Ripeness

1. Ripeness • Defined: Whether plaintiff can show a particularized and concrete injury sufficient to justify bringing the case to court. • Ripeness doctrine has its roots in Article III’s requirement of “concrete” cases & controversies. • But Abbott Labs also treated it as a discretionary aspect of the Court’s equitable jurisdiction. • That is, even if a case is “ripe” for Article III purposes, a court can find it “unripe” for prudential reasons • This kind of “ripeness” is most often an issue with pre-enforcement challenges to rulemakings. • Prior to Abbott Labs, parties generally couldn’t challenge agency regs until they were applied to them – Abbott Labs changed all this

2. Abbott Laboratories v. Gardner – the facts • Food, Drug & Cosmetic Act required drug manufacturers to print generic name on drug labels and advertisements • FDA issued regulation requiring generic name to be put on “each appearance” of the brand name • Drug manufacturing industry wanted to challenge validity of the regulation before complying with it or refusing to comply with it, claiming that the FDA had exceeded its authority under the statute • Why would the gov’t fight so hard to claim that the manufacturers’ challenge to the rule was unripe at the pre-enforcement stage? Wouldn’t it want to resolve this issue so it would know how to proceed in enforcement proceedings?

3. Abbott Labs & the req’mt of finality (a brief detour) • Independent of the doctrine of ripeness, the doctrine of finality ensures that an agency has completed an action prior to court review. • An agency action is considered “final” if it is: • the consummation of the agency’s decision-making process & and not interlocutory or tentative • an agency action by which the rights and obligations of parties will be determined – i.e., from which legal consequences will flow. • APA §704 requires (mostly) that agency actions be final before they can be appealed. Special review statutes also often contain finality requirements. • Abbott Labs incorporated the finality req’mt into it’s ripeness inquiry

4. More on finality • Abbott Labs – SCT has determined finality in a “pragmatic way” – looks to see if agency action is ONLY informal or interpretation of a subordinate official or tentative. If so, it’s NOT final. • Final rules or orders after formal adjudications are clearly final. • What about the following scenario? • An ass’n of retail stores writes to the Administrator of the Wage and Hour Division in the DOL, who is in charge of enforcing the federal minimum wage and overtime laws. The ass’n seeks clarification of the effect on the ass’n of recent congressional amendments to the laws. The Administrator responds in a letter that he interprets the laws to have a specific effect & he will use this interpretation in future actions. Is this final agency action?

5. Abbott Lab’s 2-part test (and application): • Are the issues fit for judicial decision? (Yes) • Purely a question of law (easy to resolve pre-enforcement) • Agency’s action is final (final rule after formal process – authoritative interpretation of the statute) • No benefit in reviewing multiple claims by manufacturers • Does withholding court consideration impose hardship on the parties? (Yes) • Immediate cost incurred in printing new labels, ads . . . to comply with new rules OR in risking criminal/civil penalties by continuing as it has been • Requiring drug industry to wait to challenge rules as a defense to an enforcement action could hurt consumer confidence, which is particularly important in this area • Little harm to gov’t by delaying enforcement while resolving this issue. Resolution of the issue first will eventually speed enforcement and compliance

6. Toilet Goods Assn v. Gardner – an unripe case • Pre-enforcement challenge to FDA rule authorizing suspension of “certification” to manufacturers of cosmetics who deny FDA inspectors access to facilities, etc. Manufacturers claimed that rule exceeded FDA’s rulemaking authority. • SCT – action not ripe under Abbot Labs criteria • The issue is purely legal BUT unfit for judicial decision – Why? • Why does withholding court review not impose hardship in the same way as Abbott Labs?

7. Exhaustion of remedies Exhaustion: The requirement that parties challenging agency action pursue all available remedies within the administrative structure before they purse a lawsuit in court.

8. When is exhaustion required? Special Review Statutes • If a special review statute pertaining to a particular agency REQUIRES exhaustion of administrative remedies, then a party must exhaust those remedies. • Example 15 USC § 3416(a)(2): Any person aggrieved by any order issued by the Commission in a proceeding under this chapter to which such person is a party may apply for a rehearing within 30 days after the issuance of such order. . . . • No person may bring an action under this section to obtain judicial review of any order of the Commission unless - (A) such person shall have made application to the Commission for rehearing under this subsection; and (B) the Commission shall have finally acted with respect to such application.

9. When is exhaustion required absent a special review statute? When the basis for one’s suit is violation of federal law & there is no special review statute: APA § 704: Agency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court are subject to judicial review. . . . Except as otherwise expressly required by statute, agency action otherwise final is final for purposes of this section, whether or not there has been presented or determined an application for a declaratory order, for any form of reconsideration, or unless the agency otherwise requires by rule and provides that the action meanwhile is inoperative, for an appeal to superior agency authority.

10. Exhaustion under the APA after Darby v. Cisneros • In Darby, SCT held that APA § 704 means what it says, which translated is: • An agency action is final & appealable to a court once the party has exhausted all administrative remedies expressly required by a statute or regulation. • Litigants need not exhaust permissive administrative remedies. • In Darby, HUD regulations provided that a hearing was to be held before an ALJ and that ALJ’s determination was to be final unless the Sec’y of HUD reviewed the determination as a matter of discretion. Parties could petition for Sec’y review. • Parties were NOT required to petition Sec’y prior to filing lawsuits as APA § 704 requires only exhaustion of expressly required remedies.

11. Exhaustion when the claim is not statutory • Before Darby, courts routinely implied exhaustion requirements even with statutory claims not involving a special review statute mandating exhaustion. • That can no longer happen due to Darby’s interpretation of APA § 704 • BUT common law exhaustion principles still may apply in certain instances, especially when actions arise under the Constitution rather than statutes.

12. Common law exhaustion principles in a nutshell • When the claim involved is based on the common law (including the Constitution), courts generally insist that litigants exhaust anyinternal review or rehearing procedures – even if only discretionary/permissive • Exceptions • If exhaustion of administrative remedies will cause undue prejudice to subsequent court action • Where administrative remedies are inadequate due to doubt that the agency has the power to grant appropriate relief • Where the agency has been shown to be biased or has otherwise predetermined the issue