·Jul 23 2008 8I11PM .• LASERJET F"AX p,4

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STATE OF FLORIDA

DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH,

Petitioner, ·

V,. DOH case No. 2007 17831

BARRY M. SCHULTZ, M.D.,

R.espondent.

ADMIN1STRATIVE COMPLAINT

COMES NOW, Petitioner, Department of Health, by and thr ugh Its undersigned counsel, and flies this Administrative C@mplaint before the Board of Medicine against Respondent, Barry M. Schultz, M.O., and in support thereof alleges:

1. Petitioner is the state department charged with regulating the

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   practice of medicine pursuant to Section 20.43, Florida Statutes.; hapter 456, Florid Statutes; and Chapter 458, Florida Statutes,

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2. At all times material to this Complaint, Respondent !Was a

licensed physician within the State of Florida, having been issued '!license

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number ME 67047.

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3. Respon.de t's. adcfress....of record is "ii3Hi"s· Via ··ri,1'0nte-vercle

Drive, Delray Beach; Florida 33446,

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4. On or about Januc1ry 15; 2006; Respondent dlagnosei:J patient

s,c, with lumbar radiculopathy, insomnia; neck pain and anxiety. !

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: 5. On or about January 16, 2006, Respqndemt prescribed 180, 80 milligram tablets of Oxyc:ontin; 400, 30 milligram tabl ts.of Oxycodpne; and 30, 20 mg/ml solutions of ETH·Oxydose.

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1. Oxycohtin Is a semi-synthetic opiate that contains oxycodone hydrochloride, a schedule II controlled substance defined In chapter 893;

   Florida Statutes, which is Indicated for the relief -of moderate to severe

   pain. Oxycodone has a high potential for abuse and has a urrently accepted but severely restricted medical use in treatment in th United States, and abuse of o,cycodone ·may lead to severe psychol gical or · physical dependence.

2. ETH·Oxydose is a high strength concentrated liquid whose active ingredient is Oxycodone Hydrochloride.

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3. · Respondent allegedly treated patient s.c. approximatJly forty-

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eight (48) times from January 16, 2006, to November 20, 2007.

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. ·9; .. Bet:ween January·· 16; 2006,.. and··· Novem"t:i'er Zin,. ·2007 . Respondent prescribed patient S.C. approximately 11040 !units of

Oxycodone.

1. Betvveen January 16, 2006, and November 2 , 2007,

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   Respondent prescribed patient s.c. approximately 3780 units of O>tycontin.

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2. Between Januery 16, 2006, and November 20, 2007, Respondent prescribed patient s.c. approximately 2700 doses of ETH· O>:ydose.

3. Additionally, between June 4, 2006, and November 20, 2007, Respondent prescribed to patient S.C. approximately 390 Actlq l200mcg lozenge's,

13, Actiq is a. schedule II controlled subst;ance listed in Chapter 893, Florida Statutes. Actiq is a lozenge or popsicle that delivers f ntanyl through the tissues .in the mouth and Is prescribed to treat severe pain.

Fentanyl Is an opioid drug that can decrease mental alertness amd affect

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j.udgment. Fenta.nyl has a high potantial for abuse and has a currently

accepted but severely restricted medical use in treatm.ent in the!

United

States, and abuse of the substance may lead to severe psychol gical or

physical dependence.

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i4: Additfonally, between June· 3d,··2666,· and Novem6er"2o; 200.7,

Respondent prescribed to patient s.c. approxrmately 1900 350mg Carisoprodol tablets.

1. Carisoprodo1lcommonly known by the brand name Sorrja, is a muscle relaxant prescribed to treat muscular pain. According to !Chapter 893, Florida Statutes, Carlsoprodol ls a schedule IV controlled si.jbstance

   that has a low potential for abuse relative to the substances in schedule III

   and has a currently accepted medical use ln treatment In the Uniteq States, and abvse of Carisoprodo! may lead to limited physical or psycliological dependence relative to the substances in schedule III.

2. During the period that Respondent treated patient S.C,, he

   
   

   failed to adequately assess and/or diagnose patient S.C!s complain. .

3. During the period that. Respondent treated· patient s' .c.l he

   failed to document and monitor patient S.C.'s progres:s.

4. During the period that Respondent treated patien't s.c.,

   Respondent never attempted or considered any other treatment option for patient S,C.' pain.

   
   

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   During the. period that Res·ponderif treated pat1elnf· s.c.,

   
   

   Respondent never attempted to obtain additional information a out the patient's cause of alleg·ed Injury:

   1. During the period that Respondent t eated pat1e1nt s.c.,

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      Respondent never attempted to obtain diagnostic ima ing studies to obtain

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      information about patient s.C.'s pain and or ii:,jury.

   2. During the period that Respondent t$ated patiert S.C.:.,

      Respondent failed to perform testing such as urine drug screens arnd/or pill

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      counts to confirm that patient s.c. was taking prescribed.

      
      

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      the medications as

   3. During the period that Respondent treated patient S.C.,

Respondent never documented' a diagnosis which justified pr sc:rfbing

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these medications.

23, Respondent never attempted to obtain patient S.C.'s preyious

treatment records.

1. · P..espondent's treatment notes contain nearly identical en ries for each visit including descriptions For patient's history, of present Illness and review of symptoms.

   
   

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2. Petitioner realleges and incorporates paragraphs one (1) through twenty-four (24) as if fully set forth herein.

1. Section 458,331(1)(q), Florida Statutes (2006)(2.007), subjects

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   a licensee to discipline, including suspension, for prescribing, dispensing,

   administering, mb:lng, or otherwise preparing a legend drug, inclu ing any

   controlled substance, other than· in the cours · of the· ph sician's professional practice. For purposes of this _paragraph, it· shall be'

   legally

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   presumed that prescribing, dispensing, administering, mixing, or ·otherwise

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   preparing legend drugs, including all controlled substances, inappr<bpriately

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   . or in excessive or inappropriate quantities, is not In the b st Interest of the patient and is not in the course of the physician's professional practice, without regard to his Intent.

   1. Respondent prescribed, dispensed, administered, mixeJ, or . otherwise prepared a legend drug, other than in the cours of his professional practice, from in or around January 16, 2006, .through in or

      around April 30, 2007, in Delray Beach, Florida, by inappr4>prlately

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      prescribing, prescribing excessive or inappropriate quantities, dis enslng,

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      or administering a legend drug, to-wit: Oxycodone, Oxydose, Actiq, and

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      Car/sciprodol, to patient s.c., without adequately· assessln' ; and/o'r

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      diagnosing patient S.C.'s complaints; and/or without documenti g and/or

      
      

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      monitoring patient S.C.'s progress; and or without ever obtainln patient

      s.c:s previous treatment records; and or without attempting o obtain

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      diagnostic imaging studies to obtain information about patient s.¢.'s pain; and/or without performing testing such as urine drug screens arjd/or plll

      counts to confirm that patient S.C, was taking 1the medica ons as

      prescribed,

      
      

   2. Based on the forgoing, Respondent viofated Section

      
      

      458,331(1)(q), Florida Statutes (2005)(2007), when he pre crfbed,

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      dispensed, administered, mixed, or otherwise prepated a legen drug,

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      including any controlled substance, other. than In the course ': of his

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      professional practice by prescribing to patient s.c., Oxycodone, O contin,

      Oxydose, Actiq, al'ld Carisoprodol, without adequately assessing 1,and/or

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      diagnosing patient S.C.'s corriplaints; and/or wit out documenting land/or monitoring patient S.C.'s' progress; and/or without ever obtaining patient

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      S.C's previous treatment records; .and/or without attempting to i 1 obtaln

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      diagnostic imaging studies to obtain tnformatlon about patient s.c.is pain

      
      

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      arid/or without performing testing such as urine drug screens· and)or plll

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      counts···-to·· confirm that. patient sf..t.

      prescribed.

      
      

      was taki'ng the medlciatioiis as .

      
      

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   3. Petitioner realleges and incorporates paragraphs I one (1)

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      through twenty-four (24) as if fully as If fully set forth herein. ',

      
      

   4. Section 458.33l (l )(nn) 1 Florida Statutes (200 )(2007),

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      provides that violating any provision of chapters 456 o 458 Florida

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      Statutes, or any rules adopted pursuant thereto, is grounds for dlsqlpflne by

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      . the Board of Medicine,

   5. Rule 64B8-9.013(3), Florida Administrative Code, provides

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      · standards for the se of controlled substances for pain control. !, Those

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      standards require that a complete medical history and physical exam' /nation be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current amd past treatments for pain, underlying or coe)(fstlnQ diseases or conditiohs, the

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      effect of the pain on physical and psychological function, and history of substance·: abuse. The medical record also should document the prtsence of one or more recognized med!cal indications for the use of a controlred substance.

      
      

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      ..... · 32:···-As set forth ·above,..Resp6ndenf vii:ifated'thif standa"t s fof fhe

      use of controlled substances for pain control by prescribing Ofycodone,

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      O><-ycontin,. Oxydase, Actiq, and Carisaprodol, to patient S.C.1 without documenting the nature and intensity of the paln, current nd past

      treatments for pain, underlying or coexisting diseases or conditjions, the

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      effect of the pain on physJcal and psychological function, h,story of

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      substance abuse· and without performing testing such as uriine drug screians and/or pill counts to confirm that patient S.C. was ta ing the medications as prescribed.

      1. Based on the foregoing, Respondent violated Section

         458.331(1)(nn), Florida Statutes, by violating Rule 64,BB-9.013(3) Florida

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         Administrative Code, by prescribing Oxycodone, Oleydose, Actiq, and

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         Cari'soprodol, to patient S.C., without documenting the nat1,.1re and i tensity_

         of the pain, current and past treatments for pain, underlying or co xlstfng

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         diseases or conditions, the effect ·of the pain on physical and psych logical

         function, history of substance abuse and without performing testing such

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         as urine drug screens and/or pl/I counts to confi m that patient S.C, was ·

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         taking the. .medications as prescribed.

         
         

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      2. Petitioner realleges and Incorporates paragraphs, through twenty-four (24) as if fully set forth therein.

         one (1)

      3. Section 458.331(1)(t)1 1 Fforida Statutes (2006)(2007), provides

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         that committing medical malpractice constitutes grounds for di ciplinary

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         action by the Board of Medicine, Medical Ma/practice, is defined I Section

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         4S6.50, Florida Statutes (2006)(2007), to mean th"' failure to': practice

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         • medicine in accordance with the. level of care, skill, and tieatment

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           recognized in general law related to health care Ucensure, For pu poses of

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           Section 458.331(1)(t)1, Florida Statutes ( 2006) (2007)1 the Board shall give

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           great weight to the provisions of Section 766.102, Florida Statutes, which

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           provide that the prevalling professlonaf standard of re for a

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           giveh

           health

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           care provider shall be that level of care, sklll, and treatment which) rn light

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           of afl relevant surroundin·g circumstances, Js recognized as accept ble and

           appropriate by reasonably prudent similar health care providers.

      4. Respondent committed . medical malpractice by failing to practice medicine In accordance with the lever of care, skill, and tr$tment which, In llght of,all relevant surrounding circumstanc$s, is recogniized as

         
         

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         acceptable ·and· -- ai:iiiro.pr,ate ·hy""'reasonaEilv··prudent ...s,mUar•..·i:;Ja11:11··ca"re -

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         providers in one or more of the following ways:

         1. by faillng to obtain or review patient S.C/i previdus treatment records; and/or

            b, by falling to adequately assess and/or diagnose atient

            S.C.'s complaints; and/or :

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            1. by falling to document and/or monit¢>r patient S.¢.'s

               progress;

               
               

            2. by falling to obtain patient S.C.'s previous treatment records; and/or

            3. by falling to obtain diagnostic imaging studies to btain

            Information about patient S.C.'s pain;: and/or '

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            · f. by failing to consider other treatment options for fatl12nt S,C, other than the prescription of pain me icatlon; a r \

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            g. by failing to perform testing such as ; rlne drug screens and/or pill counts to confirm that patient S.C. w s taking the medications as prescribed.

      5. Based· on the forgoing, Respondent vfolated ·: Section 458,331(l)(t), Florida statutes (2006)(2007), by 'falling to \practice medicine with that level of care, skill, and treatment which is recog ized by

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         a reasonably prudent simlrar physician as being acce[Otable unde11 similar conditions and circumstances.

         
         

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         ....... "coi/NT,.FOUR··· ,.' " .. ··-·-·. ' •-;--••--. -····· ...' '

         
         

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         Petitioner rea"/leges and incorporates .. paragraphs! one (1)

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         through twenty-four (24} as If fully as If fully set forth herein.

         
         

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      7. Section 458.331(1)(m), Florfda Statutes (2006)(2007), sets forth

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         grounds fot discfplinary action by the Board of Medicine for fai/in9 to keep

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         legible medical records that justify the course of tream,ent of thi patient,

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         including, but not lfmlted to, patient histories; examination reswlts; test

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         results; records of drugs prescribed, dispensed or adminfsterrad; and reports of consultations and hospltaltzatrons.

      8. Respondent failed to keep legible medical re rds that ju$t!fy the

         • co.urse of patient s.c:s medical treatment in one or more of the fl' f)Howlng ways:

         1. by failing to document review ofpatient S.C.'s prevl((ws treatment rei::ords; and/or

            
            

            b, by faillng to document that"he adequa ly assessed bnd/or diagno ed patient S.C.'s complaints; an<lf/or ·

            
            

            
            

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            c, by fafl/ng to document and/or monitoring patient S.O.'s

            progress; and or · · ·

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            d, by faillng to document any diagnostic imaging studie to obtain information. about patient S.C.'s pafn; and/cir

            e. by failing to document other treatment Options fat p<1tlent S,C. other than the prescription of pain medication; and/or

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            F. by faifing to document the presence of one or mtjre recognized medical indications for the use of a controlled substance; and /or ·

            
            

            g. by falling to document testing such as urine drug creens a;nd/or pl/I counts to confirm that p tient S.C. s taking the medications as prescribed. '

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      9. Based on the foregoing, Respondent violated'! Section

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458.331(1)(m), Florida Statutes (2006)(2007), by falling to keep legible

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medical records that justify the course of patient S.C.'s medical tre tmel'tt.

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WHEREFORE, Petitioner respectfully requests that the oard of

. Medicine enter an order tmposlng one or more of th following prnalties:

permanent revocation or suspension of Respondent's license, restriction of

pradlce, imposition of an administrative fine, issuance of a reArimand,

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placement of the Respondent on probation, correctllie action, refund of

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fees billed or collected, remedial education and/or any other relief hat the

Board deems appropriate.

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SIGNED t ]s 26th day of June, 2009.':

Ana M. Viamonte Ros, M.D., M,P.H.

State Surgeon General

7'-l.2;,.,-1

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·.; 't/'""I,;,

. F'ILEO DEPARTMENT OF HEALTH

/71?.EP,,.UJ}'.<;;i.Rid-1••

CLERK '--

JJATI •"l,..q, 01:\

Kevin G. Neja · •

Assistant General <;:ounsel DOH Prosecutlon S rvices Unit

4052° Bald Cypress Way, Bin c- s Tallahassee, FL 32,399-3265 1 Florida Bar No. 070'i129

(850) 245-4640

(8S0) 245-4681 Fa<JSfmile

PCP Date: June 26, 2009

PCP Members: El-Bahri, Winchester and Levine

KGN/sdw

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Docket for Case No: 11-001679PL