Free Other Notice - District Court of Arizona - Arizona

PETITION FOR A WRIT OF CERTIORARI Petitioner Jeffrey H. Feingold respectfully petitions for a writ of certiorari to review the judgment of the United States Court of Appeals for the Ninth Circuit in this case. OPINION BELOW The opinion of the Ninth Circuit Court of Appeals (Pet App. 1a- 22a) has been published and is therefore precedential. 1 JURISDICTION BELOW The Ninth Circuit Court of Appeals entered its judgment on July 21, 2006. (Pet. App. 23a) The jurisdiction of this Court is invoked pursuant to 28 U.S.C. sec.1254 (1). APPLICABLE STATUTORY PROVISIONS AND REGULATIONS The crime of unlawful distribution of a controlled substance is codified at 21 U.S.C. sec. 841 (a) (1), and is provided at Pet App. 26(a). Other relevant portions of the Controlled Substances Act (21 U.S.C. sec. 821 and 823) are provided at Pet. App. 25(a) and 32(a), respectively. The law pertaining to the medical treatment of narcotics addiction, 42 USC sec.
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Oral argument was held at Stanford Law School on April 4, 2006. Rehearing has not been sought by Petitioner.
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290bb-2a is provided at Pet. App.24(a) The "legitimate medical purpose" regulation, 21 C.F.R., sec. 1306.04 is provided at Pet. App. 40(a). STATEMENT OF THE CASE A. Trial in the U.S. District Court for the District of Arizona (Phoenix) This is an appeal from the conviction and sentence of Jeffrey H. Feingold arising from the United States District Court for the District of Arizona, Phoenix division, on 185 counts of Illegal Distribution of a Controlled Substance, in violation of 21 U.S.C. sec. 841(a)(1), (b)(1)(C) and (D). The District Court had jurisdiction over this offense pursuant to 18 U.S.C. section 3231. On September 25, 2002, Jeffrey Feingold, a 58 year old naturopathic physician licensed the state of Arizona, was indicted on seven counts of Illegally Dispensing Controlled Substances, in violation of 21 U.S.C. sec. 841(a)(1), (b)(1)(C). The charges were based on his prescribing Schedule II controlled substances to undercover DEA agents without a legitimate medical purpose and outside the usual course of professional practice. A superseding indictment was filed on July 23, 2003, charging a total of 195 counts of Illegal Distribution of a Controlled Substance, in violation of 21 U.S.C. sec. 841(a)(1), (b)(1)(C) and (D). (C.R. 50; E.R. 1-14). It encompassed the original seven counts as well as 188 additional counts,

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which represented Dr. Feingold's illegal distributions of Schedule II and III controlled substances to other patients "without a legitimate medical purpose and outside the usual course of professional practice." (C.R. 50: E.R.1-14). Following a ten (10) day jury trial in the U.S. District Court (Phoenix), on May 12, 2004, a jury found Dr. Feingold guilty on each of the 185 counts that ultimately went to the jury. The district court calculated the offense level under the sentencing guidelines as 32, based on the quantity of drugs illegally prescribed by Dr. Feingold, as well as on its finding that Dr. Feingold had abused a position of public trust. The district court sentenced Dr. Feingold to 60 months for those counts that were subject to a statutory maximum, and to 144 months for the counts that were governed by the sentencing guidelines, with all sentences to run concurrently. (C.R.229; E.R. 126). 1. Dr. Jeffrey Feingold At the time of trial, Jeffrey Feingold, N.M.D. was a fifty-eight (58) year old naturopathic physician licensed in the State of Arizona who had graduated from Portland, Oregon's National College of Naturopathic Medicine in 1976. He completed both an internship and residency in

Pennsylvania. Dr. Feingold practiced in Philadelphia and founded the Pennsylvania Association of Naturopathic Physicians. In 1990, he resettled

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in Arizona with his family. After receiving his license to practice naturopathic medicine in Arizona, he eventually opened his own practice in Scottsdale, Arizona. (R.T. Excerpts 5/6-7/04, pp.2-6). Dr. Feingold received board certification from the College of Family Medicine and in 1993, he was granted a license to dispense medications and remedies from the Arizona State Naturopathic Board. (R.T. Excerpts 5/67/04, pp. 6-8). In early 2000, Arizona naturopathic physicians were granted the authority to prescribe or dispense Schedule II, III, IV, and V controlled substances. (R.T. 4/28/04, pp. 334); (R.T. 4/29/04, pp. 489-490; 529-530). In May 4, 2000, Dr. Feingold obtained the required certificate from the DEA which allowed practitioners to handle Schedule II, II, IV and V substances "pursuant to state law." (R.T. 4/29/04, p. 491). The prescriptions written by him pursuant to this certification form the basis for the government's 195 count indictment against him.2

2. The Government's case At trial, the government presented testimony from two DEA agents Effective August 22, 2002, the State of Arizona revised its laws to prohibit naturopathic physicians from dispensing Schedule I or II controlled substances except for morphine. (R.T. 4/28/04, pp. 316-317); (R.T. 4/29/04, pp. 529). Schedule II narcotic prescriptions written after that date, with the exceptions of morphine, were deemed illegal. (R.T. 4/29/04, p. 493)
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whose investigation precipitated the initial counts against Dr. Feingold. In a subsequent search of Dr. Feingold's office, the government seized his patients' charts and other records from which the government's remaining, often reluctant witnesses against Dr. Feingold were culled. The government also relied on two "medical expert" witnesses to ultimately opine that Dr. Feingold acted "outside the course of medical practice" and/or "not for a legitimate medical purpose," on the basis of traditional medical malpractice, standard of care criteria such as poor record keeping, incomplete medical exams, failure to perform diagnostic testing, failure to pursue alternative remedies, and most frequently, the sheer numerosity and frequency of the prescriptions, regardless of the small amount of active ingredient in each pill.

Dr. Feingold's Patients In addition to two DEA agents who admittedly posed as patients, complained of pain, and were consequently treated with opioid analgesics, the government called approximately ten of Dr. Feingold's patients, all of whom testified they sought prescriptions from Dr. Feingold to treat previously unalleviated pain from headaches, previous injuries, or surgeries. Several testified under a grant of immunity from prosecution by the DEA

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and at least one was a hostile witness. Some admitted misrepresenting the severity of their pain in order to continue obtaining opioid analgesic medication. Most had assured Dr. Feingold that other physicians had previously issued such prescriptions for pain relief. Two admitted developing a dependence on the drugs that they continued to demand to treat their pain, despite Dr. Feingold's attempts to "taper" or gradually reduce the medication level to mitigate the discomfort of withdrawal. Two patients also admitted that they sometimes gave their medication to others, but no one testified that Dr. Feingold ever knew they were diverting their medication. One patient, a chronic pain victim for nearly twenty-five years, claimed that morphine sulfate was nauseating and that he couldn't afford the thousand dollars traditionally charged for an equivalent amount Oxycontin. He convinced Feingold to give him smaller dosages more often. (R.T. Excerpts 5/6-7/04, p. 35). Another similarly situated witness had contested his HMO's decision to limit chronic pain medications.3 Thus, Dr. Feingold's treatment was his only source of relief. Feingold had "absolutely" helped him, and the witnesses testified that Dr. Feingold was, "and is" one of the best doctors he'd ever had. (R.T. 5/4/04, pp. 1059-1060; 1087). Unlike the majority of recent prosecutions regarding improper prescribing under the Controlled Substances Act, this case involved no allegations of health care fraud. In fact, due to his status as naturopathic physician, neither Dr. Feingold nor his patients received health insurance reimbursements.
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The Government's expert witnesses Throughout the trial, the prosecutor repeatedly elicited traditional, medical malpractice-type, "standard of care" evidence in an attempt to prove that Dr. Feingold distributed controlled substances to his patients under the criminal standard for a violation of the Controlled Substances Act, i.e., that he knowingly or intentionally distributed the controlled substances "outside the usual course of professional practice." Government witness Thomas Kruzel, N.M.D. reviewed several of Dr. Feingold's patients' records, which appeared to contain "subjective data or initial patient intake." In each case he opined that the prescriptions "appeared to be" outside the usual course of medical practice, or "probably not medically necessary," but all conclusions were predicated by references to Dr. Feingold's deficient record keeping. (R.T. 4/28/04, pp. 326; 327; 329; 343; 329-330; 315-330). Nonetheless, he acknowledged that those charts always indicated that the patients suffered from pain. (R.T. 4/28/04, pp. 346). On cross-examination, Dr. Kruzel acknowledged that prescribing controlled substances for chronic pain relief was appropriate and accepted. Furthermore, treatment of chronic pain couldn't always be tied to objective findings and a patient's subjective complaints would be essential for proper diagnosis and treatment (R.T. 4/28/04, pp. 338-339). Whether previous

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physicians had prescribed a particular controlled substance was instrumental in determining whether controlled substances were appropriate in treating new patients. (R.T. 4/28/04, p. 340; 342). Expert Witness Michael Ferrante, M.D. Over objection, expert witness Michael Ferrante, M.D. offered "standard of care" testimony which essentially misrepresented that the relevant "medical community" had adopted hard and fast guidelines for the use of opioids in chronic pain management. The Federation of State Medical Boards promulgated the Model Guidelines for Use of Controlled Substances for the Treatment of Pain ("Model Guidelines") (E.R. 171-177), which stated that a doctor should: evaluate the patient; do a good history and physical; develop a differential diagnosis; inform the patient of the risks, alternatives and benefits of treatment; determine treatment objectives; conduct periodic review; lab tests; and provide adequate documentation. (R.T. 5/5/04, pp. 1183-1184). While the federal government and the American Medical Association created a list of things which must be in a physical exam "in order to bill to a certain appropriate level," the list was "system dependent." (R.T. 5/5/04, p. 1186). Dr. Ferrante also acknowledged that with opioids, one should "titrate" or carefully increase or decrease medication according to the results." (R.T. 5/5/04, p.1185) (emphasis

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supplied). Dr. Ferrante's general observation was that Dr. Feingold's documentation did not reflect that the patients had received a "good physical examination, good medical history, outlining of treatment options, consultations, as well as periodic review for legitimate medical purposes." (R.T. 5/5/04, p. 1271). In several cases, the history was incomplete and the physical exam was non-existent. Often, the frequency and quantity of prescriptions seemed excessive, and there was frequently no treatment plan or corroborating lab work associated with the patients' medical records. Primarily for those reasons, Dr. Ferrante opined that all of the prescriptions were written "outside the usual course of professional practice" and not for a legitimate medical reason. (App. Brief at 8-12). On cross-examination, Dr. Ferrante acknowledged that pain

medication was a relatively recent specialization. (R.T. 5/5/04, p. 1259). He stated that "by definition, pain is subjective." (R.T. 5/5/04, p. 1258). He agreed with leading authority that "physical dependence and tolerance were both normal physiological consequences of using opioid medication over a period of time, requiring increasing dosages to achieve the same level of pain relief." (R.T. 5/5/04, pp. 1267-1268). A patient who was abruptly removed from opioids would go through withdrawal or "cold turkey,"

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characterized by abdominal pains, nausea, vomiting, combativeness, agitatation, and sweating. (R.T. 5/5/04, p. 1272). He agreed that "for most opioids, there does not appear to be an arbitrary upper dosage limit, as was previously thought," and that "physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction. . . . " (R.T. 5/5/04, pp. 1269-1270; 1274). He acknowledged that the Model Guidelines advised medical boards to judge "the validity of prescribing based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity (overall length of time) of the prescribing." (R.T. 5/5/04, p. 1275). He agreed with leading authority suggesting that pain patients can have a variety of responses to opioid treatment, and that someone's addiction or psychiatric disorder should not necessarily contraindicate the use of opioids. (R.T. 5/5/04, pp. 1277; 1281). Finally, Dr. Ferrante agreed that all the medications involved in this case were appropriate for the treatment of a legitimate, mild, moderate, or severe pain problem. (R.T. 5/5/04, p. 12821284).

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3. The defense's case The defense's expert witness Defense expert witness Dr. Michael Cronin was a Naturopathic Physician who had also attended the National College of Naturopathic Medicine in Portland, Oregon in 1980. The Naturopathic Physicians Board of Examiners had not promulgated guidelines concerning the dispensation or prescription of medication until 2002, when the law changed to limit prescriptions of Schedule II drugs except morphine. (R.T. 5/6/04, pp. 1371) After reviewing the medical files and charts submitted into evidence, he opined that the documents referenced "conditions that are treatable and appropriately treated with pain medication," and that such treatment was "for a legitimate medical purpose in the course of practice." (R.T. 5/6/04, pp. 1382-1383). Prescribing medication for persons at home (other than the primary patient) was not atypical in naturopathic practice. (R.T. 5/6/04, pp. 1426). For patients like construction worker Greer (who bartered his labor for Feingold's services) that needed to resume their activities of daily living, pain medication would be appropriately prescribed to accomplish those goals. (R.T. 5/6/04, p. 1405). If the patient was stable and "up to the task," it would not be inappropriate for the patient to work. (R.T. 5/6/04, pp. 1428). On cross-examination, Dr. Cronin admitted that based on their volume

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and frequency, the prescriptions issued to several of Feingold's patients appeared "excessive" and thus "outside the usual course of professional practice and without a legitimate medical reason," with the caveat that he "was generalizing, and didn't know the "particulars of the case." He cited the absence of physical exam in support of his reasoning. (R.T. 5/6/04, pp 1409;. 1410; 1412; 1414; 1415; 1416; 1419-20). Ultimately, when the prosecutor asked if the foregoing prescriptions were issued outside the usual course of professional practice, he stated only that "they seem excessive in terms of dosage and count." (R.T. 5/6/04, p. 1423). He believed any prescriptions written after August 22, 2002 would have been illegal under the new, more restrictive law. (R.T. 5/6/04, pp. 1413). Dr. Jeffrey Feingold Dr. Feingold testified that the pharmacology course he took at the National College of Naturopathic Medicine did not cover opioid medications. After receiving his DEA certificate, he was approached by many walk-in patients who complained of pain and requested controlled substances. They were not interested in his suggestions, only to remedy their pain with medicines they claimed they were already taking and knew worked for them. (R.T. Excerpts 5/6-7/04, pp. 10-11; 20; 27; 162). He initially prescribed the Percocet and Vicodin they requested. When he

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discovered that Oxycodone was safer, he eventually tried to switch his patients to Oxycodone to protect their livers. (R.T. Excerpts 5/6-7/04, pp. 13; 27; 28; 38; 148). Dr. Feingold's patients had usually been treated with pain medications by previous doctors. (R.T. Excerpts 5/6-7/04, p. 31; 41; 42; 45; 46; 49; 168. Feingold often prescribed high quantities of low dosage tables because patients would object that the stronger, more concentrated versions would be prohibitively expensive and his patients usually did not have health insurance. (R.T. Excerpts 5/6-7/04, p.17; 57). He listened as they told him what seemed to work better, and tried to titrate, i.e., adjust their dosage accordingly. (R.T. Excerpts 5/6-7/04, p. 47; 98; 120; 151; 157; 172-173). When he prescribed narcotics for patients following rehab efforts, it was because they returned to him and complained of pain. (R.T. Excerpts 5/67/04, pp. 64; 73; 91). Dr. Feingold recommended particular pharmacies to his patients because certain pharmacists were reluctant to fill prescriptions issued by naturopathic physicians, whom they didn't believe were "legitimate" doctors. (R.T. Excerpts 5/6-7/04, pp. 172-173). 4. The defective jury instructions Prior to and during trial, defense counsel unsuccessfully objected that the use of medical "standard of care" evidence was irrelevant and unduly

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prejudicial. He asserted that the "generally recognized and accepted standards of the medical community at large" was merely a negligence standard. Furthermore, the jury must look into Dr. Feingold's subjective state of mind when treating his patients. Ultimately, the judge instructed that A controlled substance is distributed by a practitioner in the usual course of his professional practice if the substance is distributed by him in good faith in medically treating a patient. Good faith is not merely a practitioner's sincere intention towards the people who come to see him, but, rather, it involves his sincerity in attempting to conduct himself in accordance with the standard of medical practice generally recognized and accepted in the country. Thus, good faith . . . in this context means an honest effort to prescribe to a patient's conditions in accordance with the standard of medical practice generally recognized and accepted in the country. (R.T. 5/11/04, pp. 1584-1585; E.R. 360-361)(Emphasis supplied). Compounding the prejudice, the district court denied counsel's request to instruct the jury that "in making a medical judgment concerning the right treatment for an individual patient, physicians have the discretion to choose among a wide range of available options." (C.R. 144; E.R. 50) B. Appeal in the Ninth Circuit Court of Appeals. After deliberation, the jury issued a "blanket verdict," convicting Dr. Feingold on all 185 counts. Dr. Feingold appealed the conviction and sentence, claiming that the district court improperly allowed expert witnesses to testify about the standard of care applicable to the distribution

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of opioid and other drugs. He argued that their testimony not only misled the jury by claiming a consensus among medical professionals in a field where none exists, but also was irrelevant and prejudicial because it prompted the jury to convict him of criminal offenses where at most, he was a negligent doctor. Furthermore, the jury was not sufficiently alerted to the fact that it must make a subjective inquiry into Dr. Feingold's mind to ensure that he indeed possessed the mens rea required for a criminal conviction under the CSA.
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The prejudice was compounded when the judge instructed the jury

that "good faith" consists of compliance with the "generally accepted standards of the medical community in the county," which mischaracterizes an actual lack of medical consensus between the DEA and the relevant medical community regarding the appropriate use of opioid medication to treat chronic pain. Prior to oral argument, Dr. Feingold provided a letter of supplemental authorities pursuant to Federal Rule of Appellate Procedure 28(j), citing this

Dr. Feingold also appealed the sentence arguing that since the jury made no specific findings regarding quantity of drugs involved, the corrected adjusted base offense level should be twelve (12) instead of thirty (30), resulting in a 10-16 month guideline range, not the 121-151 month range prescribed by an offense level of 32. He also contended that resentencing was required in light of the erroneous mandatory application of the U.S. Sentencing Guidelines, as well as the judge's misapprehension regarding the applicability of U.S.S.G. sec. 5C1.2(a)'s "safety valve" provision.
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Court's recent decision in Gonzales v. Oregon, 126 S.Ct. 904 (2006). In Gonzales, the Supreme Court noted that the statutory phrase "legitimate medical purpose" is a "generality, susceptible to more precise definition and open to varying constructions, and thus ambiguous in the relevant sense." Id. at 916. Appellant also asserted that Gonzales confirms that except for regulating detoxification of narcotics addicts, there are no "general uniform standards of medical practice," and reaffirmed that Congressional intent requires consensus views of the relevant medical and scientific community in articulating appropriate medical practice for CSA purposes. Id. at 921; 923-924. Oral Argument was held on April 4, 2006 at Stanford Law School in Palo Alto, California. In addition to the fully briefed argument, appellate counsel also argued that in light of Supreme Court's pronouncement in Gonzales v. Oregon, the Controlled Substances Act as applied to Dr. Feingold through a defective jury instructions which misrepresented the existence of a national, prevailing medical standard of care for pain management, and through which the district court sought to define an important statutory element ­ the boundaries of conduct considered "in the course of professional practice" and for a "legitimate medical purpose" for

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CSA purposes, was unconstitutionally vague and overbroad and deprived him of a fair trial in derogation of his Due Process rights. The Ninth's Circuit's Opinion On July 21, 2006, the Ninth Circuit published a twenty-two (22) page precedential opinion, provided at Pet. App. 1-22(a). The court agreed that "standard of care" evidence alone is insufficient to support the criminal conviction of a licensed practitioner under §841(a), but noted that only after assessing the standards to which medical professionals generally hold themselves is it possible to evaluate whether a practitioner's conduct has deviated so far from the "usual course of professional practice" that his actions become criminal. United States v. Feingold, 454 F.3d 1001 at 1007 (2006), citing United States v. Moore, 423 U.S. 122 at 124 (1975). The court noted that to the extent that the government's evidence created the illusion of a consensus among the medical community when no agreement actually exists about the applicable standard of care in pain management, the proper response to this problem was for Dr. Feingold to present evidence (as he actually did at trial) of the purported disputes within the medical community. Feingold, supra at 1007, n. 1. In response to Feingold's argument that through its jury instructions, the district court effectively misrepresented the elements of the crime and

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relieved the jury of its burden of convicting without an adequate determination of mens rea, the court affirmed that in order to convict a practitioner under §841(a), the government must inter alia make a finding of intent not merely with respect to distribution, but also with respect to the doctor's intent to act as a pusher rather than a medical professional. Feingold, supra at 1008. Most important, however, the court recognized that Dr. Feingold's appeal presented the question of "whether a practitioner's conviction under 21 U.S.C. § 841(a) is valid if it rests only on a finding of intentional malpractice, or whether a jury must find that the doctor intentionally engaged in even more egregious conduct. Similarly stated: can a defendant who intentionally exceeds a generally recognized `standard of medical practice' still be engaged in `the usual course of professional practice,' . . . such that he could escape criminal liability?" Feingold, supra 1009, citing Moore, 423 U.S. at 124. The Ninth Circuit recognized that "The question is a difficult and important one, and it implicates the conduct of any health care professional whose judgment about the appropriate standard of medical care may conflict with what a jury determines to be the generally accepted standard." Feingold, supra at 1009. "The threat [ ] is that doctors could be prosecuted and perhaps convicted as criminals whenever the Attorney

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General disapproves of a course of treatment, or whenever they step outside of conventional medical protocols in order to provide some sort of special treatment for uniquely needy patients." Id.5 In attempting to address the question, the Ninth Circuit relied on the Supreme Court's decision in United States v. Moore, 423 U.S. 122 (U.S. 1975) which "implicitly approved an instruction that required the jury to find `beyond a reasonable doubt that a physician, who knowingly or intentionally, did dispense or distribute [methadone] by prescription, did so other than in good faith for detoxification in the usual course of a professional practice and in accordance with a standard of medical practice generally recognized and accepted in the United States.'" Feingold, supra, citing Moore, 423 U.S. at 138-39 (emphasis supplied). The court noted that the Supreme Court and the Ninth Circuit have previously approved jury instructions that refer to a national standard of care, (implicitly with regard to the use of methadone to detoxify addicts) although no such standard has The Ninth Circuit ultimately held that "an instruction is improper if it allows a jury to convict a licensed practitioner under § 841(a) solely on a finding that he has committed malpractice, intentional or otherwise. Rather, the district court must ensure that the benchmark for criminal liability is the higher showing that the practitioner intentionally has distributed controlled substances for no legitimate medical purpose and outside the usual course of professional practice . . .. [T]he district court must ensure that the benchmark for criminal liability is the higher showing that the practitioner intentionally has distributed controlled substances for no legitimate medical purpose and outside the usual course of professional practice." Feingold, supra.
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ever been specifically articulated regarding the use of opioid medication to manage pain. Id. at 1009. Significantly, in an accompanying footnote, the court seemed to acknowledge the absence of a coherent, articulated consensus among the relevant statutory actors regarding legitimate medical practice with respect to the treatment of pain with opioid medication.6 Ultimately, the Ninth Circuit held that "it is appropriate in cases such as this for the jury to consider the practitioner's behavior against the benchmark of acceptable and accepted medical practice. Just how that benchmark is expressed to the jury -- here, the district court defined that benchmark in terms of the 'standard of medical practice generally

Where the federal government has legitimately and expressly limited the ways in which practitioners may employ controlled substances, a practitioner may be prosecuted for exceeding such federal restrictions. See Moore, 423 U.S. at 144 (noting explicit congressional authorization for the then-secretary of Health, Education, and Welfare to define the boundaries of permissible experimentation with controlled substances for the purpose of treating drug addiction). Here, we express no opinion on the validity of any federal effort to define what constitutes a legitimate medical practice with respect to the treatment of pain with opioid drugs. See Gonzales v. Oregon, 126 S. Ct. 904, 925, 163 L. Ed. 2d 748 (2005) (holding that the Attorney General lacked authority to declare illegitimate a medical standard for care and treatment of terminally ill patients that was specifically authorized under state law). Feingold, supra, at 1011, n.2. (emphasis supplied)

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recognized and accepted in the country' -- is a matter within the district court's discretion." Feingold, supra at 1011-1012 (emphasis added). In another accompanying footnote, the Court carefully noted that although the Supreme Court's decision in Moore authorized prosecution of licensed practitioners who act "outside the usual course of professional practice," 423 U.S. at 124, the Feingold district court's definition of a "standard of medical practice generally recognized and accepted in the country" may be overly broad given the diversity of views that may exist within the medical profession about the propriety of any given course of medical treatment. Nonetheless, the court considered any error harmless and the instruction appropriate in light of the court's other instructions that Dr. Feingold could not be convicted if he distributed the controlled substances "in good faith in medically treating a patient" or distributed them for a "legitimate medical purpose," despite the defective jury instructions that defined "good faith" in terms of an illusory "standard of medical practice generally recognized and accepted in the country."

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REASONS FOR GRANTING THE PETITION 1. May the benchmark of acceptable medical practice from which a DEA Registrant must deviate for criminal culpability under the CSA`s "course of professional practice" element ultimately be defined by a jury instruction which merely elaborates on already vague statutory language, remains subject only to a particular court's discretion, and may vary between court, state, and circuit, leaving medical practitioners to guess at what point their conduct becomes criminal under the CSA? This issue is one of national importance with broad consequences for health care providers and their patients - the 100 million, increasingly aging Americans who suffer with chronic pain, many of whom are unable to obtain consistent relief because physicians have become increasingly terrified of prescribing controlled substances for fear of being targeted as "drug dealers" by the DEA.7 The problem has also galvanized a national debate regarding

7

The Society for Neuroscience, the largest organization of brain researchers, estimates that 100 million Americans suffer from chronic pain. . . . The American Pain Foundation, a professional organization of pain specialists, puts the number at 75 million ­ 50 million from serious chronic pain (pain lasting six months or more), and an additional 25 million from acute pain caused by accidents, surgeries, and injuries. . . . The American Pain Society, another group, estimates that in 1995, untreated pain cost American business more than $100 billion in medical expenses, lost wages, and other costs, including 50 million workdays. . . . A 2003 article in the Journal of the American Medical Association puts the economic impact of common ailments alone-such as arthritis, back pain, and headache - at $61.2 billion per year.

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whether a physician who prescribes for a patient can, or should be prosecuted when the patient misbehaves. The still-unanswered question remains: Who decides at what point conduct rises to the level of criminal culpability under the CSA and 21 C.F.R. §1306.04's vague and ambiguous "course of professional practice" and "legitimate medical purpose" language? It was this question that the Feingold court recognized as a "difficult and important one, [which] implicates the conduct of any health care professional whose judgment about the appropriate standard of medical care may conflict with what a jury determines to be the generally accepted standard." Feingold, supra at 1009. The Ninth Circuit's ruling that a district court's discretion alone governs how the "benchmark of acceptable and accepted medical practice," in other words ­ how the vague and ill-defined statutory language "course of professional practice" and "legitimate medical purpose" is expressed to the jury, leaves the question unanswered, and medical practitioners are left to guess at which point conduct rises to the level of culpability under the CSA. Practitioners fear being subject to an ex post facto definition of the already vague "legitimate medical purpose" or "course of professional practice," language which, in the exercise of a particular court's discretion, will Ronald T. Libby, Treating Doctors as Drug Dealers: The DEA's War on Prescription Painkillers, (http://www.cato.org/pubs/pas/pa545.pdf)
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necessarily vary between court, state, and circuit, depending on the adversaries' resources in enlisting mercenary expert witnesses to support it's preferred version of the prevailing medical standard. Under these circumstances, where draconian prison sentences can and have been imposed whenever a lay jury credits one expert's opinion on complex medical issues rather than another's, doctors will inevitably be discouraged from exercising their best medical judgment when prescribing opioids. Innovation and progress in the area of pain management risk regression. Indeed, thirty-two State Attorneys General have expressed concern that federal narcotics prosecutions will have such a chilling effect, because "many physicians fear investigations and enforcement actions if they prescribe adequate levels of opioids or have many patients with prescriptions for pain medications." Letter from Attorneys General to Deputy Administrator of DEA (March 21, 2005) (Pet.

(http://www.naag.org/issues/pdf/20050321-Final-DEAComment.pdf) App. at 41(a)

A. Statutory Elements of the crime of unlawful distribution of a controlled substance. Congress enacted the Controlled Substances Act ("CSA"), 21 U.S.C. §§ 801-950, intending to address problem of drug abuse and illegal trafficking in drugs. See 21 U.S.C. § 801. Oregon v. Ashcroft, 192 F. Supp.
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2d 1077, 1080 (9th Cir. 2002), petition for certiorari granted, 368 F.3d 1118, 2004 (9th Cir. Or., 2004). The CSA makes it unlawful for any person to manufacture, distribute, or dispense any controlled substance "except as authorized by [the CSA]." 21 U.S.C. § 841(a)(1). Physicians who prescribe controlled substances are considered "practitioners" who "dispense" controlled substances, 21 U.S.C. § 802(10) and (21), and are authorized to dispense controlled substances (see 21 U.SC. sec. 829(a) & (b)) in "the course of [their] professional practice." See. 21 U.S.C. sec. 802(211); see also United States v. Moore, 423 U.S. 122, 140 (1975). Prescriptions not satisfying the requirements of this regulation, knowingly or intentionally issued, may form the predicate for a practitioner's criminal liability under 21 U.S.C. § 841. Registered physicians are not immune from prosecution under 21 U.S.C. § 841 when their activities fall outside the usual course of professional practice. United States v. Moore, 423 U.S. 122, (1975) (equating acting outside "the bounds of professional practice" with acting as a "pusher," and "diverting drugs outside of legitimate channels.") Accordingly, to convict a DEA registrant of unlawful distribution of a controlled substance, the government must prove beyond a reasonable doubt that the practitioner: (1) knowingly or intentionally; (2) prescribed or

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dispensed controlled substances; practice. Moore, supra.

(3) outside the course of professional

In 1971, under authority delegated by the Attorney General pursuant to 21 U.S.C. §871(a), the predecessor to the Administrator of the DEA adopted formal regulations implementing the CSA. One of the regulations (the "rule"), now codified at 21 C.F.R. § 1306.04, provides, in relevant part: A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. * * * An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. § 829) . . . . . Oregon v. Ashcroft, supra, quoting 21 C.F.R. § 1306.04(a) (emphasis supplied). In United States v. Moore, 423 U.S. 122 (1975), the court clarified that the rule and the statute mean the same thing. A prescription is written for a "medical purpose" if it is written in the "course of professional practice." The court in Moore equated acting "outside the bounds of professional practice" for CSA purposes with a physician acting as a "pusher," and "diverting drugs outside of legitimate channels." Id. at 143. See also Gonzalez v. Oregon, 126 S.Ct. at 923 (the crime under the CSA is "illicit drug dealing and trafficking as conventionally understood"). The
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Gonzales court keenly observed that although the regulation uses the terms "legitimate medical purpose" and "the course of professional practice," "this just repeats two statutory phrases and attempts to summarize the others. It gives little or no instruction on a central issue in this case: Who decides whether a particular activity is in "the course of professional practice" or done for a "legitimate medical purpose"? Gonzales v. Oregon, 126 S. Ct. 904, 915 (2006). B. United States v. Moore was decided in the context of a specific and legitimately enacted statutory scheme for the detoxification of narcotic addicts ­ the deviation from which could be measured against explicit statutory provisions without reducing the assessment of a practitioner's criminal culpability under the CSA to a battle of contradictory, expert witnesses, subject only to the constraints of judicial discretion. When the Controlled Substances Act was first enacted it was questionable whether DEA registrants such as physicians, pharmacists, and certain researchers could be prosecuted under Sections 841's blanket prohibition, or whether they must be prosecuted under Sections 842 and 843, which provide lesser penalties. In United States v. Moore, 423 U.S. 122 (U.S. 1975), a licensed physician registered under the Controlled Substances Act (CSA), 21 U.S.C. § 801 et seq., was convicted of knowing and unlawful distribution and dispensation of methadone (a controlled substance or addictive drug used in the treatment of heroin addicts) in violation of 21
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U.S.C. § 841(a)(1), which makes it unlawful for "any person" knowingly or intentionally to distribute or dispense a controlled substance, except as authorized by the CSA. In Moore, however, the court noted that "in the case of methadone treatment the limits of approved practice are particularly clear . . . [Respondent] was authorized only to dispense methadone for detoxification purposes. His authorization by the FDA to engage in a methadone maintenance program had been revoked. Nor was respondent unfamiliar with the procedures for conducting a legitimate detoxification program." United States v. Moore, 423 U.S. 122, 144 (1975). Courts that have since broadly relied on Moore's "implicit" approval of its particular jury instruction "that Dr. Moore could not be convicted if he merely made 'an honest effort' to prescribe for detoxification in compliance with an accepted standard of medical practice." (Moore, at 143, n. 20), have failed to note the regulatory environment in which the case was decided. The crucial distinction is that Moore dealt with prosecution of a physician who failed to comply with an already specifically and statutorily defined standard of medical practice - the uniform national standard for the medical treatment of narcotic addiction under 42 U.S.C. § 290bb-2a, which is the

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only area in which Congress has set uniform, national standards of medical practice. See Gonzales, supra at 920. 8 While the Ninth and other circuits have broadly read Moore to allow prosecution of DEA registrants under the CSA for activities falling "outside the usual course of professional practice," the Supreme Court in Moore was never asked, nor did it attempt to define the precise contours of the language "in the course of professional practice" or "legitimate medical purpose," although deviation from either or both (depending upon the judge's discretion in formulating a jury instruction - here, by reference to an equally vague definition of "good faith compliance with a generally accepted standard in the country"), appears to be the sine qua non for conviction under the CSA. Nonetheless, it was this very language that was recently denounced by the Supreme Court in Gonzales v. Oregon, 126 S. Ct. 904, 916 (2006), as suffering from "generality, susceptible to more precise

In Moore, the district court had instructed the jury that the defendant could be convicted if the jury found that he knowingly distributed controlled substances "other than in good faith for detoxification in the usual course of a professional practice and in accordance with a standard of medical practice generally recognized and accepted in the United States." Id. at 139, and that the defendant "could not be convicted if he merely made 'an honest effort' to prescribe . . . in compliance with an accepted standard of medical practice." Moore, supra at 142, n.20.
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definition and open to varying constructions, and thus ambiguous in the relevant sense." Gonzales v. Oregon, 126 S. Ct. 904, 916 (2006). C. Contemporary, pain-treating physicians face the identical jeopardy suffered by prior era detoxification specialists, a problem which Congress sought to remedy by enacting 42 U.S.C. § 290bb-2a's explicit addiction-treatment provisions, seeking to change the fact that past criminal prosecutions turned on the opinions of federal prosecutors. In United States v. Moore, 423 U.S. 122 (U.S. 1975), the Supreme Court noted that in enacting the Comprehensive Drug Abuse Prevention and Control Act of 1970, 84 Stat. 1236, Title II of which is the CSA, Congress acknowledged that because of the potential for abuse it decided that some limits on free experimentation with drugs were necessary. Id. 143-144; however, the court was also aware of the concern expressed by the Prettyman Commission that "[A] controversy has existed for fifty years over the extent to which narcotic drugs may be administered to an addict solely because he is an addict. . . .The practicing physician has . . . been confused as to when he may prescribe narcotic drugs for an addict. Out of a fear of prosecution many physicians refuse to use narcotics in the treatment of addicts except occasionally in a withdrawal regimen lasting no longer than a few weeks. In most instances they shun addicts as patients." Id. at note 21, citing Report of the President's Advisory Commission on Narcotic and Drug Abuse, 56-57 (1963), quoted in H. R. Rep. No. 91-1444, pp. 14-15.
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The Moore court noted that "Congress' solution to this problem is found in § 4 of Title I of the 1970 Act, 42 U.S.C. § 257a. which requires the Secretary of Health, Education, and Welfare, after consultation with the Attorney General and national addict treatment organizations, to "'determine the appropriate methods of professional practice in the medical treatment of....narcotic addiction . . . '." It was designed "'to clarify for the medical profession . . . the extent to which they may safely go in treating narcotic addicts as patients'." Moore, supra, citing H. R. Rep. No. 91-1444, p. 14 (emphasis supplied). Congress pointed out that "criminal prosecutions" in the past had turned on the opinions of federal prosecutors. Under the new Act, "'[t]hose physicians who comply with the recommendations made by the Secretary will no longer jeopardize their professional careers...'." Moore, supra, citing H. R. Rep. No. 91-1444, p. 15. Accord Gonzales v. Oregon, 126 S. Ct. 904 at 920, citing Moore, 423 U.S. 122 at 143-144 (1975) (noting that in enacting the addiction-treatment provisions, Congress sought to change the fact "that 'criminal prosecutions' in the past had turned on the opinions of federal prosecutors"). Today, a parallel, yet burgeoning crisis exists in the form of undertreated pain. Doctors are reluctant to prescribe medically acceptable quantities of opioid pain relievers for fear of being stripped of their practices, subjected to

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criminal prosecutions, and possibly sentenced to decades or life in prison. Physicians routinely turn away patients requiring ongoing pain management in order to avoid being targeted as drug dealers. Ronald T. Libby, Treating Doctors as Drug Dealers: The DEA's War on Prescription Painkillers, The American Pharmacists'

(http://www.cato.org/pubs/pas/pa545.pdf)

Association told Congress that "Every effort to prevent diversion and abuse has the potential to diminish appropriate prescribing and dispensing exponentially . . . Unbridled law enforcement "negatively impact[s] care to thousands of patients living in pain who could be helped by appropriate use of controlled substances." See Statement of the American Pharmacists' Association, "OxyContin and Beyond: Examining the Role of FDA and DEA in Regulating Prescription Painkillers", submitted to the House

Government Reform Committee, Subcommittee on Regulatory Affairs (Boston, Mass. - September 13, 2005) (http://www.aphanet.org/AM/Template.cfm?Section=Search§ion=A ccess_to_Drugs&template=/CM/ContentDisplay.cfm&ContentFileID=788 ). Furthermore, when prosecutors decide who to prosecute, they necessarily apply some sort of standard to the medical practices of the practitioner. Here, and in similar cases, the government has used its vast resources to hire particular expert witnesses tending to support the

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government's preferred version of the appropriate medical standard despite the lack of a legitimate, articulated consensus among the relevant statutory actors.9 In Gonzales v. Oregon, 126 S. Ct. 904, (2006), this Court observed that [t]he structure of the CSA . . . conveys unwillingness to cede medical judgments to an Executive official who lacks medical expertise." Id. at 920921. Thus, although Congress was concerned about the propriety of Federal officials determining the appropriate methods of medical practice, this is precisely what occurs through criminal prosecution of physicians whose practice has not conformed to the opinions of Federal prosecutors and their ultimate overseers.

9

In Gonzales, the Supreme Court noted that congressional commentary on the CSA's regulation noted that in 1978, in preparation for ratification of the Convention on Psychotropic Substances, Feb. 21, 1971, [1979-1980] 32 U.S. T. 543, T. I. A. S. No. 9725, Congress decided it would implement the United States' compliance through "the framework of the procedures and criteria for classification of substances provided in the" CSA. 21 U.S.C. § 801a (3). It did so to ensure that "nothing in the Convention will interfere with ethical medical practice in this country as determined by [the Secretary] on the basis of a consensus of the views of the American medical and scientific community." Ibid. "The structure of the CSA, then, conveys unwillingness to cede medical judgments to an Executive official who lacks medical expertise" Gonzales supra at 920-921.
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D. A fair reading of Moore, coupled with this Court's recent decision in Gonzales v. Oregon, 126 S. Ct. 904 (2006), suggests that the Controlled Substances Act requires an articulated "consensus" between the relevant medical community ­ here, the Secretary of Health and Welfare, the Drug Enforcement Administration ("DEA"), and the physicians responsible for treating pain, when defining the contours of legitimate medical practice regarding the use of opioids in pain management; however, no such standard has been legitimately and expressly articulated. The Feingold court wrongly approved a jury instruction which attempted to define the "course of professional practice" by reference to a non-existent, national medical standard, despite the fact that in connection to the CSA, there exists only one area in which Congress set general, uniform standards of medical practice. That area is the uniform national standard for the medical treatment of narcotic addiction under 42 U.S.C. § 290bb-2a. Gonzales at 924. Gonzales reaffirms that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute. Id. A fair reading of Moore coupled with this Court's recent decision in Gonzales v. Oregon, 126 S. Ct. 904, 916 (2006), suggests that the Controlled Substances Act requires an articulated "consensus" between the relevant medical community ­ here, the Secretary of Health and Welfare, the Drug Enforcement Administration ("DEA"), and the physicians responsible for treating pain. Until that occurs, the oft-cited "generally accepted medical
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standard in the country" for pain management actually refers to a nonexistent, fictitious standard characterized by often bitter disagreement between and the DEA and the relevant medical community which the federal government increasingly seeks to regulate. To illustrate, in August, 2004, in response to complaints from pain patients and their doctors, the DEA and leading pain specialists co-authored a set of guidelines detailing how to prescribe opioid pain relievers such as morphine or Oxycontin without running afoul of the law. The document, entitled "Prescription Pain Medications: Frequently Asked Questions for Health Care Professionals and Law Enforcement Personnel" ("FAQ") clarified that opioids such as Oxycontin are legitimate pain medications, that they are sometimes prescribed in large quantities, that they are sometimes prescribed to large numbers of patients by one doctor or clinic, and that none of these things necessarily imply shady doctoring.10 In early October, 2004, however, the DEA pain FAQ disappeared from its website without warning, only to be replaced by an "interim policy statement" on the Federal Register, detailing its objections to the earlier FAQ and retracting certain, earlier statements. The sudden retraction prompted outcry throughout the medical community and prompted virulent criticism from the This document was at one time available at http://www.deadiversion.usdoj.gov/faq/pain_meds_faqs.pdf
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physician-representatives who had co-authored the Pain FAQ. In March, 2005, in response to the DEA's hegemonistic encroachment, the Association of American Physicians and Surgeons ("AAPS") clarified that the "usual course of medical practice" encompasses no codified requirements for physical examinations or other procedures, and sets no limits on dosage, number of patients seen, length of visits, or number of pills prescribed.11 Furthermore, leading authority suggests that drug-seeking "behavior characterized as `red flags' [a term used liberally during the prosecutor's
11

An excerpt from the article: Damned If They Do, Damned If They Don't: The Need for a Comprehensive Public Policy to Address the Inadequate Management of Pain, 13 Ann. Health L. 81 (2004) is instructive: Titration involves the gradual increase of the amount of an opioid until a balance is reached between pain relief and the adverse side effects of the medication, i.e., sedation or respiratory depression. Russell K. Portenoy, Opioid Therapy for Chronic Nonmalignant Pain: Clinicians' Perspective, 24 J.L. Med. & Ethics 296, 298 (1996). . . . Although appropriate titration generally does not result in terminal sedation, it is difficult to determine the correct amount of drugs to administer. Clinicians suggest that there is no maximal or optimal quantity of an opioid analgesic drug for either chronic or cancer pain. . . . The appropriate dose is one that relieves the patient's pain without causing adverse side effects. . . . Because opioids have no ceiling effect, the dose of pain medication can be increased until pain relief is achieved or until the side effects of the medication become intolerable. . . . Article: Damned If They Do, Damned If They Don't: The Need for a Comprehensive Public Policy to Address the Inadequate Management of Pain, 13 Ann. Health L. 81, 116-117 (2004).

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direct examinations and closing argument in Feingold] 12, could be signs of undertreated pain" which "may drive human beings to desperate behaviors. . . . While society imposes punishments for drug diversion or abuse, adequate titration of medications to relieve the pain is the proper and effective treatment for `red-flag' behavior (e.g. `doctor shopping') due to undertreated pain." (E.R. 236) (emphasis supplied). To date, however, a consensus among the DEA and the relevant medical community regarding the appropriate use of opioid medication to treat pain has yet to be reached, and as was the case here, the "generally accepted standard in the country," is dictated on an adhoc, case-by-case basis by handpicked expert witnesses who further the government's increasingly prohibitive agenda. In this context, the Ninth Circuit's ruling upholding a jury instruction which defined a statutory element by reference to defendant's "good faith" compliance with a fictitious, national standard of care in pain management where none has been legitimately and expressly articulated, perpetuates a much larger, more insidious problem, and foments an atmosphere in which American physicians are increasingly reluctant to exercise their best judgment in treating pain, and American patients are left to suffer.

(R.T. 5/5/04; pp. 1292-94; R.T. 5/6/04, pp. 1408; 1417; R.T. 5/11/04, pp.1499; 1511).
12

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2. Was it harmless error to define the CSA's "course of professional practice" element by equating it with Dr. Feingold's "good faith" compliance with a fictitious, national standard of care in pain management where none has been legitimately and expressly articulated, since "good faith" was the heart of his defense, and considerable debate exists regarding the legitimate and appropriate use of opioids in pain management? Ultimately, "good faith" was at the heart of Dr. Feingold's defense. Feingold did not argue that he did not prescribe the narcotics that were the basis for the charges against him. Instead, he argued that the manner in which he used narcotics to treat chronic and debilitating pain was a medically effective approach to a difficult medical issue. Even if Dr. Feingold "admitted" that he practiced "outside the course of professional practice" when he (like the expert witnesses) parroted the prosecutor's talismanic repetition of the phrases "outside the course of professional practice" and "not for a legitimate medical purpose," the statements are not necessarily dispositive. They were more likely understood by the jury as referring to how his practice differed from the "experts" who had testified mainly as to his deficient medical charting, sometimes "excessive" dosing, and occasional dispensation of a prescription to a non-present family member, which, one expert testified, would not be atypical in a naturopathic practice.

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Each instance that the prosecutor lead her expert witnesses to conclude that Dr. Feingold's conduct was "outside of the course of professional practice" or "not for a legitimate purpose" could have been (and in other cases, has been) refutable by expert witnesses who would testify to the contrary. Indeed, the government's own witness agreed with leading authority that there was no "upper limit" on opioids. (R.T. 5/5/04, p. 1269). Compare: United States v. Hurwitz, 459 F.3d 463, 481 (4th Cir. 2006) ("good faith" instruction was warranted where defense furnished expert testimony that defendant's high-dose opioid therapy was a medically appropriate way to treat intractable pain, even where dosages appeared extraordinarily high (i.e., to a patient who was prescribed over 500,000 pills during the course treatment)). Thus, Feingold's statement cannot be viewed as a clear and unambiguous admission that he knowingly acted outside the bounds of legitimately defined, accepted medical practice in the field of pain management. C.f. United States v. Hurwitz, 459 F.3d 463, 481 (4th Cir. 2006), citing United States v. Blood, 806 F.2d 1218, 1221 (4th Cir. 1986). Compounding the prejudice, the district court denied counsel's request to instruct the jury that "in making a medical judgment concerning the right treatment for an individual patient, physicians have the discretion to choose among a wide range of available options." (C.R. 144; E.R. 50) That

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reasonable physicians may differ on what constitutes legitimate and appropriate pain management is apparent from the expert witnesses in Dr. Feingold's case, who could not agree among themselves, and often contradicted the leading authority on which they relied. (R.T. 4/5/04, pp. 1294-96) Yet, despite asserting that Dr. Feingold had departed from the "course of professional practice," when prescribing controlled substances for his patients' subjective suffering, the expert witnesses admitted that the narcotic medication in question was prescribed for pain, and that prescribing narcotic medications was an appropriate and accepted method of treating pain.13 They also acknowledged that pain could be subjective and not

always be traced to objective causes, and that diagnostic testing was not always useful.14

CONCLUSION

For the foregoing reasons, Jeffrey Feingold respectfully urges this Court to grant the petition for writ of certiorari.

(R.T. 4/28/04, pp. 338-339; 340; 342; R.T. 5/5/04, pp. 1270-71; 1282; 1284; R.T. 5/6/04, pp. 1382; 1433). 14 R.T. 4/28/04, pp. 338-339
13

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Respectfully submitted, _______________________
MICHELE R. MORETTI Counsel of Record 198 Tremont Street, # 260 Boston, Massachusetts 02116 (617) 262-5558 ____________________________ ELI D. STUTSMAN 621 SW Morrison Thirteenth Floor Portland, OR 97205 (503) 274-4048

October, 2006

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