Laurence T. McKinney; Revocation of Registration

Tag : CF Jacket
Laurence T. McKinney; Revocation of Registration

Released : Thursday, July 24, 2008 9:36 AM
DEPARTMENT OF JUSTICE (DOJ)
Drug Enforcement Administration (DEA)
Citation: "73 FR 43260"
Document Number: "Docket No. 08-29"
Page Number: "43260"
"Notices"
On February 5, 2008, I, the Deputy Administrator of the DrugEnforcement Administration, issued an Order to Show Cause andImmediate Suspension of Registration to Laurence T. McKinney, M.D.(Respondent), of Philadelphia, Pennsylvania. The Order immediatelysuspended and proposed the revocation of Respondent's DEACertificate of Registration, BM7201267, as a practitioner, on thegrounds that his continued registration was "inconsistent with thepublic interest" and "constitute[d] an imminent danger to publichealth and safety." Show Cause Order at 1 (citing 21 U.S.C.824(a)(4) & 824(d).
More specifically, the Show Cause Order alleged that Respondentwas "one of the largest prescribers of schedule II controlledsubstances in the Philadelphia area[,]" and that "[f]rom October 5,2004 to November 30, 2007 [had written] 3,101 prescriptions forschedule II narcotics." Id. Next, the Show Cause Order alleged thatRespondent sold prescriptions for narcotics for $100 perprescription, that he had issued prescriptions to undercover lawenforcement officers on five separate dates between December 14,2007, and January 30, 2008, that he had either failed to perform aphysical examination or had conducted only a "cursory physicalexamination" on the Officers, and that he had also written aprescription for one of the undercover Officer's fictitious wife.Id. at 1-2. The Show Cause Order further alleged that these"prescriptions were not issued for a legitimate medical purpose orin the normal course of professional practice" and thus violatedboth Federal and state laws and regulations. Id. at 2 (citing 21U.S.C. 841(a); 21 CFR 1306.04(a).
Based on the above, I also made the preliminary finding thatRespondent had "deliberately diverted controlled substances" andthat his "continued registration during the pendency of theseproceedings would constitute an imminent danger to the publichealth or safety because of the substantial likelihood that [hewould] continue to divert controlled substances." Id. at 2. Itherefore also ordered the immediate suspension of Respondent'sregistration. Id.
On February 15, 2008, Respondent, through his counsel, requesteda hearing on the allegations. ALJ Ex. 2. The matter was assigned toAdministrative Law Judge (ALJ) Mary Ellen Bittner. Followingpre-hearing procedures, a hearing was held on April 7, 2008 inArlington, Virginia, at which both parties introduced testimonialand documentary evidence. /1/ Upon conclusion of the hearing, bothparties submitted briefs containing their proposed findings,conclusions of law and argument.
FOOTNOTE 1 The Government also introduced recordings of severalundercover visits. END FOOTNOTE
On May 5, 2008, the ALJ issued her recommended decision (ALJ).In her decision, the ALJ specifically rejected Respondent'stestimony regarding his prescribing to the undercover patientsfinding that he was not credible. ALJ at 29. With respect to factortwo (Respondent's experience in dispensing controlled substances),the ALJ concluded that "the record establishes * * * thatRespondent issued prescriptions to the undercover Officers forcontrolled substances without any meaningful physical examinationor gathering sufficient information from the patients to arrive ata reasoned diagnosis or * * * to determine whether they had anycondition at all warranting treatment with the drugs he prescribedto them." Id. at 29-30. The ALJ thus found "that all theprescriptions Respondent issued to the undercover officers were notissued for a legitimate medical purpose." Id. at 30.
The ALJ further noted that various patient files introduced intoevidence by the Government demonstrated that Respondent had notprovided "individualized attention" to other patients. Id.Relatedly, while noting that Respondent had "introduced intoevidence patient files containing considerably more detailedinformation than those the Government offered," the ALJ reasonedthat even if these files showed that Respondent had "legitimatelytreated" some patients, the files predated November 26, 2007, thedate on which the Philadelphia Police Department had received acomplaint about Respondent and did not "diminish the weight of theevidence that he improperly prescribed controlled substances afterit." Id.
With respect to factor four (Respondent's compliance withapplicable laws), the ALJ concluded that Respondent had failed tocomply with Pennsylvania law because he had issued prescriptionsfor controlled substances without doing proper physicalexaminations, taking adequate medical histories, documenting thepatient's symptoms, his diagnosis and treatment recommendations,and that he had failed to counsel his patients regarding how thedrugs should be taken, the appropriate dosage, and their sideeffects. Id. at 31. The ALJ thus concluded that "Respondentviolated applicable Pennsylvania law and also violated 21 CFR1306.04, and thereby 21 U.S.C. 829(b)." Id.
With respect to factor five (other conduct), the ALJ rejectedRespondent's contention that he had prescribed pursuant to agood-faith belief that the undercover patients were in pain. Id.More specifically, the ALJ expressed her disbelief "that Respondentdid not know that the undercover Officers were not in pain but weretrying to obtain controlled substances for other than a legitimatemedical reason." Id. at 31. The ALJ further found that Respondenthad "refus[ed] to acknowledge his wrongdoing," and that there was"little hope" that "he will act more responsibly in the future."Id. /2/
FOOTNOTE 2 The ALJ also found that Respondent had retained hisstate medical license and that this factor supported a finding"that his continued registration would be in the public interest."ALJ at 29. The ALJ explained, however, that this factor was notdispositive because "state licensure is a necessary but notsufficient condition for DEA registration." Id. The ALJ furtherfound that while Respondent had been convicted of a felony, hisoffense did not involve an offense related to controlledsubstances. Id. at 30-31. The ALJ thus found that this factorsupported his continued registration although it too was notdispositive. END FOOTNOTE
Based on her findings with respect to three of the factors, theALJ concluded "that Respondent is unwilling or unable to accept theresponsibilities inherent in a DEA registration." Id. at 32. TheALJ thus recommended the revocation of Respondent's registrationand the denial of any pending applications. Id.
Respondent filed exceptions to the ALJ's recommended decision.In this filing, Respondent raised thirty-three exceptions to theALJ's decision. /3/ Thereafter, the record was forwarded to me forfinal agency action.
FOOTNOTE 3 Respondent's Exceptions did not, however, comply withDEA's regulation which requires citation to evidence of recordwhich supports the exception. 21 CFR 1316.66(a). END FOOTNOTE
Having considered the record as a whole, as well as Respondent'sexceptions, I hereby issue this Decision and Final Order. While Ido not adopt the ALJ's factual findings in their entirety, I adoptthe ALJ's ultimate conclusions of law with respect to each of thestatutory factors and her recommended sanction. I make thefollowing findings of fact.
Findings
Respondent is a medical doctor who treats injury and traumapatients, as well as weight loss patients, at a clinic he operatesin Philadelphia, Pennsylvania. Tr. 19-21. While Respondentpreviously held board certification in obstetrics and gynecology,he is no longer "board certified in anything." Id. at 21.
In February 1998, Respondent pled guilty in Federal Court to twocounts of mail fraud based on fraudulent billing practices. Id. at48. Respondent was sentenced to a term of imprisonment of twelvemonths and one day which he served at the Federal CorrectionalInstitution at Loretto, Pennsylvania, and in a halfway house. /4/Id. at 48-49; 266-67.
FOOTNOTE 4 In March 2000, the State of Pennsylvania suspendedRespondent's medical license for a period of four years based onhis mail fraud convictions. Tr. 267. The State, however, stayed thesuspension after nine months. Id. Shortly thereafter, Respondentwas granted a new DEA registration. GX 1, at 2. END FOOTNOTE
Respondent currently holds DEA Certificate of Registration,BM7201267, which before I suspended it, authorized him to handlecontrolled substances in schedules II through V as a practitionerat his registered location of 7514 Frankford Avenue, Philadelphia,Pa. GX 1, at 1. Respondent's registration does not expire untilJanuary 31, 2010. Id.
On November 26, 2007, the Philadelphia Police Departmentreceived a citizen's complaint which alleged that Respondent wasprescribing controlled substances such as Xanax (alprazolam), andPercocet, a drug which contains oxycodone and acetaminophen. /5/ GX48. More specifically, the caller alleged that "all theneighborhood kids know about" Respondent, that all one had to do toget an appointment was to call his office and possibly tell himthat "you were referred by a neighbor," that "the Doctor will tellyou to come in and tell you to bring $100," and that "[t]ell thedoctor you have some type of aliment [sic] and he will write you aprescription for Xanax, Percocet, Oxycodone etc." Id.
FOOTNOTE 5 Oxycodone is a schedule II controlled substance andderivative of opium. 21 CFR 1308.12(b)(1). Xanax is the brand nameof alprazolam, a schedule IV controlled substance. See id. SEC1308.14(c). END FOOTNOTE
Upon receipt of this tip, the Philadelphia Police Department'sIntensive Drug Investigation Squad (IDIS) contacted DEA'sPhiladelphia Diversion Group, which had also received complaintsabout Respondent from local pharmacists. Tr. 154. As part of theirinvestigation, the decision was made to have several IDIS membersattempt to obtain prescriptions from Respondent. Id. at 83-84.
The First Undercover Visit
On December 6, 2007, an undercover Officer using the name ofNicole Hodge went to Respondent's office. Id. at 130. The Officerpaid Respondent $100 in cash and told him that she had not been inan accident and did not have an injury but wanted a prescriptionfor Percocet. Id. Respondent attempted to get the Officer to talkabout an injury but she refused to. Id. Respondent refused to issuethe prescription and told her to leave his office. Id. at 131.Respondent subsequently noted in Nicole Hodge's patient file that"Pt. lied, Ask for Percocet. Patient is not injured." GX 23.
The Second Undercover Visit
On December 14, 2007, another IDIS Officer, who used the namedAnthony Wilson, visited Respondent. After paying $100 in cash,Respondent asked the Officer whether he had been in an accident./6/ Tr. 86. The Officer stated that he had been. Id. Respondentthen asked the Officer some unspecified question about pain; thelatter answered that he "hurt all over." Id. at 86-87. Moreover,the evidence includes a medical history form on which the Officerindicated as his complaint: "Hurt All Over," that the location ofhis condition was "all over," and that its severity was "bad pain."GX 22, at 7.
FOOTNOTE 6 According to the record, Respondent would instructhis "patients" when they called for an appointment that they shouldhave cash. Tr. 92. END FOOTNOTE
According to the DEA Special Agent who debriefed the Officer,the latter did not exhibit any signs of injury and Respondent didnot ask him to rate his pain level on a scale of one to ten. Tr.87. The Officer reported that Respondent's physical examination waslimited to touching him lightly on the shoulder and back; moreover,Respondent did not listen to his heart and lungs, and no one tookhis blood pressure. Id. at 88.
Respondent did not order any diagnostic tests such as an x-rayor mri. Id. at 198. Respondent nonetheless diagnosed the Officer ashaving back and neck contusions and prescribed to him 90 Percocet(10 mg.), 60 Xanax (1 mg.), and 60 Cataflam, a non-controlledsubstance. Id. at 89; GX 16. The prescription indicated that thePercocet should be taken every eight hours as needed for pain andthat the Xanax should be taken every twelve hours as need formuscle spasms or anxiety. GX 16, at 2. Respondent did not, however,counsel the Officer regarding the dosing and frequency of takingthe drugs, the drug's potential side effects and its interactionswith other drugs. Tr. at 92.
Another form in the patient file indicates that the Officer'sblood pressure was 120/82, as well as a height and weight. GX 22,at 5. Under the heading of "history of pertinent facts," the formappears to state: "Passenger in MVA driver side" and "8/10 painscale." Id. Finally, another form entitled "ROM--AMA Guides" has anotation of "+2" in the blocks for "Cervical Spine," "Dorsal Spine"and Lumbar/Sacral." Id. at 6.
While Respondent testified that either he or a nurse had takenthe Officer's blood pressure, Tr. 312-13, the ALJ specificallycredited the testimony of the DEA agent /7/ regarding the variousundercover visits and rejected Respondent's testimony pertaining tothem. More specifically, the ALJ found that "Respondent did notimpress [her] as credible and appeared to try to tailor histestimony to suit his own purposes, particularly with respect tohis insistence that he complied with Pennsylvania's requirementsfor prescribing controlled substances." ALJ at 29. I adopt theALJ's credibility findings noting that she was in the best positionto observe the demeanor of the respective witnesses. I thereforefind that neither Respondent nor a nurse took the Officer's bloodpressure during the visit. I further find that the history form forthis visit contains no notation in the blocks for the patient's"heart" and "lungs" (nor in any of the other blocks save one inwhich findings pertaining to various bodily functions arerecorded). I therefore further find that Respondent did not listento Respondent's heart or lungs on this date.
FOOTNOTE 7 As the ALJ explained, the Agent, in contrast toRespondent, "appeared to be straightforward and candid." ALJ at 29.END FOOTNOTE
The Third Undercover Visit
On January 3, 2008, the Officer returned to Respondent's officeand again presented himself as Anthony Wilson and paid $100 for thevisit. Tr. 97, 103. The same DEA Special Agent conductedsurveillance of the visit. ALJ at 12.
Apparently while the Officer was in the waiting room, Respondentstarted calling out the names of patients. When Respondent calledthe Officer's undercover name, he asked him whether he was therefor physical therapy. GX 3, at 2. At some point, the Officer wastaken back to an exam room and was told by Respondent to take offhis jacket. Id. The Officer stated to Respondent: "last time yousaid I had neck and back contusions." Id. Respondent told theOfficer to have a seat and asked him his first name. Id. TheOfficer answered: "Anthony." Id.
Following an unintelligible statement of Respondent, the Officeroffered to come back for physical therapy. Id. After Respondent wasinterrupted by several phone calls, the Officer offered to comeback on Sunday for therapy and Respondent agreed. Id. The Officerthen stated that the "the first time I was here you didn't havetherapy," and asked whether he had "to fill out the paperworkagain, or did she find my file?" Id. Respondent answered: "Nothat's all right, I saw it the other day, that's alright." Id. TheOfficer then asked whether if "when I have the therapy and themedicine it's the same price or is it?" Id. Respondent answeredthat it was the "[s]ame price if you come in for just theprescription its 100 dollars, if you come in for the prescriptionand exam and therapy its 100 dollars, if you come in for justtherapy its 100 dollars, o.k." Id.
During the visit, Respondent gave the Officer prescriptions for90 Percocet (10/325 mg.) and 60 Xanax (1 mg.). Id. at 3; GX 17.While Respondent asked the Officer how he had been doing,Respondent limited his physical exam to pressing on the Officer'sback and shoulder and did not listen to the Officer's heart andlungs or take his blood pressure. Tr. 99-100. Moreover, while itwas less than three weeks since the Officer's previous visit (atwhich Respondent had also given him prescriptions for 90 Percocetand 60 Xanax, each of which should have lasted thirty days),Respondent did not question him about why he needed newprescriptions so soon. Id. at 102. Furthermore, once again,Respondent did not counsel the Officer about the two drugs. Id.Finally, the patient file for "Anthony Wilson" contains nodocumentation of this visit. See GX 22.
The Fourth and Fifth Undercover Visits
On January 18, at approximately 4:10 p.m., the Officer returnedto Respondent's office and was accompanied by another Officer whoused the name of Richard Johnson. Tr. 104. Respondent called forJohnson first, and asked him if it was his first visit. GX 5, at 1.Although the Officer had not previously been to Respondent'soffice, the Officer responded: "No, I was here December 14th." /8/Id. Respondent then collected $100 from the Officer. Id.
FOOTNOTE 8 The DEA Agent testified that Respondent attempted tofind the Officer's patient file. Tr. 110-11. END FOOTNOTE
About twenty minutes later, Respondent again asked the Officerhis name. Upon being told "Richard Johnson," Respondent asked theOfficer: "You said you been here before * * * you do constructionright?" Id. The Officer answered: "Yes, sir." Id. After discussingthe Officer's age and taking a phone call, Respondent asked theOfficer: "How you been doing since you [were] put on painmedication?" Id. at 2. The Officer answered: "pretty good." Id.When Respondent asked: "Did it work real well?"; the Officeranswered: "Yes."
Respondent next asked: "you['ve] been taking the yellow onesthree times a day?" Id. /9/ The Officer answered: "Yes." Id.Respondent then stated: "I had you on the blue ones at night"; theOfficer commented: "Yeah, at night." Id. Respondent then asked theOfficer to "stand up," and stated: "7:05 p.m. Ok, what I'm going todo is refill your medication * * * we can finally get you out ofhere." Id. After taking a phone call, and commenting about peoplestealing pens from his office, Respondent noted that it was "7:08p.m." and stated: "60 of the Xanax, 90 of the Percocet." Id. Asevidenced by the actual prescriptions, Respondent prescribed 90Percocet (10/325), which was to be taken every eight hours, and 60Xanax 1 mg., which was to be taken every 12 hours. GX 18, at 2.
FOOTNOTE 9 I take official notice of the Product IdentificationGuide found in the Physician's Desk Reference (2005). According tothe Guide, Percocet 10/325 mg. tablets are yellow, id. at 311, andXanax 1 mg. tablets are blue. Id. at 330. Based on this and theprescriptions Respondent wrote, I conclude that Respondent'sreferences to the yellows ones and the blue ones were references toPercocet and Xanax respectively. In accordance with theAdministrative Procedure Act and DEA regulations, Respondent isentitled to an opportunity to refute the facts which I have takenofficial notice by filing a motion for reconsideration withinfifteen days of service of this Order, which shall begin on thedate of mailing. See 5 U.S.C. 556(e); 21 CFR 1316.59(e). ENDFOOTNOTE
Respondent's physical exam was limited to tapping the Officerlightly on the back and shoulder. Tr. 112 Moreover, Respondent didnot order any diagnostic tests. Id. at 113. During a subsequentsearch of Respondent's office, no patient file was found forRichard Johnson. Id. at 215.
Approximately 45 minutes later, Respondent saw the other Officer(Anthony Wilson) who was waiting in an exam room. GX 5, at 4.Respondent asked him "how are you doing?," to which the Officerresponded: "I'll pay you now." /10/ Id. About a minute later,Respondent entered the exam room and stated: "I am going crazyright now, turn around this way." Id. In response, the Officerstated: "I know it's been a long day." Id.
FOOTNOTE 10 It is unclear whether Respondent had actuallyentered the exam room at this point or just stuck his head in it.END FOOTNOTE
Respondent replied: "You have no idea." Id. Respondent thenstated: "stand up facing me, try to bend down knees and touch yourtoes, come back up, alright, have a seat, look[s] like your doing alittle better." Id. The Officer replied: "Yes sir, yes sir." Id.
Respondent then stated: "Last time I gave you Percocet 10's andXanax right?" Id. The Officer responded: "Yes sir." Id. Respondentthen stated: "So that seems it gotta be working." Id. The Officeragreed, and added that "the last time I didn't have any problemscashing the [unintelligible]." Id. Respondent then stated "script."Id. The Officer again commented to the effect that he had not hadany problems filling his prescriptions. Id. at 5. /11/ Respondentdid not ask Wilson why he had returned only fifteen days after theprevious visit. See generally GX 5, at 4-5.
FOOTNOTE 11 Most of the remaining conversation betweenRespondent and the Officer centered on the Officer's problems withhis ex-wife, although at one point the Officer stated: "You saidlower back and neck," and Respondent agreed. GX 5, at 5. ENDFOOTNOTE
During the visit, Respondent issued the Officer additionalprescriptions for 90 Percocet (10/325 mg.) and 60 Xanax (1 mg.). GX18, at 1. The prescriptions called for the Percocet to be takenevery eight hours and for the Xanax to be taken every twelve hours.Id.
The Sixth and Seventh Undercover Visits
On the night of January 22, 2008, at 8:07 p.m., the Officer whohad previously presented herself as Nicole Hodge went back toRespondent's office. Tr. 131. The Officer was accompanied byanother Officer, who used the name "John Rio," and apparently posedas her boyfriend. See GX 6, at 1. /12/
FOOTNOTE 12 According to GX 6, the Officers entered Respondent'soffice together. GX 6, at 1. It is unclear, however, whether theyarrived in the same vehicle. END FOOTNOTE
Shortly after her arrival, Respondent called her name and asked:"Why are you here dear?" GX 6, at 1. The Officer stated that shehad been in an accident two days earlier. Id. Respondent asked:"Nicole the last time you were here you didn't have an injuryremember?" Id. The Officer answered: "I know." Id. Respondent thenasked the Officer whether she swore that she was injured this time.Id. The Officer answered that she had been "out with my boyfriendand got hit by a car the other day." Id. The Officer then explainedthat "I ran out before him * * * he pisses me off a lot." Id.Respondent laughed and asked: "Well I'm sure you don't haveanything to do with that at all, right?" Id. The Officer then askedthe Officer posing as her boyfriend: "Did you push me in front ofthat car?"; the latter answered: "No." Id.
Respondent then told "John Rio" to have a seat in an exam roomand asked him: "You been here before right?" Id. The Officeranswered "Yeah," Id. although he had not been. Tr. 123. The femaleOfficer then stated: "I can hear you." GX 6, at 1. Respondentreplied: "I'm sure you can hear us, that's the point, we want youto hear us"; the female Officer responded: "Oh." Id.
Respondent then asked the male Officer if he was having backpain. Id. The Officer answered affirmatively. Id. at 2. After someextraneous comments about his ex-wife, either Respondent or anassistant hooked the male Officer up to a physical therapy machine,recommended twenty minutes of treatment and started the machine.Tr. 126. The Officer then complained that the treatment "hurts toomuch, man." GX 6, at 2. Respondent then told an assistant to "cutit back to the minimum level"; the assistant acknowledgedRespondent's order. Id. Several minutes later, the Officerdisconnected himself from the machine and told Respondent's staffthat he was doing so. Tr. 126-27. The record does not, however,establish whether Respondent was advised that the Officer haddisconnected the machine. /13/ Id. at 127.
FOOTNOTE 13 The ALJ further found that during the visit,Respondent did not take a medical history or order any diagnostictests. Tr. 126. END FOOTNOTE
At some point during the visit, Respondent issued to the Officerprescriptions for 90 Percocet (5/325 mg.); 30 Xanax (1 mg); and forFlexeril, a non-controlled muscle relaxant. GX 19, at 1-2. Duringthe visit, while Respondent put two fingers on the Officer's back,he did not check the Officer's heart or lungs. Tr. 125. Nor did hecounsel the Officer regarding the controlled substances heprescribed. Id. at 128-29. Moreover, during the subsequent searchof Respondent's office, the authorities did not find a patient filefor the Officer. Id. at 125. In his testimony, Respondent assertedthat he maintained a file on the Officer and that this visit wasprobably the Officer's third visit with him. Id. at 313. I find,however, that it was the first visit.
Respondent then turned his attention to the female Officer andasked her if she had been driving. GX 6, at 2. The Officeranswered: "No, we were walking." Id. Respondent then asked her ifshe had gone to the hospital; Respondent answered: "No."
Respondent then asked her: "What areas are hurting?" Id. Thevideo indicates that the Officer answered that her knee, left hip,and lower back were. GX 14. Next, Respondent asked her tonumerically rank her pain level with one "being no pain and tenbeing the worst possible pain." GX 6, at 2. The Officer stated thather pain level was "a six." Id. Respondent then told her to "let metake your pulse." Id. /14/
FOOTNOTE 14 In his testimony, Respondent maintained that helistened to the Officer's heart and lungs and that a nurse took herblood pressure. Tr. 310, 312, 334. END FOOTNOTE
Following this, Respondent told the Officer: "turn towards me,no turn, turn back and back up, back up, back up, that's good * * *within your comfort zone, if I ask you to do anything that causessevere pain don't do it." Id. The Officer acknowledged this bystating: "OK." Id. at 3.
Respondent then directed the Officer to "Put your head back,down to your chest, back to normal position, ok head to the side,the other side, back to normal position, rotate, to the right, backto normal position, bring your shoulders up." Id. The Officer thenstated: "like that hurts, down the center of my back." Id.Continuing, Respondent stated to the Officer: "Side, other side,back to the normal position, backward and now touch your toes, turnaround, relax your arms," and asked if there was "no pain where [hewas] pressing." Id. In response, the Officer answered: "naw." Id.
Next, Respondent told the Officer to "bring [your] right leg upas high as you can." Id. The Officer laughed. Respondent then toldthe Officer to "bring [your] left leg up as high as you can." Id.He then told the Officer to "have a seat up here"; the Officerresponded: "OK." Id.
Continuing, Respondent instructed the Officer to "hold yourhands together for me, relax, unpress them," and remarked "that'stender." Id. Next, he told the Officer to "lay on your back, crossyour legs, raise your legs up," and then asked "where's the pain?"Id. The Officer answered: "my lower back." Respondent then told theOfficer to "sit up," and asked her several questions regardingwhether she had filed a report with her insurance company, andwhether she was planning any legal action. Id.
Respondent then left the room to get another form. Id. When hereturned, Respondent explained to the Officer that she had mildsprains of her neck, middle lower back, left hip and both knees.Id. He further noted that her injuries would take four to six weeksto heal and asked if she was paying cash for her prescription. Id.After the Officer stated "Yep," Respondent told her that he wasgoing to prescribe a drug that was a mild anti-inflammatory andpain medication, as well as a mild muscle relaxant to help hersleep. Id. With respect to the first drug, Respondent told theofficer to "only take one twice a day." Id. Respondent also toldthe Officer to take the muscle relaxant "every 12 hours if you have[a] muscle spasm," and to ice her knees three times a day forfifteen minutes. Id. at 4. Respondent further told the Officer tocome back "in a few weeks" and that she could come back withoutmaking an appointment. Id. Respondent prescribed sixty tablets ofVicoprofen, a schedule III controlled substance which containshydrocodone and ibuprofen, and Soma (carisoprodol), anon-controlled substance. GX 19, at 3.
The Eighth and Ninth Undercover Visits
On January 30, 2008, at 6:45 p.m., the Officers who hadpreviously posed as Anthony Wilson and Richard Johnson returned toRespondent's office. GX 7, at 1. At 7:49 p.m., Respondent asked:"Who's for prescription refills?" GX 7, at 1. The Officer posing asAnthony Wilson answered: "Right here." Id.
Seven minutes later, the Officer told Respondent that the "lasttime I have my wife with me, but she couldn't make it today, can Ipick up her script for her?" Id. Respondent replied: "your wife,yeah, you can do that one time." Id. The Officer then stated:"thank you, that's for her and that's for me." Id. Respondent thensaid: "OK, you gotta tell me who the wife is." Id. The Officerstated that his wife's name was "Shania Wilson." /15/ Id.Respondent subsequently gave the Officer prescriptions issued inthe name of T. Wilson for 60 Xanax (1 mg.), and 90 Percocet (5/325mg.). See GX 20, at 1-2; GX 7, at 2. /16/
FOOTNOTE 15 As was the Officer's undercover identity, ShaniaWilson was also a fictitious name. END FOOTNOTE
FOOTNOTE 16 While Shania Wilson was not a real person, the DEAAgent testified that he believed that Respondent had a patient withthe name that Respondent used on the prescriptions. Tr. 144, 229.To protect her privacy, her first name will not be used. ENDFOOTNOTE
Shortly thereafter, Respondent asked the Officer: "WhichPercocet are you getting--either yellow or the greens ones?" GX 7,at 2. The Officer answered: "the yellow." Id. Respondent then gavethe Officer prescriptions issued in the name of Anthony Wilson for60 Xanax (1 mg.) and 90 Percocet (10/325 mg.). Id.
Respondent also issued to the Officer posing as Richard Johnsonprescriptions for 90 Percocet (10/325 mg.) and 60 Xanax (1 mg.). GX20, at 3. During these visits, Respondent did not perform any typeof examination on either of the Officers and did not even discusswith them their conditions. Tr. 144-45.
Regarding his issuance of the prescription to the firstOfficer's fictitious wife, Respondent testified that he told theOfficer that he normally did not do this but that the Officer hadstated that his wife "was in such severe pain that she couldn't getout of bed, and she really needed a refill." Id. at 317. Respondentfurther asserted that the Officer had given him the name "T------," so he "pulled her chart," and "verified that," and "wrotethe prescription." Id. at 318. Respondent further maintained thathe based his decision on when Ms. Wilson "had her last refill." Id.Respondent, however, produced no evidence from this patient's chartestablishing that he had previously diagnosed her with a conditionthat warranted the prescribing of Percocet and Xanax. Moreover, theonly evidence on this issue indicated that the real Ms. Wilson hadlast been prescribed Percocet more than four months earlier. See GX45, at 95.
The ALJ specifically found incredible Respondent's testimonyregard his filling of the prescription for the fictional Ms.Wilson. ALJ at 18. While Respondent may have pulled a chart for thereal Ms. Wilson, see GX 7, at 2 (Officer stating "that's my wifethere"); neither the transcript nor the video contain any evidencethat the Officer had represented that his wife was in such severepain that she could not get out of bed. Accordingly, I adopt theALJ's credibility finding to the extent she rejected Respondent'stestimony that the Officer represented that his wife was in severepain and could not get out of bed and his testimony that he basedhis decision on when Ms. Wilson had her last refill. /17/
FOOTNOTE 17 In his testimony, Respondent did not identify whenhe had last seen the patient or the medical condition whichjustified the prescribing of Percocet and Xanax. END FOOTNOTE
Respondent also testified regarding his having issuedprescriptions before previous prescriptions which were for athirty-day supply should have run out. As found above, Respondentissued prescriptions for both 60 Xanax and 90 Percocet to theOfficer who posed as Anthony Wilson on December 14, 2007, and onJanuary 3, 18, and 30, 2008. Moreover, Respondent issuedprescriptions for Xanax and Percocet to Richard Johnson on bothJanuary 18 and 30, 2008.
Regarding these prescriptions, Respondent testified that "[i]none case the person indicated that they were going to be awayduring that particular week, and [asked] could they get theirprescriptions a week early." Tr. 318-19. Respondent furtherexplained that with respect to the other patient, "it was a matterof not being able to locate that individual's chart, and because Icouldn't locate the chart, at that particular time, which was Ithink the 18th of January or so, I took him at his word and goodfaith." Id. at 319.
Continuing, Respondent testified: "I asked him, I said, `Are yousure that it has been 30 days since you had your lastprescription?' And he said, `Yes, it was.' So, then, I wrote outhis prescription." Id. Respondent also maintained that "whathappened was that [the] copy that was made did not get back intohis chart, so when he came back on the 30th, it looked as though ** * he was * * * last here on around the 30th of December, so hewas issued another prescription." Id.
Respondent further attempted to justify his issuance of earlyprescriptions by contending that there were "safeguards" in placeagainst the early filling of his prescriptions. Id. Morespecifically, Respondent testified that if the patient "eithertakes it to the same pharmacy or tries to use his insurance, theywill notify me that the prescription has been filled less than 30days, and then I can reject it." Id.
It is unclear whether the ALJ credited Respondent's testimonyregarding his issuance of the early prescriptions to Anthony Wilsonand Richard Johnson. See ALJ at 17-18. /18/ In any event, asultimate factfinder, I reject Respondent's testimony. Respondent'stestimony was vague in that he did not identify which of the twoundercover Officers had stated that he was going to be away andneeded the new prescription/early refill. /19/ Moreover, there isno credible evidence to support Respondent's claim that eitherOfficer (Anthony Wilson or Richard Johnson) had ever representedthat they were going to be away when their prescriptions ran out.As for Respondent's assertion that he asked the other patientwhether it had been thirty days since the last prescription, thereis likewise no credible evidence of his having done so.
FOOTNOTE 18 In contrast to the testimony regarding Respondent'sissuance of a prescription to Ms. Wilson which she specificallyrejected, the ALJ did not expressly address whether she found thistestimony credible. ALJ at 17-18. END FOOTNOTE
FOOTNOTE 19 Under Federal law, a prescription for a schedule IIcontrolled substance cannot be refilled. 21 U.S.C. SEC 829(a). ENDFOOTNOTE
I also reject Respondent's testimony regarding the safeguards toprotect against the early filling of prescriptions. As for hiscontention that an insurance company would notify him if a patientattempted an early refill, notably the undercover officers did notuse insurance, but rather, paid cash for their visits. As forRespondent's contention that the pharmacy would notify him that apatient was attempting an early refill, this would be true only ifthe patient used the same pharmacy. Drug abusers typically knowbetter than to take an early refill to the same pharmacy (unlessthe pharmacy is in cahoots with the prescriber).
Other Evidence
Both parties also submitted into evidence additional patientrecords. The Government introduced sixteen patient files; nearlyall of the patients received prescriptions for Percocet and Xanax.See GXs 24-39. Moreover, some of the files lack documentation of aphysical exam and/or a medical history. See GX 25 (J.L.); GX 26(E.L.); GX 27 (J.L.); GX 31 (A.L.); GX 32 (B.L.); GX 33 (O.G.); GX34 (B.G.); GX 35 (J.L.); GX 36 (M.K.); GX 38 (R.K.); GX 39 (M.G.).
Respondent submitted four patient files into evidence. Notably,and in contrast to the patient files cited above, three of thesefiles contain extensive documentation of the findings of an initialphysical exam, Respondent's assessment/diagnosis, and his treatmentrecommendations. See RX 13A, at 670-72; RX 13B, at 764; RX 13D, at4740-42. Moreover, each of the files contains documentation of thephysical exams performed, the assessments made, and treatmentrecommendations given on followup visits. See RX 13A, at 677-78,681-82, 694; 702, 703; RX 13B, at 774, 781, 788, 814; RX 13C, at4024, 4035; RX 13D, at 4727-28, 4731, 4746, 4753, 4754, 4757,4759-61, 4762, 4775.
Respondent also introduced into evidence copies of fourdifferent notices he had posted in his office. Two of these warnedhis patients that it was a felony offense to obtain prescriptiondrugs by fraud or "for other than prescribed reasons," as well asto resell them. RXs 1 & 2. Another notice listed numerousexcuses used by drug-abusing patients to obtain early refills andwhich Respondent deemed to be "unacceptable." RX 3.
In the fourth of the notices, Respondent stated that it hadrecently come to his attention that several of his patients were"faking their illnesses, injuring themselves intentionally an [sic]lying to [him] for the purpose of obtained controlled IIIprescriptions (I.E. Perococet [sic]) and controlled IIprescriptions (Xanax)." RX 4. Respondent further asserted that "Iam sickened by you individuals," and that "I am not a `dirtydoctor.' " Id. Respondent then maintained that he was going todischarge "[a]ll patient [sic] referred by the individual who havenot been in auto accidents who are not treating three times perweek." Id. Respondent further stated that he would "no longerprescribe Controlled III [and] Controlled II medications toanyone," and while he would continue to treat all of his legitimatepatients, he would so "without Controlled II or III medications."Id. /20/
FOOTNOTE 20 Respondent also introduced into evidence copies ofvarious prescriptions which he maintained had been written bypatients who had stolen his prescription pads. See RXs 5-10. ENDFOOTNOTE
Discussion
Section 304(a) of the Controlled Substances Act (CSA) providesthat a registration to "dispense a controlled substance * * * maybe suspended or revoked by the Attorney General upon a finding thatthe registrant * * * has committed such acts as would render hisregistration under section 823 of this title inconsistent with thepublic interest as determined under such section." 21 U.S.C.824(a)(4). With respect to a practitioner, the Act requires theconsideration of the following factors in making the publicinterest determination:
(1) The recommendation of the appropriate State licensing boardor professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlledsubstances.
(3) The applicant's conviction record under Federal or Statelaws relating to the manufacture, distribution, or dispensing ofcontrolled substances.
(4) Compliance with applicable State, Federal, or local lawsrelating to controlled substances.
(5) Such other conduct which may threaten the public health andsafety.
Id.
"[T]hese factors are * * * considered in the disjunctive."Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I "may rely onany one or a combination of factors, and may give each factor theweight [I] deem[] appropriate in determining whether a registrationshould be revoked." Id. Moreover, I am "not required to makefindings as to all of the factors." Hoxie v. DEA, 419 F.3d 477, 482(6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C.Cir. 2005).
Having considered all of the statutory factors, I conclude thaton balance, the evidence pertaining to Respondent's experience indispensing controlled substances (factor two) and his record ofcompliance with applicable laws related to the prescribing ofcontrolled substances (factor four) establish that his continuedregistration would be "inconsistent with the public interest." /21/21 U.S.C. 823(f). Moreover, while I do not find that all of theprescriptions he issued were illegal under Federal law, I agreewith the ALJ's finding under factor five that Respondent has failedacknowledge his wrongdoing and therefore cannot be entrusted with aregistration.
FOOTNOTE 21 I acknowledge that there is no evidence that thePennsylvania Board has taken action against Respondent's medicallicense (factor one). There is also no evidence that Respondent hasbeen convicted of an offense related to controlled substances underFederal or State law (factor three). END FOOTNOTE
Factor Two and Four--Respondent's Experience in DispensingControlled Substances and Record of Compliance With ApplicableControlled Substance Laws
Under DEA regulations, a prescription for a controlled substanceis not "effective" unless it is "issued for a legitimate medicalpurpose by an individual practitioner acting in the usual course ofhis professional practice." 21 CFR 1306.04(a). This regulationfurther provides that "an order purporting to be a prescriptionissued not in the usual course of professional treatment * * * isnot a prescription within the meaning and intent of [21 U.S.C. SEC829] and * * * the person issuing it, shall be subject to thepenalties provided for violations of the provisions of law relatedto controlled substances." Id. See also 21 U.S.C. 802(10) (definingthe term "dispense" as meaning "to deliver a controlled substanceto an ultimate user * * * pursuant to the lawful order of * * * apractitioner, including the prescribing and administering of acontrolled substance") (emphasis added).
As the Supreme Court recently explained, "the prescriptionrequirement * * * ensures patients use controlled substances underthe supervision of a doctor so as to prevent addiction andrecreational abuse. As a corollary, [it] also bars doctors frompeddling to patients who crave the drugs for those prohibiteduses." Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing Moore,423 U.S. 122, 135 (1975). /22/
FOOTNOTE 22 It is fundamental that a practitioner must establisha bonafide doctor-patient relationship in order to be acting "inthe usual course of * * * professional practice" and to issue aprescription for a "legitimate medical purpose." 21 CFR 1306.04(a);see also United States v. Moore, 423 U.S. 122, 142-43 (1975). TheCSA, however, generally looks to state law to determine whether adoctor and patient have established a bonafide doctor-patientrelationship. See Kamir Garces-Mejias, 72 FR 54931, 54935 (2007);United Prescription Services, Inc., 72 FR 50397, 50407-08 (2007);Dispensing and Purchasing Controlled Substances Over the Internet,66 FR 21181, 21182-83 (2001). END FOOTNOTE
Consistent with the standards of Federal law, Pennsylvania lawprohibits "[t]he * * * prescription of any controlled substance byany practitioner * * * unless done (i) in good faith in the courseof his professional practice; (ii) within the scope of the patientrelationship; (iii) in accordance with treatment principlesaccepted by a responsible segment of the medical profession." 35Pa. Stat. SEC 780-113(a)(14). Moreover, under the PennsylvaniaAdministrative Code, a practitioner must meet certain "minimumstandards" /23/ before prescribing a controlled substance includingtaking an initial medical history and conducting "an initialphysical examination * * * unless emergency circumstances justifyotherwise." /24/ 49 Pa. Code SEC 16.92(a)(1). Furthermore, "[t]hephysical examination shall include an evaluation of the heart,lungs, blood pressure and body functions that relate to thepatient's specific complaint." Id. (emphasis added).
FOOTNOTE 23 The regulation further states that it "establishesminimum standards for the prescription, administration anddispensation of controlled substances by persons licensed topractice medicine and surgery in" Pennsylvania. 49 Pa. Code SEC16.92(b). END FOOTNOTE
FOOTNOTE 24 Respondent does not contend that any of theundercover patients presented a medical emergency. END FOOTNOTE
This regulation also requires that a physician provide"[a]ppropriate counseling * * * to the patient regarding thecondition diagnosed and the controlled substance prescribed." Id.SEC 16.92(a)(3). Furthermore, "[u]nless the patient is in aninpatient care setting, the patient shall be specifically counseledabout dosage levels, instructions for use, frequency and durationof use and possible side effects." Id.
Finally, the regulation requires that the physician record"certain information * * * in the patient's medical record on eachoccasion when a controlled substance is prescribed," which "shallinclude the name of the controlled substance, its strength, thequantity and the date it was prescribed." Id. SEC 16.92(a)(4). Theregulation further mandates that "[o]n the initial occasion when acontrolled substance is prescribed * * * to a patient, the medicalrecord shall * * * include a specification of the symptoms observedand reported, the diagnosis of the condition for which thecontrolled substance is being given and the directions given to thepatient for the use of the controlled substance." Id.
Applying these standards, I do not find that the Government hasproved that each of the prescriptions issued to the undercoverofficers violated Federal law. The evidence nonetheless establishesthat on several occasions, Respondent issued prescriptions to theundercover officers for Percocet and Xanax--both of which arehighly abused drugs--that did not comply with Federal law. Ifurther find--based on the lack of any supporting documentation ofa physical exam in various files--that Respondent issued numerousother prescriptions for controlled substances in violation ofPennsylvania's regulation.
The Visits of Nicole Hodge
At the outset, I note that Respondent did not commit any illegalacts when he was first approached by "Nicole Hodge." Rather, whenthe Officer asked for Percocet and made clear that she was notinjured, Respondent told her to leave his office, and did not issueher any prescription.
Respondent's interaction with "Nicole Hodge" during the secondvisit is more problematic. The evidence shows that Respondentspecifically questioned her about what areas were hurting and askedher to rank her pain level. The Officer unambiguously presented amedical complaint by stating that her "lower back" was hurting andthat her pain level was "six" on a scale of one to ten. Respondentthen put the Officer through several different range-of-motiontests. Moreover, Respondent took her pulse. Finally, Respondentdiagnosed her injuries, explained his diagnosis and treatmentrecommendations, and provided the Officer with instructions on howto take the medicines he prescribed.
The ALJ did not credit Respondent's testimony that he listenedto the Officer's heart and lungs and had a nurse take her bloodpressure. Tr. 310 & 312. Moreover, there is no documentation inthe patient file that he did so. See GX 23, at 7. That being said,as the Supreme Court explained in Gonzalez, "the [CSA] and our caselaw amply support the conclusion that Congress regulates medicalpractice insofar as it bars doctors from using theirprescription-writing powers as a means to engage in illicit drugdealing and trafficking as conventionally understood." 546 U.S. at270.
Likewise, numerous court decisions make plain that the offenseof unlawful distribution requires proof that the practitioner'sconduct went "beyond the bounds of any legitimate medical practice,including that which would constitute civil negligence." UnitedStates v. McIver, 470 F.3d 550, 559 (4th Cir. 2006); see alsoUnited States v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006)("[T]he Moore Court based its decision not merely on the fact thatthe doctor had committed malpractice, or even intentionalmalpractice, but rather on the fact that his actions completelybetrayed any semblance of legitimate medical treatment."). As theFourth Circuit has further explained, "the scope of unlawfulconduct under SEC 841(a)(1) [requires proof that a physician] usedhis authority to prescribe controlled substances * * * not fortreatment of a patient, but for the purpose of assisting another inthe maintenance of a drug habit or some other illegitimatepurposes, such as his own personal profit." 470 F.3d at 559 (int.quotations and citation omitted).
Accordingly, while Respondent's failure to listen to theOfficer's heart and lungs and take her blood pressure violatedPennsylvania's regulation, the totality of the evidence surroundingthis visit does not establish that he, in issuing the Vicoprofenprescription to Ms. Hodge, lacked a legitimate medical purpose andacted outside of the course of professional practice. The Officerpresented a medical complaint, identified specific areas of herbody as the cause of her pain, and complained of a relatively highpain level. Moreover, at no point did the Officer convey toRespondent that she was not in pain. Notwithstanding thatRespondent failed to perform several steps required by Pennsylvanialaw, the physical exam he conducted cannot be characterized asdeficient or cursory in the absence of expert testimonyestablishing as much.
At most, the evidence suggests that Respondent committedmalpractice. It does not, however, support the conclusion thatRespondent used his prescription writing authority to engage inillicit drug dealing when he issued the Vicoprofen prescription toMs. Hodge. /25/ See McIver, 470 F.3d at 559.
FOOTNOTE 25 The Government does not cite to any decision inwhich the Pennsylvania Courts or Medical Board have held that aphysician's failure to comply with this regulation in all respectsestablishes a violation of the Pennsylvania Controlled SubstancesAct. END FOOTNOTE
The Visits of Anthony Wilson
At his first visit, Anthony Wilson presented as his medicalcomplaint that he "Hurt All Over," that the location of hiscondition was "all over," and its severity was "bad pain." WhileRespondent did not ask the Officer to rate his pain level on anumerical scale, the Government offered no evidence to show that apractitioner must do so when the patient has already indicated thathe has "bad pain."
The evidence further establishes that Respondent's physical examwas limited to touching him lightly on the shoulder and back, thatRespondent did not listen to his heart and lungs, and that neitherRespondent nor anyone else took his blood pressure. Based on thisphysical exam, and without ordering any diagnostic testing,Respondent diagnosed the Officer as having back and neck contusionsand issued him prescriptions for 90 Percocet (10 mg.), 60 Xanax (1mg.), as well as Cataflam, a non-controlled drug. /26/ Respondentdid not, however, counsel the patient regarding the taking of thedrugs. At a minimum, Respondent's conduct violated Pennsylvania'sAdministrative Regulation pertaining to the prescribing ofcontrolled substances. /27/
FOOTNOTE 26 Based on the dosing instructions, both the Percocetand Xanax should have lasted thirty days. END FOOTNOTE
FOOTNOTE 27 Respondent's conduct creates a strong suspicion thathis prescribing exceeded the course of professional practice asthis term is used in Federal law and was also not "in accordancewith treatment principles accepted by a responsible segment of themedical profession" as required by Pennsylvania law. 35 P.S. SEC780-113(a)(14). But while the Government cited several cases whichupheld the convictions of physicians who engaged in similar conductto Respondent, in all but one of the cases there was experttestimony establishing that the physician's conduct exceeded thebounds of professional practice. See United States v. Bek, 493 F.3d790, 799-800 (7th Cir. 790); McIver, 470 F.3d at 556; Feingold, 454F.3d at 1005; United States v. Alerre, 430 F.3d 681, 686 (4th Cir.2005).
Moreover, in the only case cited by the Government in whichthere was no expert testimony, the undercover officer made clearthat he was seeking Percocet to party and would share the drugswith others. United States v. Celio, 230 Fed. Appx. 818, 822 (10thCir. 2007). By contrast, in this case, with the exception of thefirst visit of Nicole Hodge, the undercover officers frequentlycomplained of pain and made no statements which indicated that theywere seeking the drugs for non-medical purposes.
The Government also cites a state case to contend that "experttestimony is not always necessary to determine whether apractitioner may be convicted under" the Pennsylvania statute. Gov.Prop. Findings at 11 n.2 (citing Commonwealth v. Manuel, 844 A.2d 1(Pa. Super. Ct. 2004). Notwithstanding the court's statement inManuel, there, the State presented expert testimony as to theappropriateness of the physician's prescribing practices. See 844A.2d at 11. END FOOTNOTE
On January 3, 2008--less than three weeks later--the Officerreturned. While Respondent asked the Officer how he was doing andpressed on his back and shoulder, he proceeded to issue him moreprescriptions for 90 Percocet and 60 Xanax even though theprescription he had previously issued should not have beenexhausted. Respondent did not ask the Officer why he needed hisprescription refilled ten days early. Furthermore, the Respondentdid not document the prescribing in the Officer's patient file asrequired by the Pennsylvania regulation.
On January 18, 2008--only fifteen days after the previousvisit--the Officer saw Respondent again. Respondent asked theOfficer how we was doing, and performed a physical exam which waslimited to having the Officer attempt to bend his knees and try totouch his toes. While Respondent asked whether he had previouslygiven the Officer Percocet 10s and Xanax, once again he did notquestion the Officer as to why he had returned when the secondprescription should have lasted another fifteen days. Respondentnonetheless gave the Officer another prescription for 90 Percocet(10/325) and 60 Xanax (1 mg.).
On January 30, 2008--which was only twelve days since theprevious visit--the Officer returned to Respondent's clinic for afourth time. Approximately one hour after his arrival, Respondentappeared in the waiting area and asked: "Who's for prescriptionrefills?," to which the Officer said: "right here."
A few minutes later, the Officer told Respondent that the "lasttime I have my wife with me, but she couldn't make it today, can Ipick up her script for her?" Respondent replied that the Officercould "do that one time." The Officer subsequently told Respondentthat his wife's name was "Shania Wilson." Subsequently, Respondentissued prescriptions to Anthony Wilson for 90 Percocet (10/325 mg.)and 60 Xanax (1 mg.). He also issued prescriptions for a T. Wilsonfor 90 Percocet (5/325 mg.) and 60 Xanax (1 mg.), which he gave tothe Officer.
Notably, Respondent did not even ask the Officer how he wasdoing and issued the prescriptions to him without even the pretenseof conducting a physical exam. Indeed, the only question he askedthe Officer was which color Percocet tablet he was getting, thusgiving the "patient" the right to decide what strength of drug hewanted. Moreover, it was the third time in less than a month thatthe Officer had sought prescriptions for these drugs well beforethe previously issued prescriptions should have run out. Yet again,Respondent did not question the Officer as to why he had returnedso soon.
Given these circumstances, expert testimony is not required toconclude that in issuing these prescriptions, Respondent exceededthe bounds of professional practice and that the prescriptionslacked a legitimate medical purpose because Respondent failed totake any steps to determine whether there was a continuing medicalneed for the prescriptions. See 21 CFR 1306.04. Beyond that, heissued the prescriptions notwithstanding that even a cursory reviewof the Officer's file would have indicated that he had issuedprescriptions to the Officer only twelve days earlier. Likewise,the decision as to what strength of drug a patient should take isthe physician's responsibility and is not the province of thepatient. In short, Respondent's issuance of the prescriptions onthis date does not remotely resemble the legitimate practice ofmedicine or even the negligent practice of legitimate medicine.Rather, it is out-and-out drug pushing.
Likewise, expert testimony is not required to conclude thatRespondent lacked a legitimate medical purpose and exceeded thebounds of professional practice in issuing the prescriptions forthe Officer's fictitious wife. Notably, the Officer had repeatedlysought and obtained new prescriptions well before previousprescriptions would have run out and had thus demonstrated a clearand obvious pattern of drug-seeking behavior. Moreover, Respondentissued the prescriptions to a patient who was not physicallypresent and thus could neither be questioned as to whether she hada medical condition that required controlled substances norphysically examined. And he did so notwithstanding that the Officermade no representation that his "wife" had a medical need for theprescriptions.
Furthermore, Respondent did not even attempt to contact "her" todetermine whether there was a medical justification for theprescriptions. Cf. 49 Pa. Code SEC 16.92(a)(5) (authorizing theissuance of a "a prudent, short-term prescription" based on "anemergency phone call by a known patient"). Finally, both thePercocet and Xanax prescriptions were for a thirty-day supply andappear to be well beyond what Pennsylvania authorizes on anemergency basis. /28/
FOOTNOTE 28 Even if the Officer pointed to the patient file fora real Ms. Wilson, the fact remains that the Officer did notidentify any medical reason for why his "wife" needed aprescription. Moreover, Respondent made no attempt to contact Ms.Wilson to determine whether she had a continuing medical need forthe prescription and whether the requirements were met for issuingan emergency prescription under Pennsylvania's regulation. ENDFOOTNOTE
I thus conclude that Respondent exceeded the bound ofprofessional practice in issuing the prescriptions to Ms. Wilsonand that these prescriptions were not supported by a legitimatemedical purpose. 21 CFR 1306.04. In short, Respondent's issuance ofthese prescriptions was not simply the negligent practice ofmedicine but rather drug pushing.
The Visits of Richard Johnson
On January 18, 2008, another undercover officer, who used thename Richard Johnson, visited Respondent. When asked by Respondentwhether it was his first visit, the Officer represented that he hadpreviously seen Respondent on December 14th although he had not.Later, and apparently while in the exam room, Respondent asked theOfficer how he had been doing since he was put on pain medication;the Officer answered "pretty good." Respondent asked a followupquestion as to whether the medication worked well; the Officeranswered "yes."
The evidence establishes that Respondent performed a limitedphysical examination by lightly tapping the Officer on the back andshoulder. Moreover, Respondent acknowledged that he had been takingthe yellow ones (a reference to Percocet) and the blue ones (areference to Xanax). Respondent then stated that he was going torefill the Officer's prescriptions and issued him prescriptions for90 Percocet and 60 Xanax. During the subsequent search ofRespondent's office, no file was found for Richard Johnson.
While it is clear that the Officer misrepresented his status asa prior patient, there is no evidence establishing that Respondentknew this to be false. Moreover, the Government produced noevidence regarding the proper course of professional practice whena patient represents that he has recently been treated and thephysician cannot find the patient's medical records. At most then,the evidence establishes that Respondent violated Pennsylvania'sregulation because he failed to document the issuance of theprescriptions. /29/ See 49 Pa. Code SEC 16.92(a)(4).
FOOTNOTE 29 While the Pennsylvania regulation clearly requiresthat a practitioner perform a physical examination (or that one hasbeen performed by another practitioner within the "immediatelypreceding 30 days," 49 Pa. Code SEC 16.92(a)(1), before commencingtreatment with a controlled substance, the Government produced noevidence establishing that a physical examination is required atevery follow-up visit at which a controlled substance isprescribed. END FOOTNOTE
Twelve days later, Richard Johnson returned to Respondent'soffice. Respondent issued him prescriptions for 90 Percocet (10/325mg.) and 60 Xanax (1mg.) without even asking him about hiscondition. Moreover, Respondent did not ask the Officer as to whyhe needed new prescriptions after only twelve days. Given thecircumstances of this visit, it is clear that there was nolegitimate medical purpose for the prescriptions and thatRespondent exceeded the bounds of professional practice in issuingthem. See 21 CFR 1306.04(a). As was the case with the prescriptionsissued to the Officer on January 18, Respondent did not documentthe prescriptions and violated the Pennsylvania regulation for thisreason as well. 49 Pa. Code SEC 16.92(a)(4).
The Visit of John Rio
On the night that "Nicole Hodge" made her second visit, anOfficer posing as "John Rio" accompanied her. Although the Officerhad not previously been to Respondent's office, he told Respondentthat he had been. Moreover, when asked by Respondent if he had backpain, the Officer answered affirmatively. Respondent thenrecommended that the Officer receive twenty minutes of physicaltherapy and either Respondent or an assistant proceeded to set upthe machine and started the treatment. After the Officer complainedthat the treatment hurt too much, Respondent told an assistant tocut back the level of the treatment. While the Officer subsequentlydisconnected the machine and told Respondent's staff that he wasdoing so, there is no evidence that Respondent was advised of this.During the visit, Respondent gave the Officer prescriptions for 90Percocet, 30 Xanax, and a muscle relaxant which is not controlled.Moreover, during the subsequent search of Respondent's office, theauthorities did not find a patient file for him.
As was the case with the first visit of "Richard Johnson," theevidence does not establish that Respondent violated Federal law inissuing the prescriptions. Here again, there is no evidence as tothe proper course of professional practice when a patientrepresents that he has previously been treated by a physician. Atmost, the evidence establishes a violation of the Pennsylvaniaregulation requiring that each issuance of a controlled-substanceprescription be documented in the patient's medical record. See 49Pa. Code SEC 16.92(a)(4).
Other Violations
As found above, the record includes numerous patient files whichshow that Respondent prescribed controlled substances and yet lackany documentation that he (or another physician /30/) took amedical history, performed a physical examination and diagnosed amedical condition which warranted the various prescribings. Indeed,the documentation contained in these files is charitably describedas threadbare and stands in stark contrast to the level ofthoroughness and detail found in the four patient files whichRespondent submitted as evidence of the appropriateness of hisrecordkeeping practices. Compare, e.g., GXs 25-27, 31-36, 38-39,with RXs 13A-D; see also Tr. 302-306 (Respondent's testimony thatRXs 13A-D were "representative of how [he] maintained a patientfile"). At a minimum, this evidence establishes numerous additionalinstances in which Respondent violated the Pennsylvania regulation.
FOOTNOTE 30 See 49 Pa. Code SEC 16.92(a)(1). END FOOTNOTE