Document ID: ./input/supremecourt_opinions/opinions/23pdf/23-235_n7ip.pdf
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FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE 

Syllabus 

stayed  the  District  Court’s  order  pending  the  disposition  of 
proceedings  in  the  Fifth  Circuit  and  this  Court.    On  the  merits,  the 
Fifth  Circuit  held  that  plaintiffs  had  standing.   It  concluded  that 
plaintiffs  were  unlikely  to  succeed  on  their  challenge  to  FDA’s  2000 
and 2019 drug approvals, but were likely to succeed in showing that
FDA’s  2016  and  2021  actions  were  unlawful.    This  Court  granted
certiorari with respect to the 2016 and 2021 FDA actions. 

Held: Plaintiffs  lack  Article  III  standing  to  challenge  FDA’s  actions 

regarding the regulation of mifepristone.  Pp. 5–25.

(a) Article III standing is a “bedrock constitutional requirement that 
this Court has applied to all manner of important disputes.”  United 
States v. Texas, 599 U. S. 670, 675.  Standing is “built on a single basic
idea—the idea of separation of powers.”  Ibid.  Article III confines the 
jurisdiction of federal courts to “Cases” and “Controversies.”  Federal 
courts do not operate as an open forum for citizens “to press general 
complaints  about  the  way  in  which  government  goes  about  its 
business.”    Allen  v.  Wright, 468  U. S.  737,  760.    To  obtain  a  judicial
determination  of  what  the  governing  law  is,  a  plaintiff  must  have  a 
“personal  stake”  in  the  dispute.    TransUnion  LLC  v.  Ramirez,  594 
U. S. 413, 423. 

To establish standing, a plaintiff must demonstrate (i) that she has
suffered or likely will suffer an injury in fact, (ii) that the injury likely 
was caused or will be caused by the defendant, and (iii) that the injury 
likely  would  be  redressed  by  the  requested  judicial  relief.  See 
Summers v. Earth Island Institute, 555 U. S. 488, 493.  The two key 
questions in most standing disputes are injury in fact and causation. 
By requiring the plaintiff to show an injury in fact, Article III standing 
screens  out  plaintiffs  who  might  have  only  a  general  legal,  moral, 
ideological,  or  policy  objection  to  a  particular  government  action. 
Causation requires the plaintiff to establish that the plaintiff ’s injury 
likely was caused or likely will be caused by the defendant’s conduct. 
Causation is “ordinarily substantially more difficult to establish” when 
(as here) a plaintiff challenges the government’s “unlawful regulation 
(or lack of regulation) of someone else.”  Lujan v. Defenders of Wildlife, 
504 U. S. 555, 560–561.  That is because unregulated parties often may
have more difficulty linking their asserted injuries to the government’s 
regulation (or lack of regulation) of someone else.  Pp. 5–12.

(b) Plaintiffs are pro-life, oppose elective abortion, and have sincere
legal,  moral,  ideological,  and  policy  objections  to  mifepristone  being
prescribed and used by others.  Because plaintiffs do not prescribe or 
use  mifepristone,  plaintiffs  are  unregulated  parties  who  seek  to 
challenge  FDA’s  regulation  of  others.  Plaintiffs  advance  several 
complicated  causation  theories  to  connect  FDA’s  actions  to  the 
plaintiffs’  alleged  injuries  in  fact.  None  of  these  theories  suffices  to