Opposition Brief — Gonzales v. Oregon

(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} <o emen erro ty

(a) Make the initial determination of whether a patient

has 4 terminal disease, is capable, and has made the request

voluntarily;

(©) Request that the patient demonstrate Oregon

residency pursuant to ORS 127.860;

(c) To ensure that the patient is making an informed

decision, inform the patient of:

(A) His or her medical diagnosis:

(C) The potential risks associated with taking the

medication to be prescribed:

(D) The probable result of taking the medication to be

prescribed; and

App. 5

(e) Refer the patient for counseling if appropriate

pursuant to ORS 127.825;

(f) Recommend that the patient notify next of kin;

(g) Counsel the patient about the importance of having

another person present when the patient takes the medication

prescribed pursuant to ORS 127.800 to 127.897 and of not

taking the medication in a public place;

(h) Inform the patient that he or she has an opportunity

to rescind the request at any time and in any manner, and offer

the patient an opportunity to rescind at the end of the 15 day

waiting period pursuant to ORS 127.840;

*) Verify, i fiately prior to writing the —_

sor med ation wader ORS 127.800 to 127.897, thatthe patient

is making an informed decision;

(j) Pulfill the medical record documentation

requirements of ORS 127.855;

(k) Ensure that all appropriate steps are carried out in

accordance with ORS 127.800 to 127.897 prior to writing #

App. 6

prescription for medication to enable a qualified patient to end

his or her life in a humane and dignified manner; and

(IA) Dispense medications directly, including ancills

medications intended to facilitate the desired effect to minimize

Pe er ye oe ee

as a dispensing physician with the Board of Medical

Examiners, has a current Drug Enforcement Administration

certificate and complies with any applicable administrative rule;

or

(B) With the patient’s written consent:

(i) Contact a pharmacist and inform the pharmacist of

the prescription; and

(ii) Deliver the written prescription personally or by

mail to the pharmacist, who will dispense the medications to

either the patient, the attending physician or an express!

identified agent of the patient.

(2) Notwithstanding any other provision of law, the

attending physician may sign the patient's death certificate.

[1995 c.3 §3.01; 1999 c.423 §3]

127.820 §3.02. Consulting physician confirmation.

Before a patient is qualified under ORS 127.800 to 127.897, a

consulting physician shai] examine the patient and his or her

relevant medical records and confirm, in writing, the attending

physician's diagnosis that the patient is suffering from a terminal

disease, and verify that the patient is capable, is acting

voluntarily and has made an informed decision. [1995 c.3 §3.02]

App. 7

127.825 $3.03. Counseling referral. If in the opinion of

the attending physician or the consulting physician a pathent may

127.830 §3.04. Informed decision. No person shall

receive a prescription for medication to end his or her life in a

humane and dignified manner unless he or she has made an

infeed desisian os defines tn OBS 127.500 (7), Dement

ior to writing a prescription for medication

7 800 to 127.897, the attending physician shall verify that the

patient is making an informed decision. [1995 c.3 §3.04]

127.835 §3.05. Family notification. The attending

physician shall recommend that the patient notify the next of kin

of his or her request for medication pursuant to ORS 127.800 to

127.897. A patient who declines or is unable to notify next of

kin shall not have his or her request denied for that reason.

[1995 c.3 §3.05; 1999 c.423 §6]

127.840 $3.06. Written and oral requests. In order to

receive a prescription for medication to end his or her life in a

humane and dignified manner, a qualified patient shall have

made an oral request and a written request, and reiterate the oral

request to his or her attending physician no less than fifteen (15)

days after making the initial oral request. At the time the

App. 8

qualified patient makes his or her second oral request, the

rescind the request. [1995 c.3 §3.06]

127.845 §3.07. Right to rescind request. A patient may

rescind his or her request at any time and in any manner without

regard to his or her mental state. No prescription for medication

under ORS 127.800 to 127.897 may be written without the

attending physician offering the qualified patient an opportunity

to rescind the request. [1995 c.3 §3.07]

127.850 §3.08. Waiting periods. No less than fifteen

(15) days shall elapse between the patient's initial oral request

and the writing of a prescription under ORS 127.800 to

127.897. No less than 48 hours shall elapse between the

patient's written request and the writing of a prescription under

ORS 127.800 to 127.897. [1995 c.3 §3.08]

127.855 §3.09. Medical record documentation

requirements. The following shall be documented or filed in the

patient's medical record:

(1) All oral requests by a patient for medication to end

his or her life in a humane and dignified manner;

(2) All written requests by a patient for medication to

end his or her life in a humane and dignified manner;

(3) The attending physician's diagnosis and prognosis,

Getermination that the patient is capable, acting voluntarily and

has made an informed decision;

(4) The consulting physician's diagnosis and prognosis,

and verification that the patient is capable, acting voluntarily and

has made an informed decision;

(5) A report of the outcome and determinations made

during counseling, if performed;

(6) The attending physician's offer to the patient to

rescind his or her request at the time of the patient’s second oral

request pursuant to ORS 127.840; and

(7) A note by the attending physician indicating that all

requirements under ORS 127.800 to 127.897 have been met and

indicating the steps taken to carry out the request, including a

notation of the medication prescribed. [1995 c.3 §3.09]

127.860 §3.10. Residency requirement. Only requests

made by Oregon residents under ORS 127.800 to 127.897 shall

be granted. Factors demonstrating Oregon residency include but

are not limited to:

(1) Possession of an Oregon driver license;

(2) Registration to vote in Oregon;

(3) Evidence that the person owns or leases property in

Oregon; or

(4) Filing of an Oregon tax return for the most recent

tax year. [1995 c.3 §3.10; 1999 c.423 §8]

App. 10

127.865 §3.11. Reporting requirements. (1)(a) The

Department of Human Services shall annually review a sample

of records maintained pursuant to ORS 127.800 to 127.897.

(b) The department shall require any health care

provider upon dispensing medication pursuant to ORS 127.800

to 127.897 to file a copy of the dispensing record with the

department.

(2) The department shall make rules to facilitate the

collection of information regarding compliance with ORS

127.800 to 127.897. Except as otherwise required by law, the

information collected shall not be a public record and may not

be made available for inspection by the public.

(3) The department shall generate and make available to

the public an annual statistical report of information collected

under subsection (2) of this section. [1995 c.3 §3.11; 1999

c.423 §9; 2001 c.104 $40)

127.870 §3.12. Effect on construction of wills,

contracts and statutes. (1) No provision in a contract, will or

other agreement, whether written or oral, to the extent the

provision would affect whether a person may make or rescind a

request for medication to end his or her life in a humane and

dignified manner, shall be valid.

(2) No obligation owing under any currently existing

contract shall be conditioned or affected by the making or

rescinding of a request, by a person, for medication to end his

or her life in a humane and dignified manner. [1995 c.3 $3.12]

App. 11

127.875 $3.13. Insurance or annuity policies. The

sale, procurement, or issuance of any life, health, or accident

insurance or annuity policy or the rate charged for any policy

shall not be conditioned upon or affected by the making or

rescinding of a request, by a person, for medication to end his

or her life in a humane and dignified manner. Neither shall a

qualified patient’s act of ingesting medication to end his or her

life in a humane and dignified manner have an effect upon a

life, health, or accident insurance or annuity policy. [1995 c.3

§3.13)

127.880 §3.14. Construction of Act. Nothing in ORS

127.800 to 127.897 shall be construed to authorize a physician

or any other person to end a patient's life by lethal injection,

mercy killing or active euthanasia. Actions taken in accordance

with ORS 127.800 to 127.897 shall not, for any purpose,

constitute suicide, assisted suicide, mercy killing or homicide,

under the law. [1995 c.3 §3.14]

(Immunities and Liabilities)

(Section 4)

127.885 $4.01. Immunities; basis for prohibiting

health care provider from participation; notification;

permissible sanctions. Except as provided in ORS 127.890:

(1) No person shall be subject to civil or criminal

liability or professional disciplinary action for participating in

good faith compliance with ORS 127.800 to 127.897. This

includes being present when a qualified patient takes the

App. 12

prescribed medication to end his or her life i

in a humane and

(2) No professional organization or association, or health

care provider, may subject a person to censure, disciptine,

suspension, loss of license, loss of privileges, loss of

membership or other penalty for participating or refusing to

Perucipate in good faith compliance with ORS 127.800 to

(3) No request by a patient for or i

| , provision by an

attending physician of medication in good faith compliance with

the provisions of ORS 127.800 to 127.897 shall constitute

neglect for any purpose of law or provide the sole basis for the

appointment of a guardian or conservator.

(4) No health care provider shall be under any duty

whether by contract, by statute or by any other legal

requirement to participate in the provision to a qualified patient

of medication to end his or her life in a humane and dignified

manner. If @ health care provider is unable or unwilling to carry

Out @ patient's request under ORS 127.800 to 127.897, and the

patient transfers his or her care to a new health care provider

the prior health care provider shall transfer, upon request, a

ee records to the new health

(5a) Notwithstanding any other provision of law, a

health care provider may prohibit another health care provider

from participating in ORS 127.800 to 127.897 on the premises

of the prohibiting provider if the prohibiting provider has

notified the health care provider of the prohibiting provider's

App. 13

policy regarding participating in ORS 127.800 to 127.897.

Nothing in this paragraph prevents a health care provider from

providing health care services to a patient that do not constitute

participation in ORS 127.800 to 127.897.

(b) Notwithstanding the provisions of subsections (1) to

(4) of this section, a health care provider may subject another

health care provider to the sanctions stated in this paragraph if

the sanctioning health care provider has notified the sanctioned

provider prior to participation in ORS 127.800 to 127.897 that it

prohibits participation in ORS 127.800 to 127.897:

(A) Loss of privileges, loss of membership or other

sanction provided pursuant to the medical staff bylaws, policies

and procedures of the sanctioning health care provider if the

sanctioned provider is a member of the sanctioning provider's

medical staff and participates in ORS 127.800 to 127.897 while

on the health care facility premises, as defined in ORS 442.015,

of the sanctioning health care provider, but not including the

private medical office of a physician or other provider;

(B) Termination of lease or other property contract or

other nonmonetary remedies provided by lease contract, not

including loss or restriction of medical staff privileges or

exclusion from a provider panel, if the sanctioned provider

participates in ORS 127.800 to 127.897 while on the premises

of the sanctioning health care provider or on property that is

owned by or under the direct control of the sanctioning health

care provider; or

(C) Termination of contract or other nonmonetary

remedies provided by contract if the sanctioned provider

App. 14

participates in ORS 127.800 to 127.897 while acting in the

course and scope of the sanctioned provider's capacity as an

employee or independent contractor of the sanctioning health

care provider. Nothing in this subparagraph shall be construed

prevent:

(i) A health care provider from participating in ORS

127.800 to 127.897 while acting outside the course and scope of

the provicer’s capacity as an employee or independent

contractor; or

. (ii) A patient from contracting with his or her attending

physician and consulting physician to act outside the course and

scope of the provider's capacity as an employee or independent

contractor of the sanctioning health care provider.

(c) A health care provider that imposes sanctions

pursuant to paragraph (b) of this subsection must follow all due

process and other procedures the sanctioning health care

provider may have that are related to the imposition of sanctions

on another health care provider.

(d) For purposes of this subsection:

(A) “Notify” means a separate statement in writing to

the health care provider specifically informing the health care

provider prior to the provider's participation in ORS 127.800 to

127.897 of the sanctioning health care provider’s policy about

participation in activities covered by ORS 127.800 to 127.897.

(B) “Participate in ORS 127.800 to 127.897" means to

perform the duties of an attending physician pursuant to ORS

App. 15

127.815, the consulting physician function pursuant to ORS

127.820 or the counseling function pursuant to ORS 127.825.

"Participate in ORS 127.800 to 127.897° does not include:

(i) Making an initial determination that a patient has a

terminal disease and informing the patient of the medical

prognosis;

(ii) Providing information about the Oregon Death with

Dignity Act to a patient upon the request of the patient;

(iii) Providing a patient, upon the request of the patient,

with a referral to another physician; or

(iv) A patient contracting with his or her attending

physician and consulting physician to act outside of the course

and scope of the provider’s capacity as an employee or

independent contractor of the sanctioning health care provider.

(6) Suspension or termination of staff membership or

privileges under subsection (5) of this section is not reportable

under ORS 441.820. Action taken pursuant to ORS 127.810,

127.815, 127.820 or 127.825 shall not be.the sole basis for a

report of unprofessional or dishonorable conduct under ORS

677.415 (2) or (3).

(7) No provision of ORS 127.800 to 127.897 shall be

construed to allow a lower standard of care for patients in the

community where the patient is treated or a similar community.

[1995 c.3 §4.01; 1999 c.423 §10)

App. 16

Note: As originally enacted by the people, the leadline

to section 4.01 read “Immunities.” The remainder of the leadline

was added by editorial action.

127.890 §4.02. Liabilities. (1) A person who without

authorization of the patient willfully alters or forges a request

for medication or conceals or destroys a rescission of that

request with the intent or effect of causing the patient’s death

shall be guilty of a Class A felony.

(2) A person who coerces or exerts undue influence on a

patient to request medication for the purpose of ending the

patient's life, or to destroy a rescission of such a request, shall

be guilty of a Class A felony.

| (3) Nothing in ORS 127.800 to 127.897 limits further

liability for civil damages resulting from other negligent conduct

or intentional misconduct by any person.

(4) The penalties in ORS 127.800 to 127.897 do not

preclude criminal penalties applicable under other law for

conduct which is inconsistent with the provisions of ORS

127.800 to 127.897. [1995 ¢.3 $4.02]

127.892 Claims by governmental entity for costs

incurred. Any governmental entity that incurs costs resulting

from a person terminating his or her life pursuant to the

provisions of ORS 127.800 to 127.897 in a public place shall

have a claim against the estate of the person to recover such

costs and reasonable attorney fees related to enforcing the claim.

[1999 c.423 §5a]

App. 17

(Severability)

(Section 5)

127.895 §5.01. Severability. Any section of ORS

127.800 to 127.897 being held invalid as to any person or

circumstance shall not affect the application of any other section

of ORS 127.800 to 127.897 which can be given full effect

without the invalid section or application. [1995 c.3 §5.01)

(Form of the Request)

(Section 6)

127.897 §6.01. Form of the request. A request for a

medication as authorized ty ORS 127.800 to 127.897 shall be in

substantially the following form:

REQUEST FOR MEDICATION

TO END MY LIFE IN A HUMANE

AND DIGNIFIED MANNER

I, , am an adult of sound mind.

I am suffering from , which my attending physician

has determined is a terminal disease and which has been

medically confirmed by a consulting physician.

I have been fully informed of my diagnosis, prognosis, the

nature of medication to be prescribed and potential associated

App. 18

risks, the expected result, and the feasible alternatives, inchuding

comfort care, hospice care and pain control.

I request that my attending physician prescribe medication that

will end my life in a humane and dignified manner.

INITIAL ONE:

—— ! have informed my family of my decision and taken

their opinions into consideration

——— ! have decided not to inform my family of my decision.

——___ ! have no family to inform of my decision.

I understand that I have the right to rescind this request at any

time.

| understand the full import of this request and |

expect to die

when I take the medication to be prescribed. | further

understand that although most deaths occur within three hours.

my death may take longer and my physician has counseled me

about this possibility.

I make this request voluntarily and without reservation, and I

accept full moral responsibility for my actions.

Signed:

Dated:

App. 19

DECLARATION OF WITNESSES

We declare that the person signing this request:

(a) Is personally known to us or has provided proof of identity;

(b) Signed this request in our presence;

(c) Appears to be of sound mind and not under duress, fraud or

undue influence;

(4) Is not a patient for whom either of us is attending physician.

Witness 1/Date

Witness 2/Date

NOTE: One witness shall not be a relative (by blood, marriage

or adoption) of the person signing this request, shall not be

entitled to any portion of the person's estate upon death and

shall not own, operate or be employed at a health care facility

where the person is a patient or resident. If the patient is an

inpatient at a health care facility, one of the witnesses shall be

an individual designated by the facility.

App. 20

163.125 Manslaughter im the second degree. (1) Criminal

homicide constitutes manslaughter in the second degree when:

(a) It is committed recklessly;

(>) 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: