§ 11.2.3 Ripeness - 675
Abbot Labs v. Gardner - 675
What did the statute require?
What did the FDA require through a regulation?
Why did Abbot and others want pre-enforcement judicial review?
What did plaintiffs argue was wrong with the regulation?
Why did the FDA claim the action was not ripe?
What is the first question in a ripeness analysis?
What is the two part test?
Is this a question of law or fact?
Does it depend on agency discretion?
Does defendant have a significant injury?
Did plaintiffs ask for an injunction?
Why did the court say this matters?
Did the United States Supreme Court allow the review to continue?
Toilet Goods v. Gardner - 678
What was the factual issue in this case?
How was the injury requirement different in this case and Abbott?
What is the equitable problem with defendant's complaint?
Notes and Questions - 680
What is the agency cost of allowing pre-enforcement review?
How does this affect the necessary rulemaking record?
How does pre-enforcement review help beneficiaries of the regulation?
What is the finality problem with reviewing non-legislative rules, i.e., guidelines,
letter rulings, etc.?
3 - How was this met in the coin-operated laundries case?
5 - Short time limits on review
What if congress sets a 60 day limit on reviewing a rule?
Why do they do this?
JEM Broadcasting does not quite say what the book claims - the court did say
that the plaintiff's challenge to the rule was time barred, but it also said
that it would have failed because the rule was only procedural and did not require
notice and comment rulemaking.
See - N.L.R.B. Union v. Federal Labor Relations Authority, 834 F.2d 191, 56
USLW 2364, 126 L.R.R.M. (BNA) 3290, 266 U.S.App.D.C. 165 D.C.Cir. Dec 04, 1987
An agency's regulations may be attacked in two ways once the statutory limitations
period has expired.
First, a party who possesses standing may challenge regulations directly on
the ground that the issuing agency acted in excess of its statutory authority
in promulgating them. A challenge of this sort might be raised, for example,
by way of defense in an enforcement proceeding
As applied to rules and regulations, the statutory time limit restricting
judicial review of [agency] action is applicable *196 **170 only to cut off
review directly from the order promulgating a rule. It does not foreclose subsequent
examination of a rule where properly brought before this court for review of
further [agency] action applying it. For unlike ordinary adjudicative orders,
administrative rules and regulations are capable of continuing application;
limiting the right of review of the underlying rule would effectively deny many
parties ultimately affected by a rule an opportunity to question its validity.
The second method of obtaining judicial review of agency regulations once
the limitations period has run is to petition the agency for amendment or rescission
of the regulations and then to appeal the agency's decision. We have distinguished
three types of challenges on appeal.
(a) A petitioner's contention that a regulation suffers from some procedural
infirmity, such as an agency's unjustified refusal to allow affected parties
to comment on a rule before issuing it in final form, will not be heard outside
of the statutory limitations period. This court held in Natural Resources Defense
Council v. NRC, 666 F.2d 595 (D.C.Cir.1981), that "[w]ith respect to routine
procedural challenges made by those against whom the agency is not proceeding
to enforce the regulation," id. at 603, "[t]he 60 day period for seeking
judicial review ... is jurisdictional in nature and may not be enlarged or altered
by the courts." Id. at 602. Countenancing such challenges, the court reasoned,
would on balance waste administrative resources and unjustifiably impair the
reliance interests of those who conformed their conduct to the contested regulation.
Hence, the court dismissed as untimely NRDC's procedural objection to the Commission's
decision to promulgate final rules without a notice-and-comment period.
(b) A petitioner's claim that a regulation suffers from some substantive deficiency
other than the agency's lack of statutory authority to issue that regulation
may be brought by petitioning the agency for amendment or rescission and then
appealing the denial of that petition. For example, in Gage v. Atomic Energy
Commission, 479 F.2d 1214 (D.C.Cir 1973), this court first noted that "petitioners
retain the right to initiate rulemaking before the AEC by formally proposing
the promulgation of the expanded rules they desire," and then said in a
Petitioners do have the right to petition the Commission for institution of
a rulemaking proceeding under 10 C.F.R. §§ 2.802 and 2.803.... Denial of such
a petition would constitute a final order reviewable by this court.
479 F.2d at 1222 & n. 27. An appellate court's review in cases of this
kind, however, is limited to the "narrow issues as defined by the denial
of the petition for rulemaking," and does not extend to a challenge of
the agency's original action in promulgating the disputed rule. Professional
Drivers Council v. Bureau of Motor Carrier Safety, 706 F.2d 1216, 1217 n. 2
(D.C.Cir.1983) (emphasis added); see also Natural Resources Defense Council
v. EPA, 824 F.2d 1146, 1150 (D.C.Cir.1987) (en banc). Furthermore, review of
an agency's decision not to promulgate a rule proposed by the petitioner is
extremely limited. See WWHT, Inc. v. FCC, 656 F.2d 807, 816-20 (D.C.Cir.1981).
(c) Finally, a petitioner's contention that a regulation should be amended
or rescinded because it conflicts with the statute from which its authority
derives is reviewable outside of a statutory limitations period. See Natural
Resources Defense Council v. NRC, 666 F.2d at 603-04. Judicial review of this
sort is often said to proceed--somewhat misleadingly--under the "arbitrary
and capricious" standard, see, e.g., id. at 603, but challenges to an agency's
statutory authority to issue a given regulation are assessed in a different
manner than other allegations of "arbitrary *197 **171 and capricious"
agency action once the limitations period has lapsed. We describe the proper
approach to such cases in Part II.B. infra.
7 - Judicial Stays
Why is getting an injunction critical to pre-enforcement review?
What are the factors the court should consider in reviewing a request for
an injunction in a pre-enforcement challenge case??
§ 11.2.4 Exhaustion of Administrative Remedies - 686
McCarthy v. Madigan - 686
NOTE - This case has been overruled by statute for prisoners - see supplement.
It is still good law in other situations.
What action did the prisoner bring?
What remedy was he seeking?
Was that remedy available from the prison administrative grievance process?
What can the prisoner gain by exhausting his administrative remedies?
How does the prison appeals process burden the inmate?
What are the twin purposes of the exhaustion doctrine and how does it support
What is the most important determinate of whether exhaustion applies in the
Did Congress require exhaustion for prisoner Biven's claims?
Does the prisoner have to exhaust his remedies?
Why does seeking access to medical care increase the chance that the prisoner
can skip the appeals process?
Will the record of the appeals process assist the court in making its decision?
What did the concurrence say?
New Jersey Civil Service Ass'n. (NJCSA) v. State - 691
What was being contested in this case?
Was there a final action, which ends the exhaustion problem?
Was the AG's opinion a final agency action?
What made it final?
What is the other ground for skipping exhaustion?
Notes and Questions - 693
1 - Exhaustion of remedies or of litigants?
What is the futility doctrine and how do you satisfy it?
What does this look like from other areas of adlaw?
What are the factors to balance in exhaustion cases?
Exhaustion and Federal law questions
While the federal courts generally require exhaustion, when may the litigant
go directly to court?
What if Congress requires exhaustion and the plaintiff is bringing a facial
7 - Exhaustion as preclusion
How is this like a trial?
How was this modified in Sims v. Apfel, 530 U.S. 103 (2000) - supplement?
Do plaintiffs bringing 1983 claims have to exhaust state administrative proceedings?
Is this a good policy?
§ 11.2.5 Primary Jurisdiction - 699
Farmers Insurance Exchange v. Superior Court - 699
How do primary jurisdiction and exhaustion differ?
Notes and Questions - 703
1 - What are the standards the court should use to determine who has primary
May courts defer to agency findings in criminal cases?
5 - Private rights of action
Cort v. Ash, 422 U.S. 66, 95 S.Ct. 2080, 45 L.Ed.2d 26 U.S.Pa. Jun 17, 1975
What are the factors relevant in determining whether a private remedy is implicit
in a statute not expressly providing one?
End of the course!!!
The Law, Science & Public
Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster