# JOHNSON & JOHNSON HEALTH CARE SYSTEMS INC. v. SAVE ON SP, LLC

> District Court, D. New Jersey · June 10, 2025

URL: https://www.frixlaw.com/law-library/cases/11068968

## Case

- **Court:** District Court, D. New Jersey
- **Decided:** June 10, 2025
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

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## Opinion text

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

JOHNSON & JOHNSON HEALTH CARE
SYSTEMS INC., Civil Action No. 22-02632 (CCC) (CLW)

Plaintiff,
OPINION AND ORDER
v.
SAVE ON SP, LLC et al,
Defendants.

CATHY L. WALDOR, U.S.M.J.
This matter comes before the Court upon Express Scripts, Inc., and Accredo Health Group,
Inc.’s Appeal of the Special Master’s Order to Compel Discovery pursuant to Federal Rule of Civil
Procedure 53(f)(2) and Local Rule 72.1(c)(1) entered on April 7, 2025, by Special Master Freda
Wolfson, U.S.D.J. (ret.). (ECF No. 582). In accordance with Federal Rule of Civil Procedure 78
and Local Civil Rule 78.1, the Court addresses Express Scripts, Inc., and Accredo Health Group,
Inc.’s appeal without oral argument. Upon careful consideration of the record for this matter, and
for the reasons discussed herein, Express Scripts, Inc., and Accredo Health Group, Inc.’s appeal is
DENIED, and the Special Master’s Order is AFFIRMED.
I. RELEVANT BACKGROUND AND PROCEDURAL HISTORY
Plaintiff Johnson & Johnson Health Care Systems, Inc. (“Plaintiff”) initiated this action
against Defendants Save On SP, LLC, Express Scripts, Inc. (“ESI”), and Accredo Health Group,
Inc. (“Accredo”), for their alleged involvement in a scheme to procure financial benefit by
thwarting Plaintiff’s payment assistance program intended to provide financial assistance for
patients using certain costly prescription medications. (See generally, Second Amended
Complaint, ECF No. 618). Prior to the addition of Defendants Accredo and ESI to the present
dispute on October 2, 2024, (see First Amended Complaint, ECF No. 395), this Court entered a

Discovery Confidentiality Order on November 22, 2022, (ECF No. 62), which counsel to ESI and
Accredo later endorsed in connection with Plaintiff’s service of third-party subpoenas on
November 10, 2023. (See Motion to Compel, Ex. 3, ECF No. 507-1).
The Confidentiality Order provides that this action is likely to involve the disclosure of
significant confidential health information for patient-subscribers. (See Discovery Confidentiality
Order, ECF No. 62). The term “Confidential Health Information” (“CHI”) incorporates all
“protected health information” (“PHI”) as defined by the Standards for Privacy of Individually
Identifiable Health Information, 45 CFR parts 160 and 164, promulgated pursuant to the Health
Insurance Portability and Accountability Act of 1996 (“HIPAA”). (Id. at ¶ 3(a)). For the purposes
of this litigation and subject to the conditions within the Confidentiality Order, the parties are to

produce all unredacted CHI, including PHI, in response to a discovery request. (Id. at ¶ 3(c)).
Upon the conclusion of this litigation, the parties are mandated to destroy or return material
produced or notes derived from the receipt of confidential materials subsumed within the scope of
the Confidentiality Order. (Id. at ¶ 19). The Confidentiality Order’s intended purpose is to
constitute a “Qualified Protective Order” as understood by HIPAA and its accompanying
regulations. (Id. at ¶ 3(d)).1
On December 12, 2024, having recognized that this action would entail significant
discovery and case management, the undersigned issued an Order appointing the Honorable Freda

1 The Court will refer to the Confidentiality Order as a “Qualified Protective Order” interchangeably, though
both are the same.
L. Wolfson, U.S.D.J. (ret.) (“Special Master”) as a Special Master to oversee the progression of
discovery and to resolve discovery disputes. (Order Appointing Special Master, ECF No. 184).
Between October 2024 and January 2025, after Plaintiff included Accredo and ESI as Defendants,
the parties began exchanging documents and initiated meet and confer efforts to resolve certain

PHI redactions made by ESI and Accredo. (Motion to Compel, Exs. 1–10, ECF No. 507-1).
Those efforts reached an impasse, and Plaintiff filed a Motion to Compel the Production
of Documents Without Redaction pursuant to the Confidentiality Order on February 3, 2025.
(Motion to Compel, ECF No. 507). ESI and Accredo opposed the Motion, contending that it must
comply with both HIPAA and the Confidentiality Order because the Confidentiality Order “does
not explicitly require that [ESI] and Accredo produce PHI without regard to HIPAA’s ‘minimum
necessary rule’” absent a court order or a sufficient explanation from Plaintiff as to why the
information it seeks meets the “minimum necessary rule.” (Opposition to Motion to Compel at 2–
3, ECF No. 525). In reply, Plaintiff asserted that the language of the Confidentiality Order
envelops PHI in its definition of CHI, and that PHI should have been produced unredacted because

the Confidentiality Order constitutes an exception to HIPAA’s “minimum necessary rule” as a
disclosure required by law. (Reply to Opposition to Motion to Compel at 3–4, ECF No. 531).
At oral argument before the Special Master, ESI and Accredo argued that HIPAA
regulations distinguish disclosures made by law pursuant to 45 C.F.R. § 164.512(a) and disclosures
permitted within judicial and administrative procedures under to 45 C.F.R. § 164.512(e). (Plf.
Appeal Opposition Brief, Ex. 3 at 60–64, ECF No. 643-2). ESI and Accredo took the position that
the regulations do not include civil discovery responses in the definition of “required by law” under
45 C.F.R. § 164.103, and therefore the “minimum necessary rule” applies to disclosures made
within judicial and administrative procedures. (Id. at 62–64). And because the Confidentiality
Order notes that it is a Qualified Protective Order as contemplated by § 164.512(e), ESI and
Accredo asserted that the parties did not agree for the producible content governed by the
Confidentiality Order to qualify as a disclosure “required by law” under § 164.512(a). (Id. at 63–
65). Thus, in order to comply with HIPAA, ESI and Accredo proposed that Plaintiff must identify

the specific information it seeks for them to produce documents consistent with HIPAA’s
“minimum necessary rule.” (Id.). In response, Plaintiff argued that the HIPAA-compliant
Confidentiality Order requires production of unredacted PHI and that ESI and Accredo are simply
violating its terms. (Id. at 67–70).
The Special Master rejected ESI and Accredo’s arguments, stating that the Confidentiality
Order was not favorable to their position and ordered the PHI to be produced unredacted. (Id. at
71). On April 7, 2025, the Special Master entered an order with an accompanying opinion to that
effect. (Special Master Opinion, ECF No. 582). In her written opinion, the Special Master
construed the HIPAA regulations and applicable caselaw to determine that the “minimum
necessary requirement” does not apply in judicial proceedings where a qualified protective order

is in place and that the information sought by Plaintiff fell within the scope of the Confidentiality
Order, thereby subjecting the requested CHI to the safeguards established by HIPAA. (Id. at 23–
25).
Pursuant to Federal Rule of Civil Procedure 53(f), ESI and Accredo filed an objection to
the Special Master’s Order. (Appeal of Special Master Order, ECF No. 600). Plaintiff filed an
opposition, (ECF No. 643), and ESI and Accredo filed a reply, (ECF No. 651).
II. LEGAL STANDARD
a. Standard of Review
The Order Appointing the Special Master incorporates Federal Rule of Civil Procedure
53(f), which governs this Court’s review of the Special Master’s order compelling discovery. (See
Order Appointing Special Master ¶10, ECF No. 184). According to Rule 53(f), the Court reviews
factual findings and legal conclusions de novo and reviews procedural matters for an abuse of

discretion. Fed. R. Civ. P. 53(f)(3)–(5). “The phrase ‘de novo determination’ . . . means an
independent determination of a controversy that accords no deference to any prior resolution of
the same controversy.” United States v. Raddatz, 447 U.S. 667, 690 (1980) (Stewart, J.,
dissenting).
However, for procedural matters, the Special Master’s decision may only be set aside for
an abuse of discretion. Fed. R. Civ. P. 53(f)(5). Similar to that of a Magistrate Judge,
the Special Master’s management of the discovery process “is entitled to great deference.”
See Schiano v. MBNA, No. 05-cv-01771, 2009 WL 1416040, at *3 (D.N.J. May 19,
2009); Honeywell v. Minolta Camera Co., No. 87-cv-04847, 1990 WL 66182, at *1 (D.N.J. May
15, 1990). In applying the same standard of review for decisions of a Magistrate Judge to the

Special Master, the Court may reverse the Special Master’s non-dispositive decision only if it was
clearly erroneous or contrary to law. See L. Civ. R. 72.1(c)(A); McDonough v. Horizon Blue Cross
Blue Shield of N.J., Inc., No. 09-0571, 2013 WL 322595, at *2 (D.N.J. Jan. 22, 2013).
A “finding is clearly erroneous when, although there may be some evidence to support it,
the reviewing court, after considering the entirety of the evidence, is left with the definite and firm
conviction that a mistake has been committed.” Coyle v. Hornell Brewing Co., No. 08-cv-2797,
2009 WL 1652399, at *3 (D.N.J. June 9, 2009) (quoting Kounelis v. Sherrer, 529 F. Supp. 2d 503,
518 (D.N.J. 2008)). “A [ruling] is contrary to law if the magistrate judge has misinterpreted or
misapplied applicable law.” Gunter v. Ridgewood Energy Corp., 32 F. Supp. 2d 162, 164 (D.N.J.
1998). “The party filing the notice of appeal bears the burden of demonstrating that the magistrate
judge’s decision was clearly erroneous or contrary to law.” Marks v. Struble, 347 F. Supp. 2d 136,
149 (D.N.J. 2004) (quoting Cardona v. Gen. Motors Corp., 942 F. Supp. 968, 971 (D.N.J. 1996)).
b. Principles of Statutory and Regulatory Interpretation

Because this appeal concerns whether the “minimum necessary rule” applies in judicial
proceedings where a qualified protective order is in place, the Court must interpret and apply
HIPAA’s statutory and regulatory text, which is a question of law this Court must review de novo.
Idahoan Fresh v. Advantage Produce, Inc., 157 F.3d 197, 202 (3d Cir. 1998) (citing Shell Oil Co.
v. Babbitt, 125 F.3d 172, 175 (3d Cir. 1997)). “It is the cardinal canon of [regulatory] interpretation
that a court must begin with the [regulatory] language.” In re Philadelphia Newspapers, LLC, 599
F.3d 298, 305 (3d Cir. 2010). When interpreting a regulation, the Court must avoid an
interpretation which renders superfluous any element of the text. Id. (collecting cases). The Court
must also read the entire statutory and regulatory text in a way that renders the provisions
compatible. United States v. Bass, 404 U.S. 336, 344 (1971). As such, the Court must “read the

[regulation] in its ordinary and natural sense.” Harvard Secured Liquidation Tr. v. I.R.S., 568 F.3d
444, 451 (3d Cir. 2009).
The Court may only defer to an agency’s interpretation of its own regulation when a
genuine ambiguity exists after it exhausted “all the ‘traditional tools’ of construction.” Kisor v.
Wilkie, 588 U.S. 558, 559 (2019) (citing Chevron U.S.A. Inc. v. Natural Res. Defense Council, Inc.,
467 U.S. 837, 843 n.9 (1984), overruled on other grounds by Loper Bright Enters. v. Raimondo,
603 U.S. 369 (2024)). “A provision is ambiguous only where the disputed language is ‘reasonably
susceptible of different interpretations.’” In re Philadelphia, 599 F.3d at 304 (quoting Dobrek v.
Phelan, 419 F.3d 259, 264 (3d Cir. 2005)). “When the words of a statute are unambiguous, then
this first canon is also the last: judicial inquiry is complete.” Conn. Nat’l Bank v. Germain, 503
U.S. 249, 253–54 (1992) (internal citations and quotations omitted); see also Hartford
Underwriters Ins. v. Union Planters Bank, N.A., 530 U.S. 1, 6 (2000) (“[W]hen a [regulation’s]
language is plain, the sole function of the courts, at least where the disposition by the text is

not absurd, is to enforce it according to its terms.” (first alteration in original)).
c. Relevant HIPAA Provisions
HIPAA is a complex stature intended to address the exchange for health-related
information. Nat. Abortion Fed. v. Ashcroft, No. 03-cv-8695, 2004 WL 555701 at *2 (S.D.N.Y.
Mar. 19, 2024). Congress delegated to the Secretary of Health and Human Services authority to
promulgate regulations, among other things, to protect the privacy of PHI. See 45 C.F.R. §
164.500–.534; South Carolina Med. Ass’n v. Thompson, 327 F.3d 346, 349 (4th Cir. 2003).
Relevant to the present dispute, the HIPAA rules generally prevent a covered entity—such
as the Defendants here—from using or disclosing protected health information except as permitted
or required, inter alia, to comply with § 164.512. 45 C.F.R. § 164.502(a). But when using or

disclosing protected health information, a covered entity must make reasonable efforts to protect
such information by disclosing the minimum information necessary to satisfy the requested
disclosure. Id. at (b)(1). This is the “minimum necessary requirement” central to the present
dispute. One of the exceptions to the “minimum necessary requirement” is uses or disclosures
required by law provided by § 164.512(a). Id. at (b)(2)(v).
Under § 164.512(a),
(1) A covered entity may use or disclose protected health
information to the extent that such use or disclosure is required by
law and the use or disclosure complies with and is limited to the
relevant requirements of such law.
(2) A covered entity must meet the requirements described in
paragraph . . . (e) . . . of this section for uses or disclosures required
by law.

45 C.F.R. § 164.512(a) (emphases added). The term “required by law” means a mandate
compelling “an entity to make a use or disclosure of protected health information that is
enforceable in a court of law” and “includes, but is not limited to, court orders.” 45 C.F.R. §
164.103 (emphases added).
Paragraph (e) of § 164.512 governs disclosures for judicial and administrative proceedings.
It permits disclosure in either one of two circumstances. The first permits disclosure “[i]n response
to an order of a court . . . provided that the covered entity discloses only the protected health
information expressly authorized by such order.” 45 C.F.R. § 164.512 (e)(1)(i). The second
permits disclosure “in response to a [ ] discovery request [ ] that is not accompanied by an order
of a court” provided that “the covered entity receives satisfactory assurance, as described in
paragraph (e)(1)(iv) of this section, from the party seeking the information that reasonable efforts
have been made by such party to secure a qualified protective order that meets the requirements
of paragraph (e)(1)(v).” 45 C.F.R. § 164.512 (e)(1)(ii) (emphases added).
Paragraph (e)(1)(iv) provides that a covered entity receives a satisfactory assurance from
the party seeking PHI when the covered entity receives a writing that the parties to the dispute
agreed to a qualified protective order and have presented it to the court or the party seeking PHI
made an application to the court for a qualified protective order. Id. at (e)(1)(iv). A qualified
protective order means “an order of a court” or “a stipulation by the parties to the litigation” that:
(A) Prohibits the parties from using or disclosing the protected
health information for any purpose other than the litigation or
proceeding for which such information was requested; and
(B) Requires the return to the covered entity or destruction of the
protected health information (including all copies made) at the end
of the litigation or proceeding.

Id. at (e)(1)(v). Put simply, paragraph (e) permits a covered entity to “disclose medical information
without violating HIPAA if served with (1) a court order authorizing the disclosure of such
information or, alternatively, (2) a formal discovery request accompanied by certain required
assurances and notices.” Howard v. Rustin, No. 06-cv-0200, 2007 WL 2811828 at *2 (W.D. Pa.
Sept. 24, 2007).
III. DISCUSSION
a. The Parties’ Arguments
ESI and Accredo’s objection to the Special Master’s decision rests on the premise that
HIPAA’s “minimum necessary requirement” applies in judicial proceedings because the term
“judicial proceedings” is not expressly listed as an exception to the requirement under § 164.502
(b)(2). (Appeal of Special Master Order at 10–11, ECF No. 600). ESI and Accredo advance that
“required by law” exception under § 164.515(a) has two independent sub-parts, and that the
existence of the Qualified Protective Order here is sufficient to satisfy § 164.515(a)(2) but not §
164.512(a)(1). (Id. at 12–14). Instead, they posit that absent an additional court order to mandate
or compel the disclosure PHI, disclosure in response to Plaintiff’s requests for production §
164.515(e) is not a disclosure “required by law” according to § 164.515(a), and consequently, the
“minimum necessary rule” applies to the disclosure. (Id. at 14–18). ESI and Accredo additionally
contend that the Special Master’s decision ordering compulsion of unredacted PHI in accordance
with the Qualified Protective Order does not satisfy the “required by law” subparts under
subsection (a) because her order did not exist before the Special Master held that the “minimum
necessary rule” was inapplicable. (Id. at 18). ESI and Accredo further challenge the Special
Master’s decision to compel unredacted PHI on the basis that Plaintiff did not articulate the specific
categories of PHI that are necessary for discovery, and therefore, requests the Court to particularize
which PHI must be disclosed if the Court orders disclosure. (Id. at 19–24).
In opposition, Plaintiff asserts that ESI and Accredo waived much of their statutory

interpretation arguments—specifically, the arguments concerning Auer deference to the
Department of Health and Human Services’ interpretation of the HIPAA rules and the canon
against surplusage. (Opposition to Appeal at 11–13, ECF No. 643). Plaintiff contends that a
covered entity may use or disclose PHI to the extent it complies with a court order so long as the
requirements of § 164.515(e) are met, which mandate that a covered entity disclosing PHI pursuant
to a discovery request ensures that the party seeking PHI receives a satisfactory assurance by
making reasonable efforts to secure a Qualified Protective Order. (Id. at 14–15). Plaintiff argues
that § 164.515(a)(1) has an independent meaning because disclosure of PHI would have to comply
with the terms set forth by the Qualified Protective Order, and therefore, the “minimum necessary
rule” does not apply when a Qualified Protective Order is in place. (Id. at 15–20 & 15, n.2).

Finally, Plaintiff asserts that the Special Master correctly found that all relevant, non-privileged
CHI was critical to developing its case and that it needs unredacted CHI because Defendants
employed varying methods to track patient-subscriber identification. (Id. at 21–22).
In reply, ESI and Accredo contend that Plaintiff’s reading of § 164.515(a) is incorrect and
that the “minimum necessary rule” does not apply only if (1) disclosure is required by law and (2)
a Qualified Protective Order exists. (Reply at 8–9, ECF No. 651). They assert, that under
Plaintiff’s reading, both subparts of paragraph (a) would have identical—not independent—
meaning. (Id. at 9–10). ESI and Accredo propose that the Qualified Protective Order does not
render the production “required by law” because it does not mandate production and ESI and
Accredo cannot limit their disclosure to what is explicitly required by the Qualified Protective
Order. (Id. at 11). Therefore, ESI and Accredo aver that if the Qualified Protective Order does not
compel production of PHI, then it must meet the “necessary rule” because HIPAA contemplates
that the Court will conduct a “specific analysis” before ordering production of “specific PHI,” and

that the Special Master failed to conduct that analysis here. (Id. at 12–14).
The Court is not persuaded by ESI and Accredo’s reading of the HIPAA regulations.
As an initial matter, ESI and Accredo’s reliance on the Department of Human Health and
Services’ interpretation of the HIPAA regulations mandates a finding that the regulations are truly
ambiguous after exhausting all traditional means of statutory interpretation. See Kisor, 588 U.S.
at 559. The Court will not make such a finding as it was not before the Special Master. “It is well-
settled that arguments not presented to a [Special Master] and raised for the first time on appeal
are deemed waived.” Easterday v. USPack Logistics, LLC, No. 15-cv-7559, 2020 WL 7137859 at
*4 (D.N.J. Dec. 4, 2020). An argument is “waived unless a party raises it in its opening brief, and
for those purposes, ‘a passing reference to an issue . . . will not suffice to bring that issue before

this court.’” Laborers’ Int’l Union of N.A. v. Foster Wheeler Energy Corp., 26 F.3d 375, 398 (3d
Cir. 1994) (quoting Simmons v. City of Philadelphia, 947 F.2d 1042, 1066 (3d Cir. 1991)).
The questions this Court must address therefore remain whether the Special Master
correctly construed HIPAA’s regulations to determine that the “minimum necessary rule” does not
apply, and if so, whether the Special Master properly compelled production of unredacted PHI
pursuant to the terms of the Qualified Protective Order. The Court answers both questions in the
affirmative.
b. The “Minimum Necessary Rule” Does Not Apply This Judicial Proceeding
Because Both Subsections of § 164.512(a) Have Been Established
As both parties acknowledge, for the “required by law” exception to the “minimum
necessary rule” to apply, both subsections of § 164.512(a) must be met. Meaning, the covered
entity must: (1) use or disclose PHI to the extent required by law and in accordance with such
law; and (2) comply with subsection (e). See 45 C.F.R. § 164.512(a).
To satisfy paragraph (a)(1), there must be a court order mandating a covered entity to make
use of or disclose PHI and that order must be enforceable in the court. See 45 C.F.R. §
164.103(a)(1). The Court finds the first prong unquestionably met here. The Qualified Protective

Order entered by this Court mandates PHI to be disclosed in discovery unredacted. (See Discovery
Confidentiality Order ¶ 3(c) (“[T]he parties shall produce Discovery Material containing
Confidential Health Information in response to discovery requests of another party in this litigation
without redaction,” (emphases added)), ECF No. 62). The Qualified Protective Order is
nonetheless an enforceable order of this Court to make use of CHI—including PHI—in discovery
subject to its terms. Any violation of the order may be punished by sanctions, including contempt
of the Court. (See id. ¶ 21). And ESI and Accredo twice assented to the terms of the Qualified
Protective Order—once as non-parties and then after they became named defendants. (See Motion
to Compel, Exs. 1, 2, & 3, ECF No. 507-1). Accordingly, once this Court entered the Qualified
Protective Order, it became a mandate in law requiring ESI and Accredo to disclose all PHI

throughout discovery subject to the terms of the Order. (See Discovery Confidentiality Order ¶
3(c), ECF No. 62).
As the Special Master astutely observed, it is no surprise that courts do not apply the
“minimum necessary” analysis when a HIPAA Qualified Protective Order is in place. (Special
Master Opinion at 14, ECF No. 582). This is because “it is evidently denudate that a purpose of
HIPAA was that health information, that may eventually be used in litigation or court proceedings,
should be made available during the discovery phase.” Bayne v. Provost, 359 F. Supp. 2d 234, 237
(N.D.N.Y. 2005). Therefore, when a valid protective order permits PHI disclosure tailored to the
conditions set forth within it, HIPAA serves as no additional barrier. See Ruggles v. WellPoint,

Inc., No. 08-cv-0201, 2010 WL 11570681, at *14 (N.D.N.Y. Dec. 28, 2010); Lowe v. Vadlamudi,
No. 08-cv-10269, 2010 WL 2474806, at *3 (E.D. Mich. June 4, 2010).2
Turning to the second requirement of paragraph (a), the covered entity must ensure
compliance with paragraph (e). See 45 C.F.R. § 164.103(a)(2). Compliance with paragraph (e)
sufficient to satisfy prong two of § 164.512(a) requires that the covered entity respond either to a
court order authorizing disclosure, or a formal discovery request accompanied by assurances from
the party seeking PHI. Howard, 2007 WL 2811828 at *2. A “satisfactory assurance” is provided
by documents that demonstrate that the parties agreed to a Qualified Protective Order and
presented it to the court or that party seeking the protected information has requested a Qualified
Protective Order from the court. 45 C.F.R. § 164.512(e)(1)(iv). Contrary to ESI and Accredo’s

reading of the “required by law” sub-parts, it is not the Court’s entry of the Qualified Protective
Order which establishes compliance with paragraph (e) sufficient to establish prong two of §
164.512(a), but that efforts were made to secure one in connection with Plaintiff’s formal discovery

2 The Court finds no merit in ESI and Accredo’s proposition that the Special Master’s order compelling
discovery of unredacted PHI also does not satisfy § 164.512(a) because the order did not exist before she held that the
“minimum necessary rule” did not apply. Indeed, various other courts have recognized that, although not required by
the HIPAA rules, an order compelling discovery used in conjunction with a protective order bolsters HIPAA’s strong
policy to protect patient medical information. See Howard, 2007 WL 2811828 at *3 n.5; Ruggles, 2010 WL 11570681,
at *14; E.E.O.C. v. Boston Market Corp., No. 03-cv-4227, 2004 WL 3327264, at *4 n.5 (E.D.N.Y. Dec.16, 2004);
Law v. Zuckerman, 307 F. Supp. 2d 705, 711 (D. Md. 2004). ESI and Accredo assert no legal authority to the contrary.
For all intents and purposes, the Special Master’s order authorizing and compelling discovery of all PHI subject to the
terms of the Qualified Protective Order independently satisfies the “required by law” exception to the “minimum
necessary rule.”
requests. And because the Court entered one here, it therefore follows that both paragraphs (e)
and (a)(2) have been met.
Because the Court finds that both sub-parts of paragraph (a) are established, ESI and
Accredo’s PHI disclosures in response to Plaintiff’s document requests are not subject to HIPAA’s

“minimum necessary requirement.” See Handy v. Del. River Surgical Suites, LLC, No. 19-cv-
1028, 2024 WL 1539599 at *4, *6 (E.D. Pa. Feb. 29, 2024) (ordering compulsion of unredacted
PHI and patient lists after finding that the “minimum necessary rule” did not apply because a
Qualified Protective Order existed); MSP Recovery Claims, Series, LLC v. Sanofi-Aventis U.S.
LLC, No. 18-cv-2111, 2023 WL 4562998 at *5 (D.N.J. July 14, 2023) (finding the “minimum
necessary requirement” inapplicable to disclosures required by law because a Qualified Protective
Order was in place to secure confidential information); Jackson v. Wexford Health Sources, Inc.,
No. 20-cv-0900, 2022 WL 3644158 at *5 n.4 (S.D. Ill. Aug. 24, 2022) (rejecting defendant’s
proposed insertion of a “minimum necessary” PHI disclosure provision into the parties’ proposed
amended Qualified Protective Order because the requirements of § 164.512(a) were satisfied).

This Court therefore holds that the “minimum necessary rule” does not apply because the existence
of the Qualified Protective Order mandating compulsion of all unredacted PHI in connection with
the Plaintiff’s discovery requests satisfies § 164.512(a). The Special Master’s decision is affirmed.
c. Plaintiff Asserts Good Reason to Seek All Unredacted PHI
This Court rejects ESI and Accredo’s challenge to the Special Master’s order compelling
disclosure of all unredacted PHI. ESI and Accredo again do not assert any law to support the
argument that the Special Master abused her discretion by ordering all unredacted PHI to be
propounded in discovery in accordance with the Qualified Protective Order. Additionally, the
Court discerns no clear errors of law. Consequently, the Court defers to and adopts the Special
Master’s reasoning that Plaintiff adequately exhibited a need for all PHI. See L. Civ. R. 72.1(c)(A);
McDonough, 2013 WL 322595, at *2. Accordingly, the Special Master’s order compelling
disclosure of unredacted PHI pursuant to the terms of the Qualified Protective Order is affirmed.
For the avoidance of doubt, the Court finds that good cause exists to produce all unredacted

PHI because it is within the scope of discoverable information provided by the Qualified Protective
Order and Plaintiff asserted sufficient reason for acquiring such unredacted information as a result
of the inconsistent manner in which ESI and Accredo tracked patient-subscribers. (Opposition to
Appeal at 21–22, ECF No. 643). Additionally, the Qualified Protective Order obviates the need
for ESI and Accredo’s confidentiality concerns because PHI may only be used in connection with
this litigation and PHI obtained during the proceedings must be returned or destroyed at the
conclusion of the litigation. (See Discovery Confidentiality Order ¶ 19, ECF No. 62). Indeed, the
Qualified Protective Order is more protective than what HIPAA requires because it affords the
producing parties the ability to place an “Attorneys’ Eyes Only” designation on any document
with sensitive information. (Id. at ¶ 2). ESI and Accredo must produce all CHI and PHI unredacted

as defined by Paragraph 3 of the Confidentiality Order.
IV. CONCLUSION
Based on the foregoing, Express Scripts, Inc., and Accredo Health Group, Inc.’s appeal is
DENIED, and the Special Master’s Order is AFFIRMED. The “minimum necessary rule” does
not apply here, and Plaintiff adequately articulated a need for disclosure of all PHI within the scope
of the Qualified Protective Order.
It therefore is on this 10th day of June, 2025,
ORDERED that the Special Master’s Order (ECF No. 582) is AFFIRMED; and it is further
ORDERED that ESI and Accredo produce all unredacted CHI and PHI requested by
Plaintiff in discovery in accordance with Paragraph 3 of the Qualified Protective Order.

s/ Cathy L. Waldor
Hon. Cathy L. Waldor
United States Magistrate Judge

Cc: Hon. Claire C. Cecchi, U.S.D.J.
Hon. Freda L. Wolfson, U.S.D.J. (ret.), Special Master

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/11068968. Public record. Not legal advice.