Jeri Hassman, M.D.; Denial of Application
Federal RegisterFeb 23, 2010
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-62]
Jeri Hassman, M.D.; Denial of Application
On June 1, 2006, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration issued an Order to Show Cause to Jeri Hassman, M.D. (Respondent), of Tucson, Arizona. The Show Cause Order proposed the denial of Respondent's application for a new DEA Certificate of Registration as a practitioner, authorizing her to dispense controlled substances in schedules II through V, on the grounds that the Respondent had “been convicted of a felony under the Controlled Substances Act, [had] materially falsified [her] application, and ha[d] committed such other acts as would render [her] registration under 21 U.S.C. 823 inconsistent with the public interest.” ALJ Ex. 1, at 1 (citing 21 U.S.C. 824(a)(1)(2) and (4), 824(a) and 823).
More specifically, the Show Cause Order alleged that on November 1, 2002, DEA had immediately suspended Respondent's DEA registration on the ground that she “regularly engaged in the practice of prescribing excessive amounts of controlled substances * * * to patients for no legitimate medical purpose.”
Id.
at 1-2. The Show Cause Order next alleged that patients to whom she had prescribed controlled substances had died of overdoses.
Id.
at 2-3.
Next, the Show Cause Order alleged that Respondent “prescribed excessive quantities of controlled substances to patients, including frequent early refills” to a number of other patients.
Id.
at 3. The Show Cause Order alleged that Respondent:
generally failed to adequately evaluate patients, failed to conduct complete physical examinations, failed to obtain adequate histories, failed to include pain ratings, failed to determine the exact location or character of the pain, failed to obtain information concerning previous treatment from other physicians or medication used.
Id.
In addition, the Show Cause Order stated that “[d]espite these inadequate evaluations, [Respondent] immediately prescribed controlled substances to these patients.”
Id.
The Order to Show Cause also alleged that Respondent was “made aware of possible diversion incidents but continued to prescribe controlled substances for patients who were engaged in diversion.”
Id.
at 4. The Show Cause Order related five known incidents involving (1) F.L. and his son B.L., both patients of Respondent; (2) & (3) J.O. and her husband W.O., both patients of Respondent; (4) M.H., P.H., and A.B., a mother and two “daughters”, all patients of Respondent; and (5) S.R., a patient of Respondent.
Id.
at 4-6.
The Show Cause Order further alleged that on January 29, 2004, Respondent pled guilty to “four felony violations of 18 U.S.C. 3 involving controlled substances: Accessory After the Fact to Possession of Controlled Substances by Misrepresentation, Fraud, Forgery, Deception or Subterfuge, 21 U.S.C. 843(a)(3).”
Id.
at 6.
Next, the Show Cause Order alleged that on March 10, 2004, Respondent “entered into a Consent Agreement with the Arizona Medical Board (the Board), in which the Board found that [Respondent] failed in many ways to properly care for [her] patients, including the prescribing of excessive amounts of controlled substances.”
Id.
According to the Show Cause Order:
The Board also found that [Respondent] failed to conduct physical examinations, failed to obtain adequate patient histories and failed to obtain prior medical records. The Board also found that [her] patient notes often did not provide sufficient information to support the diagnoses, justify the treatments, accurately document the results, or indicate advice and cautionary warnings provided to the patients.
* * * Under the Consent Agreement the Board found [Respondent] guilty of unprofessional conduct and placed [Respondent's] Arizona medical license on probation for two years from the effective date of the Consent Agreement.
Id.
Finally, the Show Cause Order alleged that Respondent materially falsified her application, when, on January 28, 2005, Respondent applied for her DEA registration, she marked “no” to question 4(d), which “asked, in pertinent part, whether [Respondent] had ever had a State professional license revoked, suspended or placed upon probation.”
Id.
Respondent timely requested a hearing on the allegations, ALJ Ex. 2, and the matter was placed on the docket of the Agency's Administrative Law Judges (ALJ). Following pre-hearing procedures, a hearing was held on January 22-26, 2007 and February 27 to March 2, 2007, in Tucson, Arizona. Moreover, on March 13, 2007, the ALJ conducted a transcribed telephone conference at which Respondent gave her closing argument. Thereafter, both parties filed post-hearing briefs.
On October 9, 2008 the ALJ issued her Opinion and Recommended Decision (ALJ). With respect to factor one (the recommendation of the State licensing board), the ALJ noted that, while Respondent has twice been placed on probation and either censured or reprimanded, she currently holds an active, unrestricted medical license, and that this factor weighs in favor of her continued registration. ALJ at 147-48.
With respect to factor two (Respondent's experience in dispensing controlled substances) and factor four (Respondent's compliance with applicable laws relating to controlled substances), the ALJ concluded that the Government had established that Respondent issued prescriptions to two persons (H.T. and R.T.) which lacked a legitimate medical purpose. ALJ at 150. The ALJ reasoned, however, that these were “only two patients out of more than 900 whom Respondent was treating at that time,” and thus the Government had not shown that “Respondent's overall medical practices [were] consistently lacking in legitimate purpose.”
Id.
at 150.
The ALJ specifically rejected the evidence of the Government's Expert with respect to twenty-three other patients, noting that various physicians who testified on behalf of Respondent had disagreed with the conclusions of the Government's Expert.
Id.
at 151. According to the ALJ, this was “not to minimize the seriousness of the Respondent's cavalier attitude toward handling controlled substances during 2001 and 2002, but rather to demonstrate that it is not clear that her general treatment practices were lacking in medical purpose.”
Id.
In support of her conclusion, the ALJ cited various areas in which she maintained “that there was no clear consensus in the medical community regarding which practices were required to meet the standard of care during 2001 and 2002.”
Id.
According to the ALJ, these areas included the role of physical examinations in treating chronic pain patients, the use of laboratory tests, the need to refer patients to other doctors as part of the course of treatment, appropriate dosage levels of controlled substances for treating chronic pain, and the propriety of prescribing both long and short-acting opioids simultaneously.
Id.
The ALJ also rejected the Government's contention that Respondent's falsification of H.T.'s medical record (who performed multiple undercover visits and wore a recording device) justified the denial of her application.
Id.
at 153-55. While acknowledging that “[i]t is indeed disturbing that the Respondent apparently altered H.T.'s medical chart to include a physical examination that
was not reflected in the recorded interaction between the Respondent and H.T.,”
id.
at 153, the ALJ concluded “that a single instance does not rise to the level of [a] pervasive pattern of falsification.”
Id.
at 155. In this regard, the ALJ also noted that Respondent was working with another physician to improve her recordkeeping practices.
1
Id.
at 155-56. The ALJ did not, however, expressly find whether the evidence under factors two and four satisfied the Government's
prima facie
burden.
1
The ALJ also noted that a 2002 DEA Audit of controlled substances which Respondent physically dispensed had found that Respondent was unable to account for 150 dosage units out of a total of 7,560 dosage units which were on hand.
Id.
at 153. DEA Investigators also found that Respondent had failed to keep receiving records for samples of controlled substances which her office received, that the records did not contain all of the information required by regulations, and that some records may have been missing because Respondent was not aware that she was required to keep them for two years.
Id.
I agree with the ALJ that these deficiencies are not sufficient by themselves to justify denying her application.
Finally, the ALJ rejected the Government's contention that Respondent had materially falsified her application because she answered “no” to the question whether her State license had ever been sanctioned.
Id.
at 160. The ALJ found that Respondent had attached to her application a letter from the Arizona Medical Board which indicated that she would “continue to be monitored every six months until the end of
her
probation in March 2007.”
Id.
(quoting GX 3, at 4). According to Respondent, based on the wording of the letter she believed that she—and not her medical license—had been placed on probation by the Board.
Id.
In light of Respondent's having provided the letter with her application, as well as her having truthfully answered the other questions on the application, I agree with the ALJ that she “lacked the intent to deceive the” Agency.
Id.
at 161.
The ALJ further found that Respondent had been convicted of four counts of the felony offense of “Accessory After the Fact to Possession of Controlled Substances by Misrepresentation, Fraud, Forgery Deception or Subterfuge,” and that the convictions could be considered as either an offense “under Federal * * * laws relating to the * * * dispensing of controlled substances,” 21 U.S.C. 823(f)(4), or as “[s]uch other conduct which may threaten the public health and safety.”
Id.
§ 823(f)(5);
see also id.
at 158. While the ALJ found that Respondent's convictions “could * * * weigh in favor of denial of the * * * application,”
id.
at 158, she also did not address whether this factor established the Government's
prima facie
case.
The ALJ further found that Respondent had “engaged in extensive remedial training,” that she has “improved skills now available to her, including the use of risk assessment tools and [the] collection of extensive addiction histories on each patient,” and that she would continue to consult with another pain management expert.
Id.
at 161-62. The ALJ also found it significant that the State Board would conduct regular reviews of her medical charts and quarterly compliance reports.
Id.
at 162. Finally, the ALJ found that “Respondent's willingness to admit her past mistakes, accept responsibility for her actions, and remedy her professional deficiencies should weigh heavily in favor of granting her application.”
Id.
at 162. The ALJ thus recommended that I grant Respondent a new registration subject to the conditions that she continue her mentoring arrangement with a pain management specialist for a period of three years and also submit the quarterly reports required by the State Board to the Agency.
Id.
at 163.
On November 3, 2008, the Government filed its exceptions to the ALJ's decision; and on November 28, 2008, Respondent submitted her response to the Government's exceptions. On December 22, 2008, the ALJ forwarded the record to me for final agency action.
Having considered the entire record in this matter, including the ALJ's decision and the parties' briefs, I adopt the ALJ's conclusion of law with respect to the allegations of material falsification. I also agree with the ALJ that Respondent's prescriptions for H.T. lacked a legitimate medical purpose. I reject, however, the ALJ's conclusions with respect to factors two and four.
The ALJ's failure to acknowledge that the Government established a
prima facie
case for denying the application was largely based on her conclusion that the Government had only proved that Respondent issued unlawful prescriptions to two patients and that it had not shown that her “other medical practices [were] consistently lacking in legitimate purpose.” The ALJ's reasoning is erroneous for several reasons.
First, it is inconsistent with Agency precedent, which holds that proof of as few as two acts of diversion satisfies the Government's
prima facie
burden under the public interest standard and supports the revocation of a practitioner's registration when she fails to accept responsibility for her misconduct.
See Alan H. Olefsky
, 57 FR 928, 928-29 (1992);
see also Sokoloff
v.
Saxbe
, 501 F.2d 571, 576 (2d Cir. 1974). The record here, however, supports the conclusion that Respondent knowingly issued multiple prescriptions to H.T. which lacked a legitimate medical purpose and violated Federal law. Moreover, while the ALJ stated that she had made extensive findings to place Respondent's treatment of various patients in context, ALJ at 151 n.34, she nonetheless frequently ignored relevant evidence establishing numerous other instances in which Respondent issued prescriptions which clearly violated the prescription requirement of Federal law. 21 CFR 1306.04(a).
Second, the ALJ's reasoning ignores longstanding precedent that the Agency's authority to revoke a registration or deny an application is not limited to those instances in which a practitioner intentionally diverts. Rather, a practitioner who ignores the warning signs that her patients are either personally abusing or diverting to others, commits acts inconsistent with the public interest even if her conduct is merely reckless or negligent.
See Paul J. Caragine, Jr.,
63 FR 51592 (1998). My review of the patient records establishes numerous instances in which Respondent ignored obvious warning signs that her patients were either personally abusing or diverting. Relatedly, the ALJ did not make detailed findings regarding the frequency of Respondent's issuance of new prescriptions even though this was one of the significant issues in this matter. Moreover, I reject the ALJ's conclusion that Respondent only falsified H.T.'s patient record once and conclude that substantial evidence supports the finding that on six different occasions she falsified his patient record to indicate that she had performed a physical exam when she had not.
While I acknowledge that Respondent has undertaken some measures to improve her practice, I am compelled to reject the ALJ's findings that she has willingly “admit[ted] her past mistakes,” and “accepted responsibility for her actions.” ALJ at 162. As explained more fully below, with respect to the prescriptions she issued to H.T., Respondent continues to deny that she did anything wrong. Moreover, in her testimony, Respondent maintained that there is nothing wrong with persons using a controlled substance that has not been prescribed to them but to family members and that she did not know what the term “early refill” meant even though this was one of the central issues in this case. Accordingly, I conclude that Respondent has not rebutted the Government's
prima facie
showing that granting her a registration would be “inconsistent with the public interest.” 21 U.S.C. 823(f). Respondent's application will therefore be denied. As ultimate factfinder, I make the following findings.
Findings
2
2
In this document I take official notice of several material facts because the record is unclear. Under the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” U.S. Dept. of Justice,
Attorney General's Manual on the Administrative Procedure Act
80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA's regulations, Respondent is “entitled on timely request to an opportunity to show to the contrary.” 5 U.S.C. 556(e);
see also
21 CFR 1316.59(e). To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within fifteen days of service of this order which shall commence with the mailing of the order.
Respondent graduated from New York University Medical School in 1981. Tr. 1346. She has been board-certified in physical medicine and rehabilitation since 1988, and she has practiced medicine in the State of Arizona since 1986.
Id.
Respondent practices as a physiatrist, a physician who specializes in physical medicine and rehabilitation.
Id.
Respondent formerly held DEA registration BH1192359. ALJ Ex. 1, at 1. In August 2001, the Arizona Medical Board initiated an investigation of Respondent in response to two complaints from health care plans and one complaint from a pharmacy concerning Respondent's prescribing of controlled substances. GX 73, at 4. In July 2001, in response to complaints received from Tucson area pharmacists about Respondent's prescribing of controlled substances, DEA also initiated an investigation. GX 70, at 3. On May 16, 2002, DEA, along with law enforcement officers from other agencies, executed a search warrant at Respondent's registered location, Calmwood Medical in Tucson, Arizona.
Id.
at 20-21. On November 1, 2002, my predecessor immediately suspended Respondent's DEA registration. ALJ Ex. 1, at 1.
On March 26, 2003, a Federal grand jury indicted Respondent, charging her with numerous violations of Federal law.
See
GX 5. Thereafter, Respondent and the Government agreed to a plea bargain; and on January 29, 2004, Respondent pled guilty to four counts of Accessory After the Fact to Possession of Controlled Substances by Misrepresentation, Fraud, Forgery, Deception, or Subterfuge. GX 6, at 1.
The Consent Agreement With the Arizona Medical Board
On March 10, 2004, following the entry of the plea agreement on January 29, 2004, Respondent entered into a Consent Agreement For Decree of Censure And Probation with the Arizona Medical Board (“the Board”).
See
GX 73. In the consent agreement, the Board noted that its staff had reviewed twenty-three patient charts and that the Board's outside consultants had reviewed these charts and were critical of Respondent's practices in prescribing opioids.
Id.
at 4. The Board specifically found that: (1) Respondent “often failed to obtain adequate medical histories or perform adequate physical examinations” before prescribing controlled substances to the patients, (2) that much of her “medical histories came from information provided by the patients themselves,” (3) that in some cases she “failed to further substantiate actual diagnoses and physical findings with prior medical records,” and (4) that sometimes she “failed to obtain histories of previous drug abuse or monitor for signs of current drug abuse.”
Id.
at 4.
The Board also found that in prescribing controlled substance medications, “Respondent [often] failed to maintain adequate records on the patients.”
Id.
More specifically, the Board found that Respondent's “written notes often did not provide sufficient information to support the diagnoses, justify the treatments, accurately document the results and indicate advice and cautionary warnings provided to the patients.”
Id.
The Board also found that Respondent “may have inappropriately prescribed higher than indicated doses of long- and short-acting opioid medication.”
Id.
The Board further concluded that Respondent had engaged in “unprofessional conduct” under Arizona law for various reasons including,
inter alia,
that she had failed or refused to maintain adequate medical records and had engaged in conduct or practices “that is or might be harmful or dangerous to the health of the patient or the public.”
Id.
at 6. Respondent was censured and placed on probation for two years with her office management and record-keeping practices under monitoring.
Id.
The Consent Agreement also provided for another two years of probation at the time that “her DEA Certificate is restored.”
Id.
at 7. Respondent completed her initial probation on March 10, 2006. RX 30.
Respondent submitted a letter from the Arizona Medical Board, dated December 23, 2004, indicating that she was in compliance with the terms of the order and that Respondent “has the Board's support to pursue her DEA reinstatement.” RX 53. The letter, however, also stated that “at no time [had Respondent] attempted to divert medications for non-medical purposes.”
Id.
3
She also submitted a letter from the Board dated January 8, 2007, which indicated that her probation terminated on March 10, 2006, but that new two-year probation would commence “when her DEA certificate is restored.” RX 30. The letter indicated that Respondent's “license is currently active without restriction and she is off probation.”
Id.
3
As explained below, the record in this matter establishes instances in which Respondent did divert for non-medical purposes.
The Consent Agreement also had required Respondent to complete ten hours of Continuing Medical Education (CME) in “the principles and practices of pain management or addiction medicine” before applying for a new DEA registration. GX 73, at 7. Respondent completed twelve hours of the required CME by April 2004. RX 53. “Since January 2004, she has also acquired 51.25 hours in a wide range of topics relating to pain management.”
Id.
4
4
In June 2006, the Arizona Medical Board also reprimanded Respondent and placed her on probation for two years for performing “excessive joint and soft tissue injections without adequate indications and for inadequate documentation of the quantities of pharmaceuticals injected.” GX 7, at 12.
Respondent applied for her DEA Certificate of Registration on January 28, 2005. ALJ Ex. 1, at 6.
Respondent's Prescribing Practices
The Expert Testimony
Both parties put on extensive testimony relevant to the issue of whether Respondent's prescriptions were issued in the usual course of professional practice and were for a legitimate medical purpose.
5
The Government's expert was Dr. Bradford D. Hare
6
; Respondent's experts were Dr.
Jennifer Schneider,
7
who testified as an expert in pain management, and Marylee O'Connor, a Doctor of Pharmacy, who testified as both a fact witness and expert witness on pharmacy although she was not formally qualified as such.
See
Tr. 1137.
8
5
While much of the testimony of both parties' experts was couched as to what practices were required to meet the standard of care, numerous courts have recognized that such testimony is relevant in determining whether a physician acted in the usual course of professional practice and for a legitimate medical purpose in prescribing a controlled substance.
See United States
v.
Feingold,
454 F.3d 1001, 1012 n.3 (9th Cir. 2006) (in criminal case, jury can appropriately “consider the practitioner's behavior against the benchmark of acceptable and accepted medical practice”);
see also United States
v.
Alerre,
430 F.3d 681, 691 (4th Cir. 2005) (in criminal case, “evidence that a physician's performance has consistently departed from accepted professional standards supports the proposition that the physician was not practicing medicine, but was instead cloaking drug deals under the guise of a professional medical practice”).
6
Dr. Hare is an associate professor of anesthesiology and pharmacology at the University of Utah School of Medicine, where he is also the director of the pain management fellowship and the vice president of the Department of Pain Management Services. Tr. 144-45; GX 47. He is fellowship-trained and board-certified in pain management. Tr. 145. He has an M.D., special certifications from the Board of Anesthesiology and
Pain Management, and a Ph.D. in pharmacology.
Id.; see
also GX 47. He has performed research in pain management and is currently engaged in the practice of pain management. Tr. 147-48;
see also
GX 47.
7
Dr. Schneider is board-certified in internal medicine, is certified by the American Society of Addiction Medicine, and is a diplomate of the American Academy of Pain Management. Tr. 807;
see also
RX K-1, at 1; RX 43, at 1. Respondent hired Dr. Schneider several months after the DEA executed its search warrant to mentor Respondent in record-keeping and in pain management. Tr. 808.
8
Respondent also introduced a written report from Dr. Sharon Weinstein, an Associate Professor of Anesthesiology, Neurology and Oncology at the University of Utah and the Director of Pain Medicine and Palliative Care at the University of Utah's Huntsman Cancer Institute. RX 32, at 1. Dr. Weinstein did not, however, testify at the hearing.
In her report, Dr. Weinstein criticized “Dr. Hare's judgment of [Respondent's] pain management practices [as] appear[ing] to be based at least in part upon * * * assumptions that are erroneous as stated,” and than listed what she attributed as being his assumptions.
Id.
at 2. It is unclear, however, the extent to which Dr. Weinstein has accurately characterized Dr. Hare's assumptions, and in any event, many of her criticisms rely on snippets taken from his opinions and ignore extensive other evidence in the patient files that he relied upon.
Dr. Weinstein also opined “that the prescriptions by [Respondent] were written in the usual course of professional practice and for legitimate medical purposes.”
Id.
at 1. Because Dr. Weinstein did not testify and was thus not subject to cross-examination, her opinion lacks probative force.
In her decision, the ALJ concluded “that there was no clear consensus in the medical community regarding what practices were required to meet the standard of care during 2001 and 2002.” ALJ at 151. The ALJ's finding paints with too broad a brush. While it is true that there were some issues on which the parties' experts disagreed (
e.g.,
the scope of an appropriate physical examination, the need to order diagnostic testing, appropriate dosing levels), there was substantial agreement as to what practices are necessary to meet the standard of care.
9
9
Respondent disputed the validity of Dr. Hare, who practiced in Utah, opining on the standard of care applicable to an Arizona practitioner. Tr. 1420-21. Even if the standard of care varies from one State to another (rather than simply between competing schools of thought within a medical practice specialty), Dr. Hare and Dr. Schneider (who practices in Arizona) had significant areas of agreement.
Respondent also disputed whether her prescribing practices should be evaluated under the standard of care applicable to a pain management specialist rather than the standard applicable to a physiatrist. Resp. Br. at 195. In her brief, Respondent apparently contends that the standard of care applicable to a physiatrist did not require her to obtain other provider's medical records or to obtain addiction histories on her patients prior to prescribing controlled substances.
See id.
The short answer to this contention is that the Arizona Medical Board specifically found that “Respondent failed to further substantiate actual diagnoses and physical findings with prior medical records,” and “failed to obtain adequate histories of previous drug abuse.” GX 73, at 4. The Board further cited these findings as evidence that Respondent had engaged in unprofessional conduct under Arizona law.
Id.
at 6. Respondent's contention is therefore meritless.
Initial Visit
Dr. Hare testified that at the initial visit, he asks the patient to characterize the pain and rate it on a scale of 1 to 10. Tr. 155. Dr. Hare also obtains the patient's medical history and “drug history”; as part of the latter, Dr. Hare gathers information on the patient's history of substance abuse including the use of both prescription and illicit drugs.
Id.
at 158. As Dr. Hare testified, he would “be more cautious” in handling a patient with a “significant drug abuse history.”
Id.
at 158. Dr. Hare also explained that he tries to get records from other physicians who have treated the patient, as well as the results of diagnostic studies.
Id.
at 156-57.
Dr. Hare then performs a physical examination focusing on the area of the body where the pain is occurring, but which also involves a more general examination. Tr. 152-53. The examination includes “a neurologic examination, an examination for strength, an examination for reflexes, an examination for tenderness, changes in sensitivity of the skin, tenderness in muscles, a whole range of different things, again depending on the nature of what the pain complaint is.”
Id.
at 153. Moreover, his examination would include “the vital signs, in other words[,] blood pressure, respiratory rate, heart rate, comments about just general appearance of the patient.”
Id.
Also, as part of his physical examination, Dr. Hare checks a patient's heart, chest and abdomen.
10
Id.
at 154.
10
Dr. Hare proceeded to distinguish different types of pain and the treatments appropriate to them. For instance, myofascial pain, characterized by “tender spots in the muscles” and which is usually the result of “an injury of some sort,” does not respond well to opioid medication although opioid medication may take the “edge off a bit.”
Id.
at 159. Dr. Hare also discussed neuropathic pain, “pain that's due to nerve injury,” and stated that it “is a type of pain again that is first treated not with opioids but * * * with drugs like tricyclic antidepressants or the anticonvulsive agents.”
Id.
at 160.
Dr. Schneider (Respondent's expert) testified that in her practice, she will not treat a patient absent “old records.” Tr. 854. Dr. Schneider explained that the day before the initial visit, her office calls “to remind” patients that if they do not bring records with them, their physician will be called at the visit and asked to fax the records. Tr. 854-55. However, she noted that Respondent, as a physiatrist, would often have the first visit after an injury so that there would not be prior records of treatment of a particular injury and so “it's less essential to start out on day one with old records.” Tr. 855.
Dr. Schneider likewise testified as to the importance of obtaining a patient's substance abuse history. According to Dr. Schneider, a patient who has a history of substance abuse can still be prescribed opioids for chronic pain, but the history is a “relative contraindication” for such treatment. Tr. 881. A physician thus needs to “get a careful history and * * * have much more stringent monitoring,” but, depending on “the nature of the previous substance abuse, on how long it's been since the person last abused the substance and what kind of treatment they had for it,” a physician could still safely prescribe controlled substances. Tr. 881-82.
Dr. Schneider testified that her initial appointment usually takes 45 minutes. Tr. 863-64. In that time, she goes through “the four As.” Tr. 864. The first “A” is
analgesia,
and Dr. Schneider asks for a pain rating on a scale of 1-10.
Id.
The second “A” is
activities of daily living,
about how the patient is functioning, as “treating chronic pain is a lot about function, at least as much as about pain relief.”
Id.
The third “A” is
adverse effects,
such as side effects.
Id.
The fourth and final “A” is
aberrant drug related behaviors,
which is “anything that's out of the ordinary, like if they say I need an early refill.” Tr. 865.
Dr. Schneider also testified that it is medically appropriate for a physician to prescribe based on a “focused physical exam.” Tr. 870. According to Dr. Schneider, when a physician sees “somebody for a particular problem, and this is not just in pain, but this is in any field, you limit your exam to that part.”
Id.
The exam is “called a focused physical exam because it is limited to the part of the body that the person is having trouble with.”
Id.
11
While the parties thus disagree as to the proper scope of a physical exam, I assume without deciding that a focused physical exam is adequate to diagnose a patient.
12
11
Dr Schneider also testified that there is no lethal blood opioid level for non-opioid-naïve patients, and that insurance companies are often the reason why prescriptions may be written for high volume with low dosing. Tr. 904, 909-11.
12
As one of the grounds for her finding that “there was no clear consensus” regarding what was required to meet the standard of care, the ALJ noted that “Dr. Hare concluded that the Respondent's failure to always perform physical examinations or order tests to verify symptoms constituted
inadequate treatment of the patient for whom she prescribed controlled substances. Yet, Dr. Weinstein found that Dr. Hare's conclusion rested on the erroneous assumption that all painful conditions would be objectively verifiable by a physical exam or test results.” ALJ at 52.
It is unclear, however, whether the ALJ was referring to Dr. Hare's testimony regarding the need for the initial exam or for follow-up exams when patients report new symptoms. If the ALJ's comment was referring to whether a patient should be physically examined at the initial visit, even Dr. Schneider indicated that the exam is part of the standard of medical practice. To the extent the ALJ was referring to the need for a physician to perform a physical exam on a subsequent visit when a patient reports new symptoms, obviously the necessity of performing a further physical exam depends upon the patient's symptoms and complaint. Accordingly, whether an exam was required to meet the accepted standard of medical practice cannot be evaluated outside of the context of a specific patient.
At the first visit, the physician should create a treatment plan.
Id.
at 170. According to Dr. Hare, he “[t]ypically” does not prescribe opioids on the first visit because he lacks other physicians' records, test results, and the opportunity to consult with other members in his practice group.
Id.
at 164. However, it appears this may be also because Dr. Hare and the other physicians in his practice “oftentimes see the patient as a group,” and after evaluating the patient, discuss among themselves whether they “have something to offer that patient.”
Id.
Accordingly, to the extent Dr. Hare's testimony suggests that is outside of the course of professional practice to prescribe a controlled substance at a patient's first visit, it is not conclusive.
It was undisputed, however, that “the appropriateness of prescribing [controlled substance] medications * * * depends on the level of medical documentation.”
Id.
at 228. According to Dr. Hare, “[w]ithout the appropriate documentation it's inappropriate to prescribe the controlled substances.”
Id.
at 229.
Titration of Dosing and Follow-up Visits
Both Dr. Hare and Dr. Schneider testified that when any medication has been prescribed, there will be follow-up visits at which the physician questions the patient about whether there has been improvement in his pain level and functionality, whether there have been side effects, and the continuing benefits of taking the medication.
Id.
at 172 & 181 (testimony of Dr. Hare);
id.
at 864 & 949 (Dr. Schneider's testimony that she reviews the four “A”s with her patients at every visit). At follow-up visits, the physician should question the patient as to whether he is using the medication appropriately.
13
Id.
The physician should document the patient's response to medication, functionality, and adverse effects in the patient chart.
Id.
at 173;
id.
at 865 & 951.
13
Dr. Hare also testified that he asks his patients about their mood and sleep as chronic pain patients “almost uniformly * * * have problems with anxiety and depression.” Tr. 172. He indicated that the failure to monitor sleep and mood could cause a physician to “miss the boat” in medicating with opioids.
Id.
at 182.
Moreover, both parties' expert were in agreement that when a patient is currently not on opioids they should be started at a low dose and titrated up slowly to achieve pain relief while minimizing the side effects such as nausea and sedation. Tr. 971-72;
see also id.
at 177 (testimony of Dr. Hare that “you don't want to increase too quickly for fear of overshooting and getting the patient in trouble” by causing “dangerous side effects”).
Dr. Hare noted that in the event that the medication is increased, the usual increase is in the amount of 50 percent of the prior dosage.
Id.
at 176. However, according Dr. O'Connor, it is acceptable to titrate at a rate of “no more than 50% to 100% every 5 or more days” so long as the increase in the dose does not cause adverse effects. RX 8, at 2. Moreover, because people respond differently to opioids, there can be great variability as to the dose necessary to alleviate a patient's pain. Tr. 972. In treating unrelieved pain, “there is no dose which is too high unless the patient has toxicity or side effects.” RX 9, at 2.
14
14
According to Dr. Hare, if a patient states that the medications are not working well, “then we'd have to decide whether we've just undershot the prescribing or we're dealing with a pain problem that isn't going to respond to pain medicine.”
Id.
at 174. In the latter case, he would “make plans to back off on these opioids and look at other ways to manage the pain.”
Id.
While this testimony suggests the existence of a dispute over the maximum dosage levels, it is not necessary to resolve this dispute.
Managing Patients Who Are Receiving Controlled Substances
Both Drs. Hare and Schneider testified as to the importance of setting boundaries with patients who are receiving controlled substances through the use of written agreements. Tr. 161. As Dr. Schneider testified: “I have all my patients sign an agreement [which] lays down the rules and it says that they're [the patients] not to make any changes in their medications without first consulting me.”
15
Id.
at 876. Dr. Schneider further explained that if she gives a patient permission to increase his dose, she documents it.
Id.
at 877.
16
If a patient comes in reporting that he took more medication than prescribed, Dr. Schneider asks why and if the response is not reasonable, her “reaction is * * * to build more structure around them.”
Id.
Sometimes this involves having a family member administer the medication,
id.
at 878; it may also involve writing very small prescriptions and having more frequent visits.
Id.
at 879. Similarly, Dr. Hare noted that “if a patient has overused medication,” a physician needs to find out why, and if the patient does not offer a “good reason, the physician should counsel the patient to use his medication as prescribed and “hold them to it.”
17
Id.
at 163.
15
Dr. Schneider further explained that there is a “loss of control thing that is part of addiction [and] an addict who wants more medication is not going to be willing to call me in the office and leave a message and have me call him back four hours later to tell him that yes, you can take another pill because you're having more pain.”
Id.
at 876.
16
Subsequently, Dr. Schneider testified that “three” to “five years” ago, a lot of people were not aware of pain agreements and were not using them. Tr. 1012-13. Dr. Hare, however, testified that the agreements had been in use for as “as long as” he could remember and in excess of fifteen years.
Id.
at 187-88. I further note that the record contains a pain management agreement signed by a patient of Respondent in July 2001.
See
RX 72, at 3-4. Whether or not the usual course of professional practice requires that the physician enter into a written agreement setting forth her expectations and what rules her patient must follow while being treated, it is undisputed that a physician must carefully monitor her patients' use of controlled substances.
17
The record contains a copy of a pain management agreement Respondent used in treating R.T. GX 72, at 3-4. The agreement reads in relevant part:
I understand that if I break this Agreement, my doctor will stop prescribing these pain-control medicines.
In this case, my doctor will taper off the medicine over a period of several days, as necessary, to avoid withdrawal symptoms. Also, a drug-dependence treatment program may be recommended.
I will communicate fully with my doctor about the character and intensity of my pain, the effect of pain on my daily life, and how well the medicine is helping to relieve the pain.
I will not use any illegal controlled substances, including marijuana, cocaine, etc.
I will not share, sell or trade my medication with anyone.
I will not attempt to obtain any controlled substances, including opioid pain medicines, controlled stimulants, or antianxiety medications from any other doctor.
I will safeguard my pain medicine from loss or theft. Lost or stolen medicines will only be replaced at the doctor's discretion.
* * *
I agree to use ____ Pharmacy, located at ______, Telephone number ______, for filling prescriptions for all my pain medicine.
* * *
I agree that I will submit to a blood or urine test if requested by my doctor to determine my compliance with my program of pain control medicine.
I agree that I will use my medicine at a rate no greater than the prescribed rate and that use of my medicine at a greater rate will result in my being without medication for a period of time.
I will bring all unused medicine to every office visit.
GX 72, at 3a-3b.
Both Drs. Hare and Schneider testified that they require their patients to agree to obtain their medications only from themselves and not from other physicians.
18
Id.
at 161;
id.
at 963. Dr. Schneider testified that if she found out that a patient was obtaining drugs from another source, she would question the patient and determine the circumstances.
Id.
at 962. Moreover, if the patient was obtaining the drugs from another physician, she would call the physician and remind him that “the patient has a contract with” her, which the other physician knows about because she sends reports to him, and that she tells the other physician that he “cannot be prescribing for the patient.”
Id.
at 963. Dr. Schneider added that if the patient does it again, she “may discharge them.”
Id.
at 964.
18
Dr. Hare further explained that his agreement provides the patients with instructions for obtaining refills and also establishes rules for dealing with a patient's claim that his medication was lost or stolen.
Id.
at 161. According to Dr. Hare, the agreement “makes it clear that we may or may not choose to refill the medications under those circumstances.”
Id.
Continuing, he explained that his practice is “usually pretty flexible” the first time a patient reports that his medication has been lost or stolen and will issue a new prescription while counseling the patient.
Id.
at 162. If, however, it happens again, it raises a concern that the patient is “overusing their medicine” and “perhaps diverting them.”
Id.
Dr. Schneider further testified that if a patient is giving drugs to a family member, she counsels them that this is a felony offense and she is “certainly not going to replace a pill that [a patient] ha[s] one less of because [she] gave it to a family member.”
Id.
at 1007. Moreover, she documents the incident in the patient record.
Id.
at 1008. Dr. Schneider also noted that it is especially “egregious” when a patient is buying drugs on the street.
Id.
at 1006.
With respect to requests for early refills, Dr. Hare testified that “we try to come up with a plan that's going to meet the patient's needs until the time of the next visit,” including “a reasonable type of medicine,” and “a reasonable amount of medication.”
Id.
at 163. Dr Hare further explained that “[w]e do our refills on a 30-day basis,” and we set “the dates that the refill is supposed to occur * * * so we have all of that information in our records” and that this allows for the physician “to quickly access * * * and determine when a refill is appropriate” and “when it's not.”
Id.
at 164.
To similar effect, Dr. Schneider testified that when a patient ask for early refills, she discusses with the patient why the refill is needed and documents this in the patient record.
Id.
at 949. Moreover, Dr. Schneider may decline to refill the prescription. She also noted that she has a page in her charts in which every prescription and the date of its issuance is recorded so that a refill request can be properly evaluated to determine whether it is too early.
19
Id.
19
Dr. Schneider also testified that many doctors “simply write down the prescription they wrote that day in the body of the records, meaning that the next time the patient comes, they've got to be rifling back through to see what was the last one.” Tr. 1001.
Dr. Schneider testified that when an anonymous phone call is received which indicates that a patient is either selling or abusing a drug, “[y]ou have to look into it * * * You have to pursue all these angles.”
Id.
at 830. According to Dr. Schneider, “there are some times when the information has a lot of validity and you have to follow it, and when the doctor doesn't that's a bad scene.”
Id.
As to a patient using “somebody's prescription that happened to be around the house because they had a bad headache or whatever,” Schneider testified that “counseling them, and advising them, and warning them and so forth may be enough.”
Id.
at 836. However, if in truth it is a situation of “an active addiction problem,” the physician needs to inform the patient that the addiction will interfere with the prescribing and “that they need to get some help with their addiction problem.”
Id.
Dr. Schneider further testified that there are “many sets of tools on the Internet to help pain specialists assess their patients for a history of addiction and for addiction issues and on how to monitor them and how to follow them.”
Id.
at 824. In addition, a physician should use such measures as pill counts (
i.e.,
requiring patients to bring in their prescriptions to determine whether they are taking them as prescribed) and random drug screening through either blood or urine tests to determine whether the patient is taking the prescribed medication and/or taking illicit drugs.
See
GX 72, at 4 (requiring that Respondent's patients agree to “submit to a blood or urine test * * * to determine my compliance with my program of pain control medicine” and that they “bring all unused pain medicine to every office visit”).
20
20
In her testimony, Dr. Schneider vaguely suggested that in 2001-2002, the use of urine drugs screens was not generally accepted as required by the standard of care. Tr. 1013. In August 1998, however, Dr. Schneider published an article in which she noted that required her patients to “
obtain urine drug screens when asked.
This feature of the contract prevents any refusals from the patient and lets me request a urine screen at any suspicion of drug addiction problems.” Jennifer P. Schneider,
Management of Chronic Non-Cancer Pain: A Guide To Appropriate Use Of Opioids,
4 J. Care Mgmt. 10, 18 (Aug. 1998). Therein, Dr. Schneider also noted the role of asking a patient “to bring in partly-used medication containers for a pill count” in assessing whether the patient has lost control over his/her drug use.
Id.
at 13. In accordance with 5 U.S.C. 556(e), I take official note of Dr. Schneider's article and reject her suggestion that urine drug screens were not required to meet the standard of care in prescribing controlled substances by a pain specialist. Moreover, the Arizona Board found that Respondent had failed to monitor her patients for signs of current drug abuse. GX 73, at 4.
Dr. Schneider also contended that in 2001-2002, urine drugs screens were difficult to interpret, in part because of the difference between opioids (which are semi-synthetic or synthetic) and opiates (which are derivatives of morphine), and that the opioids would not show up on a standard urine drug screen and that the physician had to specifically request that the lab test for them. Tr. 892. Putting aside whether a competent physician should have known the difference between opioids and opiates and how to properly screen for them, in her article she also noted that urine drugs screens were useful in determining whether a patient is abusing illicit drugs. Were it the case that Respondent required her patients to undergo urine drug screens and mistakenly failed to request the correct test, it would be a relevant consideration. However, Respondent rarely required her patients to undergo urine drug screens.
Dr. Schneider testified that it is important for a doctor to communicate with other doctors. Tr. 853. Dr. Schneider sends a copy of her notes on “every visit” to the primary care physician.
Id.
If she knows of a patient's “ongoing relationship with some other specialist related to their pain problem,” she also sends a copy of the notes from every visit.
Id.
After making a referral to a specialist, she also requests “a copy of that report and of imaging studies.”
Id.
Alleged General Practices
At the request of the DEA Investigators, Dr. Hare reviewed the medical records of Respondent's patients.
21
GX 46. In his first report (January 15, 2003), Dr. Hare indicated that he had reviewed the records of eight patients and found that Respondent's care exhibited the following “general problems”:
21
In a subsequent report, Dr. Hare reviewed the medical records for an additional seven patients.
See
GX 46A.
• Respondent “failed to adequately evaluate” patients by not obtaining an adequate “pain history” and by not “obtaining[ing] information from previous treatment such as records of treating physicians and the previous medications used.” GX 46, at 1. These would “have allowed [Respondent] to determine if there had been problems with medications or patient compliance.”
Id.
• Despite the fact that “[t]he information in [Respondent's] records was insufficient to make a proper diagnosis,” Respondent “prescribed Controlled Substances.”
Id.
• Respondent “did not properly track the use of medications.”
Id.
at 2. She did
not “comment on the lack of patient compliance” when patients used controlled substances “in excess of the prescribed amounts.”
Id.
Rather, she “usually increased the amount of the prescription to meet the patient's use of medication, rather than exercising any control over the patient's consumption.”
Id.
• Respondent switched from one controlled substance to another, “based on patient request, not on what was reasonable therapeutically.”
Id.
On cross-examination, Respondent admitted that she failed to take addiction histories. Tr. 2344. However, when asked whether she routinely failed to obtain prior medical records, she stated that “there is no obligation or rule that you have to get medical records.”
Id.; but see
GX 73, at 4 (State Board's finding that “Respondent failed to further substantiate actual diagnoses and physical findings with prior medical records.”). She stated that in many cases she did get parts of medical records.
Id.
at 2345. She admitted that others might not always be able to “glean” her rationale for increasing opioid dosages from her records.
Id.
at 2346. When asked whether she often issued early refills on controlled substance prescriptions without documenting the reason in her medical records, Respondent said that she did not know what the term “early refill” meant.
Id.
at 2345-46. She indicated that she did not find doing frequent MRIs useful, that with chronic pain that was just a waste of medical resources.
Id.
at 1381.
Respondent testified that she always did an evaluation on new injury cases, that there was always a physical examination, and that it was always documented.
Id.
at 2347-48. She testified that she did not ignore that some patients had histories of addiction and that she did not ignore warning signs of addiction or abuse.
Id.
at 2348-49. She admitted that she was not in contact with primary care physicians in all cases, but she also justified that in the case of J.N., noting that her primary care physician wasn't practicing due to a licensing issue.
Id.
at 2349. Respondent admitted that on occasion she failed to document the reason for increasing an opioid dose.
Id.
at 2351.
Respondent also stated that she did not believe in reprimanding patients when she found out that they were giving their controlled substances to another person.
Id.
at 2393-94. She compared the situation to one where a diabetic patient is not following his diabetic diet.
Id.
Evidence Regarding Specific Patients
J.N.
On September 11, 2000, J.N., who was then forty-three years old and who undergone a cervical fusion in 1994, started treating with Respondent. GX 9, at 1. She “had been sexually assaulted and suffered [a] cervical fracture and needed emergency surgery.”
Id.
Her pain had recently worsened, and Respondent noted in her medical record that she “need[ed] another cervical fusion.”
Id.
J.N. had been on disability since 1994.
Id.
There is no indication in J.N.'s patient record that Respondent inquired about any history of substance abuse at the initial visit.
Id.
at 1-2. At the first visit, Respondent performed a physical exam and diagnosed J.N. as having “[s]evere neck pain,” “left upper extremity pain,” and “signs of left cervical radiculopathy.”
Id.
at 2. Respondent gave J.N. a free trial of 21 tablets of OxyContin 40 mg q8h
22
(one tablet every eight hours), 50 tablets of Oxycodone IR “1-2 q4h PRN for breakthrough pain,” and a prescription for 60 tablets of Xanax 0.5 mg twice a day, with one refill, although nothing in the patient record documented that J.N. experienced anxiety.
Id.
at 2. Respondent was to “[r]echeck in 1 week.”
Id.
22
The record establishes that “q” means every, and that “h” means hour(s), and “hs” at bedtime.
See
Tr. 1122 & RX L, at 6; Tr. 1151 & GX 9, at 8; Tr. 1165 & GX 13, at 6; Tr. 1175. Thus, “q4h” means every four hours, “q6h” means every six hours, “q8h” means every eight hours, and “q12h” means every twelve hours.
See
Tr. 1122 & RX L, at 6; Tr. 1175;
id.
at 1151 & GX 9, at 8. In addition, the abbreviation “BID” means “twice a day,” Tr. 355 & RX 13, at 1; “TID” means “three times a day,” Tr. 403 & RX 13, at 1; and “QID” means “four times a day.”
Id.
at 358 & GX 22, at 18. The abbreviation “PRN” means “as needed.”
Id.
at 1174. It is also undisputed that prescribing in excess of 4 grams or 4000 mg. per day of drugs containing acetaminophen risks liver toxicity.
See id.
at 403-04.
On September 15, Respondent noted that J.N. “is better on the OxyContin and Oxycodone. She feels less pain,” yet Respondent increased the OxyContin prescription to 60 (160 mg.) tablets, with one tablet to be taken every eight hours, (a twenty-day supply), which was a four-fold increase in the dosage over the initial prescription.
Id.
Respondent also issued prescriptions for 50 milliliters of Oxyfast 20 mg/ml, “1-2 ml q4h PRN breakthrough pain,” 360 tablets of MS Contin 100 mg., (4 tabs q8h), as well as 100 milliliters of morphine elixir “20 mg/ml 5 ml q6h PRN breakthrough pain.”
Id.
at 2-3. Respondent noted that the latter two prescriptions were being issued in “[i]n case Pima insurance doesn't cover” the other medications.
Id.
Respondent also increased the dosage of Xanax four-fold to 2 mg. twice a day, again without any finding regarding anxiety.
Id.
J.N. returned on October 5 and reported that she was “much better than she has been because of the MS Contin,” and Respondent wrote prescriptions for MS Contin at the same dosing and also MSIR (morphine sulfate immediate release) “30 mg 6qh PRN breakthrough pain #120,” to “recheck in one month.”
Id.
at 3. Respondent also added a prescription for ten tablets of Dilaudid 4 mg., 1-2 four times a day.
Id.
On October 25, J.N. reported that the medications helped with her pain and with sleep and that she would like more Dilaudid.
Id.
She also reported having had an EMG/NCV with a Dr. L. on September 14, but did not know the results.
Id.
at 4. Respondent wrote prescriptions for Dilaudid, MS Contin, MSIR, as well as Fioricet for “headache.”
23
Id.
at 4. J.N. continued on Dilaudid, MS Contin, Xanax and Fioricet through June 14, 2001.
Id.
at 4-9.
23
The patient record also indicated that Respondent issued her a prescription for Amoxicillin, a non-controlled drug.
J.N.'s patient record includes a Discharge Summary from University Medical Center in Tucson, Arizona, which was faxed to Respondent on January 16, 2001. Notably, the first page states that JN had a “history of IV heroin abuse”.
Id.
at 13. Continuing, the Summary stated that “she quit several years ago, but started using again one week ago because of increasing abdominal pain.”
Id.
at 13-14. The Summary also noted that a urine toxicology screen was “positive for opiates, barbiturates, benzodiazepines, and marijuana.”
Id.
at 15.
The Discharge Summary listed five medical problems J.N. had including “Chronic pain/narcotic addiction.”
Id.
at 15-16. The Summary specifically noted that J.N. was “preoccupied with her pain medications, requesting p.r.n. medications frequently” and was “resistant to weaning attempts.”
Id.
Moreover, while the hospital offered J.N. “drug abuse placement,” she “refused,” stating that “she was not an addict, and was only unable to get off Morphine due to her medical condition.”
Id.
at 16. The Summary also noted that on discharge, J.N. was given MS Contin, Dilaudid and Xanax in the doses that she had been receiving from Respondent and in quantities that would last until she could see her pain specialist.
Id.
While the patient record indicates that Respondent was notified on
December 4, 2000 that J.N. had been hospitalized, GX 9, at 5, she did not obtain the Discharge Summary for another month. Moreover, J.N.'s medical record contains a note dated January 24, 2001, that Respondent “received records from UMC and discharge diagnosis was sludge in gallbladder”; the note contains no mention of either the results of the drug screen done by the hospital or of J.N's statement to the hospital staff that she had recently started using heroin again.
Id.
at 6.
J.N.'s record contains no indication that Respondent attempted to monitor her use of controlled substances through drug screens and pill counts.
See generally id.
Moreover, the medical record contains no indication that Respondent questioned J.N. about her use of marijuana, heroin, or the barbiturate (which Respondent had not prescribed to her).
On subsequent visits, Respondent primarily prescribed 120 tablets of Dilaudid 4 mg. (QID—one tablet four times a day), 180 tablets of MS Contin 200 mg. (two tablets every eight hours), Xanax 2 mg. (BID -one tablet twice a day), and Restoril (temazepam) (two tablets at bed time).
24
Id.
at 5-9. After J.N.'s hospitalization, all of the MS Contin prescriptions and all but two of the Dilaudid prescriptions were for a quantity equaling 30 days of dosing.
See id.
Approximately half of the Dilaudid and MS Contin prescriptions were refilled at least five days early, with some being refilled as early as eight or nine days before the previous prescription would have run out.
See id.
(Rxs for: 180 MS Contin on 12/18, 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14; for 120 Dilaudid on 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14).
24
Both Xanax (alprazolam) and Restoril (temazepam) are benzodiazepines and schedule IV depressants.
See
21 CFR 1308.14(c).
J.N. died of an overdose on June 18, 2001. According to a police report, “several syringes were found at the scene,” as well as various drugs including hydromorphone and morphine sulfate.
25
GX 8, at 18. The police also found a white powder in the living room and were told by J.N.'s boyfriend that the two of them would mix “her prescription medication with water and inject it using the used syringes.” GX 8, at 19. Moreover, in an interview with investigators, J.N.'s boyfriend stated that she would crush up the Dilaudid (hydromorphone) she obtained from Respondent and inject it. GX 43, at 11. J.N.'s boyfriend also related that “[s]he didn't have veins” and that it was very hard to get blood from her.
Id.
at 22. Yet there is no indication in J.N.'s medical record that Respondent ever noticed this.
See generally
GX 9.
25
According to the police report, twenty syringes were found, several of which had been opened. GX 8, at 18-19. In addition to hydromorphone and morphine sulfate, the police found Duramorph, methocarbamol, Pancrease, Zyprexa, Naproxen, and Cimetidine.
Id.
at 18.
The Medical Examiner determined that the cause of J.N.'s death was “acute intoxication due to the combined effects of opiates, cyclobenzaprine, and amitriptyline.” GX 8, at 2. Respondent disputed the Medical Examiner's conclusion. One of her experts (Dr. Schneider) maintained that it was not “black and white that a morphine overdose was her cause of death,” and indicated (in response to Respondent's question whether her opinion would change if J.N. had been on the same dose of extended release morphine for the previous ten months), that unless J.N. had “suddenly taken a lot more” of the drug, she would question whether J.N.'s death was caused by a morphine overdose. Tr. 921-22. Dr. Schneider was not asked, however, whether her opinion would be different if J.N. had taken the drug intravenously.
Relatedly, another of Respondent's experts (Dr. O'Connor) testified that J.N.'s taking of the cyclobenzaprine and amitriptyline (neither of which was prescribed by Respondent) would have “certainly” caused her to have a heart attack.
Id.
at 1154. Yet the Medical Examiner did not note any evidence of a heart attack.
See generally
GX 8. Moreover, when Respondent asked her whether there are “any interactions between opiates, such as morphine, and * * * amitriptyline or cyclobenzaprine,” the witness answered:
Certainly in [an] opioid-naïve patient, if they took * * * Tylenol with codeine, and then they took some cyclobenzaprine or flexeril on top of that * * * they might get more sleepy. The same goes for amitriptyline or tricyclics. In an opioid-tolerant patient, no.
Tr. 1157. The expert's testimony does not make clear whether her answer as to the effect that would occur in an opioid-tolerant patient applies to a patient taking opiates other than Tylenol with codeine, a drug which is far less potent than either MS Contin 200 mg. or Dilaudid. Furthermore, the Medical Examiner did not conclude that J.N.'s death was caused solely by her use of morphine, but rather, the combined effects of opiates and the other two drugs.
26
GX 8, at 2.
26
Respondent also introduced into evidence an article discussing a survey of blood levels of opiates in opioid-tolerant patients.
See
RX 39. More specifically, Respondent pointed to a table which indicated that a patient with a Morphine SR blood level of 2837 ng/ml, a level which was higher than that found in JN (2374 ng/ml) following her death, was capable of functioning.
Compare
RX 39, at 4 with GX 8, at 10. Respondent did not, however, offer any evidence that she conducted blood tests of J.N. while she was alive to show what level she was functional act.
In any event, it is not necessary to resolve the factual dispute. Even if J.N's intravenous use of either Dilaudid or MS Contin did not contribute to her death—it just being a coincidence that syringes and crushed medication were found in the vicinity of her body—the evidence nonetheless clearly established that she was abusing drugs, that Respondent had reason to know that she was abusing drugs, and that Respondent failed to properly supervise her use of controlled substances.
With respect to the discharge summary, which clearly indicated that J.N. was abusing drugs, Respondent testified that she failed to read the entire hospital discharge summary because it “was a lot of pages.” Tr. 2367. According to Respondent, she “looked at the beginning” and “looked at the end” of the document but that the reference to J.N.'s heroin abuse was “buried in” the report.
Id.
at 1850 & 2367-68.
27
27
Respondent testified that, despite being aware of the addiction history, the attending physician had continued the medications that she prescribed for JN—MS Contin 400 mg., Dilaudid 2 mg., and immediate release morphine 30 mg. Tr. 2368; GX 9, at 13. The Respondent was also listed as J.N.'s pain specialist in the discharge report. GX 9, at 13.
The discharge summary was, however, only five pages in length (and the fifth page did not contain any medical information).
See
GX 9, at 13-17. Moreover, the reference to J.N.'s “history of IV heroin abuse” was on the bottom of the first page.
See id.
at 1.
In her testimony, Respondent also maintained that that she was unaware that J.N. had crushed and injected her medication until she inferred it from a question DI Llenas asked her the day of the search warrant in May 2002. Tr. 2377. Yet other evidence indicated that J.N. had no veins and that it was difficult to draw blood from her, something which Respondent apparently never noticed.
With respect to J.N.'s initial visit, Dr. Hare concluded that Respondent “failed to obtain [an] adequate history * * * and [that] she did not obtain records from * * * the neurologist, by whom the patient had been evaluated,” that she conducted a “minimal and inadequate physical examination,” and that “the evaluation was inadequate to allow proper diagnosis and therefore the prescribing of controlled substances.” GX 46, at 4. As to J.N.'s second visit, Dr. Hare's review of her patient record noted that her “already large dose of
OxyContin” was “dramatically increased” “six-fold”
28
on September 15, 2000, “despite the patient's improvement.”
Id.
He also noted that the strength of the alternative prescription that was written for MS Contin 100 mg. would “translate to about 8 times the original OxyContin [sic] dose.”
29
Id.
at 5.
28
Dr. Hare noted that the OxyContin 160 mg. was to be taken every four hours, but the patient chart indicated only every eight hours. I find that the dose increase was four-fold, not six-fold.
29
In a patient narrative that Respondent wrote on C.O., which was included in C.O.'s medical record, Respondent wrote of her prescribings that “[t]he dose was increased by approximately 50%-100% at a time, when necessary, as is the appropriate way to titrate opioids.” GX 36, at 35.
Dr. Hare further noted that on January 11, 2001, the patient record “indicate[d] that the patient's [niece] died and that the patient was quite distressed.”
Id.
He also remarked that “[t]his was the very first mention in the records of anxiety and depression, even though the patient had been treated with Xanax for a considerable period of time prior to this.”
Id.
Dr. Hare also noted that on several occasions Respondent prescribed medications for J.N. that other doctors, in other specialties, had previously prescribed for J.N., without attempting to coordinate care with those physicians.
Id.
Dr. Hare also observed that Respondent did not notice signs of abuse, did not acknowledge the Discharge Summary's information about J.N.'s current abuse and history of substance abuse, and failed to treat J.N. for depression or give a psychiatric referral.
30
Id.
at 6. Dr. Hare thus concluded that Respondent's care of J.N. was “substandard” and “probably negligent.”
Id.
at 6.
30
Respondent testified that she made efforts to refer J.N. to a psychiatrist but did not record that in the patient file. Tr. 2356.
With respect to J.N. (as well as three other patients N.F., W.F., and C.O.), Dr. Schneider observed in her report that:
All had evidence of “aberrant drug-related behaviors” which should have been pursued but weren't, and all received early refills without adequate documentation. These charts certainly showed problems which indicated that [Respondent] needed additional education about obtaining an addiction history, careful monitoring, and review of the “big picture.”
RX K-1, at 6.
W.F.
W.F. first visited Respondent in September 2001. At that time he was a disabled 44-year-old veteran. GX 13, at 1. W.F. had been in a severe jeep accident in 1973 while in the Marine Corps, fracturing his pelvis, femur, right wrist and left mandible.
Id.;
Tr. 1958. He walked with crutches. GX 13, at 1.
At the first visit, W.F. brought in an impairment rating from the Veteran's Administration (VA) establishing that he was disabled.
Id.
Respondent did not, however, contact the VA to obtain copies of his treatment records.
Id.
Nor is there any indication in the patient record that Respondent inquired about W.F.'s substance abuse history at the initial visit, nor is there any indication that she asked for pain ratings.
See id.
Respondent's physical exam involved observing W.F. walk with his crutches, noting that he had “severe pain with lumbar range of motion,” “tenderness over bilateral lumbar paraspinals,” and “tenderness over [his] right wrist and pain with right wrist range of motion.”
Id.
W.F.'s patient file includes several letters which advised Respondent that he had a history of substance abuse. The first letter, which was dated January 8, 2002, was written by Dr. H.G., a psychiatrist with Cope Behavioral Health. GX 13, at 13. Therein, Dr. H.G. explained that W.F. was “currently under court ordered treatment by the Psychiatric Security Review Board which mandates that all [of] his medications are to be prescribed by either psychiatrists at Cope * * * or by the VA.”
Id.
The letter further states that W.F.'s “case manager * * * has recently learned that [he] was receiving narcotics & psychotropics from your office; unfortunately, this history has repeated itself to poor outcomes in the past for [W.F.] (addiction issues).”
Id.
On January 24, 2002, Dr. H.G. sent another letter to Respondent.
Id.
at 15. Therein, he indicated that it was permissible for Respondent to prescribe for W.F. because he could not get an appointment at the VA until April. Dr. H.G. noted, however, that “[a]lthough he currently denies symptoms of abuse, please be aware he has had narcotics addiction problems in the past.”
Id.
at 15.
Finally, on January 28, 2002, J.G., a case manager at Cope Behavioral Health, indicated that Cope had “received a phone call this afternoon from a family member of [W.F.], who is concerned that [W.F.] might be abusing his pain meds.”
Id.
at 17.
The patient record contains some indication that on January 29, 2002, Respondent discussed addiction issues with W.F., as Respondent wrote: “[p]atient insists that the medications help with the pain, and he cannot function without the medications.”
Id.
at 5. Respondent wrote prescriptions for 100 Methadone 10 mg. 1-2 QID (one to two tablets four times a day) and 100 Roxicodone 30 mg. q4h PRN (one tablet every four hours as needed for pain).
Id.
at 6. Respondent issued the same prescriptions on February 11, 2002. Respondent had also previously written prescriptions for temazepam with multiple refills on October 29, 2001, and December 17, 2001.
Id.
at 3, 5.
On February 24, 2002, W.F. was found dead. The Medical Examiner's report concluded that W.F. “died of undetermined cause. Possibilities include seizure related and drug intoxication.” GX 11, at 2. A toxicology report found that W.F. had a temazepam level of 1148 ng/ml;
id.
at 14, however, the Medical Examiner subsequently indicated in a letter to Respondent that this level of the drug “would not be expected to cause death.” RX 52. The Medical Examiner also found that “[o]ther drugs identified in his body were in too low a concentration to allow me to come to the conclusion that death was likely the result of the combination of drugs, including Temazepam.”
Id.
Relatedly, the toxicology tests found only a small amount of oxycodone and no presence of methadone in W.F. GX 11, at 9-15.
Dr. Hare observed that at the initial visit, Respondent did not obtain an adequate medical history and did not inquire about substance abuse issues. GX 46, at 3. Also, “the physical examination was minimal and inadequate to characterize various pain complaints.”
Id.
Dr. Hare also faulted Respondent, who then knew of the history of substance abuse, for not limiting W.F.'s medication and not “requesting toxicology screens * * * to determine if he was using medications other than those she prescribed, or actually using the medication she was prescribing.”
Id.
at 4. Dr. Hare further noted that the toxicology report done as part of the autopsy “was negative for opioids which he had been prescribed in sizable amounts” and that “[t]he lack of opioids would suggest that the patient was diverting significant portions or the entire prescriptions.”
Id.
31
He concluded that Respondent's care was “substandard and inappropriate regarding the controlled substance prescriptions.”
Id.
31
The ALJ's findings contrast this with an excerpt from Dr. Weinstein's report in which she wrote: “Dr. Hare states, `considering the huge amounts of medications and lack of side effects, the patient was likely diverting,' an inference that cannot be made from therapeutic information alone.” ALJ at 82. I note that this comment was made in response to the patient file of a patient other than W.F. Given that the toxicology screen found no evidence of methadone, a drug with a very long half life, it is reasonable to infer that W.F. was not been taking the medication prescribed but rather was diverting it. Moreover, W.F. was identified by Dr. Schneider as a patient who had likely engaged in aberrant drug-related behavior. RX K-1, at 6.
On cross-examination, Respondent testified that she had heeded the psychiatrist's warning about the past heroin addiction and also his “judgment” that pain medications were appropriate.
32
Tr. 2382. She admitted that she never did an addiction history.
Id.
In her testimony, Respondent did not, however, respond to Dr. Hare's contention that her physical exam was minimal and inadequate.
32
Relatedly, the ALJ quoted Dr. Weinstein's report that Respondent “had received communication from a treating psychiatrist, agreeing that the medications she was prescribing for their mutual patient were appropriate.” ALJ at 80 (FOF 289; quoting RX 32, at 3). Dr Weinstein also wrote, “In this instance, [Respondent] had a concurring opinion from a psychiatrist for her management plan.” RX 32, at 3.
This is a fundamental mischaracterization of the evidence as there is no indication in W.F.'s file that Respondent had a plan to manage his use of controlled substances. Moreover, Dr. H.G.'s letter merely stated that because W.F. could not see the VA for another three months, he was “in agreement that he should see you until his appointment.” GX 13, at 15. Moreover, Dr. H.G. and his staff repeatedly cautioned Respondent about W.F.'s narcotics abuse history.
See id.
at 13-15. This is hardly a concurrence in whatever prescriptions Respondent would write.
The ALJ credited Respondent's testimony that oxycodone is a short-acting medication and that half of it is gone after two hours. ALJ at 82 (citing Tr. 2165). The ALJ also credited Respondent's testimony that it was “quite possible that a patient could take a level of less than five,” and that this “doesn't mean that a person is not taking his or her oxycodone.”
Id.
Respondent did not, however, address why there was no methadone, a medication with a much longer half-life than oxycodone, in W.F. at the time of his death.
W.F. was one of those patients about whom Dr. Schneider concluded that there was “evidence of `aberrant drug-related behaviors', which should have been pursued but weren't.” RX K-1, at 6. Dr. Schneider further noted W.F. had “received early refills without adequate documentation and explanations,” and that Respondent's charts indicated that Respondent “needed additional education about obtaining an addiction history, careful monitoring and review of the big picture.”
Id.
M.D. and S.R.
M.D. and S.R., who were both patients of Respondent, were unmarried but lived together. M.D. first visited Respondent on May 21, 2001, when he complained of having “fallen off a bicycle” and of a “back and leg injury.” GX 17, at 1. M.D. further related that another physician had prescribed to him OxyContin 80 mg. (at a dosing of one tablet every twelve hours), Oxyfast, and methadone, but that the physician had left the office and that he had been off the drugs for several months.
Id.
Respondent did not, however, attempt to contact the other physician's office to verify the statement and/or to obtain treatment records.
Respondent's physical exam noted that M.D. was a “lethargic male in no acute distress with antalgic limp, favoring left lower extremity,” “pain with range of motion of the left ankle,” “tenderness over bilateral thoracic and lumbar paraspinals,” and “decreased lumbar range of motion associated with pain.”
Id.
Respondent did not, however, otherwise indicate how severe M.D's pain was.
Id.
Respondent also had M.D. sign a pain contract and issued him prescriptions for 60 OxyContin 80 mg. q12h, 30 milliliters of Oxyfast, and 30 tablets of Oxycodone 5 mg. PRN.
Id.
Later the same day, Respondent documented having received a phone call (apparently from a pharmacy) reporting that M.D. was “known to forge prescriptions and was arrested.”
Id.
at 2. Respondent notified the pharmacy where M.D. had indicated on the pain contract that he would fill his prescriptions not to fill them.
Id.
M.D., however, filled the OxyContin prescription at a Walgreen's pharmacy.
Id.
On June 8, 2001, M.D. returned to Respondent seeking a new OxyContin prescription.
Id.
M.D. reported that he was taking double the dose of the OxyContin.
Id.
He also did not remember what had happened at the pharmacy which had reported him to Respondent.
Id.
Respondent refused to issue the prescription.
Id.
There are no further visits recorded in M.D.'s patient record.
Id.
The record indicates, however, that on October 8, 2001, the patient pharmacy manager at Tucson Medical Center reported that M.D. had been admitted to the hospital in a coma seven days earlier and had in his possession methadone 40 mg. tablets which were contained in a prescription bottle; the label indicated that the prescription was for Dilaudid 4 mg. and had been issued by Respondent to S.R.
33
Id.
33
On January 6, 2002, M.D. was found dead at his residence. GX 18, at 3. The Medical Examiner found that M.D.'s death was caused by “opiate, cocaine and methadone intoxication.”
Id.
at 2. Respondent had not seen M.D. in seven months.
S.R. first saw Respondent on August 3, 2001, complaining of abdominal and pelvic pain. GX 15, at 1. S.R. reported that she had a history of interstitial cystitis and active hepatitis C, but apparently she did not bring records about either condition with her.
See id.
S.R. indicated that she was taking Xanax and Vicodin, which she obtained from another doctor.
Id.
She also stated that she was taking her deceased husband's OxyContin and Dilaudid.
34
Id.
34
This incident of diversion furnished the basis of one of the counts of Accessory After the Fact in Respondent's plea agreement.
See
GX 6, at 7.
Respondent's physical exam indicated that S.R. was “in moderate distress,” that she had “pain with ambulation and limp,” and had “tenderness over [her] abdomen.”
Id.
Respondent diagnosed S.R. as having “interstitial cystitis and chronic pain,” as well as Hepatitis C.
Id.
Respondent discussed the risks and benefits of long-acting opioids, including addiction and side effects, and prescribed Dilaudid 2 mg. “QID #30,” OxyContin 10 mg. “q12h #30,” and Xanax 0.5 mg. “TID PRN #90.”
Id.
There is no indication that Respondent contacted the physician who had prescribed Vicodin and Xanax to her.
See id.
Moreover, there is no indication as to why she prescribed Xanax, an anti-anxiety drug. Nor did she counsel S.R. about the use of her deceased husband's medications. Tr. 2353.
S.R. returned seventeen days later, reported that she was out of Dilaudid and OxyContin, and asked for stronger medication. GX 15, at 1-2. Respondent found that S.R. had “pain with ambulation and limp” and “tenderness over [her] abdomen.”
Id.
at 2. Respondent increased both the strength and quantity of the Dilaudid to 4 mg. “QID #60,” and the strength of the OxyContin to 20 mg., with the same dosing and number of tablets (“q12h #30”). She also issued a new prescription for Xanax, 0.5 mg., TID PRN #90.
Id.
at 2.
On September 4, 2001, S.R. again saw Respondent. Respondent noted that S.R.'s urologist had “diagnosed interstitial cystitis,” and that she needed to “obtain records from Dr. [M].”
Id.
Respondent also noted that while S.R. “gets abdominal pain,” “she is more comfortable.”
Id.
Respondent again wrote prescriptions for Dilaudid and OxyContin, doubling the strength of the latter to 40 mg. with the same dosing instruction of “q12h.”
Id.
On September 18, S.R. complained of “continued pain” and wanted a higher dose of OxyContin even though she was “more comfortable.”
Id.
Respondent doubled the strength of the OxyContin to 80 mg. “q12h #30” and also wrote a prescription for 60 Dilaudid 4 mg.
Id.
at 3. Respondent noted that she “sent another request for records from Dr. [M].”
Id.
On October 2, Respondent discontinued OxyContin in favor of MS Contin, 100 mg. “q8h #100,” which was “less expensive,” and also wrote a
prescription for Dilaudid.
Id.
She also issued S.R. a prescription for 100 Xanax (1 mg.), with two refills, which was double the strength of the previous prescription, after S.R. had claimed that “the pills got wet and they dissolved.”
Id.
Respondent also noted that S.R. “has severe anxiety and needs the Xanax” and was complaining of abdominal pain.
Id.
The next day Respondent gave S.R. a prescription for 200 Methadone 10 mg. “3 tabs QID” for pain when S.R. returned, having not filled the MS Contin prescription due to its cost.
Id.
On October 8, Respondent received the phone call described above reporting that M.D. had been admitted in a coma seven days earlier.
Id.
at 4. At S.R.'s next visit, which was on October 12, Respondent “explained to [her] that she must be very careful with her medications.”
Id.
According to the patient record, S.R. “denie[d] that [M.D.] could have ever gotten his [sic] medications.”
Id.
Respondent reported that S.R. was still complaining of abdominal pain and issued her a new prescription for 60 Dilaudid 4 mg.
Id.
Moreover, a week later, Respondent issued S.R. a new prescription for 200 Methadone 10 mg. Respondent did not institute any kind of monitoring on S.R.'s use of her medication.
Id.
On November 2, S.R. returned “complaining of abdominal pain.”
Id.
Respondent referred her to another physician “for interstitial cystitis treatment and work-up.”
Id.
Respondent also wrote S.R. prescriptions for 60 Dilaudid 4 mg. and 200 Methadone 10 mg.
Id.
On November 19, S.R. returned to obtain more “prescriptions, and [was] very irate that they weren't ready.”
Id.
Respondent explained she would not write prescriptions for more opioids without further documentation of S.R.'s condition.
Id.
at 5. Respondent also noted that S.R. had indicated that she had not seen the physician who was to evaluate her for cystitis because her primary care doctor had not authorized the visit.
Id.
On December 4, the patient record indicates that S.R. “HA[d] CALLED FOR THE PAST 3 DAYS REQUESTING RX—EVERYONE HAS EXPLAINED TO HER THAT UNTIL MEDICAL RECORDS ARE RECEIVED TO CONFIRM HER CONDITION RX WILL NOT BE WRITTEN PER [Respondent].”
Id.
S.R. offered money for the prescriptions and said that she would go back to Detroit to pick up her medical records “BUT NEED[ED] MEDS TO GO.”
Id.
Respondent told her to go to her primary care physician to get the prescriptions.
Id.
The final entry, December 14, indicates that S.R.'s medical records were printed out for her to pick up.
Id.
Dr. Hare did not review M.D.'s patient file, but he did review S.R.'s. Dr. Hare found that Respondent performed only a “minimal” physical examination and did not insist on getting documentation of the diagnosed interstitial cystitis and hepatitis until she had treated S.R. for several months. GX 46A, at 13. He indicated that Respondent's “evaluation of the patient was insufficient to justify the prescribing of controlled substances.”
Id.
at 14. Dr. Hare further found that Respondent “escalated opioid doses by patient request, not because of favorable responses.”
Id.
While he found that it was “unlikely” that Respondent's prescribing contributed to S.R.'s death, he suggested that Respondent's prescribing “perpetuated an ongoing drug abuse problem.”
Id.
J.R.
J.R. (GX 24) had been convicted of distributing marijuana. Tr. 1995. Respondent maintained, however, that he had turned his life around and was proud of that.
Id.
J.R. first visited Respondent at her Calmwood Medical clinic in August 1999, but she had treated him at another clinic previously and had not transferred those medical records into his chart.
See
GX 24, at 1.
Respondent maintained that J.R. needed to take “a very high dose of OxyContin” in order to work, and that without the medication, the migraine headaches were so bad he could not function. Tr. 1996-97. Respondent testified that she thought J.R. was a legitimate patient.
Id.
at 1997.
The ALJ also credited the testimony of Dr. O'Connor that she saw J.R. “when he picked up his prescribed medications at Wilmot Pharmacy” and he “was functional, his words were never slurred, and he appeared `fine.' ” ALJ at 106. There is, however, no evidence in the record that Dr. O'Connor ever worked at Wilmot Pharmacy,
see
Tr. 1107-08, where J.R. picked up nearly all of his prescriptions. GX 23;
see also
RX 8 (affidavit of Dr. O'Connor indicating places of employment which do not include Wilmot Pharmacy). Moreover, Dr. O'Connor testified that she “remember[ed] how I talked to him on the phone several times.” Tr. 1129. At no point did Dr. O'Connor testify that she had actually seen J.R. when he picked up his prescriptions.
35
Id.
at 1129-30. I therefore reject the ALJ's finding.
35
Dr. O'Connor also testified that she was aware of J.R.'s diagnosis and his work situation. Tr. 1129-30. With respect to the latter, she maintained that it was “just general patient knowledge. You ask them what they do, how their life is, to assess any addiction factors or anything else like that.”
Id.
at 1130. Again, there is no evidence that Dr. O'Connor worked at the pharmacy where J.R. filled his prescriptions. Her testimony is not credible.
At J.R.'s first visit recorded in the patient file, August 25, 1999, Respondent noted that he suffered “chronic severe migraine headaches,” and that he “has been on opioids with good relief.”
36
GX 24, at 1. She also noted that he was on “methadone because it is inexpensive.”
Id.
That day she prescribed Oxycodone IR “2 tabs q8h 180” (a thirty-day supply), Percodan #200 (with no dosing instruction), OxyContin 40 mg. “4 tabs q8h #360 (a thirty-day supply), and methadone 5 mg. “QID #60 (a fifteen-day supply).
Id.
On September 15, twenty-one days later, Respondent again prescribed to J.R. Oxycodone IR “2 tabs q8h #180 (a thirty-day supply), Percodan #200, OxyContin 40 mg. “4 tabs q8h #360” (a thirty-day supply), and methadone 5 mg. “QID #60” (a fifteen-day supply).
Id.
J.R.'s record also indicated that on September 22 (a week later), she issued “replacement prescriptions,” but gave no reason for doing so.
Id.
36
It is unclear, however, whether Respondent had previously treated J.R. for migraines.
On October 20, J.R. again visited Respondent. Respondent wrote prescriptions for Oxycodone IR “2 tabs q8h #180” (a thirty-day supply), Percodan #200, OxyContin 40 mg. “4 tabs q8h #360” (a thirty-day supply), and Methadone 10 mg. “QID #60.”
Id.
No reason was cited for increasing the Methadone.
See id.
On November 11 (twenty-two days later), J.R. returned and reported that he had taken “extra medicine this week because of low back pain,” which “started a few days ago.”
Id.
at 2. Respondent wrote him prescriptions for Methadone 10 mg. “QID #60,” Oxycodone IR “2 tabs q8h #180” (a thirty-day supply), OxyContin 40 mg. “4 tabs q8h #360” (a thirty-day supply), and “OxyContin #100.”
Id.
at 2. The patient chart indicates that the prescriptions for Oxycodone and the 360 OxyContin 40 mg. were for the Patient Assistance Program (PAP), with the 100 extra OxyContin “to fill now until medications arrive in the mail.”
Id.
On November 18, Respondent wrote another prescription for OxyContin 40 mg. “4 tabs q8h #360” (a thirty-day supply).
Id.
On December 13, Respondent wrote the same prescriptions for 360 OxyContin 40 mg., 60 Methadone 10 mg., 180 Oxycodone IR, and 200 Percodan.
Id.
The record indicates that the Oxycodone prescription was for PAP, and Respondent additionally wrote a prescription for Valium 10 mg.
“TID #60 with three refills” (an eighty-day supply), and for Fioricet.
37
Id.
The patient record gives no indication at to what medical purpose supported the prescribing of the Valium.
Id.
37
Fioricet is not a controlled substance.
On January 4, 2000, Respondent wrote that J.R. “continues on Oxycodone IR and OxyContin around the clock for excellent control of migraine headaches.”
Id.
She wrote the usual prescriptions for 360 OxyContin 40 mg. (thirty-day supply), 60 Methadone 10 mg., 200 Percodan and 180 Oxycodone IR (thirty-day supply), the latter “for PAP.”
Id.
at 3.
On January 21 (seventeen days later), J.R. returned and received two prescriptions for 360 OxyContin 40 mg. (two thirty-day supplies; “[o]ne prescription to be mailed to PAP, and other one to be filled locally”), and prescriptions for Methadone, Percodan and Oxycodone IR (again a thirty-day supply of the latter for PAP).
Id.
On February 7 (again after only seventeen days), Respondent again wrote two prescriptions for 360 tablets of OxyContin 40 mg., with one to be filled locally and one to be sent to PAP.
Id.
At the same visit, Respondent also wrote prescriptions for 180 Oxycodone IR (for PAP), 60 Methadone, and 200 Percodan.
Id.
at 4.
After just another fifteen days, on February 22, 2000, J.R. reported “a severe headache on Sunday, February 20.”
Id.
Respondent planned to “[c]ontinue same dose of medications,” but “[i]f he has another severe headache within the next 3 months,” she planned to “increase his dose by probably about 60-80 mg per day.”
Id.
She again wrote two prescriptions for 360 OxyContin 40 mg. (each a thirty-day supply), one “to be mailed to PAP, and other one to be filled locally.”
Id.
She also prescribed 100 Methadone 10 mg., 200 Percodan, and 180 Oxycodone IR (the latter for PAP, a thirty-day supply).
Twenty days later, on March 13, J.R. returned with another report of a “severe headache,” having taken “extra of the OxyContin and Oxycodone IR, and also methadone.”
Id.
Respondent decided to increase both the OxyContin and Oxycodone IR and wrote two prescriptions for both drugs with one to be sent to the PAP: OxyContin 40 mg. “5 tabs q8h #450” (a thirty-day supply), and Oxycodone IR “4 tabs q8h #360” (a thirty-day supply).
Id.
at 5. She also wrote prescriptions for an increased dosage of Methadone 10 mg. (“3 tabs TID #100”) and for Percodan (“2 tabs q4h #200”).
Id.
The next day, for no reported reason, Respondent wrote two new prescriptions for OxyContin and Oxycodone IR, backdating them to March 5.
Id.
No mention was made of whether J.R returned the prescriptions which she wrote the day before.
See generally id.
Eight days later, on March 22, J.R. returned and reported that he would be going to “a rally in California,” and that he needed “extra medications for control of migraine headaches.”
Id.
Respondent prescribed Methadone 10 mg. “3 tabs TID #30” (3-4 days supply) and OxyContin 40 mg. “5 tabs q8h #30” (two-day supply).
Id.
On April 12 (twenty-one days later), J.R. again reported a severe headache and that he was taking “extra medications.”
Id.
Respondent again wrote two prescriptions each for a thirty-day supply of 450 OxyContin 40 mg. and 360 Oxycodone IR, as well as Methadone 10 mg. “TID #100” and 200 Percodan.
Id.
at 6.
On May 2 (twenty days later), the patient record states that J.R. “needs to increase his OxyContin because he had a severe headache for 3 days.”
Id.
Respondent wrote a prescription for OxyContin 80 mg. “q8h #270” (a thirty-day supply) and noted that the next day, she would write prescriptions for OxyContin and Oxycodone IR for the PAP.
Id.
On May 8 (six days later), Respondent wrote two prescriptions for OxyContin: one for 270 tablets of 80 mg. strength for PAP (a thirty-day supply based on her dosing instruction of 3 tabs q8h) and one for 450 tablets of 40 mg. strength (also a thirty-day supply). Moreover, Respondent wrote prescriptions for 360 Oxycodone IR (2 tabs q8h, a sixty-day supply) for PAP, as well as a 180 Oxycodone IR (2 tabs q8h, a thirty-day supply).
Id.
at 7.
On May 15, (a week later), Respondent wrote additional prescriptions which were to be filled by PAP: 270 tablets of OxyContin 80 mg. and 360 tablets of Oxycodone IR “to remail.”
Id.
Two days later, Respondent gave J.R. prescriptions for a one-week supply of both OxyContin 40 mg. (126 tablets) and Oxycodone IR (84 tablets), the latter being a “free 1 week trial.”
Id.
On May 31, Respondent wrote prescriptions for Percodan “q4h PRN #200,” Methadone 10 mg. “QID #120” (a thirty-day supply), OxyContin 40 mg. “5 tabs q8h #540 (a thirty-six day supply) and Oxycodone IR ”4 tabs q8h #360” (a thirty-day supply).
Id.
On June 9, when J.R. complained “of worse headaches,” Respondent concluded that “we need to increase the OxyContin dose again” because he “doesn't tolerate any lower dose of OxyContin.”
Id.
at 8. She again wrote for OxyContin 80 mg. “3 tabs q8h #270” (thirty-day supply). Six days later, on June 15, Respondent wrote prescriptions for OxyContin 80 mg. “3 tabs q8h #360” (thirty-day supply), Methadone 10 mg. “QID #120” (a thirty-day supply), OxyContin 40 mg. “5 tabs q8h #540” (a thirty-six day supply, with no explanation of why J.R. needed both 40 and 80 mg. OxyContin), and Oxycodone IR “4 tabs q8h #360” (thirty-day supply).
Id.
The final sentence in the record for that date is “For PAP program,” but it does not indicate whether that is just the Oxycodone or all the prescriptions.
Id.
This pattern of early prescribing and not explaining seemingly duplicative dosages continues in the treatment of this patient through its conclusion in April 2002. Notwithstanding the large quantities of drugs she was prescribing to J.R., there is no indication in the medical record that Respondent ever required him to undergo blood or urine tests to determine whether he was actually taking the drugs. Nor did she require him to bring in his medications for pill counts.
Subsequent to Respondent's treatment of J.R., his next doctor (Dr. H.) wanted to reduce the amount of controlled substances that he was prescribed, as Dr. H. suspected diversion. GX 70, at 35-36. Dr. H. also told a DI that a third doctor who later treated J.R was surprised that, when J.R. reported running out of medication, he was not experiencing withdrawal symptoms.
Id.
at 36. That doctor reportedly referred J.R. for detoxification treatment.
Id.
Respondent asserted that Dr. H. had given contradictory statements by saying that he was “positive [J.R.] is diverting and selling all of those medications, and not taking them, and yet he is exhibiting signs of withdrawal.” Tr. 1994. The record indicates, however, that Dr. H. had been told by the third physician that J.R. was not “exhibiting any signs of withdrawal.” GX 70, at 36. According to Respondent, J.R. ultimately self-declared as a heroin addict in order to get methadone. Tr. 2001.
Regarding J.R., Dr. Hare observed that while Respondent had previously treated him at another clinic, there were no records from the clinic “indicating evaluation to confirm the diagnosis of migraine headache or to further characterize his headaches,” and that there were no “records from other physicians or record of treatment with” non-opioid medications even though migraines “typically respond to a number of non-controlled substance medications” which should have been tried first. GX 46, at 13.
Relatedly, Dr. Schneider testified that in treating a migraine headache of a recurring nature, a CAT scan should be ordered even though it will probably be “completely normal.” Tr. 872. There is, however, no evidence in the patient record that Respondent ordered a CAT scan for J.R.
Dr. Hare further noted that Respondent was giving J. R. “duplicate prescriptions for OxyContin, one to fill immediately and one to send to the Patient Assistance Program, and yet Respondent did not seem aware that she was giving him twice the amount of medication.”
38
GX 46, at 14. He further noted that, while in March 2000, J.R. was only periodically having worse headaches, Respondent increased the dosing of both the OxyContin (long-acting) and Oxy IR (short-acting), when “an increase in short-acting medications would have been a more appropriate step, if any change was indicated.”
Id.
Finally, Dr. Hare concluded that there was “no treatment plan,” and that “[a]ny time this patient wanted to increase medications, he did, and [Respondent] accommodated him by increasing the prescriptions.” GX 46, at 14-15.
38
Dr. Hare also noted that J.R. was being prescribed methadone because “it is inexpensive, and yet the methadone was only a small part of the patient's total opioid intake, particularly as compared to OxyContin.” GX 46, at 13-14.
N.F.
N.F. had previously been identified by two faxnets issued to Tucson area pharmacies by the Arizona State Board of Pharmacy as having allegedly engaged in doctor shopping and calling in fraudulent prescriptions for Lortab (hydrocodone). GX 35; Tr. 287-89. The faxnets were dated May 8, 2000, and April 13, 2001. GX 35, at 1-2.
In February 2003, a DEA Investigator interviewed N.F., who admitted to being addicted and to having gone initially to Respondent to “feed her addiction.” GX 70, at 38. N.F. told the Investigator that a pharmacist had called Respondent in N.F.'s presence and told Respondent that he did not want to fill a prescription Respondent had written because he believed N.F. had a drug problem.
Id.
According to the DI's declaration, Respondent continued to prescribe for N.F. for another sixteen months after receiving the phone call and “never questioned [N.F.] about her medical history.”
Id.
at 39.
N.F.'s first visit with Respondent was on November 13, 2000, after the first faxnet, which alleged that N.F. was engaged in doctor shopping.
See
GX 34, at 1; GX 35, at 1-2. N.F. told Respondent that her vehicle had been rear ended in March 2000 and that she was experiencing neck, shoulder, and back pain. GX 34, at 1. There is no indication in N.F.'s record that Respondent inquired about her substance abuse history.
See generally id.
at 1-2. N.F. complained of numbness in her left mid-thigh, muscle spasms and headaches.
Id.
at 1. Respondent performed a physical exam, which the Government's Expert concluded was adequate, and diagnosed her as having a “post acute cervical sprain and acute lumbar sprain. Postpartum.”
Id.
at 2; GX 46, at 10. Respondent issued N.F. a prescription for thirty tablets of Vicodin ES with two refills, gave her samples of Skelaxin, recommended a program of physical therapy, and indicated that she would take Vioxx, which apparently had been prescribed after a knee surgery a year earlier. GX 34, at 2.
According to N.F.'s patient file, later that day, “Rachel from Albertson's * * * called regarding multiple doctors prescribing Vicodin ES for” her.
Id.
According to the note, Albertson's “will cancel the refills.”
Id.
39
Notwithstanding this phone call, four days later Respondent gave N.F. a prescription for 30 tablets of Lortab 7.5/500 mg. (1-2 q4h to take as needed but maximum of eight tablets per day), another combination drug which (like Vicodin) contains hydrocodone and acetaminophen, with two refills.
Id.
at 3. Respondent also wrote additional prescriptions for Lortab with two refills on November 28.
Id.
On December 1, however, Albertson's again called and told Respondent that N.F. wanted an early refill, which Respondent approved.
Id.
39
The ALJ gave N.F.'s interview with the DI “little weight” because “[n]either N.F. nor the pharmacist testified at the hearing,” and N.F. had a “history of questionable truthfulness, honesty, and completeness” and had “fail[ed] to tell the Respondent of her addiction.” ALJ at 78 n.17. The ALJ also noted that “there is no evidence that the Respondent was made aware of N.F.'s addiction issues during the course of treatment.”
Id.
I credit N.F.'s interview because the patient file corroborates her story regarding the pharmacist who called Respondent and reported that she was obtaining Vicodin prescriptions from multiple doctors. GX 34, at 2. I also expressly reject the ALJ's finding that there is no evidence that Respondent was aware of N.F.'s addiction during the course of treating her as it is clear that Respondent had reason to know of N.F.'s potential addiction on the same day as the initial visit when the pharmacist told her that she was a doctor shopper. As for the ALJ's reasoning that N.F.'s statement is not credible because she “fail[ed] to tell Respondent of her addiction,” one would hardly expect a person who seeks drugs to abuse them to tell a doctor the real reason she wanted the drugs.
On December 8, Respondent increased the Lortab prescription to forty tablets with two refills.
Id.
at 4. On December 22, Respondent re-issued the Lortab prescription with two refills.
Id.
at 5.
Thereafter, N.F. began a pattern of seeking early refills. On January 2, Respondent issued N.F. a prescription for forty Lortab with three refills (with the same dosing).
Id.
While the prescription and refills should have lasted until January 22, on January 16, N.F. complained that she still had severe neck pain and Respondent issued another prescription for forty Lortab 7.5/500 with three refills.
Id.
at 6. However, on January 25, nine days later, Respondent issued a new prescription (again for 40 tablets with three refills) but which increased the strength of the Lortab to 10/500.
40
Id.
40
Due to the toxicity of acetaminophen, 4000 mg. is the maximum recommend daily dose. Tr. 403-04.
From early on in Respondent's treatment of her, N.F. displayed a pattern of requesting early refills, which Respondent did not appear to notice as she always wrote the prescriptions as requested. For instance, on January 16, 2001, Respondent wrote a prescription for “Lortab 7.5/500 1-2 q6h PRN #40 with 3 refills,” which should have lasted at least twenty days.
Id.
However, on January 25, just nine days later, when N.F. complained that the medication wasn't “strong enough,” Respondent increased the dose to “Lortab 10/500 #40 with 3 refills,” which should again have lasted twenty days, assuming that the dosing remained the same.
Id.
However, N.F. returned on February 7, complaining of recent headaches and pain in both her neck and back. Respondent again issued her a prescription for “Lortab 10/500 #40 with 3 refills.”
Id.
On February 16, Respondent issued N.F. another prescription for 40 tablets of Lortab 10/500 with three refills.
Id.
at 7.
On April 25, Respondent switched N.F. from Lortab to Percocet (a drug combining oxycodone and acetaminophen), and approximately two weeks later added Percodan, a drug combining oxycodone with aspirin.
Id.
at 9-10. Four days later, Respondent changed from Percodan to oxycodone 5 mg. and continued to prescribe Percocet. Respondent prescribed both drugs on several occasions.
Id.
at 11-12.
On June 11, N.F. visited Respondent. According to N.F.'s file, she had “suffered [a] burn” in her “right thoracic area,” but did not “remember burning herself.”
Id.
at 12. Respondent continued to prescribe oxycodone and Percocet throughout the summer months.
Id.
at 12-14. Respondent, however, stopped prescribing the Percocet in late July when N.F. complained that it made her sick.
Id.
at 15. By September 11, N.F. was taking 30
oxycodone tablets per day, and Respondent switched her prescription to 100 tablets of Roxicodone 30 mg. (q4h PRN).
Id.
at 17.
An entry in N.F.'s patient record for September 19, 2001, indicates that she was to move to Illinois at the end of the week and that she could not fill the Roxicodone prescription because of its cost.
Id.
at 18. On this date, Respondent wrote a prescription for 100 tablets of oxycodone 5 mg. (3-4 q4h PRN).
Id.
Two days later, N.F. returned. N.F. told Respondent that she was not “moving until next Friday,” and “would like to get Roxicodone.”
Id.
Respondent issued a prescription for another 100 tablets of oxycodone 5 mg.
Id.
On September 27, however, Respondent gave N.F. a prescription for 100 tablets of Roxicodone 30 mg (1-2 q4h PRN).
Id.
On October 2, N.F. was “back here to pick up her truck.”
Id.
Respondent gave her another prescription for 100 Roxicodone 30 mg. q4h.
Id.
A note dated October 5 indicates that “[p]atient's brother to pick up prescription for Roxicodone 30 mg q4h PRN 100.”
Id.
at 18-19. Moreover, a note dated October 9 indicates that N.F.'s cousin was to pick up a similar prescription for another 30 tablets of Roxicodone 30 mg.
Id.
at 19. Another note dated October 12, again indicated that N.F.'s cousin had picked up the prescription.
Id.
On October 15, N.F. was back in town “to testify for the state” and reported that “[s]he ha[d] moved to Joliet.”
Id.
N.F. reported that she had continued pain but that she wanted to decrease her Oxycodone intake.
Id.
Respondent issued her a prescription for 200 tablets of Roxicodone 5 mg. (2-3 tabs q4h PRN) and indicated that N.F. “will see another doctor in Illinois.”
Id.
On October 17, N.F. was back to see Respondent and underwent therapy.
Id.
Notwithstanding that just two days earlier N.F. had stated that she wanted to reduce her oxycodone intake, Respondent gave her a prescription for 100 tablets of Roxicodone 15 mg., 2-3 tab q4h PRN.
Id.
The dosing instruction was thus even greater than the dosing instructions of several of the previous prescriptions Respondent had written.
Id.
Notwithstanding N.F.'s claims of having moved to Joliet, she continued to appear at Respondent's office multiple times each month through May 10, 2002, to obtain prescriptions.
See id.
at 19-33. At no point is there documentation that Respondent questioned N.F. about why she was still coming in for prescriptions if she had moved.
See id.
Instead, she authorized early refills.
See id.
at 18-19.
According to DI Llenas' Declaration, N.F. told her that “for approximately one month” she had told Respondent “that she was moving to Illinois.” GX 70, at 39. During that time, individuals “pos[ing] as family members” would go to Respondent's office to obtain refill prescriptions for N.F.
Id.
N.F. did this in order “to obtain early refills, under the guise that the `family members' needed time to mail the prescriptions to Ms. [F.] in Illinois.”
Id.
On October 17, 2001, in addition to the Roxicodone 15 mg. that N.F. was already taking (“2-3 tabs q4h PRN #100”), Respondent prescribed 30 Vicodin for “dental pain.”
41
GX 34, at 19. There is, however, no evidence that Respondent referred N.F. to a dentist, who could properly diagnose the cause of her condition. Nor, given the Roxicodone that Respondent was prescribing, is it clear why N.F. would need to take Vicodin as well.
41
Respondent also prescribed penicillin for a dental infection.
On October 19 (two days later), Respondent issued N.F. a prescription for 200 tablets of Roxicodone 15 mg. (1-2 q4h).
Id.
Moreover, on October 24 (five days later), Respondent issued N.F. a prescription for 200 tablets of Roxicodone 5 mg (3-4 tablets q4h).
Id.
On October 26 (two days later), N.F. was back again, complaining of additional symptoms including tingling and numbness, and that her right hand was turning purple.
Id.
Respondent did not conduct a neurologic or vascular exam and instead gave her another prescription for Roxicodone; the prescription was for 50 tablets 30 mg.-strength
1/2
tab q4h PRN.
Id.
at 20;
see also
GX 46, at 11.
On October 29 (three days later), Respondent gave N.F. another prescription for 100 tablets of Roxicodone 30 mg. q4h. GX 34, at 20. While the prescription should have lasted sixteen days, on November 1, Respondent gave N.F another prescription (to be filled the next day), for 100 tablets of Roxicodone 30 mg. q4h.
Id.
On November 5, Respondent gave N.F. a prescription for 200 tablets of Roxicodone 5 mg. (3-4 q4h), and indicated in the patient record that N.F. could not fill the prescription because the pharmacy did not have the drug.
Id.
Yet there is no indication that Respondent checked with the pharmacy or asked N.F. to return the prescription.
Id.
While this prescription should have lasted eight days, on November 7 (two days later) Respondent issued N.F. another prescription for 100 tablets of Roxicodone 30 mg. 1-2 q4h PRN.
Id.
at 21. Five days later (on November 12), Respondent gave N.F. another prescription for 100 Roxicodone.
Id.
On November 14, N.F., who apparently had not moved to Illinois after all—although at no point does it appear that Respondent questioned her about this—returned to Respondent and reported that she “had a motor vehicle accident at 6:30 this morning” with “increased neck pain.”
Id.
Respondent noted that N.F. “has increased muscle spasm and difficulty sleeping secondary to the motor vehicle accident,” which had occurred earlier that day.
Id.
Respondent gave N.F. a new prescription for 100 Roxicodone 30 mg., to be filled on November 19.
Id.
On November 19, N.F. reported that she had lost her prescription.
Id.
Respondent noted that she had called TMC pharmacy and that the prescription had not been filled.
Id.
She also indicated that N.F.'s insurance would not cover another prescription if the prescription had already been filled.
Id.
Respondent wrote another prescription for 100 Roxicodone 30 mg.
Id.
42
42
As Dr. Hare noted, “this does not exclude the possibility that [N.F.] was paying for the prescriptions herself.” GX 46, at 11. Moreover, N.F. could have filled the prescription at another pharmacy.
On November 21 (two days later), N.F. needed more “medications before * * * the weekend.”
Id.
Respondent noted that N.F. had “increased tenderness and muscle spasm” and gave her a prescription for 200 Roxicodone 5 mg. (5-6 tabs q4h PRN).”
Id.
at 22. On November 26, N.F. told Respondent that she had “been beaten up by her neighbors over the Thanksgiving weekend” and that “[t]hey stole her medications and her money.”
Id.
Respondent further noted that N.F. “has a police report.”
Id.
It is unclear, however, whether N.F. showed the report to Respondent.
Dr. Hare noted further incidents of suspicious behavior on the part of N.F. For example, on January 24, 2002, N.F. reported that she had taken her children roller skating and had “increased soreness ever since.”
Id.
at 24. Respondent gave N.F. a new prescription for 100 tablets of Roxicodone and increased the dosing from 1-2 tablets every four hours to 3-4 tablets every four hours.
Id.
Dr. Hare again found that Respondent “inadequately evaluated” the patient and that N.F.'s “condition did not warrant [c]ontrolled [s]ubstance prescriptions.” GX 46, at 12. In addition, Dr. Hare opined that N.F. “was placed on excessive medication and took more than prescribed and [with] no clear
benefit”; that “[c]hanges were made and new medications added with no explanations”; that N.F. “escalated her use of medication with no clear benefit, and prescriptions were increased to accommodate her”; and that with the “medication amounts and uses patterns such as [N.F.'s], abuse and diversion of these medications ha[ve] to be suspected. ”
Id.
Dr. Hare further observed that “[n]o drug screen was done to see if the patient was using these medications, or other medications not prescribed by” Respondent.
Id.
Respondent's expert, Dr. Schneider, included N.F. as one of the patients for which there was “evidence of `aberrant drug-related behaviors' which should have been pursued but weren't.” RX K-1, at 6. As explained above, N.F.'s chart was among those that “showed problems which indicated that [Respondent] needed additional education about obtaining addiction history, careful monitoring, and review of the `big picture.' ”
Id.
Indeed, the patient record indicates that Respondent made absolutely no attempt to monitor N.F. even though she received information as early as the day of N.F.'s first visit that she was a doctor shopper.
See
GX 34. In addition, Respondent ignored other evidence of suspicious behavior on N.F.'s part such as her continued visits even when she she had supposedly moved to Illinois, her suffering a second-degree burn but not remembering why, and her claim that her neighbors had beaten her and stolen her medications and money.
43
43
In her findings for NF, the ALJ also relied on Dr. Weinstein's criticism in her letter that Dr. Hare “describe[d] titration of opioid medications as dosages being `dramatically increased,' `aggressive,' and given in `huge amounts,' without noting subsequent stabilization of dosages.” ALJ at 78. However, Dr. Weinstein's criticism was not directed specifically at Dr. Hare's findings on N.F. While Dr. Hare did at one point write that N.F. herself increased “her use of hydrocodone (Lortab by this time) to excessive amounts,” Dr. Hare did not so characterize Respondent's prescribing. GX 46, at 11.
C.O.
C.O. first treated with Respondent on March 5, 1999, complaining of neck and lower back pain from an industrial injury. GX 36, at 1. He was 28 years old.
Id.
His last visit with Respondent was on June 29, 2001.
Id.
at 34.
According to C.O.'s medical record, several weeks before he started treating with Respondent, C.O. had been in an industrial accident during which the brakes on a man-lift failed and the lift hit the ground hard.
Id.
at 1. C.O. went to the emergency room, where x-rays were taken of his lumbar and cervical spines, as well as his right knee; the x-rays were, however, negative.
Id.
The emergency room gave him a prescription for Vicodin.
Id.
At the first visit, C.O. complained of severe pain in both his back and neck, with a pins-and-needles sensation in his right leg, including his foot, and a dull aching in his back.
Id.
He also complained of headaches and that his fingers were stiff and numb.
Id.
at 1-2. With respect to the initial visit, the Government's expert concluded that Respondent's physical exam was adequate but noted that she had not taken a history of his medication use and possible substance abuse. GX 46, at 12. Respondent prescribed 40 Lortab 7.5/500 with two refills and physical therapy. GX 36, at 2.
On March 10, Respondent noted that C.O. was “complaining of severe neck pain and low back pain”; the next day, she noted that he was “taking 1 ½ of the Lortab 7.5.”
Id.
at 3. Respondent then gave C.O. a prescription for 40 tablets of Lortab 10/500 with two refills.
Id.
On March 17, C.O. returned to Respondent's practice and was seen by a Family Nurse Practitioner (F.N.P.).
Id.
According to the progress note, C.O. reported that he was out of medications, needed more, and had gone through 40 Lortab in six days.
Id.
The F.N.P. further recorded that “Patient requesting pain medication refill—he has two refills left. He swears he does not. Asking him to bring in bottle.”
Id.
On March 19, C.O. returned and saw Respondent.
Id.
C.O. said that he had refilled the Lortab 7.5 two times and that he had no refills on the Lortab 10 even though the progress note for March 11 indicated that Respondent had authorized two refills.
Id.
He also said that he was taking up to 12 Lortab per day.
Id.
At this level, C.O. was exceeding by 2000 mg. the recommended maximum limit of 4000 mg. of acetaminophen per day.
On March 22, C.O. returned and complained of continued pain between his shoulder blades.
Id.
C.O. reported that he had only three Lortab 7.5 mg. remaining.
Id.
The progress note also indicates that C.O. had no refills on the Lortab 10.
Id.
Respondent performed a physical exam and found that C.O “ha[d] no obvious pain with ambulation.”
Id.
at 4. She also found that he had “generalized tenderness over [his] mid thoracic area and complains of mid back pain with range of motion of the shoulders.”
Id.
Respondent prescribed thirty tablets of OxyContin 20 mg. q8h (1 tablet every eight hours).
C.O. returned on March 26 (five days later), saw the F.N.P., and reported that his back pain was worse.
Id.
The F.N.P. observed that C.O.'s “speech is slightly slurred.”
Id.
She also noted that C.O. had “just t[aken] two OxyContin 20 at 4 p.m. today,” which was twice the dose prescribed by Respondent.
Id.
The F.N.P. physically examined Respondent and did not find anything abnormal.
Id.
The F.N.P. further noted that she would “not refill OxyContin,” but would “speak with” Respondent.
Id.
The same day, Respondent gave C.O. a new prescription for 60 tablets of OxyContin 20 mg. (2q8h).
Id.
at 5. On April 2, Respondent gave C.O. an additional prescription for 60 OxyContin 20 mg. (2q8h).
Id.
On April 9, C.O. saw the F.N.P. and complained that the “pain medication is not working anymore,” that his neck, shoulder, and the base of his spine were stiff, and that his back felt tight.
Id.
He also reported that he started taking three tablets, three times a day, which was again in excess of the prescribed dose.
Id.
With the exception of the F.N.P.'s finding that C.O.'s mid-back muscles were tense and that he complained of low back pain on forward flexion, the physical exam was normal.
Id.
The F.N.P. further noted that C.O. had “used 390 pain pills in 35 days”; she further recommended that C.O. “decrease pain medication use.”
Id.
at 6. Finally, the F.N.P. noted that she discussed C.O.'s treatment with Respondent and that C.O. should undergo an MRI of his cervical spine.
Id.
There is no indication in C.O.'s file that he went for this MRI.
See generally id.
On April 12, C.O. saw Respondent and complained of continued pain in his neck and back.
Id.
He also denied “any side effects from the OxyContin” and maintained that it “allow[ed] him to work.”
Id.
Respondent wrote him a new prescription for OxyContin 20 mg., increasing the number of tablets to 100 and the dosing to three tablets every eight hours. C.O. saw Respondent approximately every nine to ten days and complained of stiffness and pain; Respondent continued to issue him the same prescription until his visit of June 16.
Id.
at 7-8. At this visit, Respondent decided to lower the dosing of the OxyContin to 2qam, 3qpm, and 2qhs because three months had passed since he was injured and “he should be able to tolerate a lower dose.”
Id.
at 9. At C.O.'s next visit (June 28), Respondent wrote the same prescription.
Id.
On July 12, Respondent gave C.O. another prescription for OxyContin 20 mg.
Id.
However, she reduced the quantity to 84 tablets and the dosing to two tablets every eight hours.
Id.
Moreover, on both July 14 and July 19, C.O. reported that he had increased pain since Respondent had lowered the dose; Respondent did not, however, change the dose.
Id.
at 9-10. In the July 19 note,
Respondent also indicated that C.O. had undergone MRIs of both his thoracic and lumbar spines, and that each exam was negative.
Id.
at 10.
On July 26, however, C.O. complained of severe pain. Respondent gave him a new prescription for 130 tablets of OxyContin and increased the dosing to three tablets, three times a day.
Id.
at 11, 13. At the next visit (August 9), Respondent gave C.O. a new prescription for 130 tablets of OxyContin 20mg. (3 q8h).
Id.
at 14. Respondent also gave him a prescription for 30 Percocet, but did not document why.
Id.
Moreover, on August 16, C.O. reported that he was taking four tablets every eight hours.
Id.
Respondent then issued a prescription for 100 tablets and increased the dosing to four tablets every eight hours.
Id.
Respondent also wrote another prescription for 30 Percocet.
Id.
The progress note contains no indication, however, as to whether she asked C.O. about how he was using the Percocet.
On August 23, Respondent gave C.O. a new prescription which increased the strength of the OxyContin to 40 mg., but which reduced the dosing to two tablets every eight hours.
Id.
At C.O.'s next visit (September 1), he again reported that he had increased his dosing from two tablets to three tablets every eight hours; C.O. claimed that three tablets relieved his pain but that two tablets did not.
Id.
Respondent performed a physical exam and noted that C.O. had chronic neck and mid back pain, that he had less lower back pain, and a continued muscle spasm.
Id.
Respondent gave C.O. a prescription for 70 tablets of OxyContin and increased the dosing to three tablets every eight hours; she also gave him a prescription for 60 Percocet.
Id.
Respondent continued to prescribe OxyContin 40 mg. (3 q8h) until October 22, when she decided to discontinue the drug and instead prescribed 200 tablets of MS Contin 60 mg. (3 q8h).
Id.
at 17. No explanation for the change was given.
See id.
At C.O.'s next visit (which was on October 29), Respondent was back to prescribing OxyContin 40 mg., and gave him a prescription for 200 tablets (3 q8h).
Id.
The October 29 entry does not indicate why Respondent changed back to OxyContin.
Id.
On November 19, C.O. saw Respondent and reported that the MS Contin did not help with the pain, that he was taking nine tablets a day, and that the pain was “getting worse.”
Id.
Respondent performed a physical exam and concluded that C.O. still had neck and back pain secondary to the February accident.
Id.
at 18. Respondent gave him prescriptions for 225 tablets of OxyContin 40, with a dosing of ten tablets per day (3 qam, 4 qpm, 3 qhs).
On December 10, C.O. again saw Respondent and complained of various pains. In the note, Respondent indicated that C.O. “would like to increase the OxyContin to 4 tabs q8h.”
Id.
Respondent performed a physical exam which “show[ed] no obvious pain with ambulation, but he complains of pain.” Respondent also found that CO “has tenderness over bilateral cervical paraspinals, bilateral thoracic muscles and bilateral lumbar paraspinals” and “has hypertonicity of spinal muscles.”
Id.
Respondent concluded that C.O. had chronic neck, mid-back and lower-back pain” and gave him a new prescription for 252 tablets of OxyContin 40 mg. and increased the dosing to four tablets every eight hours.
Id.
at 19. She also gave him a prescription for 50 tablets of Lortab 10/500 (q6h PRN) for breakthrough pain with two refills.
Id.
On December 27, C.O. again saw Respondent. While the note for the visit indicated that C.O. “ha[d] been sick with the flu,” it did not document that C.O. complained of any pain.
Id.
at 19. Moreover, Respondent performed a physical exam which found that he had “generalized tenderness over bilateral thoracic and lumbar paraspinals.”
Id.
C.O., however, “ha[d] no pain with ambulation” and had a “full range of motion of both upper and lower extremities.”
Id.
Respondent again concluded that C.O. had “chronic neck pain, mid back pain and low pack pain,” and gave him prescriptions for 252 tablets of OxyContin 40 mg. (4 q8h), 50 Lortab 10/500 (q6h PRN) with two refills, and 50 Percocet 10/650.
Id.
On January 21, Respondent again saw C.O. and stated that “this dose of 160 mg.” every eight hours worked and that while he had some stiffness, he was able to “handle the pain as long as he takes the OxyContin.”
Id.
He also “denie[d] any mental changes or ever feeling euphoria from the medications.”
Id.
Following a physical exam in which she noted that he had general tenderness over his cervical, thoracic and lumbar paraspinals, normal ambulation without pain, and pain with both the cervical and lumbar range of motion, Respondent reissued the three previous prescriptions for 252 OxyContin 40 mg., 50 Percocet 10/650, and 50 Lortab 10/500 with two refills.
Id.
Three days later, Respondent noted that C.O.'s insurance had “denied coverage for any medications” and that he had undergone “an independent medical examination by [another physician] in early December.”
Id.
at 21. Respondent indicated that C.O. had been unable to fill the OxyContin prescription “because of the cost” and wrote him a new prescription for 50 tablets.
Id.
The note does not indicate, however, what happened to the original prescription or whether C.O. had partially filled it.
Id.
Respondent continued to treat C.O. through June 29, 2001, and generally prescribed the same drugs (OxyContin 40 mg., Lortab 10/500,
44
Percocet 5/325
45
) with the same dosing as before.
See generally
GX 36. According to the record, at the September 8, 2000 visit, C.O. reported that he had obtained a job on a cruise ship.
Id.
at 28.
44
Respondent also prescribed Percocet along with Lortab.
45
Respondent last prescribed Percocet on June 19, 2000. GX 36, at 26. On several occasions (including January 21, February 9, March 3, March 29, and May 1, 2000), Respondent prescribed both Lortab with three refills, and Percocet.
Id.
at 20-26.
At C.O.'s next visit (October 10), he reported having injured his back and neck on the ship.
Id.
at 28. Respondent's physical exam “show[ed] no obvious pain with ambulation” and found “minimal tenderness over lower cervical paraspinal and over lumbar paraspinals.”
Id.
at 29. Respondent also did a neurological exam of his upper and lower extremities; the exams were normal.
Id.
Respondent then issued four prescriptions for OxyContin 40 mg. (each dosing at four tablets every eight hours); the quantities were for 168 on two of the scripts, with 84 and 80 on the remaining two.
Id.
She also gave C.O. a prescription for 350 Lortab 10/500 (q4h PRN) with no refills.
Id.
On October 31, C.O. returned to Respondent and told her that he would be going on a ship “in a few days and be gone for almost 13 weeks.”
Id.
C.O. also told Respondent that he had not filled the two prescriptions for 168 OxyContin.
Id.
She performed a physical exam which found that C.O. had slight stiffness with ambulation and with lumbar range of motion.
Id.
She also found tenderness over his cervical, thoracic and lumbar paraspinals.
Id.
Respondent gave him a prescription for 60 OxyContin 40mg (4 q8h), and 360 Lortab 10/500 (q4h PRN) with three refills.
Id.
Moreover, on November 3, Respondent gave C.O. a prescription for another 60 OxyContin 40 mg.
Id.
at 30.
Five days later (on November 8), C.O. had still not gone on the ship.
Id.
C.O. told Respondent that he still had neck and back pain and that he would “be on the ship until January 22, 2000.”
Id.
Respondent performed a physical exam in which she found “minimal tenderness over [his] cervical, thoracic and lumbar spine.”
Id.
Respondent issued him four prescriptions for OxyContin 40 mg (4 q8h); the quantities
were 372, 280, 144 and 92 tablets.
Id.
Respondent also gave him a prescription for 350 Lortab 10/500 with no refills.
Id.
On December 22, C.O. returned to Respondent seeking another prescription for OxyContin.
Id.
According to the note, C.O. “ran out of medications this Sunday” and claimed “that he tore up the prescriptions.”
Id.
Respondent noted that C.O. “show[ed] very slurred speech,” and concluded that “he probably took excess Soma.”
Id.
She referred him to the “emergency room or for drug testing.”
Id.
Notwithstanding that C.O. had previously told Respondent that he would be working on a cruise ship until late January, there is no indication that Respondent questioned him as to why he was back so soon.
Id.
Indeed, according to a pharmacy profile which listed prescriptions C.O. had filled at Tucson area pharmacies, he had filled prescriptions for controlled substances on November 21, 22, and 27, as well as December 6, 21, and 22, 2000. GX 37, at 2.
On December 27, C.O. returned to Respondent seeking more OxyContin. GX 36, at 30. Respondent decided to taper C.O. down on the OxyContin to three tablets every twelve hours (for a total of 240 mg. of oxycodone) and wrote him prescriptions for sixteen and eight tablets.
46
Id.
at 31. Respondent issued additional prescriptions for OxyContin 40 mg. in smaller quantities with the same dosing instruction on January 3, 8, 15 and 22; at the January 15 visit, Respondent also gave him a prescription for 100 Lortab 10/500 with two refills.
Id.
46
There is no indication as to whether Respondent followed up to determine whether C.O. went to the emergency room or for the drug test.
On February 5, 2001, C.O. complained that he could not afford OxyContin and would like more Lortab and Soma.
Id.
Respondent told C.O. that there was a daily maximum dose of acetaminophen, which is used in Lortab.
Id.
Instead, Respondent prescribed 200 tablets of Roxicodone 5 mg. (5-6 q3h PRN).
Id.
Based on this prescription, C.O. would have taken a maximum of 240 mg. of oxycodone per day.
On February 14, Respondent gave him a prescription for 100 tablets of Roxicodone 30 mg., but the dosing instructions were not, however, recorded in C.O.'s record.
Id.
Respondent also gave C.O. a prescription for 100 Lortab 10/500 with five refills; this prescription thus authorized the dispensing of 600 tablets.
Id.
Based on the maximum daily recommended safe dose of acetaminophen of 4000 mgs., the Lortab should have lasted seventy-five days.
By February 20, however, Respondent was prescribing two tablets of Roxicodone 30 mg. every 3 hours, for a total dosage of 480 mg. of oxycodone a day; this was the same daily amount of oxycodone as Respondent had been dosing on December 22.
47
Id.
There is no indication in the February 20 note that C.O. had complained of worse pain or that Respondent had examined him.
Id.
47
On February 20, Respondent gave CO three 50-tablet prescriptions for Roxicodone 30 mg. GX 36, at 32.
Respondent issued additional prescriptions for Roxicodone 30 mg. on March 9 (50 tablets) and 13 (three 50-tablet prescriptions), although she reduced the dosing to one to two tablets every four hours for a maximum daily dose of 360 mg. of oxycodone.
Id.
On March 27, Respondent gave C.O. not only a prescription for 50 Roxicodone 30 mg., but also for 100 Lortab 10/500 with five refills, even though the previous Lortab prescription (Feb. 14) with refills should have lasted seventy-five days or until late April.
Id.
There is no indication in the March 27 note that Respondent even recognized this.
Respondent issued additional Roxicodone prescriptions and by April 17, was back to prescribing 480 mg. of oxycodone a day.
Id.
On April 27, C.O. was again out of Lortab even though the March 27 prescription with refills should have lasted well into June.
Id.
at 33. Respondent noted that she told him that he could not take more than eight Lortab a day and that there would be “no more acetaminophen containing medications at least for now.”
Id.
Respondent, however, gave C.O. a new prescription for 100 tablets of Roxicodone 30 mg., 1-2 tablets every three hours.
Id.
Respondent continued to prescribe Roxicodone to C.O. and noted on May 11, that he was taking “approximately 16 Roxicodone per day.”
Id.
Between May 11 and June 29, Respondent issued eight prescriptions for 100 Roxicodone 30 mg.
Id.
at 33-34. Moreover, on June 8, Respondent indicated that she was “discontinu[ing] Lortab and start[ing] Norco10/325 1-2 q4h PRN # 100 with five refills, maximum twelve per day.”
Id.
at 34. This was an even greater dose of hydrocodone than before, and yet the note for June 8 contains no medical reason for issuing the prescription.
Id.
Respondent issued additional prescriptions for 100 tablets of Roxicodone on June 18, 25 and 29.
Id.
On July 3, C.O. entered drug rehab.
Id.
Following this entry Respondent wrote a two-page plus narrative of how she had treated C.O.
Id.
at 35-37. Therein, she maintained that she had closely “watch[ed] his intake of Lortab” because of “the danger” associated with taking too much acetaminophen.
48
Id.
at 36. Respondent also wrote:
48
Respondent observed that she “would not allow his daily dose of acetaminophen to go above 4000 mg.” GX 36, at 36.
Id.
If [C.O.] did in fact become “addicted” to either Roxicodone or Soma, it was not because I neglected to try to avoid that. He had a true injury, he was truly in pain and he truly required the medication to function. In rare instances, patients become “addicted” to medications that were prescribed appropriately. I do not know if this is the case with [C.O.], since I have had not follow up information on him since June 2001.
[C.O.] suffered no harm or injury as a result of the medications.
49
49
In describing her treatment of C.O., Respondent maintained that it was C.O.'s overuse of Soma which caused him “to have slurred speech on 2 occasions.” GX 36, at 36. The first of these incidents was on March 26, 1999, when C.O. told the F.N.P. that he had taken double the dose of OxyContin that was prescribed.
Id.
at 4. Moreover, in the progress notes for this visit, there is no indication that C.O. was either asked about his Soma use or stated that how many tablets he had taken.
Id.
at 4-5. Moreover, while Respondent indicated in the note the second incident of slurred speech that “he probably took excess Soma,” Respondent did not follow through as to whether C.O. had undergone drug testing.
Id.
at 30.
Id.
at 37.
With respect to C.O., Dr. Hare concluded that Respondent's evaluation was inadequate “to justify prescribing [c]ontrolled [s]ubstances,” and that while Respondent had developed “an acceptable treatment plan in 07/99 * * * to wean the patient from medications, * * * the medications were continued and increased.” GX 46, at 13. Dr. Hare further noted that Respondent “exerted little control over the prescriptions,” that “[t]he patient self-escalated drug doses, and then [Respondent] increased the prescription to match his use.”
Id.
Moreover, “[t]here were no consequences for excessive medication over-use, and dangerous amounts were prescribed in general, and toxic doses of acetaminophen were prescribed on several occasions.”
Id.
Finally, Dr. Hare opined that “[t]here seemed to be no plan; he was changed from medication to medication, strength to strength, dose to dose with no pattern or explanations.”
Id.
In her report, Dr. Schneider likewise concluded that C.O.'s chart “had evidence of aberrant drug-related behaviors which should have been pursued but weren't.” RX K-1, at 6 (int. quotations omitted). Dr. Schneider further noted that C.O. had “received early refills without adequate documentation and explanation,” and
that his chart “indicated that [Respondent] needed additional education about obtaining an addiction history, careful monitoring, and review of the big picture.”
Id.
(int. quotations omitted).
N.S.
On February 20, 2001, N.S., an eighteen-year-old college student, first presented at Respondent's practice. GX 57, at 1. N.S. complained of lower back pain, “especially since going to [the] University of Arizona,” and rated his pain level as “4” on a scale of 0 to 10. GX 57, at 1 & 5. N.S. denied that the “pain radiat[ed] to both lower extremities,” “denie[d] numbness and tingling or weakness of both lower extremities,” and denied “bowel and bladder problems.”
Id.
at 1. N.S. “complain[ed] of problems with getting comfortable” and of pain with sitting.
Id.
Respondent performed a physical exam. She found that N.S. “has normal ambulation without pain,” that he was “able to walk on heels and on toes without pain and hop on either foot without pain.”
Id.
Moreover, the “straight leg raising test was negative bilaterally,” and N.S. had “no pain with bringing heel to buttocks bilaterally.”
Id.
N.S. did, however, have “minimal low back pain with lumbar flexion.”
Id.
Finally, Respondent performed a neurological exam of N.S.'s lower extremities and found that he had “normal motor strength, sensation and deep tendon reflexes.”
Id.
Respondent diagnosed that N.S. had a “history of episodes of low back pain,” with a “[r]ecent increase in low back pain secondary to poor mattress and poor positioning.”
Id.
She recommended a treatment plan of joint mobilization and physiotherapy; she also prescribed 30 tablets of OxyContin 20 mg., one tablet to be taken every twelve hours.
Id.
at 2.
Two days later, N.S. complained that the OxyContin was not working.
Id.
He also told Respondent that he had “doubl[ed] up on [the] dose, but [that] didn't work either.”
Id.
Respondent then told him to try three tablets at a time.
Id.
Four days later, N.S. complained that he still had low back pain and now claimed that his pain level was a six.
Id.
at 2 & 5. He also stated that the “OxyContin helps if he takes 60 mg. and [that] he would like something for breakthrough pain.”
Id.
at 2. Respondent then gave him a prescription for 180 tablets of OxyContin 20 mg., with three tablets to be taken every twelve hours, as well as a prescription for 50 tablets of oxycodone 5 mg., one tablet to be taken every four hours as needed.
Id.
On March 6, N.S. reported that the OxyContin
50
and physical therapy (including joint mobilization) were helping his pain and that his pain level was a four.
Id.
at 3 & 5. Respondent performed a physical exam which found that “[h]e has slight stiffness with lumbar range of motion.”
Id.
at 3. She also found that “[h]e has tenderness and hypertonicity over bilateral lumbar paraspinals, but improvement in lumbar range of motion.”
Id.
As her impression, Respondent again indicated: “history of episodes of low back pain. Recent increase in low back pain secondary to poor mattress and poor positioning.”
Id.
For N.S.'s treatment plan, Respondent recommended that he continue the physiotherapy and joint mobilization.
Id.
She also recommended that he continue taking the OxyContin (the previous prescription was for a thirty-day supply).
Id.
She also gave him a prescription for 50 tablets of Roxicodone.
Id.
However, she increased the strength of the Roxicodone from five to fifteen mg., and the dosing from one tablet every four hours to one tablet every three hours.
Id.
50
On March 2, N.S. complained that the OxyContin was causing “slight nausea.” GX 57, at 2.
The last entry in N.S.'s medical record is dated March 19, 2001, and reports that N.S.'s father called and said that NS “was too sedated at home and obviously took too many.”
Id.
at 3. The father also reported that N.S. “has history of depression.”
Id.
In an interview with a DEA Investigator, N.S. admitted that he had gone to Respondent “in order to obtain OxyContin prescriptions.” GX 70, at 39. N.S. also told the Investigator that “[h]is primary purpose was drug seeking,” and that “his back pain was only secondary.”
Id.
N.S.'s father confirmed to the DI that he had called Respondent and expressed his concern about his son's being overly medicated and having “nod[ded] out in a conversation.”
Id.
at 39. According to N.S.'s father, Respondent stated that because his son “was of legal age, he could make his own decisions [and] that she had every right to prescribe whatever medications she deemed necessary.”
Id.
at 39-40. Thereafter, N.S.'s father persuaded him to stop seeing Respondent.
Id.
at 40.
Dr. Hare concluded that Respondent had “reasonably evaluated” N.S. GX 46, at 15. He also concluded the plan of care was reasonable “with the exception of the medication [she] prescribed.”
Id.
According to Dr. Hare, “[b]ased on [her] findings, there seemed to be no indication for opioids, and certainly not * * * in the aggressive doses she prescribed.”
Id.
Dr. Hare also noted that while N.S. “had denied taking previous medications[,]” he “rapidly self-escalated the medications to a large amount.”
Id.
Dr. Hare further explained that “[i]n a patient not tolerant to opioid, this dose of OxyContin, coupled with the minimal findings for a pain problem, would not be well tolerated and could have fatal consequences. The fact that the patient tolerated these large doses * * * indicated that he was not opioid-naïve, or he was not taking the medication.”
Id.
Finally, Dr. Hare observed that N.S.'s “minimal response to a rather large initial dose would raise serious questions about opioid responsiveness of the pain problem.”
Id.
Continuing, Dr. Hare explained that N.S.'s “insistence on escalating the dose would indicate an effect sought for mood or a medication-abuse situation.”
Id.
In her testimony, Respondent acknowledged that N.S.'s father had called her and expressed his concern that his son was taking excessive medication. Tr. 2173. Respondent did not respond to any of Dr. Hare's observations regarding the medical appropriateness of her prescribing OxyContin to N.S.
Id.
at 2172-73.
F.L. and B.L.
F.L. and B.L. were father and son. The records in evidence document Respondent's treatment of F.L. between August 16, 1999 and March 30, 2001, shortly before his death on April 17 due to complications from diabetes.
See
GX 49. The record does not, however, reflect when F.L. began seeing Respondent.
See id.
at 1.
In addition to having diabetes, F.L. was a recovering alcoholic. Tr. 2123. He had chronic pancreatitis and a lumbar spine condition; his diabetes had led to a below-the-knee amputation of one of his legs.
Id.
Respondent treated F.L. with a variety of drugs including large doses of OxyContin and Oxy IR. For example, on August 16, 1999, Respondent gave F.L. prescriptions for: (1) 1200 tablets of OxyContin 40 mg., twenty tablets to be taken every twelve hours; (2) 4080 tablets of Oxy IR, with seventeen tablets to be taken every three hours; (3) 140 Percocet; and (4) 200 Percodan. GX 49, at 1. On both February 21 and March 30, 2001, Respondent gave F.L. prescriptions for: (1) 1320 tablets of OxyContin 40 mg., with 22 tablets to be taken every twelve hours; (2) 4800 tablets of Oxycodone IR, with twenty tablets to be taken every three hours; (3) 280 Percocet, and (4) 400 Percodan.
Id
at 15. The note for March
30 indicated that the script for 4800 tablets of Oxycodone IR was to be filled through the “PAP program”;
51
the note also indicates that Respondent gave F.L. an additional prescription for 500 tablets of this drug “to fill locally” and an additional prescription for 280 Percocet.
52
Id.
The prescriptions Respondent issued to F.L. totaled approximately 7,000 dosage units a month.
53
51
While the note for F.L.'s last visit does not indicate that prescription for 1320 tablets of OxyContin was to be filled through the PAP program, an earlier note indicated that F.L. was “on [the] PAP program for the OxyContin and Oxycodone IR.” GX 49, at 3. I therefore find that the oxycodone prescription was also to be filled by PAP.
52
The Government's Expert did not discuss Respondent's prescribing to F.L. in either of his reports,
see
GX 46 & 46A. Nor did he testify regarding Respondent's prescribing to him.
See generally
Tr. 144-229.
53
F.L.'s patient record is devoid of any evidence that Respondent subjected him to pill counts or drug screens, even though on several occasions he stated that he had lost medications or prescriptions.
See generally
GX 49.
In October 2000, Respondent also commenced to treat B.L. (F.L.'s son) in October 2000 for Attention Deficit Disorder and an eating disorder. GX 50, at 1-2. Respondent prescribed several controlled substances including Ritalin and Dexedrine (both stimulants) to him.
Id.
at 1-2.
On April 23, 2001 (six days after F.L.'s death), B.L. visited Respondent.
Id.
at 4. During the visit, Respondent gave B.L. a prescription for 200 tablets of Dexedrine 10 mg.
Id.
at 4-5. In her testimony, Respondent maintained that she had questioned B.L. as to what had happened to the last shipment of OxyContin from the PAP to his father. Tr. 2126. (In her testimony, Respondent did not address whether she questioned B.L. regarding the other PAP prescription—for 4800 tablets of Oxycodone IR). According to Respondent's testimony, B.L. “didn't really answer [her], and [she] didn't know.” Tr. 2126. Continuing, she added that “”I never got an answer from him what [as to] what happened,” and in any case, “I didn't know when that last shipment came,” and did not “know how to contact” the company (Purdue Frederick).
54
Id.
Several months later, B.L. was hospitalized for drug addiction or dependence. GX 50, at 5.
54
Several months earlier, however, Respondent had contacted the same PAP (Purdue Frederick) with respect to another patient J.R., after his application was denied.
See
GX 24, at 22-24. As the record indicates, Respondent knew the phone numbers.
In her plea agreement, Respondent admitted that during B.L.'s April 23 office visit, she had prescribed to him 200 tablets of Dexedrine 10 mg. and that after B.L. “informed [her] that he had accepted delivery of a prescription for his recently deceased father, FL, another patient of [hers,] in order to possess the prescribed controlled substance * * * OxyContin 40 mg.” GX 6A, at 7. Moreover, in the agreement, Respondent admitted that she “upon learning this information from * * * B.L., [she] did knowingly * * * fail to rescind the prescriptions for Dexedrine for B.L.”
55
55
In the plea agreement, Respondent agreed that these “facts accurately describe my conduct in connection with the offenses to which I am pleading guilty.” GX 6A, at 6.
The incident involving B.L. was the second of the four counts of Accessory After the Fact to Possession of Controlled Substances by Misrepresentation, Fraud, Forgery, Deception or Subterfuge” to which Respondent pled guilty.
See
GX 6A (Plea Agreement; citing 18 U.S.C. 3 & 21 U.S.C. 843(a)(3)).
Respondent did not document her discussion with B.L. regarding his father's OxyContin in his medical record. GX 50, at 4-5; Tr. 2360. While Respondent admitted that this was a shortcoming, she claimed she did not document the “diversion” because she lacked information to conclude that a diversion had taken place. Tr. 2359-60. I find, however, that Respondent's admission as part of the plea agreement precludes the relitigation of the issue of whether she knew that B.L. had obtained the OxyContin tablets dispensed pursuant to his father's prescription.
56
56
The medical record does show, however, that Respondent did not prescribe any more controlled substances to B.L. after the April 23 visit.
W.O. and J.O.
W.O. and J.O. were husband and wife. Respondent began treating W.O. in September 2000 for neck and low back pain from two motor vehicle accidents, one in June 2000 and the second in August 2000. GX 53, at 1. She began treating J.O. in October 2000 for neck and low back pain from a motor vehicle accident of September 2000. GX 51, at 1. At the initial visit of each, Respondent prescribed Percocet. GX 51, at 2; GX 53, at 2. Respondent also prescribed OxyContin and Soma to both J.O. and W.O. at numerous visits.
57
57
Respondent prescribed OxyContin 20 mg. to J.O. at her initial visit, GX 51, at 2; she started prescribing OxyContin 40 mg. to both J.O. and W.O. a week after their first visits. GX 51, at 1-2; GX 53, at 1-3. In early November, Respondent increased the dosing of the OxyContin from one tablet every twelve hours to one tablet every eight hours for both J.O. and W.O. without providing any explanation in their medical records as to why doing so was medically necessary.
See
GX 51, at 2 & 4; GX 53, at 4-5.
On November 13, 2000, J.O. saw Respondent and reported that their house had been burgled and that all of her and W.O.'s medications had been stolen. GX 51, at 4. J.O., however, brought a police report with her.
Id.
Respondent wrote a replacement prescription for 60 tablets of OxyContin 40 mg., with one tablet to be taken every eight hours.
58
Id.
While this prescription should have lasted twenty days, only four days later, Respondent gave J.O. another prescription for 21 tablets of OxyContin 40 mg, as well as 60 tablets of Oxycodone IR (1-2 tablets every four hours for breakthrough pain).
Id.
Moreover, on November 21, after only four more days, Respondent gave J.O. a prescription for another 100 tablets of OxyContin 40 mg., with the same dosing of one tablet every eight hours. This was followed by additional prescriptions for OxyContin 40 mg. December 20 (100 tablets); December 29 (50 tablets), January 12 (100 tablets of OxyContin 80 mg.).
Id.
at 5. Throughout the next four months, Respondent prescribed to J.O. OxyContin and either Oxycodone IR, Percocet, or Oxycodone.
59
58
Respondent also issued to W.O. prescriptions for Percocet, oxycodone 5 mg. and Oxyfast 20 mg./ml., and Roxicodone 30 mg. at various visits. After being on Roxicodone for several months, W.O. complained that it was expensive, and Respondent started prescribing methadone. GX 53, at 17. On September 21, W.O. also complained about the cost of Dilaudid; Respondent discontinued prescribing the drug and increased the methadone.
Id.
at 19. However, on November 1 and 14, she again prescribed Dilaudid, only to stop prescribing the drug at the November 26 visit.
Id.
at 20. However, while Respondent had increased the dosing of methadone when she initially discontinued the Dilaudid,
id.
at 19; she did not decrease the methadone dosing when she resumed prescribing the Dilaudid.
Id.
at 20.
As for Percocet, on October 3, Respondent issued W.O. a prescription for 300 Percocet “to fill October 20.”
Id.
Yet on October 19, she issued W.O. another prescription for 300 Percocet.
Id.
at 19-20. The file contains no explanation as to why the latter prescription was needed.
59
Here again there were frequent instances in which Respondent issued new prescriptions when J.O. should have had ample medication remaining from previous prescriptions. For example, on March 9, 2001, Respondent gave J.O. a prescription for 200 tablets of Roxicodone 30 mg., with one tablet to be taken every three hours. GX 51, at 14. While this prescription should have lasted twenty-five days, on March 21 (only twelve days later), Respondent gave J.O. a prescription for another 100 tablets with the same dosing.
Id.
at 15. And while these two prescriptions should have lasted until approximately April 15, Respondent gave her another prescription for 100 tablets on April 3.
Id.
at 16.
On November 13, 2000, Respondent also saw W.O., performed a physical exam on him, and gave him a prescription for 100 tablets of Percocet. GX 53, at 5. Later that day, she wrote a replacement prescription for 100 Percocet in W.O.'s name, (which she apparently gave to J.O.) based on J.O.'s report that their medications had been stolen.
Id.
There is no indication, however, that Respondent asked J.O. about what time the robbery had
occurred and whether W.O. had even had time to fill the first prescription she wrote on that day.
Thereafter, on November 17, Respondent gave W.O. a prescription for 21 tablets of OxyContin 40 mg (q8h—a week's supply), and 60 tablets of oxycodone (1-2 q4h).
Id.
Respondent wrote W.O. additional prescriptions for 100 tablets of OxyContin 40 (q8h—a thirty-three day supply) on November 20, as well as on December 8 and December 15.
Id.
at 7. On January 8, 2001, she doubled the dosing and gave him a prescription for 100 tablets of OxyContin 80 (q8h).
Id.
at 9. On January 18, she issued another prescription for 100 tablets of OxyContin 40 and doubled the dose to two tablets every eight hours; yet, on January 31, the dosing of the prescription was back to one table of OxyContin 40 every eight hours.
Id.
at 11. Moreover, on February 12, while W.O.'s low back pain was then a “zero,' she gave him another prescription for 100 tablets of OxyContin 40 and increased the dosing back to two tablets every eight hours.
Id.
at 13.
On May 14, 2001, Respondent switched W.O. from OxyContin to Dilaudid because of the former's cost, GX 53, at 17; on May 18, 2001, she did the same for J.O. GX 51, at 17. At their respective visits, Respondent wrote W.O. prescriptions for Dilaudid 8 mg. “2 tabs QID # 100” and 300 Percocet; she wrote J.O. prescriptions for Dilaudid 4 mg. “4 tabs QID #200,” as well as for 100 Roxicodone (1-2 q3h) and 200 Percocet. GX 53, at 17; GX 51, at 17. Moreover, on June 25 and 26, Respondent started prescribing methadone 10 mg, with four tablets to be taken four times a day, to both J.O. and W.O.
60
GX 51, at 18; GX 53, at 17.
60
On July 17, Respondent doubled J.O.'s dose of methadone to eight tablets, four times a day. GX 51, at 18. There is, however, no indication in J.O.'s patient file explaining the basis for doing so.
See id.
On November 9, Respondent wrote J.O. a prescription for 200 Percocet q4h PRN, which was to be filled on November 14 (along with prescriptions for Dilaudid and Methadone). GX 51, at 20. However, on November 15, 2001, W.O. (J.O.'s husband) came to Respondent's office to pick up a replacement prescription for the November 9 prescription, which had been altered.
Id.
W.O. “insist[ed that the] prescription was ripped in his pocket even though the other 2 prescriptions were unripped.”
Id.
Respondent had the pharmacy mail the prescription to her and found that the “fill date of November 14 was obviously torn out.”
Id.
Respondent did not write a replacement prescription.
Id.
On November 21, J.O. went back to Respondent and asked for a replacement prescription for the Percocet.
Id.
Respondent “explained “the modification of prescription and that it was illegal.”
Id.
J.O. claimed that she knew nothing about the modification of the prescription and that it was W.O. who had picked it up and dropped it off at the pharmacy.
Id.
The notation for this visit also states that Respondent had “received anonymous call that [J.O.] selling Percocet.”
Id.
Respondent told J.O. that she “would not and could not” write controlled substance prescriptions for her anymore.
Id.
at 21. Respondent placed J.O. on a tapering schedule for methadone and did not prescribe other controlled substances thereafter.
Id.
However, at J.O.'s very next visit, December 3, 2001, J.O. “had more pain on the Methadone only.”
Id.
Respondent then abandoned the plan to taper J.O. off the methadone and increased her dose.
Id.
On March 4, 2002, J.O. brought to Respondent a consent agreement she had entered into with the State Nursing Board.
Id.
at 22. Apparently, the Nursing Board had initiated a disciplinary proceeding against J.O. because she had abused medications and taken some from a nursing home at which she worked.
Id.
Under the Consent Agreement, J.O. needed to have Respondent “notify the nursing board about what medications she is on.”
Id.
At the visit Respondent gave J.O. a prescription for 600 methadone 10 mg.
Id.
at 22.
On March 12, J.O. appeared “need[ing] half of [the] methadone prescription because she gave [W.O] half of them.”
61
Id.
Respondent obliged and issued her a prescription for 300 tablets of methadone.
Id.
Respondent further noted that that she and J.O. had “discussed problems with [W.O.], but [Respondent] didn't tell her what he did.”
Id.
According to W.O.'s patient file, on February 27, 2002, Respondent had received a phone call from G.A. stating that W.O. had stolen approximately 100 OxyContin tablets from him. GX 53, at 21.
61
On February 25, W.O. had picked up a prescription for 600 tablets of Methadone. GX 53, at 21. W.O. did not return to Respondent's office after that.
On April 16, Respondent wrote a letter to the Arizona State Board of Nursing, listing J.O.'s medications. GX 51, at 24. Notwithstanding the report she had previously received that J.O. was selling her medication, the incident with the torn prescription, and J.O.'s having admitted to giving half of a methadone prescription to W.O., Respondent wrote that she was “aware of [the] history of this nurse's diversion of drug
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