In Re: Motion to Quash Administrative Subpoena to Rhode Island Hospital

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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
In Re: Administrative Subpoena 25-1431-032
to Rhode Island Hospital.
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C.A. No. 1:26-mc-0007-MSM-AEM
MEMORANDUM AND ORDER
Mary S. McElroy, United States District Judge.
The 	United 	States 	Department 	of 	Justice 	(“DOJ”) 	possesses 	immense
prosecutorial authority and discretion. As citizens, we trust that federal prosecutors,
when wielding this awesome power against a state, a company, or certainly against
vulnerable children, will play fair and be honest with its counterparts and the
judiciary.
DOJ has proven unworthy of this trust at every point in this case. 	It has
misrepresented and withheld information to both this Court and the United States
District Court for the Northern District of Texas (the “Texas court”). It did so in an
obvious effort to shield it’s recent investigative tactics—previously rejected by every
other court to review them—from this Court’s review, in favor of a distant forum that
DOJ deems friendly to its political positions.1 Its representatives have, under oath,
1 The presiding judge in the Texas court has branded “the Department of Justice, the
world's largest law firm” a “frequent forum shopper.” Opening Remarks from Judge
Reed O'Connor [2024 TX Chapters Conference], The Federalist Society (Oct. 22,
2024), https://www.youtube.com/watch?v=HMTt9pxWBhA [https://perma.cc/GR7A-
H6N8]. It is clear that the DOJ has done so here.
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misrepresented salient facts. It has misled the parties with whom it was negotiating
in Rhode Island, who have now been placed in an untenable and unprecedented
procedural position. 	And when its attorneys came to this Court to explain their
conduct, the senior attorney—who was present at many of the events that took place
in this case—sat silently by as his counterpart, a junior attorney who has been
practicing law for approximately six months and had no relevant information, was
forced to answer questions about DOJ’s blatant disregard for the proper course of
negotiations.
Now before the Court is the petitioner, the Child Advocate for the State of
Rhode Island’s (the “Child Advocate”) Emergency Motion to Quash a subpoena duces
tecum issued by DOJ as well as Rhode Island Hospital’s (“RIH”) Motion to Quash the
same subpoena. (ECF Nos. 1, 28.) For the following reasons, the Court GRANTS both
Motions to Quash and enjoins the DOJ from seeking or receiving any documents
related to this now invalid subpoena.
I. 	BACKGROUND
This 	matter 	arises 	out 	of 	an 	ostensible 	nationwide 	healthcare 	fraud
investigation that seeks to examine the manner in which children throughout the
United States receive gender-affirming care. Because the issue decided here occurred
during what appears to be the preliminary phase of one aspect of this wide-ranging
investigation, the Court begins by laying the foundation that prompted the instant
dispute.
Beginning in July 2025, the DOJ issued a broad and sweeping administrative
subpoena—pursuant to 18 U.S.C. § 3486—to RIH seeking over half a decade of
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sensitive medical information of
every minor patient that had received gender
affirming care at that hospital.2 (ECF No. 1-2.) Specifically, this subpoena sought to
sweep in information about these children including: (1) their names; (2) Social
Security numbers; (3) addresses; (4) diagnoses; (5) clinical histories; and (6) familial
information.
Id. at 5–7. 	Upon its receipt of this HIPAA subpoena, RIH elected to
negotiate with DOJ over the subpoena’s applicability and scope. No. 4:26-mc-00006-
0 (N.D. Tex.), ECF No. 1-3. 	Following an initial production, the parties began to
negotiate the more granular aspects of 	RIH’s compliance with this subpoena,
including the proper search terms and parameters needed to make a more fulsome
production to the DOJ. 	Notwithstanding the parties’ active engagement with one
another, beginning in February 2026, the DOJ appears to have inexplicably ceased
communicating with RIH.3 (ECF No. 28-11.) The hearing before this Court on May
12, 2026, was the first time that this Court was made aware of the ongoing nature of
these negotiations and of the fact that several conferences had been held since the
issuance of the subpoena. Prior to this, the DOJ had represented to this Court that
“[t]he Hospital chose not to move to quash the subpoena, and in fact engaged with
2 The DOJ issued this subpoena as authorized by the Health Insurance Portability
and 	Accountability 	Act, 	otherwise 	known 	as 	HIPAA.
	See 18 	U.S.C. 	§ 	3486.
Sometimes, individuals colloquially refer to these subpoenas as “HIPAA subpoenas.”
3 With respect to the parties’ negotiation of RIH’s options to comply with the
subpoena, Counsel Gunn for the DOJ stated that he cannot “specifically recall”
whether the parties discussed accepting anonymized patient information. (ECF No.
32-1.) 	The attorney for RIH represented that the DOJ had not discussed that with
them. The Court credits RIH’s representation.
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the Government and led the Government to believe it would comply with the
subpoena. However, the Hospital never complied and never moved to quash.” (ECF
No. 9 at 2.) Notably, and misleadingly, the DOJ never acknowledged that it had failed
to respond in any way to the February message from RIH where it suggested search
terms for compliance with the subpoena.
Thereafter, on April 28, 2026, email correspondence between the DOJ and RIH
reveals that DOJ reinitiated contact with RIH, explained that the responsible
prosecutor had “been out for a few weeks[,]” and requested that the parties conference
“this week” regarding Rhode Island Hospital’s next production. 	(ECF No. 28-11.)
Notwithstanding this representation to RIH, and roughly forty-eight hours later,
DOJ instead decided to file an unannounced Petition for Enforcement of this
same
administrative subpoena in the Northern District of Texas, Fort Worth Division. No.
4:26-mc-00006-O, ECF No. 1. 	At 6:10 PM on April 30, DOJ emailed RIH reversing
its previous negotiating position and announcing that there was “[n]o immediate need
to connect now.” 	(ECF No. 28-11 at 2.) 	This omission leads the Court to conclude
this request was a subterfuge to prevent RIH from realizing that DOJ had decided to
go to Texas for an order compelling production of the very records that they had been
discussing for months.4
4 It is well established that counsel are responsible for working in a cooperative,
rather than an adversarial manner, and to confer in good faith when negotiating the
parameters of a subpoena.
	In re Risner, 338 F.R.D. 380, 383 (S.D. Ohio 2021). The
parties had done so up until DOJ’s about face on April 30, when it repaired to the
Texas court and presented RIH with a
fait-accompli motion to enforce (after it had
submitted it), followed a few hours later by an order granting that motion. The Child
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Alongside their Petition for Enforcement, the DOJ attached: (1) the subpoena
itself; (2) preliminary email correspondence between the DOJ and Rhode Island
Hospital; (3) and, of particular relevance here, a declaration from the Acting Director
of the Enforcement & Affirmative Litigation Branch within the Civil Division of the
DOJ, Lisa K. Hsiao. (ECF No. 1-1–3.) With respect to Ms. Hsiao’s declaration itself,
she represented that RIH had failed to comply with the subpoena and provided the
following factual summary to the Texas court:
The return date on the subpoena was Thursday August 7,
2025. 	In early conversations with counsel for RIH, the
Government communicated that it would be willing to
receive documents responsive to the subpoena past the
return date but that it did not expect to extend that grace
period beyond reason. Counsel for RIH has communicated
several times that it intends to and would be producing
responsive 	documents.
	However, 	the 	last 	such
communication was on February 4, 2026, and to date, RIH
has produced only one document totaling six pages. 	In
other words, RIH has failed to comply in any meaningful
way with the subpoena.
(ECF 1-3 ¶ 46.)
This representation that the communication with RIH had ceased as of
February 4, 2026, was clearly misleading, if not utterly false. At the hearing on this
Motion, DOJ’s attorney attempted to justify the glaring omission by saying that the
February 4, 2026 email was the last “such” communication. This is patently untrue
because, just the day before filing the declaration containing this representation the
attorneys for RIH had sent an email in response to DOJ’s request for a conference to
Advocate learned of the subpoena and motion that targeted its children’s private
information by a DOJ press release the next day.
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discuss the terms provided in the February 4th email. This reckless disregard for the
duty of candor owed to a federal court is appalling.5
Ms. Hsiao also represented that requests regarding “patient-level clinical
practices and drug safety” (Requests 11–15) were necessary because “without this
information, DOJ cannot fully determine the scope of the violations, identify patterns
of misbranding or fraudulent billing, or assess whether the conduct was undertaken
with intent to defraud or mislead, as required for felony liability under 21 U.S.C. §
333(a)(2).”6 But Ms. Hsiao neglected to inform the Texas court that DOJ had agreed
to anonymized data in several other jurisdictions. 	Her assertion that DOJ
needed
this information was therefore, at best, deceptive, if not intentionally and knowingly
false.
With respect to this case’s purported nexus to Texas, the DOJ claims that its
investigation is taking place in the Northern District of Texas. Notwithstanding the
DOJ’s belated disclosure, this update came as a surprise to RIH and the Child
Advocate. Ms. Hsiao as well as all other attorneys, save one Assistant U.S. Attorney,
5 This is not the first time Ms. Hsiao and her subordinates have, in their crusade to
obtain transgender children’s medical records, acted in ways that appear to deviate
from the norms of professional conduct expected of attorneys representing the United
States.
	See, e.g.,
In re Subp. No. 25-1431-014, 810 F. Supp. 3d 555, 582 (E.D. Pa.
2025) (taking note of an “inconsistency” in Ms. Hsiao’s sworn declaration there and
reminding counsel “sworn declarations filed in federal court must reflect verified
facts, not speculation recast as fact”);
QueerDoc, PLLC v. U.S. Dept. of J., 807 F.
Supp. 3d 1295, 1303 n.2 (W.D. Wash. 2025) (describing a filing reflecting “a
fundamental misunderstanding—or deliberate misuse—of court procedure”).
6 During the Court’s hearing on this matter, RIH’s counsel represented that the
parties had not yet conferred at any time regarding production of Requests 11–15.
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who appear to be assigned to this nationwide investigation, and to this matter itself,
are based in Washington D.C., where the DOJ’s Civil Division/Enforcement and
Affirmative Litigation Branch is located.
	See No. 4:26-mc-00006-O (N.D. Tex.). At
all times, RIH conferred with counsel based in Washington D.C. or Rhode Island. The
records sought were in Rhode Island, from a Rhode Island corporation, and of Rhode
Island citizens. Additionally, during the hearing before this Court, counsel for DOJ
represented that the investigation began in Washington D.C. but could not specify
when it transferred this investigation to the Northern District of Texas.
Following its receipt of DOJ’s motion, the Texas court summarily granted it,
without any notice to or response from RIH. No. 4:26-MC-0006-O (N.D. Tex. Apr. 30,
2026), ECF No. 2. That order commanded RIH to “provide all records responsive to
each request in the subpoena” by May 14, 2026, and warned that “failure to fully
comply with the subpoena or show just cause for continued noncompliance” could
result in sanctions, up to and including contempt.
Id.
RIH moved to stay the Texas court’s order pending their appeal in the Fifth
Circuit. 	The Texas court denied RIH’s motion to stay and refused to “exercise [its]
judicial discretion” to “grant extraordinary relief” because it determined that RIH
had not demonstrated a likelihood of success on any of its claims. No. 4:26-MC-0006-
O (N.D. Tex. Apr. 30, 2026), ECF No. 12 at 2, 8. In reaching this decision, the Texas
court relied on the “Government’s representation in the initial Hsiao Declaration”
and the facts as presented to it at that time.
Id. at 8. RIH simultaneously moved to
stay pending its appeal to the Fifth Circuit, which promptly denied its motion in a
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one sentence order.
	See United States v. Rhode Island Hospital, No. 26-10431 (5th
Cir. May 12, 2026).
This Court held a hearing on the Child Advocate’s and RIH’s Emergency
Motion to Quash on May 12, 2026. Further facts are set forth, as necessary, below.
II. 	DISCUSSION
A. The Child Advocate Has Standing to Challenge the Administrative Subpoena
DOJ contests the Child Advocate’s standing to challenge the administrative
subpoena. 	(ECF No. 9 at 3–5.) 	To have standing, a plaintiff must demonstrate “(1)
an injury in fact, (2) a causal connection between the injury and the conduct
complained of, and (3) a likelihood that the injury will be redressed by a favorable
decision.”
Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992). An injury sufficient
to establish standing “does not arise only when a defendant causes a tangible harm
to a plaintiff, like a physical injury or monetary loss. 	It can also arise when a
defendant burdens a plaintiff’s constitutional rights.”
	First Choice Women’s Res.
Ctrs., Inc. v. Davenport, No. 24-781, 2026 WL 1153029, at *8 (U.S. Apr. 29, 2026).
The Child Advocate meets the requirements to have standing here. 	First, as
addressed below, the children represented by the Child Advocate have individual
rights to informational privacy that will surely be injured by the disclosure of their
extremely personal medical information under these circumstances.
	See In re
Children’s Nat’l Hosp., No. 1:25-CV-03780-JRR, 2026 WL 160792, at *4–6 (D. Md.
Jan. 21, 2026);
In re: 2025 UPMC Subpoena, 2025 WL 3724705, at *1 (W.D. Pa. Dec.
24, 2025). Second, this imminent injury is causally connected to the administrative
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subpoena they challenge here. Third, as the following discussion explains, the injury
is redressable by this Court notwithstanding the Texas court’s Order.
B. The Collateral Attack Doctrine Does Not Bar the Child Advocate or RIH’s
Requested Relief
“A ‘collateral attack’ is a tactic whereby a party seeks to circumvent an earlier
ruling of one court by filing a subsequent action in another court.”
	Pratt v. Ventas,
Inc., 365 F.3d 514, 519 (6th Cir. 2004). 	This tactic is generally prohibited by the
“collateral attack doctrine,” under which a district court “lacks authority to hear an
appeal of the rulings made by another federal judge.”
	Verogna v. Johnstone, 583 F.
Supp. 3d 331, 337 (D.N.H. 2022) (collecting cases),
aff’d, No. 22-1364, 2022 WL
19795808 (1st Cir. Nov. 14, 2022). 	Instead, the proper avenue for challenging a
district court’s order is typically through a motion with that court or through appeal.
The DOJ contests the ability of both the Child Advocate and RIH to seek
quashal here given the Texas court’s Order. (ECF No. 9 at 5–6.) According to DOJ,
the parties seek an order here that would effectively circumvent the Texas court’s
Order.
	Id. at 6. 	Were the circumstances of this case akin to those that typically
implicate 	the 	collateral 	attack 	doctrine 	(for 	example, 	where 	a 	party 	seeks 	to
invalidate one court’s pecuniary or penal judgment by petitioning another court for
injunctive relief) the DOJ would likely be correct. But the peculiar facts of this case—
including RIH’s lack of notice prior to the Texas court’s Order, the Child Advocate’s
nonparty status with respect to that case, and the underlying challenge here being to
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an agency’s administrative subpoena rather than to a court’s judgment—appear to be
distinguishable from the typical case.7
The collateral attack doctrine is based on the principles underpinning
res
judicata, i.e., claim preclusion.
	Cf. Baella-Silva, 454 F.3d 5, 9 (1st Cir. 2006) (“A
district court’s express or implicit determination that it has jurisdiction is open to
direct review, but it is
res judicata when collaterally attacked.”) (italics in original).
The elements of res judicata are “(1) a final judgment on the merits in an earlier suit,
(2) sufficient identicality between the causes of action asserted in the earlier and later
suits, and (3) sufficient identicality between the parties in the two suits.”
	In re
Iannochino, 242 F.3d 36, 43 (1st Cir. 2001) (quoting
Mass. School of Law v. American
Bar Assoc., 142 F.3d 26, 37 (1st Cir.1998)). For the Child Advocate, the third element
is most at issue here because it was not itself party to the Texas court proceedings.
In
	Martin 	v. 	Wilks, 	the 	Supreme 	Court 	evaluated 	what 	it 	termed 	the
“impermissible collateral attack doctrine.” 	490 U.S. 755, 765 (1989). 	The plaintiffs
there were white employees challenging alleged race-conscious employment decisions
that were made pursuant to consent decrees entered in collateral litigation between
the defendants and the NAACP.
	Id. at 759–60. The Supreme Court found that the
plaintiffs were not precluded from challenging the employment decisions because
they were not parties to the litigation from which the consent decrees stemmed.
	Id.
at 761–62. 	As the Court explained, “[a]ll agree that ‘it is a principle of general
7 The Court is unaware of any similar case where a party has petitioned a court to
quash an administrative subpoena that another court ordered enforced without prior
notice or opportunity to be heard.
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application in Anglo-American jurisprudence that one is not bound by a judgment in
personam in a litigation in which he is not designated as a party or to which he has
not been made a party by service of process.”
	Id. at 761 (quoting
Hansberry v. Lee,
311 U.S. 32, 40 (1940)). 	Thus, “[a] judgment or decree among parties to a lawsuit
resolves issues as among them, but it does not conclude the rights of strangers to
those proceedings.”
Id. at 762.8
Here, the Child Advocate alleges injuries that flow from another court’s
decision to which it was not a party. And, similarly to how the white firefighters in
Wilks had distinct interests from those litigated in the consent decree to which they
were not parties, the interests of the children that the Child Advocate represents (the
“legal, civil, and special rights of children” under protective care,
see R.I. Gen. Laws
§ 42-73-7) are distinct from those that either were or could have been litigated in the
Texas court—a fact that was acknowledged by the Texas court itself.
	See In Re:
Administrative Subpoena 25-1431-032, No. 4-26MC-006-0 (N.D. Tex.) ECF No. 9 at 9
(“Thus, RIH has not shown how it would be harmed rather than its patients, who are
third parties.”). And while
Wilks recognized an exception to the general rule against
nonparty preclusion in “limited circumstances” where a nonparty “has his interests
adequately represented by someone with the same interests who is a party,” 490 U.S.
at 762 n.2, this exception typically applies to class actions and suits involving
8 The Supreme Court has since found
Wilks to have been superseded by statute,
insofar as it allows collateral attacks on consent decrees.
	See Landgraf v. USI Film
Products, 511 U.S. 244, 251 (1994). 	But
	Landgraf did not repudiate
	Wilks’s
reasoning.
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fiduciaries, and is inapplicable here, particularly given that the record reflects that
the Child Advocate’s interests were
not adequately represented in the Texas court.
See Taylor v. Sturgell, 553 U.S. 880, 894 (2008) (“Representative suits with preclusive
effect on nonparties include properly conducted class actions, and suits brought by
trustees, guardians, and other fiduciaries.”) (internal citations omitted).
It also appears unlikely that quashal—the primary relief sought by the Child
Advocate 	here—constitutes 	a 	collateral 	attack 	on 	the 	Texas 	court’s 	Order,
notwithstanding the fact that quashal necessarily implicates that Order. 	Unlike a
traditional judicial subpoena issued under the authority of a court, such as one issued
under Federal Rule of Civil Procedure 45, the administrative subpoena here is the
product of the DOJ’s own statutory authority,
see 18 U.S.C. § 3846. It was not issued
by the Texas court, whose order is premised on that subpoena’s legal force. It seems
to follow that, as with APA claims—where a district court has the power to vacate
challenged agency action even where vacatur may necessarily implicate other courts’
judgments regarding that same action—the Court has the power to effectively vacate
(i.e., quash) the administrative subpoena at issue here despite the fact that doing so
necessarily implicates the parties’ responsibilities under the Texas court’s Order.
As such, the collateral attack doctrine poses no barrier to the Child Advocate’s
Petition. It also seems likely that, based on the underlying principles of res judicata,
the collateral attack doctrine does not bar RIH’s intervention here because it was not
provided notice and an opportunity to be heard before the Texas court ordered the
administrative subpoena enforced. As the Supreme Court has explained:
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The doctrine of res judicata rests at bottom upon the ground that the
party to be affected, or some other with whom he is in privity, has
litigated or had an opportunity to litigate the same matter in a former
action in a court of competent jurisdiction. The opportunity to be heard
is an essential requisite of due process of law in judicial proceedings.
Postal Telegraph Cable Co. v. City of Newport, Ky., 247 U.S. 464, 476 (1918). Thus,
this Court “may not, consistently with the Fourteenth Amendment, enforce a
judgment against a party named in the proceedings without a hearing or an
opportunity to be heard.”
	Id.;
see also Blonder-Tongue Laboratories, Inc. v. U. of
Illinois Found., 402 U.S. 313, 329 (1971) (“Some litigants—those who never appeared
in a prior action—may not be collaterally estopped without litigating the issue.”).
While RIH may have subsequently had an opportunity to seek reconsideration
of the Texas court’s Order, the preclusive effect of that order seems questionable given
that it was granted
before RIH had any notice or opportunity to be heard as due
process requires. 	Further, “[r]econsideration of a judgment after its entry is an
extraordinary remedy that should be used sparingly.”
	Templet v. HydroChem Inc.,
367 F.3d 473, 479 (5th Cir. 2004). Thus, RIH (and, by extension, the Child Advocate)
was deprived of any opportunity to argue the propriety of the subpoena in a posture
that did not demand “extraordinary relief” or was not summary in nature, and should
not be precluded from litigating that issue here.
C. 	The Merits
Given that the collateral attack doctrine does not preclude consideration of the
Petitioners’ Motions to Quash, the Court proceeds to the merits of those Motions.
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1. 	The Subpoena Lacks A Congressionally Authorized Purpose
To enforce an administrative subpoena issued under 18 U.S.C. § 3486, the DOJ
must show that “(1) the subpoena is issued for a congressionally authorized purpose,
the information sought is (2) relevant to the authorized purpose and (3) adequately
described, and (4) proper procedures have been employed in issuing the subpoena.”
U.S. Dep’t of Just. v. Ricco Jonas, 24 F.4th 718, 726 (1st Cir. 2022) (quoting
United
States v. Sturm, Ruger & Co., 84 F.3d 1, 4 (1st Cir. 1996)). 	Here, the DOJ fails to
meet the first element, and that failure is fatal to their subpoena.
The DOJ asserts that it issued this subpoena to investigate potential violations
of the Food, Drug, and Cosmetic Act (“FDCA”), specifically the FDCA’s prohibition on
misbranding. 	Their argument proceeds as follows: when a physician prescribes a
drug for an off-label use, the drug’s “intended use” within the meaning of 21 C.F.R. §
201.128 changes. 	This changed intended use then renders the drug’s labeling
inadequate under 21 U.S.C. § 352(f)(1), and then any party in the distribution chain
who helped place that drug in commerce—including a hospital whose physicians
wrote the prescriptions—faces criminal liability under 21 U.S.C. §§ 331, 333(a)(1),
which also potentially includes individual administrators under the responsible
corporate officer doctrine of
United States v. Park, 421 U.S. 658 (1975).
But the First Circuit has held that “medical professionals may lawfully
prescribe and administer a device for an off-label use as long as that device has
received [FDA] clearance for any intended use.”
	United States v. Facteau, 89 F.4th
1, 15 (1st Cir. 2023),
cert. denied, 145 S. Ct. 137 (2024). The drugs at issue—puberty
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blockers and cross-sex hormones—are FDA-approved for various uses, and RIH’s
physicians prescribe and administer them in clinical care. The DOJ’s theory that off-
label prescribing by licensed practitioners gives rise to FDCA criminal liability cannot
be squared with
Facteau.
	See also In re Celexa & Lexapro Mktg. & Sales Pracs.
Litig., 915 F.3d 1, 5 (1st Cir. 2019) (“The FDCA . . . does not prohibit doctors from
prescribing drugs for off-label uses.”).
Congress 	did 	not 	merely 	leave 	off-label 	prescribing 	unregulated: 	it
affirmatively protected it. 	Section 396 of the FDCA provides that “[n]othing in this
chapter shall be construed to limit or interfere with the authority of a health care
practitioner to prescribe or administer any legally marketed device to a patient for
any 	condition 	or 	disease 	within 	a 	legitimate 	health 	care 	practitioner-patient
relationship.” 	21 U.S.C. § 396. 	Further, the regulation of the practice of medicine
has long been understood to remain within the states’ prerogative, and the Executive
may not adopt novel interpretations of federal statutes to displace a state’s medical
regulatory framework without clear congressional authorization to do so.
	See
Gonzales v. Oregon, 546 U.S. 243, 269-70 (2006). 	Rhode Island has expressly
protected gender-affirming care as lawful medical practice. R.I. Gen. Laws §§ 5-37.8-
1, 23-101-2. The DOJ acknowledges that merely writing off-label prescriptions is not
an 	FDCA 	offense 	but 	attempts 	to 	reach 	prescribing 	hospitals 	indirectly 	by
characterizing their participation in a supply chain as causing the distribution of
misbranded drugs. That reframing does not save the theory.
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Because off-label prescribing by physicians is lawful, which the DOJ does not
dispute, it is therefore logically impossible to construct an aiding-and-abetting,
facilitation, or conspiracy theory predicated on nothing more than the physician’s own
lawful prescribing act.9 	No court has extended FDCA misbranding liability to a
hospital or physician on this basis. 	As one court considering a similar subpoena
observed, the DOJ “seeks all this while not offering one iota of suspicion” that RIH
engaged in the off-label promotion that the FDCA does actually prohibit.
	In re
Admin. Subpoena No. 25-1431-019, 800 F. Supp. 3d 229, 238 (D. Mass. 2025).
The DOJ’s current litigation position is also in direct conflict with its own prior
legal interpretations of the same statutory scheme. The FDA has stated publicly that
once 	a 	drug 	is 	approved, 	healthcare 	providers 	may 	generally 	prescribe 	it 	for
unapproved uses when they determine that doing so is medically appropriate. FDA,
Understanding Unapproved Use of Approved Drugs “Off Label” (Feb. 5, 2018),
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-
options/understanding-unapproved-use-approved-drugs-label. The FDA, in guidance
that is final but pending before the Office of Management and Budget, restated that
position in guidance issued as recently as January 2025.
See FDA,
Communications
From 	Firms 	to 	Health 	Care 	Providers 	Regarding 	Scientific 	Information 	on
Unapproved Uses of Approved/Cleared Medical Products; Questions and Answers;
Guidance for Industry 8–9 (Jan. 2025), https://www.fda.gov/media/184871/download.
9 The DOJ has also made references, in the Hsiao Declaration and at oral argument,
to theories based on conspiracy, billing fraud, and healthcare fraud. 	But these
theories are also tethered to off-label use and fail for the same reasons.
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More significantly, the DOJ’s own Office of Legal Counsel (“OLC”) has concluded that
the “FDA does not regulate the practice of medicine, which includes ‘off-label’
prescribing,” and that “[w]hile the FDCA bars a manufacturer or distributor from
selling any drug or device for an unapproved use, physicians may, with limited
exceptions, 	prescribe 	and 	administer 	FDA-approved 	drugs 	and 	devices 	for
unapproved uses.” 	Steven A. Engel,
Whether the Food & Drug Administration Has
Jurisdiction Over Articles Intended for Use in Lawful Executions, 43 Op. O.L.C. 81,
85 (2019).
There also is a separate and independently sufficient basis on which the DOJ’s
misbranding claim fails as applied to RIH. 	Section 353(b)(2) exempts from the
requirements of § 352 any drug “dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such drug.” 	21 U.S.C. §
353(b)(2). 	Thus, § 352(f) (the adequate-directions-for-use requirement on which the
DOJ’s 	entire 	misbranding 	theory 	rests) 	does 	not 	apply 	to 	prescription 	drugs
dispensed pursuant to a licensed practitioner’s prescription. 	RIH’s physicians
prescribe medications to patients in the clinical setting pursuant to their medical
judgment. That conduct falls squarely within § 353(b)(2)’s exemption.
In sum, the DOJ’s FDCA theory does not constitute a legally cognizable basis
for this investigation as applied to a prescribing hospital.
	See Facteau, 89 F.4th at
15. 	The off-label prescribing conduct at the core of the DOJ’s theory is not illegal
under the FDCA. 	Section 353(b)(2) exempts the specific misbranding provision the
DOJ invokes. 	The DOJ’s own OLC has interpreted the same statutory scheme in a
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manner that directly contradicts their current litigation position. 	The subpoena
therefore lacks a congressionally authorized purpose and must be quashed.
See Ricco
Jonas, 24 F.4th at 726.
2. 	Improper Purpose
The Court additionally concludes that the subpoena should be quashed because
it was issued for an improper purpose in bad faith. 	A subpoena “issued for an
improper purpose, such as to harass” a recipient or “to put pressure on him” or “for
any other purpose reflecting on the good faith of the particular investigation” cannot
be enforced.
United States v. Powell, 379 U.S. 48, 58 (1964);
United States v. Comley,
890 F.2d 539, 542 (1st Cir. 1989) (recognizing that courts have “adequate justification
to deny enforcement of [a] subpoena” when there is evidence of bad faith). Where the
DOJ issues a subpoena for an improper purpose, quashal is warranted when that
improper purpose is the sole purpose of the investigation.
	United States v. Gertner,
65 F.3d 963, 970 (1st Cir. 1995).
The evidence of improper purpose here is in the DOJ’s own public record and
detailed in the decisions of the seven other federal courts that have considered
identical 	subpoenas. 	The 	Administration 	has 	publicly 	characterized 	gender-
affirming care for minors as abuse, directed the DOJ to bring its practice to an end,
and celebrated when hospitals curtailed such programs as a result of this subpoena
campaign. (ECF No. 20-1 at 22, 23 n.8.)
The DOJ, however, contends that even if a policy purpose exists, a legitimate
FDCA 	investigation 	runs 	alongside 	it 	and 	the
	Gertner 	sole-purpose 	standard
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therefore cannot be satisfied.
	See 65 F.3d at 970. But this would require a genuine
legitimate investigative purpose, not merely a legal theory, which, as described above,
is not legally cognizable as applied to a prescribing hospital. To hold otherwise would
allow the DOJ to immunize any coercive investigation from the improper purpose
doctrine simply by appending an untenable legal theory to it.
Seven other federal courts have found these subpoenas to have been issued for
an improper purpose, and this Court finds their reasoning persuasive and applies it
her.
See QueerDoc, PLLC v. U.S. Dep't of Just., 807 F. Supp. 3d 1295, 1303–04 (W.D.
Wash. 2025);
In re Admin. Subpoena No. 25-1431-019, 800 F. Supp. 3d 229, 239 (D.
Mass. 2025);
In re Subpoena Duces Tecum No. 25-1431-016, No. 25-mc-41, 2025 WL
3562151, at *12–13 (W.D. Wash. Sept. 3, 2025);
In re Dep't of Just. Admin. Subpoena
No. 25-1431-030, No. 25-mc-63, 2026 WL 33398, at *11 (D. Colo. Jan. 5, 2026);
In re
Children’s Nat’l Hosp., No. 1:25-cv-03780-JRR, 2026 WL 160792, at *8 (D. Md. Jan.
21, 2026);
In re Subpoena No. 25-1431-014, 810 F. Supp. 3d 555, 580 (E.D. Pa. 2025);
In re 2025 UPMC Subpoena, No. 2:25-MC-01069-CB, 2026 WL 570419 (W.D. Pa. Mar.
2, 2026).
3. 	The Fourteenth Amendment Right to Informational Privacy
But there is another ground warranting quashal. The Child Advocate contends
that the children who are the subject of the medical records themselves possess a
Fourteenth Amendment right to informational privacy in these records and that
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RIH’s compliance with the full scope of the requests contained within the subpoena
would violate this right. (ECF No. 1 at 39–41.) The Court agrees.10
Nearly 	half 	a 	century 	ago, 	the 	Supreme 	Court 	recognized 	a 	right 	to
informational privacy, which prevents the compelled disclosure of personal matters.
See Whalen v. Roe, 429 U.S. 589, 599 (1977) (describing the “individual interest in
avoiding disclosure of personal matters[.]”). Following its initial acknowledgement of
this right, the Supreme Court has repeatedly acknowledged its existence in the
decades that followed.
	See Nat’l Aeronautics & Space Admin. v. Nelson, 562 U.S.
134, 138 (2011) (Alito, J.) (“We assume, without deciding, that the Constitution
protects a privacy interest of the sort mentioned in
Whalen and
Nixon.”);
Dobbs v.
Jackson Women’s Health Organization, 597 U.S. 215, 219 (2022) (Alito, J.) (“But
Roe
conflated the right to shield information from disclosure and the right to make and
implement personal decisions without governmental interference.”) (citing
Whalen,
429 U.S. at 599–600).
Throughout its history, the First Circuit has also acknowledged the existence
of an individual’s constitutional right to informational privacy.
See Borucki v. Ryan,
827 F.2d 836, 845–49 (1st Cir. 1987) (grappling with
Whalen’s “paucity of concrete
guidance”);
see also Vega-Rodriguez v. Puerto Rico Telephone Co., 110 F.3d 174 (1st
Cir. 1997) (Selya, J.) (“Even if the right of confidentiality has a range broader than
that associated with the right of autonomy, that range has not extended beyond
10 In doing so, the Court provides no view on whether, as asserted by the Child
Advocate, 	the 	Fourth 	Amendment 	provides 	a 	separate, 	independent 	source 	of
constitutional protection in this context.
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prohibiting profligate disclosure of
medical, financial, and other intimately personal
data.”) (emphasis added).
Finally, at least one court within the First Circuit has also: (1) concluded that
the constitutional right to informational privacy exists; and (2) applied it to litigants
appearing before it in that matter.
See Arroyo Gonzelez v. Rossello Nevares, 305 F.
Supp. 3d 327, 333 (D.P.R. 2018) (determining that Puerto Rico’s ban on changing the
gender markers in the plaintiffs’ birth certificates violates their right to informational
privacy).11
Here, the Child Advocate has successfully demonstrated that the subpoena’s
enforcement in full would violate the right to informational privacy of the children
that it represents. Specifically, the Court determines that DOJ’s request for intimate
medical details from one of this country’s most vulnerable populations constitutes a
drastic overreach of its investigative authority. As discussed elsewhere, not only has
the DOJ failed to specify
how this information is related to its legitimate authority to
conduct its investigation, but it has also failed to assuage the Court of its serious
concerns for how DOJ would adequately protect and otherwise safeguard this
information. When faced with the very real — and likely irreparable — harm to the
children in the State’s current or former care that unfettered, compelled disclosure
11 	Notwithstanding the legal developments that have taken place within the First
Circuit, courts across the country have had a myriad of opportunities to address, and
develop, the constitutional right to informational privacy.
See Carmel Shachar &
Carleen Zubrzycki,
Informational Privacy After Dobbs, 75 ALA. L. REV . 1, 19 (2023).
Separately, the Court thanks the amici for their helpful and speedy submissions in
this matter.
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that compliance with this subpoena would create, this Court concludes that RIH’s
compliance would violate affected children’s rights to informational privacy.12 As a
result, the Court determines that the application of this right constitutes a separate
basis for quashal of the subpoena.
The Court turns to the scope of relief this separate finding would require. The
DOJ argued that any remedy grounded in the children’s constitutional right should
be limited to records pertaining to children in DCYF custody or care—those whose
rights the Child Advocate represents. The Court rejects this proposed limitation on
practical grounds.
To implement a carveout limited to DCYF children, RIH would first have to
identify which among its minor patients are DCYF wards: reviewing each responsive
record to determine which patients are in state custody or care before segregating
those records from the rest. That identification process would itself expose precisely
the sensitive intersection of information the constitutional right is designed to
protect: which gender-affirming care patients are vulnerable wards of the state.
When asked at oral argument how the DOJ envisioned this segregation process
working in practice, the DOJ offered no adequate answer. The Court is left with no
basis to conclude that a DCYF-only carveout is operationally feasible, and every
reason to conclude it is not.
12 To provide a more concrete example of the potential harm at issue here, the DOJ
conceded during the Court’s hearing that their investigative efforts would include
attempting to locate and question both children and their caregivers in its search for
criminal conduct.
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There is no way to protect the informational privacy rights of DCYF children
without first doing what the constitutional right forbids: identifying them as DCYF
wards in the process of separating their records from those of other minor patients.
The relief this Court grants therefore necessarily extends to the records of all minors.
This extension flows not from any expansion of the Child Advocate’s standing, but
from the practical impossibility of implementing a narrower remedy without violating
the very right the remedy is designed to vindicate.
III. 	CONCLUSION
Ultimately, the Court’s decision is based solely on its application of the law to the
administrative subpoena at issue here. 	But the discrepancy between the honorable
conduct expected of federal prosecutors and DOJ’s tactics in this case is unsettling.
The Court cannot help but share the sentiment that “[t]he presumption of regularity
that has previously been extended to [DOJ] that it could be taken at its word—with
little doubt about its intentions and stated purposes—no longer holds.”
United States
v. Oregon, No. 6:25-CV-01666-MTK, 2026 WL 318402, at *11 (D. Or. Feb. 5, 2026). It
is regrettable that this is now the case.
The Emergency Motions to Quash (ECF Nos. 1 & 28) are GRANTED. 	In
granting 	these 	Motions, 	this 	Court 	quashes 	the 	administrative 	subpoena—the
instrument issued by the DOJ—not the enforcement order entered by the Texas
court. 	What this Court holds is that the subpoena itself lacks a congressionally
authorized purpose, was issued for an improper purpose, and demands the production
of records that cannot be obtained consistent with the constitutional privacy rights of
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Rhode Island children. Those are independent grounds for quashal of the subpoena
that this Court has authority to adjudicate.
In addition, the DOJ is hereby ENJOINED from receiving, using, retaining, or
disseminating any patient-identifying information or protected health information
produced by RIH in response to Administrative Subpoena No. 25-1431-032, including
all materials responsive to Requests 11 through 15 and any other materials that
identify, or reasonably permit the identification of, Rhode Island’s children.
IT IS SO ORDERED.
_____________________________
Mary S. McElroy
United States District Judge
May 13, 2026
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