COPAN ITALIA SPA et al v. PURITAN MEDICAL PRODUCTS COMPANY LLC et al

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UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
COPAN ITALIA S.P.A., et al., 	)
)
)
Plaintiffs, 	)
)
v. 	) 1:18-cv-00218-JDL
)
PURITAN MEDICAL PRODUCTS 	)
COMPANY, LLC, et al., 	)
)
Defendants. 	)
ORDER ON DEFENDANTS’ PARTIAL MOTION TO DISMISS
Defendants Puritan Medical Products Company LLC, Puritan Diagnostics
LLC, Hardwood Products Company LP, and Hardwood Products Company LLC
(collectively, “Puritan”) move to partially dismiss (ECF No. 212) the amended
complaint (ECF No. 84) filed by Plaintiffs Copan Italia S.p.A. and Copan Diagnostics,
Inc. (collectively, “Copan Italia”). 	This case pertains to flocked swabs: small rods
tipped with fibers used for taking and releasing biological samples. 	Copan Italia
alleges patent infringement, false advertising under the Lanham Act, and violations
of Maine’s Uniform Deceptive Trade Practices Act. 	Puritan’s motion seeks the
dismissal of all of the counts with respect to flocked swabs manufactured at Puritan’s
P3 factory, citing the immunity provision of the Public Readiness and Emergency
Preparedness Act 	(the “PREP Act”). 	See 42 U.S.C.A. § 247d-6d (West 2022).
Puritan’s motion also contains a request for leave to amend Puritan’s answer. 	For
reasons I will explain, the Partial Motion to Dismiss is denied, and the embedded
motion for leave to amend the answer is granted.
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I. BACKGROUND
The PREP Act provides protections from liability upon the declaration of a
public health emergency by the Secretary of the Department of Health and Human
Services. 	See id. § 247d-6d(a)(1), (b)(1). 	The key subsection states that those
protections apply to certain claims related to “covered countermeasure[s]”:
Subject to the other provisions of this section, a covered person shall be
immune from suit and liability under Federal and State law with respect
to all claims for loss caused by, arising out of, relating to, or resulting
from the administration to or the use by an individual of a covered
countermeasure if a declaration under subsection (b) has been issued
with respect to such countermeasure.
Id. § 247d-6d(a)(1).
There are four ways for a product to qualify as a covered countermeasure under
the PREP Act. 	Id. § 247d-6d(i)(1). 	Puritan argues that the first of the four ways to
qualify applies here: 	Covered countermeasures include “a qualified pandemic or
epidemic product.” Id. § 247d-6d(i)(1)(A). That phrase is itself defined, and Puritan
invokes the portions of the definition providing that a product is a qualified pandemic
or epidemic product when it is (1) a “device” that is (2) “manufactured, used, designed,
developed, modified, licensed, or procured” to “diagnose, mitigate, prevent, treat, or
cure a pandemic or epidemic” and is (3) “authorized for emergency use in accordance
with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act.” 	Id.
§ 247d-6d(i)(7).
In response to the COVID-19 pandemic, the Secretary issued a PREP Act
declaration on March 17, 2020. 	Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85
Fed. Reg. 15198 (Mar. 17, 2020). 	As alluded to in the block quotation above, PREP
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Act immunity exists only for those covered countermeasures identified by the
Secretary’s declaration, which might be a narrower set of products than would satisfy
the statutory definition of “covered countermeasure.” 	See 42 U.S.C.A. § 247d-
6d(a)(1), (b)(1). 	As subsequently amended, the declaration makes explicit that
immunity applies to all qualified pandemic and epidemic products under the PREP
Act, i.e., the portion of the definition of “covered countermeasure” that Puritan relies
on. 	Fourth 	Amendment 	to 	the 	Declaration 	Under 	the 	Public 	Readiness 	and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and
Republication of the Declaration, 85 Fed. Reg. 79190, 79193, 79196 (Dec. 9, 2020).1
The PREP Act also requires the Secretary to specify whether immunity “is
effective 	only 	to 	a 	particular 	means 	of 	distribution 	. 	. 	. 	for 	obtaining 	the
countermeasure.” 	42 U.S.C.A. § 247d-6d(b)(2)(E). 	Here, the declaration specifies
three means of distribution. Fourth Amendment to the Declaration Under the Public
1 The original declaration has been amended 10 times, but the sections relevant to the resolution of
Puritan’s Partial Motion to Dismiss have not changed since the fourth amendment went into effect.
See Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for
Medical Countermeasures Against COVID-19, 85 Fed. Reg. 21012 (Apr. 15, 2020); Second Amendment
to 	Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 35100 (June 8, 2020); Third Amendment to
Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 52136 (Aug. 24, 2020); Fourth Amendment to the
Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19 and Republication of the Declaration, 85 Fed. Reg. 79190 (Dec.
9, 2020); Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness
Act for Medical Countermeasures Against COVID-19, 86 Fed. Reg. 7872 (Feb. 2, 2021); Sixth
Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 86 Fed. Reg. 9516 (Feb. 16, 2021); Seventh Amendment to
Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19, 86 Fed. Reg. 14462 (Mar. 16, 2021); Eighth Amendment to
Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19, 86 Fed. Reg. 41977 (Aug. 4, 2021); Ninth Amendment to
Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19, 86 Fed. Reg. 51160 (Sept. 14, 2021); Tenth Amendment to
Declaration 	Under 	the 	Public 	Readiness 	and 	Emergency 	Preparedness 	Act 	for 	Medical
Countermeasures Against COVID-19, 87 Fed. Reg. 982 (Jan. 7, 2022).
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Readiness and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19 and Republication of the Declaration, 85 Fed. Reg. at 79194, 79196-97.
Puritan appears to rely on the first: “(a) Covered Countermeasures that are related
to 	present 	or 	future 	federal 	contracts, 	cooperative 	agreements, 	grants, 	other
transactions, interagency agreements, memoranda of understanding, or other federal
agreements.” Id. at 79196.
In its motion to dismiss, Puritan alleges that on July 29, 2020, Puritan entered
into a contract with the U.S. Air Force to increase production of flocked swabs for
COVID-19 testing. 	The contract does not obligate Puritan to provide flocked swabs
to the Air Force, only to expand Puritan’s manufacturing capacity. 	It specifies that
Puritan will procure or produce 15 Ultra Flock Tipping machines and six packaging
machines with funds provided by the Air Force (plus another five Puritan-funded
Ultra Flock Tipping machines) and implement facility upgrades to accommodate
them. 	The contract mentions that Puritan intended to procure a new facility via
capital investment.
Puritan further alleges that the contract was supplemented on October 2, 2020.
The supplemental agreement discusses PREP Act immunity:
In accordance with the [PREP Act] as well as the Secretary of HHS’s
Declaration[,] . . . this Agreement is being entered into for purposes of
production capability expansion for “Covered Countermeasures” for
responding to the COVID-19 public health emergency . . . . 	Therefore,
. . . the Air Force expressly acknowledges and agrees that [Puritan] shall
be immune from suit and liability to the extent and as long as [Puritan’s]
activities fall within the terms and conditions of the PREP Act and the
PREP Act Declaration.
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ECF No. 214 at 6-7 (citation omitted). According to Puritan, it built the P3 factory to
meet its contractual obligations and, therefore, immunity exists with respect to any
flocked swabs produced there.
II. ANALYSIS
A. 	Leave to Amend
PREP Act immunity is an affirmative defense because it is a statutory
limitation on liability. 	“While a statutory limitation on liability is not enumerated
among the listed [affirmative] defenses [of Federal Rule of Civil Procedure 8(c)(1)],
we think it falls within the Rule’s residuary clause” because the “defense shares the
common characteristic of a bar to the right of recovery even if the general complaint
were more or less admitted to.” Jakobsen v. Mass. Port Auth., 520 F.2d 810, 813 (1st
Cir. 1975); accord Knapp Shoes, Inc. v. Sylvania Shoe Mfg. Corp., 15 F.3d 1222, 1226
(1st Cir. 1994); Carrasquillo-Serrano v. Mun. of Canovanas, 991 F.3d 32, 43 (1st Cir.
2021); see also Tonkinson v. Walmart, Inc., Case No. 21-2588, 2022 WL 425868, at *2
(D. Kan. Feb. 11, 2022) (“As many courts have held, the immunity from suit afforded
under the PREP Act is considered an affirmative defense . . . .”); Mackey v. Tower Hill
Rehab., LLC, No. 21 C 2608, 2021 WL 5050292, at *7 (N.D. Ill. Nov. 1, 2021);
Colpits v. NHC Healthcare Clinton, LLC, Case No. 6:20-cv-04065, 2021 WL 5332436,
at *1 n.1 (D.S.C. July 1, 2021); Thomas v. Century Villa Inc., Case No. 2:21-cv-03013,
2021 WL 2400970, at *6 (C.D. Cal. June 10, 2021).
Puritan did not plead PREP Act immunity in its answer (ECF No. 96), as is
required for affirmative defenses under Federal Rule of Civil Procedure 8(c)(1) (“In
responding 	to 	a 	pleading, 	a 	party 	must 	affirmatively 	state 	any 	avoidance 	or
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affirmative defense . . . .”). However, Puritan’s motion to dismiss includes a request
for leave to amend its answer to assert PREP Act immunity, as well as a proposed
amended answer.
Puritan filed its answer before the COVID-19 pandemic and thus had no
reason to plead PREP Act immunity then. Puritan’s request for leave to amend was
made 	diligently 	and 	within 	the 	deadline 	imposed 	by 	the 	Scheduling 	Order.
Accordingly, leave to amend is granted and PREP Act immunity is presented as an
affirmative defense to the complaint.
B. 	PREP Act Immunity
“As a general rule, a properly raised affirmative defense can be adjudicated on
a motion to dismiss so long as (i) the facts establishing the defense are definitively
ascertainable from the complaint and the other allowable sources of information, and
(ii) those facts suffice to establish the affirmative defense with certitude.” 	Rodi v.
S. New Eng. Sch. of L., 389 F.3d 5, 12 (1st Cir. 2004); see also Garcia v. Welltower
OpCo Grp. LLC, 522 F. Supp. 3d 734, 745 (C.D. Cal. 2021) (“As an affirmative defense,
immunity via the PREP Act can provide a basis for dismissal at the pleadings stage
under Rule 12(b)(6) provided the elements of the defense appear on the face of the
complaint.”), abrogated on other grounds by Saldana v. Glenhaven Healthcare LLC,
27 F.4th 679 (9th Cir. 2022). 	“[R]eview of the complaint, together with any other
documents appropriately considered under Fed. R. Civ. P. 12(b)(6), must ‘leave no
doubt’ that the plaintiff’s action is barred by the asserted defense.” Blackstone Realty
LLC v. FDIC, 244 F.3d 193, 197 (1st Cir. 2001) (quoting LaChapelle v. Berkshire Life
Ins., 142 F.3d 507, 509 (1st Cir. 1998)).
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Copan Italia urges the Court to deny the motion to dismiss because the motion
is premised on facts that do not appear in the operative complaint, which was filed in
March 2019 before the pandemic began. 	Copan Italia contends that it has not yet
had an opportunity to conduct discovery into Puritan’s allegations about PREP Act
immunity because this case was stayed for most of the pandemic and discovery
resumed only last October.
Puritan seeks to supplement the motion-to-dismiss record by requesting
judicial notice of its agreements with the Air Force. 	See Fed. R. Evid. 201(b) (“The
court may judicially notice a fact that is not subject to reasonable dispute because it
. . . can be accurately and readily determined from sources whose accuracy cannot
reasonably be questioned.”). 	Puritan also impliedly seeks judicial notice of a letter
appearing on the Food and Drug Administration’s website that Puritan describes as
an emergency use authorization for a COVID-19 diagnostic kit with a nasal swab.
Copan Italia opposes the request for judicial notice, seemingly because it believes that
these documents are not the types of documents of which a court may take judicial
notice. 	As I will explain, I need not resolve the parties’ dispute regarding judicial
notice because, even if it were assumed that judicial notice of both agreements and
the letter is appropriate, the motion-to-dismiss record would not establish Puritan’s
affirmative defense with the certitude required to partially dismiss the complaint.
As previously noted, Puritan argues that the flocked swabs manufactured at
the P3 factory have been authorized for emergency use in accordance with section
564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act. 	Under Puritan’s
theory for why PREP Act immunity exists here, that emergency authorization is one
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of the three requirements that must be satisfied for flocked swabs from the P3 factory
to be a qualified pandemic or epidemic product and thus a covered countermeasure.
Puritan offers the aforementioned letter from the Food and Drug Administration as
evidence that the flocked swabs from P3 are authorized for emergency use. However,
the document does not mention Puritan, the P3 factory, or even flocked swabs.
Instead, it appears to authorize emergency use of the OraRisk COVID-19 RT-PCR, a
test to detect whether COVID-19 is present on a swab, at a laboratory in Minnesota.2
Additionally, because the letter is unsigned, I cannot discern from its four corners
whether it was intended to be final and binding. Further, Puritan has not presented
any argument as to why the Food and Drug Administration’s emergency approval of
a test capable of detecting COVID-19 on a swab also constitutes emergency approval
of the swabs used in conjunction with the test.
Puritan’s other evidence that the flocked swabs from the P3 factory are covered
countermeasures is the Air Force’s statement to that effect in the supplemental
agreement. Again, that agreement states:
2 In relevant part, the letter states:
I am authorizing the emergency use of your product . . . . Your product is a qualitative
test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab and
nasal swab specimens collected in universal transport media, nasal swabs collected in
saline oral rinse, and saline oral rinse specimens from individuals suspected of COVID-
19 by their healthcare provider. This test is also for use with nasal swab specimens
that are collected using the binx health At-home Nasal Swab COVID-19 Sample
Collection Kit when used consistent with its authorization. Testing is limited to Access
Genetics, LLC laboratory, located at 7400 Flying Cloud Drive, Eden Prairie, MN
55344, which is certified under CLIA 42 U.S.C. §263a, and meets the requirements to
perform high complexity tests.
Letter from Rear Admiral Denise Hinton, Chief Scientist, Food and Drug Administration, to
Ronald C. McGlennen, President and Medical Director, Access Genetics, LLC, d.b.a. OralDNA
Labs 2-3 (July 28, 2021), https://www.fda.gov/media/140290/download.
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In accordance with the [PREP Act] as well as the Secretary of HHS’s
Declaration[,] . . . this Agreement is being entered into for purposes of
production capability expansion for “Covered Countermeasures” for
responding to the COVID-19 public health emergency . . . . 	Therefore,
. . . the Air Force expressly acknowledges and agrees that [Puritan] shall
be immune from suit and liability to the extent and as long as [Puritan’s]
activities fall within the terms and conditions of the PREP Act and the
PREP Act Declaration.
ECF No. 214 at 6-7 (citation omitted). 	This statement is offered without any
explanation 	as 	to 	why 	the 	swabs 	meet 	the 	statutory 	definition 	of 	“covered
countermeasure,” and Puritan has not developed any argument as to why the Air
Force’s stated opinion merits deference. Moreover, the Air Force does not administer
the 	PREP 	Act. 	Thus, 	its 	unexplained conclusion 	stated in the 	supplemental
agreement is not entitled to judicial deference. See United States v. Mead Corp., 533
U.S. 218, 228 (2001) (“The fair measure of deference to an agency administering its
own statute has been understood to vary with circumstances, and courts have looked
to the degree of the agency’s care, its consistency, formality, and relative expertness,
and to the persuasiveness of the agency’s position.” (footnotes omitted) (citing
Skidmore v. Swift & Co., 323 U.S. 134, 139-40 (1944))). 	Because the Air Force’s
statement leaves some doubt as to whether the flocked swabs from P3 are covered
countermeasures, I cannot credit Puritan’s affirmative defense at the motion-to-
dismiss stage.
Additionally, recall that (1) the PREP Act requires the Secretary to specify
whether immunity is effective only as to particular means of distribution for
obtaining covered countermeasures; (2) Puritan relies on the first of the means
specified in the Secretary’s declaration: covered countermeasures related to federal
contracts or other federal agreements; and (3) Puritan seeks the dismissal of all
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counts with respect to flocked swabs manufactured at Puritan’s P3 factory. 	But
Puritan’s proposed evidence does not establish that Puritan carried through with its
contractual obligations, that it did so at its P3 factory, or that all of the flocked swabs
from its P3 factory (as opposed to some subset) are produced in relation to its
government contract. 	The agreements and the letter do not mention the P3 factory
or what transpired after the agreements were entered into. 	The original Air Force
contract merely states that Puritan intended to procure an unspecified new facility
via capital investment. 	Accordingly, without a more fulsome record of the relevant
facts, I cannot conclude with certainty that all of the flocked swabs manufactured at
the P3 factory are related to a federal agreement.
In light of the evidentiary gaps I have noted, the dismissal of the amended
complaint is not supported because the limited record before me does not show that
the PREP Act affirmative defense has been proven. For that reason, I do not decide
the subsidiary question of whether judicial notice of the relevant documents is proper,
nor do I evaluate Copan Italia’s other arguments challenging Puritan’s assertion of
PREP Act immunity.
III. CONCLUSION
Puritan’s Motion for Leave to Amend (ECF No. 212) is GRANTED, and
Puritan’s Partial Motion to Dismiss (ECF No. 212) is DENIED.
SO ORDERED.
Dated: June 1, 2022
/s/ JON D. LEVY
CHIEF U.S. DISTRICT JUDGE
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