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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-34]

Zvi H. Perper, M.D., Decision and Order

On July 19, 2011, Administrative Law Judge (ALJ) Gail A. Randall issued the attached recommended decision. The Respondent did not file exceptions to the decision.

Having reviewed the entire record, I have decided to adopt the ALJ's recommended rulings, findings of fact, conclusions of law, and recommended Order except for her legal conclusions as to the initial visits of the two undercover officers (UCs) and her discussion in the first full paragraph at page 34 of her slip opinion.1 However, I need not decide whether the prescriptions Respondent issued at the initial visits of the two UCs violated 21 CFR 1306.04(a), because there is substantial evidence to support the ALJ's legal conclusions that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing prescriptions at the UCs' subsequent visits.

More specifically, one week after the initial visit of David Hays (UC1), at which he was prescribed 150 Percocet, a drug which combines 10 mg of oxycodone with 325 mg of acetaminophen, Hays returned to Respondent complaining that the drug was causing digestive problems. Respondent then prescribed 150 Roxicodone (oxycodone) 30 mg, without any inquiry into Hays' pain level. Tr. 54, GX 3a, at 13. Respondent noted in the chart, however, that Hays "had no relief [from] pain." GX 12, at 14.

With respect to this prescription, the Government's Expert testified that the "[m]edication would not have been indicated given the complaints of the patient, [and] certainly not that particular agent and certainly not that dose or frequency." Tr. 54. Notably, thistestimony was unrefuted. I thus conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate purpose in issuing the prescription and thus violated federal law. 21 CFR 1306.04(a).

Hays returned three weeks later (May 19, 2010) and saw Respondent's Physician Assistant (PA). While during the visit, the PA initially confused Hays with a patient whose name was spelled Hayes, upon recognizing his error he nonetheless noted that Hays was "too early." GX 4, at 14. During the visit, Hays asked the PA if he could increase the Roxicodone 30 mg prescription because he was probably going to be gone for three or four months working on a tugboat.Id.at 23. The PA instead offered to give Hays "the fifteen milligrams * * * strength."Id.at 25. Hays asked the PA if he "[c]ould * * * increase the thirties * * * just to whatever is reasonable and add some fifteens," to which the PA answered: "I have to ask."Id.The PA then told Hays To "have a seat in the waiting room" and "[l]et me find out for you."Id.Notably, during this visit, Hays did not tell the PA that he was experiencing breakthrough pain.

Approximately fifteen minutes later, the PA spoke with Hays and told him that Respondent "was very generous" but that the "the deal" was that Hays could not see the PA again until after the fourth of July.Id.at 31. The PA then told Hays that Respondent had given him 210 Roxicodone 30 mg and 90 Roxicodone 15 mg.Id.at 32; GX 12, at 23 (copies of prescriptions). On the prescription for the Roxicodone 15 mg, Respondent noted that it was for "breakthrough" pain, even though Hays never complained of having breakthrough pain.2

While the progress note for this visit stated "Earliest pt. can be seen until 7/5/10,"id.at 20; on June 16, Hays returned and saw Respondent. GX 5, at 16. While Hays was nearly three weeks early, Respondent did not raise this as an issue,see id.at 16-19, even though according to the Government's Expert, this is a "red flag" indicative of "[d]rug-seeking behavior" and either abuse or diversion. Tr. 65, 67. Moreover, Hays told Respondent that he still had not been on the tugboat assignment--the purported reason for why he needed an increase in his prescriptions--and once again asked for an increase. GX 5, at 16-19.

Respondent then noted that Hays' "pain level is only a two over ten" and that this was "pretty good."Id.at 17. Respondent then asked Hays if he was "having some breakthrough pain mostly at work."Id.Hays answered: "Every now and then something feels * * * a little bit hey-wire back there," that it was "mostly in the mornings," and that he would "get all sore and stiff back there."Id.Respondent noted that at the last visit, Hays had been "given a prescription for breakthrough pain" and Hays was "going kind of rapidly with [his] medicine."Id.Notwithstanding that Hays had reported his pain level as only a two and was nearly three weeks early, Respondent gave him a prescription for 210 tablets of Roxicodone 30 mg, a prescription for 90 Roxicodone 15 mg for breakthrough pain, and a prescription for a liver function test, which Hays never obtained. GX 12, at 26.

Hays returned on July 20 and saw the PA. Hays told the PA that he was doing "pretty good" and that his back had improved. GX 6, at 3-4. During the visit, Hays told the PA that his girlfriend had gotten into his medicine (which according to the Government's Expert was indicative of "misuse and diversion," Tr. 65) and wanted to come to the clinic. GX 6, at 5. The PA told Hays that "we could only see her with a valid reason * * * like an MRI report" and "not just because [the drugs] made her feel good."Id.at 6. The PA, however, then commented that "she got that subtle euphoria and of course she liked it. But if she doesn't have a true pain area * * * it's not appropriate."Id.The PA then explained that the laws had changed and that the clinic would never fill prescriptions again and that Hays would have to go to a pharmacy to fill the prescriptions and that the clinic was going to discuss with local pharmacies where they could "at least direct patients to."Id.at 7.

The PA then discussed giving Hays "this new medicine called Dilaudid, which is a morphine derivative" for his breakthrough pain. After discussing how Dilaudid (hydromorphone) was different from oxycodone, the PA and Hays resumed discussing where the latter could fill his prescriptions with the PA stating that because of the number of pills (210 Roxicodone), it was "extremely hard to believe that [Hays would] be able to get" the Oxycodone 30s from big chain drug stores such as CVS or Publix.Id.at 11. Hays then asked the PA to recommend a pharmacy which would fill the prescriptions; the PA told him he would give him a list and that the pills would cost four dollars each.Id.at 12. In response, Hays stated that he could not afford to fill 210 pills and asked if the PA could split his prescription; the PA agreed.Id.at 12-13. The PA stated that a lot of the small pharmacies were going to "require a non-narcotic, non-controlled medicine to go with" the narcotic prescriptions and that "[t]hey wouldn't just take * * * the Roxicodone, Dilaudid script from" him because there is "a perception problem."Id.at 14-15.The PA then explained that he would give Hays a prescription for thirty Motrin to put in his "back pocket" which he could produce if the pharmacist questioned the prescriptions.Id.at 15. However, the PA told Hays to "shred" the script if the pharmacist did not question the prescriptions.Id.

Later, the PA asked Hays if he was "satisfactory in the sleep department and in the anxiety department?"Id.at 18. Hays answered: "You know, I never have anxiety, really. And I sleep pretty good."Id.Following a discussion of a new state law prohibiting pain management clinics from dispensing and a proposal to establish a state prescription database, the PA left to have Respondent review and sign the prescriptions.Id.at 23. Respondent issued Hays two prescriptions totaling 210 tablets of Roxicodone 30 mg, as well as prescriptions for 60 Dilaudid 4 mg and 30 Motrin.

Hays returned on August 18 and again saw the PA. Notably, on the Patient Comfort Assessment form, Hays indicated that the worst his pain had been in the last month was a "3" on a "0" to "10" scale, that his pain had averaged a "2" during the last month, and that it was currently a "1." GX 12, at 33. Hays also wrote that his pain "was in my lower back but feels better now" and circled that pain was "occasional" and not "continuous."

Hays told the PA that the Dilaudid made him "kind of dizzy and nauseous" and that he thought the oxycodone were "good for" him and asked if Respondent ever prescribed the 80s. GX 7, at 22-23. The PA stated that Respondent would "start out a little slower[,] like the 40's * * * but yes, we do, do the 80s."Id.at 23. Hays told the PA that he did not have any problems getting the thirties and that his "girlfriend knew [a] a place that has them * * * readily available."Id.The PA then asked Hays whether he had "hand[ed] two split scripts in in one time"; Hays said "No."Id.at 24. The PA then told Respondent that he had to get his liver function tested and told him where to get it and that it would cost $45.Id.at 24-25.

Next, the PA asked Hays if his "lower back [was] okay this month?"Id.at 25. Hays answered: "You know, I think it really feels pretty good."Id.The PA then asked: "Do you even need a breakthrough * * * I mean * * * [y]ou're taking seven * * * a day, why don't you just stick with them?"Id.Hays answered: "well, there might be that occasion when I did need it but * * * I don't know."Id.at 26. The PA replied: "I'll throw you a few Percocets then just to get on the safe side but the 15s are very hard to come by and they're very expensive."Id.

Hays asked if the stuff Michael Jackson had taken would work; the PA stated that that drug was only indicated to "put people out with and perform surgery."Id.at 27. Hays then asked "if there is some other creative way that you could deal with me?"Id.at 28. In response, the PA asked: "Are you having trouble sleeping? Is [that] what you're getting at?"Id.Hays answered "I wonder * * * I do have trouble sleeping. I don't sleep much."Id.The PA then asked Hays if he had "ever tried Valium?"Id.After Hays answered that he had not, the PA asked if he would like to.Id.Hays replied "You know I might, because there are times when I * * * and it could be because * * * I've got too much on my mind, with work and everything, and I wake up at night and then I just stay awake."Id.The PA then told Hays to "try it one hour before you want it to work," but not to drive on it and not to take it every night.3 Id.at 29.

Hays and the PA returned to discussing his use of Dilaudid, with the PA stating that he was going to discontinue it.Id.at 30.The PA then asked Hays to move each leg up to his hand, and whether doing so bothered his back; Hays indicated that it did not.Id.at 31;see alsoGX 20 (audio recording of visit). The PA asked Hays if he needed the prescriptions split again; Hays answered that he did not. GX 7, at 31. The PA then said he was going to give Hays "a couple [of] Percocet for the day" for "breakthrough" pain and advised him to "eat with them."Id.at 31-32. The PA added that "hopefully the seven thirties a day will be enough pain relief for you and you don't need anything else" and advised Hays to fill the Percocet prescription only if he needed it.Id.Following a discussion of doctor shopping, the PA went to Respondent to obtain his approval for the prescriptions.Id.at 39. Thereafter, Hays was provided with prescriptions for 210 Roxicodone 30 mg, 60 Percocet 10/325mg, 30 Valium 10mg, and Motrin. GX 12, at 35.

With respect to the Dilaudid prescription Respondent issued to Hays, the Government's Expert testified that there was no evidence that Hays was experiencing break-through pain "of any significant degree." Tr. 60. The Expert further explained that "[t]here was no history consistent with severe break-through pain and it appeared that [Hays'] pain was adequately--more than adequately managed, even based on the subjective history."Id.The Expert thus concluded that Dilaudid prescription was "not justified."Id.This testimony stands unrefuted.

I therefore conclude that substantial evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the Dilaudid prescription to Hays. 21 CFR 1306.04(a). Moreover, for the same reasons that the Expert concluded that the Dilaudid prescription was not medically justified, I also conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the May 15 and June 16 prescriptions for Roxicodone 15mg, as well as the August 18 prescription for Percocet 10, all of which were purportedly issued for breakthrough pain.

As for the Valium prescription, the Government's Expert observed that the progress note "indicated that the patient had insomnia for the past month" but that Respondent did not explain "in his note why Valium [was] being added, although the prescription is to be taken one at bedtime only."Id.at 61. Continuing, the Expert testified that while he could "hypothesize why [Valium] may have been chosen * * * there was nothing that would justify that dose * * * for this individual."Id.

The Government's Expert further explained that before prescribing Valium for insomnia, "[t]he first reasonably standard thing to do would be to ensure that the patient wasn't doing anything that may be promoting insomnia" such as having "caffeine at night or excessive meals right before bedtime."Id.at 62. Once this was addressed, the Expert stated that if "medications were indicated there are [other] agents that are appropriate for insomnia, rather than a benzodiazepine like Valium, [which is available in 2, 5 and 10 mg tablets], at its highest dose."Id.at 63. Finally, the Expert noted that Valium's "primary purpose is not [to treat] insomnia."Id.

Here too, the testimony of the Government's Expert was unrefuted. I therefore conclude that substantial evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the Valium prescription to Hays. 21 CFR 1306.04(a).4

As for the prescriptions issued to Eddie Martinez, the evidence showed that Respondent increased his prescription from 120 Percocet 10/325 at the initial visit (for a total daily dose of 40 mg of oxycodone) to 90 Oxycodone 30 mg (for a total daily dose of 90 mg of oxycodone) at the second visit. GX 13, at 16, 20. The Government's Expert opined that Martinez's complained-of pain level did not justify a prescription for Roxicodone 30, which was more than double the dosing of the previous prescription, as "[t]here wasn't any physical examination abnormality or focal neurological deficit * * * consistent with his MRI finding or even his complaints that * * * would have warranted those medications at that dose[]." Tr. 85. This testimony was unrefuted.

At the third visit, Martinez told Respondent that he had run out a week early and bought drugs on the street even though in Respondent's words "[y]ou changed from Percocet to Oxycodone, that's a much stronger medicine than what you were using" and "there's a significant increase in the total amount of medicine you're getting daily." GX 11, at 20;see also id.at 22. At the visit, Respondent wrote Martinez

prescriptions for 90 Roxicodone 30 mg, as well as 60 Percocet 10 mg, the latter being for "breakthrough pain." GX 13, at 24. Notably, on the Patient Comfort Assessment Guide for this visit, Martinez noted that at its worst, his pain was a "5" on a scale of 0 to 10, a decrease from the level of 7-8 which he reported the previous month. GX 13, at 17, 21. Moreover, at no point did Martinez complain of having breakthrough pain.SeeGX 11, at 20-24.

According to the Government's Expert, that Martinez said he had run out early and complained of unrelieved pain was not a legitimate medical justification for increasing the dosing of oxycodone because it was "[n]ot based on the history, physical, and objective information available in this patient's file." Tr. 87. The Expert further opined that while it would be within the course of professional practice to prescribe analgesic medications "if the clinical justification existed," Martinez's "history and physical" did not meet the criteria for prescribing.Id.at 90.

Here again, this testimony was unrefuted. Accordingly, I hold that substantial evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing oxycodone prescriptions to Martinez at both his second and third visits. 21 CFR 1306.04(a). I thus conclude that Respondent violated Federal law in issuing numerous controlled substance prescriptions to both UCs.

This finding provides reason alone to conclude that Respondent has committed acts which render his registration inconsistent with the public interest.See21 U.S.C. 824(a)(4). However, this conclusion is buttressed by the ALJ's additional findings and legal conclusions, including those regarding the shortages of controlled substances ordered under Respondent's registration (nearly 24,000 dosage units of oxycodone 30 and 2,565 dosage of Endocet 10/325), his failure to take initial inventories after moving his practice, 21 CFR 1304.11, and his failure "to provide any explanation for his conduct or any assurances regarding his future conduct." ALJ at 37.See also Medicine Shoppe-Jonesborough,73 FR 364, 387 (2008).5

Accordingly, I adopt the ALJ's recommended order that Respondent's registrations be revoked and any pending applications be denied. For the same reasons which led me to order the Immediate Suspension of Respondent's registrations, I conclude that the public interest requires that this Order be made effective immediately.See21 CFR 1316.67.

Order

Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration Nos. FP1312406, BP8477639, and BP3429835, issued to Zvi H. Perper, M.D., be, and they hereby are revoked. I further order that any pending applications of Zvi H. Perper, M.D., to renew or modify any of his registrations, be, and they hereby are denied. This Order is effective immediately.

Dated: October 8, 2012. Michele M. Leonhart, Administrator.
ACTION: 5As explained inMedicine Shoppe-Jonesborough,where, as here, "the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must `present[] sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.'" 73 FR at 387 (quotingSamuel S. Jackson,72 FR 23848, 23853 (2007) (quotingLeo R. Miller,53 FR 21931, 21932 (1988)). Moreover, because "past performance is the best predictor of future performance,ALRA Labs, Inc.v.DEA,54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct."Medicine Shoppe,73 FR at 387;see also Jackson,72 FR at 23853;John H. Kennedy,71 FR 35705, 35709 (2006);Prince George Daniels,60 FR 62884, 62887 (1995).See also Hoxiev.DEA,419 F.3d at 483 ("admitting fault" is "properly consider[ed]" by DEA to be an "important factor[]" in the public interest determination).