The opinion
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
ANNE JEAN CANNON, deceased, : CIVIL ACTION
and ESTATE OF ANNE JEAN :
CANNON by and through JOHN : NO. 21-1451
CANNON and FRANCIS CANNON :
Plaintiffs :
:
v. :
:
WATERMARK RETIREMENT :
COMMUNITIES, INC. d/b/a BLUE :
BELL PLACE, et al. :
Defendants :
NITZA I. QUIÑONES ALEJANDRO, J. JULY 19, 2021
MEMORANDUM OPINION1
INTRODUCTION
Plaintiffs, representing the Estate of Anne Jean Cannon, filed this civil action against
Defendants, the business entities that own and operate the Blue Bell Place senior living community
where Plaintiff Anne Jean Cannon (“Cannon”) lived during the events underlying this case. In the
amended complaint, Plaintiffs assert various claims, including claims of negligence, negligence
per se, reckless and outrageous conduct, wrongful death and survival action, all stemming from
the alleged abuse and eventual death of Cannon at Blue Bell Place. [ECF 9]. Defendants moved
to dismiss the amended complaint pursuant to Federal Rules of Civil Procedure (“Rule”) 12(b)(1)
and (b)(6), for a lack of subject-matter jurisdiction and a failure to state a claim on which relief
can be granted. Specifically, Defendants contend that they are entitled to immunity from suit under
the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §§ 247d-6d,
1 This Memorandum Opinion corresponds with this Court’s May 28, 2021 Order denying
Defendants’ motion to dismiss, [see ECF 20], in which no opinion was issued. In light of Defendants’
interlocutory appeal to the United States Court of Appeals for the District of Columbia Circuit, this Court
the reasons set forth herein, at this stage of litigation, this Court agrees with Plaintiffs.
BACKGROUND
When ruling on a motion to dismiss, this Court must accept as true all the factual allegations
in Plaintiff’s complaint and construe the complaint in the light most favorable to the Plaintiff.
Fowler v. UMPC Shadyside, 578 F.3d 203, 210-11 (3d Cir. 2009) (citing Ashcroft v. Iqbal, 556
U.S. 662, 677 (2009)). The relevant allegations in Plaintiff’s amended complaint are summarized
as follows:
Blue Bell Place is a senior living community owned and operated by
Defendants. In January 2020, Cannon became a resident of Blue Bell Place.
Plaintiffs allege that shortly after she began her residency, they noticed a series of
instances in which Cannon’s basic hygiene needs were not being met, she received
inappropriate care, and suffered physical abuse from employees at Blue Bell Place.
When the COVID-19 Pandemic began affecting the United States, Blue Bell Place
prohibited visitors in accordance with the restrictions and regulations imposed by
local government.
On or around April 20, 2020, Cannon tested positive for COVID-19,
although she showed no signs of illness and was “completely asymptomatic.” Two
days later, on April 22, 2020, a nurse assistant at Blue Bell Place called Cannon’s
son, who had Cannon’s Medical Power of Attorney, and stated that she wanted to
commence treating Cannon with an experimental treatment involving the drugs
hydroxychloroquine and doxycycline, for five days. Plaintiffs contend that
Cannon’s family was concerned about the experimental drug because it was not
FDA-approved and had a history of causing harmful reactions in patients with heart
issues, which Cannon had. Cannon’s son informed the nurse assistant that he did
not consent to his mother receiving the experimental treatment.
Plaintiffs contend that the experimental use of hydroxychloroquine and
doxycycline, at that time, was not permitted to be administered outside of a hospital
and was only authorized to be used if the patient was symptomatic and ineligible
for a clinical trial. Despite the lack of consent, the staff at Blue Bell Place
administered the experimental treatment to Cannon for five days, beginning on
April 22, 2020, against Cannon’s wishes and the directive of her son. Following
the administration of the treatment, Cannon fell ill and her condition deteriorated.
On May 4, 2020, Cannon passed away, reportedly due to “a cardiac event and
COVID-19.”
Rule 12(b)(6) permits a court to grant a motion to dismiss an action if the complaint “fail[s]
to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). When considering a
Rule 12(b)(6) motion, a court “must accept all of the complaint’s well-pleaded facts as true, but
may disregard any legal conclusions.” Fowler, 578 F.3d at 210-11 (citing Iqbal, 556 U.S. at 677).
The court must determine whether the plaintiff has pled facts sufficient to show a plausible
entitlement to relief. Fowler, 578 F.3d at 211. The complaint must do more than merely allege a
plaintiff’s entitlement to relief—it must “show such an entitlement with its facts.” Id. (citations
omitted). The plaintiff “must allege facts sufficient to ‘nudge [his or her] claims across the line
from conceivable to plausible.’” Phillips v. Cty. of Allegheny, 515 F.3d 224, 234 (3d Cir. 2008)
(quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). Mere “labels and conclusions,
and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at
555. After construing the complaint in the light most favorable to the plaintiff, if the court finds
that the plaintiff could not be entitled to relief, it can dismiss the claim. Fowler, 578 F.3d at 210.
DISCUSSION
The PREP Act provides, inter alia, that “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 [the Secretary of Health and Human Services has issued a declaration permitting
the administration of that covered countermeasure].” 42 U.S.C. § 247d-6d(a)(1). Assuming, for
the purposes of this Opinion only, that Blue Bell Place is a “covered person” under the PREP Act,2
the issue before this Court is whether Blue Bell Place administered a “covered countermeasure”
2 Plaintiffs also dispute whether Blue Bell Place is a covered person/entity under the PREP Act.
However, this dispute is not determinative of the outcome of this motion; thus, this Court will assume, for
only for “claims caused by, arising out of, relating to, or resulting from the administration to or the
use by an individual of a covered countermeasure[.]” Id.
I. Covered Countermeasure
Defendants argue that the experimental administration of hydroxychloroquine and
doxycycline is a covered countermeasure because the Secretary of Health and Human Services
(“Secretary”) issued a declaration on March 10, 2020 (the “March 10th Declaration”) defining
“medical countermeasures against COVID-19,” 85 Fed. Reg. 15198, 15201, as “any antiviral, any
other drug, any biologic, any diagnostic, [or] any other device . . . used to treat, diagnose, cure,
prevent, or mitigate COVID-19[,]” id. at 15202, that are either “‘qualified pandemic or epidemic
products,’ or ‘security countermeasures,’ or drugs, biological products, or devices authorized for
investigational or emergency use, as those terms are defined in the PREP Act, the [Federal Food,
Drug, and Cosmetics] Act, and the Public Health Service Act.” 3 Id (indicating that, in addition to
the requirement that an antiviral, drug, or device is being used to treat, diagnose, cure, prevent, or
mitigate COVID-19, the antiviral, drug, or device also “must be ‘qualified pandemic or epidemic
products,’ or ‘security countermeasures,’ or drugs, biological products, or devices authorized for
investigational or emergency use”).
Defendants contend that the experimental treatment it administered to Cannon was a drug
regimen that was authorized for emergency use under the Federal Food, Drug, and Cosmetic Act
3 The phrasing structure of this definition was changed in the Secretary’s amendment declaration
issued on December 9, 2020 (the “December 9th Declaration”), but all substantive portions relevant in this
matter (that would apply to the treatment in question) remained unchanged. One notable change that
reflects the segments of the March 10th Declaration that this Court emphasized above is that the second
requirement is restated as follows: “To be a Covered Countermeasure under the [December 9th] Declaration,
a product must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of ‘Covered Countermeasure.’” 85 Fed. Reg.
79196. The referenced statute then provides that a drug or product (as opposed to a “qualified pandemic or
epidemic product, security countermeasure, or respiratory protective device”) can only be a covered
countermeasure if it “is authorized for emergency use in accordance with section 564, 564A, or 564B of
a covered countermeasure. See Def. Br., ECF 11, at 27, 143-151. In response, Plaintiffs directed
this Court to the “fine print” of the FDA’s March 28, 2020 letter granting emergency use
authorization for the use of hydroxychloroquine sulfate (“March 28th EUA”). See Am. Compl.,
ECF 9, Ex. B, 22-30 and Def. Br., Ex. M, 143-51.
In relevant part, the March 28th EUA provides: “the scope of this authorization is limited
to chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19, as
described in this section.” Id. at 146 and at 25. The scope section (Section II) describes the limited
scope of the authorization of hydroxychloroquine sulfate as follows:
[The FDA is] authorizing use of the following hydroxychloroquine sulfate product
. . . for response to the COVID-19 pandemic: [(1) a form of hydroxychloroquine
sulfate that is already] approved by FDA for other uses[; (2) t]he
hydroxychloroquine sulfate must be administered by a healthcare provider pursuant
to a valid prescription[; and (3) t]he hydroxychloroquine sulfate may only be used
to treat adult and adolescent patients who weigh 50 kg or more, hospitalized
with COVID-19 for whom a clinical trial is not available, or participation is
not feasible.
Id. at 26 and at 147 (emphasis added).
In the amended complaint, Plaintiffs alleged that Defendants used hydroxychloroquine
sulfate to treat Cannon (1) while she was at Blue Bell Place (a senior living community) and not
in a hospital, as Ms. Cannon was never hospitalized for her asymptomatic COVID-19, (2) before
it had been determined that Ms. Cannon was not eligible for a clinical trial or that her participation
in a clinical trial was not feasible, and (3) without the consent of either Cannon or the person with
her Medical Power of Attorney.
Accepting Plaintiffs’ allegations as true, as this Court must at this motion to dismiss stage
of the proceedings, Defendants’ administration of hydroxychloroquine sulfate does not fall within
the clear, explicit, and limited scope of the drug’s FDA emergency use authorization. Therefore,
based on these allegations, the administration of the treatment as Defendants used it cannot be
emergency use, as those terms are defined in the [FDCA,]” as required by the PREP Act. 85 Fed.
Reg. 15202. Accordingly, Defendants’ motion to dismiss is denied.
Nevertheless, Defendants also argue that PREP Act immunity also applies to the “misuse”
of a covered countermeasure and, thus, even if Defendants misused the hydroxychloroquine
sulfate, they should be afforded immunity. This argument is, however, misguided. The section of
the December 9th Declaration to which Defendants cite for this contention is 85 Fed. Reg. 79197,
which amended Section IX on “Administration of Covered Countermeasures”, not Section VI
which defines Covered Countermeasures. Specifically, Section 79197 defines what the
“administration” of covered countermeasures entails. Notably, this amendment does not have any
bearing on the definition of covered countermeasures itself, or the scope thereof. The cited
amendment does establish that a covered person or entity’s deliberate choice “not [to] administer[]
a Covered Countermeasure” does constitute “administration” of a covered countermeasure under
the statute; however, that factual scenario is not present here. Defendants did not choose not to
administer a treatment to Cannon; precisely the opposite, they chose to take an affirmative action
(as opposed to an omission) and administer a treatment to Cannon without her consent. The cited
amendment says nothing about “misuse” of covered countermeasures, it only addresses the non-
use or omission of use as a conscious decision by a covered person or entity. Thus, Section 79197
does not establish what Defendants suggest. This Court finds this argument is without merit.
Defendants also cite to Advisory Opinion 21-01 on the Public Readiness and Emergency
Preparedness Act Scope of Preemption Provision issued by the Office of General Counsel for the
Secretary on January 8, 2021 (“AO 21-01”) to support their contention that immunity applies to
the misuse of a covered countermeasure. AO 21-01, which explicitly clarifies that it “sets forth
the current views of the Office of the General Counsel[,] is not a final agency action or a final
order[, and] does not have the force or effect of law[,]” addressed the narrow question of “whether
arguably ought to have been used.” U.S. Dep’t of Health & Human Services, Office of the
Secretary, General Counsel, Advisory Opinion 21-01 on the Public Readiness and Emergency
Preparedness Act Scope of Preemption Provision (Jan. 8, 2021) at p. 1, 5. As with the declaration
amendment Defendants cited (85 Fed. Reg. 79197), the advisory opinion (AO 21-01) does not
actually speak to the misuse of covered countermeasures, it only addresses “the use or non-use of
covered countermeasures[.]” Id. at p. 1. As such, AO 21-01 also does not support or establish
Defendant’s contention.
Furthermore, even if Defendants could point to some authoritative or persuasive source
establishing that the misuse of covered countermeasures is protected, such a source would be
inapplicable to this case. Defendants did not “misuse” a covered countermeasure because, in order
to misuse a covered countermeasure, the treatment in question must first satisfy the definition of a
covered countermeasure, which, as explained above, Defendants’ administration of treatment to
Cannon does not.
II. PREP Act Safe Harbor Provision
Alternatively, Defendants argue that even if the treatment was not a covered
countermeasure, they are entitled to immunity under the PREP Act’s “‘safe harbor’ provision set
forth in 42 U.S.C. § 247d-6d(a)(4)(B)[.]” Def. Reply., ECF 15, at 5. This argument is also
misguided. Section 247d-6d(a)(4)(B) provides that “the scope of immunity includes
circumstances in which [a covered] countermeasure was administered to or used by an individual
in circumstances in which the covered person reasonably could have believed that the
countermeasure was administered or used in accordance with the conditions described in
paragraph (3)(C).” Paragraph (3)(C) sets forth two conditions; to wit: “the countermeasure was
administered to or used by an individual who—(i) was in a population specified by the declaration;
and (ii) at the time of administration physically present in a geographic area specified by the
6d(a)(3)(C).
Defendants are correct that these two provisions together provide immunity for a covered
entity that “reasonably could have believed” that the countermeasure it was administering was (1)
being administered to and by the proper populations specified in the Secretary’s declaration and
(2) being administered within a proper geographic area specified in the Secretary’s declaration,
even if the countermeasure did not actually satisfy those conditions.4 However, these provisions
do not afford Defendants immunity at this stage of the proceedings where this Court must construe
the facts in Plaintiffs’ favor. Construing the facts alleged accordingly, it would not have been
reasonable for Defendants to believe that their agents’ administration of hydroxychloroquine
sulfate was being administered to a person who is part of a specified population. The very
document that authorized hydroxychloroquine sulfate for emergency use explicitly specified the
required populations to which use of the treatment was limited; to wit: the drug needed to be
“administered by a healthcare provider pursuant to a valid prescription” and administered to “adult
and adolescent patients who weigh 50 kg or more hospitalized with COVID-19 for whom a clinical
trial is not available, or participation is not feasible.” Def. Br., Ex. M, 147 and Am. Compl., Ex.
B, 26. It is not reasonable for Defendants to have believed that Cannon “was in a population
specified by the declaration,” 42 U.S.C. § 247d-6d(a)(3)(C), when the specified population was
unambiguous and Cannon indisputably did not fall within that specified population (i.e., she was
not hospitalized with COVID-19, nor had it been determined that she was not eligible for any
4 This interpretation is consistent with the interpretation of General Counsel for the Secretary, cited
by Defendants: “a person or entity that otherwise meets the requirements for PREP Act immunity will not
lose that immunity—even if the product is not a covered countermeasure—if that person or entity
reasonably could have believed that the product was a covered countermeasure.” U.S. Dep’t of Health &
Human Services, Office of the Secretary, General Counsel, Advisory Opinion on the Public Readiness and
Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act (April 17, 2021, as
6d(a)(4)(B).
CONCLUSION
For the reasons set forth herein, this Court finds that Defendants are not entitled to
immunity from suit under the PREP Act, at this stage in litigation. Accordingly, Defendants’
motion to dismiss is denied.
NITZA I. QUIÑONES ALEJANDRO, U.S.D.C. J.