Zhang v. US FDA

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND
JIANYI ZHANG,
Plaintiff,
v. 	Civil No.: 1:25-cv-00258-JRR
U.S. FOOD AND DRUG
ADMINISTRATION,
Defendant.
MEMORANDUM OPINION
Pending before the court is Defendant’s Motion to Dismiss. 	(ECF No. 11, the
“Motion.”) The court has reviewed all papers; no hearing is necessary. Local Rule 105.6 (D.
Md. 2025). For the reasons set forth below, the Motion will be granted.
I. 	BACKGROUND1
Pro se Plaintiff Jianyi Zhang is a licensed physician and resident of Maryland. (ECF
No. 1 at p. 9.) Plaintiff seeks “public interest relief” against Defendant the U.S. Food and Drug
Administration (“FDA”) “on behalf of millions of individuals who suffer from Alzheimer’s
disease and related neurological disorders.” Id. Plaintiff previously submitted a citizen petition
to the FDA urging the agency to create a regulatory pathway for Potential Therapeutic Drugs
(“PTDs”) that would permit their conditional availability, subject to stringent post-market
surveillance, for the treatment of Alzheimer’s disease. Id. at p. 2. The FDA denied Plaintiff’s
petition, explaining that “no scientific data supports the efficacy of PTDs.” Id. at p. 7.
Plaintiff acknowledges the FDA’s approval process for such treatments “requires
substantial evidence of a drug’s safety and efficacy before being marketed.” (ECF No. 1 at p.
1 For purposes of resolving the Motion to Dismiss, the court accepts as true all well-pled facts set forth in the
complaint, which Plaintiff titles as a “Petition for Public Interest Relief.” 	(ECF No. 1; the “Complaint.”)
Wikimedia Found. v. Nat’l Sec. Agency, 857 F.3d 193, 208 (4th Cir. 2017).
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 1 of 8

2
10.) He contends that although PTDs failed to show efficacy in Phase III clinical trials required
for FDA approval, the treatments are safe, and may prove effective in treating Alzheimer’s
disease in combination with other therapies. 	Id. 	Plaintiff asserts that the FDA’s actions, or
lack thereof, with regard to approval of PTDs “disproportionately harm[s] vulnerable
populations, including elderly patients with Alzheimer’s disease[.]” Id. He ultimately seeks
“to compel the FDA to modify its regulatory approval framework to permit the conditional
availability of” PTDs. Id. at p. 9.
Plaintiff challenged these same actions in his previously-filed amended complaint in
Case No. 23-1188-SAG, which the court dismissed for lack of Article III standing. See Zhang
v. U.S. FDA, No. CV SAG-23-1188, 2024 WL 4443188 (D. Md. Oct. 8, 2024). 	Plaintiff
initiated this action against Defendant FDA on January 27, 2025, reasserting his claim “under
the public interest exception to standing[.]” (ECF No. 1 at p. 2.) Plaintiff seeks judicial review
under the Administrative Procedure Act (“APA”), declaratory relief, “an injunction to prevent
the FDA from withholding further action on this matter,” and reasonable costs and fees. Id. at
p. 11. Liberally construing Plaintiff’s Complaint, the court finds that Plaintiff asserts claims
against Defendant under the Administrative Procedure Act (“APA”) 5 U.S.C. § 706, the Due
Process Clause of the Fifth Amendment, and the Equal Protection Clause of the Fourteenth
Amendment. Id. at p. 10.
On April 11, 2025, Defendant filed its Motion. 	(ECF No. 11.) 	Plaintiff filed an
opposition to the Motion on June 6, 2025, and a supplement to his opposition on June 11, 2025.
(ECF Nos. 13, 15.) Defendant filed a reply in support of its Motion on June 18, 2025. (ECF
No. 16.)
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 2 of 8

3
II. 	LEGAL STANDARDS2
A. Federal Rule of Civil Procedure 12(b)(1)
“Rule 12(b)(1) of the Federal Rules of Civil Procedure authorizes dismissal for lack of
subject matter jurisdiction.” Barnett v. United States, 193 F. Supp. 3d 515, 518 (D. Md. 2016).
“The plaintiff bears the burden of proving, by a preponderance of evidence, the existence of
subject matter jurisdiction.” Mayor & City Council of Balt. v. Trump, 416 F. Supp. 3d 452, 479
(D. Md. 2019). 	Subject matter jurisdiction challenges may proceed in two ways: a facial
challenge or a factual challenge. Id. A facial challenge asserts “that the allegations pleaded in
the complaint are insufficient to establish subject matter jurisdiction.” Id. A factual challenge
asserts “that the jurisdictional allegations of the complaint [are] not true.” Id. (quoting Kerns
v. United States, 585 F.3d 187, 192 (4th Cir. 2009)). “In a facial challenge, ‘the facts alleged
in the complaint are taken as true, and the motion must be denied if the complaint alleges
sufficient facts to invoke subject matter jurisdiction.’” 	Id. (quoting Kerns, 585 F.3d at 192
(instructing that in a facial challenge to subject matter jurisdiction the plaintiff enjoys “the same
procedural protection as . . . under a Rule 12(b)(6) consideration”)). “[I]n a factual challenge,
‘the district court is entitled to decide disputed issues of fact with respect to subject matter
jurisdiction.’” Id.
Defendant raises a facial challenge to the court’s subject matter jurisdiction, asserting
that Plaintiff’s Complaint fails to allege facts sufficient to establish Article III standing. (ECF
No. 11-1 at p. 5.) Rule 12(b)(1) also “governs motions to dismiss for mootness and for lack of
standing, which pertain to subject matter jurisdiction.” Stone v. Trump, 400 F. Supp. 3d 317,
333 (D. Md. 2019). The party invoking federal jurisdiction bears the burden of establishing
standing. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). “Since they are not mere
2 In addition to Rule 12(b)(1), the Motion invokes review under Rule 12(b)(6); however, because the court grants
the Motion under Rule 12(b)(1) grounds, the court does not set forth the standard applicable when reviewing a
motion to dismiss under Rule 12(b)(6).
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 3 of 8

4
pleading requirements but rather an indispensable part of the plaintiff's case, each element must
be supported in the same way as any other matter on which the plaintiff bears the burden of
proof, i.e., with the manner and degree of evidence required at the successive stages of the
litigation.” Id. at 561. “At the pleading stage, general factual allegations of injury resulting
from the defendant's conduct may suffice, for on a motion to dismiss we presum[e] that general
allegations embrace those specific facts that are necessary to support the claim.” Id. (citation
omitted).
“When a defendant raises standing as the basis for a motion under Rule 12(b)(1) to
dismiss for lack of subject matter jurisdiction, [the court] ‘may consider evidence outside the
pleadings without converting the proceedings to one for summary judgment.’” 	White Tail
Park, Inc. v. Stroube, 413 F.3d 451, 459 (4th Cir. 2005) (quoting Richmond, Fredericksburg &
Potomac R.R. Co. v. United States, 945 F.2d 765, 768 (4th Cir.1991)). Accordingly, the court
may consider the exhibits referenced by Defendant in its Motion. (ECF Nos. 11-2, 11-3.)
III. 	ANALYSIS
As an initial matter, the court is ever mindful that pro se filings “must be construed
liberally, . . . so as to do substantial justice,” and are held to less stringent standards than filings
drafted by lawyers. Elijah v. Dunbar, 66 F.4th 454, 460 (4th Cir. 2023) (quoting Erickson v.
Paradus, 551 U.S. 89, 94 (2007); FED. R. CIV. P. 8(f); Estelle v. Gamble, 429 U.S. 97, 106
(1976)). “In practice, this liberal construction allows courts to recognize claims despite various
formal deficiencies, such as incorrect labels or lack of cited legal authority.” Wall v. Rasnick,
42 F.4th 214, 218 (4th Cir. 2022). 	Such liberal construction, however, does not absolve
Plaintiff from pleading a plausible claim, and this court “may not act as an advocate for a self-
represented litigant” by “conjur[ing] up” issues not presented. Desgraviers v. PF-Frederick,
LLC, 501 F. Supp. 3d 348, 351 (D. Md. 2020) (quoting Bey v. Shapiro Brown & Alt, LLP, 997
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 4 of 8

5
F. Supp. 2d 310, 314 (D. Md. 2014), aff’d, 584 F. App’x 135 (4th Cir. 2014); Beaudett v. City
of Hampton, 775 F.2d 1274, 1278 (4th Cir. 1985)).
Defendant asserts two arguments in its Motion: (1) Plaintiff lacks standing, and (2)
Plaintiff has not plausibly alleged any claim for relief. (ECF No. 11-1 at pp. 5–9.) The court
first addresses Plaintiff’s standing.
A. Standing
The Constitution extends the judicial power of Article III courts to “cases” or
“controversies.” 	U.S. C ONST. ART. III, § 2, cl. 1. 	The doctrine of standing, among others,
“implements” this limit. Carney v. Adams, 592 U.S. 53, 58 (2020). To establish standing:
First, the plaintiff must have suffered an injury in fact that is both
concrete 	and 	particularized 	and 	actual 	or 	imminent, 	not
conjectural or hypothetical. 	Second, the plaintiff's injury must
be fairly traceable to the challenged action of the defendant,
meaning that there must be a causal connection between the
injury and the conduct complained of. Third, it must be likely,
as opposed to merely speculative, that the injury will be
redressed by a favorable decision.
Dep’t. of Educ v. Brown, 600 U.S. 551, 561 (2023) (citations omitted) (quoting Lujan v. Defs.
of Wildlife, 504 U.S. 555, 560–61 (1992)).
“To establish injury in fact, a plaintiff must show that he or she suffered ‘an invasion
of a legally protected interest’ that is ‘concrete and particularized’ and ‘actual or imminent, not
conjectural or hypothetical.’” Spokeo, Inc. v. Robins, 578 U.S. 330, 339 (2016) (quoting Lujan,
504 U.S. at 560). “For an injury to be ‘particularized,’ it ‘must affect the plaintiff in a personal
and individual way.’” Id. A concrete injury is one that is “‘real,’ and not ‘abstract.’” Id. at
340. Plaintiffs “must demonstrate standing ‘with the manner and degree of evidence’ required
at the relevant ‘stage[] of the litigation.’” Fernandez v. RentGrow, Inc., 116 F.4th 288, 294 (4th
Cir. 2024) (quoting Lujan, 504 U.S. at 561).
Defendant argues that this court lacks subject matter jurisdiction because Plaintiff’s
Complaint fails to “allege any concrete and particularized injury” sufficient to establish Article
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 5 of 8

6
III standing. 	(ECF No. 11-1 at p. 5.) 	Plaintiff acknowledges that his previous case was
dismissed because the court found that he had failed to allege an “injury in fact” sufficient to
confer standing. (ECF No. 1 at p. 3.) Here, Plaintiff argues that he is not required to show any
concrete or particularized injury because “the standing doctrine has become flexible,” allowing
a public interest exception. Id. He asserts that the “public interest exception allows a plaintiff
to sue on behalf of the public or an affected group when the case involves a matter of great
public significance or a violation of fundamental or constitutional rights.” Id.
Plaintiff cites several cases for the proposition that “federal courts . . . have permitted
suits invoking broad public rights to move forward under the public interest exception.” (ECF
No. 1 at p. 3.) Defendant counters that the cases Plaintiff relies upon do not, in fact, support
his position. (ECF No. 11-1 at p. 7.) The court agrees with Defendant. There is no freestanding
“public interest exception” to standing requirements.
In the first case cited by Plaintiff, Massachusetts v. EPA, the Supreme Court held that
the petitioners, including the Commonwealth of Massachusetts (the “State”), had standing to
challenge the EPA’s denial of their rulemaking petition regarding the regulation of greenhouse
gas emissions. 	549 U.S. 497, 526 (2007). 	Importantly, the Court noted that it was “of
considerable relevance that the party seeking review [was] a sovereign State and not . . . a
private individual.” Id. at 518. This was because the State had a “stake in protecting its quasi-
sovereign interests, [and was] entitled to special solicitude in [the Court’s] standing analysis.”
Id. at 520. Plaintiff here, a private physician, is not entitled to such special solicitude.
Moreover, the Supreme Court’s holding in Friends of the Earth, Inc. v. Laidlaw Env’t
Servs. (TOC), Inc., also relied upon by Plaintiff, concerned associational standing, where the
Court reiterated its rule:
An association has standing to bring suit on behalf of its
members when its members would otherwise have standing to
sue in their own right, the interests at stake are germane to the
organization’s purpose, and neither the claim asserted nor the
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 6 of 8

7
relief requested requires the participation of individual members
in the lawsuit.
528 U.S. 167, 181 (2000) (citing Hunt v. Washington State Apple Advertising Comm’n, 432
U.S. 333, 343 (1977)). In this case, Plaintiff does not file suit as an organization, nor does he
allege that he represents members who have suffered concrete, particularized injuries.
The additional cases cited by Plaintiff are also inapposite. See Flast v. Cohen, 392 U.S.
83, 105–106 (1968) (holding that “a taxpayer will have standing consistent with Article III to
invoke federal judicial power when he alleges that congressional action under the taxing and
spending clause is” unconstitutional); Pub. Citizen v. U.S. Dep’t of Just., 491 U.S. 440, 449
(1989) (finding that agency refusal to permit appellants to scrutinize records to the extent
allowed by statute “constitutes a sufficiently distinct injury to provide standing to sue”).
Plaintiff here does not assert taxpayer standing under the Taxing and Spending Clause in
Article I of the Constitution and he does not allege he was denied access to information to
which he is statutorily entitled.
Relevant here, “a plaintiff . . . asserting an abstract general interest common to all
members of the public, no matter how sincere or deeply committed a plaintiff is to vindicating
that general interest on behalf of the public,” cannot establish an “injury in fact.” Carney, 592
U.S. at 59; see also Moss v. Spartanburg Cnty. Sch. Dist. Seven, 683 F.3d 599, 604–605 (4th
Cir. 2012) (finding that “[p]laintiffs may not establish their standing to bring suit merely
because they disagree with a government policy . . . or because they share the ‘generalized
interest of all citizens in constitutional governance[]’”) (internal citations omitted). “[T]o find
standing based upon that kind of interest ‘would significantly alter the allocation of power at
the national level, with a shift away from a democratic form of government.’” 	Id. (quoting
United States v. Richardson, 418 U.S. 166, 188 (1974) (concurring opinion)).
As Plaintiff asserts in his Complaint, he “asks for judicia[l] intervention to resolve a
matter affecting millions based on the Constitution and the Supreme Court’s decision, not on
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 7 of 8

8
[his own] situation.”3 (ECF No. 1 at p. 4.) Accepting Plaintiff’s allegations as true (including
all reasonable inferences therefrom), Plaintiff alleges no concrete or imminent injury that
affects him “in a personal and individual way.” 	Spokeo, Inc., 578 U.S at 339. 	As in his
previous case before Judge Gallagher, “the universal nature of the potential harm prevents
[Plaintiff] from asserting the type of particularized injury the law requires[];” and there is no
applicable “public interest exception” that absolves him from plausibly alleging an injury in
fact to confer standing. Zhang v. U.S. FDA, No. CV SAG-23-1188, 2024 WL 4443188, at *2
(D. Md. Oct. 8, 2024). As noted by Judge Gallagher, “while Zhang should be commended for
his public-minded interest in seeking ways to combat a debilitating health condition, the
separation of powers as protected by the standing doctrine does not permit this [c]ourt’s
intervention in his pursuit.” Id.
Accordingly, having failed to establish Article III standing, Plaintiff’s Complaint will
be dismissed for lack of subject matter jurisdiction.4
IV. 	CONCLUSION
For the reasons set forth herein, by separate order, the Motion (ECF No. 11) shall be
granted.
/S/
February 18, 2026 	______________________
Julie R. Rubin
United States District Judge
3 In his Response to the Motion, Plaintiff asserts for the first time that Defendant’s categorical ban on PTDs “forces
[him] to withhold potentially life-saving therapies from patients facing a terminal illness” and this constitutes a
personalized harm sufficient to allege an injury in fact. (ECF No. 13 at p. 7.) As noted by Defendant, however,
“[i]t is well-established that parties cannot amend their complaints through briefing[.]” S. Walk at Broadlands
Homeowner’s Ass’n, Inc. v. OpenBand at Broadlands, LLC, 713 F.3d 175, 184 (4th Cir. 2013). Nonetheless, this
directly contradicts Plaintiff’s express allegation in his Complaint that he does not seek relief with respect to his
individual circumstances.
4 Given that the Complaint warrants dismissal on the grounds discussed above, the court does not reach
Defendant’s argument that Plaintiff’s Complaint should be dismissed for failure to state a claim pursuant to Rule
12(b)(6). (ECF No. 11-1 at pp. 8–9.)
Case 1:25-cv-00258-JRR Document 21 Filed 02/18/26 Page 8 of 8