OREGON v. ASHCROFT
Amicus Curiae Brief
of the
International Task Force on Euthanasia and Assisted Suicide
in Support of Defendants/Appellants
This web version of the International Task Force’s amicus curiae brief has been reformatted for ease in viewing. Footnotes have been changed to endnotes, and the Table of Authorities has been omitted. (Authorities are found in the endnotes.)
TABLE OF CONTENTS
I. The District Court Erred When It Concluded That The Attorney General Lacked Authority To Determine That Prescribing Controlled Substances For The Purpose Of Drug-Induced Death Is Not A Legitimate Medical Purpose (View)
A. The Ashcroft Directive does not control the practice of medicine (View)
B. The federal government has authority over all federally controlled substances (View)
C. Laws related to the safety of drugs and to the public health implications of federally controlled substances apply equally to all persons (View)
D. The federal government has consistently viewed drug-induced death as a threat to public health (View)
E. The State of Oregon is attempting to seize authority to exempt itself from provisions of the CSA (View)
II. The District Court Erred In Stating That The Ashcroft Directive Nullifies Oregon’s Death With Dignity Act (View)
A. The Ashcroft Directive does not apply to all prescription drugs (View)
B. Self-administration under the ODWDA is broadly interpreted in practice (View)
C. Under the ODWDA, a prescription for “medication” encompasses routes other than oral and substances other than barbiturates (View)
III. The Ashcroft Directive Does Not Violate The Commerce Clause(View)
A. Commercial activities under the ODWDA are not wholly intrastate in nature (View)
B. The interstate nature of activities permitted under the ODWDA affirms the authority of the Attorney General to preserve national standards related to the use of federal registrations to dispense controlled substances (View)
IV. The Ashcroft Directive Does Not Contravene a Patient’s Right to Palliative Care (View)
A. The Ashcroft Directive enhances the right to palliative care(View)
B. The ODWDA does not ensure that patients will receive adequate pain relief (View)
C. Barriers to adequate pain control stem from factors unrelated to whether a physician has the right to prescribe federally controlled substances to cause a drug-induced death(View)
V. The Interpretation Of A Regulation, Which Is Expressed In The Ashcroft Directive, Deserves Deference (View)
STATEMENT OF JURISDICTION
Amicus Curiae, International Task Force on Euthanasia and Assisted Suicide (ITF), adopts Defendants/Appellants’ Statement of Jurisdiction.
STATEMENT OF ISSUES
Amicus, the ITF, adopts Defendants/Appellants’ Statement of Issues.
STATEMENT OF THE CASE
Amicus, the ITF, adopts Defendants/Appellants’ Statement of the Case.
CONSENT OF THE PARTIES
This amicus brief is filed with the consent of the parties.
INTEREST OF AMICUS CURIAE
Amicus curiae, the International Task Force on Euthanasia and Assisted Suicide (ITF), is an international leader in the debate over assisted suicide and euthanasia. ITF is the operating name of the Family Living Council, a non-profit corporation formed in 1976 to provide education related to issues impacting on the family. It addresses legal and public policy issues related to death and dying, health care delivery and pain control, the rights of the terminally ill, the chronically ill, the elderly, persons with disabilities and the impact of such issues on individuals and families.
The ITF has particular expertise in analyzing the practical implications and specific information related to both Attorney General Ashcroft’s Directive and the Oregon Death with Dignity Act (ODWDA). This amicusbrief will be of particular assistance to the Court since it clarifies the interstate nature of activities under the ODWDA, which is relevant to maintaining a national standard for dispensing federally controlled substances. In addition, it demonstrates that the ODWDA may be carried out without the use of federally controlled substances, which is relevant to the fact that the Ashcroft Directive does not nullify Oregon law but, instead, affirms the role of the federal government in interpreting its own regulations.
INTRODUCTION
Although this case will be decided within the context of the debate over assisted suicide, it is not a case about whether the State of Oregon may permit the practice of assisted suicide within its borders. It is about whether a state can prevent the federal government from interpreting its own regulations.
ARGUMENT
I. The District Court Erred When It Concluded That The Attorney General Lacked Authority To Determine That Prescribing Controlled Substances For The Purpose Of Drug-Induced Death Is Not A Legitimate Medical Purpose.
The District Court erred in concluding that the Controlled Substances Act, 21 U.S.C. §§ 801-971 (2001) (“CSA”), does not “grant defendants the authority under the CSA to determine that prescribing controlled substances for purposes of physician-assisted suicide in compliance with Oregon law is not a ‘legitimate medical purpose’ under 21 C.F.R. § 1306.04 (a).” (1)
Congress granted authority to the Attorney General to carry out the CSA and the Drug Enforcement Administration (DEA) regulations that implement the CSA, including 21 C.F.R. § 1306.04 (a).
Attorney General Ashcroft’s Directive (“Ashcroft Directive”) (2) does not address the matter of whether assisted suicide may be considered a “legitimate medical practice” under Oregon law. Instead, it deals solely with whether using a federal registration to prescribe federally controlled substances to cause drug-induced death serves a “legitimate medical purpose” under the DEA regulations.
The Court incorrectly assumes that the Ashcroft Directive usurps the rights of the State of Oregon to enact and carry out its own laws. Further, the Court mistakenly concluded that the Ashcroft Directive interferes with the practice of medicine.
Plaintiff-Intervenors also advanced this mistaken notion when they claimed that it was only because of the District Court’s temporary injunction that Intervenors, a physician and a pharmacist, “can practice lawful medicine in Oregon.” (3) That claim lacks any shred of truth.
First, the Ashcroft Directive was prospective and, therefore, any prior use of federally controlled substances for assisted suicide would not subject a physician to investigation and possible revocation of a federal registration to prescribe or dispense federally controlled substances.
Second, if the Ashcroft Directive is implemented, and if a physician chooses to prescribe federally controlled substances for assisted suicide and if, after administrative proceedings, the physician’s registration were revoked or suspended, that physician would still be able to lawfully practice medicine in Oregon.
Nothing in the Ashcroft Directive prevents the State of Oregon from enforcing its own statutes. Nothing in the Ashcroft Directive prevents the State of Oregon from controlling the process of licensing physicians to practice medicine. Nothing in the Ashcroft Directive prevents Oregon physicians from engaging in assisted suicide under the Oregon Death with Dignity Act, ORS 127.800 – 995 (“ODWDA”). The Ashcroft Directive only precludes the use of a federal registration to prescribe controlled substances for the purpose of causing drug-induced deaths.
A. The Ashcroft Directive does not control the practice of medicine.
States regulate the practice of medicine. States issue medical licenses. Only states may revoke physicians’ licenses to practice medicine.
The Attorney General, under the authority granted to him under the CSA, controls the dispensing of federally controlled substances. It is the Attorney General who registers physicians to prescribe federally controlled substances and it is the Attorney General who may suspend or revoke such registrations, in accordance with administrative procedures.
Physicians in Oregon are not required to have a federal registration to practice medicine. Without a federal registration, physicians may diagnose and treat patients. They may perform surgery. They may prescribe any of thousands of medication that are not federally controlled substances. (4)
If the Ashcroft Directive is implemented, the conduct of a physician who prescribes federally controlled substances to assist suicide “may render his registration…inconsistent with the public interest and therefore subject to possible suspension or revocation under 21 U.S.C. § 824(a)(4).”(5) Prescribing or providing medications for assisted suicide that are not controlled substances would not subject a practitioner’s registration to any risk of suspension or revocation.(6)
B. The federal government has authority over all federally controlled substances.
Since 1914, the federal government has had the authority to regulate controlled substances. The Controlled Substances Act (CSA) as enacted in 1970 and amended in 1984, provides a uniform national standard for the control of potentially dangerous drugs. The CSA makes it unlawful for any person, including physicians and pharmacists, to dispense or distribute any federally controlled substance “except as authorized” in 21 U.S.C. 801-904. (7) One such exception permits physicians and pharmacists to distribute controlled substances if they obtain a registration from the Attorney General. (8)
The right to distribute controlled substances upon registration is anexception to the total ban on distributing controlled substances. Under the CSA, Congress delegated authority to the Attorney General to register applicants “unless he determines that the issuance of such registration is inconsistent with the public interest.” (9) Among the factors that the Attorney General is to consider in determining the public interest are “such facts as may be relevant to and consistent with the public health and safety.” (10) Furthermore, the Attorney General is authorized to suspend or revoke a registration if he finds that the registrant “has committed such acts as would render his registration under section 303 [21 USC 823] inconsistent with the public interest as determined under such section.” (11)
C. Laws related to the safety of drugs and to the public health implications of federally controlled substances apply equally to all persons.
When it passed the CSA, Congress found, “Many of the drugs included within this title have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” (12) Thus, the CSA grants exemptions to the overall prohibition on dispensing controlled substances so that those substances may be dispensed for the useful and legitimate medical purposes that are necessary to maintain the health and general welfare of the American people.
Suicide, including suicide by intentional overdose of federally controlled substances, has never been considered an act that maintains the “health and general welfare” of the American people.
Plaintiffs would have this Court believe that there is an implied exception to the CSA so that, for terminally ill patients, suicide – if assisted by a physician – must be permitted. They provide no basis for claiming this exception.
Nowhere is there any evidence that “Congress intended protection only for persons suffering from curable diseases.” (13) In Rutherford, the U.S. Supreme Court noted that “the concept of safety under §201 (p) is not without meaning for terminal patients.” (14) In its discussion of the Food and Drug Administration’s (“FDA”) approval of drugs for use by the public, the Court declared, “For the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit.” (15)
If the FDA will not approve a drug for use if its potential for inducing death is not offset by the possibility of therapeutic benefit, it is preposterous to think the Attorney General should be compelled to authorize prescribing controlled substances for the specific purpose of inducing death.
Just as legislative history and consistent administrative interpretation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355 et seq., (“FDCA”) gave no implicit exception to the terms “safe” and “effective” for drugs used by the terminally ill, the CSA does not imply any exception to the meaning of “public health and safety” for those who are terminally ill.
The concept of “safety” applies equally to all patients under the FDCA, including terminally ill patients. So, also, the meaning of “public health and safety” is equally applicable to all patients – young and old, rich and poor, temporarily ill and terminally ill – under the CSA.
Moreover, if prescribing federally controlled substances for the purpose of causing drug-induced death for terminally ill patients were to be considered a legitimate medical purpose, the Attorney General would be compelled to consider such prescribing a legitimate medical purpose for any and all other patients if a state so decides.
D. The federal government has consistently viewed drug-induced death as a threat to public health.
Plaintiffs have asserted that, since the CSA does not explicitly state that assisted suicide is not a legitimate medical practice, Congress did not intend to prevent a practitioner from enabling a patient to take his or her life using federally controlled substances.
On the contrary, while, in 1984, no one envisioned that any medical professional would seriously claim that enabling drug-induced death was a “legitimate medical practice,” there was great concern about the serious threat that drug-induced deaths posed to public health and safety.
When Congress amended the CSA in l984, it did so to strengthen the ability of the Attorney General to deny, suspend or revoke the registration of practitioners who dispense federally controlled substances in a way that threatens public health and safety and to give him the authority to act in cases where a state was either unable or unwilling to intervene.
At that time, supporters of amending the Act based the need to expand the Attorney General’s authority on the fact that “the most serious threat to public health and safety prompting the legal change was the frequency with which prescription drugs were involved in ‘drug-induced deaths.'” (16)
Indeed, common sense dictates that the basis for control of certain drugs is the prevention of threats to health and life. Throughout this nation’s history, intentionally participating in causing or enabling drug-induced death has never been considered a “legitimate medical practice.” Furthermore, suicide has never been viewed as a “treatment or therapy” for any medical condition.
As recently as 1999, David Satcher, M.D., the Surgeon General of the United States, declared, “Suicide is a serious public health problem.” (17) He noted that suicide was the ninth leading cause of mortality in the United States, accounting for nearly 31,000 deaths per year, a number that was more than 50% higher than the number of homicides in the United States for the same year. (18)
Surgeon General Satcher urged implementation of a comprehensive national strategy for suicide prevention as an important step in responding to the “the major public health problem of suicide in the United States.” (19) He did not urge suicide prevention for all but the terminally ill.
E. The State of Oregon is attempting to seize authority to exempt itself from provisions of the CSA.
Maintaining a uniform national standard pertaining to federally controlled substances is vital to public health and safety. However, the State of Oregon has boldly tried to carve out a new and unprecedented exception for itself. In effect, Oregon is brazenly attempting to amend the CSA so that states have the authority that has traditionally belonged to the federal government.
This creates an untenable situation since it bestows a right on Oregon to declare practitioners immune from actions taken in violation of federal regulations. Under the Oregon scheme, the state, not the federal government, decides how a federal registration may be used and whether prescribing federally controlled substances is done for a legitimate federal purpose under federal law.
Although the State of Oregon has determined that practitioners may enable patients to end their lives with medications, they may not dictate that federally controlled substances be used to do so.
II. The District Court Erred In Stating That The Ashcroft Directive Nullifies Oregon’s Death with Dignity Act.
The District Court declared that the Ashcroft directive “essentially nullified the Oregon Act.” (20) Likewise, the State of Oregon claimed, “If the DEA interpretation of the CSA were correct, it would effectively result in the preemption of portions of the Act.” (21) And Plaintiff-Intervenors argued, “The practices that are authorized by Oregon lawrequire the use of controlled substances.” (22)
The Ashcroft Directive does not nullify the ODWDA. It does not result in preempting portions of the Act. And there is nothing in the Oregon law that requires the use of controlled substances.
The ODWDA permits physicians to “prescribe, but not administer, medication to enable a qualified patient to end his or her own life.” (23) Passage of the ODWDA approved the act of physician assisted suicide. However, the ODWDA does not specify the means by which the act is to be accomplished. Nothing in the ODWDA limits “medication” to a federally controlled substance.
The Ashcroft Directive does not prevent physicians from engaging in theact of physician assisted suicide under the ODWDA. They may still write prescriptions for medication for the purpose of enabling patients to commit suicide. The Ashcroft Directive only addresses the means, by stating that practitioners may not use their federal registrations to prescribe federally controlled substances for the purpose of causing drug-induced deaths.
A. The Ashcroft Directive does not apply to all prescription drugs.
Although all federally controlled substances are prescription drugs, not all prescription medications are federally controlled substances. A federal registration is only required to dispense prescription medications that are federally controlled substances. The Ashcroft Directive applies only to those prescription drugs for which a federally issued license is necessary and only to those drugs when they are prescribed for the purpose of enabling a patient to commit suicide.
B. Self-administration under the ODWDA is broadly interpreted in practice.
As previously noted, the ODWDA gives physicians the power to prescribe medication for the purpose of enabling a patient to end his or her life. It does not permit a physician or any other person to end a patient’s life by lethal injection, mercy killing or active euthanasia. (24)
It does require self-administration. However, self-administration does not necessitate great involvement on the part of the patient. Although physicians and others may not “administer” the lethal medication, they are precluded only from taking the final act. It is only the last act – the act that results in death – that must be taken by the patient under the ODWDA.
There is a common misperception that all patients who have died under the ODWDA have done so after independently taking several pills after which they “slip peacefully away.” (25) In fact, the reality is far different. For example, the Washington Post described a woman’s death in which Plaintiff Peter Rasmussen, M.D. participated. The story illustrates the quantity of pills, the degree of assistance that may be given to a patient, and the length of time it can take for a person to die after taking federally controlled substances by mouth.
The account explained that Rasmussen opened 90 capsules – a lethal dose – of barbiturates and poured the white powder into a bowl of chocolate pudding. He gave the mixture to the woman’s son who spooned the mixture into his mother’s mouth. Another son gave her sips of water to wash the solution down. The woman died twelve hours later. (26)
The woman’s death, which occurred in 1999, complied with the ODWDA because, even though she did not mix the contents of the 90 capsules into the pudding or raise the spoon to her own lips, she did perform the last act – the act of swallowing.
Although ingested barbiturates are recorded as the lethal medications used in 90 of the 91 reported deaths in the first four years during which the OWDWA has been in effect, (27) the ODWDA does not limit deaths to those resulting from medication taken orally.
C. Under the ODWDA, a prescription for “medication” encompasses routes other than oral and substances other than barbiturates.
The ODWDA refers to a prescription for “medication” but does not define the term. However, accepted definitions of “medication” include: “medicinal substance, a drug, and treatment with remedies.” (28) “Remedy,” which falls within the meaning of “medication” is defined as “anything that relieves or cures a disease.” (29)
Shortly after passage of the ODWDA in 1994, Peter A. Goodwin, M.D. of the Oregon Health Sciences University who was one of the authors of the ODWDA appeared on ABC’s Nightline to discuss the ODWDA. He explained that no route of administration of lethal medication would be excluded under the ODWDA “as long as the patient had full responsibility.” (30)
Thus, a prescription of “medication” as permitted under the ODWDA could encompass routes other than oral and substances other than barbiturates.
The fact that the ODWDA does not preclude varied routes of administration was also noted in a 1997 Oregon State Bar Association publication:
An attending physician may write a prescription for “medication to enable a qualified patient to end his or her life in a humane and dignified manner.” ORS 127.815(9). The choice of drug, or drugs, is left to the discretion of the physician as a medical practice decision.
The route of administration is also discretionary, except that the Act expressly prohibits “lethal injection.” ORS 127.880. It appears that other routes of administration – such as oral ingestion, rectal suppository, or transdermal absorption – would fall within the Act. (31)
The publication goes on to ask and answer a query:
Would a delivery method such as inhalation be eligible for immunity, since the Act does not expressly mention “devices,” and some sort of delivery system would be needed for an inhaled gas? Interpretation may also be needed to clarify whether intravenous equipment, such as might be in place already for the treatment of pain and dehydration, may be used by the patient to deliver a slow infusion of medication. One might reasonably interpret a prescription for an “infusion” as distinct from an “injection,” and therefore be within the scope of the Act. Because the goal of the Act is to regulate voluntary self-administration, the critical question is whether the medication, by whatever route, is self-administered. (32)
It seems highly probable that devices would be permitted under the ODWDA since a device is a “remedy” and does fall within the definition of “medication.” Furthermore, prescriptions are frequently written for devices. For example, it is customary for physicians to write prescriptions for a specific type of dental appliance – known as a Mandibular Protruding Device (MPD) – as a remedy for sleep apnea.
Similarly, a device that could be used to enable a patient to end his or her life could be prescribed under the ODWDA. A physician could write a prescription for the type of assisted suicide appliance made from plastic tubing to be used with substances that are not federally controlled substances.
Alternatively, a physician could merely direct the patient about how he or she might obtain the devices that are well known, widely advertised and widely
distributed by assisted suicide proponents.
It is certainly not the intent of your amicus to provide “how to” instructions for assisted suicide. However, two examples are provided to illustrate for this Court that both oral and non-oral routes of administration and non-federally controlled drugs could be used as the means to cause death under the ODWDA.
One such means includes the use of nitrous oxide (33), either alone or in combination with tricyclic antidepressants (which cause sedation). Another means could include the infusion of a massive overdose of insulin.
Accordingly, self-administration of “medication” under the ODWDA can occur orally, by application of a patch, insertion of a suppository, activation of a device and/or inhalation of a substance.
While amicus believes that permitting assisted suicide in policy or in law is tragic for patients, dangerous for society and bad public policy, this case is not about overturning Oregon’s law permitting assisted suicide. As discussed and illustrated above, implementation of the Ashcroft Directive does not nullify the ODWDA, nor does it prevent assisted suicide deaths under the Act.
III. The Ashcroft Directive Does Not Violate The Commerce Clause.
The District Court treated the ODWDA as a strictly Oregon matter – one which confines any and all activities within Oregon’s borders. Plaintiff-Intervenors acknowledged that Congress, and Attorney General Ashcroft through his delegated power, have the authority to regulate drugs under the Commerce Clause. Nevertheless, they claimed that the Ashcroft Directive exceeds that authority because, “at the point that they [prescriptions for federally controlled substances for assisted suicide] are being scrutinized and the threat of enforcement is being aggressively signaled, they have completely left anything that had to do with interstate commerce.” (34)
However, the facts regarding the manner in which prescriptions may be filled and where they may be used shatter the myth that the ODWDA is completely intrastate in nature.
A. Commercial activities under the ODWDA are not wholly intrastate in nature.
Under the ODWDA, the prescribing process for medication that will enable a patient to end his or her life must take place in Oregon. After that, there are no controls on where the prescription may be filled, nor are there any requirements that the patient or the patient’s agent personally pick up a filled prescription.
In 1999, mail order pharmacies accounted for an estimated 10 to 15 percent of the prescription market. (35) Mail order prescriptions are convenient, particularly for patients who are severely debilitated or live in rural areas. Medications are delivered to one’s doorstep. This process permits patients to maintain personal privacy and often the costs of mail order prescriptions are lower than those filled by local pharmacies.
In 1994, shortly before the passage of the ODWDA, the American Association of Retired Persons (AARP) mail order pharmacy service confirmed that it could fill a prescription written in Oregon for 200 100-mg. capsules of barbiturates, and mail the drugs to the patient either in Oregon or in care of a third party in another state. (36)
Current procedures for the AARP pharmacy service have not changed. Any prescription can be filled. The cost of 90 capsules of Nembutal is currently $62.95. (37) The prescribed medication can be mailed to the patient’s home or elsewhere if requested.
The process is simple. The written prescription and other required information are mailed to the AARP pharmacy service in Pennsylvania. The filled prescription and an invoice are then sent to the patient at the designated address.
CVS, another major mail order pharmacy (38), provides similar accommodations for patients. Any medication that is dispensed through CVS community pharmacies can be filled by mail order. Prescriptions are mailed to CVS headquarters in Rhode Island. After processing, the medication is mailed from an Indiana distribution center to any location specified by the patient.
As discussed above, prescriptions under the ODWDA can be filled outside of Oregon and can be sent to the patient at an address outside of Oregon. In addition, even if the prescription is filled at a community pharmacy in Oregon, it is entirely possible that the patient may travel to another state where the medication will be used.
B. The interstate nature of activities permitted under the ODWDA affirms the authority of the Attorney General to preserve national standards related to the use of federal registrations to dispense controlled substances.
The Commerce Clause of the Constitution gives Congress the power to “regulate Commerce with foreign Nations, and among the several states.” (39) As this Circuit has found, “Congress has the power to regulate drugs under the Interstate Commerce Clause of the Constitution.” (40)
Plaintiff-Intervenors claim that the Ashcroft Directive seeks to enforce the CSA in a manner that exceeds Congress’s authority under the Commerce Clause. They base their claim on Lopez and Morrison (41) and argue that the Ashcroft Directive is invalid because “Congress’s commerce power does not extend to purely intrastate activities, such as acts in accordance with the ODWDA.” (42) But, as has been shown, acts in accordance with the ODWDA are not purely intrastate activities.
In Lopez, the Supreme Court found that Congress had exceeded its authority when it passed the Gun-Free School Zones Act, 18 U.S.C. § 922 (q) (1988), (“GFSZA”), making it a federal offense to possess a firearm in a school zone. The non-economic, criminal nature of possessing a firearm in a school zone was central to the Court’s conclusion. “[N]either the actors nor their conduct has a commercial character, and neither the purposes nor the design of the statute has an evident commercial nexus.” (43)
Unlike GFSZA, the CSA does have an evident commercial nexus. Furthermore, the conduct permitted under the ODWDA has a commercial character, since the prescription of medication results in a commercial transaction when the prescription is filled.
In Lopez, the Court identified three broad categories of activity that Congress may regulate under its commerce power: (1) the use of the channels of interstate commerce; (2) the instrumentalities of interstate commerce, or persons or things in interstate commerce, even though the threat may come only from intrastate activities; and (3) activities having a substantial relation to interstate commerce. (44)
As indicated above in the discussion related to mail order prescriptions, channels of interstate commerce as well as the instrumentalities of interstate commerce are permitted under the ODWDA for transactions to fill and transport prescriptions of federally controlled substances for assisted suicide through mail order pharmacies. Indeed, it is possible to fill and transport all prescriptions for medication under the ODWDA through mail order pharmacies.
Current report forms for use with the ODWDA do not require information that would indicate whether patients receive their prescriptions for assisted suicide from community pharmacies or from mail-order pharmacies so there is no way to determine the extent to which mail order prescriptions account for deaths under the ODWDA. Nonetheless, the fact remains that, since the ODWDA permits prescriptions to be filled by mail order, activities under the ODWDA are not exclusively intrastate.
In Morrison, the Supreme Court invalidated the Violence Against Women Act, 42 U.S.C. § 13981, (“VAWA”) which provided a federal civil remedy for victims of gender-motivated violence, finding that gender-motivated crimes of violence are not, in any sense, economic activity.
Unlike the actions in VAWA, the actions permitted under the ODWDA have clear economic implications. Medications for which prescriptions are written do not fall from the sky. Commercial transactions that take place when a prescription is purchased by a patient are, in every sense, economic activities.
Obviously, the ODWDA has implications far beyond one state. And it is abundantly clear that the Attorney General, as delegated by Congress in the CSA, has the authority to preserve national standards related to the use of federal registrations for dispensing federally controlled substances. If the ODWDA is permitted to trump the CSA, it will effectively usurp laws in other states where assisted suicide is not legal but where prescriptions, under the ODWDA, could be filled, received or used. If physicians are permitted to use their federal registrations to prescribe federally controlled substances for assisted suicide in Oregon, they will, by extension, be facilitating assisted suicide related activities in other states as well.
IV. The Ashcroft Directive Does Not Contravene A Patient’s Right To Palliative Care.
Plaintiffs would have this Court believe that, unless a doctor has the right to prescribe federally controlled substances to end a patient’s life, he or she cannot prescribe those substances to end a patient’s pain.
A. The Ashcroft Directive enhances the right to palliative care.
Plaintiffs claim that the Ashcroft Directive “contravenes the right to palliative care” and that it would cause a “chilling effect on doctors who prescribe medicine for palliative care.” (45) Recently, Kathryn Tucker, counsel for Plaintiff-Intervenors, compounded and exaggerated this misrepresentation when she stated that “the Ashcroft Directive would impair all patients nationwide from getting adequate pain medication.” (46)
This tired and unsuccessful assertion was also made by assisted suicide proponents in the Vacco v. Quill (47) and Glucksberg (48) cases when they contended that there was no significant difference between prescribing drugs for pain control which might result in death and prescribing drugs intended to result in death.
The U.S. Supreme Court decisively rejected that contention. In some cases “painkilling drugs may hasten a patient’s death, but the physician’s purpose and intent is, or may be, only to ease his patient’s pain….The law has long used actors’ intent or purpose to distinguish between two acts that may have the same result….[T]he law distinguishes actions taken ‘because of’ a given end [to induce death] from actions taken ‘in spite of’ their unintended but foreseen consequences [the possibility that pain control may increase the risk of death].” (49)
Far from creating legal barriers to the administration of federally controlled substances for pain relief, the Ashcroft Directive provides the strongest assurances ever given to doctors who prescribe controlled substances for the purpose of ending their patients’ pain. It explicitly states that the “use of controlled substances to manage pain [is] promoted” and sets out a procedure whereby there will not be any increased monitoring or investigation of physicians’ prescribing patterns of controlled substances used for pain relief. (50)
In addition, on the same day he issued his directive, Attorney General
Ashcroft sent a letter to physicians’ groups stating that doctors “will have no reason to fear that prescription of controlled substances to control pain will lead to increased scrutiny by the DEA, even when high doses of painkilling drugs are necessary and even when dosages needed to control pain may increase the risk of death.” He explained that, under the directive, physicians “should feel confident that they may prescribe federally controlled drugs to the full extent desirable to relieve pain without any fear that their prescriptions will be subject to greater questioning, investigation or any form of monitoring as a result of today’s action.” (51)
Strikingly, when states pass laws that ban assisted suicide and those laws contain explicit assurances – such as that in the Ashcroft letter – that physicians may prescribe pain control that might unintentionally increase the risk of death, the per capita use of opioids for pain control rises dramatically. For example, in Louisiana, morphine consumption rose by 80 percent in the year its assisted suicide ban passed and had nearly tripled two years later.(52) Likewise, according to official DEA figures, in the year before Rhode Island’s ban on assisted suicide passed, it was 46th among the states in per capita use of morphine. However, use doubled in the year following the law’s enactment, placing the state 19th in use of morphine. (53)
B. The ODWDA does not ensure that patients will receive adequate pain relief.
After the ODWDA went into effect, a survey found that the number of Oregon patients who were reported as dying in moderate to severe pain increased. The ODWDA Act went into effect in late 1997. Prior to its implementation, 33 percent of family members reported that their loved ones died in moderate to severe pain. However, in 1998 which was the first full year that the ODWDA was in effect, that rate was 54 percent. (54)
C. Barriers to adequate pain control stem from factors unrelated to whether a physician has the right to prescribe federally controlled substances to cause drug-induced death.
“Untreated and under treated pain is nothing short of a national scandal.” (55) However, barriers to pain control stem from factors unrelated to whether a physician has the right to prescribe for the purpose of enabling a patient to commit suicide.
One barrier to pain control is the lack of adequate training for physicians on the proper use of drugs to control pain. This lack of training causes physicians to fail to provide effective drugs when their patients’ pain requires it. (56) Another major barrier is imposed by states. States can and do impose restrictions on federally controlled substances that exceed those of the federal government. For example, some states impose cumbersome and expensive bureaucratic requirements such as triplicate prescription forms, making it more burdensome and, in some cases, more expensive for doctors to be able to prescribe opioids for their patients. (57) According to Richard Payne, M.D., chair of Pain and Palliative Care Services at Memorial-Sloan Kettering Cancer Center, state triplicate laws are the number one barrier to better pain management. Payne said the hassle associated with the triplicate causes many physicians in triplicate states to avoid even requesting the required forms. The result is that patients have reduced access to necessary pain treatment. (58)
Clearly, every effort should be made to make certain that patients receive palliative care. But permitting physicians to use their federal licenses to prescribe controlled substances to induce death does nothing to enhance pain control.
V. The Interpretation Of A Regulation, Which Is Expressed In The Ashcroft Directive, Deserves Deference.
Nothing in federal law gives a state the authority to adopt standards that prevent the federal government from interpreting its own regulations.
The Ashcroft Directive is an agency interpretation of 21 C.F.R. §1306.04, a textual regulation implementing the CSA, which the Attorney General is charged by Congress to administer.
When an agency interprets its own regulation, notice and comment is not required. “The APA requires that rules promulgated by administrative agencies undergo certain procedures unless those rules are ‘interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice.'” (59) This is so even if there is a prior interpretation to the contrary. An agency is “not estopped from changing legal interpretation that she believes to be erroneous.” (60)
In this instance, Attorney General Janet Reno’s Directive (“Reno Directive”), issued on June 5, 1998, was a prior interpretation of a regulation. Like Ashcroft’s interpretation, Reno’s interpretation, did not undergo notice and comment. It is of interest that, unlike Ashcroft’s interpretation, the interpretation expressed in the Reno Directive was not published in the Federal Register. Furthermore, the Reno Directive did not contain any history of the CSA or a textual analysis as the basis for the interpretation by which Reno exempted an entire state from long held national standards regarding controlled substances.
As an interpretation of a regulation, Ashcroft’s Directive deserves deference if he is construing the provisions in a reasonable way. An “agency’s interpretation [of its own regulations] must be given controlling weight unless it is plainly erroneous or inconsistent with the regulation.” (61) Ka Makani relied on the deferential standard articulated in Seminole Rock: “But the ultimate criterion is the administrative interpretation, which becomes of controlling weight unless it is plainly erroneous or inconsistent with the regulation.” (62)
Certainly, the interpretation expressed in the Ashcroft Directive – that prescribing federally controlled substances to cause drug-induced death is inconsistent with public health and welfare – is not erroneous or inconsistent with the regulation. (63)
Attorney General Ashcroft, in his directive, did not create a new regulation. As discussed above, he merely construed the textual phrases contained in the regulation. The fact that Attorney General Reno construed the phrase differently did not prevent Attorney General Ashcroft from making a different interpretation of that regulation, nor did it require Attorney General Ashcroft to do so only after notice and comment. Deference should be given to the Ashcroft Directive.
CONCLUSION
As this brief has demonstrated, the Ashcroft Directive is an appropriate interpretation of a regulation. By barring the use of a federal registration for the purpose of causing drug-induced death, it maintains a necessary national standard for dispensing federally controlled drugs. At the same time, it does not nullify a law enacted by the State of Oregon.
The District Court radically and erroneously bestowed the right on the State of Oregon to prevent the federal government from interpreting its own regulations. The District Court’s judgment should be reversed and the Permanent Injunction should be lifted.
STATEMENT OF RELATED CASES
Amicus, ITF, adopts Defendants/Appellants’ Statement of Related Cases.
Respectfully submitted,
___________________________________
Rita L. MarkerCounsel for Amicus, International Task Force on Euthanasia and Assisted Suicide
ENDNOTES
[1] Oregon v. Ashcroft, 192 F. Supp. 2d 1077, 1087 (D. Or. 2002).
[2] A. G. Order No. 2534-2001, “Dispensing Controlled Substances to Assist Suicide,” 66 Fed. Reg. 56607 (Nov. 9, 2001).
[3] Transcript of Temporary Restraining Order Proceedings, Nov. 20, 2001 at 51,Oregon v. Ashcroft, CV 01-1647.
[4] For qualifications and licensing procedure, see ORS 677.100 – 677.139. Oregon law provides that the Board of Medical Examiners may suspend or revoke a physician’s license to practice medicine if the physician violates the federal CSA. ORS 677.190 (24). However, the ODWDA prevents the state from taking such action against a physician for actions in compliance with the ODWDA. ORS 127.885 (2).
[5] Ashcroft Directive, supra note 2 (emphasis added).
[6] See further discussion of “medications” which may be used under the ODWDA at II below.
[7] 21 U.S.C. § 841.
[8] 21 U.S.C. § 822 (a).
[9] 21 U.S.C. § 823.
[10] Id.
[11] 21 U.S.C. § 824 (a) (4).
[12] 21 U.S.C. § 801 (1).
[13] United States v. Rutherford, 442 U.S. 544, 552 (1970).
[14] Id. at 555.
[15] Id. at 555-556 (emphasis added).
[16] Defendants’ Opposition to Preliminary Injunction Motion, Oregon v. Ashcroft, CV 01-1647, p. 5, citing Dangerous Drug Diversion Act of 1984: Hearing on H.R. 5656 Before House Committee on Health and the Environment, 98th Cong. 365 (1984) (testimony of Rep. Waxman).
[17] U.S. Public Health Service, The Surgeon General’s Call to Action to Prevent Suicide 3 (1999).
[18] Id.
[19] Id. at 16.
[20] Supra note 1, at 1079.
[21] Plaintiffs’ Memorandum in Support of Motion for a Temporary Restraining Order and Preliminary Injunction, Oregon v. Ashcroft, CV 01-1647, at 8.
[22] Supra note 3, at 116.
[23] Supra note 1, at 1082.
[24] ORS 127.880 (emphasis added).
[25] This was, in fact, the description used in advertisements for passage of the ODWDA in 1994. See: Analyzing the Ads, Oregonian, Oct. 14, 1994 and Mark O’Keefe, TV ad on assisted suicide leaves out part of the story, Oregonian, Nov. 4, 1994.
[26] Jennifer Page, A Death in Oregon: One Doctor’s Story, Washington Post, Nov. 3, 1999.
[27] Legalized Physician-Assisted Suicide in Oregon, 2001, 346 New Eng. J. Med. 451.
[28] Taber’s Cyclopedic Medical Dictionary (19th ed. 2001) at 1017.
[29] Id. at 1776.
[30] Nightline (ABC television broadcast, Dec. 7, 1994) (transcript No. 3533).
[31] 2 Oregon Health Law Manual 8-19, § 8.23 (Oregon CLE 1997) (emphasis added).
[32] Id. (emphasis added).
[33] The use of nitrous oxide for suicide has been described in the medical literature. See, for example: A. Chadly, B. Marc, D. Barres, M. Durigon, Suicide by Nitrous Oxide Poisoning, 10 Am. J. Forensic Med. & Pathology 330 (1989).
[34] Supra note 3, at 118.
[35] Bob Tedeschi, Want to Be an Online Drugstore? Take a Number, N.Y. Times, Feb. 2, 1999. See also: Eric M. Peterson, Notes & Comments: Doctoring Prescriptions: Federal Barriers to Combating Prescription Drug Fraud against On-Line Pharmacies, 75 Wash. L. Rev. 331, 1343 (2000). For U. S. Postal Mailing Requirements for Controlled Substances, see: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/other_cs/cs_post.htm (accessed July 20, 2002).
[36] Diane Gianelli, Oregon pharmacists wary of assisted-suicide measure, Am. Med. News, Oct. 24/31, 1994.
[37] See: http://Aarppharmacy.com/DrugPrice.asp (accessed July 23, 2002). Phone inquiries can be made at 800-289-6031.
[38] Information on CVS mail order prescriptions available at http://www.CVS.com (accessed July 23, 2002). Phone inquiries can be made at 888-700-7662.
[39] U.S. Const. Art. I, § 8, cl. 3.
[40] United States v. Rosenberg, 515 F. 2d 190, 198 (9th Cir. 1975).
[41] Plaintiff and Plaintiff-Intervenors’ Memorandum of Points and Authorities in Support of Motion for Partial Summary Judgment, Oregon v. Ashcroft, CV 01-1647 at 37-40.
[42] Id. at 38, citing United States v. Morrison 529 U.S. 598, 610-613 (2000) discussing Lopez (emphasis added).
[43] United States v. Lopez, 514 U.S. 549, 559-560, n. 4 (1995).
[44] Id. at 558-559.
[45] Patient Plaintiffs’ Brief in Support of Their Motion for Partial Summary Judgment and in Opposition to Defendants’ Motion to Dismiss, Oregon v. Ashcroft, CV 01-1647 at 27.
[46] Marcia Coyle, U.S., Oregon to Renew Suicide Fight, Nat’l. L. J., Aug. 19, 2002, at A1, A8 (emphasis added).
[47] Vacco v. Quill, 521 U.S. 793 (1997).
[48] Washington v. Glucksberg, 521 U.S. 702 (1997).
[49] Supra note 47, at 802-803.
[50] Supra note 1.
[51] Letter from Attorney General Ashcroft to Hugh C. Stelson, M.D., President of the Oregon Medical Association, Nov. 6, 2001.
[52] Eric M. Chevlen, M.D., Testimony before the Senate Judiciary Committee, April 25, 2000 Available at http://www.judiciary. senate.gov/oldsite/42520cc.htm (last accessed Aug. 30, 2002).
[53] Scott Gottlieb, Right-to-die bills defeated in more than 28 states, 171 W. J. Med. 274 (1999).
[54] Susan Tolle, Virginia Tilden, Susan Hickman, Anne Rosenfeld, Family reports of pain in dying hospitalized patients, 172 W. J. Med. 374, 376 (2000).
[55] Eric M. Chevlen and Wesley J. Smith, Power over Pain: How to Get the Pain Control You Need 1 (2002).
[56] Id. at 40-41. See also: The Case against Assisted Suicide: For the Right to End-of-Life Care 303-307 (Kathleen Foley and Herbert Hendin eds. 2002).
[57] See, for example, id. at 40; Karl Williams, Larry Simonsmeier, Joseph Fink,State Imposed Restrictions on Prescribing Anorectic Medications, 1 J. Pharm. & L. 1 (1991/1992).
[58] Pain Undertreatment: A Strikingly Large Problem, State Initiatives in End-of-Life Care at 2, 3 (April 1999).
[59] Gunderson v. Hood, 268 F. 3d 1149, 1153-1154 (9th Cir. 2001) (emphasis added).
[60] Chief Probation Officers v. Shalala, 118 F. 2d 1327, 1334 (9th Cir. 1997).
[61] Ka Makani ‘O Kohala Ohana Inc. v. Dept. of Water Supply, 2002 U.S. App. LEXIS 13036 at 7 (9th Cir. 2002), quoting Alhambra Hosp. v. Thompson, 259 F. 3d 1071 (9th Cir. 2001), quoting Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994). See also: Auer v. Robbins, 519 U.S. 452, 461 (1997).
[62] Bowles v. Seminole Rock & Sand Co., 325 U.S. 410, 414 (1945).
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