miércoles, 19 de septiembre de 2018

DOJ Lays Out Arguments Opposing APA Challenges to Vacate Rules

DOJ Lays Out Arguments Opposing APA Challenges to Vacate Rules

Link to FDA Law Blog



Posted: 18 Sep 2018 06:53 PM PDT
By Anne K. Walsh —
In a memo issued by the Attorney General to all civil litigators throughout the country, AG Sessions set forth the DOJ position that it would seek to limit courts from applying “overbroad injunctive relief” in cases involving “nationwide injunctions.”  A “nationwide injunction” is one in which the federal government is barred from enforcing a law or policy as to any person or organization regardless of whether the person is a party to the litigation challenging the law or policy.  In the FDA context, a plaintiff can bring an Administrative Procedure Act (APA) challenge to a particular FDA regulation, and the court, in deciding in favor of the plaintiff, may vacate the challenged rule so that it does not apply to any person.  (See, for example, the Washington Legal Foundation challenge to FDA’s enforcement policy against off-label communications and seeking to enjoin FDA from taking further enforcement action.)

DOJ’s position set forth in the memo is that a court cannot act outside the bounds of its authority by granting relief beyond the particular case or controversy. Although the memo asserts that this position has been longstanding under “Administrations of both parties,” the DOJ memo instructs its litigators to make the following arguments, as appropriate, to defend against the issuance of a potential nationwide injunction:

  1. Nationwide injunctions are inconsistent with constitutional limitations on judicial power – The memo focuses on the equitable power of Article III courts and modern standing doctrine;
  2. Nationwide injunctions have no basis in equitable practice – The memo calls this type of relief an “ahistorical anomaly.”
  3. Nationwide injunctions impede the consideration of a disputed legal issue by different courts – The memo seems to welcome the “organic development and discussion” by lower courts of a contested legal issue, without reference to the policy of conserving judicial resources.
  4. Nationwide injunctions undermine legal rules intended to ensure the orderly resolution of disputed legal issues – The memo argues that the class action system is sufficient to provide relief to large numbers of similarly situated people and that the federal government is entitled to relitigate matters in multiple circuits, citing the principle of nonmutual offensive collateral estoppel as not applying to the federal government.
  5. Nationwide injunctions interfere with judgments that properly belong to other branches of government – The memo claims that Congress must first establish by statute when a single court has authority to review agency actions with nationwide applicability, and that the Executive Branch (and in the particular the discretion of the Executive) decides whether to abide by an adverse ruling outside the geographical region in which the ruling is binding.
  6. The availability of nationwide injunctions undermines public confidence in the judiciary – The memo points to forum shopping as an institutional danger to the judiciary.
The memo devotes an entire section presenting arguments to be made in APA challenges. The APA states that a reviewing court can “hold unlawful and set aside agency action, findings and conclusions” that are arbitrary and capricious, contrary to constitutional rights, in excess of statutory jurisdiction, without observance of procedure, unsupported by substantial evidence, or unwarranted by the facts.  5 U.S.C. 706.  The DOJ memo argues that this statutory language does not expand the limitation on a court to grant relief only to the parties before it.  Specifically, DOJ lawyers are instructed to make the following arguments in APA cases:

  1. The relevant “agency action” is the application of the regulation to the plaintiff, not the regulation itself, so the court should not go beyond the boundaries of the case to invalidate the regulation.
  2. Even if the regulation is the subject of the challenge, the APA does not require that the rule, if found invalid, be set aside on its face or as applied to the challenger.
  3. The APA provides for declaratory and injunctive relief in the absence of a special statutory review provision, and this type of relief is traditionally limited to the parties involved in the litigation.
This APA section reads like an excerpt to be dropped directly into a legal brief, and it will be interesting whether courts ultimately will agree with these legal arguments when presented by DOJ lawyers.

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