`
`21-2158-cv(L), 21-2159-cv(CON)
`
`United States Court of Appeals
`
`for the
`Second Circuit
`
`
`
`
`
`JEFFRY LEROY, as Co-Guardian of SILVIA LEROY,
`Incapacitated Person and Individually, SILVIA LEROY,
`
`– v. –
`
`Plaintiffs-Appellees,
`
`HEATHER HUME, M.D., MIRA JOHN, M.D., MOUNT SINAI HOSPITAL, MARY
`TOUSSAINT-MILORD, M.D., KANIZ B. BANU, M.D., MAHREEN AKRAM, M.D.,
`JAMIE CELESTIN-EDWARDS, BROOKDALE HOSPITAL MEDICAL CENTER,
`JILL BERKIN, M.D., KEVIN TROY, M.D.,
`
`MINDY BRITTNER, M.D.,
`
`Defendants-Appellants,
`
`Defendant.
`
`––––––––––––––––––––––––––––––
`ON APPEAL FROM THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF NEW YORK
`
`REPLY BRIEF FOR DEFENDANTS-APPELLANTS HEATHER HUME, M.D.,
`MIRA JOHN, M.D., THE MOUNT SINAI HOSPITAL, S/H/A MOUNT SINAI
`HOSPITAL, JILL BERKIN, M.D. AND KEVIN TROY, M.D.
`
`
`
`
`
`
`
`
`John E. Hall, Jr.
`HALL BOOTH SMITH, P.C.
`191 Peachtree Street, NE,
`Suite 2900
`Atlanta, GA 30303
`404-954-5000
`
`Jeffrey T. Wolber
`HALL BOOTH SMITH, P.C.
`366 Madison Avenue
`5th Floor
`New York, NY 10017
`212-805-3639
`
`Larry David Bloomstein
`AARONSON,
`RAPPAPORT, FEINSTEIN
`& DEUTSCH, LLP
`600 Third Avenue
`New York, NY 10016
`212-593-6700
`
`Attorneys for Defendants-Appellants Heather Hume, M.D., Mira John, M.D., The Mount
`Sinai Hospital, s/h/a Mount Sinai Hospital, Jill Berkin, M.D. and Kevin Troy, M.D.
`
`
`
`
`
`
`
`
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page2 of 39
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`
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`
`
`TABLE OF CONTENTS
`
`PAGE
`
`TABLE OF AUTHORITIES ................................................................................... iv
`
`INTRODUCTION ..................................................................................................... 1
`
`REPLY TO PLAINTIFFS’ COUNTERSTATEMENT OF THE CASE .................. 3
`
`I. STATUTORY BACKGROUND .................................................................... 3
`
`II. UNDERLYING FACTS .................................................................................. 4
`
`REPLY ARGUMENT ............................................................................................... 5
`
`I. THE PREP ACT IS A COMPLETE PREEMPTION STATUTE .................. 5
`
`A. Complete preemption can occur when the exclusive federal cause of action
`is stricter than its state law counterpart, as long as it is intended to
`vindicate the same basic rights or interests .................................................. 5
`
`B. It is not necessary for a completely preemptive statute to establish a broad
`federal cause of action ................................................................................ 10
`
`C. Complete preemption is only necessary when the plaintiff has not pleaded
`the exclusive federal cause of action to begin with .................................... 13
`
`D. Whether Plaintiffs are able to recover is irrelevant .................................... 14
`
`E. Plaintiffs’ reliance on Sullivan is misplaced .............................................. 14
`
`F. Plaintiffs’ reliance on Davila is misplaced ................................................ 15
`
`G. Plaintiffs’ reliance on Caterpillar is misplaced ......................................... 17
`
`H. The Maglioli, Saldana, and Mitchell decisions should not be followed .... 18
`
`II. PLAINTIFFS’ CLAIM FALLS WITHIN THE PREEMPTIVE SCOPE OF
`THE PREP ACT ............................................................................................ 19
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`- ii -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page3 of 39
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`
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`A. Plaintiffs’ claim relates to the use and administration of covered
`countermeasures by covered persons ......................................................... 19
`
`B. The PREP Act does not require direct causation ....................................... 23
`
`C. Plaintiffs’ distinction between claims of “action” and “inaction” is
`erroneous .................................................................................................... 24
`
`D. Deference is warranted to HHS’s application of the PREP Act ................ 26
`
`E. Plaintiffs’ floodgate argument is unwarranted ........................................... 27
`
`III. REMOVAL IS PROPER UNDER THE SUBSTANTIAL FEDERAL
`QUESTION DOCTRINE .............................................................................. 28
`
`IV. JURISDICTIONAL DISCOVERY WOULD BE APPROPRIATE IN LIEU
`OF OUTRIGHT REMAND .......................................................................... 29
`
`CONCLUSION ........................................................................................................ 30
`
`CERTIFICATION OF COMPLIANCE .................................................................. 31
`
`CERTIFICATE OF SERVICE ................................................................................ 32
`
`
`
`
`- iii -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page4 of 39
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`
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`
`
`TABLE OF AUTHORITIES
`
`Cases:
`
`Aetna Health Inc. v. Davila
`542 U.S. 200 (2004)........................................... 9-10, 11-12, 15-16, 17, 18-19
`
`
`Auer v. Robbins
`519 U.S. 452 (1997)....................................................................................... 27
`
`
`Avco v. Aero Lodge No. 735, Int'l Ass'n of Machinists & Aerospace Workers
`390 U.S. 557 (1968)..................................................................................... 8-9
`
`
`Beneficial Nat. Bank v. Anderson
`539 U.S. 1 (2003) ........................................................................................... 12
`
`
`Briarpatch v. Phoenix Pictures
`373 F.3d 296 (2d Cir. 2004) ........................................................................ 7-8
`
`
`Brown v. Big Blue Healthcare
`480 F.Supp.3d 1196 (D.Kan. 2020) ........................................................ 25-26
`
`
`Casabianca v. Mount Sinai Medical Center
`No. 112790/10, 2014 WL 10413521 (N.Y. Sup. Ct. Dec. 02, 2014) ............ 25
`
`
`Caterpillar v. Williams
`482 U.S. 386 (1987)..................................................................... 12, 13, 14, 17
`
`
`City of Oakland v. BP
`969 F.3d 895 (9th Cir. 2020) ......................................................................... 18
`
`
`Crawford-El v. Britton
`523 U.S. 574 (1998)....................................................................................... 29
`
`
`DeNardo v. Municipality of Anchorage
`255 F. App’x 195 (9th Cir. 2007) .................................................................. 21
`
`
`Devon Energy Prod. v. Mosaic Potash Carlsbad
`693 F.3d 1195 (10th Cir. 2012) ....................................................................... 7
`
`- iv -
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`
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page5 of 39
`
`
`
`
`Dupervil v. All. Health Operations
`516 F. Supp. 3d 238 (E.D.N.Y. 2021) ................................................. 5, 10, 24
`
`
`Fayard v. Ne. Vehicle Servs.
`533 F.3d 42 (1st Cir. 2008) .......................................................................... 6-7
`
`
`Grable & Sons Metal Products v. Darue Eng’g. & Mf’g.
`545 U.S. 308 (2005)....................................................................................... 28
`
`
`Gutierrez v. Flores
`543 F.3d 248 (5th Cir. 2008) ........................................................................ 18
`
`
`In re Burlington N. Santa Fe Ry. Co.
`606 F.3d 379 (7th Cir. 2010) ......................................................................... 21
`
`
`In re WTC Disaster Site
`414 F.3d 352 (2d Cir. 2005) ...................................................................... 9, 11
`
`
`Lutz v. Big Blue Healthcare
`480 F.Supp.3d 1207 (D. Kan. 2020) ...................................................... 24, 26
`
`
`Maglioli v. All. HC Holdings
`16 F.4th 393 (3d Cir. 2021) ............................... 1, 5, 10, 11, 18-19, 26, 28, 29
`
`
`Mayer v. Josiah Wedgwood & Sons
`601 F. Supp. 1523 (S.D.N.Y. 1985) ................................................................ 8
`
`
`Metro. Life Ins. v. Taylor
`481 U.S. 58 (1987) ......................................................................................... 13
`
`
`Mitchell v. Advanced HCS
`28 F.4th 580 (5th Cir. 2022) ................................................ 1, 5, 10, 11, 18-19
`
`
`Principal Gov’t of Marinduque v. Placer Dome
`582 F.3d 1083 (9th Cir. 2009) ....................................................................... 28
`
`
`Saldana v. Glenhaven Healthcare
`27 F.4th 679 (9th Cir. 2022) ................................................ 1, 5, 11, 18-19, 24
`
`
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`- v -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page6 of 39
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`
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`Sullivan v. Am. Airlines
`424 F.3d 267 (2d Cir. 2005) .................................................................... 14-15
`
`
`
`Statutes:
`
`28 U.S.C. § 1331 ........................................................................................................ 1
`
`28 U.S.C. § 1441(a) ................................................................................................... 1
`
`29 U.S.C. § 1132(a) ........................................................................................... 11-12
`
`29 U.S.C. § 185(a) ................................................................................................... 11
`
`42 U.S.C. § 247d-6d(a)(1) .............................................................. 3-4, 21, 22-24, 27
`
`42 U.S.C. § 247d-6d(a)(2)(B) .................................................................. 3, 23-24, 27
`
`42 U.S.C. § 247d-6d(c)(1) ....................................................................................... 16
`
`42 U.S.C. § 247d-6d(c)(1)(A) ........................................................................ 8, 16, 25
`
`42 U.S.C. § 247d-6d(d)(1) ................................................................................... 6, 16
`
`42 U.S.C. § 247d-6d(e)(2) ......................................................................................... 9
`
`42 U.S.C. § 247d-6d(e)(3)(A) .................................................................................. 16
`
`42 U.S.C. § 247d-6d(i)(1) .......................................................................................... 3
`
`42 U.S.C. § 247d-6d(i)(1)(D) .................................................................................. 26
`
`42 U.S.C. § 247d-6d(i)(7) .......................................................................................... 3
`
`42 U.S.C. § 247d-6e ........................................................................................... 1, 3-4
`
`42 U.S.C. § 247d-6e(a) .................................................................................. 3, 23-24
`
`Air Transportation Safety and System Stabilization Act
`49 U.S.C.A. § 40101 note (Westlaw 2021) ............................................. 10-12
`
`
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`- vi -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page7 of 39
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`
`
`Coronavirus Aid, Relief, and Economic Security Act
`Pub. L. 116–136, div. A, title III, § 3103
`134 Stat. 361 (Mar. 27, 2020) .................................................................. 26-27
`
`
`Employee Retirement Income Security Act of 1974 ................................ 9-12, 15-16
`
`Labor Management Relations Act of 1947 .................................................... 8-12, 17
`
`National Bank Act, 12 U.S.C. §§ 85, 86 ............................................................ 10-12
`
`Public Readiness and Emergency Preparedness Act
`42 U.S.C. §§ 247d-6d, 247d-6e ..............................................................passim
`
`
`
`Other Authorities:
`
`76 Fed. Reg. 62306 (Oct. 7, 2011) ............................................................................. 3
`
`Declaration Under the Public Readiness and Emergency Preparedness Act for
`Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17,
`2020), amended by 85 Fed. Reg. 21012 (Apr. 15, 2020), 85 Fed. Reg. 35100
`(June 8, 2020), 85 Fed. Reg. 52136 (Aug. 24, 2020), 85 Fed. Reg. 79190 (Dec.
`9, 2020), 86 Fed. Reg. 7872 (Feb. 2, 2021), 86 Fed. Reg. 9516 (Feb. 16, 2021)
`as corrected by 86 Fed. Reg. 10588 (Feb. 22, 2021), 86 Fed. Reg. 14462 (Mar.
`16, 2021), 86 Fed. Reg. 41977 (Aug. 4, 2021), 86 Fed. Reg. 51160 (Sep. 14,
`2021) as corrected by 86 Fed. Reg. 54696 (Oct. 4, 2021), and 87 Fed. Reg. 982
`(Jan. 7, 2022) ............................................................................................ 2, 21, 23, 26
`
`
`
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`- vii -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page8 of 39
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`
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`INTRODUCTION
`
`Plaintiffs assert a “claim for loss” for which only one cause of action
`
`exists—a federal cause of action for “willful misconduct” under the Public
`
`Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §§ 247d-6d,
`
`247d-6e. Therefore, the claim “aris[es] under” federal law within the meaning of
`
`28 U.S.C. § 1331 and removal was proper under § 1441(a). The District Court’s
`
`remand order (SA1)1 should be reversed, and recent holdings from other circuits2
`
`should not be followed.
`
`The PREP Act is a completely preemptive statute. It creates a federal cause
`
`of action intended to be the “exclusive” one available for any “claim for loss” that
`
`is related to the use or administration of covered countermeasures. Complete
`
`preemption does not turn on whether the federal cause of action identical to its
`
`state law counterpart, whether a plaintiff properly pleads the federal cause of
`
`action, or whether a plaintiff could obtain recovery under the federal cause of
`
`action. What matters is whether the only cause of action available to vindicate the
`
`interests at stake is a federal one.
`
`
`1 Unless otherwise indicated, abbreviations have the same meaning as in the
`opening Brief.
`2 Maglioli v. All. HC Holdings, 16 F.4th 393 (3d Cir. 2021); Saldana v.
`Glenhaven Healthcare, 27 F.4th 679 (9th Cir. 2022); Mitchell v. Advanced HCS,
`28 F.4th 580 (5th Cir. 2022).
`
`- 1 -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page9 of 39
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`Plaintiffs’ claim against Mount Sinai Defendants3 falls under the PREP Act.
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`Their narrow construction of the statute runs contrary to its plain language, the
`
`governing Declaration,4 and Congress’s intent. Plaintiffs also ignore their own
`
`pleadings to re-cast this claim as one of a “failure to diagnose pulmonary
`
`embolism” or a “failure to act,” but such oversimplified distinctions do not even
`
`control the PREP Act analysis in the first place.
`
`This claim also raises a substantial federal question. Plaintiffs’ argument to
`
`the contrary neglects that while the PREP Act is a defense, it also provides the
`
`substantive law that governs any claim for loss falling within its scope. Further, a
`
`federal forum to ensure a uniform application of the statute is essential to the
`
`national public health response.
`
`Finally, Plaintiffs are mistaken that jurisdictional discovery would be futile.
`
`As their response makes clear, they are changing their theory of the case by the day
`
`
`3 “Mount Sinai Defendants” refers to Defendants-Appellants HEATHER
`HUME, M.D., MIRA JOHN, M.D., THE MOUNT SINAI HOSPITAL, s/h/a
`MOUNT SINAI HOSPITAL, JILL BERKIN, M.D., and KEVIN TROY, M.D.
`4 Declaration Under the Public Readiness and Emergency Preparedness Act for
`Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17,
`2020), amended by 85 Fed. Reg. 21012 (Apr. 15, 2020), 85 Fed. Reg. 35100 (June
`8, 2020), 85 Fed. Reg. 52136 (Aug. 24, 2020), 85 Fed. Reg. 79190 (Dec. 9, 2020),
`86 Fed. Reg. 7872 (Feb. 2, 2021), 86 Fed. Reg. 9516 (Feb. 16, 2021) as corrected
`by 86 Fed. Reg. 10588 (Feb. 22, 2021), 86 Fed. Reg. 14462 (Mar. 16, 2021), 86
`Fed. Reg. 41977 (Aug. 4, 2021), 86 Fed. Reg. 51160 (Sep. 14, 2021) as corrected
`by 86 Fed. Reg. 54696 (Oct. 4, 2021), and 87 Fed. Reg. 982 (Jan. 7, 2022) (herein,
`“the Declaration”).
`
`- 2 -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page10 of 39
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`
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`to try and circumvent the PREP Act. Jurisdictional discovery would help ensure
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`the statute’s immunity “from suit” is not lost to such gamesmanship.
`
`REPLY TO PLAINTIFFS’ COUNTERSTATEMENT OF THE CASE
`
`I.
`
`STATUTORY BACKGROUND
`
`Plaintiffs’ recitation of the PREP Act contains several inaccuracies that are
`
`emblematic of an overall attempt to narrow its scope.
`
`First, Plaintiffs misstate the causal nexus requirement by selectively quoting
`
`from Section 247d-6d(a)(2)(B) as if the examples provided therein were
`
`exhaustive. See RB, p. 6.5 The omitted language is revealing: “any claim for loss
`
`that has a causal relationship with the administration to or use by an individual of
`
`a covered countermeasure, including ….” 42 U.S.C. § 247d-6d(a)(2)(B) (emphasis
`
`supplied).6
`
`Second, Plaintiffs incorrectly suggest that language from a request form for
`
`no-fault CCPF/CICP7 benefits governs the scope of PREP Act preemption.
`
`
`5 “RB” refers to Plaintiffs’ Response Brief; “MSB” refers to the Mount Sinai
`Defendants’ opening Brief.
`6 Plaintiffs’ proffered definition of “covered countermeasures” is also
`incomplete. Compare RB, pp. 5-6 with 42 U.S.C. § 247d-6d(i)(1) and (i)(7).
`7 “CCPF” refers to the “Covered Countermeasure Process Fund” created by the
`PREP Act (42 U.S.C. § 247d-6e(a)); “CICP” refers to the “Countermeasures Injury
`Compensation Program” administered by the Secretary of HHS to distribute
`benefits (see 76 Fed. Reg. 62306 (Oct. 7, 2011)).
`
`- 3 -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page11 of 39
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`
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`Compare § 247d-6d(a)(1) (“caused by, arising out of, relating to, or resulting
`
`from”) with § 247d-6e (“covered injuries” and “directly caused by”).8
`
`II. UNDERLYING FACTS
`
`Plaintiffs assert the Mount Sinai Brief is “replete with incorrect statements”
`
`of fact (RB, p. 8, n. 5.) but they do not identify any specific fact as being
`
`inaccurate. Nor do they dispute that the patient was administered multiple covered
`
`countermeasures, including: a ventilator; telemetry monitoring which included
`
`electrocardiography and pulse oximetry; several drugs which included heparin,
`
`Remdesivir, and epinephrine; and supplemental oxygen via non-rebreather mask
`
`and nasal cannula. See MSB, pp. 6-8, 50-22, nn. 7-14, 33.
`
`Instead, Plaintiffs selectively quote from a single consult note to imply that
`
`the case against Mount Sinai is really about a pulmonary embolism, and not
`
`COVID-19. See RB, pp. 9-10 (citing CJA43).9 However, not only is this distinction
`
`not controlling (see infra, Part II, B), and belied by the Complaint (see infra, Part
`
`II, A), but the language Plaintiffs omit confirms that COVID-19 was the presumed
`
`cause of the cardiac arrest. See CJA43 (“35 y.o. female 30 weeks pregnant with
`
`COVID PNA [pneumonia] requiring intubation, extubated on 4/8, concern for
`
`preeclampsia and difficulty with empiric anticoagulation (now on lovenox) now
`
`8 Plaintiffs also improperly rely on the criteria for CCPF/CICP benefit
`eligibility throughout much of their legal argument. See RB, pp. 15, 41, n. 17.
`9 Mount Sinai Defendants do not concede that the patient actually suffered a
`pulmonary embolism, that is just what Plaintiffs argue.
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page12 of 39
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`with asystolic arrest witnessed on the floor on 4/12 likely hypoxic based on
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`description, events leading up to and known COVID-19 however PE [pulmonary
`
`embolism] or other complication of pregnancy remains possible.”) (emphasis
`
`marks omissions).10
`
`Finally, Plaintiffs’ statement is as to the current status of the patient is
`
`unsupported by any citation to the record. RB, p. 10. To the extent that any
`
`response is needed here, Mount Sinai Defendants dispute such allegations.
`
`REPLY ARGUMENT
`
`I.
`
`THE PREP ACT IS A COMPLETE PREEMPTION STATUTE
`
`A. Complete preemption can occur when the exclusive federal cause
`of action is stricter than its state law counterpart, as long as it is
`intended to vindicate the same basic rights or interests
`
`Plaintiffs argue that the PREP Act cannot completely preempt a claim
`
`pleaded in negligence or malpractice because those causes of action are different
`
`than “willful misconduct.” See RB, pp. 25, 33-34, 38. Several other courts,
`
`including the court below, have followed similar reasoning. See SA7-SA8;
`
`Maglioli v. All. HC Holdings, 16 F.4th 393, 411 (3d Cir. 2021); Saldana v.
`
`Glenhaven Healthcare, 27 F.4th 679, 688 (9th Cir. 2022); Mitchell v. Advanced
`
`HCS, 28 F.4th 580, 586 (5th Cir. 2022); Dupervil v. All. Health Operations, 516 F.
`
`Supp. 3d 238, 251 (E.D.N.Y. 2021).
`
`
`10 Plaintiffs also apparently do not dispute that pulmonary embolism is, itself, a
`known complication of COVID-19. See MSB, p. 5.
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page13 of 39
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`However, it does not matter whether the exclusive federal cause of action is
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`stricter than the preempted state law cause of action. See MSB, pp. 28-31. What
`
`matters is whether the claim asserted is one for which there is an exclusive federal
`
`cause of action, and whether that federal cause of action is intended to vindicate
`
`the same underlying right. Id.
`
`Here, Plaintiffs’ “claim for loss” relates to the use and administration of
`
`covered countermeasures, so they are limited to the exclusive federal cause of
`
`action provided by the PREP Act. 42 U.S.C. § 247d-6d(d)(1). Further, that
`
`exclusive cause of action is intended to vindicate the same underlying right
`
`because it allows recovery for claims of personal injury. Therefore, Plaintiffs’
`
`claim is completely preempted.
`
`The First Circuit’s discussion in Fayard v. Ne. Vehicle Servs. is instructive.
`
`533 F.3d 42 (1st Cir. 2008). There, the plaintiffs asserted state law causes of action
`
`in nuisance, misrepresentation and civil conspiracy against a railroad abutting their
`
`land. Id. at 44. The court observed that complete preemption does not require the
`
`federal claim to be “coextensive” with the state law claim asserted, and so there are
`
`situations where “the coverage that would have been supplied by the state claim is
`
`not available … and so simply disappears.” Id. at 46. Ultimately, however, the
`
`court held that the claim was not completely preempted because the Interstate
`
`Commerce Commission Termination Act (“ICCTA”) only allowed claims for
`
`- 6 -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page14 of 39
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`
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`unlawful rate practices, not to recover the nuisance-type damages the plaintiffs
`
`were seeking. Id. at 47-48.
`
`Here, by contrast, the willful misconduct cause of action is intended to
`
`provide the same type of relief as would a common law theory of negligence or
`
`malpractice: tort law damages for personal injury.11 It is irrelevant that the federal
`
`cause of action is not “coextensive” with state common law, since the underlying
`
`right at issue is the same.
`
`The Tenth Circuit has also observed that “mirror-like symmetry” between a
`
`state and federal cause of action is not required for complete preemption; what is
`
`required is that the federal cause of action “vindicate the same basic right or
`
`interest that would otherwise be vindicated under state law.” Devon Energy Prod.
`
`v. Mosaic Potash Carlsbad, 693 F.3d 1195, 1207 (10th Cir. 2012).
`
`Similarly, this Court has held that a common law claim of unjust enrichment
`
`is completely preempted by the Copyright Act when it “seeks to vindicate legal or
`
`equitable rights” that would also be protected by a copyright infringement claim,
`
`even though “enrichment” is not an element of copyright infringement. Briarpatch
`
`v. Phoenix Pictures, 373 F.3d 296, 305-07 (2d Cir. 2004). The court observed that
`
`additional elements such as “[a]wareness or intent” would not make a state law
`
`11 Further, unlike the ICCTA, the PREP Act does provide a “clear-cut” claim
`for personal injury damages, it merely requires the plaintiff to establish a higher
`degree of culpability than what would otherwise be required. See Fayard v. Ne.
`Vehicle Servs., 533 F.3d 42, 48-49 (1st Cir. 2008).
`
`- 7 -
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`Case 21-2158, Document 136, 04/18/2022, 3298843, Page15 of 39
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`
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`claim “qualitatively different” from a federal cause of action. Id. at 305-06; see
`
`also Mayer v. Josiah Wedgwood & Sons, 601 F. Supp. 1523, 1535 (S.D.N.Y.
`
`1985) (additional elements such as awareness, intent, or immorality would not
`
`qualitatively alter a claim). Thus, although a claim for “willful misconduct,” in
`
`effect, requires a certain degree of “awareness or intent” not otherwise required
`
`under common law theories, that does not make it a “qualitatively different” cause
`
`of action since the underlying right is the same. See § 247d-6d(c)(1)(A).
`
`Further, the Avco Court observed that the “breadth or narrowness” of the
`
`remedy does not control the question of federal jurisdiction. Avco v. Aero Lodge
`
`No. 735, Int'l Ass'n of Machinists & Aerospace Workers, 390 U.S. 557, 561 (1968).
`
`Plaintiffs argue that this discussion is irrelevant because it dealt with the scope of
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`remedy, not the cause of action. RB, p. 36. But this distinction lacks significance.
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`In Avco, the petitioners sought an injunction in state court on the basis that the
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`labor strike at issue was forbidden by a collective bargaining agreement. Avco, 390
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`U.S. at 558 (1968). The Court concluded that Section 301 of LMRA established
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`the substantive law governing the dispute. Id. at 559-60. It then rejected the
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`argument that federal jurisdiction should be denied merely because LMRA did not
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`permit injunctions, since the “breadth or narrowness of the relief” was “a distinct
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`question from whether the court has jurisdiction.” Id. at 560-61. Thus, Avco is
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`analogous to the case at bar, since the PREP Act establishes the substantive law
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`governing any “claim for loss” within its scope and limits plaintiffs to a cause of
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`action for “willful misconduct.”12
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` The Davila Court also addressed this issue. Aetna Health Inc. v. Davila, 542
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`U.S. 200 (2004). There, the plaintiffs asserted state law causes of action against
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`administrators of ERISA-regulated benefit plans for failing to exercise ordinary
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`care in the administration of health care benefits. Id. at 204-05. The Court held that
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`even though the claims were pleaded under state law, they were completely
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`preempted because the underlying source of the rights at issue was an ERISA-
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`regulated benefit plan, and ERISA provided the exclusive cause of action to obtain
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`benefits due under such a plan. Id. at 211-14. The Court explained that it did not
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`matter whether the claims at issue were pleaded under a theory of tort or contract.
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`Id. at 215. It also did not matter whether the state law cause of action provided
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`greater benefits or recovery, since the limited remedies available reflected
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`Congress’ “careful balancing.” Id. at 215-214. Nor was it necessary for the federal
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`cause of action to “precisely duplicate[]” the state law cause of action asserted. Id.
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`at 215-16. What mattered was that the underlying rights arose from an ERISA-
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`12 Plaintiffs note that the PREP Act incorporates state substantive law into a
`claim for “willful misconduct.” See RB, p. 7 (citing 42 U.S.C. § 247d-6d(e)(2)).
`However, both the LMRA and the ATSSSA do the same. See Avco Corp. v. Aero
`Lodge No. 735, Int'l Ass'n of Machinists & Aerospace Workers, 390 U.S. 557, 560
`(1968); In re WTC Disaster Site, F.3d 352 (2d Cir. 2005) (quoting ATSSSA
`§ 408(b)(2)).
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`regulated benefit plan, and federal law provided the exclusive cause of action to
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`recover such benefits.
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`Here, similar to Davila, Plaintiffs’ attempt to rely on a theory of negligence
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`is not controlling. Congress carefully balanced the interests at stake and
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`determined that the exclusive cause of action for Plaintiffs’ underlying claim
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`should be for “willful misconduct.” Although that cause of action is not precisely
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`duplicative of a cause of action for negligence, they both involve the same
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`underlying rights, and are thus the same claim for jurisdictional purposes.
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`B.
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`It is not necessary for a completely preemptive statute to establish
`a broad federal cause of action
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`Plaintiffs also argue that the PREP Act is not a complete preemption statute
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`because it does not create a broad cause of action like the ones created by the
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`National Bank Act,13 ERISA,14 the LMRA,15 or the ATSSSA.16 Id. at 26-28, 39-40.
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`Again, the court below and several others have followed similar reasoning. See
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`SA11; Maglioli, 16 F.4th at 412; Mitchell, 28 F.4th at 588; Dupervil, 516 F. Supp.
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`3d at 253. However, the mere fact that the PREP Act requires a high degree of
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`13 12 U.S.C. §§ 85, 86.
`14 Employee Retirement Income Security Act of 1974 (“ERISA”).
`15 Labor Management Relations Act of 1947 (“LMRA”).
`16 Air Transportation Safety and System Stabilization Act (“ATSSSA”) 49
`U.S.C.A. § 40101 note (Westlaw 2021) (reproduced in Addendum to MSB at
`AD26-AD58).
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`culpability does not mean that it does not completely preempt claims pleaded
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`under less stringent, common law causes of action.
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`Notably, Plaintiffs cite no prior authority holding that the creation of a broad
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`cause of action is necessary for complete preemption.17 Instead, they rely on this
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`Court’s decision from In re WTC Disaster Site, which addressed the ATSSSA. 414
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`F.3d 352 (2d Cir. 2005). But the WTC court did not hold that a broad federal cause
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`of action was necessary for a statute to be completely preemptive. Nor does the
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`mere fact that ATSSSA creates a broad cause of action mean that every completely
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`preemptive statute must do the same. Therefore, Plaintiffs’ attempt to distinguish
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`WTC fails, particularly when the PREP Act and the ATSSSA are so similar in
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`other key respects. See MSB, p. 33.
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`Plaintiffs’ attempt to distinguish the PREP Act from other completely
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`preemptive statutes in this regard is also unavailing. They argue that the National
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`Bank Act, ERISA, and LMRA “do not name particular causes of action like breach
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`of contract or torts.” RB, p. 28. However, the National Bank Act does refer to a
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`particular cause of action: “in an action in the nature of an action of debt.” 12
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`U.S.C. § 86 (emphasis supplied). So does the Section 301 of LMRA: “suits for
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`violation of contracts.” 29 U.S.C. § 185(a). Similarly, actions under ERISA are
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`also limited to contract claims brought concerning rights flowing from an ERISA-
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`17 They rely on the Maglioli, Saldana, and Mitchell decisions. However, as
`noted above, “mirror-like symmetry” is not required.
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`regulated benefit plan. See 29 U.S.C. § 1132(a); Davila, 542 U.S. at 208 (2004).
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`Further, as noted below (see infra, Part I, C), complete preemption does not turn on
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`the specific cause of action pleaded.18
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`Moreover, each statute should be evaluated in light of its own unique
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`legislative purpose, since respect is owed to Congress’s “careful balancing” of
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`competing interests. See Davila, 542 U.S. at 215; MSB, pp. 34-35. The focus
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`should be on whether Congress intended the federal cause of action to be
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`exclusive, not whether Congress intended the plaintiff to obtain recovery. See
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`Beneficial Nat. Bank v. Anderson, 539 U.S. 1, 9, n.5 (2003); Caterpillar v.
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`Williams, 482 U.S. 386, 391, n.4 (1987).
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`Here, Congress intended the PREP Act to facilitate a national response to an
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`urgent public health emergency. See JA242. They sought to accomplish this by
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`removing the threat of civil liability as a disincentive to private sector response
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`efforts. See id. A stringent cause of action is plainly integral to that core purpose.
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`This trade-off would be undermined if, by merely pleading a theory of negligence,
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`individual plaintiffs could ignore Congress’s mandate for an exclusive federal
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`cause of action. Further, requiring covered persons to defend themselves in fifty
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`different state court systems, with different procedural rules, and with the only
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`18 Indeed, the Anderson Court found complete preemption even though the
`“substantive” limits on the applicable interest rates were set by federal statute and
`not state usury law. Beneficial Nat. Bank v. Anderson, 539 U.S. 1, 9 (2003).
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`hope for federal review being an application to the Supreme Court on a case-by-
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`case basis, would engender the



