# Opposition Brief — Gonzales v. Oregon > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0051%3A07 ## Record - **Collection:** Supreme Court brief - **Document type:** Opposition Brief - **Published:** January 1, 2006 - **Citation:** 546 U.S. 243 ## Text (5) [Supreme Come US $$] _ FILED JAN 7 - 2005 No. 04-623 OFFICE OF THE CLERK IN THE SUPREME COURT OF THE UNITED STATES John Ashcroft, Attorney General, ef al., Petitioners, State of Oregon ef al., Respondenis. On Petition for Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit RESPONDENTS’ BRIEF IN OPPOSITION filed by Peter A. Rasmussen, M.D. and David M. Hochhalter, RPh ELI D. STUTSMAN Counsel of Record 621 SW Morrison Thirteenth Floor Portland, OR 97205 January 10, 2005 (503) 274-4048 QUESTION PRESENTED Exercising its traditional police powers, Oregon enacted laws and regulations that allow physicians to prescribe and pharmacists to dispense Schedule I] controlled substances to competent, terminally-ill adults who may use them under strictly regulated conditions to choose the time, place, and manner of their impending deaths. In enacting and amending the Controlled Substances Act (CSA), did Congress clearly authorize the Attorney Genera] to determine that physicians and pharmacists acting in accordance with those Oregon laws have violated the CSA? Page No. Questa FUG ooo ccccccceceeseeeseeeueuen i TED GE GUMMIED cccccccccccececessseeeuaeeen ii Tae CE AD nw cccccceccenseneseuneeas iii TURED OD QUE ccccccccccceeseueseeaeeuen v ltt ti‘ 1 See SE GR GMD occ cccccccecseeeseeuneuen l a ) TTT. l The Attorney General’s enforcement directive ........ 3 The Oregon Death With Dignity Act .............. 6 Reasons to Deny the Writ... 1.6... ce eee eee eee 7 1. The Attorney General exceeds the role of his office and the scope of the CSA .............. 7 2. The Attorney General misconstrues this Court’s SURUNENES ww ccc cccccceanceceseceeeeees 7 3. The Attorney General fails to allow the integration of state and federal law ............ 9 4. The Attorney General misuses the regulatory phrase “legitimate medical purpose” .......... 13 5. The regulation of medicine belongs to the States... 15 6. The practice of medicine in Oregon........... 17 7. The CSA is a law enforcement statute, not a maties OU GB . oo cc ncesesesecesueeel 19 8. The Attorney General fails to allege a single incident of illicit drug use, drug trafficking, or Gray GUO wc cc ccccceseesseeeenenan 27 Comtbetiem oc ccccccceseeeveses hee ane 28 TABLE OF AUTHORITIES cases Page No. Alden v. Maine, Ds cecéeceeoecocooecoece 16 Barsky v. Board of Regents, 347 U.S. 442 (1953) ...... vTTTTTTr 15, 16, 18 Gregory v. Ashcroft, 501 U.S. 452, 458 (1991)... ee ee eee 16 Linder v. United States, 26GB US. S (CIGAR) .ncccccccvcccecs 15, 16, 18 Printz v. United States, DTD «cecesceceouceceoses 16 Raygor v. Regents of University of Minnesota, DTD ceecceceeoecoceooses 28 Rush Prudential HMO, Inc. v. Moran, DPT occcccesccecoscees 16, 18 United States v. Green, DTD cicéegcecoesevesoces 20 United States v. Moore, je «cose eecocceees 11, 12, 14 (continued) Page No. United States v. Oakland Cannabis Buyer's Cooperative, SPEED cheered oooesaresueneé 8 Washington v. Glucksberg, ee a CED Ob cesenesesseooees 6, 28 statutes Bp WEED OS esocdoudsébdeosccteccoeescé 19 SS SGD co ccoeveesvedstsensedcéece ll SSUES Sevcccedccedcadadésebéces 10 Se Wee GED co cccccceceedestseconscoece 11 fT OPPTTTTIT TTT ee eee 14 Se Ge GED cccncevedccocedscbeboede 11 BD WE ED 6 cvcceccceseeeséedscocceces 14 Be De GED oc ccncccccseesceecsesecces 10 Be We OEP Sebo ercccccecceseeeeéeéececs 9,17 Or. Rev. Stat. 127.800 ef seq. 2... 6. ee eee ee 1, 19 TABLE OF AUTHORITIES (continued) Page No. statutes Or. Rev. Stat. 127.815 ........c0ccceeeeeees 18, 19 Or. Rev. Stat. 127.815(1MIMA) .... 2.0 e cece ee eees 17 Or. Rev. Stat. 127.855(1M1)(7) «0.2... ceceeeceeees 5 I i i a 5 Or. Rev. Stat. 163.125(1)) ... 2.22. eee cee eee cues 6 | rules , . cncscisscovcsnsees 4, 14 APPENDIX The Oregon Death With Dignity Act ..............-. 1 The Oregon Assisted Suicide Statute ............... 21 Affidavit of Peter A. Rasmussen, M.D. ............. 22 Affidavit of David M. Hochhalter, RPh ............. 28 Affidavit of David M. Hochhalter, RPh ............. 31 v One day after the State of Oregon filed suit, respondents Peter A. Rasmussen, M.D., and David M. Hochhalter, Rph, both of whom are registered with the Drug Enforcement Administration (DEA), filed a complaint in intervention suing United States Attorney General John Ashcroft, ef a/., to prevent criminal and civil enforcement proceedings against them for having prescribed and dispensed controlled substances under the Oregon Death With Dignity Act, Or. Rev. Stat. 127.800 et seq. STATEMENT OF THE CASE A. Proceedings below On November 8, 2001, the district court granted respondents’ request for a temporary restraining order, enjoining the Attorney General from enforcing the CSA against Oregon physicians and pharmacists practicing in accord with the Oregon Death With Dignity Act. CR 20. On November 20, 2001, at the conclusion of the preliminary injunction hearing, the parties agreed to extend the TRO in lieu of a court ruling on plaintiffs’ motion for a preliminary injunction. CR 60. On April 17, 2002, the district court granted summary judgment in favor of all plaintiffs, enjoining the Attorney General from enforcing, applying, or otherwise giving any legal effect to his enforcement directive. See, Pet. Cert., 97a. The district court reasoned as follows: I conclude that Congress did not intend language of the CSA, and contravenes the the CSA to override a state’s decisions express intent of Congress. concerning what constitutes legitimate medical practice, at least in the absence of The Ninth Circuit concluded its analysis as follows: an express federal law prohibiting that practice. Similarly, I conclude that In sum, the CSA was enacted to Congress never intended, through the CSA combat drug abuse. To the extent that it or through any other current federal law, authorizes the federal government to make to grant blanket authority to the Attorney decisions regarding the practice of General or the DEA to define, as a matter medicine, those decisions are delegated to of federal policy, what constitutes the the Secretary of Health and Human legitimate practice of medicine. Services, not to the Attorney General. The Attorney General's unilateral attempt Pet. Cert., 97a. | to regulate general medical practices historically entrusted to state lawmakers On May 26, 2004, the Ninth Circuit affirmed the district interferes with the democratic debate about court’s analysis, finding that the enforcement directive is unlawful physician assisted suicide and far exceeds and unenforceable because it: the scope of his authority under federal law. We therefore hold that the Ashcroft [1] violates the plain language of the CSA, Directive is invalid and may not be [2] contravenes Congress’ express enforced. legislative intent, and [3] oversteps the bounds of the Attorney General's statutory Id. at 24a. authority. The Attorney General now petitions this Court for review. Pet. Cert., 2a; see, also, id. at 9a: B. The Attorney General's enforcement directive We hold that the Attorney General lacked Congress’ requisite authorization. The In a two page enforcement directive (Pet. Cert. 100a- Ashcroft Directive violates the “clear 1005a) released November 6, 2001, the Attorney General found as Statement” rule, contradicts the plain follows: 1. Determination on Use of Federally Controlled Substances to Assist Suicide. For the reasons set forth in the OLC Opinion, | hereby determine that assisting Suicide is not a “legitimate medical purpose” within the meaning of 21 CFR § 1306.04 (2001), and that prescribing, dispensing, or administering federally controlled substances to assist suicide violates the CSA. Such conduct by a physician registered to dispense controlled substances may “render his registration * * * inconsistent with the public interest" and therefore subject to possible suspension or revocation under 21 U.S.C. 824(aX4). This conclusion applies regardless of whether state law authorizes or permits such conduct by practitioners or others and regardless of the condition of the person whose suicide is assisted. See, Pet. Cert., 102a-103a (emphasis added). The enforcement directive went into effect three days later upon being published in the Federal Register on November 9, 2001. Jd. at 100a. The Attorney General further dictated the enforcement strategy. The Oregon Death With Dignity Act' imposes statutory requirements upon the Oregon Department of Human Services.’ The Attorney General concluded that those publicly held records would facilitate enforcement proceedings: 4. Enforcement in Oregon. ** * . Those records should contain the information necessary to determine whether those holding DEA registrations who assist suicides in accordance with Oregon law are prescribing federally controlled substances for that purpose in violation of the CSA***. See, Pet. Cert., 103a-104a (emphasis added). See, Pet. Cert., 1002a (emphasis added). The Attorney General directed that his findings be immediately enforced: I hereby direct the DEA, effective upon publication of this memorandum in the Federal Register, to enforce and apply this determination, notwithstanding anything to the contrary in the June 5, 1998, Attorney General [Janet Reno]’s letter. ' In his petition, the Attorney General appends only portions of the Oregon statute. The full text of the statute is appended here at App. 1-20. ? See, App. 9-10, Or. Rev. Stat. 127.855(1)-(7) (medical record documentation requirements). > See, App. 11, Or. Rev. Stat. 127.865(3) (reporting requirements). The Attorney General determined that the DEA had the authority to obtain those records, id. at 104a, and concluded his enforcement directive with a distribution instruction: 5. Distribution. Please ensure that this Memorandum and the OLC opinion on which it is based are promptly distributed to appropriate DEA personnel, especially those with authority over the CSA in Oregon. Id. (emphasis added). Cc. The Oregon Death With Dignity Act In Washington v. Glucksberg, 521 U.S. 702 (1997), this Court declined to recognize a “generalized” constitutional right to a physician-assisted death.‘ Central to that result was the court's observation that, “the States are currently engaged in serious, thoughtful examinations of physician-assisted suicide and other similar issues." Jd. at 719. “Our holding permits this debate to continue, as it should in a democratic society." Jd. at 735. The issue is one that "is entrusted to the "laboratory’ of the States." Jd. at 737 (O'Connor, J., concurring, joined by Justices Ginsberg and Breyer); see, also, id. at 738 (Stevens, J., concurring) and at 788 (Souter, J., concurring). * Respondents use the term “assisted death” in recognition of the fact that “assisted suicide” is still a crime in Oregon. See, App. 21, Or. Rev. Stat. 163.125(1)(b). It is preferable not to use the language of a crime when referring to non-criminal activity under Oregon law. Oregon has been at the forefront of this debate. The Oregon Death With Dignity Act was adopted by the people of Oregon at the November 8, 1994 election. Three years later, on November 7, 1997, the people of Oregon decisively rejected, by a margin of 60 percent to 40 percent, a proposal to repeal the Oregon Death With Dignity Act. Two years after that, on June 30, 1999, Governor John Kitzhaber, M.D., signed into law Senate Bill 491, amending the Oregon Death With Dignity Act. See, e.g., CR 103, 106. In sum, the Oregon Death With Dignity Act is a duly enacted state law, twice approve’ by Oregon voters, subsequently amended by the state iegislature and signed into law by Oregon's governor, himself a medical doctor. It is a rare law that has been so thoroughly tested and approved by a state's REASONS TO DENY THE WRIT 1. The Attorney General exceeds the role of his office and the scope of the CSA As both the district court and the Ninth Circuit held, quoted supra, the Attorney General, in issuing his enforcement directive, exceeds the role of his office and the bounds of the CSA as he enters this policy dispute with the State of Oregon. The district and circuit courts have squarely addressed this problem and res, ondents urge this Court to end this litigation now. 2. The Attorney General misconstrues this Court’s precedent The Attorney General's November 6, 2001 enforcement directive is premised upon a misapplication of this Court's May 14, 2001 decision in United States v. Oakland Cannabis Buyer's Cooperative, as follows: As you are aware, the Supreme Court reaffirmed last term that the application of federal law regulating controlled substances is uniform throughout the United States and may not be nullified by the legislative decisions of individual States. See United States v. Oakland Cannabis Buyers’ Coop., 532 U.S. 483 (2001). Pet. Cert., 10la. Unlike the “medical marijuana" litigation emerging from California, however, the Oregon law (1) does not authorize or require the use of Schedule I banned drugs, (2) no one is asserting a “medical necessity" defense, and (3) Oregon has not sought to legalize what the CSA has banned. In sharp contrast to the California cases, the Oregon law requires only drugs that are lawfully prescribed in all 50 states,’ and Oregon does not challenge the CSA’s classification scheme. The Attorney General does not claim otherwise, and his steadfast reliance upon Oakland Cannabis Buyers’ Coop.® is therefore misplaced. * The Attorney General concedes this point too. See, Pet. Cert., 17, fn 4; see, also, Affidavit of Peter A. Rasmussen, M.D., App. 22 4 4 and App. 26 ¢ 17; Affidavit of David M. Hochhalter, RPh, App. 29 ¢ 5 and App. 31 { 4. * See, e.g., Pet. Cert., 6, 10, 15, 16, 17, 20, 22, 26. 8 3. The Attorney General fails to allow the integration of state and federal law There is no positive conflict between state and federal law such that the two “cannot consistently stand together." 21 U.S.C. 903 (Application of State law).’? The Attorney General may enforce the “uniform national policy" intended by Congress to prevent illicit drug use, drug trafficking, and drug diversion and, contemporaneously, Oregon practitioners, registered with the Board of Medical Examiners and the DEA, may possess, prescribe, and/or dispense controlled substances within “the course of their professional practice." These two policies are not mutually exclusive. The CSA describes unlawful conduct as follows: 7 Section 903 (Application of State law) provides: No provision of this title shall be construed as indicating an intent on the part of the Congress fo occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this title and that State law so that the two cannot consistently stand together. 21 U.S.C. 903 (emphasis added). 9 (a) Unlawful acts Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally— (1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; * * * . 21 U.S.C. 841(a)(1) (emphasis added). Thus, it is a crime to (1) knowingly or intentionally (2) distribute or dispense a controlled substance, unless “authorized” by the Act. Jd. Authorization is obtained by “registering” with the Attorney General: (2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. ***. 21 U.S.C. 822(a(2) (emphasis added). Persons registered with the Attorney General are authorized to possess, manufacture, distribute, or dispense controlled substances to the extent authorized by their registration: (b) Authorized activities. Persons registered by the Attorney General under this title to manufacture, distribute, or dispense controlled substances * * * are authorized to possess, manufacture, distribute, or dispense such substances or chemicals * * * fo the extent 10 authorized by their registration and in conformity with the other provisions of this title. 21 U.S.C. 822(b) (emphasis added). A physician registered with the Attorney General is a “practitioner” authorized to dispense controlled substances, see, 21 U.S.C. § 829(a)&(b), in “the course of professional practice," as follows: (21) The term “practitioner” means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. 21 U.S.C. 802(21), formerly 802(20), (emphasis added). This Court, in United States v. Moore, 423 U.S. 122 (1975), clarified that the course of professional practice standard is the applicable standard under the CSA: * * * the CSA uses the concept of “registration.” Section $22(b) defines the scope of authorization under the Act in circular terms: "Persons registered under 1] this subchapter are authorized to dispense controlled substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter." But the scheme of the Statute, viewed against the background of the legislative history, reveals an intent to limit a registered physician's dispensing authority to the course of his “prefessional practice.” Moore, 423 U.S. 122, 140 (emphasis added, internal ellipses, brackets and footnotes omitted). Under this statutory scheme, the Attorney General may enforce the uniform national policy intended by Congress to prevent illicit drug use, drug trafficking, and drug diversion, and Oregon practitioners may possess, prescribe, and dispense controlled substances in the “course of their professional practice.” The Attorney General simply erred when he applied his own subjective standard: Nothing in either the CSA or its implementing legislation makes the definition of legitimate medical purpose dependent upon state law. Pet. Cert., 19 (emphasis added). 12 + The Attorney General misuses the regulatory phrase “legitimate medical purpose” The regulatory phrase “legitimate medical purpose," upon which the Attorney General so heavily relies,’ is not the value laden term the Attorney General portrays it to be. This phrase is not found in the CSA but is instead rooted in an agency rule and is therefore limited by the statutory phrase from which it is derived, “the course of professional practice," and it means the same thing. The Attorney General attempts to change the plain meaning of this statutory language by infusing into it new meaning derived from an agency rule: * See, e.g., Pet. Cert., 9 ("the dissent observed that the Attorney General's conclusion that physician-assisted suicide is not a legitimate medical purpose is well supported by an ‘overwhelming historical, legal, and medical consensus’"), 12 ("The Attorney General clearly acted reasonably in concluding that dispensing drugs to assist a person to commit suicide is not for a ‘legitimate medical purpose’ within the meaning of the CSA and his implementing regulation"), 12 ("numerous health care experts have agreed that physician-assisted suicide is not a legitimate medical treatment"), 13-14 ("The federal regulatory scheme is built upon the dual principles that the dispensing of controlled substances should be allowed for such ‘legitimate medical purposes” but that distribution for illegitimate purposes should be prohibited"), 14 (“legitimate "medical use’ in ‘treatment’ therefore is a prerequisite to such dispensing”), 24 (“the determination whether dispensing drugs to facilitate suicide constitutes a ‘legitimate medical purpose’ turns on an interpretation of the CSA and a regulation of the Attorney General, and does not require an assessment of medical or scientific evidence"). 13 As this Court indicated in Moore, this legitimate medical purpose requirement is implicit in various provisions of the CSA, such as 21 U.S.C. 829, but is made explicit by virtue of the implementing regulation, 21 C.F.R. 1306.04(a). See, Moore 423 U.S. at 137-139 & n.13. Pet. Cert. 4 (emphasis added). Correctly stated, this Court said: The only limitation on the distribution or dispensing of Schedule V drugs is that it be "for a medical purpose.” s 829%(c). The medical purpose requirement explicit in subsection (c) could be implicit in subsections (a) and (b). Regulation s 306.04 makes it explicit. Moore, 423 U.S. at 137 n.13 (emphasis added). The Attorney General has thus transformed “medical purpose,” a phrase consistent with the statutory “course of professional practice” standard, into the value laden term that he prefers, “legitimate medical purpose.” This Court in Moore never went so far and a simple word search indicates that the phrase “legitimate medical * was used only one time, in footnote 12, when the Court quoted the text of 21 CFR § 1306.04(a). 423 U.S. at 136-137 n.12, Elsewhere in his petition, the Attorney General concedes, as he must, that departure from the “course of professional practice” is the true standard from Moore: This Court held that the CSA was intended to limit a physician's distribution 14 of controlled substances to actions “as a physician” and in the course of — practice,” 423 U.S. at 140, Pet. Cert. 18. Nonetheless, the Attorney General re i the language from the rule to the exclusion of the language from the statute as a rhetorical device to shift the debate to one about the ya ple, the Attorney General writes canvassed" the views of the medical community, state and federal law, and judicial opinions, and: ' despite Oregon voters’ approval physicians assisted suicide is not . “legitimate medical purpose.” Pet. Cert., 6 (emphasis added) Correctly . ° , stated, however, question is whether the controlled substances at issue in Oregan ane being prescribed or dispensed “in the course of professional practice," not whether a state’s determination to allow a hastened death for a terminally ill, competent, adult tient is "legitimate" in the opinion of the Attorney General. 5. The regulation of medicine belongs to the States The states, not the federal government, regulate medici See, e.g., Linder v. United States, (“Obviously, direct control of sey ath Ranch beyond the power of the federal government."); Barsky v. Board a U.S. 442, 449 (1953"It is elemental that a state ws bro power to establish and enforce standards of conduct within its borders relative to the health of everyone there. It is a 15 a vital part of a state’s police power."); Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 387 (2002) (determination of medical necessity and standards of reasonable care are “quintessentially State-law" determinations). Although the Attorney General criticizes Linder, supra, as an outdated Lochner-era opinion (Pet. Cert., 22, 27), similar propositions are found in Barsky and Rush Prudential HMO, supra. The framers of the Constitution “split the atom of sovereignty” two ways: horizontally (among the three branches of government) and vertically (between the federal and state governments). See, Alden v. Maine, 527 U.S. 706, 714-15, 751 (1999); Printz v. United States, 521 U.S. 898, 921-22 (1997). As this Court recently explained: This separation of the two spheres is one of the Constitution’s structural protections of liberty. “Just as the separation and independence of the coordinate branches of the Federal Government serve to prevent the accumulation of excessive power in any one branch, a healthy balance of power between the States and the Federal Government will reduce the risk of tyranny and abuse from either front.” Printz, 521 U.S. at 921 (emphasis added); quoting, Gregory v. Ashcroft, 501 U.S. 452, 458 (1991). The Congress, when legislating and later amending the CSA, was certainly aware of the traditional and constitutional 16 allocation of power that resides at the core of our federal form of government, and it expressly provided that, “absent a positive * See, e.g., Pet. Cert., 100a (“regardless of whether state law authorizes or permits such conduct"); 102a ("This conclusion applies regardless of whether state law authorizes or permits such conduct”); 104a (“assist suicides in accordance with Oregon law"); 104a ("in compliance with Oregon Law"); 107a (“even in a manner permitted by state law"); 116a (“legalized physician-assisted suicide"); 131a ("assisting in suicide may be permitted in some cases for Oregon physicians under local law"); 13la (“in accordance with state law"); 133a (“permissible under state law"); [34a (“physicians may assist suicides compatibly with local law”): 148a (“state that had legalized physician-assisted suicide"). ” See, App. 7 (Or. Rev. Stat. 127.815(1)1A)). 17 As part of his record in support of injunctive relief, Dr. Rasmussen demonstrated that he and others like him practicing under Oregon’s unique law are acting in their professional role in conformity with state medical practice standards (App. 22-27), an area that falls squarely within the states’ traditional police power. Linder, supra, 268 U.S. at 18; Barsky, supra 347 U.S. at 449; Rush Prudential HMO, supra, 536 U.S at 387. Or. Rev. Stat. 127.815 establishes the standard of care for an attending physician practicing under the Oregon Death With Dignity Act. App. 4-5."' Dr. Rasmussen is acting in the course of his professional practice when he is acting in accord with Oregon’s standard of care. He makes an initial determination of whether his patient has a terminal disease, is capable, and has made the request voluntarily. He ensures that the patient is making an informed decision by informing the patient of the patient’s medical diagnosis, prognosis, the potential risk and probable result associated with taking the medication to be prescribed, and the feasible alternatives, including, but not limited to, comfort care, hospice care and pain control. Dr. Rasmussen further refers his patients to a consulting physician for medical confirmation of the diagnosis and for a second opinion that the patient is capable and acting voluntarily. When appropriate, Dr. Rasmussen also refers his patients for counseling. He recommends that the patient notify next of kin and counsels the patient about the importance of having another person present when the patient takes " Respondents do not seek to convince this Court that the State of Oregon has made a correct policy choice, only that the State of Oregon has made a policy choice, implementing a matter of medical policy traditionally reserved to the states. 18 the medication prescribed under Oregon law . 25, 44 10, 11. ye Aap 2 Dr. Rasmussen further satisfies all of the statutory medical documentation requirements and provides a copy of his dispensing record to the Department of Human Services. In sum, Dr. Rasmussen ensures that all appropriate steps are carried out in accordance with Or. Rev. Stat. 127.800 to 127.897, CR 105; App. 25, 1 13, exactly what is required of him under state statutory and regulatory law, and the community standard of care. See, ¢.g., Or. Rev. Stat, 127.815; App. 1-12. 7. The CSA is a law enforcement statute, not a medical policy act Section 101 of the CSA (21 U.S.C. 801) expresses Congressional concern over the “illegal importation, manufacture, distribution, and possession and improper use of controlled Substances," and explains why intrastate trafficking in controlled 19 trafficking in illegal drugs, such as heroin and marijuana, and also to prevent diversion of legitimately produced controlled substances into illicit channels. See, ¢.g., United States v. Green, 511 F.2d 1062, 1071 (1975) (pharmacist dispensed over a million Ritalin tablets in less than a year); HR Rep No. 91-1444, 91st Cong, 2d Sess, U.S.C.C.A.N. 4566, 4581 (1970) (in 1965, almost half of the 9 billion amphetamines and barbiturates produced legitimately in this country were diverted into illicit channels), The goal is to establish “a ‘closed’ system of drug distribution for legitimate handlers of such drugs” to “reduce the widespread diversion of these drugs out of legitimate channels into the illicit market." 91 U.S.C.C.A.N. at 4571-72; see, also, S Rep No 98-225, 98th Cong, Ist Sess, U.S.C.C.A.N. 3182, 3442-49 (1983). The legislative record further demonstrates that the CSA is a law enforcement statute and that Congress never intended that it would be used to regulate medicine or to alter the state/federal framework. The following excerpts from the 1970 Senate floor debate reveal that the CSA was at first focused solely upon preventing drug trafficking and diversion; it served a law enforcement purpose and no other purpose: This measure-in concept, in spirit, and in detail—is a law-enforcement measure. It only approaches one side of the problem of drug abuse. Quoting, Senator Hughes, Cong. Rec., Senate, 973 (January 23, 1970) (emphasis added). That is my position on this problem. The legislation before us is a law enforcement bill. * * * we concluded it would be better to keep this particular piece of legislation a law enforcement Quoting, Senator Dodd, Cong. Rec., Senate 1970) ( hasi , 976 (January 23, But it cannot be overemphasized that the bill before the Senate today is entirely concerned with enforcement. It contains no medical or rehabilitative provisions. It is designed to crack down hard diverters of pep pills and goof balls. * * 1970) ( » 978 Qanuary 23, 21 * * * this title reaffirms the Federal Government's role in drug control. Basically this role is to regulate the legitimate drug trade to prevent diversion of medically useful dangerous drugs into illegitimate channels and to help reduce the criminal traffic in all narcotic and dangerous drugs on the local, national, and international level. Quoting, Senator Dodd, Cong. Rec., Senate, 996 (January 24, 1970) (emphasis added). All of these provisions are designed to reduce the diversion of drugs from the legitimate course of commerce i in the face of evidence aah ate eae amphetamine and barbiturate drugs, or between 8 and 9 billion pills, have been diverted to nonmedical use. Quoting, Senator Dodd, Cong. Rec., Senate, 996 (January 24, 1970) (emphasis added). The debate changed little as it moved to the House. The primary difference was that the House expanded the legislation to include drug research, education and treatment, in addition to the Senate’s narrower focus upon the prevention of drug trafficking and diversion. The entire debate remained, however, in the context of the drug problem: There are a limited number of approaches to attack this problem— preventive steps, aimed at stopping experimentation before it starts; control, to regulate the supply and availability of drugs; rehabilitation to lead individuals away from drug dependence and addiction. It is my conviction that the Federal Government must make a concentrated effort in all of these areas. Quoting, Representative Boland, Cong. Rec., House, 33315 (September 23, 1970). The word “control” in the title, of narcotics and opiates, marijuana, and hallucinogens such as LSD, amphetamines, barbiturates, and even any tranquilizers subject to abuse. Quoting, Representative Randall, Cong. Rec., House, 33656 (September 24, 1970) (emphasis added). Here again, nothing from the 1970 House floor debate remotely suggests that Congress intended the Attorney General to determine the “legitimacy of medicine,” or to establish medical policy in the states. To better control the rampant drug problem, 23 the House expanded the reach of the CSA to include drug research, education, treatment, and rehabilitation, but included not a word about regulating medical practice. The relevant language in the proposed legislation did not significantly change when it returned Mr. Speaker, | move to suspend the rules and pass the bill (H.R. 5656) to amend the Controlled Substances Act to strengthen the authority to prevent diversion of controlled substances, and for Act was passed in almost its entirety by the House. There were a number of minor disagreements; but more than 90 percent of the law which was reported by the Senate Subcomittee [sic] on Juvenile Delinquency will soon become the law of the land. This is no mean achievement. The Senate legislation passed the very close scrutiny of the House[,] which investigated the bill for many months. No significant changes were made, 4 procedure which does not often occur in bills sent over from the Senate. Quoting, Senator Dodd, Cong. Rec., Senate, 35051, 35052 (October 6, 1970). The 1984 amendments reveal that once again Congress was concerned about a rampant drug abuse problem, the diversion of otherwise lawful drugs to illicit or recreational uses. The bill was named the Dangerous Drug Diversion Control Act of 1984 and it was described as follows: other purposes, as smended. Quoting, Representative Hughes, Cong. Rec., House, 25846 (September 18, 1984) (emphasis added). This bill addresses one of the most critical areas of drug abuse, the abuse of prescription drugs. Prescription drugs are responsible for close to 70 percent of the deaths and injuries due to drug abuse. But I am sorry to say this aspect of drug abuse, the diversion problem, has often failed to get the societal or the enforcement attention that it deserves. Quoting, Representative Hughes, Cong. Rec., House (September 18, 1984) (emphasis added). cians teens would likely take the above “deaths and injuries" phrase out of context, just as he does in his petition (see, Pet. Cert. 22-23-- misuse of a drug in suicides and attempted suicides"), but the Congress was only concerned with illicit particularly flowing from “diversion”: on ™ Diversion is the connotation for the various means by which legitimate medical controlled substances are diverted from proper use to improper use. Invalid 25 prescriptions and pharmacy robberies are medical distributors to the illicit drug much of the drug enforcement focus has deaths and injuries due to drug abuse. been placed on the interdiction of improperly imported substances, the Quoting, Representative Gilman, Cong. Rec., House, 25851 problem of domestic diversion has quietly (September 18, 1984) (emphasis added). grown to staggering proportions. * * * . Abuse of prescription drugs i sum, whether reviewing the 1970 or the 1984 legislative through diversion at the manufacturing and history, it is clear that the CSA was intended as a solution to the distribution levels [is] severely curtailed problems of illicit drug use, drug trafficking, and drug diversion under the current law by DEA. The vast The CSA was never intended to empower the Attorney General to majority of diversions occur at the retail rule upon the legitimacy of medical practice in the States. level. ***. eeeee 8. The Attorney General fails to allege a single incident of * ** . This bill provides the Drug illicit drug use, drug trafficking, or drug diversion ’ Enforcement Agency with the necessary tools to join State agencies in reducing Contrary to the requirements of the CSA and the diversion. expectations of Congress, the record in the instant case is entirely devoid of any evidence or even an allegation of illicit drug use, Quoting, Representative Sawyer, Cong. Rec., House, 25849 drug trafficking, or drug diversion. There are, for example, none (September 18, 1984) (emphasis added). of the usual allegations that banned drugs are being used, or that physicians practicing under the Oregon law are diverting otherwise Mr. Speaker, I rise in strong lawful drugs to an illicit use. Large quantities are not prescribed, support of H.R. 5656, the Dangerous large numbers of prescriptions are not issued, patients are not Drug Diversion Control Act of 1984, The instructed to fill their prescriptions at different drug stores, bill amends the Controlled Substances Act prescriptions are not issued for one person but privately intended to attempt fo prevent the diversion of for another, prescriptions are neither issued nor filled to satisfy the controlled substances from legitimate Cravings of an addict, multiple prescriptions are not “spread out" channels of medical distribution and to avoid detection, and practitioners are not accused of using street administration to illegitimate channels for slang. In an apparent attempt to overcome this shortcoming, the of abuse. Evidence suggests that Attorney General argues that, “the taking of drugs to commit prescription drugs diverted by legitimate suicide is drug abuse" (Pet. Cert., 23), b-st this is merely an 26 27 questions, in view of the plain language of the relevant statutes and the extensive legislative history, the legal questions are relatively simple. DEA registrants practicing pursuant to Oregon statutory and regulatory law are acting in the course of their professional unmistakably clear in the language of the statute"). FOR THE FOREGOING REASONS, Peter A. Rasmussen, M.D., and David M. Hochhalter, Rph, urge that the Attorney General's petition be denied. Jarwary 10, 2005 (503) 274-4048 APPENDIX THE OREGON DEATH WITH DIGNITY ACT (General Provisions) (Section 1) Note: The division headings, subdivision headings and leadlines for 127.800 to 127.890, 127.895 and 127.897 were enacted as part of Ballot Measure 16 (1994) and were not provided by Legislative Counsel. 127.800 §1.01. Defimitions. The following words and phrases, whenever used in ORS 127.800 to 127.897, have the following meanings: (1) “Adult” means an individual who is 18 years of age or older. (2) “Attending physician” means the physician who has primary responsibility for the care of the patient and treatment of the patient’s terminal disease. (3) “Capable” means that in the opinion of a court or in the opinion of the patient's attending physician or consulting physician, psychiatrist or psychologist, a patient has the ability to make and communicate health care decisions to health care providers, including communication through persons familiar with the patient's manner of communicating if those persons are available. (4) “Consulting physician" means a physician who is qualified by specialty or experience to make a professional diagnosis and prognosis regarding the patient’s disease. App. 1 (8) “Medically confirmed" means the medical opinion of the attending physician has been confirmed by a consulting physician who has examined the patient and the patient's relevant medical records. (9) “Patient” means a person who is under the care of a hysici (10) “Physician” means a doctor of medicine or osteopathy licensed to practice medicine by the Board of Medical Examiners for the State of Oregon. (11) "Qualified patient" means a capable adult who is a resident of Oregon and has satisfied the requirements of ORS 127.800 to 127.897 in order to obtain a prescription for medication to end his or her life ina humane and dignified manner. (12) “Terminal disease” means an incurable and irreversible disease that has been medically confirmed and will, within reasonable medical judgment, produce death within six months. [1995 c.3 §1.01; 1999 c.423 §1] (Written Request for Medication to End One’s Life in a Humane and Dignified Manner) (Section 2) 127.805 §2.01. Who may initiate a written request for medication. (1) An adult who is capable, is a resident of Oregon, and has been determined by the attending physician and consulting physician to be suffering from a terminal disease, and App. 3 who has voluntarily expressed his or her wish to die, may make a written request for medication for the purpose of ending his or her life in a humane and dignified manner in accordance with ORS 127.800 to 127.897. (2) No person shall qualify under the provisions of ORS 127.800 to 127.897 solely because of age or disability. [1995 c.3 $2.01; 1999 ¢.423 §2] 127.810 §2.02. Form of the written request. (1) A valid request for medication under ORS 127.800 to 127.897 shall be in substantially the form described in ORS 127.897, signed and dated by the patient and witnessed by at least two individaals who, in the presence of the patient, attest that to the best of their knowledge and belief the patient is capable, acting voluntarily, and is not being coerced to sign the request. (2) One of the witnesses shall be a person who is not: (a) A relative of the patient by blood, marriage or adoption; (b) A person who at the time the request is signed would be entitled to any portion of the estate of the qualified patient upon death under any will or by operation of law; or (c) An owner, operator or employee of a health care facility where the qualified patient is receiving medical treatment or is a resident. (3) The patient’s attending physician at the time the request is signed shall not be a witness. App. 4 (4) If the patient is patient in a long term facility at the time the written request is made, one of the witnesses shall be an individual designated by the facility and having the qualifications specified by the Department rule. [1995 ¢.3 §2.02} ) A person intentionally causes or aids another person to commit suicide [underscore added); or (c) A person, with criminal negligence, causes the death of a child under 14 years of age o: a dependent person, as defined in ORS 163.205, and: (A) The person has previously engaged in a pattern or practice of assault or torture of the victim or another child under 14 years of age or a dependent person; or (B) The person causes the death by neglect or maltreatment, as defined in ORS 163.115. (2) Manslaughter in the second degree is a Class B felony. [1971 c.743 §89; 1975 c.577 §3; 1997 c.850 §4; 1999 c.954 §1] AFFIDAVIT OF PETER A. RASMUSSEN, M.D., IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT FILED BY PETER A. RASMUSSEN, M.D., AND DAVID M. HOCHHALTER, RPh County of Marion —) I, Peter A. Rasmussen, M.D., being duly sworn, make this affidavit based on personal knowledge in support of summary judgment in my favor, as follows: a I am a medical oncologist licensed to practice medicine in the State of Oregon. | am Board Certified in Hospice and Palliative Medicine. 2. I am also registered with the Drug Enforcement Administration (DEA) and am authorized to prescribe and dispense controlled substances under both state and federal law. 3. Asa medical oncologist and DEA registrant, I have treated terminally ill patients for 21 years in Oregon. | estimate that I am currently treating hundreds of patients facing a terminal disease. 4. Since passage of the Oregon Death With Dignity Act, I have received many requests from patients seeking information or assistance under the Act. As an attending physician and DEA registrant, I have participated under the Oregon Death With Dignity Act several times and, when appropriate und~r the Act, I have written prescriptions for controlled Substances, but not Schedule I substances. | have provided copies of my dispensing records to the Department of App. 22 Human Services as required under the Oregon Death With Dignity Act. 5. At the time of this affidavit, three of my patients have satisfied all of the requirements of the Oregon Death With Dignity Act. All three are qualified to obtain prescriptions under the Act. In order to preserve patient confidentiality, | will identify them by profile: Patient A Patient A is a woman approximately 64 years old who is dying from ovarian cancer. She has satisfied all of the requirements necessary under Oregon law to obtain controlled substances to hasten her death. Patient B Patient B is a man approximately 72 years old who is dying from lung cancer. He has satisfied all of the requirements necessary under Oregon law to obtain controlled substances to hasten his death. Patient C Patient C is a woman approximately 52 years old who is also dying from ovarian cancer. She has satisfied all of the requirements necessary dane centaanetaeeareranae tear ecetrrematens 6. I cannot predict whether any of these patients will choose to hasten their impending deaths, but all three are qualified under the law to do so. I am currently attending to their needs on an ongoing basis. For example, the prescription for Patient B has already been written and filled and I have the ene use 7. Patients A and C both know of my role in this litigation. Both Patients A and C have expressed their support and appreciation for my willingness to represent their interests. For my patients that support the options available to them under App. 23 the Oregon Death With Dignity Act, I am intentionally representing their interests in this litigation. 8 Due to the nature of my practice, at any given time, many of my patients will be terminally ill and I will continue to receive requests from patients for prescriptions and information under the Oregon Death With Dignity Act. 9. Prior to court's issuance of a temporary restraining order, my ability to meet the community standard of care as established under Oregon law and practice was severely restricted. As the direct result of this court’s preliminary injunctive relief, my ability to meet the community standard of care as established under Oregon law and practice has been restored. 10. _ As the attending physician under the Oregon Death With Dignity Act I am practicing legitimate medicine in the course of my professional practice. I comply with both state law and the standard of care when I fulfill the criteria of an “attending physician” as required by section 127.815 of the Act. For example, I make the initial determination of whether my patients have a terminal disease, are capable, and have made their request voluntarily. 1 ensure that my patients are informed by informing them of their medical diagnosis, prognosis, the potential risk and probable result associated with taking the medication to be prescribed, and the feasible alternatives, including, but not limited to, comfort care, hospice care and pain control. 11. I further refer my patients to a consulting physician for medical confirmation of the diagnosis, and for a second opinion that my patients are capable and acting voluntarily. When appropriate, I also refer my patients for counseling. I recommend that my patients notify their next of kin and counsel them about the importance of having another App. 24 person presem when they take the medication prescribed under the Oregon Death With Dignity Act. | further inform my patients that they may change their minds at any time, in any manner, and | remind my patients of this right throughout the process, including immediately prior to writing the prescription, at which point I again confirm that the patient is again making an informed decision. 12. _—_ As required under the Oregon Death With Dignity Act, I dispense the medications directly, including ancillary medications intended to facilitate the desired effect and minimize any discomfort. Or, in the alternative, | contact a pharmacist and inform the pharmacist of the prescription. I then deliver the written prescription personally or by mail to the pharmacist, who will dispense the medications to either the patient, to me as the attending physician, or the patient's chosen representative. I am at all times registered as a dispensing physician with the Board of Medical Examiners and | have a current Drug Enforcement Administration certificate. 13. I further satisfy all the statutory medical record documentation requirements and provide a copy of my _ dispensing record to the Department of Human Services. In general, I ensure that all appropriate steps are carried out in accordance with ORS 127.800 to 127.897 prior to writing a prescription for medication to enable a qualified patient to hasten his or her death. I comply with all the provisions of the Oregon Death With Dignity Act. I never engage in drug trafficking or diversion. As a physician practicing under the Oregon Death With Dignity Act, I am practicing legitimate medicine in the course of my professional practice. 14. —_ | encourage this court to award summary judgment in my favor so that I may continue to meet my patients needs under Oregon statutory law, regulatory law, and App. 25 the community standard of care established in the State of Oregon. 15. | Asa physician, I encourage patients to be in charge of their own care. An important part of what a physician does is to describe options and counsel patients on these options. Depriving me of the ability to participate under the Oregon Death With Dignity Act reduces the number of options available to my patients and will lead to unnecessary suffering for terminally ill patients. 16. If the DEA enforcement promise i[s] not enjoined, I will need to inform my patients that I cannot risk participation under the Oregon Death With Dignity Act. Due to Attorney General John Ashcroft’s directive to enforce the Controlled Substances Act against physicians like myself practicing in accord with Oregon law and the community standard of care, and in the absence of a permanent injunction, I will no longer be able to meet the community standard of care as established under Oregon law and practice. I cannot risk DEA registration revocation proceedings or other sanctions, criminal and financial. I cannot risk my ability to practice as a medical oncologist, which has provided my livelihood for 21 years. Nor can I risk my family’s security, or my ability to provide for my family. 17. In the absence of a permanent injunction, the Oregon Death With Dignity Act will be rendered useless. Only controlled substances are suitable for use under the Oregon Death With Dignity Act; they are used for what Oregon has determined to be a legitimate medical purpose in the normal course of medical practice in Oregon. These controlled substances are prescribed by physicians and dispensed by pharmacies for other purposes as well. Prescriptions for controlled substances under the Oregon Death With Dignity Act App. 26 are written by state-licensed physicians and filled by state- licensed pharmacists, in full compliance with the closed system of procedures established by the CSA and enforced by the DBA. These drugs are not otherwise available. - 18. Tim: is important and admittedly short for my patients. Some of my patients face particularly dire circumstances. Once they are qualified to receive a prescription under the Oregon Death With Dignity Act they are by definition “terminally ill," having six months or less to live. Consequently, there will be oniy a short period of time before they lose their competency, ability to self-administer, or die from their underlying disease. For my patients, and others patients similarly situated, DEA enforcement should be permanently enjoined. DATED this __ day of January, 2002. Peter A. Rasmussen, M.D. SUBSCRIBED AND SWORN TO before me this __ day of January,’ 2002. NOTARY PUBLIC FOR OREGON My Commission Expires: App. 27 AFFIDAVIT OF DAVID M. HOCHHALTER, RPh IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT FILED BY PETER A. RASMUSSEN, M.D., AND DAVID M. HOCHHALTER, RPh STATE OF OPEGON ) ) ss. County of Marion ) I, David M. Hochhalter, RPh, being duly sworn, make this affidavit based on personal knowledge in support of summary judgment in my favor, as follows: l. I am a pharmacist licensed to practice in the State of Oregon. I have been a pharmacist for almost 23 years. I also own a pharmacy that is registered with the Drug Enforcement Administration (DEA). I am authorized to possess and dispense controlled substances under both state and federal law. 2. As a licensed Oregon pharmacist and DEA registrant, I dispense controlled substances in Oregon. 3. As a licensed Oregon pharmacist and DEA registrant, | have previously filled prescriptions under the Oregon Death with Dignity Act working in conjunction with Dr. Peter Rasmussen. | have filled prescriptions for Dr. Rasmussen during the pendency of this litigation, as recently as last week. 4. As a licensed Oregon pharmacist and DEA registrant, I will continue to fill prescriptions written by Dr. Rasmussen under the Oregon Death With Dignity Act. App. 28 5. In the absence of a permanent injunction, the Oregon Death With Dignity Act will be rendered useless. Only controlled substances are suitable for use under the Oregon Death With Dignity Act; they are used for what Oregon has determined to be a legitimate medical purpose in the normal course of medical practice in Oregon. These controlled substances are prescribed by physicians and dispensed by pharmacies for other purposes as well. Prescriptions for controlled substances under the Oregon Death with Dignity Act are written by state-licensed physicians and filled by state- licensed pharmacists, in full compliance with the closed system of procedures established by the CSA. These drugs are not otherwise available. | never engage in drug trafficking or diversion. As a pharmacist dispensing under the Oregon Death With Dignity Act, I am practicing legitimate medicine in the normal course of my professional practice. 6. In the absence of a permanent injunction against Attorney General John Ashcroft’s directive to the DEA to enforce the Controlled Substances Act against DEA registrants like myself, practicing in accord with Oregon law and the community standard of care, I can no longer participate under the Oregon Death With Dignity Act. If the court’s temporary Stay against DEA enforcement is not converted into a permanent injunction, I will need to inform Dr. Rasmussen and our patients that I cannot risk participation under the Oregon Death With Dignity Act. Even if Dr. Rasmussen were willing to write the prescriptions, I would be precluded from filling them because I cannot risk DEA registration revocation proceedings or other sanctions, criminal and financial. I cannot risk my livelihood, or my family’s security. App. 29 DATED this __ day of January, 2002. David Malcom Hochhalter, RPh, SUBSCRIBED AND SWORN TO before me this _ day of January, 2002. NOTARY PUBLIC FOR OREGON My Commission Expires: App. 30 : AFFIDAVIT OF DAVID M. HOCHHALTER, RPh IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT FILED B PETER A. RASMUSSEN, M.D., AND DAVID M. HOCHHALTER, RPh STATE OF OREGON ) ) 8s. County of Marion ) I, David M. Hochhalter, RPh, being duly sworn, make this affidavit based on personal knowledge in support of summary judgment in my favor, as follows: 1. I am a pharmacist licensed to practice in the State of Oregon. I have been a pharmacist for almost 23 years. I aleo own a pharmacy that is registered with the Drug Enforcement Administration (DEA). I am authorized to possess and dispense controlled substances under both state and federal law. 2. As a licensed Oregon pharmacist and DEA registrant, I dispense controlled substances in Oregon. 3. As a licensed Oregon pharmacist and DEA registrant, I have previously filled prescriptions under the Oregon Death with Dignity Act. 4. Based upon my personal experience and my knowledge of medical practice under the Oregon Death with Dignity Act, two drugs have been used to hasten a terminally ill patient's death, Seconal (9 grams), or Nembutal (10 grams). The full retail price is $68.55 for 9 grams of Seconal, and $133.55 for 10 grams of Nembutal. Seconal was the preferred drug until November of 2001 when supplies ran short. “ince November of 2001, Nembutal has been used. I expect that App. 31 Seconal will once again be the preferred drug when supplies and inventories are restored to normal. DATED this __ day of April, 2002. David Malcom Hochhalter, RPh, SUBSCRIBED AND SWORN TO before me this ___ day of April, 2002. NOTARY PUBLIC FOR OREGON My Commission Expires: --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0051%3A07. Public record. Not legal advice.