US Pharm. 2006;12:60-71.

The numbers of cases affecting pharmacy practices that are decided by the United States Supreme Court are few and far between. When two separate cases dealing with pharmacy are decided by the nation's highest court within a few months of each other, it is a rarity and perhaps unprecedented.1 Even more remarkable, the two cases seem diametrically opposed.

Case I
The first case deals with a physician prescribing marijuana in a state (California) where doing so is legal.2 The only problem with that schematic is that federal law classifies marijuana as a schedule I controlled substance. The significance of that classification is that it applies to drugs and other substances deemed by the federal government as having no recognized medical purpose. This begs the question: If a state government legalizes the medical use of marijuana and the federal government claims the substance has no medical use, who wins? It should be noted that pharmacies and pharmacists would be permitted to dispense marijuana under this law.

Case II
The second case deals with the use of controlled substances to assist an individual in dying ("assisted suicide") in a state (Oregon) where it is legal to do so. In this situation, the U.S. Attorney General declared that it is a violation of the federal Controlled Substances Act (CSA) to prescribe a schedule II drug for use in this method. In the same breath, the Attorney General warned that he would seek revocation of Drug Enforcement Administration (DEA) registrations of those who prescribe and dispense controlled substances for this particular purpose.3 As in the first case, this situation also begs a similar question: If a state legalizes assisted suicide, but the federal government says it is unlawful to use drugs to assist suicide, who wins?

Case Histories
Both of these cases have been rattling around the courts for a number of years. The assisted suicide case was discussed in this column in June 2002. A federal district court judge decided that the Attorney General does not have the authority to make physicians and pharmacists outlaws when they act compassionately to assist an individual who voluntarily elects to end his or her life under carefully scripted procedures outlined in the state law.4 Between that ruling and the outcome in the Supreme Court, the Ninth Circuit Court of Appeals determined that the Attorney General does have the power to regulate controlled drugs in terms of why or how they are used with the intent of ending one's life.5 Somewhat similarly, but in the opposite order in the marijuana case, a federal district court judge ruled that the CSA 6 did grant authority to the Attorney General to determine whether the use of a schedule I controlled substance would ever be permitted. The same Ninth Court of Appeals reversed and determined that the Attorney General acted without any authority designated to his post by Congress.7

Same or Different Cases?
Take a guess at the outcome of the two cases when decided by the Supreme Court. Are the cases similar enough in posture to support the same outcome, or are there enough differences to justify different conclusions? It would seem, at least at first glance, that the cases involve parallel issues. Two states elected to legalize conduct that is arguably at odds with federal laws. Both involve the use of controlled substances. Both cases deal with moral and legal "hot button" controversial public debates: The use of all-but-banned marijuana, and assisted suicide with highly controlled substances. (All of the drugs involved in the Oregon case were schedule II drugs.) The cases were decided a mere seven months apart. One would not be far off the mark to think that there would be some institutional memory and that the rule of precedence would dictate the same results. Alas, one would be wrong to so conclude.

Rulings
In the California marijuana case, the Supreme Court determined that federal law preempts contrary state law. In other words, the federal government does have the right to make the use of marijuana unlawful even though the state said it is lawful to use the substance when it is prescribed by a physician. In the Oregon assisted-suicide case, the Supreme Court held that the Attorney General does not have the authority to declare that physicians who prescribe and pharmacists who dispense controlled substances to assist someone in hastening his or her death are acting illegally.

Why the Difference?
Is it because the devil is in the details? As will be seen, the cases could not have relied on analyses any more different than those employed by the justices writing for the majorities in the two cases.

The marijuana case was decided by a 6-3 majority. For those who are prone to pay attention to which justices voted which way (as the media keeps telling us how the court may change some of its controversial abortion cases with different personnel at the helm) Justices Stevens, Kennedy, Souter, Ginsburg, Scalia, and Breyer constituted the majority. This left Justices O'Connor (now retired), Rehnquist (now deceased), and Thomas in the minority.

In the assisted suicide case, there was also a 6-3 split with Justices Kennedy, Stevens, O'Connor, Souter, Ginsburg, and Breyer in the majority; Justices Scalia, Roberts (replacing Rehnquist as Chief Justice), and Thomas were in the minority. For the head counters, of the eight justices who voted in both cases, Scalia and O'Connor were the two who switched sides. So, why this vast difference in results?

Marijuana
In the marijuana case, the issue hinged on the Commerce Clause of the United States Constitution. In the context of this case, the federal government took its position to ban the use of marijuana in interstate commerce. Interstate commerce (i.e., commerce between two or more states) is how the feds get jurisdiction to take the positions they take or make the policies they make. This is all well and good, but the facts of the case showed that there was no interstate trafficking in marijuana.

One of the plaintiffs, Angel Raich, was severely disabled with  "inoperable brain tumor, wasting syndrome, chronic pain disorders, seizure disorder, nausea, scoliosis, TMJ, endometriosis, uterine tumor, and many other documented medical conditions."8 She relied on two caregivers to get her locally grown marijuana and process it into various forms for ingestion.

The other named plaintiff was Diane Monson, also disabled, who grew her own marijuana in her garden. She also processed it and ingested it in multiple forms. On August 15, 2002, county sheriffs and DEA agents came to Monson's home. The sheriffs decided that her possession of marijuana was legal under California law. After a three-hour standoff, the DEA agents seized and destroyed all six of her marijuana plants on the grounds that possession of marijuana is illegal under the CSA.

The California law at issue9 states:
The people of the State of California hereby find and declare that the purposes of the Compassionate Use Act of 1996 are as follows: (A) To ensure that seriously ill Californians have the right to obtain and use marijuana for medical purposes where that medical use is deemed appropriate and has been recommended by a physician who has determined that the person's health would benefit from the use of marijuana in the treatment of cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, or any other illness for which marijuana provides relief. (B) To ensure that patients and their primary caregivers who obtain and use marijuana for medical purposes upon the recommendation of a physician are not subject to criminal prosecution or sanction. (C) To encourage the federal and state governments to implement a plan to provide for the safe and affordable distribution of marijuana to all patients in medical need of marijuana. 10

Justice Stevens, writing the majority opinion, noted that the case was made difficult by the plaintiffs' arguments that they will suffer irreparable harm because, despite a congressional finding to the contrary, marijuana does have valid therapeutic purposes. He went on to state:

The question before us, however, is not whether it is wise to enforce the statute in these circumstances; rather, it is whether Congress' power to regulate interstate markets for medicinal substances encompasses the portions of those markets that are supplied with drugs produced and consumed locally. Well-settled law controls our answer. The CSA is a valid exercise of federal power, even as applied to the troubling facts of this case.11  

Difficult or not, the court ruled that Congress has the authority to regulate interstate commerce and make illegal the possession of marijuana when it does get into the interstate market. The majority extended this jurisdictional observation to mean that Congress can also ban intrastatecommerce of marijuana. All agreed that the marijuana grown or used by the plaintiffs originated in and stayed in the state of California. They claimed that the federal government had no place in regulating marijuana that never crossed any other borders. In a manner consistent with a very long line of commerce clause cases, the court held that Congress can regulate intrastate commerce if there could be an impact on interstate commerce. The court reasoned that the regulation of marijuana was squarely within Congress' commerce power because production of marijuana intended for home consumption had a substantial effect on supply and demand in the national market. They determined that because of enforcement difficulties in distinguishing between marijuana cultivated locally and marijuana grown elsewhere, along with concerns about diversion into illicit channels, Congress has a rational basis for believing that failure to regulate the intrastate manufacture and possession of marijuana would leave a gaping hole in the CSA. Therefore, the court declared that Congress was acting well within its authority of the Commerce Clause.12

Assisted Suicide
The analysis in the Oregon case depended on an interpretation of a rule promulgated by the DEA under authority delegated by Congress to implement the policies and findings embedded in the CSA.13 The regulation states, in part, that to be valid, a controlled substance prescription must be issued for a "legitimate medical purpose" within the context of "the course of professional practice." 14 In 2001, the Attorney General sent out a notice stating that using controlled substances to assist in a suicide is not a legitimate medical purpose and those who prescribed or dispensed drugs for this use would be disciplined under federal law, even though state law expressly made this use legal.15

Justice Kennedy issued the majority opinion of the court. He characterized the primary issue as "whether the Controlled Substances Act allows the United States Attorney General to prohibit doctors from prescribing regulated drugs for use in physician-assisted suicide, notwithstanding a state law permitting the procedure."16 He also noted that the context of the case had been discussed in prior Supreme Court opinions to the effect that "Americans are engaged in an earnest and profound debate about the morality, legality, and practicality of physician-assisted suicide."17 He further elaborated that "The dispute before us is in part a product of this political and moral debate, but its resolution requires an inquiry familiar to the courts: interpreting a federal statuteto determine whether Executive action is authorized by, or otherwise consistent with, the enactment."18 The latter quote contains a carefully worded script. The outcome depends on judicial construction of a statute, not the DEA regulation that the Attorney General took his authority from.

The majority opinion goes through a long and, at times, arduous discussion of the history of the Oregon Death With Dignity Act 19 and various attempts by the federal government to ban the practice of assisted suicide. The crux of the decision is that the Attorney General's power to regulate controlled substances is not without limits. The opinion states that the CSA "permits the Attorney General to add, remove, or reschedule substances. He may do so, however, only after making particular findings, and on scientific and medical matters he is required to accept the findings of the Secretary of Health and Human Services (Secretary). These proceedings must be on the record after an opportunity for comment." 20

This reasoning sets up an interesting dilemma: Between the Attorney General and the Secretary, who has the right to rule on medical judgments? The court found ample information in the congressional history of the CSA and concluded:

The Attorney General does not have the sole delegated authority under the CSA. He must instead share it with, and in some respects defer to, the Secretary, whose functions are likewise delineated and confined by the statute. The CSA allocates decisionmaking powers among statutory actors so that medical judgments, if they are to be decided at the federal level and for the limited objects of the statute, are placed in the hands of the Secretary. In the scheduling context, for example, the Secretary's recommendations on scientific and medical matters bind the Attorney General. The Attorney General cannot control a substance if the Secretary disagrees.21

The court also found support from other congressional testimony to the effect that "nothing in the Constitution will interfere with ethical medical practice in this country as determined by [the Secretary] on the basis of a consensus of the views of the American medical and scientific community." The court determined:

The structure of the CSA, then, conveys unwillingness to cede medical judgments to an Executive official who lacks medical expertise. In interpreting statutes that divide authority, the Court has recognized: "Because historical familiarity and policymaking expertise account in the first instance for the presumption that Congress delegates interpretive lawmaking power to the agency rather than to the reviewing court, we presume here that Congress intended to invest interpretive power in the administrative actor in the best position to develop these attributes." …This presumption works against a conclusion that the Attorney General has authority to make quintessentially medical judgments. 22

In further rebuke of the government's arguments to the contrary, Justice Kennedy wrote:
The idea that Congress gave the Attorney General such broad and unusual authority through an implicit delegation in the CSA's registration provision is not sustainable. "Congress, we have held, does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions--it does not, one might say, hide elephants in mouseholes."23

The importance of the issue of physician-assisted suicide, which has been the subject of an "earnest and profound debate" across the country, makes the oblique form of the claimed delegation all the more suspect.24Under the Government's theory, moreover, the medical judgments the Attorney General could make are not limited to physician-assisted suicide. Were this argument accepted, he could decide whether any particular drug may be used for any particular purpose, or indeed whether a physician who administers any controversial treatment could be deregistered. This would occur, under the Government's view, despite the statute's express limitation of the Attorney General's authority to registration and control, with attendant restrictions on each of those functions, and despite the statutory purposes to combat drug abuse and prevent illicit drug trafficking.

The court held that the Attorney General cannot do an end-around a state that legalizes assisted suicide by claiming that the federal CSA prohibits the use of controlled substances for this purpose.

Analysis
The cases reviewed are heavy and complex, but they are also instructive about the mix of public policy, governmental relationships, and the role of courts in determining tough questions. They should also be read with a bit of skepticism. Why would two cases with such similarities within the same approximate time frame be decided with such extreme differences? There are no easy answers. This is just the way the courts work in this political environment.

References
1. Gonzales v. Oregon, 2006 US Lexis 767 and Gonzales v. Raich, 2005 US Lexis 4656, June 6, 2005.
2. In total, there are nine states that have legalized the medical use of marijuana: Alaska, Arizona, California, Colorado, Maine, Montana, Nevada, Oregon, and Washington. "Arizona and California voters approved medical marijuana laws in 1996. Voters in Alaska, Oregon, and Washington approved laws in 1998. Voters in Maine approved their medical marijuana initiative in 1999. Voters in Colorado and Nevada approved medical marijuana laws in 2000. Most recently, Montana voters approved a medical marijuana initiative in 2004. District of Columbia voters approved an initiative in 1998 with 69 percent of the vote, but Congress later overrode the law." See: www.fairnessinfayetteville.com/faq.html. Accessed November 12, 2006.
3. With very few exceptions, pharmacists do not register with the DEA; however, all pharmacies that dispense controlled substances must register.
4. Vivian JC. States rights v. federal rights in assisted suicide. US Pharm. 2002;27:06 (June 15, 2002).
5. Gonzales v. Oregon, 368 F 3d 1118 (2004). The case was originally referenced as Rasussen v Ashcroft , Slip Op No 01-1647-JO (April 17, 2002, 2002 US Dist Lexis 6695). Attorney General Ashcroft resigned his post and Attorney General Alberto Gonzales replaced him.
6. 21 USCS § 801 et seq.
7. Raich v Ashcroft, 352 F 3d 1222, 203 US App Lexis 25317 (2003).
8. See: www.cleartest.com/testinfo/angel_raich.htm. Accessed November 12, 2006. This site has some biographical information about the plaintiff, including information indicating she "has been permanently disabled since September 1995. Angel was one of 14 ‘medical necessity' patients that the Oakland Cannabis Buyers' Cooperative was fighting for in the United States Supreme Court in 2001." The May 14, 2001, ruling by the Supreme Court in US v. Oakland Cannabis Buyer's Cooperative 121 S. Ct. 1711; 149 L. Ed. 2d 722; 2001 U.S. LEXIS 3518; 69 U.S.L.W. 4316; 2001 Cal. Daily Op. Service 3836; 2001 Daily Journal DAR 4691; 14 Fla. L. Weekly S 238;  2001 Colo. J. C.A.R. 2428; 14 Fla. L. Weekly Fed. S 238 decision applies to the manufacture and distribution of marijuana under federal law. 
9. Cal. Health & Safety Code Ann. § 11362.5 (West Supp. 2005) and additional legislation supplementing §§ 11362.7-11362.9(West Supp. 2005).
10. § 11362.5(b)(1) (West Supp. 2005).
11. Gonzales v. Raich, 2005 US Lexis 4656, June 6, 2005.
12. U.S. Const., Art. I, § 8, 21 USCS § 801(5.
13. 21 USCS § 801 et seq.
14. 21 CFR § 1306.04(a) (2005).
15. November 9, 2001 Interpretive Rule.
16. Gonzales v. Oregon, 2006 US Lexis 767, January 17, 2006.
17. Washington v. Glucksberg, 521 U.S. 702, 735, 117 S. Ct. 2258, 138 L. Ed. 2d 772 (1997).
18. See note 16.
19. Ore. Rev. Stat. § 127.800 et seq. (2003).
20. See 21 U.S.C. A. § 811 (main ed. and Supp. 2005).
21. 21 U.S.C. § 811(b). See H. R. Rep. No. 91-1444, pt. 1, p 33 (1970) (the section "is not intended to authorize the Attorney General to undertake or support medical and scientific research [for the purpose of scheduling], which is within the competence of the Department of Health, Education, and Welfare").
22. See note 16.
23. Id.
24. Glucksberg, 521 U.S. , at 735, 117 S. Ct. 2258, 138 L. Ed. 2d 772.

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