Second Amended Complaint
- Date
- 2024-05-31
Summary
The final redacted version of the Second Amended Complaint in AirBoss Defense Group, LLC v. The United States, No. 24-365, a pre-award bid protest in the United States Court of Federal Claims before Judge Lettow, filed June 17, 2024 as Document 59. AirBoss Defense Group challenges Amendment 0009, issued May 31, 2024, to Request for Proposal No. 75A50322R00008 for Level 2 Isolation Gowns for the Strategic National Stockpile. The complaint recounts the procurement history, including the 2023 award of Contract No. 75A50323C00013 to New York Embroidery Studio, protests at the Government Accountability Office and corrective actions. It asks the court to declare that HHS acted arbitrarily and capriciously and to enjoin award of contracts until the Solicitation is revised. The 30-page complaint is dated June 11, 2024 and signed by counsel Daniel P. Graham.
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Case 1:24-cv-00365-PSH Document 59 Filed 06/17/24 Page 1 of 30
Final Redacted Version
IN THE UNITED STATES COURT OF FEDERAL CLAIMS
BID PROTEST
AIRBOSS DEFENSE GROUP, LLC, )
)
Plaintiff, )
)
and )
)
STRING KING LACROSSE LLC, )
)
Plaintiff-Intervenor )
)
) No. 24-365
V. ) (Judge Lettow)
)
THE UNITED STATES, )
)
Defendant, )
)
and )
)
NEW YORK EMBROIDERY STUDIO, INC. , )
)
Defendant-Intervenor. )
SECOND AMENDED COMPLAINT
Plaintiff, AirBoss Defense Group, LLC ("ADG"), by and through its undersigned counsel,
brings this pre-award bid protest action against Defendant, the United States of America, acting
by and through the U.S. Department of Health and Human Services, Administrntion for Strategic
Preparedness and Response (collectively, "HHS" or the "Government").
On May 31, 2024, HHS released Amendment 0009 to Request for Proposal No.
75A50322R00008 for Level 2 Isolation Gowns (the "Solicitation" or "RFP"). Amendment 0009
suspends the prior solicitation in its entirety and directs offerors in the competitive range to submit
new proposals by June 17, 2024. As described in detail below, Amendment 0009 includes
requirements that are arbitnuy, capricious, unduly restrictive of competition, an abuse of
discretion, or othe1w ise not in accordance with law. ADG seeks pennanent injunctive relief
1
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preventing HHS from proceeding with the procurement. ADG does not seek emergency injunctive
relief at this time.
INTRODUCTION
1. The Solicitation seeks proposals to supply the Strntegic National Stockpile ("SNS")
with ANSI/AAMI PB70 Level 2 Isolation Gowns ("Level 2 Isolation Gowns") that are
domestically manufactured with 100% domestic components. 1
2. Level 2 Isolation Gowns are commercial products, and the Government issued the
Solicitation under FAR Pait 12 's procedures for the acquisition of commercial products.
3. ADG se1ved as one of the prima1y government suppliers of personal protective
equipment ("PPE") during the declared COVID-1 9 Public Health Emergency. As a contractor to
HHS, ADG has supplied over 150,000 powered respirators and over 3.6 million filters. In
paiiiculai·, ADG has a histo1y of competing in procurements for medical gowns. In 2021, ADG
first fo1med a coalition of small and large businesses to offer a proposal in response to HHS's
solicitation for Level 3 and Level 4 Surgical Gowns to supply the SNS. HHS publicly announced
in November 2021 that the Government was entering into negotiations with ADG to supply the
Level 3 and Level 4 gowns with the intent to awai·d a contract, which HHS reaffnmed on Januaiy
14, 2022. As explained above, Level 3 and 4 gowns require higher protection ratings and thus
have stricter testing criteria than the Level 2 gowns required by this procurement.
1
Isolation gowns are used in the healthcare setting to promote infection control practices and help
protect patients and healthcai·e workers against microorganisms and bodily fluids during routine
care, examinations, and medical procedures. The American National Standai·ds
Institute/Association for the Advancement of Medical Instrnmentation ("ANSI/AAMI") PB70
established a classification for isolation gowns that is based on the individual gown's liquid baiTier
protection. The ANSI/AAMI PB70 incorporates four standai·d tests that dete1mine the level of
protection. Based on the result of the tests, an isolation gown falls within one of four categories
of protection with Level 1 being the lowest level of protection and Level 4 being the highest level
of protection. Here, the Solicitation calls for the provision of domestic isolation gowns with a
protection rating of Level 2.
2
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4. HHS issued Amendment 0009 only to those offerors within the competitive range,
which includes ADG, and provided those offerors the opportunity to submit revised Technical and
Business Proposals. As discussed below, Amendment 0009 includes requirements that are
arbitnuy, capricious, unduly resti·ictive, an abuse of discretion, or othe1w ise not in accordance with
law. The Court should sustain this protest and enjoin HHS from proceeding with the procmement
until it amends the Solicitation to comply with applicable procmement law.
PARTIES
5. ADG is a limited liability company organized and existing under the laws of
Maiyland with its principal place of business located at 8261 Preston Comt, Jessup, MD 20794.
6. ADG provides healthcai·e, secmity, and militaiy customers around the world with
an optimized mix of mission-critical consumables, dmable major equipment, and deployed
sustainment and service suppo1t. ADG is a recognized leader in chemical and biological PPE,
rapid deployment decontamination systems, and respirato1y protective solutions. ADG has
successfully provided emergency response and protective solutions to HHS, the Depaitment of
Defense, the Federal Emergency Management Agency, the U.S. Depaitment of State's Office of
Sti·ategic Medical Prepai·edness, Centers for Disease Conti·ol and Prevention infectious disease
ti·eatment centers, as well as numerous commercial healthcai·e providers in the United States and
abroad. ADG has played a significant role in the U.S. COVID-19 response, supplying 150,000
Powered Air-Purifying Respirators and over three million Pl00 HEPA filters for urgent PPE
supply initiatives and Sti·ategic National Stockpile development.
7. Defendant is the United States of America, acting by and through the U.S.
Depaitment of Health and Human Services, Administi·ation for Su-ategic Prepai·edness and
Response, an agency of the Federal Government.
3
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JURISDICTION & STANDING
8. This Comi has jurisdiction over this action pursuant to 28 U.S.C. §1491(b).
9. ADG is an interested party within the meaning of 28 U.S.C. §1491(b). ADG is a
prospective bidder that HHS has found to be within the competitive range and thus ADG has a
direct economic interest in the procurement. ADG will suffer a non-trivial competitive injmy if
the arbitra1y , capricious, unduly restrictive, and unlawful te1ms in Amendment 0009 are not
remedied.
10. This protest is timely filed prior to the deadline for submission of proposals.
FACTUAL BACKGROUND
A. The Solicitation
11. HHS initially issued the Solicitation on June 28, 2022.
12. On October 31, 2022, HHS issued Amendment 0005, which included a revised
Solicitation superseding the previously released RFP. AR 269.
13. On November 16, 2022, HHS issued Amendment 0007, which revised the product
quantity, delive1y schedule requirements, the Statement of Work, and the evaluation factors. AR
320.
14. On May 31, 2024, the Government issued Amendment 0009, which suspends the
prior Solicitation in its entirety and directs offerors in the competitive range to submit new
proposals by June 17, 2024. See Ex. 1 (Amendment 0009).
15. The commercial product Solicitation calls for up to 75,200,000 Level 2 Isolation
Gowns plus an optional quantity of up to 150,400,000 Level 2 Isolation Gowns. The pmpose of
the procurement is to suppoli the SNS, a national reposito1y of phaimaceuticals, vaccines, medical
supplies, and medical equipment, such as the Level 2 Isolation Gowns. The SNS is designed to
supplement state and local medical supplies and equipment during public health emergencies.
4
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16. Because of the importance of the SNS, the Solicitation emphasized that the contrnct
awardee must have the capacity to meet increased demand. The Solicitation provides: "The
Contractor must be capable of responding to unanticipated demands for increased capacity within
existing capabilities covered under this SOW that may require a ' surge ' in effo1ts and/or resources.
If accelerated or increased quantities are required, the Government will determine the estimated
need that is required." Id. at 7.
17. The Solicitation includes technical requirements that set fo1th the requirements for
non-sterile, disposable gowns, used to protect healthcare personnel and patients from the transfer
of microorganisms and body fluids in routine patient care in healthcare settings.
18. Section L.4 of the Solicitation includes the inst:Iu ctions for the offerors ' technical
proposals. Technical proposals include three factors: Factor 1: Technical Compliance Domestic
End Product Criteria; Factor 2: Technical Capability; and Factor 3: Similar Experience. Factor 2
has eight Subfactors:
a. Subfactor 1: Manufacturer/Producer
b. Subfactor 2: Production Schedule/Manufacturing Capability
c. Subfactor 3: Labeling and Packaging
d. Subfactor 4: Not Made With Natural Rubber Latex
e. Subfactor 5: Catalog and Literature
f. Subfactor 6: Shelf Life
g. Sub factor 7: Test Repo1t s
h. Subfactor 8: Biocompatibility Report/Plan.
Id. at 41-46.
19. Section M sets fo1th the Evaluation Factors for Award of the Solicitation. Section
Mprovides:
The Government will award a conti·act resulting from this solicitation to the
responsible offeror whose offer demonst:I-ates that it can meet the mandato1y criteria
and will be most advantageous to the Government considering both price and the
other evaluation factors. The Government may award any resulting conti·act to other
than the lowest priced offerors, or other than the offeror with the highest non-price
rating. Price is the least impo1tant of the four (4) evaluation factors with Factor 1-
5
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being significantly more important than price. However, as proposals become more
equal in their non-price factors, the price factor will become more impo1iant.
Id. at 49.
20. The Solicitation emphasizes that this procmement is a "best value acquisition
conducted in accordance with Federal Acquisition Regulation (FAR) 12.602; the Government
intends to select the best overall offer, based upon an integrated assessment of Technical and
Business Proposals." Id. at 54. The Solicitation farther provides that a contract will be awarded
to the offeror whose proposal "is judged by an overall assessment of the evaluation factors and sub
factors to be most advantageous to the Government." Id.
B. Procurement History
21. Offerors initially submitted proposals in November 2022. On September 25, 2023,
HHS made a single contract award of Contract No. 75A50323C00013 to New York Embroide1y
Studio ("NYES"). AR 1347. HHS awarded NYES a base quantity of 75,200,000 gowns at $1.98
per gown for a total price of $148,896,000, with additional options for increased quantities.
22. On September 26 and 27, 2023, HHS sent ADG and the other offerors Unsuccessful
Offeror Notices. AR 13 80-141 5. ADG timely requested a debriefing and, on September 29, 2023,
HHS provided ADG a written debriefing explaining that HHS
_ _ AR 1417.
23. ADG filed an initial protest challenging HHS's evaluation and award decision at
the U.S . Government Accountability Office ("GAO") on October 4, 2023. GAO docketed ADG's
October 4 protest as B-420935.4. AR 1499. HHS issued NYES a Stop Work Order on October
5, 2023. AR 1437.
6
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24. ADG filed supplemental protests at GAO identifying additional defects in HHS's
evaluation and award decision on October 10, 2023 (AR 1619), and October 20, 2023 (AR 1624).
GAO docketed ADG's October 10 and 20 protests as B-420935.7 and B-420935.10, respectively.
25. fu addition to ADG's protests, five other contractors filed protests challenging
HHS's award decision, Sti·ing King Lacrosse LLC ("Sti·ingKing") (AR 1438, 1457), Atlantic
Trading, Essential Safety PPE ("Essential"), Gredale, and Health Supply US. GAO docketed these
other protests as B-420935.2-.3, .5-.6, and -.8-.9.
26. On October 27, 2023, prior to the filing of an adminisu-ative record in ADG' s GAO
protest, HHS filed a Notice of Con ective Action and Request for Dismissal. AR 1629.
27. HHS's Notice of Conective Action stated that HHS had detennined that corrective
action was wairnnted based on the protests and stated that HHS would:
a. Reconsider the Agency's technical evaluation of proposals, specifically relating
to the findings which were challenged and, to the extent necessaiy, issue an
amended Technical Evaluation Panel Report;
b. After reconsidering the proposal evaluation findings, detennine (within the
Agency's discretion) whether discussions or additional clarifications are
necessa1y ;
c. Make a new source selection decision; and
d. Take other actions, as deemed necessaiy and appropriate by the Agency.
28. ADG did not object to HHS's proposed conective action, and GAO dismissed all
of the protests regarding the award to NYES as academic on November 3, 2023. AR 1636-1647.
29. On November 13, 2023, Sti·ingKing filed an agency-level protest ai·guing that HHS
had failed to take the conective action HHS had committed to in response to St1ingKing's GAO
protest. AR 1648. Specifically, Su-ingKing ai·gued that HHS had failed to cancel the conti·act
award to NYES despite having represented in HHS's Notice of Con ective Action filed at GAO
that HHS would make a new source selection decision. Id.
7
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C. HHS's February 2024 Competitive Range Decision
30. ADG heard nothing from HHS until Febmaiy 16, 2024, when ADG received a letter
from HHS advising ADG that HHS had completed its initial review of proposals in connection
with its conective action, had found ADG's proposal
AR 1904. ADG timely requested a debriefing and, on Febmaiy
21 , 2024, HHS provided ADG with a written debriefing letter.
31. After establishing the competitive range, which included
HHS issued Amendment 0008 only to those offerors within the competitive range.
AR 1916. Amendment 0008 revised the Solicitation to removed shelf-life as a consideration for
HHS when conducting its best vale detennination. AR 917. Amendment 0008 also pennitted
offerors within the competitive range to submit revised Technical Proposals.
32. HHS never issued a decision on StringKing's agency-level protests, instead
dismissing it as moot on Febmaiy 20, 2024, citing the issuance of Amendment 0008.
33. On Febmaiy 26, 2024, StringKing filed at pre-award protest at GAO challenging
the tenns of Amendment 0008 and arguing that HHS had improperly modified the Solicitation
by removing shelf life from the evaluation criteria for Factor 4 (Price) and from the best value
detennination. AR 1923.
34. On Febmaiy 28, 2024, submitted
revised Technical Proposals. AR 1950-2013.
D. ADG's First Complaint Before this Court
35. ADG timely filed its initial Complaint before this Comi on Mai·ch 7, 2024, which
it amended on March 25, 2024. ADG sought pe1manent declarato1y and injunctive relief to remedy
HHS' s arbitra1y and unlawful decision to
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36. On March 28, 2024, the Government filed a Notice of Con ective Action and
Motion to Suspend Future Deadlines in this protest. ECF No. 27. The Government represented
that it was:
a. Canceling Request for Proposals No. 75A50322R00008;
b. Te1m inating the award to defendant-intervenor New York Embroide1y Studio,
fuc. (NYES) (Contract No. 75A50323C00013), made under the agency's 2023
award decision, which has been under a stop work order since October 5, 2023;
c. Reviewing and reconsidering the agency's requirement for isolation gowns, to
include shelf-life considerations, which will likely include additional and/or
updated market research;
d. Preparing a new or revised acquisition plan for a new solicitation; and
e. Taking other actions, as deemed necessaiy and appropriate by the agency.
37. HHS filed a similai· notice in response to StringKing's GAO protest, leading GAO
to dismiss the protest on April 9, 2024. AR 2011.
38. On April 15, 2024, the Government reversed course and dete1mined it would not
cancel the Solicitation and instead would reconsider its competitive range dete1mination within
thirty days, issue an amendment to the solicitation revising the current requirements, engage in
discussions as needed, and solicit revised final proposals. ECF No. 31.
39. On April 23, 2024, Plaintiff-futervenor StringKing filed a Complaint in this Comt
outlining its challenges to HHS's issuance of Amendment 0008 and HHS's competitive range
dete1mination.
40. On April 26, 2024, the Government again changed its timeline to take con ective
action and info1med the Comt that HHS's intended conective action schedule includes the
following:
a. By May 10, 2024, HHS will make a new competitive range dete1mination and
notify offerors who ai·e in the competitive range.
b. By the end of May 2024, HHS will issue an amendment to the solicitation to
offerors in the competitive range. As pa.It of the amendment, HHS intends to
revise the cmTent shelf-life requirements, fmther clarify the cmTent sleeve
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length and device registrntion requirements, allow offerors to submit
solicitation questions, and allow offerors to submit revised proposals.
c. By the end of July 2024, HHS will evaluate revised proposals and make a new
award decision.
ECFNo. 38.
41. On May 6, 2024, the Comi issued an Order directing the Government to file the
Administrative Record in this case by May 10, 2024. ECF No. 42.
42. After a request for an extension of time, which the Comi granted, the Government
filed the Administrative Record on May 24, 2024. ECF No. 48.
E. Amendment 0009
43. On May 30, 2024-twenty days after the Government said in its April 26 fling it
would make a new competitive range detennination-the Government finally notified ADG that
the Government had revised its prior competitive range detennination and that HHS ■
44. On May 31, 2024, HHS issued Amendment 0009 to the Solicitation. See Ex. 1.
45. Amendment 0009 suspends the prior solicitation in its entirety and directs offerors
in the competitive range to submit new technical and business proposals by June 17, 2024.
46. Amendment 0009 provides that the Solicitation is being amended to "revise the
shelf-life requirements, clarify gown dimensions, clarify device registrntion requirements, clarify
labeling requirements, delete the volume discount tables in Section B.4, make minor clarifications
as needed to update language and dates and to update to the cmTent clauses." Ex. 1 at 2.
47. On June 4, 2024, ADG, through the undersigned counsel, ale1ied the
Government's counsel to several defects in, and other issues with, Amendment 0009. Ex. 2 (June
4, 2024 Email). ADG noted that Amendment 0009 (a) indicates that the Solicitation was paiiially
set aside for small businesses; (b) is ainbiguous regai·ding how sleeve length is to be measmed;
Case 1:24-cv-00365-PSH Document 59 Filed 06/17/24 Page 11 of 30
and (c) fundamentally alters the nature of the Isolation Gowns that HHS seeks to procure by
eliminating shelf-life as an evaluation criteria. Id. at 6-7. ADG indicated that it would file a
Second Amended Complaint in this case and requested an indefinite extension of the due date for
submission of proposals until the resolution of this litigation. Id.
48. ADG's June 4 email also noted that the administrative record indicates that HHS
and NYES are cmTently negotiating some so1i of payment by HHS to NYES that would improperly
and unfairly subsidize NYES 's costs for this procurement. ADG's June 4 email requested that
HHS agree not to make any payment of money to any offerer in connection with this procurement
until this litigation is resolved. Id. at 7.
49. On June 5, 2024, ADG subinitted questions to HHS regarding Amendment 0009.
50. On June 6, 2024, the Government responded to ADG's June 4 email indicating that
the Government would amend the Solicitation to state that it was not set aside for small businesses,
and that the Government was considering "a short extension of the due date for proposal
submissions to give offerers additional time to consider the agency's answers" to questions
received by offerers regarding Amendment 0009. Id. at 1. The Government refused to agree to
not make any payment to NYES during the pendency of this litigation. Id.
51. On June 7, 2024, HHS issued Amendment 0010 to the Solicitation, which states
that the Solicitation is not set aside, in whole or in part, to small business. Ex. 3 (Amendment
0010). Amendment 0010 does not address any of the other concerns identify by ADG in its June
4 email.
CLAIMS FOR RELIEF
COUNTI
Amendment 0009 Contains A Patent Ambiguity.
52. ADG inco1porates the foregoing paragraphs by reference as though fully restated
herein.
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53. Amendment 0009 provides that gown dimensions "shall be measured with the
Isolation Gown laying flat with the back closed and gown dimensions repo1ted in inches. Isolation
Gown dimensions must meet the minimum to maximum ranges below." Ex. 1 at 12. Regarding
sleeve length, Amendment 0009 provides that, "[f]or large Isolation Gowns, the finished sleeve
length shall be 21 -24 inches. For extra-large Isolation Gowns, the finished sleeve length shall be
23-25 inches." Id.
54. Amendment 0009 contains no point of reference for where sleeve length should be
measured from (e.g. , collar to cuff, shoulder to cuff, under aim to cuff, etc.).
55. Previously, Amendment 0005 provided that: "Isolation Gown dimensions must
meet gown length, chest width, and sleeve lengths commonly used in the commercial industiy, per
the specific size. Dimensions that do not meet the minimum or that significantly exceed the
minimum length, chest, width, and sleeve length will not be considered." AR 281. Regarding
sleeve length, Amendment 0005 explained that "[l]arge and exti·a-large gown sizes should reflect
dimensions cunently available in the collllllercial market. Examples of approximate gown
dimensions include chest width: large 27 inches and exti·a-large 30-31 inches; sleeve length: large
22-23 inches and extra-large 24 inches; and gown length 46 inches." Id.
56. In revising the Solicitation, HHS removed any requirement that gown dimensions
shall comply with collllllon industiy standards, despite this bring a procurement for commercial
products. Fmther, instead of providing examples of approximate gown dimensions, Amendment
0009 mandates an arbiu-aiy sleeve length of 21-24 inches for large gowns, and 23-25 inches for
exu-a-large gowns. Ex. 1 at 12.
57. As is collllllon industiy practice, in ADG 's November 22, 2022 proposal, ADG
. AR 357.
12
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58. ill both its protest before this Comi and in its previous protests before GAO, ADG
provided HHS with an exhibit showing that multiple other gowns commonly sold in the
commercial market . ECF No.
1 at Ex. 10.
59. ill both HHS's initial evaluation of ADG's proposal and in HHS's evaluation
following its con ective action, HHS ignored the common indusby practice and deemed ADG's
proposal
AR 1200, 1724, 1853. HHS appeared to have been relying solely on the
"examples" of sleeve lengths provided in the RFP and obtusely ignored the fact that ADG' s gowns
60. ill fact, HHS knew that its evaluation of ADG's proposal was likely wrong because
- The Government, however, never sought that clarification from ADG.
61. When ADG protested HHS's evaluation of sleeve length at GAO, HHS elected to
take con ective action and stated that it would "[r]econsider the Agency's technical evaluation of
proposals, specifically relating to the findings which were challenged" by ADG. AR 1629.
62. HHS never sought dismissal of ADG's protest grounds on the basis that ADG's
inte1p retation of the sleeve length provision was unreasonable. illstead, by representing to GAO
that HHS would "reconsider" its evaluation and that HHS's reconsideration rendered ADG's
protest "academic," HHS acknowledged to GAO that ADG's inte1pretation of these provisions
was, in fact, reasonable, and that there was a reasonable possibility that ADG would be awarded a
contract.
13
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63. Yet despite HHS's acknowledgment that ADG's inte1pretation of the sleeve length
requirement was reasonable, HHS again found
AR 1724.
64. fu both its Complaint and Amended Complaint filed before this Comt , ADG
challenged HHS's inte1pretation that ADG's sleeve length did not comply with the requirements
of the RFP.
65. Despite representing to the Comt that it would "fmther clarify the cmTent sleeve
length" requirements in the Solicitation, ECF No. 37 at 2, HHS has failed to address the ambiguity
that ADG has identified in its protests. Amendment 0009 provides no indication of how offerors
should measure the sleeve length of proposed gowns and does not identify the point of
measurement for the minimum and maximum dimensions identified in Amendment 0009.
66. A patent ambiguity is "present when the contract contains facially inconsistent
provisions that would place a reasonable contractor on notice and prompt the contractor to rectify
the inconsistency by inquiring of the appropriate paities." Stratos Mobile Networks USA, LLC v.
United States, 213 F.3d 1375, 1381 (Fed. Cir. 2000). When a solicitation contains a patent
ambiguity, the offeror has "a duty to seek clarification from the government, and its failure to do
so precludes acceptance of its inte1pretation" in a subsequent comi action. Blue & Gold Fleet,
L.P. v. US. , 492 F.3d 1308, 1313 (Fed. Cir. 2007) (quoting Stratos Mobile Networks, 213 F.3d at
1381).
67. On June 4, 2024, ADG ale1ied the Government to the ambiguity in Amendment
0009 regai·ding how sleeve length is measured, writing "despite the fact that ADG's protests at
GAO and the Comi specifically alleged that the solicitation is ambiguous regai·ding how sleeve
length is to be measured (from the collar, shoulder, undera1m, spine, etc.), Amendment 0009
14
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attempts to impose a more nan ow range of acceptable sleeve length without specifying the point
of measurement. ADG therefore has no way to be ce1iain what gowns will or will not satisfy
Amendment 0009." Ex. 2 (June 4, 2024 Email).
68. To date, Offerors have received no clarification from the Government regarding
this ambiguity.
COUNT II
HHS's Sleeve Length Requirements are Inconsistent with Customary Commercial Practice
in Violation of FASA and FAR Part 12.
69. ADG inco1p orates the foregoing paragraphs by reference as though folly restated
herein.
70. The Federal Acquisition Streamlining Act of 1994 ("FASA"), and its implementing
regulations found at FAR Pali 12, require the Federal government to purchase commercial items
under commercial te1ms to the extent practicable. 41 U.S.C. § 3307(e)(2)(B); FAR 12.301 (a).
71. Specifically, FAR Part 12 requires that "contracts for the acquisition of commercial
products or commercial services shall, to the maximum extent practicable, include only those
clauses" required by law or "[d]ete1m ined to be consistent with customaiy commercial practice."
FAR 12.301(a). It also precludes inclusion of "any additional te1ms or conditions in a solicitation
or contract for commercial items in a manner that is inconsistent with customaiy commercial
practice for the item being acquired unless a waiver is approved in accordance with agency
procedures." FAR 12.302(c).
72. Fmiher, when acquiring commercial items, the agency must "[c]onduct mai·ket
research to dete1mine whether commercial products, commercial se1v ices, or nondevelopmental
items ai·e available that could meet the agency's requirements." FAR 12. l0l (a). Thus, the agency
must use the mai·ket reseai·ch in evaluating whether a solicitation 's te1ms ai·e consistent with
customaiy commercial practice.
15
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73. Amendment 0009 provides "[f]or large Isolation Gowns, the finished sleeve length
shall be 21 -24 inches. For extrn-large Isolation Gowns, the finished sleeve length shall be 23-25
inches." Ex. 1 at 12.
74. The minimum and maximum sleeve length dimensions required by Amendment
0009 are inconsistent with customaiy coilllllercial practice, and HHS 's mai·ket research, as
reflected in the Administrative Record, does not suppo1i the required dimensions. Nor does the
market research suppo1i HHS 's arbitra1y decision not to allow for the various different points of
measurement for sleeve length used in the commercial market, despite ADG raising this issue in
its GAO protests and its Complaint and First Amended Complaint in this case.
75. The Administrative Record includes HHS's Mai·ket Research Repo1i which details
the mai·ket reseai·ch HHS conducted before issuing the original Solicitation, but the report does not
mention product dimensions, let alone sleeve length. The Repo1i does not include any documents
or infonnation establishing that Amendment 0009 's required sleeve lengths reflect customaiy
commercial practice. See AR 11-18. Nor does the repo1i provide any suppo1i for HHS's decision
to require offerors to guess the point of measurement for HHS's mandato1y dimensions (which
have no basis in the coilllllercial mai·ket). Id.
76. Specifically, the Mai·ket Research Repo1i states that SNS "held market reseai·ch
discussions with FDA in an effo1i to understand cmTent industiy capabilities and potential vendors
of domestically manufactured isolation gowns" and that "ASPR reached out to the vendors FDA
indicated as showing in their pre-mai·ket database as having domestic manufacturing for medical
gowns . . . requesting capabilities and location of manufacturing to further understand cmTent
industiy capabilities." AR 12. The repo1i also states that SNS perfo1med fmiher research within
GSAAdvantage, SAM.gov, previous conti·acts, the VA National Acquisition Center "for potential
capable vendors and pricing info1mation." Id. The ASPR Supply Chain Conti·ol Tower and
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funovation and Industrial Expansion Branch also perfo1med supply chain research and analysis.
Id.
77. Nothing in the Market Research Repoit states that this research yielded information
about gown sleeve lengths common to the commercial market or the point measurement for sleeve
length that is customaiy commercial practice.
78. Moreover, the Market Reseai·ch Report concedes that some of the infonnation
gathered may be inaccurate, explaining that "FDA did provide a disclaimer and made SNS aware
that the database used to identify the(] vendors is data directly input by vendors and may be
inaccurate, did not indicate the type of gown (surgical or isolation), and did not indicate at which
level of protection the manufactured gowns were being made." Id. at 14.
79. The Mai·ket Reseai·ch Repo1i also states that in June 2021, Contracting Officer
Annette Wright issued a Request for Info1mation for isolation and surgical gowns, which received
68 responses. Id. The results were reviewed by the SNS Science team, which "developed a
summa1y of the results in both written and Excel spreadsheet fo1m." Id. at 12.
80. The SNS Science Teain's sUilllnai·ies are not included in the Administrative Record,
and the Mai·ket Research Repo1i does not include any indication that the sUilllnai-ies include
conclusions about the customa1y commercial practice for gown sleeve lengths or points of
measurement.
81. In a Notice of CoITective Action filed on March 28, 2024, Defendant explained that
HHS's coITective action "will likely include additional and/or updated market research," but the
Administrative Record demonstrates that the Government did not conduct any fmiher mai·ket
research to suppo1i the requirements in Amendment 0009. ECF No. 27.
82. Moreover, ADG has identified numerous exainples of Level 2 Isolation Gowns sold
m the commercial mai·ket that have sleeve lengths that differ from Amendment 0009 's
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requirements and/or use different points of measurement than HHS appears to be using. For
example:
a. Gilman Gear 's Disposable Isolation Gown, size XL sleeve length 27 inches
measured from the shoulder to thumbhole.
b. Medicom's Isolation Gown, size L sleeve length 65 centimeters (25.6 inches)
measured from the shoulder to cuff.
c. Safety Plire's Non Sterile Isolation Gown-Level 2, shoulder and sleeve length
33 inches.
d. AllHea1i's Urbane Essentials Unisex Medical Isolation Gown, sleeve length 34
¾ inches.
e. KSE Suppliers ' Level II Isolation Gown, sleeve length 32 inches measured
from collar to cuff; and 20 inches measured from annpit to cuff opening.
Ex. 4 (Commercially Available Gown Dimensions).
83. In addition, multiple other offerors ' proposals include gowns with sleeve lengths
that differ from Amendment 0009 's requirements:
a.
b.
84. The Administrative Record does not contain any evidence that HHS obtained or
even sought a waiver to include te1m s inconsistent with customaiy commercial practice as required
by FAR 12.302(c).
85. As explained above, Amendment 0009's minimum and maximum sleeve length
requirements, and failure to specify the point of measurement for sleeve length, are inconsistent
with customaiy collllllercial practice and are therefore in violation of FASA and FAR Pait 12.
COUNT III
Amendment 0009 Arbitrarily and Capriciously Eliminates the Consideration of Shelf Life.
86. ADG inco1porates the foregoing paragraphs by reference as though folly restated
herein.
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87. Solicitation section "C.1 Background" states that the Government is procuring
isolation gowns for the Strategic National Stockpile ("SNS"), which is a national reposito1y of
phannaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations
around the United States. AR 277. Section "C.2 Pmpose" originally fmther explained that,
through this procurement, "the Government is attempting to increase the availability of
domestically produced compliant PPE. This will enable the United States to ensure sufficient
domestic availability of such items during national emergencies and/or pandeinic events." Id.
88. It is only natural that the evaluation of proposals submitted in response to the
Government's effo1ts to strategically stockpile gowns for future emergencies and pandemics
would include consideration of the products' shelf life. That is, the length of time for which the
medical isolation gowns remain effective and usable, after which the gowns must be discarded or
replaced.
89. Specifically, the Solicitation's Factor 2, Subfactor 6: Shelf Life originally required
that, for offerors making shelf-life claims, the gowns "when delivered to the SNS, shall have no
more than 20% of total shelf-life expended." AR 328. The Solicitation fuither stated that
" [o]fferors will be evaluated based on providing appropriate data and documentation, such as
accelerated aging and real-time testing repo1ts and other validating documentation, to suppo1t their
shelf-life claims." AR 330.
90. The Solicitation also originally factored shelf life into the price and best value
detennination, explaining that "[t]he Government's overall best value detennination will consider
the cost of the product as it relates to the shelf-life at time of delive1y and the best value
detennination will also consider the time, effo1t, and cost to sustain product with lesser shelf-life."
AR317.
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91. Despite the stockpiling of medical isolation gowns being the prima1y purpose of
the procurement, and shelf life being among the original price and best value evaluation criteria,
HHS internally questioned the value of longer shelf lives in its technical evaluations of offerors'
proposals. HHS stated:
USG should consider if it is appropriate, allowable, and beneficial to stockpile a
gown for over 10 years, as the industry n01m for personal protective equipment
(PPE) shelf life is 5 years, and, longer dated shelf life could hinder the domestic
manufacturing industry
AR 1190.
92. HHS then took its devaluation of shelf life a step fmi her in issuing Amendment
0008, which removed shelf life from the price and best value detennination criteria altogether.
AR 1917.
93. Despite removing shelf life from the evaluation criteria, HHS stated that "[t]here
have been no alterations to the government's requirements in Section 'C.1 Background' and 'C.2
Pmpose,"' in response an offeror's question as to whether, in connection with Amendment 0008,
"there [had] been a change to the general needs of the agency found in sections 'C.1 Background'
and 'C.2 Pmpose."' AR 1920. In other words, HHS still sought to stockpile gowns to ensure
domestic availability during future emergencies and pandemics.
94. On May 31, 2024, HHS changed the Solicitation's requirements with respect to
shelf life again with Amendment 0009, specifying for the first time that "Isolation Gowns must
have a shelf life of 3 years, and, at the time of delive1y to the SNS, isolation gowns shall have no
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more than 3 months expended since the date of manufacture, as listed on the gown packaging
labels."2 Ex. 1 at 16.
95. Amendment 0009 fmt her explains that a "shelf life longer than 3 years will not be
evaluated higher or considered to be an additional strength." Id. at 53.
96. The amendment does not reinstate shelf life as pait of the evaluation criteria for
price and best value determination. See id at 54.
97. Moreover, Amendment 0009 removed from the Solicitation's section "C.2
Pmpose" the statements that HHS was "attempting to increase the availability of domestically
produced compliant PPE," and that the procurement "will enable the United States to ensme
sufficient domestic availability of such items dming national emergencies and/or pandemic
events." See Ex. 1 at 10.
98. By establishing a specific shelf life requirement that is lower than what HHS
ostensibly identified as the industiy nonn (5 yeai·s) 3 , openly questioning the value of longer shelf
lives in its technical evaluations, and removing the pmpose of "ensm[ing] sufficient domestic
availability" of gowns for future emergencies and pandemics, HHS has effectively eliminated shelf
life as an impo1tant evaluation criterion.
2
While Amendment 0007 previously included a requirement that "no more than 3 months
expended since the date of manufactme, as listed on the gown packaging," this requirement only
applied to offerors who made no shelf-life claim. AR 328-30.
Read naiTowly, Amendment 0009 requires all gowns to have a shelf-life of exactly three yeai·s,
and would exclude as unacceptable gowns with a longer shelf life. Because such a reading would
have the absmd result of rendering unacceptable nearly all of the proposals HHS received in
response to previous versions of the Solicitation, ADG inte1p rets Amendment 0009 to require a
minimum shelf-life of three yeai·s. To the extent that the Government intended to impose a sti·ict,
three-yeai· requirement, such a requirement would be all the more unreasonable and illegal, for
each of the reasons discussed in this Count
3 ADG notes that this alleged industiy n01m is not suppo1ted by HHS's Mai·ket Research Repo11,
which does not discuss customaiy commercial practice for shelf life at all. See AR 11-18.
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99. Doing so arbitrarily and capriciously transfonns the procurement to one that is
inconsistent with the Solicitation's original stated purpose, as well as the inherent pmpose of the
SNS, which is to stockpile supplies like medical isolation gowns that will be usable and effective
during future emergencies and pandemics.
100. By effectively removing shelf life as a consideration, the Government has failed to
adequately consider "life-cycle cost" as required by FAR 7 .105. The FAR defines life-cycle cost
as "the total cost to the Government of acquiring, operating, suppo1iing, and (if applicable)
disposing of the items being acquired." FAR 7.101. Under Amendment 0009, the Govermnent
considers a gown with three years of shelf-life to have no greater value than a gown with six or
nine years of shelf-life, despite the obvious increased cost to the Government of having to replenish
gowns in the SNS that expire, which cost will necessarily be higher than gowns with a sho11er
shelf life.
101. The Government's Acquisition Plan for this procurement dismisses life-cycle costs
entirely, stating: "Life-cyle cost does not apply to this commercial medical supply acquisition."
AR 105. The Government's statement is nonsense, and displays either a complete
misunderstanding of (a) what life-cycle costs are, (b) the fact that shelf-life is routinely considered
in the collllllercial marketplace by non-government customers when selecting gowns, or (c) both.
As discussed above, gowns with a longer shelf-life necessarily have higher life-cycle costs,
paiiicularly where, as here, the Government's objective is to stockpile gowns for use during a
future emergency.
102. fuexplicably, the Government refused to collllllunicate to offerors its conclusion
that "life-cycle cost does not apply" to isolation gowns. fu response to multiple questions from
offerors regai·ding how life-cycle costs would be considered, the Government evasively responded,
"The Government intends to evaluate and make award(s) in accordance with the tenns of the
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Solicitation and all applicable statutes and regulations." AR 1920 (Q&A nos. 8-10). The
Government elected not to share with offerors its detennination that life-cycle costs would not be
considered because those costs did not "apply" to isolation gowns.
103. By effectively removing shelf life as consideration, the Government also will not
meaningfolly evaluate cost and price as required by 41 U. S.C. § 3306(c)(l)(B). Amendment 0009
violates this mandate by ignoring altogether the higher costs associated with gowns with a sho1i er
shelf life, relying instead on the misleading, and illuso1y unit price of lower-quality gowns.
104. Finally, making such a significant change to the Solicitation's purpose and
evaluation criteria so late in the procurement process is unreasonable and ignores the substantial
work that offerors have put in over the last two years to prepare and submit responsive, competitive
proposals.
COUNT IV
The Government Has Engaged in Disparate Treatment and Bias.
105. ADG inco1porates the foregoing paragraphs by reference as though folly restated
herein.
106. As discussed above, there is no legitimate explanation for HHS's decision not to
consider shelf-life in a procurement for the SNS.
107. The only plausible explanation is that HHS seeks to make its award to NYES for
NYES's cheaper, lower-quality gowns afait accompli.
108. By eliminating shelf-life from the evaluation scheme, HHS can reaffom its award
to NYES without having to consider that NYES's gowns will expire no later t h a n - from
manufacture, in contrast to ADG's gowns, which have a- shelf life.
109. The administrative record reveals that NYES has repeatedly complained to HHS
that delays in this and other Isolation Gown procurements have placed enonnous financial stress
on NYES. NYES communicated to HHS that it had
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to create the new manufacturing facility that it
identified in its proposal. AR 2232. NYES complained that
Id.
110. The record also reveals that NYES has submitted a "Request for Equitable
Adjustment" under the contract that was awarded to NYES in September 2023 and that this request
is under consideration by HHS. AR 2257. The record indicates that this request is related to
NYES 's repeated statements in the March-April 2024 timeframe that delays to this procurement
have put a severe financial strain on NYES. E.g. , AR 2256
111. Given that perfonnance was stayed on NYES 's contract immediately after award,
NYES has no basis to seek any "Request for Equitable Adjustment" under that contract.
112. Any moneys that NYES might seek from HHS can only be a lifeline to reimburse
NYES for pre-award costs and/or subsidize NYES 's overhead costs pending a new award decision.
113. That HHS is actively negotiating such a lifeline with NYES at the ve1y same time
it is tailoring its requirements to ensure that NYES receives the contract is blatant disparate
treatment.
114. Like NYES, ADG has also invested in production and pre-
production activities to be prepared to accommodate the volumes of Level 2 Isolation Gowns
contemplated by the Solicitation.
115. Unlike NYES, however, ADG does not cmTently hold a contract with HHS that
HHS has acknowledged was improperly awarded, but that HHS is willing to use to reimburse
ADG's costs.
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116. FAR 3.101 commands: "Government business shall be conducted in a manner
above reproach and, except as authorized by statute or regulation, with complete impa1i iality and
with preferential treatment for none."
117. HHS' s actions violate FAR 3.101 because they provide preferential treatment for
NYES, tailor the procurement to bolster the 2023 contract award to NYES, and provide NYES
with the lifeline it has requested pending reaffmnation of its award decision.
COUNTV
HHS Is Conducting a Lowest-Price, Technically Acceptable Source Selection, Contrary to
the Terms of the Solicitation (Supplemental Protest Ground).
11 8. ADG inco1porates the foregoing paragraphs by reference as though folly restated
herein.
119. The solicitation invites offerers to submit proposals that exceed the requirements
of the solicitation, stating that HHS will perfo1m a trade-off between price and non-price factors:
This is a best value acquisition conducted in accordance with Federal Acquisition
Regulation (FAR) 12.602; the Government intends to select the best overall offer,
based upon an integrated assessment of Technical and Business Proposals. The
Contract will be awarded to the offerer who is deemed responsible in accordance
with the FAR, whose proposal confonns to the solicitation's requirements (to
include all stated tenns, conditions, representations, ceitifications, and all other
info1mation required by Section L of this solicitation); and is judged by an overall
assessment of the evaluation factors and sub factors to be most advantageous to he
Government. As pali of making the assessment, an analysis to dete1mine whether
or not exceeding the minimum requirements at an associated price preinium
provides the best value to the Government will be perfo1med if necessa1y .
AR 318; Ex. 1 at 54.
120. Both Amendment 0005 and Amendment 0009 provide that HHS will review the
technical capability of proposals and assign a rating of "outstanding," "acceptable," or
"unacceptable." AR 314; Ex. 1 at 50.
121. The administrative record, however, indicates that HHS never considered whether
any proposal was more than "acceptable," and the only ratings assigned by HHS during the initial
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evaluation and the coITective action evaluation were "acceptable" and "unacceptable." Although
Amendment 0009 retains the same language as Amendment 0005 regarding a best-value tradeoff,
the administrntive record makes clear that the Government intends to make an award on a lowest-
price, technically acceptable basis.
122. The use of a lowest-price, technically acceptable source selection process for the
acquisition of personal protective equipment such as the gowns violates Section 880 of the John
S. McCain National Defense Authorization Act for Fiscal Year 2019, Pub. L. 115-232, 41 U.S.C.
3701 Note, and FAR 15.101-2(d).
123. FAR 15.101-2 notes that LPTA procurements shall only be used when "[t]he
agency would realize no, or minimal, value from a proposal that exceeds the minimum technical
or perfo1m ance requirements" and " [t]he contracting officer documents the contract file describing
the circumstances that justify the use of the lowest price technically acceptable source selection
process." FAR 15.101-2(c). Here the purpose of the procurement is to provide Level 2 Isolation
Gowns to suppo1i the Strategic National Stockpile, whose mission it is to "provide the right
materiel at the right time to secure the nation's health." Ex. 1 at 10. Nowhere has the Contracting
Officer made the argument, nor could they reasonably do so, that proposals that exceed the
requirements of the solicitation do not provide a better value to the government. Thus, HHS must
peifonn a trade-off between price and non-price factors.
124. The Solicitation also does not advise offerors of the basis for award, as required by
41 U.S.C. § 3306(b)(l) and FAR 15.304(d).
COUNT VI
Amendment 0009 Arbitrarily Precludes Level 2 Isolation Gowns Manufactured More Than
Three Months Before Delivery.
125. ADG incorporates the foregoing paragraphs by reference as though fully restated
herein.
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126. fu issuing Amendment 0009 HHS arbitrarily resti·icts offerors from supplying the
Government with Level 2 Isolation Gowns with a manufacture date more than three months prior
to the delive1y date:
Offerors shall provide a signed statement from the gown manufacturer ce1iifying
the offered Isolation Gown(s) has a shelf life of 3 years and the Isolation Gowns, at
the time of delive1y to the SNS, shall have no more than 3 months expended since
the date of manufacture listed on the gown packaging label.
Ex.I at 46.
127. HHS took this step at the same time it announced it would give no additional
consideration to gowns with a shelf life of greater than three years.
128. Amendment 0009 arbitrarily prioritizes Level 2 Isolation Gowns with a sho1i shelf
life, but a recent manufacture date, over gowns that may have been manufactured over three
months ago, but that have a far longer shelf life. For example, under Amendment 0009, HHS
would accept delive1y of a Level 2 Isolation Gown with a three-year shelf life that was
manufactured three months prior to delive1y and therefore had only thi1iy-three months of
remaining shelf-life. By conti·ast, HHS would reject delive1y of a gown with a ten-year shelf life
that was manufactured two years ago, even though that gown has eight years of remaining shelf-
life.
129. Amendment 0007 only required that Level 2 Isolation Gowns "have no more than
20% of total shelf-life expended upon delive1y to the SNS." AR 329. Under Amendment 0007, a
Level 2 Isolation Gown with a 10-year shelf life would be accepted up to 2 years post
manufacturing date.
130. HHS's decision to amend the Solicitation to allow the delive1y of gowns with a
sho1ier useful life, while precluding the delive1y of gowns that could be used for a much greater
period of time is arbiti·a1y and capricious. The purpose of the Solicitation is to provide Level 2
Isolation Gowns to the SNS. HHS has no justification to prioritize those gowns that could not be
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Case 1:24-cv-00365-PSH Document 59 Filed 06/17/24 Page 28 of 30
used by the nation's healthcare system in three years while rejecting those gowns that would be
available for use for a decade or longer.
131. Fmt her, HHS's decision unreasonably haim s those offerors who began to scale up
manufactming in response to this procmement. Offerors who began producing Level 2 Isolation
Gowns so that they could be in the best position possible to meet the Government's needs in the
event of contract award ai·e unfairly hanned by this new requirement as this procmement has now
dragged on far longer than the three-month manufactming deadline the Government now imposes.
COUNT VII
Amendment 0009 Arbitrarily Excludes the Most Relevant Past Performance.
132. ADG inco1porates the foregoing paragraphs by reference as though folly restated
herein.
133. Amendment 0005, released on October 31 , 2022, directed offerors to "provide a
description of two projects perfonned within the past three yeai·s that cleai·ly demonstrates the
Offeror's satisfacto1y past perfo1mance in perfo1ming projects of similar scope, size and
complexity and domestic somcing to the requirement described in the RFP." AR 311. This
lookback period gave offerors the ability to describe projects perfo1m ed dming the dmation of the
pandemic.
134. Amendment 0009 leaves the similai· experience requirement unchanged. However,
due to HHS' s string of missteps and mismanagement that have led to multiple protests and several
rounds of conective action, this procmement has been delayed two years. Unlike Amendment
0005, which allowed offerors to list similar experience dating back to October 2019, Amendment
0009 restricts similar experiences to those perfo1m ed after May 2021.
135. By prohibiting offerors from listing similar experiences perfo1m ed more than three
years before the due date of proposals, Amendment 0009 precludes consideration of similai·
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Case 1:24-cv-00365-PSH Document 59 Filed 06/17/24 Page 29 of 30
experiences that are directly relevant to the offerors ' ability to perfonn, and which HHS had
previously found relevant to its consideration of proposals.
136. HHS' s decision to limit past experience is arbitraiy and unreasonable as the similar
experience lookback period no longer covers the full pandemic period when many offerors were
supplying Isolation Gowns to the Government. In mandating that offerors list only those projects
peifonned within the last three yeai·s, HHS unduly restricts from competition those offerors who
may have directly relevant experience obtained dming the pandemic, but that due to HHS's long
delays, have not recently supplied Isolation Gowns.
PRAYER FOR RELIEF
WHEREFORE, ADG respectfully requests this Court:
137. Declai·e that HHS acted arbitrai·ily and capriciously or othe1wise contra1y to law;
138. Pe1m anently enjoin HHS from proceeding with the award of contracts under the
RFP without revising the Solicitation to comply with applicable law; and
139. Grant all other relief that the Comi finds to be just and proper.
Dated: June 11, 2024 Respectfully submitted,
Isl Daniel P. Grahain
Daniel P. Graham
Llewelyn M. Engel
MCDERMOTT WILL & EMERY LLP
500 No1ih Capitol Street, N .W.
Washington, DC 20001
202-756-8890
Counsel for AirBoss Defense Group, LLC
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Case 1:24-cv-00365-PSH Document 59 Filed 06/17/24 Page 30 of 30
CERTIFICATE OF SERVICE
I hereby certify that on June 11, 2024, I caused a copy of the foregoing document to be
electronically filed with the clerk using the Court’s CM/ECF system. I further certify that I have
served the foregoing document via Electronic Mail on the following:
United States Department of Justice
Commercial Litigation Branch
Civil Division, 8th Floor
1100 L Street NW
Washington, DC 20530
E-mail: nationalcourts.bidprotest@usdoj.gov
Dated: June 11, 2024
s/ Daniel P. Graham
Daniel P. Graham
MCDERMOTT WILL & EMERY LLP
500 North Capitol Street, N.W.
Washington, DC 20001
202-756-8890
Counsel for AirBoss Defense Group, LLC
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