Opposition Brief — Gonzales v. Oregon

Supreme Court brief2006

Ask Donna

What actually matters in this document.

Text

No. 04-623

IN THE

Gnited States Supreme Court

>><¢

JOHN ASHCROFT, Attorney General, et al.,

Petitioners,

Vv.

STATE OF OREGON, et al.,

Respondents.

On Petition For A Writ of Certiorari

To United States Court of Appeals for the Ninth Circuit

PATIENT-RESPONDENTS’ BRIEF IN OPPOSITION

Nicholas W. van Aelstyn Kathryn L. Tucker

Counsel of Record COMPASSION & CHOICES

Aaron S. Jacobs 120i Third Avenue, 40th Floor

Charles W. Burk Seattle, Washington 98101-3000

HELLER EHRMAN WHITE Telephone: 206-367-2134

& MCAULIFFE LLP Facsimile: 206-583-8500

333 Bush Street

San Francisco, California 94104-2878

Telephone: 415-772-6000

Facsimile: 415-772-6268

Counsel for Patient-Respondents

QUESTION PRESENTED

Exercising its traditional police powers, Oregon enacted

a law that allows physicians to prescribe and pharmacists

to dispense Schedule II controlled substances to compe-

tent, 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 General to determine that physi-

cians and pharmacists acting in accordance with Oregon

law have violated the CSA?

PARTIES TO THE PROCEEDING TABLE OF CONTENTS

Petitioners are John Ashcroft, Attorney General of the | Pass

United States; Karen Tandy, Administrator of the Drug ;

Enforcement Administration; Kenneth W. McGee, Assis- QUESTION PRESENTED.....................005. '

tant Special Agent-in-Charge of the Portland Office of the p .

Drug Enforcement Administration; the United States of eee eee Dene eNO onsen nenne neces,

America; the United States Department of Justice; and the TABLE OF CONTENTS........................... TF

Drug Enforcement Administration.

Respondents are the State of Oregon, Peter A. Rasmussen,

David Malcolm Hochhalter, John Doe #1 and Don W.

James.

STATUTES AND REGULATIONS INVOLVED..

STATEMENT OF THE CASE .....................

Il. Ashcroft’s Interpretations of the CSA and Its

Regu'»tions Are Not Entitled to Deference. ... 7

A. Ashcroft’s Interpretation of the CSA Is Not

| Entitled to Heightened Deference............ x

1. The Mead and Barnhart factors require

Skidmore respect, rather than Chevron

EEE 9

2. Ashcroft’s interpretation is entitled to

little respect under Skidmore............ 13

Page

B. Ashcroft’s Interpretation of § 1306.04 Is Not

Entitled to Seminole [ok Deference......... 15

IIl. Petitioners’ Contention That the Directive

Sets Forth the “Prevailing Views” of

Physician-Assisted Dying Is Unsupported

Sy IED, cnncdthcnitsincutanananinttedenns 18

A. The Public, the Medical Community, and

the States Are Divided on the Question of

Physician-Assisted Dying................... 19

B. The Data Regarding Oregon's Experience

with the ODWDA Demonstrate That Legal

Physician-Assisted Dying Poses No Threat

i 20

iinet ti 23

TABLE OF AUTHORITIES

Cases Page

Alaska Dept. of Environmental Conservation v.

EPA, 540 U.S. 461, 124 S. Ct. 983 (2004).....

Barnhart v. Walton,

S3S UB. ZIZ (BOGE). on ccccccccccccccccccccceses 9.

Bedford County Mem'l Hosp. v. HHS,

769 F.2d 1017 (4th Cir. 1985)..................

Bowles v. Seminole Rock & Sand Co..,

325 U.S. 410 (1945)... 20. ccc ce cece eee eee 15,

Caruso v. Blockbuster-Sony Music Entertainment

Centre, 193 F.3d 730 (3d Cir. 1999) ...........

Chevron U.S.A.., Inc. v. Natural Resources Defense

Council, Inc., 467 U.S. 837 (1984) ............ 8.

Christensen v. Harris County,

LER) Le ee

Cruzan v. Director, Mo. Dept. of Health,

ree

Dubois v. U.S. Dept of Agriculture,

102 F.3d 1273 (ist Cir. 1996)..................

Gardebring v. Jenkins,

ere

Hall v. U.S. EPA,

273 F.3d 1146 (9th Cir. 2001).................. 14,

Humphreys v. DEA,

96 F.3d 658 (3d Cir. 1996) ...............--55-.

In re Sang-Su Lee,

277 F.3d 1338 (Fed. Cir. 2002) ................

James v. Von Zemenszky,

301 F.3d 1364 (Fed. Cir. 2002) ................

Lee v. Harcleroad.,

Se I tieninutnddedsineaninseonene

Lee v. Oregon,

869 F. Supp. 1491 (D. Or. 1994)...............

Lee v. Oregon,

891 F. Supp. 1429 (D. Or. 1995)......0 00000...

Lee v. Oregon,

107 F.3d 1382 (9th Cir. 1997)............00....

Martin v. Occupational Safety and Health Review

Comm'n, 499 U.S. 144 (1991)... 0000000.

Menorah Med. Ctr. v. Heckler.

768 F.2d 292 (8th Cir. 1985)...................

Motor Vehicle Manufacturers Association of the

United States, Inc. v. State Farm Mutual Auto

Insurance, 463 U.S. 29 (1983).................

NLRB v. Brown.

I, id a

Norfolk S. Railway v. Shanklin,

og EEE TES ree ae

Olenhouse v. Commodity Credit Corp.,

42 F.3d 1560 (10th Cir. 1994)....0000 000,

vil

Page

Oregon v. Ashcroft,

192 F. Supp. 2d 1077 (D. Or. 2002) ........ 1,5, 14, 18

Oregon v. Ashcroft,

368 F.3d 1118 (9th Cir. 2004) ................. 1, 3, 4,5

Pacific Coast Fed'n of Fishermen's Ass'n, Inc.

v. Nat'l Marine Fisheries Serv.,

265 F.3d 1028 (9th Cir. 2001)............--.... 12

Puerto Rico Higher Educ. Assistance Corp. v.

Riley, 10 F.3d 847 (D.C. Cir. 1993)............ 13

Sierra Club v. Martin,

168 F.3d 1 (11th Cir. 1999) ............-..-006. 12

Skidmore v. Swift & Co.,

323 UB. 196 (IDES)... ccccccccccccccccccccececs 8, 14

Solid Waste Agency of Northern Cook County v.

United States Army Corps of Engineers,

E'S) fT: | errr 17

St. James Hospital v. Heckler,

760 F.2d 1460 (7th Cir. 1985).........-.-..-04. 13

Texas Office of Pub. Util. Counsel v. FCC,

265 F.3d 313 (Sth Cir. 2001), cert. denied

535 U.S. 986 (April 15, 2002) ................. 12

Thomas Jefferson Univ. v. Shalala,

S82 UD. SOE CIDE. ccccccccccccccccccscccsces 15, 17

United States v. Mead Corp..,

533 U.S. ZIG CABG)... cccccccccccccccccccccscces 9, 10

United States v. Oakland Cannabis Buyers’ Coop,

$32 U.S. 4E3 (BBG)... cccccccccccccccccccccccses 14

vill

Page

Washington v. Glucksberg,

Se ES FE edbdebisnsdddedsdnaddiadude 3,19

Statutes and Regulations

ee es SE btiddddsndndiaddncsedadanieussdens 11

FO FER, TD, GOS III OD os ccccccccccsccccccesccccse 16

ee SE ei inidtndisdedddinotsnnuietee 16

I I 16

66 Fed. Reg. $6,607 (2001) ..........ccccccccccccees 5

Be iiidtednddncdeacivenctwedenes 20

5. Rep. No. 105-372, 105th Congress,

PIED dnnnddaseensscdsseocsidedesbons 4

S. Rep. No. 106-299, 106th Congress,

EE ukb dbiuhbcdadncddddediddededes 4

Miscellaneous

Quill, Timothy E. MD; Cassel, Christine K. MD,

Professional Organizations’ Position Statements

on Physician-Assisted Suicide: A Case for

Studied Neutrality, Annals of Internal Medicine,

I ini 19-20

Lunge, R.; Royle, M.; Slater, M.; Legislative

Council, Oregon's Death With Dignity Law and

Euthanasia in the Netherlands: Factual

Disputes (2004), found at: http://www.leg.

state. vt.us/reports/04Death/ Death _With_

REN, TOURGTR TID . ccccccoccccoscccccéconccce 20, 22

Page

Fifth Annual Report on Oregon's Death with

Dignity Act, Department of Human Services,

Office of Disease Prevention and Epidemiology.

i Er rrr rrr rT Try eT 21

Sixth Annual Report on Oregon’s Death with

Dignity Act, Department of Human Services

Office of Disease Prevention and Epidemiology,

Dares 10, 2OO46.....ccccccccccccccccsccccccceces 21

IN THE

Supreme Court of the Gnited States

No. 04-623

JOHN ASHCROFT, Attorney General, ef a/.,

Petitioners,

STATE OF OREGON, ef al...

Respondents.

On Petition For A Writ of Certiorari

From the United States Court of Appeals for the Ninth Circuit

PATIENT-RESPONDENTS’ BRIEF IN OPPOSITION

OPINIONS BELOW

The opinion of the Court of Appeals, Pet. App. |a-63a,

is reported at Oregon v. Ashcroft, 368 F.3d 1118 (9th Cir.

2004). The opinion of the District Court, Pet. App. 64a-

97a, is reported at Oregon v. Ashcroft, 192 F. Supp. 2d

1077 (D. Or. 2002).

STATEMENT OF JURISDICTION

The judgment of the Court of Appeals was entered on

May 26, 2004. A petition for rehearing was denied on

August I1, 2004. Pet. App. 98a-99a. The petition for a writ

of certiorari was filed on November 9, 2004. The jurisdic-

tion of this Court is invoked under 28 U.S.C. § 1254(1).

STATUTES AND REGULATIONS INVOLVED

Certain provisions of the Controlled Substances Act

(“CSA”) Pub. L. No. 91-513, Tit. Il, 84 Stat. 1242 (21

U.S.C. §§ 801 ef seqg.), and a regulation promulgated

thereunder, 21 C.F.R. § 1306.04, are set out in the Peti-

tioner’s Appendix at Pet. App. 149a-16la. Certain provi-

sions of the Oregon Death with Dignity Act (*ODWDA”)

are set out in the Petitioner's Appendix at Pet. App. 162a-

16Sa.

STATEMENT OF THE CASE

Patient-Respondents' adopt, for the purpose of this

opposition to the petition for certiorari, Respondent State

of Oregon’s Statement of the Case.

Oregon voters approved the Oregon Death With Dignity

Act (“ODWDA”) on November 8, 1994. On November 23.

1994, opponents of the measure filed suit in federal court,

alleging that the ODWDA violated their constitutional and

statutory rights. See Lee v. Oregon, 869 F. Supp. 1491, 1493

(D. Or. 1994). The district court agreed and enjoined the

ODWDA, id. at 1503 (granting preliminary injunction);

Lee v. Oregon, 891 F. Supp. 1429 (D. Or. 1995) (granting

permanent injunction), but in February of 1997 the Court

of Appeals dismissed the complaint. Lee v. Oregon, 107

F.3d 1382, 1386 and 1392 (9th Cir. 1997).

' The “Patient-Respondents” are Respondents John Doe #1 and Don

W. James.

Four months later, on June 27, 1997, this Court issued

its decision in Washington v. Glucksberg, 521 U.S. 702

(1997), wherein the Court concluded:

Throughout the Nation, Americans are engaged

in an earnest and profound debate about the

morality, legality, and practicality of physician-

assisted suicide. Our holding permits this debate

to continue, as it should in a democratic society.

Id. at 735. Concurring with the Court, Justice O’Connor

explained:

There is no reason to think the democratic

process will not strike the proper balance

between the interests of terminally ill, mentally

competent individuals who would seek to end

their suffering and the State’s interests in pro-

tecting those who might seek to end life mistak-

enly or under pressure. ... [T]he . . . challenging

task of crafting appropriate procedures for safe-

guarding .. . liberty interests is entrusted to the

“laboratory” of the States ... in the first instance.

Id. at 737 (O’Connor, J., concurring) (quotation marks omit-

ted) (quoting Cruzan v. Director, Mo. Dept. of Health, 497

U.S. 261, 292 (1990) (O’Connor, J. concurring)). Shortly

thereafter, this Court denied the Lee plaintiffs’ petition for

certiorari. Lee v. Harcleroad, 522 U.S. 927 (1997).

On November 4, 1997, after three years of litigation, the

citizens of Oregon once again voted on the ODWDA, reaf-

firming their support for it by a margin of 60%. See Official

Results State Measure 51 Nov. 4, 1997 State Wide Special

Election at: http://www.sos.state.or.us/elections/nov497/

other.info/mS5labst.html. See also Oregon v. Ashcroft, 368

F.3d at 1122, Pet. App. at 6a-7a.

In response to requests by members of Congress in late

1997, including then-Senator Ashcroft, Attorney General

Reno analyzed the question of whether practitioners acting

in accordance with the ODWDA contravened the CSA. On

June 5, 1998, Reno issued her interpretation of the CSA:

The Department has reviewed the issue thor-

oughly and has concluded that adverse action

against a physician who has assisted in a suicide

in full compliance with the Oregon Act would not

be authorized by the CSA.

Letter from Reno to Hyde (June 5, 1998), Opp. App. at.

50a. Reno explained that “[t]here is no evidence that Con-

gress, in the CSA, intended to displace the states as the pri-

mary regulators of the medical profession, or to override a

State's determination as to what constitutes legitimate

medical practice in the absence of a federal law prohibit-

ing that practice.” /d., Opp. App. at 52a.

Later that year the ODWDA’s Congressional oppenents,

again including then-Senator Ashcroft, introduced the

Lethal Drug Abuse Prevention Act of 1998 (the

“LDAPA”), see S. Rep. No. 105-372, Lethal Drug Abuse

Prevention Act, 105th Congress, 2d Session (1998), but it

failed to reach the floor of the House or the Senate. See

H.R. 4006 and S. 2151, 105th Congress (1998). They then

introduced the Pain Relief Promotion Act of 1999 (the

“PRPA”). See S. Rep. No. 106-299, The Pain Relief Pro-

motion Act, 106th Congress, 2d Session (2000). The PRPA

passed the House in 1999 and made it out of the Senate

Judiciary Committee in 2000, but failed to reach a vote on

the floor of the Senate. See H.R. 2260 and S. 1272, 106th

Congress (1999). See also Oregon v. Ashcroft, 368 F.3d at

1123 n.4, Pet. App. at 7a-8a. Both the LDAPA and the

PRPA would have expanded the scope of the CSA to nulli-

fy the ODWDA. Both tailed.

In November of 2000, the citizens of Missouri voted

Senator Ashcroft out of office. President Bush then

appointed him to be the Attorney General. Understandably

concerned, Oregon's Attorney General wrote to Ashcroft,

asking that Oregon be consulted in the event that the

Department of Justice decided to reconsider the ODWDA.

Letter from Hardy Myers, Oregon Attorney General, to

John Ashcroft, United States Attorney General (February

2, 2001), Opp. App. at 55a. In response, Ashcroft stated

that he “would be happy to include [Oregon’s]} views” if he

ever revisited the matter. Letter from Lori Sharpe, Director

and Advisor to the U.S. Attorney General, to Hardy Myers,

Oregon Attorney General (April 17, 2001), Opp. App. at

58a.

However, on November 6, 2001, without even notifying

Oregon, Ashcroft announced that he had reversed his pre-

decessor’s decision. Under his new interpretation of the

CSA—even without passage of the LDAPA or the PRPA—

prescribing controlled substances under the ODWDA is a

violation of the CSA and will result in the revocation of a

practitioner's license. See 66 Fed. Reg. 56,607 (November

9, 2001), Pet. App. at 100a. Respondents then filed this

action. The District Court permanently enjoined the

Ashcroft Directive, Oregon v. Ashcroft, 192 F. Supp. 2d

1077 (D. Or. 2002), Pet. App. at 64a, and the Court of

Appeals affirmed, Oregon v. Ashcroft, 368 F.3d 1118 (9th

Cir. 2004), Pet. App. at la. This petition followed.

REASONS FOR DENYING THE PETITION

Il. Introductio.

The petition seeks review of a decision that rests upon a

straightforward and narrow statutory interpretation of the

Controlled Substances Act. That decision presents no split

among the circuits, and, despite petitioner’s best efforts,

no constitutional issues.? For these reasons alone review is

not warranted.

In addition, the petition rests on several clearly incorrect

contentions in an effort to call the decision into question.

This is especially clear with respect to two contentions that

lie at the heart of the petition:

There can be no question, then, that the Attor-

ney General’s interpretive ruling [1] is consis-

tent with the prevailing views regarding medical

practice and [2] on that basis is, at the very

least, reasonable and entitled to deference.

Pet. at 13. Both statements are clearly and demonstrably

wrong, yet they constitute a critical basis of the petition.

Indeed, petitioner demands deference from this Court at

the outset, claiming Chevron deference and more for the

Attorney General’s interpretation of what constitutes a

“legitimate medical practice.” Pet. at 11-12.

While one may or may not agree with petitioner’s views

on physician-assisted dying—an issue that is deeply per-

sonal, highly sensitive and controversial—to contend that

> Petitioner's deeply flawed constitutional arguments are addressed

in the brief of Respondent State of Oregon. Patient-Respondents there-

fore do not address this aspect of the petition and instead join the State

of Oregon's Opposition.

they are nigh-universal and thus “the prevailing views”

is simply wrong. Petitioner’s bold assertions ignore the

record in this case and the wider reality. There is, in fact,

a robust debate across the nation about empowering dying

patients to control the time and manner of death, and

thereby avoid protracted and intolerable suffering, by

obtaining medications from their physicians which they

can self-administer to bring about a humane and peace-

ful death.

To assert that the Attorney General’s (mis)characteriza-

tion of the prevailing views of medical practice is entitled

to great deference compounds the error. The relevant author-

ities make clear that Ashcroft’s unilateral assertion of exec-

utive power overriding the intent of Congress, the will of

the people of Oregon, the guidance of this Court in G/ucks-

berg, and the wealth of data from both the medical com-

munity and the wider society, is not entitled to deference.

That petitioner should make such strained arguments

demonstrates his desperation to manufacture issues worthy

of the attention of this Court. He has failed to do so on

each of these core issues—that of the profound questions

regarding dying and modern medicine that lie at the heart

of this dispute, and that of the question of how much

power is accorded to the executive alone in our federal

system.

Il. Asheroft’s Interpretations of the CSA and Its

Regulations Are Not Entitled to Deference.

Petitioner contends that the Court of Appeals erred by

failing to accord Ashcroft’s Directive proper deference.

Yet he provides no support for this bold assertion of exec-

utive power.

An agency's action is subject to separate standards of

review depending upon whether it is interpreting a statute

or its own regulation. Some actions implicate both, as

here. Although Ashcroft stated that “assisting suicide is

not a ‘legitimate medical purpose’ within the meaning of

21 C.F.R. § 1306.04 (2001),” Pet. App. at 102a, Section

1306.04 has nothing to do with suspending a health care

provider's DEA registration. As such, Ashcroft turned to

the CSA itself: “Such conduct by a physician . . . may ren-

der his registration .. . subject to possible suspension or

revocation under 21 U.S.C. § 824(a)(4).” Jd. (quotation

marks omitted).

A. Ashcroft’s Interpretation of the CSA Is not

Entitled to Heightened Deference.

An agency's interpretation of a statute is generally enti-

tled to one of two levels of deference—either the higher

level of deference laid out by Chevron U.S.A., Inc. v. Nat-

ural Resources Defense Council, Inc., 467 U.S. 837 (1984),

or the lower level of respect described in Skidmore v. Swift

& Co., 323 U.S. 134 (1944). Until petitioning this Court,

Ashcroft did not claim Chevron deference; he expressly

relied upon Skidmore below. See, e.g., Br. for Appellants,

2002 WL 32157019 at 22 and 38-40 (Sept. 23, 2002).

Notably, although petitioner demands Chevron deference

in Section |.A.1 of the petition, he does not actually con-

duct a Chevron analysis or even argue for respect under

Skidmore. See Pet. at 11-13. Rather, petitioner simply cites

the standard-setting cases and assumes that the courts must

accord the Directive deference. This is improper.

As a threshold matter, an agency’s interpretation of a

statute is entitled to Chevron deference only if it “appears

that.Congress delegated authority to the agency generally

to make rules carrying the force of law, and that the agency

interpretation claiming deference was promulgated in the

exercise of that authority.” United States v. Mead Corp..

533 U.S. 218, 226-27 (2001). If an agency passes the first

test,’ it still must establish the right to Chevron deference

rather than Skidmore respect. This Court’s recent decisions

in Barnhart v. Walton, 535 U.S. 212 (2002), and Mead

identified the factors used to select between these two

standards. In particular, a court should consider: (1) the

formality of interpretation; (2) the interstitial nature of the

legal question; (3) the expertise of the agency; (4) the

importance of the question to the administration of the

statute; (5) the complexity of that administrative scheme;

(6) the care of consideration; (7) the duration of consider-

ation; and (8) the consistency of interpretation. See Barn-

hart, 535 U.S. at 222; Mead, 533 U.S. at 231-34; see also

James v. Von Zemenszky, 301 F.3d 1364 (Fed. Cir. 2002)

(discussing same). Petitioner neither engaged in an analy-

sis of these factors nor even cited Barnhart or Mead. Their

absence is not surprising, however, as each of the factors

point towards Skidmore s lesser level of respect.

1. The Mead and Barnhart factors require Skid-

more respect, rather than Chevron deference.

First, as even petitioner admits, the Ashcroft Directive

is an “interpretive rule.” See Pet. at 7 (“On November 9,

2001, the Attorney General published an interpretive rule .

...”). Chevron deference is normally withheld from infor-

3 Petitioner simply assumes that he has such power. State of Ore-

gon’s Opposition correctly explains why this is not the case. However,

for the purposes of the following discussion, it may be assumed that he

does possess such authority.

mal agency actions such as interpretive rulings. Barnhart,

535 U.S. at 222. As this Court explained, interpretive rules

are not entitled to the same deference as norms

that derive from the exercise of [an agency’s]

delegated lawmaking powers. Ins‘ead, interpreta-

tions contained in formats such as opinion letters

are ‘entitled to respect’ under [the] decision in

Skidmore v. Swift & Co., but only to the extent

that those interpretations have the power to per-

suade.

Christensen v. Harris County, 529 U.S. 576, 587 (2000)

(quoting Martin v. Occupational Safety and Health Review

Comm'n, 499 U.S. 144, 157 (1991)) (citations and quota-

tion marks omitted).* While discussing this provision, this

Court noted in Mead that “the overwhelming number of

our cases applying Chevron deference have reviewed the

fruits of notice-and-comment rulemaking or formal adjudi-

cation.” Mead, 533 U.S. at 230 n.12. Indeed, just last year

this Court again refused to apply Chevron deference in a

situation similar to the one here. Alaska Dept. of Environ-

mental Conservation v. EPA, 540 U.S. 461; 124 S. Cr. 983,

1001 (2004) (holding that an EPA “internal guidance mem-

oranda ... does not qualify for the dispositive force

described in Chevron”) (citing Christensen, 529 U.S. at

587, and Mead, 533 U.S. at 234).

Second, the Ashcroft Directive was hardly an attempt to

fill an interstitial gap. Unlike in Barnhart, the Ashcroft

Directive does not plug a small hole in a regulatory scheme.

Barnhart, 535 U.S. at 214-215, 223-224 (accepting the

* See also Mead, 533 U.S. at 232 (“{I)nterpretive rules . . . enjoy

no Chevron status as a class.”). Chevron itself explained that it applied

only to “legislative regulations.” Chevron, 467 U.S. at 844.

Social Security Administration’s definitions of “inability”

and “expected to last,” notwithstanding the informal

method used to arrive at those definitions).

Third, the Department of Justice lacks expertise in the

medical field. In fact, in passing the CSA Congress specif-

ically denied the Attorney General the power to make med-

ical or scientific decisions with regards to drug control

within the United States. Instead, Congress placed respon-

sibility for making such decisions in the Department of

Health and Human Service:

The Attorney General shall, before initiating pro-

ceedings [to Schedule a drug], request from the

Secretary [of Health and Human Services] a sci-

entific and medical evaluation, and his recom-

mendations, as to whether such drug or other

substance should be so controlled .... The rec-

ommendations of the Secretary to the Attorney

General shall be binding on the Attorney Gener-

al as to such scientific and medical matters, and

if the Secretary recommends that a drug or other

substance not be controlled, the Attorney Gener-

al shall not control the drug or other substance.

21 U.S.C. § 811(b), Opp. App. at la. Congress certainly

did not intend to grant the Attorney General the power to

decide what constitutes a legitimate medical practice if it

withheld the authority to make medical or scientific deci-

sions as to the scheduling of drugs.

Fourth, the ODWDA is of no importance to the admin-

istration of the CSA, which Congress intended to prevent

drug trafficking and diversion. As the courts’ exhaustive

analyses below have made clear, the CSA was not intend-

ed to address the situations covered by the ODWDA. Pet.

App. at 13a-l14a & n.7; Pet. App. at 89a-92a.

Fifth, the CSA’s administrative scheme has been made

no more complex by protecting Oregon’s physicians from

prosecution when assisting in hastening humanely the

deaths of competent, terminally ill patients in accordance

with the ODWDA. Under the Ashcroft Directive it would be

quite the opposite. DEA agents would be required to deter-

mine a doctor's intent, post-facto, whenever a patient dies

after obtaining a prescription from that patient’s doctor.

Sixth, the Attorney General did not consider the matter

with care. The most probative evidence on the question of

whether physician-assisted dying poses a threat to the pub-

lic is the substantive data gathered pursuant to the

ODWDA.° Yet this wealth of information was not cited

once by either the OLC Memorandum or the Ashcroft

Directive, and there are no findings or analyses anywhere

in them that purport to show how this data relates to the

alleged threat to the public interest. As this Court has

noted, “an agency rule would be arbitrary and capricious if

the agency ... entirely failed to consider an important

aspect of the problem.” Motor Vehicle Manufacturers

Association of the United States, Inc. v. State Farm Mutu-

al Auto Insurance, 463 U.S. 29, 43 (1983).°

> See Section III.B, infra.

* Many courts have heeded this ruling in striking administrative

rules based upon such a lack of honest consideration. See, e.g., /n re

Sang-Su Lee, 277 F.3d 1338, 1344-45 (Fed. Cir. 2002); Texas Office of

Pub. Util. Counsel v. FCC, 265 F.3d 313, 323 (Sth Cir. 2001) cert.

denied 535 U.S. 986 (April 15, 2002); Pacific Coast Fed'n of Fisher-

mens Ass'n, Inc. v. Nat'l Marine Fisheries Serv., 265 F.3d 1028, 1035-

37 (9th Cir. 2001); Sierra Club v. Martin, 168 F.3d 1, 7 (11th Cir.

1999): Dubois v. U.S. Dep't of Agriculture, 102 F.3d 1273, 1285 (ist

Seventh, it is impossible to tell how long the Attorney

General considered his position, as the process occurred

behind closed doors.

Eighth, the Directive is inconsistent with the Attorney

General's prior, definitive position. Attorney General Reno

previously “concluded that the CSA does not authorize

DEA to prosecute, or to revoke the DEA registration of, a

physician who has assisted in a suicide in compliance with

Oregon law.” Letter from Janet Reno, United States Attor-

ney General, Department of Justice, to Henry J. Hyde,

Chairman, Committee on the Judiciary, House of Repre-

sentatives (June 5, 1998), Opp. App. at 53a. Ashcroft’s

interpretation is a complete and improper reversal of this

position.

Thus, all of the factors laid out in Barnhart and Mead

indicate that the Directive is not entitled to Chevron defer-

ence. At most it warrants only Skidmore respect.

2. Ashcroft’s interpretation is entitled to little

respect under Skidmore.

Under Skidmore, an agency’s interpretation of a statute

may be entitled to respect, but the value of this respect

“depend[s] upon the thoroughness evident in its consider-

ation, the validity of its reasoning, its consistency with

earlier and later pronouncements, and all those factors

Cir. 1996); Humphreys v. DEA, 96 F.3d 658, 663 (3d Cir. 1996); Olen-

house v. Commodity Credit Corp., 42 F.3d 1560, 1574-75 (10th Cir.

1994); Puerto Rico Higher Educ. Assistance Corp. v. Rilev, 10 F.3d

847, 852 (D.C. Cir. 1993); Bedford County Mem'l Hosp. v. HHS, 769

F.2d 1017, 1022 (4th Cir. 1985); Menorah Med. Ctr. v. Heckler, 768

F.2d 292, 295-96 (8th Cir. 1985); St. James Hospital v. Heckler, 760

F.2d 1460, 1467-68 (7th Cir. 1985).

which give it power to persuade ... .”. Skidmore, 323

U.S. at 140. Ashcroft’s interpretation fails each of these

criteria—which petitioner did not analyze—and, as

such, was given the proper amount of respect by the court

below.

Ashcroft did not thoroughly consider the matter.

Although Ashcroft told Oregon's Attorney General that he

“would be happy to include [Oregon’s] views” if he ever

revisited the ODWDA, he neither informed Oregon of the

reconsideration nor included its views. See Letter from

Sharpe to Myers (April 17, 2001), Opp. App. 58a. Neither

did he consider any of the data gathered during the first

four years of the ODWDA’s existence. This is more edict

than analysis, and does not merit Skidmore respect.

Ashcroft’s legal reasoning lacks merit. The only legal

precedent cited in the Directive is United States v. Oakland

Cannabis Buyers Coop, 532 U.S. 483 (2001). Pet. App. at

10la (citing same). Yet petitioner entirely abandoned this

authority in the district court and mentioned it only in

passing in the Court of Appeals. See Oregon v. Ashcroft,

192 F. Supp. 2d at 1092 n.20 (citation omitted), Pet. App.

at 94a. This was not surprising as Oakland Cannabis’ sole

holding was that “medical necessity is not a defense to

manufacturing and distributing marijuana.” 532 U.S. at

494. The doctrine of medical necessity is not at issue here,

nor are Schedule | substances, and thus Oakland Cannabis

provides no support for the Directive.

Ashcroft’s interpretation is inconsistent with previous

interpretations. Lastly, as noted above, Ashcroft’s inter-

pretation conflicts with that of his predecessor. See, e.g.,

Hall v. U.S. EPA, 273 F.3d 1146, 1156 (9th Cir. 2001)

‘a

(refusing to defer to an “interpretation advanced [by the

EPA that] does not fit with prior interpretations”).

Based upon the Skidmore factors, petitioner’s interpreta-

tion of the CSA should receive no deference and little

respect.

B. Ashcroft’s Interpretation of § 1306.04 Is Not

Entitled to Seminole Rock Deference.

Just as with its power to interpret statutes, an agency's

power to interpret its regulations is neither unbounded

nor unchecked. Courts “are not obliged to stand aside and

rubberstamp their affirmance of administrative decisions

that they deem inconsistent with a statutory mandate or

that frustrate the congressional policy underlying a

statute.” NLRB v. Brown, 380 U.S. 278, 291 (1965).

Instead, under Seminole Rock, such interpretations must

be struck if “plainly erroneous or inconsistent with the

regulation.” Bowles v. Seminole Rock & Sand Co., 325

U.S. 410, 414 (1945). Although petitioner cites certain

cases from the Seminole Rock line of precedent, he again

simply assumes deference without analysis. See Pet. at

11-12.

An agency must have some regulatory scheme in mind

when it promulgates a rule and may not later depart from

it without promulgating new rules. See Thomas Jefferson

Univ. v. Shalala, 512 U.S. 504, 512 (1994) (noting that a

court should not defer to an agency’s interpretation where

an “alternative reading is compelled by the regulation’s

plain language or by other indications of the Secretary s

intent at the time of the regulation ’s promulgation”) (quot-

ing Gardebring v. Jenkins, 485 U.S. 415, 430 (1988))

(emphasis added).’ Yet this is exactly what Ashcroft

attempted to do by reinterpreting a thirty-year-old regula-

tion to preempt the States’ traditional role as the regulators

of the medical profession within their borders.

In 1971, the Bureau of Narcotics and Dangerous Drugs

published notice of the “Proposed Regulations Implement-

ing the Comprehensive Drug Abuse Prevention and Con-

trol Act of 1970.” Purpose of Issue of Prescription, 36 Fed.

Reg. 4948 (1971), Opp. App. at 3a-4a. The proposed regu-

lation included no official commentary and almost went

unnoticed. The on/y public comment was summarized as

follows: “The National Association of Retail Druggists

objected to the responsibility placed upon a pharmacist

under § [1306.04] to determine the legitimacy of a pre-

scription. The language has been revised to require knowl-

edge.” Comments and Objections to Part 306, 36 Fed.

Reg. 7777 (1971), Opp. App. at 5a-7a. The regulation was

adopted substantially unchanged and has since remained

untouched and largely unconstrued. Purpose of Issue of

Prescription, 36 Fed. Reg. 7799 (1971), Opp. App. at

8a-9a.

Neither the regulation itself nor its lone public com-

ment even hinted at Ashcroft’s expansive interpretation.

If it was intended as Ashcroft later interpreted it, the pro-

posed regulation surely would have been accompanied by

agency commentaries and would have prompted hundreds

of public comments from medical groups and the states.

See, e.g., Caruso v. Blockbuster-Sony Music Entertainment Cen-

tre, 193 F.3d 730, 736-37 (3d Cir. 1999) (“An agency is not allowed to

change a legislative rule retroactively through the process of disingen-

uous interpretation of the rule to mean something other than its origi-

nal meaning.”) (citation omitted).

Moreover, it is rather unlikely that a shift of this mag-

nitude in the constitutional role of the states would have

been achieved by means of a single regulation routinely

promulgated amidst many others. The obvious conclu-

sion is that the Bureau did not intend to federalize the

field of medicine. Ashcroft’s interpretation of § 1306.04

is unreasonable. Thomas Jefferson University, 512 U.S.

at 512.

Lastly, the Ashcroft Directive warrants no deference

because it is contrary to Attorney General Reno’s 1998

interpretation of the same regulation. Ne folk S. Railway v.

Shanklin, 529 U.S. 344, 356 (2000) (striking agency’s

interpretation where it was inconsistent with prior con-

struction). As this Court recently wrote in an analogous

situation, “[a]lthough generally an agency’s construction

of its own regulations is entitled to substantial deference,

no such deference is appropriate here. Not only is the

[agency's] interpretation inconsistent with the text of [the

regulation], but it also contradicts the agency’s own previ-

ous construction ....” /d. (citation omitted).*

Given these faults, the Directive is “plainly erroneous

[and] inconsistent with the regulation.” Seminole Rock,

325 U.S. at 414. Ashcroft’s interpretation is not entitled to

Seminole Rock deference.

‘See also Solid Waste Agency of Northern Cook County v. Unit-

ed States Army Corps of Engineers, 531 U.S. 159, 168 (2001) (noting

that the agency interpretation before the Court reversed the agency's

prior interprevation of the same rule, yet the agency had “put forward

no persuasive evidence that the [agency] mistook Congress’ intent” the

first time); Hail, 273 F.3d at 1156.

Ill. Petitioners’ Contention That the Directive Sets

Forth the “Prevailing Views” of Physician-Assisted

Dying Is Unsupported and Unsupportable.

Notwithstanding the broad support for physician-assist-

ed dying demonstrated in the record below, petitioner con-

tinues to proclaim that the “prevailing views” of the

practice are that it is illegitimate, Pet. at 12-13, and that

those who support it are “far outside the mainstream.” Pet.

at 26-27.° This premise is unsupportable and reveals peti-

tioner’s disregard for the wide range of views on this seri-

ous issue. Petitioner’s studied ignorance extends even to

the most clearly relevant information regarding the prac-

tice of physician-assisted dying in the United States: the

data reported on Oregon’s six years of experience with

physician-assisted dying under the strict regulation of the

ODWDA.!'® While petitioner disregards the evidence, sub-

stantial support exists for the right of terminally-ill, com-

petent adults to control the time, place, and manner of their

impending deaths through the option of physician-assisted

dying. There is simply no basis to support a blanket con-

tention that a physician assisting a dying patient’s exercise

of this right by prescribing medications is acting outside

the bounds of legitimate medical practice.

% See also Pet. at 6-7 (relying on Memorandum for the Attorney

General from the Office of Legal Counsel, June 27, 2001 (“OLC

Memo”), Pet. App. at 115a-117a; Oregon v. Ashcroft, 192 F. Supp. 2d.

at 1083-84 (stating that the OLC Memo was written without any

request for or consideration of Oregon statistics or input from Oregon

representatives), Pet. App. at 75a-76a.

10 The seventh year of implementation is just concluded and a

report regarding the seventh year’s data will issue in February 2005.

A. The Public, the Medical Community, and the

States Are Divided on the Question of Physi-

cian-Assisted Dying.

Petitioner cites only selected portions of this Court's

1997 Glucksberg decision and the OLC Memo to support

his contention that the “prevailing views” toward physi-

cian-assisted dying are that the practice is illegitimate.

What is more, the OLC Memo itself relies almost exclu-

sively upon incomplete and one-sided materials—namely,

selected amici briefs submitted by opponents of physician-

assisted dying in the Glucksherg case. Of course, there also

were numerous amici briefs submitted in that case by those

supportive of the practice. Petitioner likewise disregards

the wide variety of amici that submitted briefs below in this

case supporting the legitimacy of physician-assisted dying.

Petitioner disregards the support given by the citizens of

Oregon that twice voted to adopt the ODWDA, choosing

instead to characterize this entire polity as “far outside the

mainstream.” Petitioner also ignores the vast body of liter-

ature-—including, most notably, everything that has hap-

pened since 1997—demonstrating that the debate

concerning physician-assisted dying is vibrant and ongo-

ing amongst the public, the health care community, and the

States, as this Court predicted and encouraged. Glucks-

berg, 521 U.S. at 735. Recognizing the diversity of views

within the medical community on the question, a signifi-

cant number of medical associations have decided to

embrace a position of “studied neutrality” on the question

of legalizing physician-assisted dying.'' Moreover, it is

'! See, e.g., Quill, Timothy E. MD; Cassel, Christine K. MD, Pro-

fessional Organizations’ Position Statements on Physician-Assisted Sui-

cide: A Case for Studied Neutrality, Annals of Internal Medicine. Vol.

increasingly an informed debate: as more data emerges

from the State of Oregon, speculation gives way to empir-

ical evidence about the relative risks and benefits of the

practice. !?

B. The Data Regarding Oregon’s Experience

with the ODWDA Demonstrate That Legal

Physician-Assisted Dying Poses No Threat

to Public Health.

Petitioner’s studied ignorance extends beyond the gen-

eral to the specific: he ignores the actual data collected

during Oregon’s six years of experience with legal physi-

cian-assisted dying. Ashcroft’s Directive simply assumed

that the ODWDA harmed Oregonians without examining

the facts. The Oregon data is not mentioned even once in

the Directive, the OLC Memo, petitioner’s briefs below,

nor even in the petition for certiorari.

As required by the ODWDA, Oregon’s experience with

legal physician-assisted dying has been extensively docu-

mented and studied. Or. Rev. Stat. § 127.865, Opp. App. at

10a. To date, the Oregon Health Division and/or the Ore-

gon Department of Human Service Office of Disease Pre-

vention and Epidemiology have issued six annual reports

that present and evaluate the State’s experience with the

138(3) (2003), pp. 208-211 (attaching appendix listing Medical Organi-

zations with Neutral Stance on Physician-Assisted Suicide).

2 See, e.g., Lunge, R.; Royle, M.; Slater, M.; Legislative Council,

Oregon's Death With Dignity Law and Euthanasia in the Netherlands:

Factual Disputes (2004), found at: http://www.leg.state.vt.us/reports/

04Death/ Death With Dignity Report.html (2004 report to the Ver-

mont legislature by the Vermont Legislative Council).

ODWDA.'* These reports present the only reliable data

regarding the experience of legal, regulated physician-

assisted dying in America.

The data demonstrate that physician-assisted dying

does not pose a threat to public health and safety. Physi-

cian-assisted dying is not being forced upon those who

are uneducated, uninsured or otherwise disadvantaged, a

threat that opponents of the ODWDA speculated would

materialize.

Further, the data demonstrate that use of physician-

assisted dying is quite limited. During the six years in

which the practice has been legal in Oregon, a total of 171

Oregonians have chosen this option. Sixth Annual Report

at 19, Opp. App. at 35a. The number of terminally-ill

adults choosing this option in 2003 represents only one-

seventh of one percent—i.e., 0.14 percent—of Oregonians

who died that year. /d. at 5, Opp. App. at 20a.

Indeed, rather than posing a risk to patients or the med-

ical profession, the ODWDA has led to significant

improvements in the care of the dying in Oregon. /d. at 16,

Opp. App. at 32a. In the course of considering passage of

a similar law, the State of Vermont reviewed the Oregon

experience and concluded that “it is [quite] apparent from

credible sources in and out of Oregon that the Death with

Dignity Act has not had an adverse impact on end-of-life

care and in all probability has enhanced the other options.”

See, e.g., Sixth Annual Report on Oregon's Death with Dignity

Act, Department of Human Services Office of Disease Prevention and

Epidemiology, March 10, 2004 (“Sixth Annual Report”), Opp. App. at

11a; Fifth Annual Report on Oregon's Death with Dignity Act, Depart-

ment of Human Services, Office of Disease Prevention and Epidemi-

ology, March 6, 2003, Opp. App. at 44a.

R. Lunge er a/., Oregon’s Death With Dignity Law and

Euthanasia in the Netherlands: Factual Disputes, at p. 26.

In sum, the available data demonstrate that physician-

assisted dying, far from posing any hazard to patients or

the practice of medicine, has galvanized improvements in

end-of-life care, benefiting all terminally-ill Oregonians.

Petitioner ignores this data just as he ignored it wher issu-

ing the Directive. Rather than face the facts of this data

and the fact that many within the medical community and

the wider society hold views contrary to his own, petition-

er asserts that the courts must defer to his blinkered view

of the “prevailing views.” Such studied ignorance warrants

no deference by this Court, and thus this case does not

warrant review.

CONCLUSION

The petition seeks to manufacture issues worthy of this

Court’s review where there are none. In doing so, it mis-

characterizes the state of the debate on the profound issue

of pnysician-assisted dying, and compounds this error by

contending that the courts must defer to the Attorney

General’s narrow views on the subject. The first defies the

facts and the second the law. The decision below is a well-

reasoned and narrow construction of the CSA, and is not

contrary to the decision of any other circuit. The petition

for a writ of certiorari should be denied.

Respectfully submitted,

NICHOLAS W. van AELSTYN

Counsel of Record

AARON S. JACOBS

CHARLES W. BURK

HELLER EHRMAN WillTE & MCAULIFFE LLP

333 Bush Street

San Francisco, CA 94104-2878

Telephone: (415) 772-6000

Facsimile: (415) 772-6268

Counsel for Patient-Respondents

KATHRYN L. TUCKER

COMPASSION & CHOICES

1201 3rd Avenue, 40th Floor

Seattle, WA 98101-3000

Telephone: (206) 367-2134

Facsimile: (206) 583-8500

Counsel for Patient-Respondents

APPENDIX

APPENDICES

21 U.S.C. §811(b)

§ 306.04 — Purpose of issue of Prescription,

36 Fed. Reg. 4948 (March 13, 1971)

Comments and Objections to Part 306,

36 Fed. Reg. 7777 (April 24, 1971)

§ 306.04 —Purpose of Issue of Prescription,

36 Fed. Reg. 7799 (April 24, 1971)

The Oregon Death With Dignity Act —

Or. Rev. Stat. § 127.865

Oregon Department of Human Services,

Sixth Annual Report on Oregon's Death

with Dignity Act, March 10, 2004; and

March 16, 2004 cover letter from Hilary

E. Ware submitting same to Court of Appeal

for consideration

K. Hedberg, M.D., M.P.H.; D. Hopkins, M.S.,;

M. Kohn, M.D., M.P.H.; Five Years of Legal

Physician-Assisted Suicide in Oregon,

New England Journal of Medicine,

Volume 348:961-964, March 6, 2003; and

March 19, 2003 cover letter from Hilary E.

Ware submitting same to Court of Appeal

June 5, 1998 letter from U.S. Attorney General

Janet Reno to Henry J. Hyde, Chairman of

Committee on the Judiciary, U.S. House of

February 2, 2001 letter from Hardy Myers,

Oregon Attorney General, to John Ashcroft,

Attorney General of the United States ......... 55a

April 17, 2001 letter from Lori Sharpe, Director

and Advisor to the U.S. Attorney General,

to Hardy Myers, Oregon Attorney General .... 58a

21 U.S.C. § 811(b)

§ 811. Authority and criteria for classification of

substances

(b) Evaluation of drugs and other substances

The Attorney General shall, before initiating proceed-

ings under subsection (a) of this section to control a drug

or other substance or to remove a drug or other substance

entirely from schedules, and after gathering the necessary

data, request from the Secretary a scientific and medical

evaluation, and his recommendations, as to whether such

drug or other substance should be so controlled or

removed as a controlled substance. In making such eval-

uation and recommendations, the Secretary shall consider

the factors listed in paragraphs (2), (3), (6). (7), and (8)

of subsection (c) of this section and any scientific or

medical considerations involved in paragraphs (1), (4),

and (5) of such subsection. The recommendations of the

Secretary shall include recommendations with respect to

the appropriate schedule, if any, under which such drug

or other substance should be listed. The evaluation and

the recommendations of the Secretary shall be made in

writing and submitted to the Attorney General within a

reasonable time. The recommendations of the Secretary

to the Attorney General shall be binding on the Attorney

General as to such scientific and medical matters, and if

the Secretary recommends that a drug or other substance

not be controlled, the Attorney General shall not control

the drug or other substance. If the Attorney General

determines that these facts and all other relevant data

constitute substantial evidence of potential for abuse

such as to warrant control or substantial evidence that the

drug or other substance should be removed entirely from

the schedules, he shall initiate proceedings for control or

removal, as the case may be, under subsection (a) of this

section.

FEDERAL

VOLUME 36 ° NUMBER 50

Saturday, March 13, 1971 ¢ Washington, D.C.

Department of

Justice

Bureau of Narcotics and

Dangerous Drugs

Proposed Regulations

Implementing the Comprehensive

Drug Abuse Prevention

and Control Act of 1970

PART II

PART 306—PRESCRIPTIONS

GENERAL INFORMATION

§ 306.04 Purpose of issue of prescription.

A prescription for a controlled substance to be effective

must be issued for a legitimate medical purpose by a prac-

titioner acting in the usual course of his professional prac-

tice. The responsibility for the proper prescribing and

dispensing of controlled substances is upon the prescribing

practitioner, but a corresponding responsibility rests with

the pharmacist who fills the prescription. An order pur-

porting to be a prescription issued not in the usual course

of professional treatment or in legitimate and authorized

research is not a prescription within the meaning and intent

of section 309 of the Aci (21 U.S.C. 829) and the person

filling such a prescription, as well as the person issuing it,

shall be subject to the penalties provided for violations of

the provisions of law relating to controlled substances.

FEDERAL

VOLUME 36 «© NUMBER 80

Saturday, April 24,1971 © Washington, D.C.

PART II

Department of

Justice

Bureau of Narcotics and Dangerous

Drugs

Regulations Implementing

the Comprehensive

Drug Abuse Prevention

and Control Act of 1970

COMMENTS AND OBJECTIONS TO PART 306

|. The National Association of Retail Druggists objected

to the responsibility placed upon a pharmacist under § 306.04

to determine the legitimacy of a prescription. The language

has been revised to require knowledge.

2. Several pharmacy groups protested the requirement

under § 306.11(c)(4) that, if a doctor fails to provide an

authorization for emergency order as required, the phar-

macist must so report to the Bureau or be liable for dis-

pensing a substance in schedule II without a written

prescription. The Director considered the problems and

concluded that only this mechanism assures information to

the Bureau about doctors who refuse to comply with the

Act.

3. The American Pharmaceutical Association and the

National Association of Chain Drug Stores suggested that,

in the case of a partial filling of a schedule II substance,

the pharmacist notify the doctor only when the remainder can-

not be filled, in order for the doctor to issue a new prescrip-

tion. The language was revised accordingly.

4. All retail druggist associations urged revision in the

labeling requirements for prescriptions set forth in §§ 306.14

and 306.23. In response, the Director has had the require-

ments of inclusion of the patient’s address and the doctor's

registration number deleted.

5. In response to a comment from the National Associa-

tion of Retail Druggists, a definition of prescription was

added which covers all orders for medication except hos-

pital orders (i.e., orders for medication to be administered

immediately and cannot be removed from the hospital

either by an out-patient or by an in-patient being dis-

charged). Sections 306.11, 306.21, and 306.31 were

revised to indicate that institutional practitioners (e.g.,

— can only dispense by prescription or hospital

order.

6. Several questions were asked about the status of pare-

goric. This is a schedule III substance which is not now a

prescription drug under the Food, Drug and Cosmetic Act

and therefore not subject to the prescription requirements

of the Controlled Substances Act. Until such time as it

becomes a prescription drug, the Director has determined

to treat it in the same manner as a schedule V substance.

Section 306.32 has been revised accordingly.

FEDERAL

VOLUME 36 - NUMBER 80

Saturday, April 24. 1971 ° Washington, D.C.

PART Il

Department of

Justice

Bureau of Narcotics and Dangerous

Drugs

Regulations Implementing

the Comprehensive

Drug Abuse Prevention

and Control Act of 1970

§ 306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effec-

tive must be issued for a legitimate medical purpose by an

individual practitioner acting in the usual course of his

professional practice. The responsibility for the proper

prescriting and dispensing of controlled substances is

upon the prescribing practitioner, but a corresponding

responsibility rests with the pharmacist who fills the pre-

scription. An order purporting to be a prescription issued

not in the usual course of professional treatment or in

legitimate and authorized research is not a prescription

within the meaning and intent of section 309 of the Act (21

U.S.C. 829) and the person knowingly filling such a pur-

ported prescription, as well as the person issuing it, shall

be subject to the penalties provided for violations of the

provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an indi-

vidual practitioner to obtain controlled substances for sup-

plying the individual practitioner for the purpose of general

dispensing to patients.

of narcotic drugs listed in any schedule to a narcotic drug

dependent person for the purpose of continuing his depend-

ence upon such drugs, in the course of conducting an

authorized clinical investigation in the development of a

narcotic addict rehabilitation program.

10a

The Oregon Death With Dignity Act

Or. Rev. Stat. § 127.865

Reporting requirements.

(1)(a) The Department of Human Services shall annu-

ally 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 col-

lection 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 ¢.423 §9; 2001 c.104 § 40]

[LETTERHEAD]

HELLEREHRMAN

ATTORNEYS

Hilary E. Ware

March 16, 2004 hware@hewm.com

Direct (415) 772-6459

: Main (415) 772-6

Via Hand Delivery Fax ( rr 773-4308

[Stamp]

RECEIVED

OFFICE OF THE CLERK

U.S. COURT OF APPEALS

PUBLIC INFORMATION UNIT

04 MAR 16 PM 12:03

FILED

DOCKETED

DATE INITIAL

Office of the Clerk

United States Court of Appeals for the

Ninth Circuit

P.O. Box 193939

San Francisco, CA 94119-3939

Re: State of Oregon et al., y. Ashcroft

Case No. 02-35587

Dear Sir or Madam:

Pursuant to Rule 28(j) of the Federal Rules of Appellate

Procedure, the Patient Plaintiffs-Appellees in the above-

mentioned case wish to bring to the Court’s attention a sig-

nificant supplemental authority that has recently been

released. On March 10, 2004, the Oregon Department of

|2a

Human Services released the “Sixth Annual Report on

Oregon's Death with Dignity Act,” an examination of data

from the sixth year of the Oregon Death With Dignity Act

(“ODWDA”). The Patient Plaintiffs-Appellees cited and

discussed the data contained in the reports from the first

four years of the ODWDA in their Brief at pages 13-14 and

37 n. 105, and submitted the report from the fifth year by

a similar request on March 19, 2003. This report should

also be considered in that context. | |

A copy of this report is enclosed with this request, and

is also available at / | :

chs/pas/pas.cfm. Thank you for your consideration of this

request.

Very truly yours,

/s/ HILARY E. WARE

Hilary E. Ware

-_-

cc: All Counsel of Record

Enclosures

[Letterhead bottom: ]

Heller Ehrman White & McAuliffe LLP

333 Bush Street

San Francisco, CA 94104-2878

www.hewm.com

San Francisco Silicon Valley Los Angeles San Diego

Seattle Portland Anchorage New York Washington D.C.

Madison, WI Hong Kong Singapore

Affiliated Offices: Milan Paris Rome

l3a

PROOF OF SERVICE BY FACSIMILE AND U.S. MAIL

I, Gary Padilla, declare as follows:

| am employed with the law firm of HELLER, EHRMAN,

Wuite & MCAULIFFE, whose address is 333 Bush Street,

San Francisco, California 94104-2878. | am readily famil-

iar with the business practices of this office for collection

and processing of correspondence for mailing with the

United States Postal Service and for the transmission of

documents by facsimile. | am over the age of eighteen

years and not a party to this action.

On March 16, 2004, I served the following document:

LETTER TO COURT CLERK RE SUPPLEMENTAL AUTHORITY

PURSUANT TO RULE 28(j) OF THE FEDERAL RULES OF APPEL-

LATE PROCEDURE

on the below party(s) in this action by transmitting by fac-

simile machine and by placing true copies thereof in sealed

envelopes, addressed as shown, for collection and mailing

pursuant to the ordinary business practice of this office

which is that correspondence for mailing is collected and

deposited with the United States Postal Service on the

same day in the ordinary course of business:

Gregory Katsas, Esq. Robert B. Rocklin

Mark B. Stern, Esq. Assistant Attorney General

Jonathan H. Levy, Esq. Appellate Division

U.S. Dept. of Justice — Oregon Department of Justice

Civil Division 1162 Court Street NE

Appellate Staff Salem, OR 97301-4096

Room 9541 PHB

601 D Street, N.W.

Washington, D.C. 20530-0001

l4a

Eli D. Stutsman Stephen K. Bushong

621 SW Morrison, 13th Floor Trial Division

Portland, OR 97205 Oregon Department of Justice

1162 Court Street, NE

Salem, OR 97301-4096

Kathryn Tucker

Compassion in Dying Federation

1201 3rd Avenue, 40th Floor

Seattle, WA 98101-3000

| declare under penalty of perjury under the laws of the

State of California that the foregoing is true and correct.

Executed at San Francisco, California, on March 16,

2004.

/s/ GARY PADILLA

Gary Padilla

l5a

Sixth Annual Report on

Oregon's Death with

Dignity Act

[Stamp]

STATE OF OREGON

1859

Department of Human Services

Office of Disease Prevention and Epidemiology

March 10, 2004

[Logo]

DHS

Oregon Department

of Human Services

l6a

Sixth Annual Report on

Oregon's Death with

Dignity Act

For more information contact:

Darcy Niemeyer

Department of Human Services, Health Services

Office of Disease Prevention and Epidemiology

800 N.E. Oregon Street, Suite 730

Portland, OR 97232

E-mail: darcy.niemeyer(@state.or.us

Phone: 503-731-4023

Fax: 503-731-4082

http://www. dhs. state. or.us/publichealth/chs/pas/pas.cfm

Contributing Editor: Richard Leman, MD

Date Analysis: David Hopkins, MS

Acknowledgements

This assessment was conducted as part of the required

surveillance and public health practice activities of the

Department of Human Services and was supported by

Department funds.

17a

Table of Contents

Methods

The Reporting System.......................

SI Bibi ke cats de a

Re ea

References..................

Tables

NY A BD &

18a

SUMMARY

Physician-assisted suicide ( PAS) has been legal in Ore-

gon since November 1997, when Oregon voters approved

the Death with Dignity Act (DWDA) for the second time

(see History, page 6). The Department of Human Services

(DHS) is legally required to collect information regarding

compliance with the Act and make the information avail-

able on a yearly basis. In this sixth annual report, we charac-

terize the 42 Oregonians who, in 2003, ingested medications

prescribed under provisions of the Act, and look at whether

the numbers and characteristics of these patients differ

from those who used PAS in prior years. Patients choosing

PAS were identified through mandated physician and phar-

macy reporting. Our information comes from these reports,

physician interviews and death certificates. We also com-

pare the demographic characteristics of patients participat-

ing during 1998-2003 with other Oregonians who died of

the same underlying causes.

In 2003, 42 physicians wrote a total of 67 prescriptions

of lethal doses of medication. The number of prescriptions

written increased in each of the previous years: 58 pre-

scriptions were written in 2002. 44 in 2001, 39 in 2000, 33

in 1999. and 24 in 1998. Thirty-nine of the 2003 prescrip-

tion recipients died after ingesting the medication. Of the

28 persons who did not ingest the prescribed medication,

18 died from their illnesses, and 10 were alive on Decem-

ber 31. 2003. In addition, two patients who received pre-

scriptions during 2002 and another who received a

prescription in 2001 died in 2003 after ingesting their med-

ication for a total of 42 PAS deaths during 2003.

There were four more patients who used PAS in 2003

than in 2002, and the number of patients ingesting lethal

19a

medication has increased over the six years since legaliza-

tion. In 2003, 42 patients died from PAS, compared to 38

in 2002, 21 in 2001, 27 in 2000, 27 in 1999, and 16 in 1998

co The 42 patients who ingested lethal medications in

2 represent an estimated 14/10,000 total deaths, com-

pared with 12.2 in 2002, 7.0 in 2001, 9.1 in 2000, 92 in

I 999, and 5.5 in 1998. Compared to all Oregon decedents

in 2063, PAS participants were more likely to have malig-

nant neoplasms (83%), to be younger (median age 73

years), and to have more formal education (48% had at

least a baccalaureate degree).

During the past six years, the 171 patients who took

lethal medications differed in several ways from the 53,544

Oregonians dying from the same underlying diseases

Rates of participation in PAS decreased with age, but were

higher among those who were divorced or never married

those with more years of education, and those with omy-

otrophic lateral sclerosis, HIV/AIDS, or malignant neo-

plasms ( see Patient Characteristics, page 12).

| Physicians indicated that patient requests for lethal med-

ications stemmed from multiple concerns related to auton-

omy and control at the end of life. The three most

commonly mentioned end-of-life concerns during 2003

were: loss of autonomy, a decreasing ability to participate

in activities that made life enjoyable, and a loss of dignity

(see End of Life Concerns, page 15).

During 2003, 37 patients (88%) used pentobarbital as

their lethal medication, four patients (10%) used secobar-

bital, and one (2%) used secobarbital/amobarbital (Tuinal)

(see Lethal Medication, page 14). |

During 2003, complications were reported for three

patients. All involved regurgitation and none involved

seizures (see Complications, page 14). One-half of patients

20a

became unconscious within four minutes of ingestion of

the lethal medication and died within 20 minutes. The

range of time from ingestion to death was five minutes to

48 hours. Emergency medical services were called by one

patient's family to pronounce death; neither resuscitation

nor transport was requested.

Although the number of Oregonians ingesting legally

prescribed lethal medications has increased, the overall

number of terminally ill patients ingesting lethal medica-

tion has remained small, with about 1/7 of one percent of

Oregonians dying by physician-assisted suicide.

INTRODUCTION

This sixth annual report reviews the monitoring and data

collection system that was implemented under Oregon’s

Death with Dignity Act (DWDA), which legalizes physi-

cian-assisted suicide (PAS) for terminally ill Oregon resi-

dents. This report summarizes the information collected on

patients and physicians who participated in the Act in its

sixth year of implementation (January 1, 2003 to Decem-

ber 31, 2003) and examines trends over the six years since

legalization. Using physician reports, interviews, and

death certificates. we address the following questions: Is

the number of residents using legal PAS in Oregon increas-

ing? Do patients who participated in 2003 resemble

patients using PAS in previous years and other Oregonians

dying from similar diseases? Have any changes occurred

in the PAS process during the past six years?

2la

History

| The Oregon Death with Dignity Act was a citizen's ini-

tiative first passed by Oregon voters in November 1994

with 31% in favor. Implementation was delayed by a legal

injunction, but after proceedings that included a petition

denied by the United States Supreme Court, the Ninth Cir-

cuit Court of Appeals lifted the injunction on October 27

1997. In November 1997, a measure asking Oregon voters

to repeal the Death with Dignity Act was placed on the

general election ballot (Measure 51, authorized by Oregon

House Bill 2954). Voters rejected this measure by a margin

of 60% to 40%, retaining the Death with Dignity Act. After

voters reaffirmed the DWDA in 1997, Oregon became the

only state allowing legal physician-assisted suicide [6]

Although physician-assisted suicide has been legal in

Oregon for six years, it remains highly controversial. On

November 6, 2001, US Attorney General John Ashcroft

issued a new interpretation of the Controlled Substances

Act, which would prohibit doctors from prescribing con-

trolled substances for use in physician-assisted suicide. To

date, all the medications prescribed under the Act have

been barbiturates, which are controlled substances and

therefore, would be prohibited vy this ruling for use in

PAS. In response to a lawsuit filed by the State of Oregon

on November 20, 2001, a US district court issued a tem-

porary restraining order against Ashcroft’s ruling pending

a new hearing within 5 months. On April 17, 2002, U.S

District Court Judge Robert Jones upheld the Death with

Dignity Act. In September 2002, Attorney General Ash-

croft filed an appeal, asking the Ninth U.S. Circuit Court

of Appeals to overturn the District Court's ruling. At this

time, Oregon's law remains in effect.

Requirements

The Death with Dignity Act allows terminally ill Oregon

residents to obtain and use prescriptions from their physi-

cians for self-administered, lethal medications. Under the

Act, ending one’s life in accordance with the low does not

constitute suicide. However, we use the term physician-

assisted suicide” because it is used in the medical literature

to describe ending life through the voluntary self-adminis-

tration of lethal medications prescribed by a physician for

that purpose. The Death with Dignity Act legalizes PAS,

but specifically prohibits euthanasia, where or

or other person directly administers a medication to en

another's life. [6] airy

To request a prescription for lethal medications, the

Death with Dignity Act requires that a patient must be:

e An adult (18 years of age or older),

e Aresident of Oregon,

e Capable (defined as able to make and communicate

health care decisions),

e Diagnosed with a terminal illness that will lead to

death within six months.

Patients meeting these requirements are eligible to

request a prescription for lethal medication from a licensed

Oregon physician. To receive a prescription for lethal med-

ication, the following steps must be fulfilled:

his or

The patient must make two oral requests to

: her sieuiatan, separated by at least 15 days.

i his

e The patient must provide a written statement to fh

or bor ghyetelan. signed in the presence of two wit-

nesses.

23a

¢ The prescribing physician and a consulting physi-

cian must confirm the diagnosis and prognosis.

¢ The prescribing physician and a consulting physi-

cian must determine whether the patient is capable.

¢ If either physician believes the patient’s judgment

is impaired by a psychiatric or psychological disor.

der, the patient must be referred for a psychologi-

cal examination.

e The prescribing physician must inform the patient

of feasible alternatives to assisted suicide includ-

ing comfort care, hospice care, and pain control.

¢ The prescribing physician must request, but may

not require, the patient to notify his or her next-of-

kin of the prescription request.

To comply with the law, physicians must report to the

Department of Human Services (DHS) all prescriptions for

lethal medications [7]. Reporting is not required if patients

begin the request process but never receive a prescription.

In the summer of 1999, the Oregon legislature added a

requirement that pharmacists must be informed of the pre-

scribed medication’s ultimate use. Physicians and patients

who adhere to the requirements of the Act are protected

from criminal prosecution, and the choice of legal physi-

cian-assisted suicide cannot affect the status of a patient's

health or life insurance policies. Physicians and health care

Systems are under no obligation to participate in the Death

with Dignity Act [6].

24a

METHODS

The Reporting System

DHS is required by the Act to develop and maintain a

reporting system for monitoring and collecting informa-

tion on PAS [6]. To fulfill this mandate, DHS uses a sys-

tem involving physician and pharmacist compliance reports,

death certificate reviews, and follow-up interviews [7].

When a prescription for lethal medication is written, the

physician must submit to DHS information that documents

compliance with the law. We review all physician reports

and contact physicians regarding missing or discrepant

data. DHS Vital Records files are searched periodically for

death certificates that correspond to physician reports.

These death certificates allow us to confirm patients’

deaths, and provide patient demographic data (e.g., age.

place of residence, level of education).

In addition, using our authority to conduct special stud-

ies of morbidity and mortality [8], DHS has conducted

telephone interviews with prescribing physicians after

receipt of the patients’ death certificates. Each physician

was asked to confirm whether the patient took the lethal

medications. If the patient had taken the medications, we

asked physicians for information that was not available

from physician reports or death certificates—including

insurance status and enrollment in hospice. We asked why

the patient requested a prescription, specifically exploring

concerns about the financial impact of the illness, loss of

autonomy, decreasing ability to participate in activities

that make life enjoyable, being a burden, loss of control of

bodily functions, uncontrollable pain, and loss of dignity.

We collected information on the time to unconsciousness

and death, and asked about any adverse reactions. Because

25a

physicians are not legally required to be present when a

patient ingests the medication, not all have information

about what happened when the patient ingested the med-

ication. If the prescribing physician was not present, we

accepted information they had based on discussions with

family members, friends or other health professionals who

attended the patients’ deaths. We do not interview or col-

lect any information from patients prior to their death

Reporting forms and the physician questionnaire are avail-

able at http://www.dhs.state.or.us/publichealth/chs/pas/

pasforms.cfm.

Data Analyses

We classified patients by year of participation based on

when they ingested the legally-prescribed lethal medica-

tion. Using demographic information from 1997-2002 Ore-

gon death certificates (the most recent years for which

complete data are available), we compared patients who

used legal PAS with other Oregonians who died from the

same diseases. Demographic- and disease-specific PAS

rates were computed using the number of deaths from the

same causes as the denominator. The overall PAS rates by

year were computed using the total number of resident

deaths. Annual rates were calculated using numerator and

denominator data from the same year, except for 2003

where the number of resident deaths from 2

as the denominator. ™ =

26a

RESULTS

Both the number of prescriptions written and the number

of Oregonians using PAS have increased over the six years

that PAS has been legal in Oregon. In 2003, 42 physicians

wrote 67 prescriptions for lethal doses of medication. The

number of prescriptions written has increased over the Six

years since legalization: 58 prescriptions were written in

2002, 44 in 2001, 39 in 2000, 33 in 1999 and 24 in 1998.

Thirty-nine of the 2003 prescription recipients died after

ingesting the medication. Of the 28 recipients who did not

ingest the prescribed medication in 2003, 18 died from

their illnesses, and 10 were alive on December 31, 2003. In

addition, two patients who received prescriptions during

2002 and another who received a prescription in 2001 died

in 2003, after ingesting their medication, giving a total of

42 PAS deaths during 2003 (Figure /). Thirty different

physicians wrote the 42 prescriptions for lethal medication.

}

' of DWDA Applicants and Desths by Year,

Figure 1. Number

Number

~eeeeeueaea2aes s&s

27a

The number of patients ingesting lethal medication has

increased over the six years since legalization. The 42 PAS

deaths in 2003 compare to 38 in 2002, 21 in 2001, 27 in

2000, 27 in 1999, and 16 in 1998. The 42 patients who

ingested lethal medications in 2003 represent an estimated

14/10,000 total deaths compared with 12.2 in 2002, 7.0 in

2001, 9.1 in 2000, 9.2 in 1999, and 5.5 in 1998.

The percentage of patients referred to a specialist for

psychological evaluation has declined, falling from 31 per-

cent in 1998 to five percent in 2003.

Patient Characteristics

Oregonians using PAS during 2003 differed from those

of previous years in several ways. They were more apt to be

older (their median age was 73 compared to 69 for those

using PAS in preceding years); they were more apt to have

at least a baccalaureate degree (48% did so compared to

38% of their predecessors); and a greater proportion of

patients resided in Multnomah, Clackamas, and Washing-

ton counties (45% vs. 37%). However, these figures are

based on relatively few events and do not represent statisti-

cally significant differences (Table 1).

Although year-to-year variations occur, certain demo-

graphic patterns have become evident over the past six

years. Males and females were equally likely to take advan-

tage of the DWDA, but terminally ill younger persons were

significantly more likely to turn to PAS than their older

counterparts; 18- to 34-year-olds were 5.3 times more likely

to use PAS than were those 85 or older (Table 2 and Figure

2). Asian Oregonians were about three times as likely to use

PAS as were white Oregonians. Divorced and never-mar-

ried persons were about two times more likely to use PAS

28a

than married and widowed residents. A higher level of edu-

cation was strongly associated with the use of PAS; Orego-

nians with a baccalaureate degree or higher were 7.6 times

more likely to use PAS than those without a high school

diploma. By region, residents living east of the Cascade

Range were less than half as likely to use PAS as those liv-

ing in western Oregon.

The type of terminal illness is a strong predictor of the

likelihood of a patient using PAS (Table 3). The rates of

DWDA deaths to non-PAS deaths resulting from the same

causes were high for three conditions: amyotrophic lateral

sclerosis (ALS) (249.0 per 10,000), HIV/AIDS (171.4),

and malignant neoplasms (37.6). Among the causes associ-

ated with at least three deaths, the lowest rate (9.7) was for

patients with chronic lower respiratory diseases (CLRD),

such as emphysema. Persons with ALS (Lou Gehrig’s dis-

29a

ease) were more than 25 times as likely to use PAS as were

those with CLRD.

During 2003, most patients died at home, but two died

at assisted living residences while another died in a physi-

cian’s office. All individuals had some form of health

insurance (Table 4). As in previous years, most (93%) of

the patients who used PAS in 2003 were enrolled in hos-

pice care. The median length of the patient-physician rela-

tionship was ten weeks.

Physician Characteristics

The prescribing physicians of patients who used PAS

during 2003 had been in practice a median of 21.5 years

(range 3-35). Their medical specialties included: internal

medicine (12%), oncology (38%), family medicine (45%),

and other (5%).

Prescribing physicians were present while 12 (29%) of

the 42 patients ingested the lethal medications. Among the

remaining 30 patients, 67% ingested the medication in the

presence of another health-care provider/volunteer.

During 2003, one case involving possible non-compli-

ance with DWDA provisions regarding witnessing of sig-

natures was reported to the Oregon Board of Medical

Examiners.

Lethal Medication

During 1998-2002, secobarbital was the lethal medica-

tion prescribed for 85 of the 129 patients (66%). During

2003, 37 patients (88%) used pentobarbital, four patients

used secobarbital, and one used secobarbital/amobarbital.

Since the DWDA was implemented, 52% of the PAS

30a

patients used secobarbital, 46% used pentobarbital, and 2%

used other medications (mostly secobarbital/amobarbital).

Complications

During 2003, physicians reported that three patients

experienced complications: a small emesis was reported for

one patient who died 20 minutes after ingestion of the

lethal medication. Another patient consumed about 60% of

the prescribed pentobarbital, regurgitated about one-third

of the medication consumed to that point, and then drank

one-half of the remaining medication, dying 20 minutes

later. A third patient drank one-half of the prescribed med-

ication and about 30 seconds later regurgitated one-third of

what had been consumed, retaining only about 3 grams of

the barbiturate. This patient lived for 48 hours after having

ingested only about one-third of the intended dose.

One physician reported that a patient fell asleep before

ingesting the entire dose of medication. The patient died 40

minutes after ingestion.

None of the patients regained consciousness after ingest-

ing the lethal medication.

Emergency medical services were contacted by a family

in one case to pronounce death but not to intervene or trans-

port the patient.

End of Life Concerns

Physicians were asked if, based on discussions with

patients, any of seven end-of-life concerns might have con-

tributed to the patients’ requests for lethal medication

(Table 4). In nearly all cases, physicians reported multiple

concerns contributing to the request. During 2003, one

patient (2%) was reported to have one end-of-life concern,

3la

I3 (31%) had two concerns, 15 (36%) had three concerns

nine (21%) had four concerns, and four (10%) had five con-

cerns. The most frequently reported concerns included los-

ing autonomy (93%), a decreasing ability to participate in

activities that make life enjoyable (93%), and loss of dignity

(82%). (The frequency of the latter

concern wa ,

the first time in 2003.) S assessed for

COMMENTS

During the six years since legalization, the number of

Prescriptions written for physician-assisted suicide and the

number of terminally ill patients taking lethal medication

has increased. However, the number has remained small

compared to the total number of deaths in Oregon, with

about /7 of one percent of Oregonians dying by PAS. This

Proportion is consistent with numbers from a survey of

Oregon physicians [9]. Overall, smaller numbers of

patients appear to use PAS in Oregon compared to the

Netherlands [10]. However, as detailed in previous reports

[1-5], our numbers are based on a reporting system for ter-

minally ill patients who legally receive prescriptions for

lethal medications, and do not include patients and physi-

cians who may act outside the provisions of the DWDA

Over the last six years the rate of PAS among patients

with ALS in Oregon has been substantially higher than

among patients with other illnesses. This finding is consis-

tent with other studies. In the Netherlands, where both PAS

and euthanasia are openly practiced, one in five ALS

patients died as a result of PAS or euthanasia [11]. A study

of Oregon and Washington ALS patients found that one-

third of these patients discussed wanting PAS in the last

month of life [12]. It is not known with certainty why ALS

32a

patients would be more likely to choose PAS than would

other terminally ill patients. Oregon HIV/AIDS patients are

also disproportionately likely to use PAS, a finding consis-

tent with studies elsewhere [13].

Physicians have consistently reported that concerns

about loss of autonomy and decreased ability to participate

in activities that make life enjoyable are important motivat-

ing factors in patient requests for lethal medication across

all six years. Interviews with family members during 1999

corroborated physician reports [2]. These findings were

supported by a recent study of hospice nurses and social

workers caring for PAS patients in Oregon [14].

The availability of PAS may have led to efforts to

improve end-of-life care through other modalities. While it

may be common for patients with a terminal illness to con-

sider PAS, a request for PAS can be an opportunity for a

medical provider to explore with patients their fears and

wishes around end-of-life care, and to make patients aware

of other options. Often once the provider has addressed a

patient’s concerns, he or she may choose not to pursue PAS

[15]. The availability of PAS as an option in Oregon also

may have spurred Oregon doctors to address other end-of-

life care options more effectively. In one study, Oregon

physicians reported that, since the passage of the Death

with Dignity Act in 1994, they had made efforts to improve

their knowledge of the use of pain medications in the ter-

minally ill, to improve their recognition of psychiatric dis-

orders such as depression, and to refer patients more

frequently to hospice [16].

33a

REFERENCES

. Chin G, Hedberg K, Higginson G, Fleming D. Legal-

ized Physician-assisted suicide in Oregon—The first

year's experience. N Engl J Med, 1999:340:577-83.

Sullivan AD, Hedberg K, Fleming D. Legalized physi-

clan-assisted suicide in Oregon—The second year. N

Engl J Med, 2000:342:598-604.

we enmaettoee Hedberg K, Hopkins D. Legalized physi-

clan-assisted suicide in Oregon, 1998-2000. N Ene

Med, 2001:344:605-7, —

Hedberg K, Hopkins D, Southwick K. Legalized

physician-assisted suicide in Oregon, 2001. N Eng

Med, 2002;346:450-2. cian ate

Hedberg K, Hopkins D, Kohn M. Five years of legal

physician-assisted suicide in Oregon. N EF

2003:348:961 -4. ae ian

Oregon Revised Statute 127.800-127.995. Available

at Das’

ors.cfm

Oregon Administrative Rules 333-009-000 to 333-

009-0030. Available at http://www.dhs.state.or.us/

. Oregon Revised Statute 432.060. http://www.leg.

| »)

Slate. or s/ors/432. htm]

. Ganzini L, Nelson HD, Schmidt TA, et al. Physi-

cians’ experiences with the Oregon Death with Dig-

nity Act. N Engl J Med, 2000;342:557-63.

10.

11.

13.

14.

15.

14.

34a

Willems DL, Daniels ER, van der Wal G, et al. Atti-

tudes and practices concerning the end of life: A

comparison between physicians from the United

States and from The Netherlands. Arch Intern Med,

2000; 160:63-8.

Viedink JH, Wokke JHJ, Van Der Wal G, et al.

Euthanasia and physicians-assisted suicide among

patients with amyotrophic lateral sclerosis in the

Netherlands. N Eng] J Med, 2002;346:1638-44.

Ganzini L, Silveira MJ, Johnston WS. Predictors and

correlates of interest in assisted suicide in the final

month of life among ALS patients in Oregon and Wash-

ington. J Pain Symptom Manage, 2002;3:312-7.

Bosshard G, Ulrich E, Bar W. 748 Cases of suicide

assisted by a Swiss right-to-die organization. Swiss

Med Wkly, 2003;133:310-317.

Ganzini L, Harvath TA, Jackson A, et al. Experi-

ences of Oregon nurses and social workers with hos-

pice patients who requested assistance with suicide.

N Engl J Med, 2002;347:582-8.

Bascom PB, Tolle SW. Responding to requests for

physician-assisted suicide: “these are uncharted

waters for both of us .. .”. JAMA, 2002;288:91-8.

Ganzini L, Nelson HD, Lee MA, et al. Oregon physi-

cians’ attitudes about and experiences with end-of-

life care since the passage of the Oregon Death with

Dignity Act. JAMA 2001;285:2363-9.

3Sa

Table 1. Demographic characteristics of 171 DWDA patients

who died after ingesting a lethal dose of medica-

tion, by year, Oregon, 1998-2003.

Male (°o)

45-54 (%)

55-64 (%)

65-74 (%)

75-84 (%)

85+ (%)

Median years (Range)

Race

White (°e)

Asian (%)

Other (°%)

Marital status

Married (%)

Widowed (%)

Divorced (%)

Never married (%)

Education

2003

(N = 42)"

19 (45)

23 (55)

0 (0)

2 (5)

4(10)

8 (19)

9(21)

14 (33)

§ (12)

1998-2002

(N = 129)*

71 (SS)

58 (45)

2(2)

3 (2)

10 (8)

21 (16)

46 (36)

37 (29)

10 (8)

Total

(N = 171)*

90 (53)

81 (47)

2(1)

§ (3)

14 (8)

29 (17)

55 (32)

51 (30)

15 (9)

73 (40-93) 69 (25-94) 70 (25-94)

41 (98)

| (2)

15 (36)

1229)

10 (24)

5 (12) _

Less than high school (%) 2 (5)

HS graduate (%)

8 (19)

125 (97)

4 (3)

60 (47)

29 (23)

32 (25)

_8 (6)

14 (11)

43 (33)

166 (97)

5 (3)

75 (44)

41 (24)

42 (25)

13 (8)

16 (9)

51 (30)

36a 37a

2003 1998-2002 Total Table 2. Demographic characteristics of 171 pati died

; ay — a a . patients who

Characteristics (Cont'd) (N=42)" (N=129)" (N=171) during 1998-2003 after ingesting a lethal dose of

Education (Cont'd) medication compared with 53,544 Oregonians

Some college (%) 12 (29) 23 (18) 3§ (21) dying from the same underlying diseases.

Baccalaureate DWDA

or higher (%) 20(48) 49(38) 69(40) Oregon deaths

PAS deaths,

Residence | | patients same 10.000

Metro counties (°%e)** 19 (45) 48 (37) 67 (39) 1998-2003 diseases Oregon Rate ratio

Coastal counties (%)*** 3 (7) 11 (9) 14 (8) Characteristics (N=171)* (N=§53,544)* deaths (95% CI**)

Other W. counties (%) 19(45) 60(47) 79 (46) Sex .

Underlying illness Female (%) 81 (47) 26,572 (50) 30.5 1.0.

Malignant Age

neoplasms (%) —--»-_: 35 (83)_~—-100(78) 13579) 18-34 (%) 2(1) 281(1) 71.2 $3(1.2-229/

Lung and bronchus (%) 9(21) 24(19) 3319) 35-44 (%) 5 (3) aoc 212 $3 22s |

Bees 08 8114) __ 108) __16@) 45-54(%) 14(8) 3,235 (6) 43.3 3.2(1.6-6.6)

Pancreas (°%e) 4(10) 12 (9) 16 (9) 55-64 (%) 29(17) 6,674(13) 43.5 3? (1.7-6.0)

Colon (%) 3 __7@) _F9@)_ 65-74 (%) __$5(32) 13,309 (2S) 41.3 3.1(1.7-5.4)

Other (%) _____13G1)__47,36) _ 6065) _ 75-84 (%) $1 (30) 17,969 (34) 28.4 2.1 (1.2-3.7)

Amyowophic lateral 85+ (%) 15(9) 11,091(21) 135 10

sclerosis (%) 3 (7) 10 (8) 13 (8) Median years 70 %

Chronic lower Spee

respiratory dis.(%) _1(2) 8 (6)_— 9 (5) Race

[linesses listed below (%)* 1 (1) 10 (8) 11 (6) Asian(%) = 5(3)_ —S35(1) 93.5 2.9(1.2-7.1)

oe Other(%) 0. 898(2) O 0 :

* Unknowns are excluded when calculating percentages. Unknown 0 UW _ — —

** Clackamas, Multnomah, and Washington counties.

*** Excluding Douglas and Lane counties.

# Includes aortic stenosis, congestive heart failure, diabetes mel-

litus with renal complications, gastrointestinal stromal tumor,

myelodysplastic syndrome, pulmonary disease with fibrosis, sclero-

derma, and Shy-Drager syndrome.

* Unknowns are excluded when calculating percentages.

** Confidence interval.

# The ratio is statistically significant according to the hi-square

test for trend. . -

The ratio is statistically significant according to the chi-square

test.

38a

DWDA

Oregon deaths

PAS deaths, per

patients same 10,000

1998-2003 diseases Oregon Rate ome

Characteristics (N= 171)* (N =53,544)* deaths (95% CI**)

Marital status

Married (%) _—-75: (44) 26,003 (49) 288 10

Widowed (%) 41 (24) 17,742 (33) 23.1 0.8 (0.6-1.2)

Divorced (%) 42(25) 7,530(14) 55.8 1.9(1.3-2.8)

Never :

Married (%) 13(8) 2,168(4) 60.0 2.1 (1.2-3.7)

Unknown OO 101

Educatio™

Less than high

school (%) 16(9) 12,954(25) 124 10

HS graduate (%) 51 (30) 22,855 (43) 22.3 1.8 (1.0-3.2)

Some college (%) 35 (21) 9,598 (18) 36.5 3.0(1.6-5.3)

Baccalaureate

or higher (%) 69(40) 7,392 (14) 93.3 7.6 (4.4-13.0)"

Unknown 0 745

Residence

Metro

counties (%) 67 (39) 19.333(36) 34.7 10

Coastal

counties (%) 79(46) 22,259 (42) 35.5 1.0(0.7-1.4)

E. of the

‘ui (%) 11(6) 7,578(14) 14.5 0.4 (0.2-0.8)

(Relevant footnotes are listed on the previous page.)

39a

Table 3. Underlying illnesses of 171 patients who died

during 1998-2003 after ingesting a lethal dose of

medication compared with 53.544 Oregonians

dying from the same underlying diseases.

DWDA

Oregon — deaths

PAS deaths, per

patients same 10,000

Underlying 1998-2003 diseases Oregon Rate ratio

deaths

illnesses (N=171) (N=53,544) (95% CI*)

Malignant

neoplasms (° o) 135 (79)35,906 (67) 37.6 3.9(2.0-7.6y

Lung and

bronchus (%) 33 (19) 12,037 (23) 27.4 2.8(1.4-5.9)

Breast(%) ___—-16(9)_3,037(6) $2.7 $.4(2.4-12.3)°

Pancreas (%) 16(9) 2,190(4) 73.1 7.5(3.3-17.1)

Colon (%) 10(6) 3,171 (6) 31.5 3.3(1.3-8.0)

Prostate (%) 9(5) 2,670(5) 33.7 3.5(1.4-8.8)

Ovary (%) — _9(5) 1,178 (2) 764 7.9(3.1-19.9)

Skin(%) 6 (4) $22 (1) 114.9 11.9(4.2-33.29

Other (%) 36 (21) 11,101 (21) 32.4 3.4(1.6-7.0)

Amyotrophic

_lateral sclerosis (%) | 3 (8) 522 (1) 249.0 25.7(11.1-59.9)"

Chronic lower

respiratory dis.(%)9(5) 9.300(17) 9.7 LO

HIV/AIDS (%) ——3(2)__‘175 (<1)171.4 17.7(4.8-64.9)°

Ilnesses listed

below (%)** 11 (6) _ 7,641 (14) 14.4 1.5(0.6-3.6)

* Confidence interval.

** Includes aortic stenosis, congestive heart failure, diabetes mel-

litus with renal complications, gastrointestinal stromal tumor, myelo-

dysplastic syndrome. pulmonary disease with fibrosis. scleroderma.

and Shy-Drager syndrome.

’ The ratio is statistically significant according to the chi-square

test.

40a

Table 4. Death with Dignity Act participant end of life care

and DWDA utilization. Based on physician inter-

views for 171 patients who died after ingesting a

lethal dose of medication - Oregon, 1998-2003.

2003 1998-2002 Total

Characteristics (N=42)* (N=129)* (N=171)*

End of Life Care

Hospice

Enrolled (°%o) 39(93) 106(83) 145(86)

Declined by patient (%) 3 (7) 21(17) =24(14)

Unknown ~ 2 2

Insurance

Private (°o) 22 (52) 80(63) 102(61)

Medicare or

Nese) - 22) 2(%) _

Unknown - 3 3

End of Life Concerns”

Losing autonomy (%) _ 39 (93) __-106 (85) __145 (87) _

Less able to engage in

activities making life

enjoyable (%) 39(93) 99(79) 138(83)

Loss of dignity (%)"" 31 (82) 3 (82)

Losing control of bodily

functions (%) = 24(57) 73. (58) 97 (58)

* Unknowns are excluded when calculating percentages unless

otherwise noted. —

** Patients discussing concern about inadequate pain control with

their physicians were not necessarily experiencing pain.

Affirmative answers only (“Don’t know” included in negative

answers). Available for 17 patients in 2001.

First asked in 2003.

4la

2003 1998-2002 Total

Characteristics (Cont'd) (N = 42)* (N=129)* (N=171)*

End of Life Concerns* (Cont'd)

Burden on family, friends/

caregivers (%) 16 (38) 44 (35) 60 (36)

Inadequate pain |

control (%)** 9(21) 28(22) 37 (22)

Financial implications

of treatment (%) 1 (2) 3 (2) 4(2)

PAS Process

Referred for psychiatric

evaluation (%) 2 (5) 28 (23) 30 (18)

Patient died at

Home (patient, family

or fnend (%) 39(93) 121(94) 160(94)

Long term care, assisted

living or foster care

facility (%) 2 (5) 6 (5) 8 (5)

Hospital (%) 0 1 (1) 1 (1)

Other (%) 1 (2) 1 (1) 2(1)

Lethal Medication

__Secobarbital (%) 4(10) _ 85 (66) _89 (52)

Pentobarbital (%) 37 (88) 41 (32) 78 (46)

Secobarbital/

__amobarbital (%) = 1(2)_ 22) 3.2)

_Other(%)

(Relevant footnotes are listed on the previous page.)

42a

2003 1998-2002 Total

Characteristics (Cont’d) (N=42)* (N=129)* ‘N=171)*

Health-care provider present

when medication ingested*

Prescribing physician (%) 12 (29)

Other provider,

prescribing physician

22(39) 34 (34)

not present (%) 20 (48) 29 (51) 49 (49)

No provider (%) 10 (24) 6 (11) 16 (16)

Unknown 0 2 is

Regurgitation/seizures

after medication ingested

Regurgitated(%) 3 (7) 4G) A)

So a a

Neither (%) ____39(93)__ 121 (97) __ 160 (96)

Unknown 0 4 4

Emergency Medical Services

Called for intervention after

lethal medication

ingested (%)*** 0 0 0

Not called after lethal medication

ingested(%) —=—-—s— 42 (100) 126 (100) 168 (100)

Unknown 0 3 3

* Unknowns are excluded when calculating percentages unless

otherwise noted.

*** Excludes calls to pronounce death.

# The data shown are for 2001-2003. Information about the pres-

ence of a health care provider/volunteer, in absence of the prescribing

physician, was first collected in 2001. Attendance by the prescribing

physician has been recorded since 1998. During 1998-2002 the pre-

scribing physician was present when 47% of the patients ingested the

lethal medication.

43a

2003

Characteristics (Cont’d) (N = 42)*

Timing of PAS Event

Duration (weeks) of patient-

physician relationship

Median _ : 10

Range 0-405

Duration (days) between

I st request and death

Median = 386

Range 16-737

Minutes between ingestion

and unconsciousness

Median 4

Range 1-20

Unknown 2

Minutes between ingestion

death

Median — fe 20

Range (minutes - hours) 5m-48h

Unknown te

1998-2002 Total

(N=129)* (N=171)*

13 13

0-851 0-851

43 39

5 5

1-38 1-38

18 20

nH 28

4m-37h_ — 4m-48h__

220 «730

(Relevant footnote is listed on the previous page.)

44a

[ LETTERHEAD]

HELLEREHRMAN

ATTORNEYS

Hilary E. Ware

hware@hewm.com

March 19, 2003 Direct (415) 772-6459

Main (415) 772-6000

Via Hand Delivery Fax (415) 772-6268

[Stamp]

RECEIVED

OFFICE OF THE CLERK

U.S. COURT OF APPEALS

PUBLIC INFORMATION UNIT

03 MAR 19 PM 12:34

FILED

DOCKETED

DATE INITIAL

Office of the Clerk

United States Court of Appeals for the

Ninth Circuit

P.O. Box 193939

San Francisco, CA 94119-3939

Re: State of Oregon et al., v. Ashcroft

Case No. 02-35587

Dear Sir or Madam:

Pursuant to Rule 28(j) of the Federal Rules of Appellate

Procedure, the Patient Plaintiffs-Appellees in the above-

mentioned case wish to request the Court’s permission to

cite a significant supplemental authority that has recently

been released. On March 6, 2003, the New England Jour-

45a

nal of Medicine published “Five Years of Legal Physician-

Assisted Suicide in Oregon,” an examination of data from

the fifth year of the Oregon Death With Dignity Act

(““ODWDA”). The Patient Plaintiffs-Appellees cited and

discussed the data contained in the reports from the first

four years of the ODWDA in their Brief at pages 13-14;

the report from the fifth year should also be considered in

that context.

A copy of this report is enclosed with this request, and

is also available at www.http://content.nejm.org/cgi/content/

full/348/10/961. Thank you for your consideration of this

request.

Very truly yours,

/s/ HILARY E. WARE

Hilary E. Ware

cc: All Counsel of Record

Enclosures

[ Letterhead bottom: ]

Heller Ehrman White & McAuliffe LLP

333 Bush Street

San Francisco, CA 94104-2878

www.hewm.com

San Francisco Silicon Valley Los Angeles San Diego

Seattle Portland Anchorage New York Washington D.C.

Madison, WI Hong Kong Singapore

Affiliated Offices: Milan Paris Rome

46a

The NEW ENGLAND JOURNAL of MEDICINE

CORRESPONDENCE

Volume 348:961-964

March 6, 2003

Number 10

Five Years of Legal Physician-Assisted Suicide

in Oregon

To the Editor: Physician-assisted suicide for terminally ill

residents of Oregon has been legal since October 1997!

Although it has been challenged several times in court and

by a referendum, the Oregon Death with Dignity Act

remains in effect at this time. As the state public health

agency with the mandate to monitor the use of physician-

assisted suicide, we require physicians to file reports on

patients for whom a prescription for a lethal medication is

written. We analyzed data from these report forms, inter-

views with physicians, and death certificates. As part of

follow-up to previous reports,*’*-° we characterized

patients who died in 2002 after ingesting legally pre-

scribed lethal medications and evaluated trends in the

numbers of prescriptions written and in the numbers and

characteristics of the patients who ingested lethal medica-

tions during the five years since implementation. We com-

pared all patients who chose physician-assisted suicide

during the first five years with other residents of Oregon

who died of the same underlying diseases.

47a

During 2002, 33 physicians wrote prescriptions for

lethal medications for 58 Oregon residents. The number of

prescriptions written has increased over the five-year

period since implementation (24 in 1998, 33 in 1999, 39

in 2000, 44 in 2001, and 58 in 2002; P for trend <0.001 by

the chi-square test). During 2002, 38 persons died from

ingesting the prescribed lethal medications, and 8 who

received prescriptions for lethal medications are still alive

(6 of them received prescriptions in 2002, and 2 of them

received prescriptions in 2001). The number of patients

who died from ingesting prescribed lethal medications has

increased since 1998 (16 in 1998, 27 in 1999, 27 in 2000,

21 in 2001, and 38 in 2002; P for trend <0.02 by the chi-

square test).

In the five years during which the law has been in effect,

a total of 129 people used physician-assisted suicide in

Oregon. This corresponds to a rate of 8.8 per 10,000 deaths

from any cause in Oregon. Jable / shows the characteris-

tics of patients who have ingested prescribed lethal med-

ications since legalization. Among Oregon residents who

died of the same underlying diseases as those who chose

physician-assisted suicide, rates of use of physician-assis-

ted suicide decreased with age and were higher among

those who had been divorced and among those with higher

levels of educational attainment. The rate of use of physi-

cian-assisted suicide was significantly higher among those

who had amyotrophic lateral sclerosis (374.5 per 10,000)

or cancer (61.0 per 10,000) than among those who had

other terminal illnesses. Men and women were equally

likely to choose physician-assisted suicide. Although the

majority of patients were non-Hispanic whites, the rate of

use of physician-assisted suicide among terminally ill

Asian Americans was higher (91.7 per 10,000) (Table /).

48a

Despite increases, the number of terminally ill Oregon res-

idents using physician-assisted suicide remains small rela-

tive to the overall number of deaths.

Katrina Hedberg, M.D., M.P.H.

David Hopkins, M.S.

Melvin Kohn, M.D., M.P.H.

Oregon Public Health Services

Portland, OR 97232

katrina. hedberg@state.or.us

References

Oregon's Death with Dignity Act. Oregon revised

statute 127.800-127.995. Portland: Oregon Public

Health Services, 2003. (Accessed February 14, 2003,

at http://www, healthoregon.org/chs/pas/pas.ctm. )

Chin AE, Hedberg K, Higginson GK, Fleming DW.

Legalized physician-assisted suicide in Oregon--the

first year’s experience. N Engl J Med 1999;340:577-

583. L[Abstract/Full Text]

Sullivan AD, Hedberg K, Fleming DW. Legalized

physician-assisted suicide in Oregon--the second

year. N Engl J Med 2000;342:598-604. [Abstract/

Full Text}

Sullivan AD, Hedberg K, Hopkins D. Legalized

physician-assisted suicide in Oregon, 1998-2000.

N Engl J Med 2001;344:605-607. [Full Text}

Hedberg K, Hopkins D, Southwick K. Legalized

physician-assisted suicide in Oregon, 2001. N Engl J

Med 2002;346:450-452. [Full Text]

49a

Table 1. Characteristics of Patients in Oregon Who Died

after Ingesting Legally Prescribed Lethal Med-

ication and of All Patients Who Died from the

Same Underlying Diseases.

June 5, 1998

The Honorable Henry J. Hyde

Chairman

Committee on the Judiciary

U.S. House of Representative

Washington, D.C. 20515

Dear Mr. Chairman:

This is in response to your request concerning the ques-

tion whether the Department of Justice, through the Drug

Enforcement Administration (“DEA”), may invoke the

Controlled Substances Act (“CSA”), 21 U.S.C. §§ 801-

971, to take adverse action against physicians who assist

patients in ending their lives by prescribing controlled sub-

stances. The issue has arisen in the context of Oregon's

“Death with Dignity Act,” Oreg, Rev. Stat. §§ 127.800-

127.995, which permits physicians to assist competent,

terminally ill patients in ending their lives in compliance

with certain detailed procedures. The Department has

reviewed the issue thoroughly and has concluded that

adverse action against a physician who has assisted in a

suicide in full compliance with the Oregon Act would not

be authorized by the CSA.

The Oregon Act was approved by Oregon voters on

November 8, 1994, and went in to effect on October 27,

1997. The Act provides for a detailed procedure by which

a mentally competent, terminally ill patient may request to

end his or her life “in a humane and dignified manner.”

O R.S. § 127.805. The procedure requires, for example,

that the patient's competence and the voluntariness of the

request be documented in writing and confirmed by two

Sla

witnesses, see id. § 127.810(1), that the patient's illness

and competence and the voluntariness of the request by

[sic] confirmed by a second physician, see id. § 127.820,

and that the physician and patient observe certain waiting

periods, see id. §§ 127.840, 127.850. Once a request has

been properly documented and the requisite waiting peri-

ods have expired, the patient's attending physician may

prescribe, but not administer, medication to enable the

patient to take his or her own life. As a matter of state law,

physicians acting in accordance with the Oregon Act are

immune from liability as well as any adverse disciplinary

action for having rendered such assistance.

Prior to the Oregon Act's taking effect last year, you

wrote to DEA Administrator Thomas Constantine seeking

the DEA’s view as to whether delivering, distributing, dis-

pensing. prescribing, or administering a controlled sub-

stance with the intent of assisting in a suicide would

violate the CSA notwithstanding a state law such as the

Oregon Act. In response, Administrator Constantine

explained that “physician-assisted suicide would be a new

and different application of the CSA,” and that the deter-

mination whether to pursue adverse action under the CSA

would first require “a medico-legal investigation” involv-

ing “state and local law enforcement agencies and prose-

cutors.” He also stated, however, that “the activities that

you described in your letter to us would be, in our opinion,

a violation of the CSA.” Subsequently, many other Mem-

bers of Congress have sent letters urging that | support the

DEA’s conclusions and enforce federal laws and regula-

tions accordingly. | have received other correspondence

supporting a contrary conclusion.

The Department has conducted a thorough and careful

review of the issue of whether the CSA authorizes adverse

52a

action against a physician who prescribes a controlled sub-

Stance to assist in a suicide in compliance with Oregon

law.

The CSA is a complex regulatory scheme that controls

the authorized distribution of scheduled drugs. Physicians,

for example, are authorized to prescribe and distribute

scheduled drugs only pursuant to their registration with the

DEA, and the unauthorized distribution of drugs is gener-

ally subject to criminal and administrative action. The rel-

evant provisions of the CSA provide criminal penalties for

physicians who dispense controlled substances beyond

“the course of professional practice,” 21 U.S.C. 802 (21),

see id. § 841 (b), and provide for revocation of the DEA

drug registrations of physicians who have engaged either

in such criminal conduct or in other “conduct which may

threaten the public health and safety,” id. § 823 (f).

Because these terms are not further defined by the statute,

we must look to the purpose of the CSA to understand

their scope.

The CSA was intended to keep legally available con-

trolled substances within lawful channels of distribution

and use. See S. Rep. No. 91-613, at 3 (1969). It sought to

prevent both the trafficking in these substances for unau-

thorized purposes and drug abuse. The particular drug

abuse that Congress intended to prevent was that deriving

from the drug’s “stimulant, depressant, or hallucinogenic

effect on the central nervous system,” 21 U.S.C. § 811 (f).

There is no evidence that Congress, in the CSA,

intended to displace the states as the primary regulators of

the medical profession, or to override a state's determina-

tion as to what constitutes legitimate medical practice in

the absence of a federal law prohibiting that practice.

Indeed, the CSA is essentially silent with regard to regu-

53a

lating the practice of medicine that involves legally avail-

able drugs (except for certain specific regulations dealing

with the treatment of addicts, see 42 U.S.C. § 257a; 21

C.F.R. § 291.505).

Even more fundamentally, there is no evidence that

Congress, in the CSA, intended to assign DEA the novel

role of resolving the “earnest and profound debate about

the morality, legality, and practicality of physician-assisted

suicide,” Washington v. Glucksberg, 117 S. Ct. 2258, 2275

(1997), simply because that procedure involves the use of

controlled substances. If Congress had assigned DEA this

role under the CSA, it would ultimately be DEA’s task to

determine whether assistance in the commission of a sui-

cide, in compliance with a state law specifically permitting

and regulating suck [sic ] assistance, nevertheless falls out-

side the public interest. These questions, however, are not

susceptible of scientific or fac.ual resolution, but rather are

fundamental! questions of morality and public policy. Such

a mission falls well beyond the purpose of the CSA.

The state of Oregon has reached the considered judg-

ment that physician-assisted suicide should be authorized

under narrow conditions and in compliance with certain

detailed procedures. Under these circumstances, we have

concluded that the CSA does not authorize DEA to prose-

cute, or to revoke the DEA registration of, a physician who

has assisted in a suicide in compliance with Oregon law.

We emphasize that out [sic] conclusion is limited to these

particular circumstances. Adverse action under the CSA

may well be warranted in other circumstances: for exam-

ple, where a physician assists ia a suicide in a state that has

not authorized the practice under any conditions, or where

a physician fails to comply with state procedures in doing

so. However. the federal government's pursuit of adverse

S4a

actions against Oregon physician who fully comply with

that state's Death with Dignity Ac. would be beyond the

purpose of the CSA.

Finally, notwithstanding our interpretation of the CSA

as it applies to the Oregon Act, it is important to under-

score that the President continues to maintain his long-

standing position against assisted suicide and any Federal

support for that procedure. This position was recently cod-

ified when he signed the Assisted Suicide Funding Restric-

tion Act last year. While states ordinarily have primary

responsibility for regulating physicians, the President and

the Administration nonetheless remain open to working

with you and other interested members of Congress on this

complex but extremely important issue.

Sincerely,

Janet Reno

5Sa

[ LETTERHEAD]

[Round Seal]

DEPARTMENT OF JUSTICE

1162 Court Street NE

Justice Building

Salem, Oregon 97301-4096

Telephone (503) 378-4400

TTY: (503) 378-5938

February 2, 2001

Honorable John Ashcroft

Attorney General of the United States

United States Department of Justice

Room 5111

Tenth and Constitution Avenues, NW

Washington, DC 20530

Dear Attorney General Ashcroft:

I want to extend warmest congratulations on your con-

firmation and accession to office as Attorney General of

the United States. Given your former service as Attorney

General of Missouri and your active role in the National

Association of Attorneys General, | know you assume your

new office with a strong understanding of the many-faceted

relationship between state and territorial Attorneys Gen-

eral and the United States Department of Justice. I look

forward to joining my counterparts in the other states and

territories in making that relationship with your adminis-

tration as cordial and productive as possible.

S6a

In your new service you may soon be addressing an

issue of major significance to my state: whether to support

a reversal of the United States Department of Justice's

present interpretation of the Federal Controlled Substances

Act (CSA) in relation to physician prescription of con-

trolled substances in circumstances that comply with Ore-

gon's physician-assisted suicide law (Ballot Measure 16).

As you may know, the people of Oregon adopted that law

by initiative and later rejected a measure, referred to them

by the Oregon Legislative Assembly, repealing Ballot

Measure 16.

In 1997 the United States Department of Justice con-

cluded that the CSA does not authorize the Drug Enforce-

ment Administration to revoke a physician’s federal

controlled substances registration on the ground the physi-

cian has prescribed controlled substances in conformity

with Ballot Measure 16. That conclusion followed a meet-

ing with the Department of justice at which my represen-

tative, joined by a representative of Governor Kitzhaber,

had the opportunity to present our legal analysis support-

ing the interpretation of the CSA the Department of Justice

later adopted.

Some have speculated that the previous interpretation

of the CSA may be reexamined and possibly reversed.

Such reversal would presumably subject Oregon physi-

cians to DEA revocation of their controlled substances

registration, and possible criminal prosecution, if they pre-

scribe controlled substances in compliance with Ballot

Measure 16.

If the current interpretation of the CSA in relation to

Ballot Measure 16 is to be reexamined, Governor Kitz-

haber and I request a renewed opportunity for our repre-

sentatives to meet with yours to discuss my office’s

Respectfully yours.

/S/_ HARDY Myers

HARDY Myers

Attorney General

ce: Governor John Kitzhaber

United States Senator Ron Wyden

United States Senator Gordon Smith

58a

[LETTERHEAD]

[Round Seal] U.S. Department of Justice

Office of Intergovernmental Affairs

Office of the Director Washington, D.C. 20530

April 17, 2001

The Honorable Hardy Myers

Attorney General

State of Oregon

Salem, OR 97301-4096

Dear Attorney General Hardy:

Thank you for your letter of February 2, 2001, to the

Attorney General congratulating him on his confirmation.

I am sorry for the delay in responding. In your letter you

expressed concern that the Department may revisit its

existing interpretation of the Controlled Substances Act

(CSA) as it applies to physicians prescribing a controlled

substance to assist in a suicide. The Attorney General has

asked me to respond on his behalf.

I am aware of no pending legislation in Congress that

would prompt a review of the Department’s interpretation

of the CSA as it relates to physician-assisted suicide.

Should such a review be commenced in the future, we

would be happy to include your views in that review.

On behalf of the Attorney General, I thank you for writ-

ing and expressing your views on this important matter.

Sincerely,

/s/_ LORI SHARPE

Lori Sharpe

Director and Advisor

to the Attorney General

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.