Chapter 7 The rules governing judicial review have

Chapter 7 "The rules governing judicial review have no more substance at the core than a seedless grape. " 1

Judicial Review This is a very unsettling chapter if you are looking for a bright-line test for standards for judicial review. I have heard very respected federal appeals court judges say in public lectures that they have no idea where these tests begin and end. 2

Key Questions n n Is it a facial challenge to a statute or a regulation, like Abbott? Is it an “as applied” challenge, where there is more than one reasonable interpretation? n Is picking the controlling/best interpretation a policy choice or a legal choice? Is the court reviewing a factual determination by the agency? Is the court reviewing the application of 3

Review of Rules - Pre-APA Cases From the first, there has been a way to argue in the alternative in every case, and this has continued to the present. 4

Deference - NLRB v. Hearst, 322 U. S. 111 (1944) (Newsboys) n Undoubtedly questions of statutory interpretation, especially when arising in the first instance in judicial proceedings, are for the courts to resolve, giving appropriate weight to the judgment of those whose special duty is to administer the questioned statute. But where the question is one of specific application of a broad statutory term in a proceeding in which the agency administering the statute must determine it initially, the reviewing court's function is limited. . [T]he Board's determination that specified persons are 'employees' under this Act is to be 5 accepted if it has 'warrant in the record' and a

Persuasion - Skidmore v. Swift & Co. , 323 U. S. 134, 140 (1944) n We consider that the rulings, interpretations and opinions of the Administrator under this Act, while not controlling upon the courts by reason of their authority, do constitute a body of experience and informed judgment to which courts and litigants may properly resort for guidance. The weight of such a judgment in a particular case will depend upon the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those 6 factors which give it power to persuade, if

Contemporary use of Skidmore and Hearst n n n Skidmore and Hearst are still good law and are used by the courts when it is convenient. Hearst is used when the court wants to defer to the agency but does not want to use the Chevron analysis. Skidmore is used when the court does not want to defer to the agency. It may be combined with Barnhart. 7

Review under the APA 8

APA § 706. Scope of review n To the extent necessary to decision and when presented, the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of an agency action. The reviewing court shall n (1) compel agency action unlawfully withheld or unreasonably delayed; and n (2) hold unlawful and set aside agency action, findings, and conclusions found to be – n (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; n (B) contrary to constitutional right, power, privilege, or immunity; n (C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; n (D) without observance of procedure required by law; n (E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by statute; or n (F) unwarranted by the facts to the extent that the facts are subject to trial de 9 novo by the reviewing court.

Chevron U. S. A. Inc. v. Natural Resources Defense Council, 467 U. S. 837 (1984) n The regulation - 40 CFR 51. 18(j)(1)(i) and (ii) (1983): n "(i) 'Stationary source' means any building, structure, facility, or installation which emits or may emit any air pollutant subject to regulation under the Act. n "(ii) 'Building, structure, facility, or installation' means all of the pollutant-emitting activities which belong to the same industrial grouping, are located on one or more contiguous or adjacent properties, and are under the control 10 of the same person (or persons under

Step One – Classic Statutory Analysis n “When a court reviews an agency's construction of the statute which it administers, it is confronted with two questions. First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the 11

Applying Chevron Step One n n n The statute: n "The plan provisions required by subsection (a) shall --. . . "(6) require permits for the construction and operation of new or modified major stationary sources in accordance with section 173 (relating to permit requirements). ” Does this define a stationary source as to resolve the bubble question? Would it allow the bubble definition of 12

Step Two – Who Gets to Resolve Ambiguities? n “If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based 13 on a permissible construction of the

Applying Chevron Step Two n n n If the statute is silent or ambiguous n This is frequently the case on controversial issues If the agency’s interpretation is just one of many allowable interpretations, what should the court do? n Decide which is the best interpretation? Defer to the agency – if so, why? n Why is deference to the agency the key to 14

What does it Mean to Be Silent or Ambiguous? n n n Do you just look at the statute itself? n Scalia (and his followers), usually. Do you include legislative intent? n Breyer, usually. We will discuss how this plays out in Brown and Williamson. 15

Political Control of Agencies n n n How does Chevron deference fit with the political control of agencies? Is this a liberal/conservative view? While Gorsuch was appointed because he claims to hate Chevron, Chevron can help an administration that wants to roll back regulations. n You should only hate Chevron when 16 you are out of power.

Miller v. AT&T Corp. , 250 F. 3 d 820 (4 th Cir. 2001) n n n The Family and Medical Leave Act (FMLA) entitles an eligible employee to as many as 12 weeks of unpaid leave per year for ''a serious health condition that makes the employee unable to perform the functions of the position of such employee. '' The Act defines ''serious health condition'' as an ''illness, injury, impairment, or physical or mental condition that involves(A) inpatient care in a hospital, hospice, or residential medical care facility; or (B) continuing treatment by a health care provider. '' FMLA does not define medical treatment 17

What does Medical Treatment Mean? n n What if the doctors say you are not sick or that your condition is untreatable? n Are you covered by the act? The agency makes a rule that finds that visits to the doctor that do not require specific treatment are covered by the act. Did the court accept the agency interpretation? n What did the dissent want? Why does this decision make practical sense? 18

Opinions in Litigation n n Chevron was a rulemaking, with all the attendant process and review What if the agency takes a position for the first time during litigation? n Why might the court not trust it? Why might an amicus brief in a case where the agency has no interest get more deference? In all cases, opinions raised in litigation, as opposed to part of the rulemaking, will be judged by the persuasiveness. 19

What Agency do you Defer to? n n n Courts will only defer to the agency with the primary responsibility for administering the law. n Why not defer to more than one agency? What does administering mean? n EPA sets the standards for Superfund cleanups. n It gets deference for these standards. There is a statutory mechanism for determining Superfund liability, which is overseen by the courts n EPA only enforces the liability once it is 20

Chevron and its Variations (looking ahead) n n The statutory language is broad or ambiguous and the agency must fill in the details. n Chevron The statutory language is clear, but the result is contrary to other laws and practice. n FDA versus Brown and Williamson (tobacco) The statutory language is broad or ambiguous, but the result was not anticipated when the act was passed. n Mass. v. EPA The statutory language is broad or ambiguous, but the result is so sweeping that Congress could not have meant it. (Elephants in mouse holes) n King v. Burwell 21

Brown v. Williamson 22

Changing Smoking Habits 23

Politics of Tobacco Regulation FDA v. Brown & Williamson Tobacco Corp. , 529 U. S. 120 (U. S. 2000) 24

Pharmacology of Tobacco n n Primary drug effect is nicotine n Strong nervous system drug using in classic neurophysiology research n Great natural bug killer An oily plant that makes a smoky fire n Tars from combustion cause cancer and emphysema n Is marijuana safer? 25

Public Health Impact of Tobacco n n n #1 preventable cause of illness where smoking is widespread. #1 problem is heart disease n 6 out of 7 smokers do not live to get lung cancer n Heart attack data on secondary smoking n Emphysema is the big lung issue - nasty way to live, then you die Poorly understood genetic factors affect individual risk. n Less risk for smokers in Japan – could diet 26

Second Hand Smoke n n n Children of smokers n More respiratory problems n More likely to smoke Workplaces and homes Reduction in heart attacks after smoking bans n This was unexpected – significant and quick decline after bans 27

In Defense of Tobacco n n n Tobacco will reduce life-time health care costs if you smoke enough n Ideally you will also eat a lot of burgers while sitting on the couch watching TV Limits retirement costs n Saves Medicare and Social Security n Great for private pension plans as well Also improves job opportunities for young, cheaper workers 28

Problems in Stopping Smoking n n “Giving up smoking is the easiest thing in the world. I know because I've done it thousands of times. ” n ― Mark Twain Easier to quit heroin n Why? n What about Starbucks? 29

The Surgeon General’s Report 1964 n n First official notice of risks of tobacco Began a long-term decline in smoking With some exceptions, smoking moves from the wealthy and middle class to the poor and poorly educated. n A major factor, along with alcohol and obesity in the higher morbidity and mortality in disadvantaged groups. May have plateaued after the tobacco settlement 30 n States make more money if kids smoke.

Reducing Smoking n n The price n Taxing the poor? Smoking limitations n Reduce the amount smoked n Even LA banned indoor smoking in restraurants Insurance surcharges? n This is now being done Why not ban tobacco? n How has that worked out with heroin? 31

Regulatory History of Tobacco 32

Economic History of Tobacco n n n What was the role of tobacco in the colonial period? What are the economics of tobacco? n Why has CVS banned tobacco? What is the primary role of the Bureau of Alcohol Firearms and Tobacco? n There is active smuggling from low to high tax areas and of untaxed 33 cigarettes.

Federal Cigarette Labeling and Advertising Act - 1965/1969 n n Required hazard labeling on cigarettes Banned cigarette advertising in electronic media regulated by the FCC n Why not ban it everywhere? Prevented additional state requirements n Which requirements were they worried about? n What happened in torts in 1965? What about non-tort concerns? 34

Other Legal Events n n Sale of tobacco limited to adults Cigarette vending machines banned in 1990 in places where minors could use them. The tobacco litigation settlement – 1998 n The tobacco industry agreed to voluntarily limit some marketing. n There is a settlement with the state, paid out over years, with higher payments if more minor smoke. This sets up the regs by the FDA. 35

History of the FDA 36

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FDA Jurisdiction n Based on interstate sale of the drug/device n Not the broad definition of interstate commerce used in civil rights cases n Only regulates manufacturing, interstate sale, and promotion. No authority over how drugs are prescribed and used n State regulation and state criminal law n Drug Enforcement Administration Unless there is a state FDA, you can make and sell a drug within a state and not be under FDA 39 regulation

Shared Federal Jurisdiction n n BAFT – Bureau of alcohol, tobacco, and firearms n BATF deals with tax issues of tobacco DEA – Drug Enforcement Agency n Federal limits on the prescribing and use of drugs through the Controlled Substances Act n Administrative regulation of medical prescribing and sale, with a criminal law focus. 40

FDA v. Brown & Williamson Tobacco Corp. , 529 U. S. 120 (U. S. 2000) n n n What had the FDA said about it authority to regulate regulation over the past 50 years? Which group of smokers did the regulation target? n Why this group? n How did the regulation attempt to reduce smoking in this group? What was the tobacco companies attack 41 on this regulation?

Chevron Step One What Does the Statute Say? 42

Definition of Drugs n The Act defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body. " 21 U. S. C. § 321(g)(1)(C). 43

Definition of Devices n It defines "device, " in part, as "an instrument, apparatus, implement, machine, contrivance, . . . or other similar or related article, including any component, part, or accessory, which is. . . intended to affect the structure or any function of the body. " § 321(h). 44

Definition of Combination Products n The Act also grants the FDA the authority to regulate so-called "combination products, " which "constitute a combination of a drug, device, or biologic product. " § 353(g)(1). The FDA has construed this provision as giving it the discretion to regulate combination products as drugs, as devices, or as both. See 61 Fed. Reg. 44400 (1996). 45

Cigarettes as a Combination Product n n n Is tobacco a drug under the statutory definition? n What constituent is clearly a drug? Is a cigarette a combination product? n What is the purpose of a cigarette? n Does this meet the definition of a device? How would e-cigarettes fit into this 46

Chevron - Step One n n Does tobacco fall under the statute? n Is it specifically named? n Does it effect the structure or function of the body? Do the manufacturers concede that it is sold for its effects on the body? n Why does addiction undermine their claim? 47

Would Regulating Tobacco under the FDA Lead to Results not Intended by Congress? 48

What Information is on Cigarette Labels? 49

Adulteration and Misbranding n n n The Act prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adultered or misbranded. " 21 U. S. C. § 331(a) § 352(j) deems a drug or device misbranded "[i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. ” Continued on next slide 50

Labeling Requirements n n Second, a drug or device is misbranded under the Act "[u]nless its labeling bears. . . adequate directions for use. . . in such manner and form, as are necessary for the protection of users, " except where such directions are "not necessary for the protection of the public health. " § 352(f)(1). n Difference between prescription and over the counter (OTC) drugs. Can tobacco be labeled to comply with this 51

Does the FDA Model fit Tobacco? n n Does tobacco fit within the definition of a drug? n Is tobacco safe and effective for any use? n Is it possible to label tobacco so it can be used safely? What would be the effect of applying the safe and effective test to tobacco? 52

Regulating, not Banning Tobacco n n n How does the FDA argue that it does not have to show that tobacco is safe and effective? n How can it make tobacco use safer? Is safer OK under the “safe for the intended use” test? n How is tobacco different from chemotherapy drugs? What are the arguments against banning 53 tobacco?

What are Other Factors Indicating that Congress did not Intend for the FDA to Regulate Tobacco? n n Are there other agencies that regulate tobacco? Has Congress considered regulating tobacco, but not done some when amending the FDA? What are the economic regulatory issues with tobacco? n Is tobacco taxed? n Is it a major commerce item? How would these be affected if the FDA 54

MCI Telecommunications Corp. v. American Telephone & Telegraph Co. , 512 U. S. 218 (1994) n n n “The FCC contended that, because the Act gave it the discretion to "modify any requirement" imposed under the statute, it therefore possessed the authority to render voluntary the otherwise mandatory requirement that long distance carriers file their rates. ” The MCI Court rejected this, finding that modify did not include ignoring. Why is this problematic for the FDA strategy 55 for safer cigarettes?

United States Supreme Court Opinion n “Reading the FDCA as a whole, as well as in conjunction with Congress' subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA the authority that it seeks to exercise here. For these reasons, the judgment of the Court of Appeals for the Fourth Circuit is affirmed. ” Does this now relate back and change Step 1, i. e. , is the mythical Chevron Step 0? 56 What is not ambiguous?

The Politics of Statutory Interpretation n The majority (including Scalia) said this was evidence that Congress did not intend for the FDA to regulate tobacco, and that such intent trumped Chevron. Minority (Breyer) said just look at the law n Correct for nicotine as a drug n Not correct for the safer tobacco strategy. Congress gave the FDA expanded authority over tobacco in the ‘‘Family Smoking Prevention and Tobacco Control Act’’ of 57

Vaping n n n Assuming the same statutory framework, how can the FDA argue that it can regulate vaping? Is all vaping based on nicotine? Is vaping with nicotine tobacco use as contemplated by congress? Is the vaping device a combination product? 58 Even with the deaths, is vaping still