practice, particularly as it elates to other similar practices in the region.

{¶39} "This pharmacist shirked [his/her] responsibilities in this regard, ignoring

numerous obvious indicators of illegal prescribing activity on the part of the physicians

involved in this case. Some of these indicators include the large numbers of patients

who drove very long distances to come to these physicians and this pharmacy and the

almost identical treatment of a problem (pain) that requires individualization for

treatment dosages and drugs more than any other health-related problem.

Individualized treatment for pain is required in all aspects of health care and is

specifically stated in rule 4731-21-02 of the [OAC], yet was clearly ignored by this

phaimacist. Moreover, it is significant that practically all of the patients from these

prescribers paid cash for their prescriptions instead of using insurance as is usually the

case for the overwhelming percentage of prescriptions filled today. It is clear that this

pharmacist consciously ignored his obligations to the patients simply for monetary gain."

(¶40) Strasburg Pharmacy (Common Pleas Case No. 2007 AA 01 0041),

Dennis (Common Pleas Court Case No. 2007 AA 01 0042) and Froman (Common

Pleas Case No. 2007 AA 01 0055) then appealed to the Tuscarawas County Court of

Common Pleas. Pursuant to judgment entries, filed on September 4, 2008, the trial

court reversed and vacated the Board's Orders in each case, finding that they were not

supported by reliable, probative and substantial evidence.

{¶41} The Board timely appealed all cases, and raises the same assignments of

error in each case:

Appx. A-14

Tuscarawas Cty. App. Case Nos. 2008 AP 1063, 2008 AP 1064, & 2008 AP 10 65 15

{¶42} "I. THE LOWER COURT ERRED WHEN IT FOUND THAT THE BOARD'S

ORDER WAS NOT BASED UPON RELIABLE, PROBATIVE AND SUBSTANTIAL

EVIDENCE. THE COURT FAILED TO GIVE DUE DEFERENCE TO THE BOARD'S

FINDINGS AND CONCLUSIONS.

{¶43} "II. CONSIDERATION BY THE LOWER COURT OF WHETHER OTHER

PHARMACIES OR PHARMACISTS WERE ISSUED ADMINISTRATIVE CITATIONS

BY THE BOARD WAS PREJUDICAL AND AN ABUSE OF DISCRETION.

APPELLANT'S FOURTEENTH AMENDMENT RIGHTS WERE NOT VIOLATED.

(TRIAL COURT'S JUDGMENT ENTRY, SEPTEMBER 4, 2008, P. 9).

{¶44} "III. THE LOWER COURT ERRED AND ABUSED ITS DISCRETION IN

FINDING THE TESTIMONY OF THE EXPERT WITNESS DID NOT CONSTITUTE

RELIABLE, PROBATIVE AND SUBSTANTIAL EVIDENCE. (TRIAL COURT'S

JUDGMENT ENTRY, SEPTEMBER 4, 2008 P. 10).

{145} "IV, THE LOWER COURT ABUSED ITS DISCRETION IN FAILING TO

FAIRLY CONSIDER THE FACTUAL AND EVIDENTIARY CONCLUSIONS OF THE

BOARD, AS INDICATED BY THE LANGUAGE AND STATEMENTS USED AS ITS

JUDGMENT ENTRY OF SEPTEMBER 4, 2008. (TRIAL COURT'S JUDGMENT

ENTRY, SEPTEMBER 4, 2008, P. 1-13)."

I, III

{¶46) The Board's first and third assignments of error present interrelated issues

and will be addressed together.

(¶47) In the first and third assignments of error, the Board argues that the trial

court erred when it found that the Orders were not based upon reliable, probative and

eQppaco A-15


substantial evidence. Specifically, the Board asserts the trial court erred in finding the

testimony of Gallagher and Kubasak was not reliable, probative or substantial. We

agree.

{¶48] In Clay v. Licking Cty. Prosecutor, 5th Dist. No. 02CA00011, 2002-Ohio-

4243, we stated in relevant part as follows: "In an administrative appeal pursuant to

R.C. 119.12, the trial court reviews an order to determine whether it is supported by

reliable, probative and substantial evidence and is in accordance with the law. Reliable,

probative and substantial evidence has been defined as: (1) 'Reliable' evidence is

dependable; that is, it can be confidently trusted. In order to be reliable, there must be a

reasonable probability that the evidence is true. (2) 'Probative' evidence is evidence that

tends to prove the issue in question; it must be relevant in determining the issue. (3)

'Substantial' evidence is evidence with some weight; it must have importance and value.

Our Place, Inc. v. Ohio Liquor Control Comm. (1992), 63 Ohio St.3d 570, 571, 589

N.E.2d 1303.

{¶49} "On appeal to this Court, the standard of review is more limited. Unlike

the court of common pleas, a court of appeals does not determine the weight of the

evidence. Rossford Exempted Village School Dist. Bd. of Edn. v. State Bd. of Edn.

(1992), 63 Ohio St.3d 705, 707, 590 N.E.2d 1240. In reviewing the trial court's

determination [whether] the Board of Review's order was supported by reliable,

probative and substantial evidence, this Court's role is limited to determining whether

the trial court abused its discretion. Roy v. Ohio State Med. Bd. (1992), 80 Ohio App.3d

675, 680, 610 N.E.2d 562. The term 'abuse of discretion' connotes more than an error

of law or judgment; it implies that the court's attitude is unreasonable, arbitrary or

Appx. A-16


unconscionable. Blakemoro v. 8lakemore (1983), 5 Ohio St.3d 217, 219, 450 N.E.2d

1140." Id. at ¶ 9, ¶ 10. An abuse of discretion shows "perversity of will, passion,

prejudice, partiality, or moral delinquency." Pons v. Ohio State Med. Bd. (1993), 66 Ohio

St.3d 619, 621.

{¶50} The Board, in revoking Dennis' license and suspending Froman's license,

concluded that the pharmacists were guilty of gross immorality as provided in R.C.

4729.16(A)(1), of unprofessional conduct in violation of R.C. 4729.16(A)(2), and of

willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the

violation of provisions of Chapters 2925 [drug offense) and 3719 [controlled substances]

of the Revised Code in violation of R.C. 4729.16(A)(5).

{¶51} For ease of discussion, this Court will simultaneously address the

evidence pertaining to all transgressions allegedly committed by Appellees under each

of the above divisions of R.C. 4729.16(A).

{¶52} There is sparse Ohio case law regarding the scope of a pharmacist's

"corresponding responsibility" to properly dispense prescription medicine; however,

federal courts have developed substantial case law in the context of criminal

prosecutions under the federal Controlled Substances Act, 21 USC 841, and

implementing regulations, including 21 CFR 1306.04 which is virtually identical to the

mandate of OAC 4729-5-30(A) and governs all pharmacists licensed in Ohio.

{¶53} OAC 4729-5-30(A) states, in relevant part: "A prescription, to be valid,

must be issued for a legitimate medical purpose by an individual prescriber acting in the

usual course of hislher professional practice. The responsibility for the proper

prescribing is upon the prescriber, but a corresponding responsibility rests with the

Appx. A-17


pharmacist who dispenses the prescrlption. An order purportinq to_be a prescri ption

issued not in the usual course of bona fide treatment of a patient is not a prescription

and the person knowingly dispensing such a purported prescription as well as the

person issuing it shall be subiect to the penatiies of law." (Emphasis added).

{¶54} In two recent cases decided by the U.S. Court of Appeals for the Fifth

Circuit, the court noted that hydrocodone and carisoprodol have a high abuse potential

and a high illegal street market value, and are dispensed by "pain management" clinics,

some of which operate within the bounds of the law and serve a valuable medical

purpose, but "others flood the streets with dangerous, addictive narcotics while

preserving some trappings of lawful medical practice." U.S. v. Brown, 553 F.3d 768,

773 (5th Cir. 2008); U.S. v. Armstrong, 550 F-3d 382, 386 (5th Cir. 2008). In both

cases, the convictions of pharmacists, pharmacies and doctors for violations of the

federal Controlled Substances Act were upheld when these drugs were not prescribed

legitimately at pain management cfinics."

{¶55} In addition, the U.S. Court of Appeals for the Sixth Circuit recently

discussed the meaning of "corresponding responsibility" as set forth in 21 C.F.R.

1306.04(A), as follows: "The regulation thus requires 'pharmacists [to] use common

sense judgment,' which includes paying attention to the 'number of prescriptions issued,

the number of dosage units prescribed, the duration and pattern of the alleged

treatment,' the number of doctors writing prescriptions and whether the drugs

prescribed have a high rate of abuse. Ralph J. Bertolino Pharmacy, lnc., 55 Fed.Reg. 4,

729, 4,730 (DEA Feb.9, 1990). 'When [pharmacists'] suspicions are aroused as

4 Likewise, Dr. DeHaas was indicied for federal drug offenses, pled guilty and was imprisoned.

A,519x. Q-'i 8


reasonabte professionals,' they must at least verify the prescription's propriety, and if

not satisfied by the answer they must 'refuse to dispense.' Id. see also, United States v.

Henry, 727 F.2d 1373, 1378-79 (5th Cir. 1984)." Medicine Shoppe-Jonesborough v.

DEA, 300 Fed. Appx. 409, 412, 2008 WL 4899525 (C.A.6).

{¶56} Based on the foregoing, we find that the trial court abused its discretion in

reversing and vacating the Board's Orders with respect to Appellees based on the

volume of evidence presented at the Board hearing that Appellees ignored the red flags

that were waving in front of them -- the same red flags that caused other pharmacists to

voluntarity cease dealing with PPMO. Newsletters issued by the Board to its

pharmacists discussed the "corresponding responsibility" of a pharmacist and the

factors to consider in determining whether a prescription was ►egal: whether the patient

resided within the area, whether significant numbers of persons appeared with

prescriptions for the same drugs from the same prescribers, and whether the

pharmacy's purchases of controlled substances increased dramatically_

{¶57} As is discussed in detail above, there was testimony that Appellees were

aware that large numbers of PPMO patients were traveling long distances from as far

away as Kentucky and West Virginia. Testimony also was adduced that the patients,

regardless of age, etc., primarily received the same two medications and paid in cash,

which was highly unusual. The pharmacists also admitted that PPMO patients asked

for specific colors of pills. In addition, testimony was adduced at the hearing as to the

dramatic increases in the number of monthly PPMO prescriptions.

{¶58} Expert testimony indicated the pharmacists abdicated their professional

responsibility by indiscriminately selling the same controlled substances to people again

Appx. A-19

Tuscarawas Cty. App. Case Nos. 2008 AP 1063, 2008 AP 10 64, & 2008 AP 10 65 20

and again, at a significantly increasing rate, and in cash. The volume of prescriptions

filled for a single medical practice, as well as the prices charged by Appellees, support

the Board's conclusions that Appellees knew that the prescriptions were not issued for a

legitimate medical purpose.5 One of the reasons for requiring that a pharmacist not

dispense controlled substances for other than a medical purpose is to place the

responsibility upon the trained professional, rather than the layperson, to prevent abuse

and potential for drug trafficking.

(¶59} We find the trial court's decision was arbitrary, unconscionable and

unreasonable in view of the totality of evidence and in according proper respect for the

expertise of the Board.

{¶60} The first and third assignments of error are sustained.

II.

{161} In its second assignment of error, the Board contends the trial court

abused its discretion by inferring in its decision that Agent Gallagher and the Board

selectively prosecuted Appellees.

{¶62} In this regard, the trial court indicated Agent Gallagher's "testimony fails to

explain why, if none of the prescriptions were legitimate, did he select some of the

5 Courts that have addressed the issue have indicated that medical testimony is nof necessary toestablish a prescription is issued outside the usual course of professional treatment. See, U.S.

v. Lovern,

•- F.3d ---. 2009 Wb 2871538 (10th Cir. 2009)(upholdin 9^o a wt pharmacistlegal duty not to knowingly fillof other pharmacists and DEA investigator because, g pharmacist'sprescriptions issued outside the usual course of medical practice under 21 C.F.R. 1306.04(A),'St does notstrain the imagiriation to think that some pharmacists might know and be qualified to speak about what itmeans for a prescription to be consistent or inconsistent with the usual course of medical practice.")

See also, Armstrong, supra at 388-389; U.S. v. Hayes, 595 F.2d 258, 261, n.6 .(5th Cir. 1979) ("the facts

of this case show how a pharmacist can know the prescriptions are issued for no legitimate rnedicalpurpose without his needing to know anything about medical science "(5th Cir. 1979);

Jones v. State

(1985), 684 S.W.2d 223, 225, citing Hayes; Sloman v. Board of Pharmacy Examiners of the State of

Iowa, (1989) 440 N.W.2d 609, citing Hayes and Jones; State of Ohio v. Moss, 8th Dist. Nos. 623318,

62322 (May 13, 1993), citing Hayes.

AppX. A-20


pharmacists in his territory for prosecution, but not all of the pharmacists who filled

those prescriptions during the same time frame "

{¶63) It appears to this Court that the lower court believed Agent Gallagher's

testimony was not reliable or probative because he did not issue administrative citations

to each and every pharmacist who filled PPMO prescriptions, albeit at an extremely

lower volume than Appellees.

{¶64) "To support a defense of selective or discriminatory prosecution, a

defendant bears the heavy burden of establishing, at least prima facie, (1) that, while

others similarly situated have not generally been proceeded against because of conduct

of the type forming the basis of the charge against him, he has been singled out for

prosecution, and (2) that the government's discriminatory selection of him for

prosecution has been invidious or in bad faith, i.e., based upon such impermissible

considerations as race, religion, or the desire to prevent his exercise of constitutional

rights." W. Chester Twp. Bd. of Trustees v. Speedway Superamerica, LLC, 12th Dist.

No. CA2006-05-104, 2007-Ohio-2844, 150, citing State v. Flynt (1980) 63 Ohio St.2d

132, 134.

(¶65} As stated earlier, it was the sheer volume of illegitimate prescriptions

written by Appellees that formed the basis of underlying administrative action. There is

no evidence in the record that a pharmacy or pharmacists doing a comparable amount

of PPMO business were excluded from enforcement action by the Board.s Therefore,

° This Court also presided over the administrative appeals concerning Board citatioris issued to twopharmacists, Scott Vinci and Connie Campbell at Dusini Drug, another Tuscarwaras County pharmacy.Similar to the case sub judice, the Board also took action to suspend the licensure of the pharmacistsbased upon similar allegations involving PPMO prescriptions. About 1,581 PPMO patients filledprescriptions at Dusini Drug during the same 10 month period, similar in volume to Appellees.

Vinci v.

Ohio Stale Pharmacy Board, Case No. 2008 AP 08 0052; Campbell v. Ohio State Pharmacy Board, Case

No. 2008 AP 08 0053.

e4ppac. A-21

Tuscarawas Cty. App. CaseNos. 2008 AP 10 63, 2008 AP 10 64, & 2008 AP 10 65 22

we find it was in error for the trial court to consider the testimony of Agent Gallagher

unreliable or not probative on the basis of selective enforcement.

{¶66} The second assignment of error is sustained.

IV.

(¶67) The Board, in its fourth assignment of error, argues that the trial court

abused its discretion in failing to "fairly consider" the factual findings and conclusions of

the Board. It asserts that the language used by the t(al court in its decisions show that

the decisions were based upon passion, prejudice and partiality. The Board also

contends the trial court presented a "very one-sided and slanted view of the facts and

testimony presented to the Board" and failed to acknowledge the vast amount of

evidence against Appellees.

{¶68) Based upon our disposition of the other assignments of error, we find such

assignment of error to be moot.

Appx. A-22


{¶69} The judgment of the Tuscarawas County Court of Common Pleas is

reversed and we reinstate the Decisions and Orders of the Board issued against

Appellees.

By: Delaney, J.

Gwin, P.J. and -

Edwards, J. concur.

HON. PATRICIA A. DELANEY

HON. W. SCOTT GWIN

N. JULIE A. EDWARDS

Appx. A-23

tN THE COURT OF APPEALS FOR TUSCARAWAS COUNTY, OHIOFILED

FIFTH APPELLATE DISTRICT 5th District Court of Appeals

SCP, INC. dba STRASBURGPHARMACY,AndMICHAEL T. DENNIS, R. PH.,AndAMY LYNN FROMAN, R. PH.,

Plaintiffs-Appellees-vs-

OHIO STATE BOARD OF PHARMACY

Defendant-Appellant

Tuscarawas Co., Ohio

FEB 10 2010

ROCKNE W. CLARKEClerfc of Courts

JUDGMENT ENTRY

Case Nos. 2008 AP 10 0063,2008 AP 10 0064 and 2008 AP 10 0065

For the reasons stated in our accompanying Memorandum-Opinion on file, the

judgment of the Tuscarawas County Court of Common Pleas is reversed and the

Board's Decisions and Orders are reinstated. Costs assessed to Appellees.

HON. PATRICIA A. DELANEY

P-yl,

HON. W. SCOTT GWIN

N. JULIE A. EDWARDS

fAppx. B-1

FIC.f=OCC11JRf OF COMMUN Pt.EliS

TUSCARAWAS CCtIIN T Y OHIfI

! i00B SEP - 4 P 3: 58

ROCKNE W. CLARKECLERK OF COURTS

IN THE COURT OF COMMON PLEAS

TUSCARAWAS COUNTY, OHIO

GENERAL TRIAL DIVISION

SCP, INC. dba STRASBURGPHARMACY, Case Number: 2007 AA 01 004^

Appellant,

vs.

Judge Elizabeth Lehigh Thomakos

STATE OF OHIO, OHIO STATE JUDGMENT ENTRYBOARD OF PHARMACY

Appellee.

This niatter came before the Court for an Administrative Appeal, based upon the

Notice of Appeal Pursuant to Chapter 119 of the Ohio Revised Code filed by Michael T.

Dennis ("Appellant") on January 16, 2007.

The Court held a Hearing on April 4, 2008. Appellant was present in Court, by and

Page 1 of 13

Appx, C-1

through its president, Michael T. Dennis, R.Ph., and was represented by Attorney Scott P.

Sandrock. Appellee, State of Ohio, Board of Pharmacy ("Appellee"), was present in Court

through its General Counsel David Rowland, and was represented by Assistant Attorney

General, Sally Ann Steuk.

The Court heard the arguments of counsel relative to the following filed briefs:

January 31, 2008 Brief of Appellant, SCP, Inc., dba Strasburg Pharmacy

March 6, 2008 Brief of Appellee, Ohio State Board of Pliarmacy

March 26, 2008 Reply Brief of Appellant, SCP, Inc., dba Strasburg Pharmacy

The Court has also considered the record of the underlying hearing before the State

of Ohio Board of Pharmacy, in addition to the written and oral arguments of counsel.

The Court has read the Transcript consisting of 663 pages, which addressed the

Matters of Strasburg Pharmacy (Docket No. D-050719-004), Micliael T. Dennis, R.Ph.

(Docket no. D-05719-005) and Amy Lynn Froman, R.Ph. (Docket No. D-05719-006). The

Hearing commenced November 6, 2006.

The Court has reviewed the Order of the State Board of Pharmacy dated January

11, 2007. The Board notes that under Ohio and Federal Codes a pharmacist has a

corresponding responsibility with the prescriber to ensure that a prescription is issued for

a legitimate medical purpose by a licensed prescriber in the usual course of professional

practice. 'I'he Board states that a pharmadst must review every prescription for legitirnacy

Page 2 of 13

Appx. C-2

and must then make a professional judgment on whether or not to fill the prescription. 'fhe

Board opines that the SCP pharmacists shirked their responsibilities and ignored numerous

obvious indicators of illegal prescribing activity on the part of the physicians. The Board

further opined, "It is clear that these pharmacists consciously ignored their obligations to

the patients simply for monetary gain."

Board concludes that Appellant's actions or inaction, by and through its

pharmacists, constitute being guilty of violating any provision of Chapter 4729. of the

Revised Code as provided in R.C. §4729.57(A)(3) and of violating any provision of the

federal drug abuse control laws or Chapter 2925. as provided in R.C. §4729.57(A)(5).

The resulting unanimous decision was to revoke the Terminal Distributor license,

No. 02-1383200, held by Strasburg Pharmacy. The Board then ordered the suspension of

the revocation provided there are no similar violations within a year.

Standard of Review

R.C. §119.12 provides for an appeal to the Court of Coinmon Pleas from an order of

an agency by the party adversely affected by the order. Unless as otherwise provided by

law, in the hearing of the appeal, the court is confined to the record as certlfied to it by the

agency. R.C. §119.12 further provides that the court may affirm the order of the agency

Page 3 of 13

Appx. C-3

complained of in the appeal if it finds, upon consideration of the entire record, that the

Order is supported by reliable, probative, and substantial evidence, and is in accordance

with law. In the absence of this finding, it may reverse, vacate, or modify the order or

make such other ruling as is supported by reliable, probative, and substantial evidence and

is in accordance with law,

In OUT Place, Inc. v. Ohio Liquor Control Comm. (1992), 63 Ohio St.3d 570, 571, 589

N.E.2d 1303, the Suprenie Court of Ohio defined these terms, as follows:

The evidence required by R.C. 119.12 can be defined asfollows:

(1) "Reliable" evidence is evidence that is dependable; that

is, it can be confidently trusted. In order to be reliable,

there must be a reasonable probability that the evidence

is true.

(2) "Probative" evidence is evidence that tends to prove the

issue in question; it must be relevant in deterniining the

issue.

(3) "Substantial" evidence is evidence with some weight; itmust have importance and value. (Footnotes omitted.)

A common pleas court's scope of review of an administrative order includes an

appraisal of all evidence and a determina6on of the absence or presence of the requisite

quantum of evidence. The reviewing court must give deference to the agency's

interpretation of its own regulations, and the technical and ethical requirements of its

profession. Ladd v. State, Counselor & Social Worker Bd. (1991), 76 Ohio App.3d 323, 601

N.E.2D 617; Pons v. Ohio State Medical Bd. (1993), 66 Ohio St.3d 619, 614 N.F..2d 748.

Page 4 of 13

Appx. C-4

The court of common pleas can properly reverse an administrative order which rests

upon inferences iinproperly drawn from the evidence at the administrative hearing.

Republic Steel Corp. V. Haitey (1986), 30 Ohio App.3d 103, 506 N.E.2d 1215,

An administrative regulation does not require the necessary specificity of a criuninal

statute. Salem v. Liquor Control Comm (1973), 34 Ohio St.2d 244, 246, 298 N.E.2d 138. A

regulation must provide a person of ordinary intelligence fair notice of the prohibited

conduct. Serednesky v. Ohio State Bd. Of Psychology, 2006 WL 1704105 (Ohio App. 10 Dist.),

2006-Ohio-3146, 116.

Review and D-ceis3933

Upon review of all of the foregoing, it is clear that this Court's duty is to deterniine

whether the Board of Pharmacy Order is supported by reliable, probative, and substantial

evidence, and is in accordance with law. 1n the absence of this finding, this Court may

reverse, vacate, or modify the order or make such other ruling as is supported by reliable,

probative, and substantial evidence and is in accordance with law.

The foundation of the citations against SCP, Inc. dba Strasburg Pharmacy (hereafter

"SCP"), Michael Dennis, R.Ph. (hereafter "Dennis") and Amy Lynn Froman R.Ph. (hereafter

"Froman"), is the filling of prescriptions written by Dr. Edward D. DeI-laas (hereafter

"DeHaas"), of Professional Pain Managenient Ohio, Inc. (hereafter "PPMO"). The Board's

Page 5 of 13

Appx. C-5

citation charged that Appellant SCP:

{dlid, on or about the following dates, knowingly sell, conspireto sell, and/or aid and abet the sale of a controlled substance

when the conduct was not in accordance with Chapters 3719,

4729, and 4731 of the Ohio Revised Code, to wit: you sold the

following controlled substances to the following patient when

not for a legitimate medical purposes issued by a prescriber

acting in the usual course of his professional practice and in

compliance with administrative code rules addressing pain

management and violating Rule 4729-5-30 of the OhioAdministrative Code and 21 CFR 1306.04.

The events arose in the year 2003, in Tuscarawas County, Ohio. In February,

Del-Iaas introduced himself, PPMO and the nature of his prac6ce to Appellants. Also, in

February, 2003, four pharniacists in Tuscarawas County, contacted their Compliance Agent

for the Board of Pharmacy, David Gallagher (hereafter "Agent Gallagher"), with questions

regard'ntg DeHaas and the PPMO.

Following the telephone calls, Agent Gallagher verified the licensure of DeI Iaas, and

his experience of 20 years in emergency medicine. Sometime in March or April, he

acquired a curriculum vitae of DeHaas and possibly some other prescription information

from the pharmacist at the Medicute Shop. No other action upon the telephone calls was

reported at that time.

In May, 2003, Dennis became the responsible pharmacist for SCP. He contacted

Agent Gallagher, as instructed, in order to procure his license. During his communications

Page6of 13

Appx. C-6

with Agent Gallagher in June, Dennis inquired about the PPMO. Agent Gallagher claimed

he knew nothing about the pain clinic. Thereafter, Dennis expected Agent Gallagher to

come to SCP to deliver his license. Agent Gal,lagher did not appear, but called and stated

that he would mail the license and do the inspection of the pharmacy at a later time. Agent

Gallagher did not come to SCP at any time from Jrme through November, 2003. The

inspection was not done in 2003 until six agents appeared at SCP on Deceniber 1, 2003.

Some time in July, 2003, Agent Gallagher visited the pharmacy at Walmart, the

location of two pharmacists who had called him in February. During that visit he did not

look at any documents, prescriptions or patient files relating to PPMO.

Between June and October, 2003, Agent Gallagher conducted video surveillance of

the patients of PPMO. Eventually, the surveillance was also personal and inctuded

following patients to various pharmacies.

In September, 2003, Dennis attempted to reach Agent Gallagher by telephone. A

week or more later, when the agent returned the call, he spoke with Froman. When

questioned again about PPMO, Agent Gallagher never indicated that there was a quesfion

regarding the medical appropriateness of the prescriptions. He did not share that there

were other pharmacists in the area questioning the practices of PPMO. There is nothing

in evidence to denionstrate that he was prohibited froni revealing this information.

On December 1, 2003, six agents for the Board of Pharrnacy appeared at SCP,

Page 7 of 13

Appx. C-7

explaining that they were investigating PPMO, when, in fact, they investigated SCP, Dennis

and Froman. Over a period of several days, all of the records in SCP were reviewed

relative to the PPMO prescriptions. On December 1, Dennis and Froman attenipted to

cease filling PPMO prescriptions, but were cautioned by agents that their failure to fill

PPMO prescriptions could result in criminal charges for obstruction of justice. This

testimony is uncontroverted.

Finally, the evidence is uncontroverted that Dennis and Froman, acting in the course

of their employment and on behalf of SCP, took action upon the phenonienon of the

opening of the pain clinic in Tuscarawas County, and the new business this brought to their

pharmacy. Dennis and Froman checked on the licensure of DeHaas in February and

September, 2003. Deilnis and Froman discussed the PPMO and the prescriptions with

other pharmacists. Dennis and Froinan required identification for the pick-up of the pain

medications. Dennis and Froman conducted personal conversations with patients

regarding their medical conditions and care, relative to filling the prescriptions for pain

medication. Dennis and Fronian had a written prescription for every filled prescription

leaving the Pharmacy. Dennis and Froman personally spoke with DeHaas on several

occasions and reviewed his plan of treatment with hirri. Dennis and Froman reviewed the

Ohio Medical Guidelines and Regulations on treating pain. On more than one occasion,

Dennis and Froman, on behalf of SCP, contacted their Compliance Agent for the Boarc9 of

Page 8 of 13

Appx. t'.'8

Pharinacy for guidance.

The Board clearly states in its Order, "Obviously, the dispensing pharmacist need

not review the prescriber's patient chart," yet this appears to be the only thing nQt done by

Appellant.

The pharmacist at the Medicine Shoppe called Agent Gallagher in February to

question about PPMO. Although Agent Gallagher conducted no investigation of the

Medicine Shoppe records, he relies on the pharmacist's statement that he refused to fill

prescriptions from PPMO, after filling an initial fifteen (15) prescriptions. No citation

issued against the pharmacy or pharmacist at the Medicine Shoppe.

The pharmacists at Walmart called Agent Gallagher in February to question about

PPMO, but continued to fill prescriptions for I'PMO until the clinic was closed in December

2003. No citation issued against the pharmacy or pharmacists at Walmart.

The pharmacist at Discount Drug Mart called Agent Gallagher in February to

question about PPMO, but continued to fill prescriptions for PPMO until the clinic was

closed in December 2003. No citation issued against the pharmacy or pharmacist at

Discount Drug Mart.

The pharmacists at SCP called Agent Gallagher in June and September to question

about PPMO. They continued to fill prescriptions imtil the Pharmacy Board "raid" on

December 1, 2003. '1'hereafter, they continued to fill the prescriptions under threat of

Page 9 of 13

Appx. C-9

charges of obstruction. These pharmacists were cited.

Appellees would have this Court accept the testimony of the State's expert, Robert

Kubasak, R. Ph. (hereafter "Kubasak") which includes his opinion that none of the

prescriptions were legitimate, yet overlooks the selective prosecution of some, but not all,

of the pharmacists who filled those prescriptions during the same time frame. Kubasak

concludes that the PPMO prescriptions were not medically necessary, but reviewed no

medical charts, and was unaware as to whether any of the patients had chronic pain.

Kubasak's testimony induded opinions outside his area of expertise. I3e offered an

opinion based upon incomplete information; in his testimony, he admits that he never

reviewed the statements of Dennis or Froman. He relied upon facts relayed by a third

party in a lettei which was not before the Board, i.e. matters not in evidence. I'rior to

rendering his decision, Kubasak was not made aware of any actions taken by Dennis or

Froman, as outlined above.

The Court FINDS the testimony of Kubasak is not reliable, probative and

substantial.

Appellees would have this Court accept the testimony of the Agent Gallagltier,

which inclttdes his admission that he is not qualified to determine whether or not a

prescrip6on should be filled. His testimony fails to explain why, if none of the

prescriptions were legitimate, did he select some of the pharmacists in his territory for

Page 10 of 13

Appx. C-1®

prosecvtion, but not all of the pliarmacists who filled those prescriptions dtving the same

time frame.

Appellees would have this Court accept that Agent Gallagher is not qualified to

advise Dennis or Froman regarding the appropriateness of their practices, stating, "I'm not

a pharmacist." Yet, Appellees would have this Court accept that Agent Gallagher is

qualified to advise the Board regarding the appropriateness of Dennis and Fromari s

practices.

The Court FINDS that the testimony of Agent Gallagher is not reliable, probative

and substantial.

The Court FINDS that the Appellee did not meet its burden of proof on the issue

of whether the prescriptions issued by DeHaas at PPMO were for a legitimate medical

purpose, issued by a prescriber acting in the usual course of his professional practice.

'1'here was no evidence before the Board by a medical physiaan who reviewed the patient

charts and the prescribing practices of DeHaas and concluded that the prescriptions were

not legitimate.

T`he Court FINDS that the Appellee did not meet its burden of proof on the issue

of whether Dennis knew or should have known that the prescriptions were not legitimate.

Appellee repeatedly referred to "red flags" throughout the testimony. The Board i-efers

to "indicators" in its Order. However, there has been no evidence that during 2003, there

Page 11 of 13

Appx. C-71

existed a clear and unan biguous code, regulation or other directive to the licensed

pharmacists in Ohio, to which Appellant should be held accountable.

The Court FINDS the Board's Order rests upon inferences impropeily drawn from

the evidence.

The Court has given deference to the interpretation of the pharmacy regulations and

professional requirements as determined by the Board. Upon the Court's thorough review

of the record, induding all of the testimony presented, the Court FINDS that there is an

absence of the requisite quantum of evidence necessary to affirm the Board's Decision; the

State has failed to prove by a preponderance of the evidence that the allegations charged

did in fact occur.

)r rs

Based upon the foregoing, it is ORDERED that the Decision of the State Board of

Pharmacy to revoke the Terminal Distributor license, No. 02-1383200, held by Strasburg

Pliarmacy, with a one year suspension of the revocation, as set forth in the Order of the

State Board of Pharmacy (Docket Number D-050719-004) in the Matter of Strasburg

Phannacy, shall be reversed and vacated.

It is ORDERED that all interim orders are dissolved.

Costs are assessed to the State of Oliio, Board of Phai-macy, and payment is waived.

Page ]2 of 13

Appx. C-12

T7ie Clerk of Courts shall close this file and remove it from the pending docket of the

undersigned.

IT IS SO ORDERED.

Dated: Septentber 4, 2008

cc: Scott P. Sandrock, Bsq.

Sally Ann Steuk, Asstistant Attorney General

Page 13 of 13

Appx. C°1 3

`'IL ED"UUH f OFCGHHON PtEqS

TIISC"'PAWI"S CUUNI Y oHIf1

1008SEP-4 P 3=58

ROCKNE W CLARKECLERK OF COURTS

IN THE COURT OF COMMON PLEASTUSCARAWAS COUNTY, OHIO

GENERAL TRIAL DIVISION

MICHAEL T. DENNIS, RPHCase Number: 2007 AA 01 0042

Appellant,Judge Elizabeth Lehigh Thomakos

vs.

STATE OF OHIO, OH1O STATE

BOARD OF PHARMACY

Appellee.

This matter came before the Court for an Administrative Appeal, based upon the

Notice of Appeal Pursuant to Chapter 119 of the Ohio Revised Code filed by Michael T.

Dervus ("Appellant") on January 16, 2007.

The Court held a I-Iearing on April 4, 2008. Appellant was present in Court

Page 1 of 13

Appx. ®-1

represented by Attorney Scott P. Sandrock. Appellee, State of Ohio, Board of I'harrriacy

("Appellee"), was present in Court through its General Counsel David Rowland, and was

represented by Assistant Attorney General, Sally Ann Steuk.

The Court heard the arguments of counsel relative to the following filed briefs:

January 31, 2008 Brief of Appellant, Michael Dennis

March 5, 2008 Brief of Appellee, Ohio State Board of Pharmacy

March 26, 2008 Reply Brief of Appellant Michael Dennis

The Court has also considered the record of the rmderlying hearing before the State

of Ohio Board of Pharniacy, in addition to the written and oral arguments of counsel.

The Court has read the Transcript consisting of 663 pages, whicli addressed the

Matters of Strasburg Pharmacy (Docket No. D-050719-004), Michael T. Dennis, R.Ph.

(Docket no. D-05719-005) and Amy Lynn Froman, R.Ph. (Docket No. D-05719-006). '17- e

Hearing commenced November 6, 2006.

The Court has reviewed the Order of the State Board of Pharmacy dated January

11, 2007. The Board notes that under Ohio and Federal Codes a pharmacist has a

corresponding responsibility with the prescriber to ensure that a prescription is issued for

a legitimate medical purpose by a licensed prescriber in the usual course of professional

practice. The Board states that a pharmacist must review every prescription for legitimacy

and inust then make a professional judgment on whether or not to fill the prescription. The

Page 2 of 13

Appace D-2

Board opines that Dennis shirked his responsibilities and ignored numerous obvious

indicators of illegal prescribing activity on the part of the physicians. The Board fr.n•ther

opined, "It is clear that this pharmacist consciously ignored his obligations to the patients

simply for monetary gain."

Board concludes that Dennis's actions or inaction constitute being guilty of gross

imniorality [R.C. §4729.16(A)(1)], unprofessional conduct in the practice of pharmacy [R.C.

§4729.16(A)(2)], and of willfully violating, conspiring to violate, attempting to violate, or

aiding and abetting the violation of provisions of Chapters 2925 and 3719 of the Ohio

Revised Code. [R.C. §4729.16(A)(5)].

The resulting decision was to permanently revoke the license of Michael T. Dennis

by a vote of 4 - 3.

.5-t-ins.lard_4f Iteviem:

R.C. §119.I2 provides for an appeal to the Court of Common Pleas from an order of

an agency by the party adversely affected by the order. Unless as otllerwise provided by

law, in the hearing of the appeal, the court is confined to the record as certi6ed to it by the

agericy.

R.C. §119.12 further provides that the court inay affirm the order of the agency


Page 3 of ] 3

Appx. ®m3




is in accordance with law.

In Our Place, Inc. v. Ohio Liquor Control Comm. (1992), 63 Ohio St.3d 570, 571, 589

N.E.2d 1303, the Supreme Court of Ohio defined these terms, as follows:




there must be a reasonable probability that the evidenceis true.


issue in question; it must be relevant in deterinining theissue.

(3) "Substantial" evidence is evidence with some weight; it

must have importance and value. (Footnotes omitted.)

A conimon pleas court's scope of review of an administrative order includes an

appraisal of all evidence and a determination of the absence or presence of the requisite

quantuni of evidence. The reviewing court must give deference to the agency's

interpretation of its own regtilations, and the technical and ethical requirements of its


N.E.2D 617; Pons v. Ohio State Medical Bd. (1993), 66 Ohio St.3d 619, 614 N.E.2d 748.

The court of comTnon pleas can properly reverse an administrative order which rests

Page 4 of 13

Appx. ®-4

upon inferences improperly drawn froni the evidence at the adininistrative hearing.

Repttblic Steel Corp_ V. Hrailey (1986), 30 Ohio App.3d 103, 506 N.E.2d 1215.

An administrative regulation does not require the necessary specificity of a criuninal

statute. Salem v. Liquor Control Comni (1973), 34 Ohio St.2d 244, 246, 298 N.E.2d 138. A

regulation must provide a person of ord'niary intelligence fair not3ce of the prohibited

conduct. Seredneslnj v. Ohio State Brl. Of Psycliology, 2006 WL 1704105 (Ohio App. 10 Dist.),

2006-Ohio-3146, 116.

Review and Decision

Upon review of all of the foregoing, it is clear that this Court's duty is to determine

whetlier the Board of Pharinacy Order is supported by reliable, probative, and substantial

evidence, and is in accordance with law. In the absence of this finding, this Courl may

reverse, vacate, or modify the order or make sucli other ruling as is supported by reliable,


1'he foundation of the citations against SCP, Inc. dba Strasburg Pharmacy (hereafter

"SCP"), Michael Dennis, R.Ph. (hereafter "Dennis") and Anry Lynn Fronian R.Ph. (hereafter

"Fronian"), is the filling of prescriptions written by Dr. Edward D. DeHaas (hereafter

"Del-laas"), of Professional Pain Management Ohio, Inc. (hereafter "PPMO"). The Board's

citation charged that Appellant Dennis:

Page 5 of 13

Appx. D-5

{dlid, on or about the following dates, knowingly sell, conspire

to sell, and/or aid and abet the sale of a controlled substance




not for a legitimate ntedical purposes issued by a prescriber


compliance with administrative code rules addressing pain

management and violating Rule 4729-5-30 of the Ohio

Administrative Code and 21 CFR 1306.04. Board's Citation, p.

1.

The events arose in the year 2003, in Tuscarawas County, Ohio. 7n February,

DeHaas introduced himself, I'PMO and the nature of his practice to Appellants. Also, in

February, 2003, four pharmacists in Tuscarawas County, contacted their Compliance Agent


regarding DeHaas and the PPMO.

Following the telephone calls, Agent Gallagher verified the licensure of Del Iaas, and

his experience of 20 years in emergency medicine. Sometime in March or April, lie

acquired a curriculum vitae of DeHaas and possibly some other prescription information

frorn the pharmacist at the Medicine Shop. No other action upon the telephone calls was



Agent Gallagher, as instructed, in order to procure his license. During his conuntnucations

with Agent Gallagher in June, Demiis inquired about the PPMO. Agent Gallagher claimed

Page 6 of 13

Appx. D-6

he knew nothing about the pain dinic. 'Thereafter, Dennis expected Agent Gallagher lo

come to SCP to deliver his license. Agent Gallagher did not appear, but called and stated


Gallagher did not come to SCP at any time from June through November, 2003. The

inspection was not done in 2003 until six agents appeared at SCP on December 1, 2003.

Soine time in Jtdy, 2003, Agent Gallagher visited the pharniacy at Walmart, the


look at any documents, prescriptions or patient files relating to PPMO.


the patients of PPMO. Eventually, the surveillance was also personal and included


]n September, 2003, Dennis attempted to reacli Agent Gallagher by telephone. A

week or inore later, when the agent returned the call, he spoke with Froman. When

questioned again about PPMO, Agent Gallagher never indicated that there was a question


were other pharinacists in the area questioning the practices of PPMO. 79iere is nothing

in evidence to denionstrate that he was prohibited from revealing this inforniation.

On December 1, 2003, six agents for the Board of Pharmacy appeared at SCP,

explaining that they were investigating PPMO, when, in fact, they uivestigated SCP, Dennis

Page 7 of 13

pppXo D-7


relative to the PPMO prescriptions. On December 1, Dennis and Froman attempted to

cease filling PPMO prescriptions, but were cautioned by agents that their failure to fill


testimony is uncontroverted.

Fiiially, the evidence is uncontroverted that Detuiis and Froman, acting in the course

of their employment and on behalf of SCI', took action upon the phenomenon of the


pharmacy. Dennis and Froman checked on the licensure of DeHaas in Febn.iary and

Scptember, 2003. Dennis and Froman discussed the PPMO and the prescriptions with

other pharmacists. Dennis and Froman required identificafion for the pick-up of the pain

medications. Dennis and Froman conducted personal conversations with patients


medicaHon. Dennis and Froman had a written prescription for every filled prescription

leaving the Pharmacy. Dennis and Froman personally spoke Ndith DeHaas on several

occasions and reviewed his plan of treatment with him. Deiuris and Froman reviewed the


Dennis and Froinan, on behalf of SCP, contacted their Compliance Agent for the Board of

Pharmacy for guidance.

Page S of 13

Appx. D-8

The Board clearly states in its Order, "Obviously, the dispensing pharmacist need

not review the prescriber's patient chart," yet this appears to be the only thing n done by

Appellant.


question about PPMO. Altliough Agent Giillagher conducted no investigation of the

Medicine Slioppe records, he relies on the pharmacist's statement that he refused to fill

prescriptions from PPMO, after filling an initial 6fteen (15) prescriptions. No citation


The pharmacists at Walmart called Agent Gallagher in February to quesfion about

PPMO, but continued to fill prescriptions for PPMO until the clinic was closed in December

2003. No citation issued against the pharmacy or pharmacists at Walmart.


question about PI'MO, but continued to fill prescriptions for PPMO until the clinic was

closed in December 2003. No citation issued against the pharmacy or pharmacist at

Discormt Drug Mart.

The pharmacists at SCP called Agent Gallagher in June and September to question

about PPMO. They continued to fill prescriptions until the Pharmacy Board "raid" on

December 1, 2003. Thereafter, they continued to fill the prescriptions under threat of

charges of obstruction. These pharmacists were cited.

Page 9 of 13

e4ppx. D-9

Appellees would have this Court accept the testimony of the State's expert, Robert

Kubasak, R. Ph. (hereafter "Kubasak") which includes his opinion that none of the

prescriptions were legitiniate, yet overlooks the selective prosecution of some, but not all,




Kubasak's testimony induded opinions outside his area of expertise. He offered an


reviewed the stateinents of Dennis or Froman. He relied upon facts relayed by a third

party in a letter which was not before the Board, i.e. matters not in evidence. Prior to

rendering his decision, Kubasak was not made aware of any actions taken by Dermis or


The Court FINDS the tes6mony of Kubasak is not reliable, probative and

substantial.

Appellees would have this Court accept the testimony of the Agent Gallagher,

which includes his admission that he is not qualified to determine whether or not a

prescription should be filled. His testimony fails to explain why, if none of the


prosecution, but 7iot all of the pharmacists who filled those prescriptions during the same

Page 10 of 13

Appx. D-1®

tinie franie.


advise Demiis or Froman regarding the appropriateness of their practices, stating, "I'm not

a pharmacist." Yet, Appellees would have this Court accept that Agent Gallagher is

gualified to advise the Board regarding the appropriateness of Dennis and Froman's

practices.


and substantial.


of whether the prescriptions issued by DeHaas at PPMO were for a legitimate medical

purpose, issued by a prescriber acting in the usual course of bis professional practice.

There was no evidence before the Board by a medical physician who reviewed the patient

charts and the prescribing practices of DeHaas and concluded that the prescriptions were

not legitimate.



Appellee repeatedly referred to "red flags" throughout the testimony. The Board refers


existed a clear and unanibiguous code, regulation or other directive to the licensed

Page 11 of 13

AppX. D-1 `!

pharmacists in Ohio, to which Appellant shorild be held accountable.

The Court FINDS the Board's Order rests upon inferences improperly drawn from

the evidence.

The Court has given deference to the interpretation of the pharmacy regtilations and

professional requirements as determined by the majority of 4 Board members who found

Appellant liad violated the regulations and requirements of the pharmacy profession.

Upon the Court's thorough review of the record, including all of the testimony presented,

the Court FINDS that there is an absence of the requisite quantum of evidence necessary

to affirm the Board's Decision; the State has failed to prove by a preponderance of the

evidence that the allegations charged did in fact occur.

Orders

Based upon the foregoing, it is ORDERED that the Decision of the State Board of

Pharmacy to permanently revoke the pharmacist identification card, No. 03-3-19932, held

by Michael T. Dennis and ordering the return of the identification card and license to the

office of the State Board of Pharmacy, as set forth in the Order of the State Board of

Phamracy (Docket Number D-050719-005) in the Matter of Michael T. Dennis, R.Ph, shall

be reversed and vacated.

It is ORDERED that all interirn orders are dissolved.

Page 12 of 13

Appx. D=12

Costs are assessed to the State of Ohio, Board of Pharinacy, and payment is waived.

The Clerk of Courts shall close this file and remove it from the pending docket of the

undersigned.

I'I' IS SO ORDEItED. 6-1

Dated:

cc: Scott P. Sandrock, Esq.


Page 13 of 13

zabeth Lehigh Thomakos

September 4, 2008

Appx. D-13

' ILED"611R F OE' COMMN PI.E'AS

TNSCARAiYAS COUNTY OHI11

i008 SEP -U P 3^ 5b

ROCKNE W. CLARKECLERK OF COURTy

IN THE COURT OF COMMON PLEAS

TUSCARAWAS COUNTY, OHIOGENERAL'PRIAL DIVISION

AMY LYNN FROMAN, RPH

Appellant,

vs.

Case Number: 20071L4 010055

Judge Elizabeth Lehigh Thomakos

STATE OF OHIO, OHIO STATE . TUD MENT ENTRBOARD OF PHARMACY

Appellee.

This inatter came before the Court for an Administrative Appeal, based upon the

Notice of Appeal Pursuant to O.R.C. §119.12 filed by Al:ny Lynn Froman ("Appellant") on

January19, 2007.

The Court held a Hearing on April 4, 2008. Appellant was present in Court

Page I of 13

Appx. E-1

represented by Attorney Douglas.E. Graff. Appellee, State of Ohio, Board of Pharmacy

("Appellee"), was present in Court through its Genera.l Counsel David Rowland, and was

represented by Assistant Attorney General, Sally Aim Steuk.

The Court heard the argunients of counsel relative to the following filed briefs:

February 4, 2008 Appellant Froman's Brief

March 5, 2008 Brief of Appellee, Ohio State Board of Pharniacy

March 26, 2008 Appellant Froman's Reply Brief

The Court has also considered the record of the underlying hearing before the State

of Ohio Board of Pharmacy, in addition to the written and oral arguments of counsel.

The Court lias read the Transcript consisting of 663 pages, which addressed the

Matters of Sirasburg Pharmacy (Docket No. D-050719-004), Michael T. Dennis, R.Ph.C

(Docket no. D-05719-005) and Amy Lynn Froman, R.Ph. (Docket No. D-05719-006). The

I Iearing commenced November 6, 2006.

The Court has reviewed the Order of the State Board of Phannacy dated January

11, 2007. The Board notes that tmder Ohio and Federal Codes a pharmacist has a

corresponding responsibility with the prescriber to ensure that a prescripti on is issued for

a legitintate medical purpose by a l3censed prescriber in the usual course of professional

practice. The Board states that a pltarmaeist mtist review every prescription for legitirnacy

and niust then make a professional judgment on wltether or not to fill the prescription. The

Page 2 of 13

Appx. E-2

Board opines that Froman shirked her responsibilities and ignored numerous obvious

indicators of illegal prescribing activity on the part of the physicians. The Board fiirther

opined, "It is dear that th.is pharmacist consciously ignored her obligations to the patients: "

Board concludes that Froman's actions or inaction constitute being guilty of gross

iinmorality [R.C. §4729.16(A)(1)], unprofessional conduct in the practice of pliarmacy [R.C.

§4729.16(A)(2)], and of willftrlly violating, conspiring to violate, attempting to violate, or

aiding and abetting the violation of provisions of Chapters 2925 and 3719 of the Ohio

Revised Code. [R.C. §4729.16(A)(5)].

The resulting decision, by a vote of 5 - 2, was to suspend for three years the license

of Amy Lynn Froman, with certain restrictions on employrnent and reinstatement upon

examination.

51andard Qf Review

R.C. §119.12 provides for an appeal to the Court of Common Pleas from an order of

an agency by the party adversely affected by the order. Uliless as otherwise provideci by

law, in the hearing of the appeal, the court is confined to the record as certified to it by the

agency.

R.C. §119.12 further provides that the court may affirni the order of the agency


Page3 of 13

Appx. E-3




is in accordance with law.

In Our Place, Inc. v. Ohio Liquor Control Comm. (1992), 63 Ohio St.3d 570, 571, 589

N.E.2d 1303, the.Supreme Court of Ohio defined these terms, as follows:




there must be a reasonable probability that the evidence

is true.


issue in question; it must be relevant in determining the

issue.

(3) "Substantial" cvidence is evidence with some weight; it,

mtust have importance and value. (Footnotes omitted.)

A common pleas court's scope of review of an administrative order includes an

appraisal of all evidence and a determination of the abserice or presence of the requisite

quantum of evidence. The reviewing court must give deference to,the agency's

interpretation of its own regulation.s, and the technical and ethical requirements of its


N112D 617; Pons v. Ohio State Medical Bd. (1993), 66 Ohio St.3d 619, 614 N.E.2d 748.

The court of common pleas can properly reverse an administrative order which i-ests

Page 4 of 13

Appx. E-4

upon inferences iinproperly drawn from the evidence at the admirnistrative hearing.

Republic Steel Corp. V. Hailey (1986), 30 Ohio App.3d 103, 506 N.E:2d 1215.

An administrative r'egulation does not require the necessary specificity of a cr7rninal

statute. Salem v. Liquor Control Comm (1973), 34 Ohio St.2d 244, 246, 298 N.E.2d 138. A

regulation must provide a person of ordinary intelligence fair notice of the prohibited

conduct. Seredneskij a. Ohio State Bd. Of Psychology, 2006 WL 1704105 (Ohio App. 10 Dist.),

2006-Ohio=3146, '116.

Review and DedaiSU1

Upon review of all of the foregoing, it is clear that this Court's duty is to determine

whether the Board of I'harmacy Order is supported by reliable, probative, and substantial

evidence, and is in accordance with law. In the absence of this finding, this Court inay

reverse, vacate, or modify the order or make such other niling as is supported by reliable,


The formdation of the citations against SCP, Inc. dba Strasburg Pharmacy (hereafter

"SCP'-'), Michael Demiis, R.Ph. (hereafter "Denlus") and Amy Lynn Froman R Ph. (1- ereafter

"Froman"), is the filling of prescriptions written by Dr. Edward D. DeHaas (hereafter

''DeHaas"), of Professional Pain.Management Ohio, Inc. (hereafter "PPMO"). The Board's

citation charged that Appellant Dennis:

Appx. E-5

{dlid, on or about the following dates, la- owingly sell, conspire

to sell, and/or aid and abet the sale of a controlled substance




not for a legitimate medical purposes issued by a prescriber


compliance with administrative code rules addressnig pairr

management and violating Riile 4729-5-30 of the Ohio

Administrative Code and 21 CFR 1306.04.

'I'he events arose in d1e year 2003, in 1'uscarawas County, Ohio_ hi February,

DeHaas introduced lumself, PPMO and the nature of his practice to Appellants. Also, in

February, 2003, fous pharmacists in `Puscarawas County, contacted their Compliance Agent


regarding DeHaas aiid the PPMO.

Following the telephone calls, Agent Gallagher verified the licensure of DeHaas, and

his experience of 20 years in emergency medicine. Sometime in March or April, he

acquired a carricuhun vitae of DeHaas and possibly some other prescription information

from the pharmacist at the Medicine Shop. No other acfion upon the telephone calls was



Agent Gallagher, as instnasted, in order to procure his license. During his comniunications

with Agent Gallagher in June, Dennis inqttired about the PPMO. Agent Gallagher dairned

Page 6 of 13

Ap02x. E-6

lie knew nothing about the pain clinic. Thereafter, Dennis expected Agent Gallagher to

come to SCI'to deliver his license. Agent GaIlagher did not appear, but called and stated


Gallagher did not come to SCP at any time from June through November, 2003. The

inspection was not done in 2003 until six agents appeared at SCP on December 1, 2003.

Some time in July, 2003, Agent GaIlagher visited the pharmacy at Walmart, the


look at any doctinients, prescriptions or patient files relating to PPMO.


the patients of PPMO. Eventually, the surveillance was also personal and included


In September, 2003, Dennis attenipted to reach Agent Gallagher by telephone- A

week or more later, when the agent returned the call, he spoke with Froman. When

questioned again about PPMO, Agent Gallagher never indieated that there was a question


were other pharmacists in the area questioning the practices of PPMO. There is notMng

in evidence to demonstrate that he was prohibited from revealing this information.

On December 1, 2003, six agents for the Board of Pharmacy appeared at SCP,

explaining that they were investigating PPMO, when, in fact, they investigated SCP, Dennis

Page7of 13

ApXsx. E-7


relative to the PPMO prescriptions. On December 1, Dennis.and Froman attempted to

cease fillntg PPMO prescriptions,.but werecautioned by agents that their failure to fill


testimony is uncontroverted. -

Finally, the evidence is uncontroverted that Dennis and Frornan, acting in the course

of their employment and on behalf of SCP, took action upon the phenomenon of the


pharmacy. Dennis and Froman checked on the licensure of Det-laas in February and

September, 2003. Desuus and Froman discussed the PPMO and the prescriptions witll

other pharmacists. Dennis and Froman required identificafion for the pick-up of the pain

medications. Demzis and Froman conducted persqnal conversations with patients


medication. Dennis and Froman had a written prescription for every filled prescription

leaving the Pharmacy. Deiuiis and Frornan personally spoke with DeHaas on several

occasions and reviewed his plan of treatment with him. Dennis and Froanam reviewed the


Dennis and Froman, on behalf of SCP, contacted their Compliance Agent for the Board of

Pharmacy for guidance.

Page 8 of 13

AppX. E-8

The Board clearly states in its Order, "Obviously, the dispensing pl-iarmacist need

not review the prescriber's patient chart," yet t3us appears to be the only thing not done by

Appellant.


question about PPMO. Although Agent Gallagher conducted no investigation of the

Mediciite Shoppe records, he relies on the pharmacist's statenient that he refused to fill

prescriptions froni PPMO, after filling an initial fifteen (15) prescriptions. No citation


The pharmacists at Walmart caIled Agent Gallagher in February to question about

PPMO, but continued to fill prescriptions for PPMO until the clinic was dosed in Decenrber

2003. No citation issued against the pharmacy or pharmacists at Walniart.


question about PPMO, but continued to fill prescriptions for PPMO until the clinic was

dosed in December 2003. No citation issued against the pharmacy or pharmacist at

Discotmt Drug Mart.

T'he pharmacists at SCP called Agent Gallagher in Jwie and September to question

about PPMO. They continued to fill prescriptions until the Pharmacy Board "raid" on

December 1, 2003. 1'hereafter, they continued to fill the prescriptions under threat of

charges of obstruction. 17iese pharmacists were cited.

Page 9 of 13

Appx. E-9

Appellees would have this Court accept the testi7nony of the State's expert, Robert

Kubasak, R. Ph. (hereafter "Kubasak") whicli includes his opinion that none of the

eprescriptions were legitimate, yet overlooks. the selective prosecution of some, but not all,




Kubasak's testiinony included opinions outside lus area of ezpertise.' He offered an


reviewed the statements of Dennis or Frornan. He relied upon faets relayed by a tltird

party in a letter which was not before the Board, i.e. matters not in evidence. Prior to

renderinb his decision, Kubasak was not made aware of any actions taken by Dennis or -


The Court FINDS the tesiimony of Kubasak is not reliable, probative and

substantial.

Appellees would have this Court accept the testimony of the Agent Gallagher,

which includes his admission that he is not qualified to determine whether or not a

prescription should be filled. His testimony fails to explain why, if none of the


prosecution, but not all of the pharmacists who filled those prescriptions during the same

Page 10 of 13 .

Appx. E-1®

fiine frame.


advise Dennis oX Froman regarding the appropriateness of their practices, stating; "I'm not-

a pharmacist." Yet, Appellees worild have this Court accept that Agent Gallagher is

qualified to advise the Board regarding the appropriateness of Dennis and Froman's

practices.


and substantial_

'I`he Court FINDS that the Appellee did not meet its burden of proof on the issrie

of whether the prescripHons issued by DeHaas at PPMO were for a legitimate medical

purpose, issued by a prescriber acting in the usual course of his professional practice.

There was no evidence before the Board by a medical physician who reviewed the patient

clzarts and the prescribing practices of DeHaas and concluded that the prescriptions were

not legitimate.

The Court FINDS that the Appellee did not meet its burden of proof on the issLie


Appellee repeatedly referred to "red flags" throughout the testimony. The Board refers


existed a clear and unambiguous code, regulation or other directive to the licensed

Page 11 of ] 3

Appx, E-11

pharmacists in Ohio; to wMch Appellant shoulci be held accountable.

The Court FINDS the Board's Order rests upon inferences improperly drawn from

the evidence.

The.Courthas given deference to the interpretafion of the pharmacy regulations and

professional requireinents as determined by the majority of 5 Board members who found

Appellant had violated the regtilations and reqturements of the pharmacy profession.

Upon the Court's tllorough review of the record, including all of the testimony presented,

the Court FINDS that there is an absence of the requisite quantum of evidence necessary

to affirrn the_Bo,ard's Decision; the State has failecI to prove by a preponderance of the

evidence that the allegations charged did in fact occur.

Orde

Based upon the foregoing, it is ORDERED that the Decision of the State Boar-d of

Phai-macy to suspend the pharmacist identification card, No. 03-2-16426, held by Amy

Lynn Froman, restricting her employment, requirbg examination, and ordering the return

of the identification card and license to the office of the State Board of Phamiacy, as set

forth in the Order of flie State Board of Pliarniacy (Docket Number D-050719-006) in the

Matter of Amy Lym1 Froman, R.Ph, shall be reversed and vacated.

It is ORDERED that all interim orders are dissolved.

Page 12 of 13

Appx. E-12

Costs are assessed to the State of Ohio, Board of Pharrnaoy, and payment is waived.

The Clerk of Courts shall close this file and reanove it from the pending docket of the

ruidersigned.

IT IS SO ORDERED.

Dated:

cc: Douglas E. Graff, Esq.


Page 13 of 13

izabeth Lehfgh Thomakos

September 4, 2008

Appx. E-13

OHIO STATE BOARD OF PHARMACY77 South High Street, Room 1702; Colunlbus, OH 43215-6126

-Equal Opportuniry Employcr and Scrvicc Provider

7EL 614/466-4143 E-MAIL: exec(3o bop.stute.oh.us F'AX: 614/752-4836TTY/TDD: lJse the Ohio Relay Serviee: 1-800/750-0750 URL: hiip://www.pharmacy.ohio.gov

ORDER OF THE STATE BOARD OFPHARMACY(Docket Number D-050719-004)

In The Matter Of:

STRASBURG PHARMACYc/o Michael Dennis, R.Ph.

1120 North Wooster AvenueStrasburg, Ohio 44680(T.D. No. 02-1 3 83 200)

INTRODUCTION

THE MATTER OF STRASBURG PHARMACY CAME FOR HEARING COMMENCING ON NOVEMBER 6,2006, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: JAMES E. TURNER, R.Ph. (presiding);GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.;NATHAN S. LIPSYC, R.Ph.; KEVIN J. MITCHELL, R.Ph.; HEATHER L. PASQUALE, R.Ph.; ANDDOROTIIY S. TEATER, PUBLIC MEMBER.

STRASBURG PHARMACY WAS REPRESENTED BY SCOTT P. SANDROCK. THE STATE OF OHIOWAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL

SUMMARY OF EVIDENCE

State's Witnesses:

1. David Gallagher, Ohio State Board of Pharmacy2. Robert B. Kubasak, R.Ph.

Respondent's Witnesses:

1. Michael T. Dennis, R.Ph.2. Chad Kenneth Kanouff

State's Exhibits:

SP-1 . Notice of Opportunity For Hearing letter for Strasburg Pharmacy [07-19-05]MD-i . Notice of Opportunity For Hearing letter for Michael T. Dennis, R.Ph. [07-19-05]AF-1 . Notice of Opportunity For Hearing letter for Amy Lynn Froman, R.Ph. [07-19-05]SP-1 A. Hearing Request letter from Scott P. Sandrock for Strasburg Pharmacy [08-08-05]MD-lA. Hearing Request letter from Scott P. Sandrock for Michael T. Dennis, R.Ph. [08-08-

05]AF- lA. Notice of Appearance of Counsel and Hearing Request letter from Douglas E. Graff

forAmyLynn Froman, R.Ph. [07-27-051SP-1 B. Hearing Schedule letter for Strasburg Pharmacy [08-1 1-051MD-1 B. Hearing Schedule letter for Michael T. Dennis, R.Ph. [08-1 1-05]

Appx. F-I

STRASBURG PHARMACYPage 2Order of the Board

AF-l B. Hearing Schedule letter for Amy Lynn Froman, R.Ph. [08-01-051SP, MD-1 C. Hearing Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph.

[12-28-05]AF-1 C. Motion for Continuance letter from Douglas E. Graff for Amy Lynn Froman, R-Ph. [1 2-

12-05]SP-1 D. Hearing Continuance letter for Strasburg Pharmacy [01-1 2-06]MD-1 D. Hearing Continuance letter for Michael T. Dennis, R.Ph. [01-12-06]AF-1 D. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [12-12-05]SP, MD-1 E. Hearing Continuance Request letter for Strasburg Pharmacy and Michael T.

Dennis, R.Ph. [08-31-06]AF-1 E. Letter from William T. Winsley to Douglas E. Graff [12-28-OS]SP, MD-1 F. Hearing Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph.

[09-06-06]AF-1 F. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [01-1 2-06]SP-1 G. Ohio Dangerous Drug Distributor Computer Record of Strasburg Pi-iarmacyMD-1 G. Ohio Pharmacist Computer Record of Michael T. DennisAF-1 G. Ohio Pharmacist Computer Record of Amy Lynn FromanSP, MD-1 H. Copy of Subpoenas for Donna (Dana) Coutts, Dr. Edward D. DeHaas, and Bruce

Rich [10-27-06]AF-1 H. Amy Lynn Froman's Revised Request for Issuance of Subpoenas and Subpoenas

Duces Tecum [10-30-06]AF-1 I. Motion to Quash submitted by Sally Ann Steuk, Assistant Attorney General [1 1-Ol -061AF-iJ. Motion to Quash submitted by Amanda K. Spies, Tuscarawas County Prosecuting

Attorney [11-03-06]SP, MD-1 K. Hearing Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph.

[1 1-20-06]AF-1 K. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [11-20-06]2. Copy of Notarized Statement of Ted T. Nussbaum 101-1 3-04]3. Copy of Notarized Statement of Brad White (01-28-04]4. Copy of Notarized Statement of Janine A. O'Neill [01-29-04]5. Copy of Notarized Statement of Dana I. Coutts [01-29-04]6. Eleven colored photographs [not dated]7. Copy of telephone prescriptions for Lorcet 10/650 mg and Soma 350 mg [not dated]8. Copy of letter from Erin L. Jones, Clinical Director of Professional Pain Management of

Ohio, Inc. (PPMO) to Strasburg Pharmacy [02-07-03]9. 4,159 hydrocodone/APAP 10 mg prescriptions issued by PPMO and filled at Strasburg

Pharmacy10. 4,125 carisoprodol 350 mg prescriptions issued by PPMO and filled at Strasburg

Pharmacy11. Transcript of Interview of Michael Dennis, R.Ph. [12-01-03]12. Transcript of Interview of Amy Froman, R.Ph. [12-04-03]14. Excel Spreadsheet of Round Trip Distances Travel Time For PPMO Patients [not dated]18. Pin Map of Kentucky, West Virginia and Ohio Tri-State Region [not dated]21. Excel Chart of Ohio's 2003 Top 12 Retail Pharmacies Purchasing Hydrocodone/APAP

10 mg Solid Dosage Products [not dated]24. PPMO Price Sheet [not dated]25. Excel Spreadsl eet of Strasburg hydrocodone/APAP 10 mg Sales/Purchases [not dated]26. Excel Spreadsheet of Strasburg carisoprodol 350 nig Sales/Purchases [not dated]27. PPMO Price Increase Notice to Customers [not dated]

Appx. F-2

STRASBURG PHARMACY

Page 3Order of the Board

28. Dangerous Drug Distributor Inspection Report of Strasburg Pharmacy [12-01-031;Response [12-16-03]

29. Dangerous Drug Distributor Inspection Report of Strasburg Pharmacy [02-12-04];Response [02-20-04]

30. Dangerous Drug Distributor Inspection Report of Strasburg Pharmacy [02-16-04];Response (02-20-04]

31. Opinion of Robert Kubasak, R.Ph. [08-04-04]; Resume of Robert B. Kubasak, R.Ph. [notdated]

32A. Copy of West Group Ohio Administrative Code (OAC) Section 4729-5-30 (Manner ofIssuance of a Prescription)

32B. Copy of Code of Federal Regulation 21 CFR 1306.04 (Purpose of issue of Prescription)32C. Copy of OAC Section 4731-21-02 (Utilizing Prescription Drugs for the Treatment of

Intractable Pain)32D. Copy of OAC Section 4729-5-20 (Prospective Drug Utilization Review)32E. Copy of Westlaw Ohio Revised Code (ORC) 2925.03 (Trafficking Offenses)32F. Anderson's ORC 4729.51 (Persons Who May Sell, Purchase, Distribute or Deliver

Dangerous Drugs)

Res ondent's Exhibits_

A. Licensure letter from Sharon A. Prentice to Strasburg Pharmacy with attachment [06-06-03]

D. Ohio State Board of Pharmacy News, www.pharmacy.ohio.gov, August 2004F. Copy of letter from Erin L. Jones, Clinical Director of Professional Pain Management of

Ohio, Inc. (PPMO) to Strasburg Pharmacy [02-07-03]G. Ohio Medical Board License Information in re Edward Douglas DeHaas,

www5.state.oh.us/med/license [09-22-03]H. Sealed1. Excel Spreadsheet of PPMO Rx Growth at WalMart in 2003 [not dated]M-HH. Twenty-three letters of Support [10-27-04 to 11-16-04]JJ. Copy of twenty-eight page Petition of Support [10-22-04 to 11-08-04]

FINDINGS OF FACT

After having heard the testimony, observed the demeanor of the witnesses, considered theevidence, and weighed the credibility of each, the State Board of Pharmacy finds the followingto be fact:

See attached Notice of Opportunity for Hearing letter dated July 19, 2005. Thefollowing paragraphs were dismissed on November 6, 2006 pursuant to agreement:paragraphs 33, 245, 290, 309, 315, 321, 330, 382, 386, 409, 421, 482, 554, 678,703, 718, 788, 1000, 1045, 1064, 1070, 1076, 1085, 1 1 37, 1141 , 1164, 1 1 76, 1237,1309, 1433, 1458, and 1473.

The Board is cognizant that both rule 4729-5-21 (formerly embodied in rule 4729-5-30)of the Ohio Administrative Code and Section 1306.04 of Title 21 of the Code of FederalRegulations state that a pharmacist has a corresponding responsibility with theprescriber to ensure that a prescription is issued for a legitimate medical purpose by alicensed prescriber in the usual course of professional practice. This is axiomatic inthe-pharmacy profession. This nieans that a pharmacist niust review every prescription

Appx. F-3

STRASBURG PHARMACYPage 4Order of the Board

for legitimacy and must then make a professional judgment on whether or not to fillthe prescription. Every pharmacist is accountable to this Board and to society for whathe knew or should have known due to professional training, experience, licensure, andcontinuing pharmacy education in pharmacy law. Obviously, the dispensingpharmacist need not review the prescriber's patient chart; rather, the requiredjudgment to be exercised must be based upon the pharmacist's extensive knowledgeand training in drug therapy, the pharmacist's knowledge of the patient (obtainedthrough profile information required by rule 4729-5-18 of the Ohio AdministrativeCode, a review of that profile as required by rule 4729-5-20 of the Ohio AdministrativeCode, and other discussions with the patient pursuant to rule 4729-5-22 of the OhioAdministrative Code), and the pharmacist's knowledge of the prescriber's practice,particularly as it relates to other similar practices in the region.

These pharmacists shirked their responsibilities in this regard, ignoring numerousobvious indicators of illegal prescribing activity on the part of the physicians involvedin this case. Some of these indicators include the large numbers of patients who drovevery long distances to come to these physicians and this pharmacy and the ahnostidentical treatment of a problem (pain) that requires individualization of treatmentdosages and drugs more than any other health-related problem. Individualizedtreatment for pain is required in all aspects of health care and is specifically stated inrule 4731-21-02 of the Ohio Administrative Code, yet was clearly ignored by thesepharmacists. Moreover, it is significant that practically all of the patients from theseprescribers paid cash for their prescriptions instead of using insurance as is usually thecase for the overwhelming percentage of prescriptions filled today. It is clear thatthese pharmacists consciously ignored their obligations to the patients simply formonetary gain.

CONCLUSIONS OF LAW

(1) The State Board of Pharmacy concludes that each of the paragraphs in the Findingsof Fact constitute being guilty of violating any provision of Chapter 4729. of theRevised Code as provided in Division (A)(3) of Section 4729.57 of the Ohio RevisedCode.

(2) The State Board of Pharmacy concludes that each of the paragraphs in the Findingsof Fact constitute being guilty of violating any provision of the federal drug abusecontrol laws or Chapter 2925. as provided in Division (A)(5) of Section 4729.57 of theOhio Revised Code.

DECISION OF THE BOARD

Pursuant to Section 4729.57 of the Ohio Revised Code, and after consideration of the recordas a whole, the State Board of Pharmacy hereby revokes the Terminal Distributor license, No.02-1 383200, held by Strasburg Pharmacy effective as of the date of the mailirig of this Order..Further, the Board suspends the revocation provided there are no similar violations within the

next year.

AppX. F-4

STRASBURG PHARMACYPage 5Order of the Boai-d

TiiIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY (Aye-7/Nay-0).

MOTION CARRIED.

SO ORDERED.

It is hereby certified by this Board that the above language is a copy of the Order enteredupon its journal in this case.

Section 1 19.12 of the Ohio Revised Code authorizes an appeal from this Order. An order thatdenied admission to an examination, or denied the issuance or renewal of a license orregistration, or revoked or suspended a license, may be appealed to the court of commonpleas in the Ohio county of your place of business or in your Ohio county of residence. Anyother order may be appealed to the Court of Common Pleas of Franklin County, Ohio.

Such an appeal, setting forth the order appealed from and the grounds of the appeal, must becommenced by filing_the original Notice of Anpeal with the State Board of Pharmacy and acopy with the appropriate court withinfifteen (1 5) days after the mailing of this Order and inaccordance with the requirements of Section 119.12 of the Ohio Revised Code.

BY ORDER OF THE STATE BOARD OF PHARMACY

CERTIFIED MAIL. / Return Receipt7004 2510 0006 9804 6251

ORDER MAILED & EFFECTIVE: IANUARY 1 1, 2007

By: ----WTW/If William T. Winsley, M.S., R.Ph., Executive Director

cc: Sally Ann Steuk, Assistant Attorney GeneralScott P. Sandrock, Attorney for Respondent; Brennan, Manna and Diamond; 75 East

Market Street; Akron, Ohio 44308

Appx. F-5

OHIO STATE BOARD OF PIEIARMA.C^.'77 South High Street, Room 1702; Columbus, OI3 43215-6126

-Equal Oppotlunily Fanplayer m,d Service Provider-

TEL: 614/466-4143 E-MAIL: exec@)borystate.oh.tio; PAX 6141752-48367TY/7'DD: Use The Ohio Relay Service: 1-800/750-0750 URL: http:/Avww.pharmacy.ohio.gov

ORDER OF THE STATE BOARD OF PHARMACY(Docket Number D-050719-005)

In The Matter Of:

MICHAEL T. DENNIS, R.Ph.7759 Aramis Street NWMassillon, Ohio 44646(R.Ph. No. 03-3-19932)

INTRODUCTION

THE MATTER OF MICHAEL T. DENNIS CAME FOR HEARING COMMENCING ON NOVEMBER 6,2006, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: JAMES E. TURNER, R.Ph. (presiding);GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.;NATHAN S. LIPSYC, R.Ph.; KEVIN J. MITCHELL, R.Ph.; HEATHER L. PASQUALE, R-Ph.; ANDDOROTHY S. TEATER, PUBLIC MEMBER.

MICHAEL T. DENNIS WAS REPRESENTED BY SCOTT P. SANDROCK. THE STATE OF OHIO WASREPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

SUMMARYOF EVIDENCE

State's Witnesses:

1. David Gallagher, Ohio State Board of Pharmacy2. Robert B. Kubasak, R.Ph.

Respondent's Witnesses:

1. Michael T. Dennis, R.Ph.2. Chad Kenneth Kanouff

State's Exhibits:

SP-1. Notice of Opportunity For Hearing letter for Strasburg Pharmacy [07-19-05]MD-1. Notice of Opportunity For Hearing letter for Michael T. Dennis, R.Ph. [07-19-051AF-1. Notice of Opportunity For Hearing letter for Amy Lynn Froman, R.Ph. [07-19-05]SP-1 A. Hearing Request letter from Scott P. Sandrock for Strasburg Pharmacy [08-08-05]MD-lA. Hearing Request letter from Scott P. Sandrock for Michael T. Dennis, R.Ph. [08-08-

05]AF-1A. Notice of Appearance of Counsel and Hearing Request letter froni Douglas E. Graff

for Amy Lynn Froman, R.Ph. [07-27-05]SP-1 B. Hearing Schedule letter for Strasburg Pharmacy [08-1 1-05]MD-1 B. Hearing Schedule letter for Michael T. Dennis, R.Ph. [08-1 1-05]AF-1 B. Flearing Schedule letter for Arimy Lynn Froman, R.Ph. [08-01-05]

Appx. G-1

MICHAEL T. DENNIS, R.Ph.Page 2Order of the Board

SP, MD-1 C. Hearing Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph.

[12-28-05]AF-1 C. Motion for Continuance letter from Douglas E. Graff for Amy Lynn Froman, R.Ph. [1 2-

1 2-05]SP-1 D. Hearing Continuance letter for Strasburg Pharmacy [01-12-06]MD-1 D. Hearing Continuance letter for Michael T. Dennis, R.Ph. [01-12-06]AF-1 D. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [12-12-05)SP, MD-1 E. Hearing Continuance Request letter for Strasburg Phannacy and Michael T.

Dennis, R.Ph. [08-31-061AF-1 E. Letter from William T. Winsley to Douglas E. Graff [12-28-05]SP, MD-1 F. Hearing Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph-

[09-06-06]AF-1F. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [01-12-06]SP-1 G. Ohio Dangerous Drug Distributor Computer Record of Strasburg PharmacyMD-1 G. Ohio Pharmacist Computer Record of Michael T. DennisAF-1G. Ohio Pharmacist Computer Record of Aniy Lynn FromanSP, MD-1 H. Copy of Subpoenas for Donna (Dana) Coutts, Dr. Edward D. DeHaas, and Bruce

Rich (10-27-06]AF-1 H. Amy Lynn Froman's Revised Request for Issuance of Subpoenas and Subpoenas

Duces Tecum [10-30-06]AF-1 I. Motion to Quash submitted by Sally Ann Steulc, Assistant Attorney General [1 1-01-06]AF-1j. Motion to Quash submitted by Amanda K. Spies, Tuscarawas County Prosecuting

Attorney [11-03-06]SP, MD-1 K. Hearing Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph.

[1 1-20-06]AF-1 K. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [11-20-06]2. Copy of Notarized Statement of Ted T. Nussbaum [01 -13-04]3. Copy of Notarized Statement of Brad White [01-28-04]4. Copy of Notarized Statement of)anine A. O'Neill [01-29-04]5. Copy of Notarized Statement of Dana I. Coutts [01-29-04]6. Eleven colored photographs [not dated]7. Copy of telephone prescriptions for Lorcet 10/650 nig and Soma 350 mg [not dated]8. Copy of letter from Erin L. Jones, Clinical Director of Professional Pain Management of

Ohio, Inc. (PPMO) to Strasburg Pharmacy [02-07-03]9. 4,159 hydrocodone/APAP 10 mg prescriptions issued by PPMO and filled at Strasburg

Pharmacy10- 4,125 carisoprodol 350 mg prescriptions issued by PPMO and filled at Strasburg

Pharmacy1 1. Transcript of Interview of Michael Dennis, R.Ph. [12-01-03]12. Transcript of Interview of Amy Froman, R.Ph. [12-04-03]14. Excel Spreadsheet of Round Trip Distances Travel Time For PPMO Patients [not dated]1 8. Pin Map of Kentucky, West Virginia and Ohio Tri-State Region [not dated]21. Excel Chart of Ohio's 2003 Top 12 Retail Pharmacies Purchasing Hydrocodone/APAP

10 mg Solid Dosage Products [not dated]24. PPMO Price Sheet [not dated]25. Excel Spreadsheet of Strasburg hydrocodone/APAP 10 mg Sales/Purchases [not dated)26. Excel Spreadsheet of Strasburg carisoprodol 350 mg Sales/Purchases [not dated]27. PPMO Price Increase Notice to Custorners [not dated]

Appx. G-2

MICHAEL T- DENNIS, R.Ph.Page 3Order of the Board

28. Dangerous Drug Distributor Inspection Report of Strasburg Pharmacy [12-01-03];

Response [12-16-03129. Dangerous Drug Distributor Inspection Report of Strasburg Pharmacy [02-12-041;

Response [02-20-04]30. Dangerous Drug Distributor Inspection Report of Strasburg Pharmacy [02-16-04];

Response [02-20-04]31. Opinion of Robert Kubasak, R.Ph. [08-04-04]; Resume of Robert B. Kubasak, R.Ph. [not

dated]32A. Copy of West Group Ohio Administrative Code (OAC) Section 4729-5-30 (Manner of

Issuance of a Prescription)32B. Copy of Code of Federal Regulation 21 CFR 1306.04 (Purpose of Issue of Prescription)32C. Copy of OAC Section 4731-21-02 (Utilizing Prescription Drugs for the Treatnient of

Intractable Pain)32D. Copy of OAC Section 4729-5-20 (Prospective Drug Utilization Review)32E. Copy of Westlaw Ohio Itevised Code (ORC) 2925.03 (Trafficking Offenses)32F. Anderson's ORC 4729.51 (Persons Who May Sell, Purchase, Distribute or Deliver

Dangerous Drugs)

Resspondent's Exhibits:A. Licensure letter from Sharon A. Prentice to Strasburg Pharmacy with attachment [06-06-

03]D. Ohio State Board of Pharmacy News, www.pharmacy.ohio.gov, August 2004F. Copy of letter from Erin L. Jones, Clinical Director of Professional Pain Management of

Ohio, Inc. (PPMO) to Strasburg Pharmacy [02-07-031G. Ohio Medical Board License Information in re Edward Douglas DeHaas,

www5.state.oh.us/med/license (09-22-03]H. Sealed List of Discharged Patients1. Excel Spreadsheet of PPMO Rx Growth at WalMart in 2003 [not dated]M-IiH. Twenty-three letters of Support 110-27-04 to 1 1-16-04]JJ. Copy of twenty-eight page Petition of Support 110-22-04 to 1 1-08-04]

FINDINGS OF FACT

After having heard the testimony, observed the demeanor of the witnesses, considered theevidence, and weighed the credibility of each, the State Board of Pharmacy finds the following

to be fact:

See attached Notice of Opportunity for Hearing letter dated July 19, 2005. Thefollowing paragraphs were dismissed on November 6, 2006 pursuant to agreement:paragraphs 33, 245, 290, 309, 315, 321, 330, 382, 386, 409, 421, 482, 554, 678,703, 718, 788, 1000, 1045, 1064, 1070, 1076, 1085, 1137, 1141, 1164, 1176, 1237,1309, 1433, 1458, and 1473.

The Board is cognizant that both rule 4729-5-21 (formerly embodied in rule 4729-5-30)of the Ohio Administrative Code and Section 1306.04 of Title 21 of the Code of FederalRegulations state that a pharmacist has a corresponding responsibility with theprescriber to ensure that a prescription is issued for a legitimate medical purpose by alicensed prescriber in the usual course of professional practice. This is axiomatic in

Appx. G-3


the pharmacy profession. This means that a pharmacist must review every prescriptionfor legitimacy and must then make a professional judgment on whether or not to fillthe prescription. Every pharmacist is accountable to this Board and to society for whathe knew or should have known due to professional training, experience, licensure, andcontinuing pharmacy education in pharmacy law. Obviously, the dispensingpharmacist need not review the prescriber's patient chart; rather, the requiredjudgment to be exercised ntust be based upon the pharmacist's extensive knowledgeand training in drug therapy, the pharmacist's knowledge of the patient (obtainedthrough profile information required by rule 4729-5-18 of the Ohio AdministrativeCode, a review of that profile as required by rule 4729-5-20 of the Ohio AdniinistrativeCode, and other discussions with the patient pursuant to rule 4729-5-22 of the OhioAdministrative Code), and the pharmacist's knowledge of the prescriber's practice,particularly as it relates to other similar practices in the region.

This pharmacist shirked his responsibilities in this regard, ignoring nunierous obviousindicators of illegal prescribing activity on the part of the physicians involved in thiscase. Some of these indicators include the large numbers of patients who drove verylong distances to come to these physicians and this pharmacy and the almost identicaltreatment of a problem (pain) that requires individualization of treatment dosages anddrugs more than any other health-related problem. individualized treatment for pain isrequired in all aspects of health care and is specifically stated in rule 4731-21-02 of theOhio Administrative Code, yet was clearly ignored by this pharmacist. Moreover, it issignificant that practically all of the patients from these prescribers paid cash for theirprescriptions instead of using insurance as is usually the case for the overwhelmingpercentage of prescriptions filled today. It is clear that this pharmacist consciouslyignored his obligations to the patients simply for monetary gain.

CONCLUSIONS OF LAW

(1) The State Board of Pharmacy concludes that each of the paragraphs in ttie Findingsof Fact constitute being guilty of gross immorality as provided in Division (A)(1) of

Section 4729.16 of the Ohio Revised Code.

(2) The State Board of Pharmacy concludes that each of the paragraphs in the Findingsof Fact constitute being guilty of unprofessional conduct in the practice of pharniacy asprovided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

(3) The State Board of Pharmacy concludes that each of the paragraphs in the Findingsof Fact constitute being guilty of willfully violating, conspiring to violate, attempting toviolate, or aiding and abetting the violation of provisions of Chapters 292S. and 3719.of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio

Revised Code.

DEC151ON OF THE BOARD

Pursuant to Section 4729.16 of the Ohio Revised Code, and after consideration of the recordas a whole, the State Board of Pharmacy adjudicates the matter of Michael T. Dennis as

follows:Appx. G-4


(A) On the basis of the Findings of Fact and paragraph (1) of the Conclusions of Lawset forth above, the State Board of Pharmacy hereby revokes pernianently the pharma-cist identification card, No. 03-3-19932, held by Michael T. Dennis effective as of thedate of the mailing of this Order.

(B) On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Lawset forth above, the State Board of Pharmacy hereby revokes permanently the pharma-cist identification card, No. 03-3-19932, held by Michael T. Dennis effective as of thedate of the mailing of this Order.

(C) On the basis of the Findings of Fact and paragraph (3) of the Conclusions of Lawset forth above, the State Board of Pharmacy hereby revokes permanently the pharma-cist identification card, No. 03-3-19932, held by Michael T. Dennis effective as of thedate of the mailing of this Order.

Pursuant to Section 4729.16(B) of the Ohio Revised Code, Michael T. Dennis rnust return hisidentification card and license (wall certificate) to the office of the State Board of Pharmacywithin ten days after receipt of this Order unless the Board office is already in possession ofboth. The identification card and wall certificate should be sent by certified mail, returnreceipt requested.

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY (Aye-4/Nay-3).

MOTION CARRIED.

SO ORDERED.

It is hereby certified by this Board that the above language is a copy of the Order enteredupon its journal in this case.

Section 1 19.12 of the Ohio Revised Code authorizes an appeal from this Order. An order thatdenied admission to an examination, or denied the issuance or renewal of a license orregistration, or revoked or suspended a license, may be appealed to the court of commonpleas in the Ohio county of your place of business or in your Ohio county of residence. Anyother order may be appealed to the Court of Common Pleas of Franklin County, Ohio.

Appx. G-5

MICIiAEL T. DENNIS, R.Ph.Page 6Order of the Board

Such an appeal, setting forth the order appealed from and the grounds of the appeal, must becommenced by filin the original Notice of_Appeal with the State Board of Pharmacy and acopy with the appropriate court within fifteen (15^__days after the mailing of this Order and inaccordance with the requirements of Section l 19.12 of the Ohio Revised Code.

BY ORDER OF THE STATE BOARD OF PHARMACY

CERTIFIED MAIL / Return Receipt7004 2510 0006 9804 6268

ORDER MAILED & EFFECTIVE: IANUARY 11, 2007

By:yTW/if William T. Winsley, M.S., R.Ph., Executive Directo.r

cc: Sally Ann Steuk, Assistant Attorney GeneralScott P. Sandrock, Attorney for Respondent; Brennan, Manna and Diamond; 75 E.

Market Street; Akron, Ohio 44308

Appx. G°6

OUlrO STATE BCYARD OF P'HAIZIVIA C'Y77 Squ`dli7Tigh titrect„7tootn 1702,.C'nhzoihtasy t)lt 43215-6126

d`y,eil iTrfeen:,tiii;'.Cmpia)sr aaS$cn ivelSnSdC- .

1:13.; 041460-41,13 1'-r431L:. eu,cubQ p;.s14dc,011.us 1:=i.t:- 61V752-1336

177V1)/3- i:'_etlie nhio-Relii}Sarvicin:3-81i0175t1-1)75Yf LHI.:-ailtpli^niw.pharm'it^-iihiu^gies•

C'1RDER OF THE STATE BOARD OF PHARMACY(Docket Num6er D-050 7 1 9-006)

1n Th"e Matter Of:

AMY LYNN EROMAN,. R.Ph.8871 Daniel Lane NW

Strasburg, Ohio 44580(R.Ph. No. 03-2716426)

INTRODUCTION

THE iv1AT1".ER OF AMY LYNN FROMAN CAME FOR HEAdtING COMMENCING ON NOVEMBER 6,2006, BEFORE THE FOLLC>WING MEMBERS OF THE BOARD: JAMES E. TURNER; R:Ph: (presiding);GREGORY [3RAYLOLilC, R:Ph,', SUZANNE R: EASTMAN, R:P.ii.; ELIZliBE'TH I. GREGG, R.Ph.;NATHAN S. LlPSYC, R.Ph.; KEVIN J. MITCHELL, R.Ph.; HEATHER L. PASQUALE, R.Ph-; ANDDOROTFiY S. TEATER, PUBLIC MEIJIBER.

AMY LYNN FROMAN WAS REPRESENTED BY DOUGLAS E. GRAFF: THE STATE OF OHIO WASREPRESENTED BY SALLY ANN S7'EUK, ASSISTANT ATTORNEY GENERAL.

SUMMA_RY_ t3F EVIDENCE

State's Witnesse5;

1. David Gallagher, Ohio State Board of Phaimacy2. Roliert B. I<ubasalt, R.Ph.

Resporident's_Witn.e5s:

1. Arny Lynn Froman, R.Ph., Respondent

State's Exhibits:

SP-1. Notice of opportunity For Hearing letter for StraSburg Pharmacy [07 19-05]MD-1. Notice ofOpportunny For Hearing7etter for Michael T. Dennis:,.R.Ph. [07-19-0s]AF•1. Notice of Opportunity Fo,r Hearing letter for Amy Lynn Froman, R.Ph. [07-19-.05]SP-1A: Hearing Request letter frorii Scott P.Sandrock for Strasburg Pharmacy [08-0f3-051MD-1 A. Hearing Request letter from Scott P. Sandrock for Michael T. Dennis; R.Ph. [08-08-

051AF-lA: Notice of Appearance of Counselaiid Hearing Request letter from Douglas E. Graff

for Amy Lynn Froman, R-Ph. [07=27-05)SP-li3. tiearlny Schedule letterforStrasurg Pharmaty [08-11-05J1vID-lB. Hearitig Schedule Ifltterfor Michael T. Dennis, R.Ph. {08-11-05]AF-1 B, Nearing 5chedule letter for Aniy Lynn Froman, R.Ph. [08-01-05]

Appx. !i®'!

Aniy Lyrrii Froman, R.Ph.Page 2Order of the Board

SP„MD-1 C. Hearing Continuance letter for Sirashurcu Pharmacy and Michael T. Dennis, R.Ph.[l 2-28-051

AF-1 C. Motion for Continuance letter frorn Douglas E. Graff for Amy Lynn Froman, t2.Ph. [1 2-12-051,

SP-1 D. Flearing Continuance letter for Strasburg Pharrnacy [01,12-06]MD I D. Hearing i3ontinuance letter for Michael T.Rennis, R.Ph. [01-1 2-06]AF-1 D. Hearing Continuance letter for Amy Lynn Froman, R.Ph. [12-12=05]5P, MD-7 E. Hearing Continuance Request letter for Strasburg Pharmacy and Michael T.

Dennis, R,PIi:, [08-31-06]AF-I E. Letter from William T. Winsley to Douglas E. GYaff [i 2-28-05]SP, tv10-1 F. Flearfng Continuance letter for Strasburg Pharmacy and Michael T. Dennis, R.Ph.

[09-06-06]AF-1 F. Hearing Continuance letter for An3yLynn Froman, R:Ph. [01 -1 2-06]SP--1 G.Ohio DaYrgerous Drug Distributor eoitiputer Recorcl of Strasburg PharmacyMD-liG. Ohio Pharmacist Computer Record of MichaefT. DennisAF-1 G- Ohio Pharmacist Computer Record of Aniy Lynn FromanSP, NfD-1 H. Copy of Subpoenas for Donna (Dana) Goutts, Dr: Edward D. DeHaas, and Liruce

Rich [10-27-06]AF-ll-{, Amy Lynn Froman's Revised Request for issuance of Subpoenas and Subpoenas

D1.ices Tecuni [10-30-06]AF-l 1. Motion to Quash submitted by Sally Anrr Steuk, Assistant Attorney General 11 1-01-06]AF-1). Motion to Quash submitted by Arnanda K. Spies, Tuscarawas County Prosecuting

Attorney [11-03-06]SP, MD-1K. Hearing Continuance letterfior Strashurg Pharmacy and Michael T. Dennis, R.Ph.

[1 1-Z0-06)AF-11<. HearingContinuance letter for Amy Lynn Fror7nan, R.P.It. [7 1-20-06)2. Copy of Notai'ized Statementof Ted T. Nussbaum [01 1 3-04]3. Copy of Notarized Statement of' Brad White [01 2t3-Q4],4. Copy of Notarized Statement of)anine A. O'Neill [0] •29•04]5. Copy of Notarized Statement of Dana I. COUtts [01-29-04]6. Eleven colored photographs [not dated)7. Copy of telepl7one prescriptions for Lorcet 10/650 mg and Soma 350 mg [not dated]8. Copy of letter fron7 frirt L. Jones, Clinical Director of Professional Pain Management of

Ohio, inc. (PPMO) to Strasburg Pharmacy [02-07 03]9. 4,1 59 hydrocodone/APAP 10 mg presci'iptions issued by PPMO and filled at Strasburg

Pharmacy10. 4,125 carisoprodol 350 tng prescriptions issued by. PPMO and filled at Strasiiurg

Pharmacy1 1. Transcript of Interview of Michael Dennis, R.Ph. [12-01-03]12. Transcript of Interview of Amy Froman, R.Ph. [12-04-03]14. Excel Spreadsheet of Round Trip Distances TravefTime For PPMO Patients [not dated]18. Pin Map of Kentucky, West Virginia and Ohio Tri-State Region [not dated]21. Excel Chart of Ohio's 2003 Top 12 Retail Pharniacies Purchasing Hydrocodone/APAP

10 mg Solid Dosage Produets [not datecl)24. PPMO Price Sheet [not dated)25. Excel Spreadslieet of Strasbtirg hydrocodorie/APAP 10 rng Sales/Purchases [not dated]26. Excel Spreadsheet of Strasburg carisoprodol 350 ntcj Sales/Purchases [not dated]27. PPMO Price Increase Notice to Customers [not dated]

Appx. H-2

Amy Lynn Frornan, R.Ph.Page 3Order of the Board

28. Dangerous Drug Distributor Inspection Report of Strasburg PharmacyResponse 112-16 03]

[12-01-03];

29. Dangerous Drug Distributor Inspection Report of Strasburg PharmacyResponse (02-20-041

[02•12-04];

30. Dangerous Drug Distributor Inspection Report of Strasbmrg Pharmacy [02-16-04];

Response [02 20-04)31. Opinion of Robert Kubasak, R..Ph. [08-04-04]; Resunie of Robert B. Kubasak, R.Ph. [not

dated]32A. Copy of West Group Ohio Adrniriistrative Code (OAC) Section 4729-5-30 (Manner of

lssuance of a Prescription)3213. Copy of Code of Federal Regulation 21 CFR 1306.04 (Purpose of Issue of Prescription)32C. Copy af OAC Section 4731°21-02 (Utilizing Prescription Drugs for the Treatntent of

lntractable Pain)32D. Copy of OAC Section 4729-5-20 (Prospective Qrug Utilization Review)32E. Copy of Westlaw Ohio Revrsed Code (ORC) 2925.03 (Trafficking Offenses)32F. Anderson's ORC 4729.5.1 (Persons Who May Sell, Purchase, Distribute or De[Ever

Dangerous Drtrgs)

Respondent's Exhibits_

A. Resume of Amy Lynn FromanF. Sealed Medical i-iistoriesG. Seventy-two Letters of Support 110-19-04 to 12-06-061H. Copy ofthirty-twopage Pet3sfon of Support 110-22-04 to 11-11-09]

FINDING5^0F FACT

After having heard the testimony, observed the demeanor of the witliesses; consldered theevidence, and weighed the credibility of each, theStaCe Board of Pharniacyfinds the following

to be fact^

See attached Notice of Opportunity for Nearing letter dated )uly 19, 2005. Thefollowing paragraphs were dismissed on November 6, 2006 pursuant to agreement:paragraphs 33, 245, 290, 309, 315, 321, 330, 382, 386, 409, 421, 482, 554, 678,703, 718, 788, l OQO; 1045, 1064, 1070, 1076, 1085, 1137, 1141, 1164, 1176, 1237,

1309, 1433, 1458, and 1473.

The Board is cognizant that both rule 4729-5-21 (formerfy embodied in rule 4729-5-30)of the Ohio Administrative Code and Section 1306.04 of Title 21 of the Code of FederalRegulations state that a pharmacist lias a correspondincd responsibility with theprescriber to ensure that a prescription is issued for a legitimate medical purpose by alicensed prescriber in the usual course of professional practice. This is axioniatic inthe pharmacy profession. This tneans that a iihanracist.mustrevSew every prescriptionfor legitimacy and must then make a professionaf judgment on whether or not to fillthe prescription. Every pharmacist is actountable to this 8oard and to society for whatshe knew or should have known due to professional tralning, experience, licensure,and continuing pharmacy education in phai-macy law. Obviously, the dispensingpharniacist need not review the prescriber's patient cliart; rather, the requiredjudgriient to be exercised niust be based upon the pharmacist's exterisive knowiedgeand trainirig in drug therapy, the pharmacist's luiowledge of the patient (obtained

Appxo H-3

Arny t-yrin Froman, R.Ph.Page 4-Order of the Board

through profile information required by rule 4729-5-18 of the Ohio AdministrativeCocle, a review of that profile as required by rule 4729 5-2p of the Ohio AefministrativeCode, and other discussions with the patient pursuant to rule 4729-5-22 of the OhioAdrtiinistrative Code), and the pharniacist's knowledge of the prescriber's practice,particularlyas it refates to,other similar practices in theregion.

This pharmacist shirked her responsibilities in this regard,ignoring. numerous obviousindicators of illegal prescribing activity on the part of the physieians involved in thiscase. Sorrie of these indicators include the large numbers of patients who drove verylong distances to come to these physicians and this pkiarmacy andthe almost identicaltreatment of a pro}ilem (13ain)that requires individualization af treatment do;sages anddr4gs more than any, other health-relatecl problem. Indiviclt,ralized treatment for pain isrequirad in a1 11 aspectsofhealth care and is specifically stated in rule 4731-2102 of theO(iio Administrative Code, yet was clearly ignored by this pharmacist. Moreover, it issignificant that practically all of the patients from these prescribers paid cash for theirpres'criptions instead qf using insurance as is usually the case for the overwhelmingpercentage of prescriptiorss filled today. It is clear that this pharmacist consciouslyignored:her obligations to the jratients.

CONCLUSlONS OF LAW

(1) Y'he State Board of Pharmacy concludes that each of the, paragraphs In the Findingsof Fact constitute being guilty of gross immorality as provided in Division (A)(f) ofSection 4729.16 of the Ohio Revised. Code.

(2) The State Board of Pharmacy concludes that each of the paragraphs in the Findingsof Fact constitute being_guilty of unprofessional conduct in the practice of pharmacy asprovided in Division (A)(2)of^Section 4729.1-6 of the Ohio Revised Code.

(3) The State Board of Pharmacy concludes that each of the paragraphs in the Findingsof Fact constitute being guilty of willfully violating, conspiring to violate, attempting toviolate, or aiding and abetting the violation of provisions of Chapters 2925. and 3719.of the Revised Code as provided, in Division(A)(;) of Section 4729.16 of the Ohio

Revised Code.

DEC1Sf©N OF THE. [30ARD

Pursuant to Section 4729.16 of the Ohio Revised Code, and after consideration of the recordas a whole, the State Board of Pharrnacy hereby suspends for three years the pharmacistiderrtification card, No. 03-2-16426, held by Amy Lynn Frornan and such suspertsion is

effective as of the date of the mailing of this Order.

(A) Aniy Lyiin Frornan, pursuant toRule 4729-9-01(F) of the Ohio Administrative Code,may not be employed by or work in a facility licensed by the State Board of Pharmacyto possess or distribute dangerous drugs during such period of suspension.

(B) Amy Lynn Froman, pursuant to Section 4729-.16(B) of the Ohio Revised Code, mustreturn her identification card and lice_iise (wall certificate) to the office of the StateBoard of Pharmacy within ten days after receipt of this Order unless the Board office is

Appx. H-4

Atny Lynrr Froman, R.PIt.Page SOrder.of the ¢oard

already iri possession of both. The identification card attd wal.l cettificate should beserit by certrfied mail, return receipt requestec.

(C) Amy Lynn Frornan must; within six,nionths precedfng reinstatement, take and passthe Multistate Pharniacy Jcrrisprudence Examination, or an equivalent examinationapproved by the Board, and submit documentation of this to the Board office. If Ms.Froman does not pass ttie examination within tt e six-month period, her license willremain.suspended.until this condition has been achieved.

`11-11S ORDER WA5 APPROVED BY A VOTE OF THE STATE BOAR6 OF PHARMACY (Aye-5/iJay-2).

MO7lON CARRIED.

SO ORDERED.

it is hereby certifiecl by this Board that the above ianguag:e is a copy of the Order enteredupon its journal in thfs case:

Sectiori 119.12 of the Ohio Revised Codeauthorizes an appeal from this Order. An order thatdenied admission ta ah examination, or denied the issuance or renewal of a license orregistration, or revoiced or suspended a license, may be appealed to the court of coninionpleas in the Ohio county of your place ofbusiness or in your Ohio county of residence. Anyother order may be appealed to tlie Court of Comniora Pleas of Kranldin County, Ohio.

Such an appeal, settfnpfortlt the order appealed from and the grounds of the appeal, must beconimenced by filing the oriainal Notice of Alipeal with the State Board of Pharmacy and acopy with the appropriate court wiihin fifteen (15) days after the mailin^c of ttlis Order and inaccordance with the requirements of Section 119.12 of the Ohio Revised Code.

BY ORDER OF l-tiE STATE BOARD OF PHARMACY

ORDER MAILED & EFFECTIVE:,___.IANUARY 11,_2007

CER'I'IFIED MAIL / ReturnReceipt7004 2510 0006 9804 6237

uy. -___--_-_^-

^y3^jf william7.Ydinsley, M.5„R.Ph., Executive Director

cc: Sally Ann Steul<, Assistant Attorney GeneralDouglas E. Graff, Attorney for Respondent; Graff & Associates, L.P.A.; 604 East Rich

Street; Columbus, Oliio 4321 S

Appx. H°5

strasburg v. state bd. of pharmacy, case no. 2007 … of appeals failed to articulate how the trial...

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