Petition for Writ of Certiorari — Avco Corporation, Petitioner v. Jill Sikkelee, Individually and as Personal Representative of the Estate of David Sikkelee, Deceased, et al.

APPENDIX

TABLE OF CONTENTS

Appendix A:

Court of appeals opinion,

Oct. 25, 2018 ................................................ 1a

Appendix B:

Court of appeals order,

Dec. 11, 2018 ............................................. 45a

Appendix C

District court memorandum opinion,

Aug. 3, 2017 ............................................... 47a

Appendix D:

District court order

granting summary judgment,

Aug. 3, 2017 ............................................. 155a

Appendix E:

District court order

granting reconsideration,

Aug. 3, 2017 ............................................. 157a

Appendix F:

Court of appeals opinion,

Apr. 19, 2016 ........................................... 163a

Appendix G:

Court of appeals order,

June 7, 2016 ............................................. 217a

Appendix H:

District court opinion,

Sept. 10, 2014 .......................................... 219a

Appendix I:

District court opinion,

Aug. 13, 2010 ........................................... 275a

Appendix J:

Statutory provisions ............................... 297a

APPENDIX A

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

No. 17-3006

JILL SIKKELEE, Individually and as Personal Representative of the Estate of David Sikkelee, deceased,

Appellant

v.

PRECISION AIRMOTIVE CORPORATION; PRECISION AIRMOTIVE LLC, Individually and as Successor-In-Interest to Precision Airmotive Corporation;

BURNS INTERNATIONAL SERVICES CORPORATION, Individually and as Successor-In-Interest to

Borg-Warner Corporation, and Marvel-Schebler, a Division of Borg-Warner Corporation; TEXTRON LYCOMING RECIPROCATING ENGINE DIVISION, A

Division of Avco Corporation; AVCO CORPORATION;

KELLY AEROSPACE, INC., Individually and Joint

Venturer and a Successor-In-Interest; KELLY AEROSPACE POWER SYSTEMS, INC., Individually and as

Joint Venturer and Successor-In-Interest also known as

Electrosystems, Inc. also known as Confuel Inc.; ELECTROSYSTEMS, INC., Individually and as Joint Venturer and as Successor-In-Interest also known as Consolidated Fuel Systems, Inc. also known as Confuel, Inc.;

CONSOLIDATED FUEL SYSTEMS, INC., also known

as Confuel, Inc.

(1a)

2a

APPEAL FROM THE UNITED STATES DISTRICT

COURT FOR THE MIDDLE DISTRICT

OF PENNSYLVANIA

(D.C. No. 4-07-cv-00886)

District Judge: Hon. Matthew W. Brann

Argued: July 11, 2018

Before: SHWARTZ, ROTH, and RENDELL, Circuit

Judges.

Filed: July 11, 2018

OPINION

SHWARTZ, Circuit Judge.

David Sikkelee died in a plane crash, and his wife,

Plaintiff Jill Sikkelee, brought state-law strict liability and

negligence claims against the engine’s manufacturer,

AVCO Corporation, and its Textron Lycoming Reciprocating Engine Division (“Lycoming”), among other defendants. Sikkelee alleges that the engine has a design defect. We previously held that Sikkelee’s state-law claims

are not barred based on the doctrine of field preemption,

but we remanded to allow the District Court to consider

whether they are barred under conflict preemption. Sikkelee v. Precision Airmotive Corp. (Sikkelee II), 822 F.3d

680 (3d Cir. 2016), cert. denied, AVCO Corp. v. Sikkelee,

137 S. Ct. 495 (2016). The District Court concluded the

claims are conflict-preempted and that, even if they were

not, Lycoming is entitled to summary judgment on Sikkelee’s strict liability and negligence claims based on

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Pennsylvania law. Sikkelee v. AVCO Corp. (Sikkelee III),

268 F. Supp. 3d 660 (M.D. Pa. 2017). The Court also revisited an earlier ruling and granted summary judgment in

favor of Lycoming on Sikkelee’s claim that Lycoming violated 14 C.F.R. § 21.3 because it failed to notify the Federal Aviation Administration (“FAA”) of the alleged defect. Sikkelee v. AVCO Corp. (Sikkelee IV), No. 4:07-CV00886, 2017 WL 3310953 (M.D. Pa. Aug. 3, 2017)

We conclude that the District Court erred in concluding Sikkelee’s claims are conflict-preempted because Lycoming has not produced clear evidence that the FAA

would not have allowed it to change the engine’s design as

set forth in the type certificate. The Court also erred in

granting Lycoming summary judgment on Sikkelee’s

strict liability and negligence claims because there are

genuine disputes of material fact concerning, among other

things, causation. However, it properly granted summary

judgment on her failure-to-notify-the-FAA claim. Thus,

we will reverse the Court’s order granting summary judgment on conflict-preemption and state-law grounds, affirm its order granting Lycoming’s motion for reconsideration on the failure-to-notify claim, and remand for further proceedings.

I.

A. 1

In July 2005, David Sikkelee was piloting a Cessna

172N aircraft (the “Cessna” or “aircraft”) when it crashed

1

Because the parties do not dispute the relevant factual, statutory, or regulatory backgrounds, we draw largely from our prior opinion in this case, Sikkelee II, 822 F.3d 680, and the District Court’s

opinion, Sikkelee III, 268 F. Supp. 3d 660.

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shortly after taking off from Transylvania County Airport

in Brevard, North Carolina. He was killed in the crash. At

that time, the aircraft had a Textron Lycoming O-320D2C engine (the “engine”). Sikkelee alleges the aircraft

lost power and crashed due to a defect in the design of the

engine and its carburetor—which, when working

properly, regulates the mixture of fuel and air entering

the engine’s cylinders.

In 1966, the FAA issued Lycoming a type certificate

for the engine. A type certificate certifies that the design

of the aircraft or its part performs properly and satisfies

federal aviation regulations. Lycoming’s engine’s type

certificate included approval of an MA-4SPA carburetor,

which was manufactured by a different company, MarvelSchebler. The MA-4SPA carburetor consists of two

halves—the float bowl, on bottom, which contains fuel,

and the throttle body, on top, which meters the flow of air

and fuel to the cylinders—and the two halves are joined

by four hex-head bolts and lock-tab washers. The FAA initially required safety wire to be used to prevent the bolts

on MA-4SPA carburetors from loosening. 29 Fed. Reg.

16,317, 16,318 (Dec. 5, 1964). Lycoming asked the agency

to remove that requirement and instead allow the use of

hex screws and lock tabs, and the agency permitted it to

do so. Lycoming implemented the change with an engineering change order, which was signed by Lycoming’s

Designated Engineering Representative (“DER”). 2 The

The FAA may delegate to certain qualified persons—designated engineering representatives (“DERs”)—the authority to conduct examinations, testing, and inspections necessary to issue a certificate, and to issue a certificate. 49 U.S.C. § 44702(d)(1); see 14

C.F.R. §§ 183.1, 183.13, 183.15, 183.29 (designation of DERs and termination of such designation); FAA Order 8110.37F, Designated Engineering Representative (DER) Handbook (2017); see also Steen2

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company subsequently included the lock tab washer in its

design and maintenance instructions.

Lycoming manufactured the engine at issue here in

1969 in Pennsylvania and shipped it to an aircraft company in England the same year. At that time, it was

equipped with a Marvel-Schebler MA-4SPA carburetor.

Lycoming has been aware the carburetor’s screws

were not completely effective in holding together the float

bowl and throttle body. The FAA sent Lycoming a letter

in 1971, listing sixteen incidents of the screws on the Marvel-Schebler carburetor loosening. The FAA sent another

letter in 1972 referring to these incidents again and met

with Lycoming representatives to advise the company

that reports of loosening screws were still being received.

Indeed, by that time, the FAA had forwarded to Lycoming forty-five “Malfunction or Defect Reports on this

subject.” App. 557. The agency requested Lycoming to

“review these reports and provide comments to this office

holdt v. FAA, 314 F.3d 633, 634-35 (D.C. Cir. 2003) (discussing appointment and designation of DERs and the FAA’s oversight of

DERs). DERs are typically members of the private sector and employees of aircraft manufacturers, see United States v. S.A. Empresa

de Viacao Aerea Rio Grandense (Varig Airlines), 467 U.S. 797, 807

(1984); FAA, Order 8110.37F, at 2-1 to 2-2, but their specific roles,

authorizations, and responsibilities are established by agreement between the DER and the FAA office responsible for supervising the

DER, FAA, Order 8110.37F, at 2-2, app. C at C-1. In determining

whether a manufacturer meets the requirements for a type certificate, a DER must follow the same procedures an FAA engineer must

follow. See 14 C.F.R. § 183.29(e); FAA, Order 8110.37F, at 2-1. DERs

may approve minor design changes and, if specifically authorized,

also may approve major changes. FAA, Order 8110.37F, at 2-2, 4-4;

see infra at 19.

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as to any action you may propose that will help in alleviating this problem.” Id. The same year, the FAA also issued

a memorandum stating that “Marvel Schebler carburetors are a part of the engine type design and are not approved separately. The type certificate holder is responsible for the type design and also the correction of service

problems.” App. 579.

Lycoming responded to these reports in 1973 with

Service Bulletin 366 (“SB366”). SB366 acknowledged that

“[i]nstances have been reported of leakage through the

gasket between the bowl assembly and throttle body of

the carburetor, evidenced by fuel stains in the area of the

leak. Leakage of this type is accompanied by loose screws

that attach the bowl and throttle body.” App. 567. Lycoming advised that during inspection, the screws should

be checked for tightness, and if there appeared to be leakage and the screws were loose, the bowl should be removed, the gasket should be replaced, and the screws

should be retightened. 3

Service records show that the problem persisted.

Owners and mechanics reported to Lycoming loose

screws, leaking carburetors, and poor engine performance. In 2004, Precision Airmotive LLC (“Precision”),

which acquired the Marvel-Schebler carburetor line,

wrote Lycoming two letters regarding the carburetor’s

screws and leaking. As described in its first letter, in reviewing the FAA’s service difficulty report database, Precision “identified a trend”: “[o]ne of the items that has

been reported on multiple occasions is loose bowl to body

3

Between 2003 and 2008, Lycoming discussed internally how to

revise SB366. An updated bulletin (“SB366A”) was issued in 2007,

again recommending, during inspection, to ensure the screws are

tight and, if they are loose, to replace the gasket and retighten them.

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attach screws on the MA-4SPA model carburetor,” and “a

significant percentage of the incidents were on the Cessna

172 aircraft,” App. 581, the type of aircraft Sikkelee was

flying. Precision identified no such trends with other carburetor models, or with the MA-4SPA on other aircraft.

In its next letter, Precision confirmed the same trend and,

although reports of loose bowl screws had not increased

since the 1970s, “there continue[d] to be reports of loose

screws on certain carburetors, particularly those used on

O-320 engines in Cessna 172 aircraft.” App. 582. Precision

recommended that Lycoming identify the circumstances

that allowed screws to loosen and “evaluate[ ]” “the pros

and cons of a different attachment system.” App. 583.

The engine in Sikkelee’s plane was in storage until

1998, when it was installed into the Cessna in accordance

with the type certificate. 4 The engine was removed from

the aircraft in 2004, after the aircraft was struck by lightning, and defendant Triad Aviation, Inc. overhauled the

engine. As part of the overhaul, defendants Kelly Aerospace, Inc. and Kelly Aerospace Power Systems, Inc. (together, “Kelly”) “completely rebuilt or overhauled” the

carburetor and shipped it back to Triad for installation.

App. 616. Kelly held both an FAA repair station certificate, which permitted Kelly to overhaul Marvin-Schebler

carburetors, and a parts manufacturer approval (“PMA”)

from the FAA, which permitted Kelly to manufacture certain carburetor replacement parts. The carburetor was

rebuilt with a combination of parts. It appears one-half

was manufactured by Marvel-Schebler in the 1960s and

one-half by Marvel-Schebler in the 1970s, and Kelly used

its own aftermarket parts to join the two components.

Kelly performed this work in accordance with the service

4

Lycoming did not install the engine.

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manual and bulletins Lycoming and Precision had issued,

such as SB366, which recommended that the technician

detach the two halves of the carburetor, replace the gasket, and reassemble the carburetor using new lock tabs.

The carburetor as overhauled had the same design as the

original carburetor.

The plane was placed back into service, and in July

2005, David Sikkelee rented it. The Cessna crashed

shortly after takeoff. David Sikkelee was killed, and his

brother, who was a passenger, sustained severe injuries

but survived. Sikkelee asserts that the crash was the result of the carburetor’s faulty design for attaching the

float bowl and throttle body. She alleges that vibrations

from the engine loosened the bolts holding the float bowl

and throttle body together, which allowed fuel to leak out

of the carburetor into the engine and caused the Cessna

to crash.

B.

In 2007, Sikkelee filed a wrongful-death and survival

action against Lycoming, Kelly, and other defendants in

the United States District Court for the Middle District

of Pennsylvania. She asserted several Pennsylvania statelaw claims, including for strict liability and negligence,

and in 2010, the District Court granted defendants’ motion for judgment on the pleadings, holding that her

claims fell within the preempted field of air safety described in Abdullah v. American Airlines, Inc., 181 F.3d

363 (3d Cir. 1999). Sikkelee v. Precision Airmotive Corp.,

731 F. Supp. 2d 429 (M.D. Pa. 2010). Sikkelee then filed

an amended complaint, asserting state law claims but incorporating federal standards of care by alleging violations of several FAA regulations. After motion practice

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and settling her claims with Kelly, Sikkelee narrowed her

claims against Lycoming to strict liability, negligence, and

failure to warn, relying on 14 C.F.R. § 21.3. Just before

trial, the Court expressed concern that the federal standards of care did not allow the Court to formulate intelligible or practical legal standards. It ordered Sikkelee to

submit further briefing on the appropriate standard of

care, and subsequently invited Lycoming to file a motion

for summary judgment.

The District Court granted Lycoming partial summary judgment on the ground that the FAA’s issuance of

a type certificate for the engine meant that the federal

standard of care had been satisfied. The Court denied

summary judgment on Sikkelee’s failure-to-warn claims,

which were based on Lycoming’s alleged violation of 14

C.F.R. § 21.3 for failure to “report any failure, malfunction, or defect in any product, part, process, or article”

that Lycoming made. Sikkelee v. Precision Airmotive

Corp. (Sikkelee I), 45 F. Supp. 3d 431, 459-60 (M.D. Pa.

2014). The District Court certified its order for immediate

appeal to address “the reach of Abdullah and the scope of

preemption in the airlines industry.” Sikkelee II, 822 F.3d

at 687.

We granted interlocutory review and held field

preemption does not apply to state-law aircraft products

liability claims because (1) “the Federal Aviation Act, the

General Aviation Revitalization Act of 1994, and the regulations promulgated by the [FAA] reflect that Congress

did not intend to preempt aircraft products liability claims

in a categorical way,” Id. at 683; (2) “Congress has not created a federal standard of care for persons injured by defective airplanes,” Id. at 696; and (3) “the type certification process cannot as a categorical matter displace the

10a

need for compliance in this context with state standards

of care,” Id. Thus, aircraft products liability cases like Sikkelee’s may proceed using a state standard of care, “subject to traditional principles of conflict preemption, including in connection with the specifications expressly set

forth in a given type certificate.” Id. at 683. We therefore

vacated the grant of summary judgment in Lycoming’s favor and remanded for further proceedings. Id. at 683, 709.

Lycoming again moved for summary judgment, asserting Sikkelee’s claims are subject to conflict preemption and would, in any event, fail under Pennsylvania law.

The District Court granted Lycoming’s motions, concluding (1) Sikkelee’s claims were conflict preempted because

FAA regulations made it impossible for Lycoming to unilaterally implement the design changes Pennsylvania law

allegedly would have required, Sikkelee III, 268 F. Supp.

3d at 692-709, and (2) there was no genuine dispute of material fact as to either her negligence or strict liability

claims, Id. at 709-15. The District Court also reconsidered

its earlier summary judgment order, Sikkelee I, 45 F.

Supp. 3d at 435, and granted summary judgment to Lycoming on Sikkelee’s claim that Lycoming violated 14

C.F.R. § 21.3. Sikkelee IV, 2017 WL 3310953, at *2-3.

Sikkelee appeals.

II. 5

A.

We exercise plenary review of the District Court’s orders granting summary judgment. Sikkelee II, 822 F.3d

5

The District Court had jurisdiction pursuant to 28 U.S.C.

§ 1332(a). We have jurisdiction pursuant to 28 U.S.C. § 1291.

11a

at 687. We apply the same standard as the District Court,

viewing facts and drawing all reasonable inferences in the

non-movant’s favor. Hugh v. Butler Cty. Family YMCA,

418 F.3d 265, 266-67 (3d Cir. 2005). Summary judgment is

appropriate where “there is no genuine dispute as to any

material fact and the movant is entitled to judgment as a

matter of law.” Fed. R. Civ. P. 56(a).

We also review questions of preemption de novo. Sikkelee II, 822 F.3d at 687. Preemption is an affirmative defense on which Lycoming bears the burden of production

and persuasion. In re Vehicle Carrier Servs. Antitrust

Litig., 846 F.3d 71, 84 (3d Cir. 2017); El v. Se. Pa. Transp.

Auth., 479 F.3d 232, 237 & n.6 (3d Cir. 2007).

B.

Lycoming asserts Sikkelee’s claims are conflictpreempted under the doctrine of impossibility preemption

because it “cannot independently do under federal law

what state law requires.” Appellee’s Br. at 38. It also argues that Sikkelee’s claims fail as a matter of Pennsylvania law and the District Court properly granted summary

judgment on her § 21.3 claim. We will first address Lycoming’s preemption defense.

1.

The doctrine of preemption has constitutional roots in

the Supremacy Clause, which provides that “the Laws of

the United States . . . shall be the supreme Law of the

Land . . . any Thing in the Constitution or Laws of any

State to the Contrary notwithstanding.” U.S. Const. art.

VI, cl. 2. Congress thus has the power to preempt state

law. Arizona v. United States, 567 U.S. 387, 399 (2012).

We are nevertheless mindful that the federal and state

12a

governments “possess concurrent sovereignty” in some

areas. Sikkelee II, 822 F.3d at 687. For example, we assume “that the historic police powers of the States were

not to be superseded by [a] [f]ederal [a]ct unless that was

the clear and manifest purpose of Congress.” Id. (quoting

Wyeth v. Levine, 555 U.S. 555, 565 (2009)). This presumption against preemption applies in the context of aviation

products liability law. Id. at 690-92, 707-08.

There are several types of preemption: express and

implied, and within implied, field and conflict. Express

preemption has not been asserted and, in Sikkelee II, we

held Congress has not preempted the field of state-law design- and manufacturing-defect claims concerning aircraft products, Id. at 683. 6 We did not, however, decide

whether conflict preemption bars Sikkelee’s claims. See

Id. at 683, 695, 702, 709.

There are two types of conflict preemption: (1) impossibility preemption, where compliance with both federal

and state duties is impossible; and (2) obstacle preemption, where compliance with both laws is possible, but

state law poses an obstacle to the full achievement of federal purposes. In re Vehicle Carrier Servs., 846 F.3d at 84.

We concluded the Federal Aviation Act and related regulations

“do not indicate a clear and manifest congressional intent to preempt

state law products liability claims; Congress has not created a federal

standard of care for persons injured by defective airplanes; and the

type certification process cannot as a categorical matter displace the

need for compliance in this context with state standards of care.” Sikkelee II, 822 F.3d at 696. We also held the General Aviation Revitalization Act of 1994 (“GARA”), Pub. L. No. 103-298, 108 Stat. 1552 (codified at 49 U.S.C. § 40101 note), does not express any such congressional intent. Sikkelee II, 822 F.3d at 696-99.

6

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Lycoming argues Sikkelee’s claims are barred under impossibility preemption. 7 “The question for ‘impossibility’

[preemption] is whether the private party could independently do under federal law what state law requires of

it.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011).

2.

“Pre-emption analysis requires us to compare federal

and state law. We therefore begin by identifying the state

tort duties and federal . . . requirements applicable to” Lycoming. Id. at 611. Under Pennsylvania law, a seller may

be liable in strict liability and negligence for injuries

caused by its defective products. The test for strict liability is set forth in the Restatement (Second) of Torts

§ 402A (1965). Tincher v. Omega Flex, Inc., 104 A.3d 328,

351, 384-433 (Pa. 2014). 8 This requires a plaintiff to prove:

“(1) that the product was defective; (2) that the defect was

Because preemption is an affirmative defense, we examine only

the defense asserted before us. In re Vehicle Carrier Servs., 846 F.3d

at 84.

7

8

Section 402A provides:

(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate

user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation

and sale of his product, and

(b) the user or consumer has not bought the product from or

entered into any contractual relation with the seller.

Restatement (Second) of Torts § 402A.

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a proximate cause of the plaintiff’s injuries; and (3) that

the defect causing the injury existed at the time the product left the seller’s hands.” Pavlik v. Lane Ltd./Tobacco

Exps. Int’l, 135 F.3d 876, 881 (3d Cir. 1998) (citing Davis

v. Berwind Corp., 690 A.2d 186, 190 (Pa. 1997)). A plaintiff

may prove a “defective condition” exists by showing either “(1) the danger is unknowable and unacceptable to

the average or ordinary consumer” (the “consumer expectations standard”), or “(2) a reasonable person would conclude that the probability and seriousness of harm caused

by the product outweigh the burden or costs of taking precautions” (the “risk-utility standard”). Tincher, 104 A.3d

at 335, 387, 389.

Pennsylvania law also recognizes a negligence cause of

action for products liability. See Tincher, 104 A.3d at 38384; Phillips v. Cricket Lighters, 841 A.2d 1000, 1008 (Pa.

2003). To maintain such a claim, a plaintiff must demonstrate “[1] that the defendant had a duty to conform to a

certain standard of conduct; [2] that the defendant

breached that duty; [3] that such breach caused the injury

in question; and [4] actual loss or damage.” Phillips, 841

A.2d at 1008 (citation and internal quotation marks omitted).

Sikkelee argues that Lycoming’s design for affixing

the carburetor parts was defective and that, under Pennsylvania law, Lycoming would be liable for failing to use a

different design. Specifically, she asserts that Lycoming

should have used safety wire to secure the bolts that attach the float bowl and throttle body.

3.

We next examine the federal regulations applicable to

the design of aircraft products. Congress has imposed

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federal oversight of certain aspects of aviation. Sikkelee

II, 822 F.3d at 684. The 1958 Federal Aviation Act consolidated regulatory authority in a single entity, the FAA,

and adopted the earlier statutory framework for the

promulgation of minimum standards for design safety and

the process for the issuance of certificates that indicated

compliance with those regulations. Id. Under federal law,

an aviation-products manufacturer must obtain a type

certificate from the FAA. 49 U.S.C. § 44704(a); 14 C.F.R.

§ 21.31; Sikkelee II, 822 F.3d at 684. “[A] type

certificate . . . certifies that a new design for an aircraft or

aircraft part performs properly and meets the safety

standards defined in aviation regulations, 49 U.S.C.

§ 44704(a); 14 C.F.R. § 21.31.” Sikkelee II, 822 F.3d at 684

(emphasis omitted). 9 If the FAA determines that a product “is properly designed and manufactured, performs

properly, and meets the regulations and minimum standards prescribed under [49 U.S.C. §] 44701(a),” it issues a

type certificate. Sikkelee II, 822 F.3d at 684 (alteration in

original) (quoting 49 U.S.C. § 44704(a)(1); see also 14

C.F.R. § 21.21. A type certificate includes

the type design, which outlines the detailed specifications, dimensions, and materials used for a

given product; the product’s operating limitations;

9

The FAA also issues

production certificate[s], which certif[y] that a duplicate part produced for a particular plane will conform to the design in the type

certificate, 49 U.S.C. § 44704(c); 14 C.F.R. § 21.137. Before a new

aircraft may legally fly, it must also receive . . . an airworthiness

certificate, which certifies that the plane and its component parts

conform to its type certificate and are in condition for safe operation. 49 U.S.C. §§ 44704(d), 44711(a)(1).

Sikkelee II, 822 F.3d at 684 (emphasis omitted).

16a

a “certificate data sheet,” which denotes the conditions and limitations necessary to meet airworthiness requirements; and any other conditions or

limitations prescribed under FAA regulations.

Sikkelee II, 822 F.3d at 684 (citing 14 C.F.R. §§ 21.31,

21.41; FAA, Order 8110.4C, change 5, Type Certification,

ch. 3-3(a) (2011)). A type certificate remains in effect “until surrendered, suspended, revoked, or a termination

date is otherwise established by the FAA.” Id. at 685

(quoting 14 C.F.R. § 21.51).

A manufacturer generally must make the product in

accordance with that certificate. A manufacturer may

make a “minor” change through “a pertinent ‘method acceptable to the FAA.’ ” Id. (quoting 14 C.F.R. § 21.95). A

minor change “is one that has no appreciable effect on the

weight, balance, structural strength, reliability, operational characteristics, or other characteristics affecting

the airworthiness of the product.” 14 C.F.R. § 21.93(a). All

other changes are “major” changes. Id.; see also Sikkelee

II, 822 F.3d at 703 n.21; 14 C.F.R. pt. 43, app. A (listing

major alterations and repairs). Major changes require advance FAA approval and issuance of an amended or supplemental type certificate. 49 U.S.C. § 44704(b); Sikkelee

II, 822 F.3d at 685, 703 n.21; 14 C.F.R. §§ 21.97; FAA Order 8110.4C, change 1, Type Certification, ch. 4-1(a), 4-2

(2011). A DER may approve minor changes and, with specific authorization, may approve major changes. FAA, Order 8110.37F at 2-2, 4-4; see supra note 2.

The FAA also regulates aftermarket parts. A manufacturer seeking to make replacement parts generally

must obtain a PMA, which allows the manufacturer to

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produce replacement parts for use on certificated products. See 14 C.F.R. §§ 21.8, 21.9, 21.303(a). A PMA holder

may manufacture aftermarket parts, but must do so in accordance with the type certificate for the product, and

must follow the same procedures as the type certificate

holder. 14 C.F.R. §§ 21.8, 21.9, 21.303(a), 21.319; FAA Order 8120.22A, Production Approval Process, ch. 4-5, at 47 to 4-8 (2016). The manufacturer may obtain a PMA by

showing (1) its product is identical to the certificated product, through evidence of a licensing agreement; (2) its

product is identical to the certificated product, without a

licensing agreement; or (3) tests and computations showing that its product meets airworthiness requirements.

See 14 C.F.R. § 21.303; FAA, Order 8120.22A, 4-7 to 4-8.

The process for changing a PMA design is the same as

that for certificated designs; changes are classified as

“major” and “minor,” and major changes must receive

FAA approval before they can be included in the design,

while minor changes can be approved using a method acceptable to the FAA. 14 C.F.R. § 21.319. At oral argument, the parties agreed that Sikkelee’s proposed change

to the carburetor’s design would be a minor change. 10 We

need not decide whether the change would be minor or

major because, either way, there is no impossibility

preemption here.

4.

Lycoming asks us to affirm the District Court’s ruling

on impossibility preemption because its FAA-approved

type certificate precludes it from unilaterally changing its

10

Although we disagree with our dissenting colleague’s characterization of the concession concerning whether the change here

would be minor, Dissent at 12, we agree that the distinction is irrelevant to the preemption issue before us.

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design, and thus it could not simultaneously comply with

federal and state law, where state law would require it to

adopt a different design. Lycoming relies primarily on

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual

Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). In

contrast, Sikkelee relies on the impossibility preemption

standard articulated in Wyeth v. Levine, 555 U.S. 555

(2009). To understand the relevance of these cases, some

background is required.

All three of these cases concerned tort claims relating

to warning labels provided in connection with pharmaceutical drugs. PLIVA and Bartlett involved claims against

generic drug manufacturers. Under federal law, a generic

drug manufacturer may produce a drug that is identical

to one made by a brand-name manufacturer, but when it

receives permission to do so, it must use the same FDAapproved design and warning labels as the brand-name

manufacturer. See Bartlett, 570 U.S. at 483-84, 486;

PLIVA, 564 U.S. at 612-13, 612 n.2. This is because the

generic manufacturer is given the opportunity to market

its product without performing the same comprehensive

testing as the brand-name manufacturer performed on its

product, with the idea being that such examination is not

needed if the products and warnings are identical. See,

e.g., In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132, 143-44 (3d Cir. 2017); In re

Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No.

II), 751 F.3d 150, 153 (3d Cir. 2014). Thus, both the products and the warnings must be identical.

PLIVA involved state-law failure-to-warn claims

against manufacturers of a generic drug. 564 U.S. at 60809, 611-12. Generic drug manufacturers are required, under the Food, Drug, and Cosmetic Act (the “FDCA”) and

19a

FDA regulations, to use labels that match those of the

brand-name manufacturers, and these generic drug manufacturers may not “independently chang[e]” their labels.

Id. at 618. Assuming state law required a different label,

the Supreme Court concluded federal law did not permit

the generic company to do what state law required—provide a different, stronger label, Id. at 617-18—and thus, it

was impossible for the generic company to change the

warnings, Id. at 618.

The Supreme Court reached the same conclusion in

Bartlett, where the manufacturer of a generic drug was

sued for an alleged design defect. 570 U.S. at 475. In Bartlett, the Court held redesign was not possible because “the

FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength,

and labeling as the brand-name drug on which it is based.”

Id. at 483-84. As a result, the Court concluded “state-law

design-defect claims like New Hampshire’s that place a

duty on manufacturers to render a drug safer by either

altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from

unilaterally altering drug composition or labeling.” Id. at

490. Thus, in both cases, the state-law claims were conflict-preempted because it would be impossible to comply

with the federally mandated label and the modified label

purportedly required by state law. Id. at 486-87, 490;

PLIVA, 564 U.S. at 618, 624.

Lycoming argues that it—like the generic drug manufacturers in those cases—cannot unilaterally change the

FAA-approved design in the type certificate without FAA

approval, and thus, it cannot both comply with federal law

and do what Sikkelee claims state law requires it to do.

Similarly, Lycoming asserts Kelly could not unilaterally

20a

alter the carburetor’s design because, as a PMA holder, it

was obliged to follow the design as set forth in Lycoming’s

type certificate.

We are not persuaded. In PLIVA and Bartlett, the defendant generic manufacturers were obligated to use the

design and labeling of their brand-name counterparts.

Lycoming is not in that position. As discussed above, the

Federal Aviation Act and FAA regulations require FAA

approval of a type certificate and changes to it. Lycoming,

however, is not stuck with the design initially adopted and

approved in a type certificate. Indeed, Lycoming has

made numerous changes to the type certificate for its O320 engine, which the FAA approved in short order. As to

the carburetor specifically, Lycoming was in communication with the FAA about its design, sought to change the

requirement that safety wires be used, and obtained FAA

permission to use hex screws and lock tab washers instead.

This case therefore is more like Wyeth, where the

preemption defense failed. In Wyeth, the Supreme Court

concluded the plaintiff’s state-law failure-to-warn claim

against a brand-name drug manufacturer was not

preempted because a “changes being effected [‘CBE’]”

regulation permitted it to change a label to strengthen a

warning upon filing a supplemental application with the

FDA, and the brand-name manufacturer did not need to

wait for agency approval. 555 U.S. at 568. Thus, “absent

clear evidence that the FDA would not have approved a

change to [the drug’s] label, [the Court could] not conclude that it was impossible for Wyeth to comply with both

federal and state requirements.” Id. at 571.

21a

The principles of Wyeth apply here. The nature of

FAA regulations and Lycoming’s interactions with the

FAA—including the changes it has made to its type certificate—demonstrate that Lycoming could have—indeed

it had—adjusted its design. Thus, Lycoming is in a position more akin to that of the brand-name manufacturer in

Wyeth than that of the generic manufacturers in PLIVA

and Bartlett, who were unable to deviate from the brandname manufacturers’ labels. 11 For Lycoming to be entitled to an impossibility-preemption defense, it must present “clear evidence that the [FAA] would not have approved a change.” Wyeth, 555 U.S. at 571. 12 This it cannot

do.

Our dissenting colleague encourages us to read “the Supreme

Court’s impossibility decisions in concert,” Dissent at 15. We have

done so and have considered how the principles in Wyeth, PLIVA,

and Bartlett apply to the FAA regulatory scheme. Unlike the generic

manufacturers in PLIVA and Bartlett, who must accept without modification, the brand-names’ approved design, Lycoming had the freedom to request changes to its type certificate to change its design,

just like a brand-name manufacturer. Although the FAA does not explicitly have a CBE-type process that allows the certificate holder to

make a change before obtaining approval, the FAA allows the certificate holder to request permission to make a minor or major change.

11

Sikkelee “propose[s] the following rule: When a defendant can

implement a change or alteration to a design, product, or article without first seeking approval from an employee of the FAA, a state-law

claim requiring that change is not preempted unless the defendant

proves with clear evidence that the FAA would reject the change or

alteration.” Appellant’s Br. at 22-23, 34. She thus proposes a rule

based on approval by an actual employee of the FAA. Sikkelee argues

that any DER-approved changes do not involve FAA approval because DERs are not FAA employees (and can be employees of the

manufacturers themselves): “[w]hile the DER represents the government, he is emphatically not the government, and that defeats impossibility.” Appellant’s Br. at 35; see also id. at 23, 33-36.

12

22a

There is no evidence in the record showing that the

FAA would not have approved a change to the carburetor’s screws or attachment system. To the contrary, viewing the record in the light most favorable to the nonmovant, it shows that the FAA likely would have approved

a change, which also would have meant Kelly would not

have used the same allegedly defective design when it

overhauled and reinstalled the carburetor in 2004. The

FAA was aware, as its correspondence with Lycoming

shows, that the carburetor’s screws loosened in some

cases and caused fuel to leak. As a result, the FAA asked

Lycoming to review the malfunction or defect service reports of loosening screws “and provide comments to this

office as to any action you may propose that will help in

alleviating this problem.” App. 557. The FAA also reminded Lycoming that “Marvel Schebler carburetors are

a part of the engine type design and are not approved separately. The type certificate holder is responsible for the

type design and also the correction of service problems.”

App. 579. This shows that the FAA wanted Lycoming to

address the situation. Moreover, the FAA had previously

required the use of safety wire, the very design change

Sikkelee alleges would have cured the defect. Based on

this record, the FAA likely would have approved a proposed change to the attachment system. Thus, it was not

We decline to adopt the rule Sikkelee proposes. As we have noted,

see supra n.2, DERs are agents of the FAA, and so their involvement

does not mean the FAA has not approved a design. Second, to the

extent she is arguing FAA approval provides no guarantee of safety

because the agency delegates much of its certification work to DERs,

we have rejected that argument and noted that the involvement of

DERs in the certification- and change-approval process alone cannot

defeat conflict preemption. Sikkelee II, 822 F.3d at 708.

23a

“impossible” for Lycoming to change its allegedly defective design, and Lycoming’s conflict-preemption defense

fails.

In addition, allowing state-law claims to proceed in

this context complements, rather than conflicts with, the

federal scheme. See Fellner v. Tri-Union Seafoods,

L.L.C., 539 F.3d 237, 249 (3d Cir. 2008) (“[S]tate tort law

and other similar state remedial actions are often deemed

complementary to federal regulatory regimes, and this

appears to be such a case.”). “[T]he regulations are

framed in terms of standards to acquire FAA approvals

and certificates—and not as standards governing manufacturing generally,” which indicates “that the acquisition

of a type certificate is merely a baseline requirement.”

Sikkelee II, 822 F.3d at 694. Thus, “in the manufacturing

context, the statutory language indicating that these are

‘minimum standards,’ means what it says.” Id. (internal

citation omitted) (quoting 49 U.S.C. § 44701). State-law

claims, such as Sikkelee’s, supplement the federal scheme

and further its central purpose: safe aircrafts. 13

The FAA, in its brief submitted to our Court in connection with

the last appeal, asserts the FAA’s express approval of an aircraft or

part design would preempt, under conflict preemption principles, a

plaintiff’s state tort suit arguing for an alternative design. App. 1183.

We noted the FAA’s position that “to the extent that the FAA has not

made an affirmative determination with respect to the challenged design aspect, and the agency has left that design aspect to the manufacturer’s discretion, the claim would not be preempted.” Sikkelee,

822 F.3d at 702 (quoting FAA Letter Br. at 11; App. 1184). We concluded:

13

A type certificate thus would not create such a conflict in the

FAA’s view where unilateral changes are permissible without

preapproval or where an allegation of negligence arises after

the issuance of a type certificate, such as claims related to . . .

24a

Moreover, “immuniz[ing] aircraft and aviation component part manufacturers from liability for their defective

product designs” is “inconsistent with the [Federal Aviation] Act and its goal of fostering aviation safety.” Amicus

Am. Ass’n for Justice Br. at 4-5. A manufacturer would

have little incentive to correct problems with its plane or

parts if it could rely on a type certificate to avoid liability.

This would undermine both the goal of the federal regulatory regime and the interests of states in ensuring the

safety of their residents. 14

For these reasons, the District Court erred in holding

Sikkelee’s claims were conflict-preempted and granting

Lycoming summary judgment on that basis.

issuance of service bulletins to correct an issue that has come

to the manufacturer’s attention . . . .

Id. at 702 n.19 (citing FAA Letter Br. at 10-11, 12-13 n.2; App. 118386). That is precisely the situation here: Lycoming was aware the carburetor’s screws could and did come loose on numerous occasions,

leading to fuel leaks—in the Cessna 172 in particular—and Lycoming

issued service bulletins in an apparent attempt to address the issue

(but did not change the design). Thus, our conclusion that Sikkelee’s

claims are not preempted is consistent with the FAA’s position on the

impact of state law on the federal regulatory scheme.

14

Our dissenting colleague opines that preemption applies because the regulatory scheme does not allow a certificate holder to unilaterally make a change, even though they could request permission

to do so. Taking this view to its logical conclusion means that certificate holders could be aware of conditions that threaten safety or airworthiness and not be required to take any action to address those

conditions. This approach would insulate the certificate holder from

liability and leave those injured without a remedy.

25a

C.

We next address Sikkelee’s state-law strict liability

and negligence claims and conclude Lycoming is not entitled to summary judgment on them.

Sikkelee asserts Lycoming’s engine design is defective, Lycoming knew about the problem and failed to correct it, and the engine’s defect proximately caused David

Sikkelee’s death. She further argues the engine’s condition did not substantially change between 1969 and the

crash, and any changes that did occur were reasonably

foreseeable. She also argues that Lycoming is liable for

defects in the overhauled carburetor because manufacturers can be liable for defects in aftermarket parts installed

on their products. Lycoming disputes Sikkelee’s arguments as to causation, substantial change, foreseeability,

and negligence, and argues that it cannot be held liable

because it was not in the replacement carburetor’s chain

of distribution.

The District Court should have permitted Sikkelee’s

strict liability and negligence claims to be decided by the

jury. Pennsylvania law provides that whether a product is

defective “is a question of fact ordinarily submitted for determination to the finder of fact; the question is removed

from the jury’s consideration only where it is clear that

reasonable minds could not differ on the issue.” Tincher,

104 A.3d at 335. Similarly, the issues of proximate causation, whether a change to the product was substantial, and

whether that change was reasonably foreseeable, are generally for the jury. Merriweather v. E.W. Bliss Co., 636

F.2d 42, 44-45 (3d Cir. 1980); Hamil v. Bashline, 392 A.2d

1280, 1287-88 (Pa. 1978); D’Antona v. Hampton Grinding

Wheel Co., 310 A.2d 307, 310 (Pa. Super. Ct. 1973).

26a

Here, the record indicates that reasonable minds

could differ on these issues. For example, there is a genuine dispute of material fact as to causation. Sikkelee’s experts posit the carburetor—due to its loosening screws

and fuel leakage—caused the engine to fail and the plane

to crash, while Lycoming’s experts dispute Sikkelee’s experts’ conclusions. Moreover, contrary to Lycoming’s argument, there are circumstances in which a manufacturer

can be held liable for a component part that caused a

plaintiff’s injury, even when the part was made by a different entity, and particularly when that entity was required to follow the manufacturer’s design. See D’Antona,

310 A.2d at 309-10 (holding that “appellant’s averment

that a defective condition in [the] machine caused the

wheel to explode sufficiently states a cause of action

against [defendant] despite the fact that the explosion occurred in a component part manufactured by someone

else”); see also Pridgen v. Parker Hannifin Corp., 916

A.2d 619, 623 (Pa. 2007) (“[W]e agree with [plaintiffs’] observation that [defendants, including Lycoming] sit at the

top of the aviation food chain with respect to all components comprising the type certificated engine. Thus, in the

absence of GARA repose, [defendants] might indeed be

liable for design defects in replacement parts and/or the

aircraft systems within which such components function.”

(citation and internal quotation marks omitted)).

Therefore, the District Court erred in granting Lycoming summary judgment on Sikkelee’s state-law

claims. 15

We note the District Court made repeated reference to Sikkelee’s $2 million settlement with Kelly. Sikkelee III, 268 F. Supp. 3d

at 690, 709, 717. The settlement with Kelly is irrelevant to any of the

legal issues presented here, and we hope the District Court’s analysis

and tone were not influenced by it. See, e.g., id. at 717 (stating that

15

27a

D.

Finally, Sikkelee argues the District Court erred in

granting Lycoming summary judgment on her failure-tonotify-the-FAA claim, based on 14 C.F.R. § 21.3. That

provision provides that “[t]he holder of a type certificate

(including amended or supplemental type certificates), a

PMA, or a TSO [technical standard order] authorization,

or the licensee of a type certificate must report any failure, malfunction, or defect in any product or article manufactured by it that it determines has resulted in any of

the occurrences listed in paragraph (c) of this section.” 14

C.F.R. § 21.3(a). Paragraph (c) includes situations that fit

the alleged defect and carburetor malfunction here. Id.

§ 21.3(c)(1)-(2), (6), (10). Sikkelee argues Lycoming failed

to comply with this regulation, and the FAA would have

taken corrective action if Lycoming had complied.

Lycoming is entitled to summary judgment on this

claim. Sikkelee has attempted to use a federal duty and

standard of care as the basis for this state-law negligence

claim. See Reply Br. at 17 (“Lycoming is liable in negligence for failing to report known product defects to the

FAA.”). However, as we held in Sikkelee II, “Congress

has not created a federal standard of care for persons injured by defective airplanes.” 822 F.3d at 696; cf. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 353

(2001) (holding state-law fraud-on-the-FDA claims were

impliedly preempted by federal law, and noting that

“were plaintiffs to maintain their fraud-on-the-agency

claims here, they would not be relying on traditional state

tort law which had predated the federal enactments in

because of this settlement, “sympathy for unrealized pecuniary losses

is not in order for the Plaintiff here”).

28a

question[ ]. On the contrary, the existence of these federal

enactments is a critical element in their case”). The District Court therefore properly granted summary judgment to Lycoming on this claim.

III

For the foregoing reasons, we will reverse the District

Court’s order granting Lycoming summary judgment on

Sikkelee’s state-law claims, affirm the Court’s order

granting Lycoming’s motion for reconsideration on Sikkelee’s failure-to-warn-the-FAA claim, and remand for

further proceedings.

ROTH, dissenting in part.

The Majority holds that Sikkelee’s claims against Lycoming are not conflict preempted. Applying the Supreme

Court’s decision in Wyeth v. Levine, 1 the Majority concludes that, because Lycoming has not produced clear evidence that the FAA would have prevented Lycoming

from implementing certain design changes to the engine,

it was not impossible for Lycoming to unilaterally implement the design changes allegedly required under Pennsylvania law.

The Majority errs in two key ways. First, the Majority

takes a piecemeal approach to the Supreme Court’s impossibility preemption precedents, without considering it

in the aggregate. Second, the Majority misframes the applicable regulatory regime, which requires prior FAA approval for all changes, major and minor.

1

555 U.S. 555 (2009).

29a

Without disregarding Wyeth, I find that, given the nature of the regulatory regime at issue, the Supreme

Court’s subsequent decisions in PLIVA, Inc. v. Mensing 2

and Mutual Pharmaceutical Co. v. Bartlett 3 are controlling. In short, applicable FAA regulations prohibited Lycoming from implementing the allegedly required change

without some form of prior FAA approval. As a result, under the Supreme Court’s conflict preemption precedents,

compliance with state law would have been impossible. I

therefore respectfully dissent from the portion of the Majority opinion that holds that Sikkelee’s claims are not

conflict preempted. 4

I.

The Majority and all parties to this appeal agree that

the Supreme Court’s recent decisions in Wyeth, PLIVA,

and Bartlett set out the governing standards for impossibility preemption. Although the Majority opinion cogently

summarizes those decisions, it fails to consider their combined import. Together, those decisions present a cohesive standard: when federal regulations prevent a manufacturer from altering its product without prior agency

approval, design defect claims are preempted; when federal regulations allow a manufacturer to independently alter its product without such prior approval, design defect

2

564 U.S. 604 (2011).

3

570 U.S. 472 (2013).

4

I agree with my colleagues that the District Court correctly

granted summary judgment in favor of Lycoming on Sikkelee’s failure-to-notify-the-FAA claim based on 14 C.F.R. § 21.3. I therefore

join Part II.D of the Majority opinion. In addition, I reach the question of preemption in this Dissent because I agree with my colleagues

that there are disputed issues of material fact that would preclude

summary judgment on the merits of Sikkelee’s state-law tort claims.

30a

claims ordinarily are not preempted. Revisiting Wyeth,

PLIVA, and Bartlett shows why that is the applicable

standard.

In Wyeth, the plaintiff suffered serious injury after receiving an intravenous administration of the brand-name

drug Phenergan, through a method known as “IV push.”

The drug’s FDA-approved label included a general warning about the risks involved in IV administration but did

not specifically instruct physicians to use the safer “IV

drip” method instead of the riskier “IV push” method. 5

The plaintiff brought state-law claims for negligence and

strict liability against the drug maker, Wyeth, premised

upon Wyeth’s failure to include on the label a more specific warning about the dangers of IV push administration. Wyeth argued that the plaintiff’s claims were conflict

preempted because the FDA had approved Phenergan’s

label, and FDA regulations generally forbid drug makers

from altering an approved label, rendering it impossible

for Wyeth to comply with its state-law duty to enhance the

label. The Supreme Court, however, rejected Wyeth’s

conflict preemption defense because an exception in the

FDA regulations, the so-called “changes being effected”

(CBE) exception, 6 allowed drug makers to unilaterally

add warnings to their labels, subject to the FDA’s authority to subsequently rescind or modify such changes. 7 Setting out the rule now applied by the Majority in this case,

the Court held that “absent clear evidence that the FDA

would not have approved a change to Phenergan’s label,

5

Wyeth, 555 U.S. at 559-60.

6

21 C.F.R. § 314.70(c)(6)(iii).

7

Wyeth, 555 U.S. at 568-71.

31a

we will not conclude that it was impossible for Wyeth to

comply with both federal and state requirements.” 8

The Supreme Court returned to conflict preemption

two years later in PLIVA. 9 PLIVA involved a set of facts

generally similar to those of Wyeth: Plaintiffs took Defendant’s drug, suffered an injury, and brought state-law

tort claims against Defendant premised upon Defendant’s

failure to include a sufficient warning on the drug’s label. 10

The Court, however, noted a key distinction from Wyeth

with regard to the applicable federal regulations. The

drug at issue in PLIVA was a generic, and FDA regulations required that generic drugs bear the exact same

warning label as their brand-name equivalent. 11 The regulations for generic drugs included no exception comparable to the CBE provision that allowed brand-name makers to unilaterally alter their warning label. 12 Notably,

however, the Court did not find that generic drug makers

were incapable of ever making their warning labels safer.

Instead, relying on the representations of the FDA as

amicus, the Court assumed that generic drug makers

“could have proposed—indeed, were required to propose—stronger warning labels to the [FDA] if they believed such warnings were needed” and that “[i]f the FDA

had agreed that a label change was necessary, it would

have worked with the brand-name manufacturer to create

a new label for both the brand-name and generic drug.” 13

8

Id. at 571.

9

564 U.S. 604.

10

Id. at 609-10.

11

Id. at 613.

12

See id. at 614-15.

13

Id. at 616 (emphasis added).

32a

Despite this duty, the Court concluded that, for purposes of conflict preemption, such a regulatory regime

rendered it impossible for the generic manufacturer to

simultaneously comply with state tort law and the federal

regulatory requirement without prior agency approval.

The Court explained that “[t]he question for ‘impossibility’ is whether the private party could independently do

under federal law what state law requires of it.” 14 There,

the drug maker could not. The Court specifically noted

that the drug maker would not have satisfied its state law

duties by proposing changes to the label or otherwise engaging in dialogue with the FDA. Rather, “[s]tate law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of

a safer label.” 15

PLIVA concludes with a clear standard: “[W]hen a

party cannot satisfy its state duties without the Federal

Government’s special permission and assistance, which is

dependent on the exercise of judgment by a federal

agency, that party cannot independently satisfy those

state duties for pre-emption purposes.” 16 In the Supreme

Court’s words, “Wyeth is not to the contrary.” 17 That is so

because the CBE regulation “applicable to Wyeth allowed

the company, of its own volition, to strengthen its label in

compliance with its state tort duty.”18

14

Id. at 620 (emphasis added).

15

Id. at 619.

16

Id. at 623-24.

17

Id. at 624.

18

Id.

33a

Finally, in Mutual Pharmaceutical Co. v. Bartlett,19

the Supreme Court reaffirmed and further clarified its

conflict preemption analysis. Bartlett, like PLIVA, began

as a state-law tort suit against a generic drug manufacturer whose product had injured the plaintiff. The federal

regulatory scheme was the same. The key factual distinction was that, in Bartlett, the plaintiff’s state-law claims

alleged a design defect, not merely a failure to warn. 20 The

plaintiff argued—and the First Circuit had held—that

such claims were not preempted because the drug manufacturer could comply with both state and federal law by

simply choosing not to make the drug at all. 21 The Supreme Court rejected this line of reasoning. The Court

noted that preemption doctrine “presume[s] that an actor

seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to

avoid liability.”22 The Court concluded that the drug

maker could have satisfied its duty under state law only

by altering the drug’s composition or its label. Because

federal regulation did not allow the drug maker to implement either of these measures without prior FDA approval, the state-law design defect claim was preempted. 23

Distilled to their essence, the Supreme Court’s recent

conflict preemption decisions present a guiding principle:

When a manufacturer operating in a federally regulated

industry has a means of altering its product independently and without prior agency approval—such as a

19

570 U.S. 472.

20

Id. at 479.

21

Id.

22

Id.at 488.

23

Id.at 491-92.

34a

brand-name drug manufacturer who may implement labeling alterations via the CBE process—state-law claims

against the manufacturer alleging a tortious failure to

make those alterations ordinarily are not preempted; but,

when federal regulations prohibit a manufacturer from altering its product without prior agency approval, statelaw claims imposing a duty to make a different, safer

product are preempted. Crucially, the question is not

whether a manufacturer may ever alter its product under

the applicable federal regulatory scheme. Rather, the

question is whether a manufacturer may do so without

prior agency approval. Thus, despite being decided after

Wyeth, PLIVA and Bartlett are more logically understood

as setting the general standard for impossibility preemption in cases involving an industry subject to thorough

federal regulation prohibiting independent changes to an

agency-approved product. By contrast, the clear evidence

standard announced in Wyeth applies only if the regulatory regime includes an exception, such as the CBE process, allowing manufacturers to independently implement

design changes without prior agency approval.

The Third Circuit’s recent decision in In re Fosamax 24

reflects a faithful application of this principle. Fosamax,

like Wyeth, was a state-law action against a brand-name

drug maker who could have unilaterally updated its warning label by availing itself of the CBE exception. Applying

Wyeth, the Third Circuit held that “the mere availability

of a CBE label amendment” could, but “would not always[,] defeat a manufacturer’s preemption defense, because the FDA retains authority to reject labeling

24

In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852

F.3d 268 (3d Cir. 2017), cert. granted sub nom. Merck Sharp & Dohme

Corp. v. Albrecht, No. 17-290, 2018 WL 3148288 (U.S. June 28, 2018).

35a

changes.” 25 The Court concluded that “where there is

‘clear evidence that the FDA would not have approved a

change’ to the label, federal law preempts state-law claims

premised on the manufacturer’s failure to make that

change.” 26 Because the drug maker could have unilaterally implemented labeling changes via the CBE exception

and had not offered clear evidence that the FDA would

have subsequently rejected the proposed label amendment, this Court held that the drug maker’s impossibility

preemption defense failed. Accordingly, Fosamax is entirely consistent with the core principle we derive from

Wyeth, PLIVA, and Bartlett.

II.

With the Supreme Court’s impossibility preemption

framework squarely in focus, I turn to the applicable federal regulatory regime, which prohibited Lycoming from

making changes to its engine without first obtaining FAA

approval. The Federal Aviation Act of 1958 (the Act) 27 established the FAA and empowered it to promulgate and

enforce safety regulations in the field of civil aeronautics.

Thus, FAA regulations and the Act itself prescribe the operative safety standards for the manufacture of airplanes

and their components, including aircraft engines. For an

aircraft engine manufacturer who wishes to produce a

particular model of engine, the first step in the regulatory

process is obtaining a “type certificate” from the FAA to

confirm compliance with applicable safety standards. 28

25

Id. at 283.

26

Id. (quoting Wyeth, 555 U.S. at 571).

27

Pub. L. No. 85-726, 72 Stat. 731.

28

See 49 U.S.C. § 44704(a); 14 C.F.R. § 21.21.

36a

With limited exceptions not applicable here, a manufacturer cannot produce an aircraft engine unless a type certificate for that specific engine design has been obtained

by the manufacturer or an entity with whom the manufacturer has a licensing agreement. 29 When applying for a

type certificate, an engine manufacturer is required to

submit, among other things, “a description of the engine

design features, the engine operating characteristics, and

the proposed engine operating limitations,”30 as well as

“the type design, test reports, and computations necessary to show that the product to be certificated [sic] meets

the applicable airworthiness . . . requirements.” 31 The

“type design” portion of the application “outlines the detailed specifications, dimensions, and materials used for a

given product.” 32 This Court has previously described the

type certification process as “intensive and painstaking.”33 The issuance of a type certificate by the FAA represents the FAA’s “find[ing] that the . . . aircraft engine .

. . is properly designed and manufactured, performs

properly, and meets the regulations and minimum standards prescribed under [the Act].” 34

As the Majority acknowledges, once the FAA has approved a particular engine design and issued a type certificate, the engine manufacturer must continue to manu-

29

See 14 C.F.R. § 21.6.

30

14 C.F.R. § 21.15.

31

14 C.F.R. § 21.21(b).

Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 684 (3d

Cir. 2016).

32

33

Id.

34

49 U.S.C. § 44704(a)(1).

37a

facture the engine in compliance with the type certificate. 35 The manufacturer may not make changes to the engine design without FAA approval. 36 Federal regulations

divide possible changes to an engine model into two categories: “major changes” and “minor changes.” 37

A minor change is “one that has no appreciable effect

on the weight, balance, structural strength, reliability, operational characteristics, or other characteristics affecting the airworthiness of the product,”38 and thus “may be

approved under a method acceptable to the FAA.” 39 One

of these methods is to receive approval from an individual

engineering expert who has been certified by the FAA as

a Designated Engineering Representative (DER). DERs

may be hired by a manufacturer, but their authority to approve minor changes exists solely as the result of a delegation of authority by the FAA, as allowed under the

Act. 40 DERs act “within limits prescribed by and under

the general supervision of the [FAA] Administrator,” 41

and their decisions may be appealed to the Administrator

or reconsidered by the Administrator at his or her own

initiative. 42 As the Majority correctly notes, “DERs are

agents of the FAA, and so their involvement does not

35

Maj. Op. at 19.

See 14 C.F.R. §§ 21.95, 21.97 (requiring FAA approval for both

minor and major changes).

36

37

14 C.F.R. § 21.93.

38

Id.

39

14 C.F.R. § 21.95.

40

See 49 U.S.C. § 44702(d).

41

14 C.F.R. § 183.29.

42

49 U.S.C. § 44702(d)(3).

38a

mean the FAA has not approved a design.”43 Accordingly,

DER approval is a form of FAA approval. Although the

applicable regulations, including the availability of DERs,

provide manufacturers with flexibility when seeking to

implement minor changes, neither federal regulations nor

any other authority cited by the Majority or by Sikkelee

supports the conclusion that a manufacturer may actually

implement a minor change prior to receiving FAA approval. 44

All changes that are not minor are classified as major. 45 A manufacturer seeking to implement a major

change must first obtain a new or supplemental type certificate from the FAA. 46 A manufacturer applying for approval of a major change must “[p]rovide substantiating

data and necessary descriptive data for inclusion in the

type design” and must show that the proposed change

complies with all FAA regulations. 47 As such, it is clear

that major changes require prior FAA approval. Aside

from major and minor changes, FAA regulations provide

no other means through which an original manufacturer

can implement changes to the design of a type certified

product. 48 In other words, in the field of safety regulation

43

Maj. Op. at 25 n.12.

Sikkelee argues that prior DER approval provides manufacturers with such an avenue, because DER approval is not actually FAA

approval. Appellant’s Br. at 33. As noted above, all three members

of this Panel reject that argument.

44

45

14 C.F.R. § 21.93.

46

14 C.F.R. § 21.113.

47

14 C.F.R. § 21.97.

As correctly summarized in the Majority opinion, additional

FAA regulations govern changes to airplane parts made by aftermarket parts manufacturers who hold an FAA-issued PMA. Maj.

48

39a

of civil aeronautics, there is no CBE process for a manufacturer to effect changes to a type certificate prior to

FAA approval of that change.

Moreover, concerning major versus minor changes,

the Majority asserts that, at oral argument, both parties

agreed that Sikkelee’s proposed change to the carburetor

would be a minor change. 49 In fact, the parties were not in

such perfect agreement. Lycoming’s precise position at

oral argument was that, while Lycoming viewed the proposed change as having no impact on airworthiness and

thus as minor, Sikkelee’s theory of tort liability inherently

required the conclusion that the change was major. 50 I

find Lycoming’s argument persuasive and note the inherent tension in Sikkelee’s position that a proposed change

could have prevented the crash but, at the same time,

should be considered minor, i.e., having no impact on airworthiness. However, the question need not be resolved.

Sikkelee’s claims are preempted regardless of whether

the proposed change is classified as minor or major because, as we have explained, both processes require prior

FAA approval before they are implemented.

III.

As a result of this comprehensive regulatory scheme,

Sikkelee’s strict liability and negligence claims against

Op. at 20. These regulations are not directly applicable to an original manufacturer such as Lycoming.

49

Maj. Op. at 20-21.

50

See Oral Arg. Audio Recording at 32:25-48, available at

http://www2.ca3.uscourts.gov/oralargument/audio/173006_Sikkeleev.Precision-Airmotive.mp3.

40a

Lycoming are conflict preempted. Lycoming, as the original manufacturer of and type certificate holder for the O320-D2C engine (the Engine), had two paths through

which it could lawfully implement changes to the Engine’s

design: the minor change process for changes having no

appreciable impact on the airworthiness of the Engine, or

the major change process for all other changes. As outlined above, both paths would have required prior FAA

approval before Lycoming could implement a proposed

change. No exception akin to the CBE process in Wyeth

applied here. Accordingly, the regulatory regime places

this case squarely in the realm of PLIVA and Bartlett.

That result is readily apparent when we consider the

question of impossibility in the precise language provided

by the Supreme Court: Could Lycoming independently do

under federal law what state law required of it, 51 i.e., alter

the design of the carburetor’s fastening mechanism from

lock-tab washers to safety wire? Under the applicable

FAA regulations, the answer to that fundamental question is clearly no, regardless of whether such a change

would have been minor or major. PLIVA and Bartlett instruct that that answer is sufficient to find conflict between Lycoming’s state and federal duties, and thus to

create impossibility preemption. We must go no further.

We should not inquire into the likelihood that the FAA

might have approved a proposed change. 52

51

Cf. PLIVA, 564 U.S. at 620.

52

PLIVA, 564 U.S. at 623 (“[P]re-emption analysis should not involve speculation about ways in which federal agency and third-party

actions could potentially reconcile federal duties with conflicting state

duties. When the ‘ordinary meaning’ of federal law blocks a private

party from independently accomplishing what state law requires, that

party Maj. Op. at 24 n.11. has established pre-emption.”).

41a

The Majority disagrees, finding that Wyeth provides

the applicable standard and that we must thus consiwhether Lycoming offered sufficient evidence that the

FAA would have rejected the proposed change. But, in

support of its application of Wyeth, the Majority fails to

identify any provision in the federal regulations that

would have allowed Lycoming to independently implement the proposed change without prior FAA approval.

Quite the contrary, the Majority candidly acknowledges

that the FAA does not have a CBE-type process. 53 That

should be the end of our Wyeth inquiry. But instead, the

Majority relies on “the nature of FAA regulations and Lycoming’s interactions with the FAA” to support its conclusion that Lycoming “could have . . . adjusted its design”

and that Wyeth’s standard should thus apply. 54 In particular, the Majority points out that Lycoming has amended

its type certificate for the O-320 engine a number of times

over the years and that Lycoming had been “in communication with the FAA” about the carburetor design and reports of loose bolts. 55

I take no issue with those statements to the extent that

they are simply factual assertions. 56 But the Majority errs

in concluding that those facts establish that Wyeth alone

supplies the applicable standard for conflict preemption

analysis in this case. Reading the Supreme Court’s impossibility preemption decisions in concert, the key initial

53

Maj. Op. at 24 n.11.

54

Maj. Op. at 24.

55

Maj. Op. at 23.

56

It bears noting that nothing in the record suggests these

amendments occurred without prior FAA approval. See J.A. 561. See

also J.A. 559-61 re list of applications for and revised type certificates

issued by FAA for the Engine.

42a

question for impossibility is not whether a manufacturer

has engaged in dialogue with a federal agency regarding

possible design changes or even whether the agency

might ultimately approve a proposed change at the conclusion of such dialogue. Rather, as previously stated, we

must start with the question whether the manufacturer

could have implemented the change independently, i.e.,

without prior agency approval. This issue was, in fact, addressed in PLIVA, where the Supreme Court expressly

contemplated whether a preemption defense was foreclosed by the type of manufacturer-agency dialogue that

the Majority now relies upon. There, the Court assumed

that a generic drug maker had a duty to warn the FDA of

safety problems and could have proposed and asked the

FDA to approve a new warning label for both the generic

and brand-name drug. 57 But that fact did not defeat

preemption or even trigger the Wyeth inquiry because the

manufacturer still could not independently implement the

proposed change without prior agency approval. 58 The

case here is similar.

Likewise, the Majority may well be correct that “the

FAA wanted Lycoming to address the situation” 59 of loosening bolts in the Engine’s carburetor. But that alone

does not negate impossibility, because nothing in the record or FAA regulations suggests that Lycoming could

have implemented any design changes without prior FAA

approval. On the contrary, the natural reading of the regulations is that FAA approval is required for any change,

57

PLIVA, 564 U.S. at 616-17.

58

Id. at 619-20.

59

Maj. Op. at 26.

43a

major or minor. 60 In fact, it would be logical to infer that

Lycoming and the FAA engaged in dialogue about boltloosening precisely because both parties recognized that

FAA approval would be required before Lycoming could

implement any remedial design change. That Lycoming

“has made numerous changes to the type certificate for its

O-320 engine”61 also does not alter the impossibility analysis. As outlined above, changes to a type certificate,

whether minor or major, require prior FAA approval, and

the record reflects such approval for the other changes

that Lycoming made. 62

Ultimately, although this case involves a detailed regulatory regime governing a complex industry, the correct

result of this appeal is dictated by a few key facts. Under

FAA regulations, Lycoming, as the original manufacturer

of and type certificate holder for the Engine, had two

means of implementing changes to its design—the major

change process and the minor change process. The plain

language of the regulations and the record in this case

show that, under either process, some form of FAA approval would have been required before Lycoming could

have implemented the design change proposed by Sikkelee. Thus, the answer to the fundamental question of

impossibility preemption—could Lycoming independently do under federal law what state law allegedly

required of it—is clearly no. The Supreme Court instructs

60

See supra section II.

61

Maj. Op. at 23.

62

J.A. 559-61 (Type Certificate Data Sheet No. E-274) (listing applications for and issuance of new or revised type certificates for O320 engine models between 1952 and 2003).

44a

that such an answer supports a finding of impossibility

preemption and requires that our inquiry go no further.

IV.

For the reasons stated above, I conclude that the Majority has erred by relying upon Wyeth in isolation and by

expanding its inquiry to consider whether Lycoming presented clear evidence that the FAA would not have approved the design change now proposed by Sikkelee. FAA

regulations prohibited Lycoming from independently implementing changes to the design of the Engine without

prior FAA approval. As such, pursuant to PLIVA and

Bartlett, Lycoming has established a valid impossibility

preemption defense. I therefore respectfully dissent in

part from the Majority opinion and would affirm the judgment of the District Court.

45a

APPENDIX B

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

No. 17-3006

JILL SIKKELEE, individually and as personal representative of the estate of David Sikkelee, deceased,

Appellant

v.

PRECISION AIRMOTIVE CORPORATION; PRECISION AIRMOTIVE LLC, individually and as Successor-in-Interest to Precision Airmotive Corporation;

BURNS INTERNATIONAL SERVICES CORPORATION, individually and as Successor-in-Interest to BorgWarner Corporation, and Marvel-Schebler, a Division of

Borg-Warner Corporation; TEXTRON LYCOMING

RECIPROCATING ENGINE DIVISION, a Division of

Avco Corporation; AVCO CORPORATION; KELLY

AEROSPACE, INC., individually and Joint Venturer

and as Successor-in-Interest; KELLY AEROSPACE

POWER SYSTEMS, INC., individually and as Joint

Venturer and Successor-in-Interest, also known as Electrosystems, Inc., also known as Confuel, Inc.; ELECTROSYSTEMS, INC., individually and as Joint Venturer and as Successor-in-Interest, also known as Consolidated Fuel Systems, Inc., also known as Confuel,

Inc.; CONSOLIDATED FUEL SYSTEMS, INC., also

known as Confuel, Inc.

(M.D. Pa. No. 4-07-cv-00886)

46a

SUR PETITION FOR PANEL REHEARING

Present: SHWARTZ, ROTH, and RENDELL, Circuit

Judges.

The petition for rehearing filed by Appellees in the

above-entitled case having been submitted to the judges

who participated in the decision of this Court, it is hereby

ORDERED that the petition for rehearing by the panel is

denied.

BY THE COURT,

s/Patty Shwartz

Circuit Judge

Dated: December 11, 2018

Lmr/cc: David I. Katzman

Tejinder Singh

Amy M. Saharia

Kannon K. Shanmugam

Catherine B. Slavin

Jeffrey R. White

Daryl E. Christopher

Lauren L. Haertlein

47a

APPENDIX C

IN THE UNITED STATES DISTRICT COURT FOR

THE MIDDLE DISTRICT OF PENNSYLVANIA

JILL SIKKELEE, Individually and as Personal Representative of the ESTATE OF DAVID SIKKELEE,

deceased,

Plaintiff,

v.

AVCO CORPORATION, et al.,

Defendants.

No. 4:07-CV-00886

Filed: August 3, 2017

MEMORANDUM OPINION

BRANN, United States District Judge.

A weightless innocence so often attends our daydreams of flight. As the American aviator John Gillespie

Magee, Jr., loftily described it, pilots “dance[ ] the skies

on laughter-silvered wings,” soaring “high in the sunlit silence.” 1 Sadly, it would seem that Magee’s “high untrespassed sanctity of space” must belong to a universe far

1

John Gillespie Magee, Jr., “High Flight” (1941).

48a

away from the dark origins and convoluted history of this

case.

Initiated in 2007, two years after David Sikkelee, Jr.,

died in a fiery plane crash, the instant litigation has

charted an eventful path full of intricate factual, legal, and

regulatory detours. At its core is an allegation by the

Plaintiff that her deceased husband’s plane lost power

when screws that held the engine’s carburetor together

came loose. AVCO Corporation’s Lycoming Engine division (hereinafter “Lycoming”), who filed the two pending

motions, did not manufacture or install the carburetor

that powered the aircraft on that fateful day.

In January 2013, the matter was reassigned to me, and

in September 2014, relying upon Abdullah v. American

Airlines, Inc. 181 F.3d 363 (3d Cir. 1999), I held that

Plaintiff’s state tort claims against Lycoming were field

preempted by Federal Aviation Administration (FAA)

regulations. Sikkelee v. Precision Airmotive Corp., 45 F.

Supp. 3d 431 (M.D. Pa. 2014). In April 2016, during the

ensuing interlocutory appeal, the United States Court of

Appeals for the Third Circuit repudiated Abdullah’s

breadth but instructed me to consider whether Plaintiff’s

state law claims might nevertheless be conflict

preempted. Sikkelee v. Precision Airmotive Corp., 822

F.3d 680 (3d Cir. 2016). Thereafter, in November 2016,

the Supreme Court of the United States denied Lycoming’s petition for a writ of certiorari. AVCO Corp. v.

Sikkelee, 137 S. Ct. 495 (2016).

On remand, Lycoming has submitted two new motions

for summary judgment. One motion challenges the extent

of Lycoming’s liability for third-party modifications; the

other sounds in recent conflict preemption jurisprudence.

49a

I conducted oral argument on May 19, 2017 and received

supplemental briefing.

Lycoming has on numerous occasions vociferously

challenged a prior decision in this case that exposed it to

liability for subsequent modifications made by an aftermarket parts manufacturer. That holding was reached by

my colleague, the Honorable John E. Jones III, to whom

this matter was originally assigned. In particular, Judge

Jones concluded that Lycoming, a type certificate holder,

could be held liable for modifications made by the thirdparty manufacturer who overhauled the engine’s carburetor. In Judge Jones’s view, “while Lycoming’s hands were

not physically present in the plant during the manufacture or in the shop during the overhaul, its invisible hands

were undeniably present.” ECF No. 299 at 17.

Although I have previously expressed skepticism at

this holding, it is evident now, with the benefit of thorough

argument, that this expanded notion of liability is unsupported by the law and is partially responsible for sending

this litigation into an academic tailspin. One might say

that since I was first assigned to this matter, “I have acquired new wisdom . . . or, to put it more critically, have

discarded old ignorance.” Ring v. Arizona, 536 U.S. 584,

611 (2002) (Scalia, J., concurring). Now having gained familiarity with the applicable regulations, the FAA approvals, and the production history at issue here, I must conclude that Lycoming’s connection to the allegedly defective component was too far removed to subject it to tort

liability. Indeed, the third-party manufacturer, without

Lycoming’s knowledge or approval, acted pursuant to its

own aftermarket parts agreement when it overhauled the

carburetor in a manner that Lycoming could never have

50a

foreseen. Summary judgment is warranted on that

ground alone.

Further, by arguing that those subsequent carburetor

modifications were attributable to Lycoming because the

third-party manufacturer was bound by regulation to follow the type certificate holder’s designs, Plaintiff has

chanced upon a second reason why her claims must fail:

they are conflict preempted. Because it was impossible for

Lycoming and the aftermarket parts manufacturer to unilaterally comply with both state tort law and federal regulations, as in Mutual Pharmaceutical Co. v. Bartlett, 133

S. Ct. 2466 (2013), and PLIVA, Inc. v. Mensing, 564 U.S.

604 (2011), I will grant summary judgment in Lycoming’s

favor on this independent ground.

I. BACKGROUND

As the late Honorable Robert H. Jackson, Associate

Justice of the Supreme Court, once remarked, “Planes do

not wander about in the sky like vagrant clouds. They

move only by federal permission, subject to federal inspection, in the hands of federally certified personnel and

under an intricate system of federal commands.” Northwest Airlines v. State of Minnesota, 322 U.S. 292, 303

(1944). Justice Jackson’s observation sprang from “the

national responsibility for regulating air commerce” and

reinforced the notion that the “air is too precious as an

open highway to permit it to be owned” by local interests.

Id. “Local exactions and barriers to free transit in the air

would neutralize its indifference to space and its conquest

of time.” Id.

Nearly three-quarters of a century later, Justice Jackson’s prescient concerns about an excessively splintered

airway regulatory system ring just as true. Indeed, those

51a

animating federalist principles are precisely why Congress has established an administration whose sole mission is to assure the safety of our nation’s skies. This background section examines the FAA’s intricate framework

of regulations, a fraction of whose existence Justice Jackson could only imagine in 1944. It then connects those regulations to the narrative of this case.

A.

In 1958, Congress Creates The Federal Aviation Agency And Bestows Upon It Dominion

Over The Skies.

Congress passed the Federal Aviation Act of 1958 to

regulate aviation in a way that would “best foster its development and safety” and would ensure the “safe and efficient use of the airspace.” 85 Pub. L. No. 726, 72 Stat.

731. The Act created the position of an Administrator who

would be appointed by the president to head the agency.

49 U.S.C. §§ 106(b). As part of his official role, the Administrator must prescribe, among other regulations, minimum standards for the design, construction, inspection,

and overhauling of aircraft and their engines. Id.

§ 44701(a)(1)–(2).

Concerned with a lack of coordination amongst our nation’s transportation systems, President Lyndon B. Johnson worked jointly with Congress to create the Department of Transportation (DOT) in 1967, at which time the

Federal Aviation Agency was renamed the Federal Aviation Administration (FAA) and brought within the DOT’s

purview. See A Brief History of the FAA. 2 Since that time,

the FAA has continued to fulfill its regulatory mission,

and today, its nearly 50,000 employees make it the largest

2

https://www.faa.gov/about/history/brief_history/.

52a

subdivision within the DOT. See FACT SHEET. 3 Recent

estimates suggest that more than 1.7 million passengers

board a flight in the United States every day, and the FAA

oversees more than 50 million commercial, military, and

general aviation flights per year. See id.

Acting on the powers vested in it by Congress through

the Federal Aviation Act and corresponding grants, the

FAA has littered the books with a maze of regulations not

readily traversed by most laypersons. Like other parallel

regulatory regimes that have exposed state tort claims to

conflict preemption defenses, Mutual Pharmaceutical

Co. v. Bartlett, 133 S. Ct. 2466 (2013) (FDA drug regulations); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)

(same), the FAA’s regulations are highly particularized,

govern nearly every aspect of the regulated field, and are

born from the twin aims of ensuring the safety of consumers and protecting the public. See, e.g., Elsworth v. Beech

Aircraft Corp., 691 P.2d 630, 636 (Cal. 1984) (FAA regulations protect not only “those who fly in airplanes” but also

anyone “affected by their flight”).

The FAA’s regulations, found at Title 14 of the Code

of Federal Regulations, are divided into three volumes,

sixty-eight parts, and thousands more detailed subparts.

See Overview—Title 14 of the Code of Federal Regulations, at 12–1. 4 Volume I contains those FAA regulations

governing definitions (Parts 1 & 3); procedure (Parts 11,

13, 14, 15, 16, & 17); and aircrafts (Parts 21, 23, 25, 27, 29,

31, 33, 34, 35, 36, 39, 43, 45, 47 & 49). Volume II contains

https://www.faa.gov.news/press_releases/news_story.cfm?news

ID=12903.

3

4

https://www.faa.gov/regulations_policies/handbooks_manuals/aircraft/amt_handbook/media/FAA–8083–30_Ch12.pdf.

53a

the regulations governing airmen (Parts 61, 63, 65, & 67);

airspace (Parts 71, 73, & 77); air traffic and operation

(Parts 91, 93, 95, 97, 99, 101, 103, & 105); and air carriers

(Parts 119, 121, 125, 129, 133, 135, 136, 137, & 139). Volume

III covers flight schools (Parts 141, 142, 145 & 147); airports (Parts 150, 151, 152, 155, 156, 157, 158, 161, & 169);

navigational facilities (Parts 170 & 171); administrative

regulations (Parts 183, 185, 187, 189, & 193); and insurance (Part 198). Id. at 12–2. In fact, the FAA typically only

assigns odd numbers to its major batches of regulations

in order to leave room for new regulations that will eventually fill in the even-numbered gaps. See id. at 12–3.

According to an FAA letter brief submitted to the

Third Circuit in this case, the FAA has instituted a threestage process to ensure that all new aircrafts components

comply with established design standards. See FAA Ltr.

Br., ECF No. 534-1, at 4 (hereinafter “FAA Ltr. Br.”).

These three steps are: (1) type certification; (2) production certification; and (3) airworthiness certification. For

the purpose of resolving the pending motions, I will review the pertinent regulations with an emphasis on those

comprising type certification. Then, I will discuss how a

type certificate might be amended and how aftermarket

manufacturers who do not possess the type certificate

nevertheless may produce replacement parts by way of a

“Parts Manufacturer Approval.” Finally, I will explain

how those regulations apply to this dispute.

54a

B.

Obtaining A Type Certificate Is An Onerous

Process Requiring Numerous Submissions

That Precisely Detail The Specifications Of

The Proposed Aircraft, Its Engine, And Related Components.

The first step in production requires a manufacturer

who wishes to produce a new aircraft, aircraft engine, or

propeller to obtain a “type certificate.” A type certificate

confirms that the aircraft or its component is properly designed and manufactured, and satisfies all applicable regulatory standards. See id. See also 49 U.S.C. § 44704(a);

14 C.F.R. § 21.21. A manufacturer must obtain a type certificate before producing a new aircraft or engine, unless

a type certificate already exists for the precise design or

it has a licensing agreement to produce the aircraft or engine with the type certificate holder. 14 C.F.R. § 21.6.

All type certificate applications are required to be

completed on a form and in a manner prescribed by the

FAA. Id. § 21.15. They are submitted to the appropriate

aircraft certification office and must be accompanied by a

three-view drawing of the aircraft, available preliminary

basic data, a description of the engine design features, the

engine operating characteristics, and the proposed engine

operating limitations. Id. § 21.15. A type certificate application must demonstrate compliance with all applicable

regulatory requirements, must provide the FAA the

means by which such compliance has been shown, and

must also supply a statement certifying as much. Id.

§ 21.20.

An applicant may not obtain a type certificate unless

the FAA Administrator expressly finds that the proposed

aircraft, aircraft engine, propeller, or appliance is

55a

“properly designed and manufactured, performs

properly, and meets the regulations and minimum standards.” 49 U.S.C. § 44704(a). Indeed, 14 C.F.R. § 21.21 (entitled “Issue of type certificate: normal, utility, acrobatic,

commuter, and transport category aircraft; manned free

balloons; special classes of aircraft; aircraft engines; propellers”) instructs applicants as follows:

An applicant is entitled to a type certificate for an

aircraft in the normal, utility, acrobatic, commuter,

or transport category, or for a manned free balloon, special class of aircraft, or an aircraft engine

or propeller, if—

...

(b)

The applicant submits the type design, test

reports, and computations necessary to

show that the product to be certificated

meets the applicable airworthiness, aircraft

noise, fuel venting, and exhaust emission requirements of this subchapter and any special conditions prescribed by the FAA, and

the FAA finds—

(1)

Upon examination of the type design, and after completing all tests

and inspections, that the type design and the product meet the applicable noise, fuel venting, and

emissions requirements of this

subchapter, and further finds that

they meet the applicable airworthiness requirements of this subchapter or that any airworthiness provisions not complied with are com-

56a

pensated for by factors that provide an equivalent level of safety;

and

(2)

For an aircraft, that no feature or

characteristic makes it unsafe for

the category in which certification

is requested.

As that regulation makes clear, the FAA must receive

a number of submissions, including the type design, test

reports, and computations that show that the product for

which certification is sought meets all applicable regulatory standards. This process is often “intensive and painstaking”: a commercial aircraft manufacturer seeking a

new type certificated aircraft might submit 300,000 drawings, 2,000 engineering reports, and 200 other reports in

addition to completing approximately 80 ground tests and

1,600 hours of flight tests. Sikkelee, 822 F.3d at 684–85

(citing United States v. S.A. Empresa de Viacao Aerea

Rio Grandense (Varig Airlines), 467 U.S. 797, 805 n. 7

(1984)).

The “type design” portion of the type certificate application is governed by 14 C.F.R. § 21.31. Under that regulation, the type design must consist of: (1) drawings and

specifications; (2) structural information on materials and

dimensions; (3) a showing of continued airworthiness; (4)

inspection and preventative maintenance programs; and

(5) any other information relevant to airworthiness, noise,

fuel venting, and emissions determinations. In addition,

the type certificate applicant must submit to the FAA a

statement confirming that the manufactured aircraft engine or propeller presented for certification in fact conforms to its submitted type design. Id. § 21.53(a).

57a

The concept of “airworthiness” as the type design regulation refers to it, is explained in greater detail at 14

C.F.R. § 23 for aircrafts and at 14 C.F.R. § 33 for aircraft

engines. For instance, § 21.23 (aircrafts) contains subparts on flight (§§ 23.21–23.255); structure (§§ 23.301–

23.575); design and construction (§§ 23.601–23.871); powerplant (§§ 23.901–23.1203); equipment (§§ 23.1301–

23.1461); and operating limitations and information

(§§ 23.1501–23.1589).

As to an engine specifically, the airworthiness regulations require that its materials be established on the basis

of experience or tests and conform to approved specifications that ensure their strength and continued durability.

Id. § 33.15. A separate regulation provides that an engine’s design and construction “must minimize the development of an unsafe condition of the engine between overhaul periods.” Id. § 33.19(a). Other regulations governing

engine construction in general pertain to engine mounting

attachments (§ 33.23) and engine instrument connections

(§ 33.29).

Fueling mechanism are regulated in part by 14 C.F.R.

§ 33.35(a), which requires that a reciprocating or piston

engine’s fuel injection system “be designed and constructed to supply an appropriate mixture of fuel to the

cylinders throughout the complete operating range of the

engine under all flight and atmospheric conditions.” One

regulation in that subpart also requires that the engine be

designed and constructed in such a way that avoids excessive stress or vibrations. Id. § 33.33. Another regulation

also governs an engine’s lubrication system. Id. § 33.39.

In addition to the type design and its components, all

type certificate applicants must permit the FAA to conduct any necessary inspections, flight tests, and ground

58a

tests necessary to show that the proposed product satisfies all applicable regulations. Id. § 21.33. These inspections ensure, among other things, that (1) the proposed

product complies with the applicable airworthiness, aircraft noise, fuel venting, and exhaust emission requirements; (2) materials and products conform to the specifications in the type design; (3) parts of the products conform to the drawings in the type design; and (4) the manufacturing processes, construction and assembly conform

to those specified in the type design. Id. § 21.33(b).

Once the applicable ground tests and compliance are

completed, the applicant must conduct flight tests to determine whether there is reasonable assurance that the

aircraft, its components, and its equipment are reliable

and functioning properly. Id. § 21.35(b)(2). Such tests require upwards of 150 to 300 hours of flight time, depending upon whether the particular engine type was already

incorporated in an earlier type certificated aircraft. Id.

§ 21.35(f)(1)–(2). By regulation, these flight tests must be

conducted by a certified pilot. Id. § 21.37. The applicant

must also submit all reports regarding calibration of testing instruments and allow the FAA to audit the accuracy

of those reports. Id. § 21.39.

Importantly, every type certificate “is considered to

include” the type design, the operating limitations, the

certificate data sheet, and other applicable specifications

submitted thereto. Id. § 21.41.

The type certificate data sheet, which § 21.41 explicitly

incorporates into the type certificate itself, has been defined in various FAA orders as “the part of the type certificate documenting the conditions and limitations necessary to meet certification airworthiness requirements.”

59a

See FAA Order 8110.4C, Type Certification, at 68 (hereinafter “FAA Type Certification Order”). 5 The type certificate data sheet “provid[es] a concise definition of the

configuration of a type-certificated product” and “is necessary to enable any person to easily find information

about a specific product.” Id. In other words, it “records

the type certification data of a product (such as control

surface movement limits, operating limitations, placards,

and weight and balance) that may also be available in the

flight manual or maintenance manual in accordance with

FAA Order 8110.4.” See FAA Order 8110.121, Type Certificate Data Sheet Notes, at 2 (hereinafter “FAA TCDS

Order”). 6 Although 14 C.F.R. § 21.41 does not separate

the type certificate data sheet into a main section and a

notes section, the FAA has elected to do so for clarification and standardization purposes. Id.

A type certificate remains effective until it is surrendered, suspended, revoked, or a termination date set by

the FAA has passed. Id. § 21.51. Holders of type certificates and other related production authorizations have a

continuing duty to report known defects, failures, and

malfunctions to the extent that they result in any of a

number of enumerated occurrences. Id. § 21.3.

https://www.faa.gov/documentLibrary/media/Order/FAA_Order_8110_4C_Chg_6.pdf.

5

6

https://www.faa.gov/documentLibrary/media/Order/FAA_Or

der_8110_121.pdf.

60a

C.

A Type Certificate Holder May Not Independently Change A Type Certificate’s Type

Design Details Without First Obtaining FAA

Approval.

A type certificate holder may not implement type design changes absent the FAA first explicitly approving

such modifications. Command of several of the regulations’ terms of art is required to see why this is so. The

FAA has set forth two types of modifications relevant

here: (1) alterations and (2) type design changes. 7 The

regulations conceive of type design changes as a specific

subset of alterations that would modify the type design.

Recall that the regulations make clear that the “type design” includes all pertinent drawings and specifications

necessary to define the configuration and the design features of the product; information on dimensions, materials, and processes necessary to define the structural

strength of the product; and the required airworthiness

criteria. 14 C.F.R. § 21.31.

To add an additional layer of classification, the regulations also define all alterations and type design changes

as “major” or “minor.” The definition of a major alteration

The regulations name a third category: “repairs,” which mirror

alterations. However, because Plaintiff’s proposed modifications constitute alterations and not repairs, I focus on the former. See FAA

Order 8110.37E, Designated Engineering Representative (DER)

Handbook, https://www.faa.gov/docmentLibrary/media/Order/

8110.37E.pdf, at 27 (hereinafter “FAA DER Handbook”). (“A repair

is the restoration of a damaged product or article accomplished in

such a manner and using material of such quality that its restored

condition will be at least equal to its original or properly altered condition. . . . An alteration is the modification of an aircraft from one

sound state to another sound state; the aircraft meets the applicable

airworthiness standards both before and after the modification.”).

7

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is not coextensive with that of a major type design. Consequently, a major alteration need not also be a major

type design change. This background is important because the particular form of FAA approval necessary depends upon whether the proposed modification is a major

or minor alteration and on whether it constitutes a major

or minor type design change (if it constitutes a type design

change at all).

To be clear from the outset, the regulations and the

FAA’s interpretation of its own regulations make explicit

that FAA approval is required to implement all type design changes, regardless of whether they are major or minor. As the FAA has previously explained to our Court of

Appeals during this litigation, “Certain ‘minor’ changes,

defined by regulation, may not require an amended or

supplemental type certificate, but are still subject to approval by the FAA.” FAA Ltr. Br. at 5 (citing 14 C.F.R.

§ 21.95). “[N]o matter what role a manufacturer plays in

the type-certification process, the decision to approve the

type design ultimately rests with the FAA.” FAA Ltr. Br.

at 15. “This is true even for ‘minor’ type design changes,

14 C.F.R. § 21.93(a), which are approved under a method

acceptable to the FAA.” Id. Thus, as I will discuss more

fully herein, to the extent that Plaintiff’s tort claims are

premised on a modification that would have constituted a

type design change, her tort claims fail on conflict

preemption grounds.

I note that the FAA’s interpretation of its own regulations, as provided in the cited Letter Brief, is not plainly

erroneous or inconsistent with the regulations’ text. See

Auer v. Robbins, 519 U.S. 452 (1997). To begin with, 14

C.F.R. § 21.93(a) provides that a “minor change” has no

appreciable effect on the weight, balance, structural

62a

strength, reliability, operational characteristics, or other

characteristics of the aircraft. 8 All other changes are major changes. Id. The regulations further clarify that major

changes in type design require submission all substantiating and descriptive data for inclusion in the type design

and compliance statement, all of which is subject to FAA

approval. 14 C.F.R. § 21.97. 9

Minor type design changes may be approved “under a

method acceptable to the FAA.” 14 C.F.R. § 21.95. The

FAA has clarified that implementation of minor type design changes still requires FAA approval. FAA Ltr. Br. at

5, 15. This is true in part because not only must the applicant choose a method acceptable to the FAA to effectuate

minor type design changes, but “at a minimum,” such minor changes also must be “recorded in the descriptive

The regulations do not define “appreciable.” I note that Merriam-Webster defines the term as “capable of being perceived or

measured.”

8

A manufacturer must obtain a new type certificate when it proposes any change in design, power, thrust, or weight that is so extensive that the FAA believes a substantially renewed investigation of

compliance is required. 14 C.F.R. § 21.19. The same is true of type

design changes that appreciably affect those factors. Id. § 21.93(a).

Such changes may be implemented via the issuance of an amended or

supplemental type certificate. Id. § 21.113(a). If a manufacturer does

not hold the type certificate for a product but wishes to alter that

product by introducing a major change in type design that does not

require an application for a new type certificate under § 21.19, that

person must apply to the appropriate aircraft certification office for a

supplemental type certificate. Id. §§ 21.85; 21.113(b). Consequently,

“[e]ven where a manufacturer identifies and reports a defect, it may

not unilaterally make a major change to its preapproved design; instead, the FAA must either preapprove such a change or issue an airworthiness directive that provides legally enforceable instructions to

make the product safe.” Sikkelee, 822 F.3d at 704 n.21.

9

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data, with the FAA and the applicant determining an acceptable process for approving the data supporting the

type design changes.” FAA DER Handbook at 12. The

FAA’s interpretation of its own regulations thus makes

clear that even though major type design changes often

require more formalized methods of review, minor type

design changes still must be approved before their implementation—albeit through more informal means as appropriate.

Relatedly, major and minor alterations are defined at

14 C.F.R. § 1.1. A major alteration is any alteration not

listed in the aircraft, aircraft engine, or propeller specifications that (1) might appreciably affect weight, balance,

structural strength, performance, powerplant operation,

flight characteristics, or other qualities affecting airworthiness; or that (2) is not performed according to accepted practices or cannot be performed by elementary

operations. Id. All other alterations are minor alterations.

Id. Appendix A to 14 C.F.R. § 43 provides as follows:

(a)

Major Alterations—

...

(2) Powerplant major alterations. The following alterations of a powerplant when

not listed in the engine specifications issued by the FAA, are powerplant major

alterations:

(i)

Conversion of an aircraft engine

from one approved model to another, involving any changes in

compression ratio, propeller reduction gear, impeller gear ratios or

the substitution of major engine

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parts which requires extensive rework and testing of the engine.

(ii)

Changes to the engine by replacing

aircraft engine structural parts

with parts not supplied by the original manufacturer or parts not specifically approved by the Administrator.

(iii) Installation of an accessory which is

not approved for the engine.

(iv) Removal of accessories that are

listed as required equipment on the

aircraft or engine specification.

(v)

Installation of structural parts

other than the type of parts approved for the installation.

(vi) Conversions of any sort for the purpose of using fuel of a rating or

grade other than that listed in the

engine specifications.

When a type certificate holder makes a major alteration or delegates implementation of a major alteration to

an authorized party, the alteration must be completed “in

accordance with technical data approved by the Administrator.” Id. § 379(b). The same requirement applies to certificated repair stations who perform major alterations.

Id. § 145.201(c)(2). “Approved data” used to make major

alterations means data approved by the FAA or any person to whom the FAA has delegated its authority as to the

alteration. FAA Order 8300.16 CHG 1, at 13 (hereinafter

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“FAA Data Approval Order”). 10 “All data used to substantiate a major repair or alteration, regardless of the source,

must be approved before being used.” Id. at 13–14.

In contrast, to perform minor alterations, the applicant or an authorized third-party performs the alteration

using data “acceptable to the FAA” and must document it

in maintenance records. Id. at 1. “Acceptable data” means

data acceptable to the FAA. Id. at 13. Although acceptable

data does not “necessarily require FAA review and acceptance prior to” use, the authorized party must be able

to demonstrate that the data “meets all applicable regulatory requirements,” and the FAA may challenge that data

in a subsequent enforcement action. Id.

In that same Order describing the types of data necessary for major versus minor alterations, the FAA explained:

The use of the term(s) major and minor are sometimes inappropriately applied or misunderstood. A

major change in type design can be approved only

by an ACO as an amended type certificate (TC) or

supplemental type certificate (STC). A major alteration requires the use of FAA-approved technical data. Minor alterations only require data that

is acceptable to the FAA. During an evaluation, an

anticipated major alteration may be subsequently

classified as a major change in type design, and

thus would require application for an amended TC

or STC.

Id. at 1.

10

https://www.faa.gov/documentLibrary/media/Order/8300_16

_CHG_1.pdf.

66a

The following flowchart supplied by the FAA on page

5 of its Data Approval Order assists in visualizing a manufacturer’s regulatory burden when it seeks to implement

an alteration:

Figure 1. Alterations Flowchart

67a

Table 1 below, categorizes the changes and regulatory

burdens outlined by the regulations and the FAA’s

flowchart:

Table 1. Regulatory Burden by Modification Type

Major Alterations/Repairs

Proposed

Modification

Major

Type

Design

Change

Minor

Type

Design

Change

Minor Alterations/Repairs

No Type

Design

Change

Major

Type

Design

Change

Minor

Type

Design

Change

No Type

Design

Change

Regulatory Burden

must submit all substantiating and descriptive

data for inclusion in the

type design and compliance statement; subject

to FAA approval

may be approved under a

method acceptable to the

FAA; subject to FAA approval; requires the submission of “approved

data”

Requires the submission

of “approved data”

must submit all substantiating and descriptive

data for inclusion in the

type design and compliance statement; subject

to FAA approval

may be approved under a

method acceptable to the

FAA; subject to FAA approval

applicant performs repairs and documents in

maintenance records using data “acceptable to

the FAA”

Source

14 C.F.R.§ 21.97

14 C.F.R.§ 21.95

FAA Ltr. Br. At 5, 15

14 C.F.R.§ 121.379(b)

14 C.F.R.§ 145.201(c)(2)

14 C.F.R.§ 121.379

14 C.F.R.§ 145.201(c)(2)

14 C.F.R.§ 21.97

14 C.F.R.§ 21.95

FAA Ltr. Br. at 5, 15

FAA Order 8300.16 at 1

68a

To summarize, FAA approval is required for any major or minor changes to an article’s type design, as well as

for any major alteration. A major alteration is one that

“might appreciably affect weight, balance, structural

strength, performance, powerplant operation, flight characteristics, or other qualities affecting airworthiness,”

D.

Designated Engineering Representatives

(DERs) Pose No Issue As To Conflict Preemption Because At All Times, DERs Act Within

The Scope Of Their FAA Delegation And Ensure That FAA Regulations Are Followed.

Recall that minor type design changes may be approved “under a method acceptable to the FAA.” 14

C.F.R. § 21.95. One such method requires obtaining approval from an FAA designated engineering representative (DER). Plaintiff has suggested that changes implemented by way of DER approval would not be conflict

preempted because some DERs may nominally be hired

by private aircraft manufacturers. That argument is unavailing, however, because the FAA delegates to its DERs

the power to approve modifications and otherwise act on

the Administration’s own behalf. Further, DER approval

would likely have been insufficient to implement the proposed changes complained of here.

Section 44702(d) of the Federal Aviation Act (entitled

“Delegation”), sets forth the authority for the FAA to empanel DERs to act as surrogates of the Administration,

subject at all times to its regulations. That Section provides as follows:

(1)

Subject to regulations, supervision, and review

the Administrator may prescribe, the Administrator may delegate to a qualified private person,

69a

or to an employee under the supervision of that

person, a matter related to—

(A) the examination, testing, and inspection necessary to issue a certificate under this chapter; and

(B) issuing the certificate.

The FAA exercises significant control over its DERs

in the performance of their official duties. For instance,

DERs are typically designated to serve one-year terms,

capable of renewal for additional one-year periods at the

FAA’s discretion. See Steenholdt v. FAA, 314 F.3d 633,

635 (D.C. Cir. 2003) (Sentelle, J.) (citing 14 C.F.R.

§ 183.15). Moreover, a DER’s designation may be rescinded should the FAA find that the DER has not

properly performed his or her duties, is no longer necessary, or “for any reason the Administrator considers appropriate.” 14 C.F.R. § 183.15; 49 U.S.C. § 44702(d)(2). In

fact, the United States Court of Appeals for the District

of Columbia Circuit has held that there are “no constraints” on the FAA’s power to rescind a DER’s official

designation and that such a decision is not substantively

reviewable under the Administrative Procedures Act.

Steenholdt, 314 F.3d at 639.

Any decision by a DER may be appealed to the FAA.

Id. § 44702(d)(3), and the FAA may, “on the Administrator’s own initiative,” reconsider a DER decision at any

time. If the FAA believes that the DER’s decision was

“unreasonable or unwarranted,” it can modify or reverse

it in toto. Id.

70a

A corresponding regulation, 14 C.F.R. § 183.29(a), explicitly provides that a DER may approve structural engineering information and other structural considerations

only when he or she determines that the revisions comply

with all applicable FAA regulations. At all times, the DER

acts “within limits prescribed by and under the general

supervision of the Administrator.” Id. As the FAA’s official DER Handbook explains, “Specific roles, authorized

areas, and responsibilities of a DER are established by an

agreement between the [FAA’s Air Craft Certification Office (ACO)] and the DER at the initial appointment of a

DER, and, may be further limited for specific FAA projects.” FAA DER Handbook at 6. Moreover, DERs can

only “find compliance” on behalf of the FAA “in the delegated functions and authorized areas for which they were

appointed.” Id. at 11. The FAA also “retains authority and

responsibility for establishing the certification basis” in

such a way that “limits the data that a DER can approve.”

Id. at 12.

That same Handbook characterizes the delegatory relationship between the FAA and its DERs as follows:

Title 49, United States Code, Section 44704 (49

U.S.C. § 44704) empowers the Administrator to issue type certificates (TC) for aircraft, aircraft engines, and propellers, and to specify regulations as

applicable to the type certification function. Section 44702(d) authorizes the Administrator to delegate to a qualified private person, or to an employee under the supervision of that person, a matter related to the examination, testing, and inspection necessary to the issuance of such certificates.

Delegations are limited in scope: all requirements,

71a

policy, direction, and interpretations remain with

the Administrator.

Id. at 6. Further, any DER “must follow the same procedures that an FAA engineer must follow when performing

compliance finding functions, such as those appearing in

Order 8110.4, Type Certification, Order 8110.42, Parts

Manufacturer Approval Procedures, and Order 8110.54,

Instructions for Continued Airworthiness Responsibilities, Requirements, and Contents.” Id. The DER Manual

explains that FAA pre-authorization is required “before

exercising authority on any certification project,” and in

all cases, the DER “must follow FAA policy in determining compliance with pertinent regulations.” Id. at 21.

According to the DER Handbook, major changes require specific DER authorization. FAA DER Handbook

at 24. However, the FAA “may approve minor changes in

type design under a method acceptable to the Administrator, per 14 CFR § 21.95.” Id. This method may include approval by a DER.” Id. Thus, even where a manufacturer

believes that a proposed change is a minor one, it cannot

take independent action to make that change—its implementation instead depends upon the DER’s approval and

still remains subject to the FAA’s broad oversight at several junctures. This is consistent with the FAA’s interpretation of its own regulations. FAA Ltr. Br. at 5, 15.

Although the applicant may suggest to the DER

whether it believes a type design change is major or minor, “the FAA retains final approval of that decision, and

it cannot be delegated.” Id. at 12. To that end, the DER is

not authorized to interpret FAA regulations. Id. Instead

it “must be guided by” the FAA’s “existing policies, procedures, specifications, processes, and standards.” Id. In

72a

addition, not only must the applicant choose a method acceptable to the FAA to effectuate minor changes, but “at

a minimum,” minor changes also must be “recorded in the

descriptive data, with the FAA and the applicant determining an acceptable process for approving the data supporting the type design changes.” Id.

The United States Court of Appeals for the Fifth Circuit has described DERs as “independent contractors” of

the FAA, who although hired by the private aircraft industry to inspect private airplanes, may only approve

modifications within their delegated authority by first ensuring that the changes would comply with the regulations. Ligon v. LaHood, 614 F.3d 150, 152 (5th Cir. 2010).

“Stated differently, the DER process enables the FAA to

appoint qualified private individuals to perform examinations, tests, and inspections required to determine compliance with FAA airworthiness regulations,” ensuring “that

private industry clients who hire the DER are in compliance with FAA regulations for airworthiness standards.”

Jones v. LaHood, 667 F. Supp. 2d 714, 715 (N.D. Tex.

2009), aff’d sub nom. Jones v. United States, 625 F.3d 827

(5th Cir. 2010). See also Leica Geosystems, Inc. v. L.W.S.

Leasing, Inc., 872 F. Supp. 2d 1191, 1195 (D. Colo. 2012)

(explaining that a DER “works as a special liaison” between the FAA and private repair stations “to ensure that

the modification is in compliance with FAA regulations”).

The Supreme Court has cast the surrogacy relationship between the FAA and its DER designees in the following light:

With fewer than 400 engineers, the FAA obviously

cannot complete this elaborate compliance review

73a

process alone. Accordingly, 49 U.S.C. § 1355 authorizes the Secretary to delegate certain inspection and certification responsibilities to properly

qualified private persons. By regulation, the Secretary has provided for the appointment of private

individuals to serve as designated engineering representatives to assist in the FAA certification process. 14 CFR § 183.29 (1984). These representatives are typically employees of aircraft manufacturers who possess detailed knowledge of an aircraft’s design based upon their day-to-day involvement in its development. The representatives act

as surrogates of the FAA in examining, inspecting,

and testing aircraft for purposes of certification. 14

CFR § 183.1 (1984). In determining whether an

aircraft complies with FAA regulations, they are

guided by the same requirements, instructions,

and procedures as FAA employees. FAA employees may briefly review the reports and other data

submitted by representatives before certificating a

subject aircraft.

United States v. S.A. Empresa de Viacao Aerea Rio

Grandense (Varig Airlines), 467 U.S. 797, 807 (1984) (internal citations omitted).

As such, I note that a DER serves as a functional extension of the FAA, working to make the Administration’s

approval process more efficient—not to lower the applicable regulatory standards. As the FAA has explained, the

DER’s purpose is to “expedit[e] accomplishment of required demonstrations of compliance with applicable airworthiness standards” and to “reduce or eliminate delays

in obtaining required certifications.” Designated Airworthiness Representatives, 48 Fed. Reg. 16176.

74a

Neither is it significant that DERs may at times be

nominally employed third-party aviation entities when

they perform the regulatory role that the FAA has delegated them. “The FAA has stated that ‘when performing

a delegated function, designees are legally distinct from

and act independent of the organizations that employ

them.’” Swanstrom v. Teledyne Cont’l Motors, Inc., 531

F. Supp. 2d 1325, 1333 (S.D. Ala. 2008) (quoting Establishment of Organization Designation Authorization Program, 70 Fed. Reg. 59932, 59933 (Oct. 13, 2005)). In fact,

the district court in Swanstrom described DERS as being

“subject to administrative regulations by the FAA” and

perhaps capable of being classified as “persons acting under a federal officer” for the purposes of federal removal

jurisdiction. 531 F. Supp. 2d at 1332. Moreover, a failure

by a DER to fulfill his obligations for the continued

maintenance of FAA certification is “a failure as a DER,

not as an individual airman.” Duchek v. Nat’l Transp.

Safety Bd., 364 F.3d 311, 316 (D.C. Cir. 2004). See also

Marcy v. FAA, 936 F.2d 583 (10th Cir. 1991) (upholding

substantive reasonableness of FAA’s decision not to renew DER’s commission when DER “exceeded the bounds

of his authority in violation of agency regulations” by

“continu[ing] to insist upon his own interpretation of the

appropriate regulations”).

Further, the law is clear that courts must prioritize

functional realities over cursory labels when analyzing

employment or delegation relationships. In determining

upon whose behalf an individual performs his work, “economic reality rather than technical concepts is to be the

test.” In re Enterprise Rent-A-Car Wage & Hour Employment Practices Litig., 683 F.3d 462, 467 (3d Cir. 2012)

(Garth, J.). Thus, courts in the Third Circuit’s vicinage

75a

must examine “the totality of the circumstances to determine the economic realities of the relationship” between

two entities. Jochim v. Jean Madeline Education Center

of Cosmetology, Inc., 98 F. Supp. 3d 750, 757 (E.D. Pa.

2015).

These authorities thus point to one conclusion: DER

approval is not independently undertaken by a private

manufacturer unconstrained by FAA regulations. Rather,

it is a type of delegated approval that will only be granted

when compliance with the pertinent regulations is adequately shown, and the DER has acted within the scope

of the Administration’s delegation.

E.

Parts Manufacturer Approval (PMA) Holders

Who Submit Their Own Tests And Computations To The FAA Are Not Legally Bound By

The Type Certificate Holder’s Design Decisions. Instead, Market Forces Incentivize

Them To Produce Replacement Parts Sufficiently Close To Those Approved In The Type

Certificate.

In general, aircraft replacement components may not

be produced except under the original type certificate or

a production agreement, such as a Parts Manufacturer

Approval (PMA). 14 C.F.R. §§ 21.8; 21.9(a)–(b). A type

certificate may also be transferred or made available to

third parties by way of a licensing agreement. 21 C.F.R.

§ 21.47(a). In that case, the type certificate holder must

provide to the other party to the licensing agreement a

formal written agreement acceptable to the FAA. Id.

§ 21.55. Lycoming had no licensing agreement with its codefendants regarding the subject carburetor. Instead, the

76a

co-defendants produced that part independently according to a separate agreement that they had reached with

the FAA to which Lycoming was not a party.

Make no mistake about it: type certificate holders and

PMA holders are not entities who sit at different stages of

a unified supply chain. To the extent that earlier decisions

of this Court have imputed as much, those decisions gave

analysis of this relationship much too short shrift. To the

contrary, type certificate holders and PMA holders are

competitors, as are most original equipment manufacturers (OEMs) relative to their aftermarket counterparts.

The hallmark of any such economic relationship is the

trade-off between the quality of imitations and price savings. As it were, OEMs like type certificate holders were

quick to disparage the quality of PMA parts when they

were first authorized to sell aftermarket products. In fact,

an early FAA Special Airworthiness Information Bulletin

rebuked one OEM’s attempt to analogize PMA holders to

second-rate Elvis impersonators. See FAA SAIB: NE-0840. 11 Tellingly, the FAA wrote the following in that very

same bulletin: “The FAA understands that the [type certificate] holder has no knowledge or data about the PMA

and STC parts installed in the product and, therefore, can

only assess the airworthiness and systems effects of their

parts installed in the product.”

This strict dichotomy between OEMs like type certificate holders and aftermarket part producers like PMA

holders is further illustrated by the regulations. Specifically, the first regulation in the subpart on PMAs makes

11

http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgSAIB.

nsf/dc7bd4f27e5f107486257221005f069d/af4cd7d303d7ba628625749f0

06afbc7/$FILE/NE–08–40.pdf.

77a

clear that the section governs only the procedures for obtaining a PMA and the duties of PMA holders—it does not

apply to the type certification process discussed above. 14

C.F.R. § 21.301.

Third-party manufacturers seeking PMA approval

typically must obtain it by satisfying one of three methods: (1) identicality with a licensing agreement; (2) identicality without a licensing agreement; or (3) tests and computations. FAA Order 8120.22A, Production Approval

Process, at 4-7–4-8 (hereinafter “PMA Order”). 12 The parties do not dispute that the PMA relevant to the pending

motions was obtained by the tests and computations

method. This is a particularly compelling fact when considering the extent of Lycoming’s liability for subsequent

modifications, as the tests and computations method is the

type of approval that relies least upon demonstrating an

identity of structure between the type certificate holder’s

article and the article for which the PMA is sought.

In the context of the PMA process, “identicality” is a

strict notion. It requires that the PMA applicant “show[ ]

that the design of the article is identical to the design of

an article that is covered under a type certificate.” 14

C.F.R. § 21.303(4). An applicant seeking approval by way

of identicality must certify that the proposed design “is

identical in all respects” to the already-approved design.

PMA Order at 4–8. That certification must be supported

by data. Id. Further, identicality with an existing PMA is

insufficient to obtain approval for a subsequent PMA. Id.

The previously approved design from which identicality is

12

https://www.faa.gov/documentLibrary/media/Order/FAA_Order_8120_22A.pdf.

78a

measured must have received type certification or an

equivalent approval. Id.

Absent such a showing, the applicant must submit test

reports and computations showing that the design of the

article meets the applicable airworthiness requirements.

Id. When a PMA applicant selects the tests and computations route, it must submit a “data package” indicating

that “all design, materials, processes, test specifications,

system compatibility, and interchangeability are supported by an appropriate test and substantiation plan for

FAA review and approval.” Id. A tests and computations

application must contain: (1) a compliance checklist as to

the regulatory requirements; (2) test reports and computations; (3) a safety assessment; and (4) a continued operation safety plan. See FAA Advisory Circular 21.303-4, at

5 (hereinafter “PMA Advisory Circular”). 13

The test reports and computations must “show that an

article’s design meets the applicable airworthiness requirements of its respective product.” Id. at 7. Although

the scope and rigor of each test may vary, the FAA requires that they at least include: (1) a safety assessment

that characterizes the nature of the article and its effect

on safety; (2) computations that show regulatory compliance or substantiate the comparative analysis; and (3) test

results that show direct regulatory compliance or verify

the comparative analyses. Id. At all times, the focus is on

the proposed articles “purpose, physical characteristics,

13

https://www.faa.gov/documentLibrary/media/Advisory_Circular/AC_21.303–4.pdf.

79a

interfaces with its product, and hot its failure modes impact safety.” Id. 14

All of these tests are completed and summarized by

the PMA applicant, not by the type certificate holder. Id.

Indeed, the type certificate holder has no place in the

PMA process. As counsel for Plaintiff, Tejinder Singh,

Esquire, explained at oral argument, the relationship between a PMA article and a type-certificated one is primarily that of imitation motivated by economic incentives. As

Mr. Singh described, “[T]he reason that [the PMA holder]

designs things the way it does is not so much that the FAA

. . . created a design for it to follow. It is that it wants to

produce parts for use on [the type certificate holder’s] engines. Right. That’s its economic motivation.” Tr. of May

In an eleventh-hour argument, Plaintiff contended in supplemental briefing that the PMA holder in this case may have been exempted from obtaining FAA approval because it qualified as an FAAcertified “repair station.” This argument is unavailing for several reasons. First, the facts reveal that the subject carburetor overhaul discussed more fully herein was accomplished by virtue of the manufacturer’s status as a PMA holder, not in its capacity as a repair station

as Plaintiff’s post hoc characterization might suggest. Second, no evidence in the record suggests that the carburetor overhaul would have

qualified as a “repair” as the FAA regulations define that term, rather than an as “alteration.” To the contrary, it appears that the overhaul process began with the subject engine in an airworthy state.

Third, FAA repair stations, similar to DERs, are bound by the scope

of their FAA designation, and Plaintiff has presented no evidence that

the FAA would have permitted this particular aftermarket manufacturer to institute such a change in engine design that would have allegedly had a significant impact on reliability and airworthiness under the guise of a “repair.” Finally, the record is silent as to when

precisely this PMA holder became an FAA-certified repair station

and whether that designation was active at the time of the 2004 overhaul.

14

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19, 2017 Oral Arg., ECF No. 562, at 138:22–25 (hereinafter “May 2017 Tr.”). “The reason that manufacturers like

[the PMA holder] get in the position they’re in is because

they just to sell parts for these engines,” he continued.

“[T]hey follow the OEM design as closely as possible.” Id.

at 139:09–12.

In response to my follow-up question “So you are saying out of their own free will that they would follow the

type certificate design? Not a mandate from someone?”

Mr. Singh answered, “Well, it’s not their own—so the reason they seek the approval they seek, yes, is to conform to

the type certificate and design. Yeah, that’s a decision

they make.” Id. Mr. Singh would go on to explain:

[T]hat’s not how the PMA business works. If you

want to make parts to put on [type-certificated] engines, you mimic the design as closely as possible.

Right?

You may not want to have to source your parts

from [the type certificate holder]. You may want to

get them yourself cheaper. You may want to sell

them to whoever [sic] you want to sell them to. All

of that, as a matter of economics, makes perfect

sense.

Id. at 101:19–25.

“Only the FAA or an [Organization Designation Authorization (ODA)] can issue PMA. DERs do not issue

PMAs, but support the FAA approval process with findings within their limitations.” In addition, “a DER may

only recommend approval within the scope of their authority for critical parts.” Id. FAA Order 8110.42D, Parts

Manufacturer Approval Procedures, at 3–2 (hereinafter

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“FAA PMA Procedures”). 15 A “critical part” is typically

one “for which a replacement time, inspection interval, or

related procedure is specified in the Airworthiness Limitations section of a manufacturer’s maintenance manual

or Instructions for Continued Airworthiness.” 14 C.F.R.

§ 45.15(c).

Further, Appendix A to the FAA’s DER Handbook

(entitled “Limitations on DER Functions”) specifically

states that “The following items are approved or issued

only by the FAA: . . . (d) TCs, PMAs, . . . . ” A provision in

the Handbook directly reference the list of functions reserved to the FAA states: “[W]e generally reserve for

ourselves the approval of items listed in appendix A, paragraph 2. If we do delegate, we should do it carefully and

consistently as follows: . . . (4) PMA Design Approvals. A

DER may make findings of identicality or findings of compliance to the airworthiness requirements by test and

computation that contribute to PMA design approvals,

within the scope of delegation from the project ACO. The

DER must be specifically authorized to make a finding of

identicality by the managing ACO.”

The process for implementing design changes to a

PMA tracks those for type certificates and type design

changes. In particular, 14 C.F.R. § 21.319(a) defines a

“minor change” to a PMA as “one that has no appreciable

effect” on its basis for approval. All other design changes

are “major changes.” Id. For major changes, the PMA

holder “must obtain FAA approval” before including the

change in a renewed design. Id. 21.319(b). Minor changes

to the basic design of a PMA “may be approved using a

15

https://www.faa.gov/documentLibrary/media/Order/8110.42D.pdf.

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method acceptable to the FAA.” Id. Recall that “a method

acceptable to the FAA” is the same language that the

FAA has previously interpreted in this case to require

FAA approval before independent action can be taken.

FAA Ltr. Br. at 5, 15. The scope of a DER’s authority to

implement post–PMA major repairs or alterations is limited in the same way as his authority to make those repairs and alterations to type certificates. FAA DER

Handbook at 27.

F.

The Subject Engine Leaves Lycoming’s

Hands In 1969, Only To Be Placed In Storage

And Lost To Time.

With that regulatory background in mind, I now turn

to the operative facts of this case. The engine at issue, Lycoming model O-320-D2C, serial number L-6540-39A, was

manufactured on August 13, 1969 by Lycoming Engines

in Williamsport, Lycoming County, Pennsylvania. Expert

Report of W. Jeffrey Edwards, ECF No. 384-1, at 57

(hereinafter “Edwards Report”). The engine was FAA

certified under Lycoming’s E-274 Type Certificate on

May 2, 1966.

On September 4, 1969, shortly after Neil Armstrong

walked on the moon, Lycoming shipped the engine at the

heart of this dispute to Beagle Aircraft, Ltd., a British aircraft manufacturer. Declaration of James R. Stabley,

ECF No. 221–1, ¶ 3 (hereinafter “Stabley Decl.”). Beagle

apparently planned to install the engine in a small, singleengine model known as the Beagle Pup. Edwards Report

at 57–58; May Tr. at 45:18–21. However, for reasons unknown to the parties and likely lost to history, the engine

was diverted to permanent storage before it ever was installed on any aircraft whatsoever. Edwards Report at

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57–58; Stabley Report at 4. According to Mr. Edwards’s

report, Beagle was dissolved late in 1969 and its assets

were liquidated. Edwards Report at 57.

Lycoming has no record of the engine ever being returned to its factory for service after the original September 4, 1969 shipment. Stabley Decl. ¶ 6. In fact, the “Received for Repairs” section of Lycoming’s internal engine

record form for the engine is entirely blank for that time

period. ECF No. 221-1 Ex. A. Moreover, the parties suspect that the individual who signed certain of the earliest

available records has either since died or has become non

compos mentis. May 2017 Tr. at 10:14–19. Lycoming

maintained no further records of the subject engine until

after the accident was reported—it did not know where

the engine was or even that it still existed.

At the time Lycoming manufactured and shipped the

engine to Beagle in 1969, the engine was equipped with a

Marvel-Schebler model MA-4SPA, setting 10-3678-32,

carburetor with serial number A-25-15850. Stabley Decl.

¶ 4. The carburetor is critical to ensuring that the engine

itself generates sufficient power for the aircraft, as the

carburetor is responsible for delivering the appropriate

mix of air and fuel for combustion in the engine. The specific workings of this carburetor are explained more fully

herein.

84a

G.

In 1998, After 29 Years In Storage, The Subject

Engine Is Removed, Maintenance Is Performed, And The Engine Is Installed On An

Aircraft For The First Time, Which Aircraft

Did Not Even Exist In 1969.

On September 1, 1998, the subject engine was removed from storage. Edwards Report at 59. One additional expert report submitted in this case points out that

during this period of long-term storage, the engine at

least twice would have missed its scheduled 12-year overhaul date and therefore would not be in compliance with

Lycoming’s service instructions. Expert Report of James

R. Stabley, ECF No. 381-1, at 7 (hereinafter “Stabley Report”). The following maintenance was performed in 1998

as recorded in the engine’s logbook:

(a) “Removed 4 cylinders and prop flange crankshaft

plug, inspection found new condition”;

(b) “Replaced cylinders using new Lycoming original

kits”;

(c) “Replaced Prop Flange Bushings with new”;

(d) “Replaced Magnetos with Slick mag and harness

kit”;

(e) “Install serviceable Alt Motorcraft 00 FF 103000

OH 1-23-95”;

(f) “Install new OH carb 10-5135 SN CK-611739”; and

(g) “Installed new Lycoming Alt drive belt, new

Champion REM40E plugs.”

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Edwards Report at 59.

By October 16, 1998, the engine was installed on a 1976

Cessna 172N bearing registration N73747 after a previous engine was removed from that same plane. Id. All of

the maintenance work and reinstallation was performed

by a third-party and not by Lycoming. See id. at 58–59. In

fact, at that time, the engine was not even type certificated

for installation in the 1976 Cessna 172N, presumably because the Cessna 172N did not exist at the time Lycoming

obtained the original type certificate for its engine. Id. See

also Tr. of Nov. 13, 2013 Fed. R. Evid. 104 Hr’g, ECF No.

459, at 229:19–21 (hereinafter “Nov. 2013 Tr.”); May 2017

Tr. at 22:13–18.

An exemplar of a Cessna 172N taken from Mr. Edwards’s Report is depicted below:

Figure 2. Cessna 172N Exemplar

86a

All told, after having been left in storage for nearly

three decades, the engine was removed, maintenance was

performed, and it was installed an aircraft for which it was

not originally certified and for which supplemental approval was required. The owner of the Cessna at that time

was listed as LaGrange Machine Shop, Inc., whose business address was 1706 Shorewood Drive, LaGrange, GA

30240. See ECF No. 234-1 at 6–7. Based on that same

hoary 1998 maintenance record, the individual who performed the maintenance on behalf of LaGrange appears

to be James O. Perry. Id. Nothing in the record indicates

the LaGrange or Mr. Perry bore any relationship to Lycoming whatsoever. Until this litigation commenced, Lycoming likely never knew either existed.

Because the engine was not type certificated for installation on a Cessna 172N, Mr. Perry was required to submit an FAA Major Alteration Form 337, dated December

1, 1998. See ECF No. 234-1 at 6–7. That alteration was

field approved by Peter J. Van Leeuwuen, acting within

the scope of his FAA inspection authorization. See id. at

6. 16 On the approval form, Mr. Van Leeuwen’s address is

the same as LaGrange’s above.

Mr. Edwards’s report also suggests that the October

1998 installation did not comply with Lycoming Service

Instruction 1009AM regarding overhaul periodicity and

failed to address several outstanding airworthiness directives. Edwards Report at 59. This is “consistent with substandard maintenance,” Mr. Edwards wrote, as the aircraft was operated while not airworthy between October

16

“Field approval” is a method by which the FAA grants one-time

approval for technical data used to accomplish a major repair or a

major alteration on a single aircraft. FAA Data Approval Order at 3.

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1998 and December 1998, and again between December

1998 and August 2004. Id.

According to Mr. Edwards, the reason that the engine

required such immediate repair in December 1998 after

its October 1998 installation was because it sustained a

broken lifter body component after being placed into service for just 12.3 hours. Id. at 60. According to his report,

“The engine had significant problems due to corrosion

from its long-term storage, necessitating a complete disassembly and inspection.” Id.

H.

The Subject Aircraft Is Struck By Lightning,

After Which Time And Without Lycoming’s

Approval Or Knowledge, Kelly Aerospace

Overhauls The Subject Carburetor And Replaces It With An Aftermarket Conglomerate,

Pursuant To An Independent, Third-Party

PMA From The FAA.

In July 2004, the engine was removed after the aircraft

was struck by lightning. Stabley Report at 4; Edwards

Report at 61. The record is unclear as to whether the

strike occurred while the aircraft was grounded or in

flight and whether the aircraft was activated at the time

of the strike. Nevertheless, from December 1998 until the

July 2004 lightning strike, the aircraft flew for 1,262.6

problem-free hours. Stabley Report at 4; Edwards Report

at 61.

At that time and while the engine was removed for inspection, Triad Aviation, Inc., overhauled the entire engine. Stabley Report at 4; Edwards Report at 62. During

the overhaul, Triad removed the carburetor itself from

the engine and sent it to Kelly Aerospace Power Systems

to be overhauled separately. Kelly’s principal place of

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business was Alabama. Second Am. Compl., ECF No. 205,

at ¶ 4.

Under 14 C.F.R. § 43.2, “overhaul” is a regulatory

term of art, which describes the process by which a component, using methods, techniques, and practices acceptable to the FAA, has been disassembled, cleaned, inspected, repaired as necessary, and reassembled. Overhaul methods must be conducted in accordance with FAAapproved standards and technical data, and adequately

documented. Id. Component overhauls, for instance, follow a sort of Humpty-Dumpty process, whereby the components are disassembled and all of the internal parts are

separated, repaired, or replaced, at which point the overhauling entity endeavors to put all of the pieces back together again. See Defendant Kelly’s Revised Responses

to Lycoming’s Request for Admission, ECF No. 221-2

(hereinafter “Kelly Admissions”).

As discussed earlier, the carburetor is the engine component that meters the air-fuel mixture supplied to the engine so that the combustion process functions efficiently

and powers the engine accordingly. During the November

2013 Rule 104 Hearing before this Court, Plaintiff’s expert, Donald E. Sommer, explained the significance of the

carburetor to an aircraft engine, as well as how a carburetor like the one at issue typically functions. Sitting upright, the bottom of the carburetor connects to the air box

from which it receives air, and the top of the carburetor

connects to the engine into which it supplies metered air.

Nov. 2013 Tr. at 22:20–23:04.

The bottom of the carburetor is called the float bowl

because it is a bowl-shaped compartment that contains

the fuel. Id. at 23:05–08. The top half of the carburetor is

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known as the throttle body because it contains the throttle, the device that meters the flow of air and fuel to the

engine. Id. at 23:08–11. The two parts parts—the float

bowl and the throttle body—connected by four hex head

screws and bolts. Id. at 23:11–13. Two schematics from

Mr. Sommer’s report are depicted below for reference:

Figure 3. MA-4SPA Carburetor Operational Schematic

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Figure 4. MA-4SPA Carburetor Throttle Body Screws

Schematic

According to Mr. Sommer, it is very important that

the carburetor regulate how much air passes through it,

because the metered fuel should emerge as a fine mist or

spray. Id. at 24:17–20. If the fuel is emitted in globules or

large droplets, however, the engine will not be able to

burn it efficiently, and the aircraft’s horsepower will be

minimal. Id. at 24:20–25. Eventually, if the fuel content in

the mixture is continuously concentrated rather than

finely dispersed, the engine may even cease to run. Id. at

24:25–25:01.

In between the float bowl and the throttle body is a

gasket that permits an airtight seal. Id. at 28:02–04. That

gasket is held in place by four bolts and lock washers that

connect the throttle body to the float bowl. Id. at 28:05–

06. The bolt has a screw slot, but it also features a hexed

head, so that it can be installed either by a screwdriver or

a wrench. Id. at 29:16–19. When a mechanic fastens the

91a

system together after a repair or overhaul, he or she

would take the bolt, drop it into the lock washer holes,

drop the bolts into the throttle body holes, put the throttle

body on top of the float bowl, and screw the bolts into the

threaded holes featured on the float bowl. Id. at 29:19–23.

A corresponding photo from Mr. Edward’s report depicts

not only this portion of the MA-4SPA carburetor fastening process, but also the entire carburetor reconstruction:

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Figure 5. MA-4SPA Carburetor Bolt Fastening

Schematic

With those visuals in mind, I now turn the precise facts

of Kelly’s 2004 overhaul of the subject carburetor. This is

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an important juncture in the engine’s history, because although Plaintiff alleges that faulty carburetor screws

caused the plain to lose power, the original MA-4SPA carburetor shipped by Lycoming with the original in 1969

was entirely gutted and replaced by Kelly during the

overhaul. Somewhat remarkably, that fact is undisputed

(and has been) through the pendency of this litigation. Indeed, Judge Jones, in a 2012 decision, memorialized those

admissions as follows:

•

“Plaintiff admits that the carburetor that was installed on the Cessna 172N was not the same carburetor that Lycoming shipped with the engine in

1969.”

•

“Plaintiff does not dispute, that the Kelly Defendants manufactured, replaced, and shipped the carburetor and its component parts.”

•

“Plaintiff admits that Lycoming’s hands did not

physically touch the carburetor.”

ECF No. 299 at 8, 13, 15.

It is also admitted that Triad shipped the carburetor

from North Carolina to Kelly for overhaul. Kelly Admissions ¶ 5. Kelly overhauled the carburetor on or about August 3–5, 2004 using a throttle body and float bowl from

Kelly’s own core parts bank. Id. ¶ 6. Kelly also manufactured the pump plunger, the valve and seat assembly, the

single piece venturi, and the throttle shaft, and used them

to rebuild the carburetor during the overhaul. Id. ¶ 13–14.

An important facet of Kelly’s overhaul of the subject

was its selection of parts comprising the float bowl (bot-

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tom) and throttle body (top) of the carburetor. In particular, Kelly admitted that the physical manufacturing of the

float bowl was performed by an outside vendor. Id. ¶ 16.

Subsequent discovery has suggested that one half of the

carburetor was likely manufactured by Marvel-Schebler

in the 1960s because it was painted black, a practice the

company stopped in that decade. May Tr. at 16:09–14. See

also Stabley Report at 8. Another Defendant produced a

record showing that the other half of the carburetor was

manufactured in the 1970s. May Tr. at 16:14–15. Then,

Kelly used its own aftermarket parts to fasten the two

halves together. Id. at 16–20. In essence, Kelly created

what counsel for Defendant, Catherine Slavin, Esquire,

termed “a Frankenstein’s monster”—literally melding together two distinct aftermarket carburetor halves produced in subsequent decades before adjoining those two

halves with a third set of parts from a different aftermarket parts manufacturer. May Tr. at 16:09–20; 84:15–16.

Lycoming was not involved with 2004 overhaul in any

way. It had no practical control over how Kelly overhauled

the engine, and at no time did it instruct Kelly to use the

parts that Kelly ultimately selected. In fact, we now know

that Lycoming was not even aware that one of its engines

had been placed on this specific Cessna aircraft, never

mind having had its carburetor overhauled in such a

hodgepodge manner, until after the accident occurred in

the summer of 2005.

To the contrary, when Kelly overhauled the plane, it

acted pursuant to a separate PMA that it had obtained

from the FAA. Lycoming was not party to that PMA, and

Kelly at no time had a licensing agreement with Lycoming. Instead, Kelly obtained its PMA by way of the

tests and computations avenue, having run its own tests

95a

on its parts and having submitted its own proposed designs and its own supporting data. To the extent that

Kelly’s parts were similar to Lycoming’s, it was because

Kelly consciously decided as much, not because its hand

was forced by Lycoming.

As Mr. Sommer, Plaintiff’s own expert, testified at the

Rule 104 hearing, Kelly obtained its PMA “by going to the

FAA and showing that their [sic] parts were similar in fit,

form, and function and preparing an application and receiving approval.” Nov. 2013 Tr. at 127:11–15. Mr. Sommer explained that Lycoming itself could not have even

sold the engine with aftermarket Kelly parts, as it stood

in its post-overhaul form. Id. at 127:20–24. “Kelly is not

included in the Cessna 172 Lycoming type certification.

So it can’t come out of the factory.” Id. at 127:23–24. In

fact, Kelly did not obtain FAA approval to implement the

subject PMA parts until the 1980s, well after Lycoming

had released the engine into the stream of commerce.

Nov. 2013 Tr. at 128:03–09. Thus, to the extent that

Kelly’s independent designs and configurations resembled Lycoming’s, it was because, as Mr. Singh explained

at oral argument, Kelly freely chose to model its parts after the type certificate holder’s, not because Lycoming

controlled or coerced Kelly to do as much. To the contrary, it appears highly disadvantageous from a type certificate holder’s point of view for comparable aftermarket

replacement parts to be available at all, let alone at lower

price points.

During the July 2004 engine overhaul, Plaintiff alleges

that the Defendants complied with a service bulletin previously issued by Lycoming, known as Service Bulletin

366. That bulletin was broadly issued on September 14,

1973 to any and all parts manufacturers or end users who

96a

might be responsible for securing maintenance on “All

AVCO Lycoming engines equipped with Marvel-Schebler

carburetors.” ECF No. 234-10 at 2. The Bulletin consists

of three short paragraphs, together approximately onehalf page in length.

The Bulletin is written generally and provides no direct guidance for the particular parts or methods eventually employed 31 years later by Kelly. See id. Instead it

merely notifies recipients that if leaking is evident or the

screws are loose, the carburetor may be disassembled so

that the gasket may be replaced and the screws retightened. Id. Further, it makes no mention of the types of

components or the designs that should be used when an

aftermarket parts manufacturer seeks a PMA pertaining

to the carburetor. See id.

I.

The Carburetor Is Reinstalled In The Engine,

The Engine Is Reinstalled In The Aircraft, And

After Just 400 Hours Of Flight Time, The Aircraft Crashes With An Inexperienced Pilot In

Command.

The plane was placed back into service on September

9, 2004, and the plane was flown for just under 400 additional hours when, on Sunday, July 10, 2005, it crashed

near the rural Transylvania County Airport in Brevard,

North Carolina. Edwards Report at 5, 65–66. Just after

take-off, the plane collided with the ground and caught

fire. Id. at 5. Prior to the August 2004 overhaul, the plane

had flown for at least 1,200 hours. Id. at 66. The last annual inspection occurred on February 4, 2005, approximately 200 hours after the overhaul. Id. The last known

maintenance occurred on June 20, 2005, at which time

97a

work was performed on the carburetor within a few inches

of the subject carburetor body-to-bowl screws. Id.

The plane was registered to a private owner, Randall

F. Winchester of Greenville Aviation, a full-service pilot

training center. Id. at 56. At the time of the crash, it was

being flown by pilot David Sikkelee, Jr., with his brother

Craig Sikkelee riding along as a passenger. Id. at 5–7. The

pair was purportedly on a business trip. Id. at 1. David

Sikkelee sustained fatal injuries in the crash, while Craig

Sikkelee received serious injuries but survived. Id.

David Sikkelee’s pilot history was reconstructed from

existing records, including FAA records on file at the

FAA record center in Oklahoma City, Oklahoma, as his

pilot logbook was damaged by the post-crash fire. Id. 7–8.

In 2004, Mr. Sikkelee received an FAA private pilot single-engine land certificate, the lowest pilot certificate that

allows one to act as a pilot in command carrying passengers in this class of aircraft. Id. at 8. According to the certification records, Mr. Sikkelee had approximately 50 total hours of certifying flight time and 14 hours as a pilot in

command, none of which were accumulated in a Cessna

172N. Id. The certifying instructor apparently only spent

a total of 3.9 hours with Mr. Sikkelee. Id. Further, although Mr. Sikkelee reported 68 total hours of flight time,

with 4 hours in the six months preceding the accident, Mr.

Edwards believes that an analysis of Mr. Sikkelee’s rental

and FAA certificate records revealed that he had only 55

hours of total flight time, 2.5 of which occurred in the preceding six months. Id. Prior to the day of the accident, Mr.

Sikkelee had flown a Cessna 172 model aircraft for just

1.8 total hours. Id. Altogether, he had flown for approximately 5.6 hours in the year before the accident and not

all in the preceding 60 days. Id. at 8–9.

98a

This lawsuit was filed in 2007, in which Plaintiff alleges

that the throttle body to float bowl screws had come loose

and caused the engine to lose power. Lycoming contends

that the screws were not defective and that the accident

was likely caused by pilot inexperience, a botched 2004

overhaul, or any number of chance occurrences for which

it was not legally responsible. As one of the Lycoming’s

experts reminded:

When an aircraft crashes, there may be any one of

a thousand and one reasons why it did so. The overall task confronting the investigator is one of initiating a program aimed specifically at eliminating

those possibilities which could not conceivably

have been involved under the particular circumstances.

Expert Report of Thomas W. Eagar, ECF No. 489-2, at 4

(quoting FAA Aircraft Accident Investigator’s Desk Reference Guide (1991)).

In 2010, the Plaintiff entered into a settlement agreement with Kelly, who overhauled the carburetor in 2004.

Kelly agreed to pay Plaintiff $2 million for the injuries suffered by her decedent in connection with the 2004 crash.

ECF No. 145–46.

In 2014, I held that Plaintiff’s claims against Lycoming

were field preempted. In 2016, our Court of Appeals reversed that determination with instructions that I consider conflict preemption on remand. 17 I now hold that Lycoming is entitled to summary judgment.

17

Specifically, our Court of Appeals instructed me as follows:

99a

II. LAW 18

“One of the principal purposes of the summary judgment rule is to isolate and dispose of factually unsupported claims or defenses, and we think it should be interpreted in a way that allows it to accomplish this purpose.”

Celotex Corp. v. Catrett, 477 U.S. 317, 323–24, 106 (1986).

Summary judgment is appropriate where “the movant

shows that there is no genuine dispute as to any material

fact and the movant is entitled to judgment as a matter of

law.” Fed. R. Civ. P. 56(a). “Facts that could alter the outcome are ‘material facts,’ and disputes are ‘genuine’ if evidence exists from which a rational person could conclude

that the position of the person with the burden of proof on

the disputed issue is correct.” Clark v. Modern Grp. Ltd.,

We have no need here to demarcate the boundaries of those

tort suits that will be preempted as a result of a conflict between state law and a given type certificate, nor which FAA

documents incorporated by reference in a type certificate

might give rise to such a conflict. While the parties responded

to the FAA’s submission by arguing for the first time in supplemental submissions whether the alleged design defect at issue in this case is a design aspect that was expressly incorporated into the type certificate for the Textron Lycoming O–

320–D2C engine and what significance that might have for conflict preemption, we will leave those issues for the District

Court to consider on remand.

Sikkelee, 822 F.3d at 702.

18

Plaintiff suggests that the instant motions should be assessed

using the standard for reconsideration. I disagree. The Third Circuit

supplied explicit instructions for me to revisit these issues on remand.

Regardless, even if viewed through the lens of reconsideration,

changes in the applicable legal principles starting with Tincher v.

Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), as well as what appear to

be earlier errors applying that law, both justify my conclusions.

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9 F.3d 321, 326 (3d Cir. 1993) (Hutchinson, J.) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986) and

Celotex, 477 U.S. at 322).

“A defendant meets this standard when there is an absence of evidence that rationally supports the plaintiff’s

case.” Clark, 9 F.3d at 326. “A plaintiff, on the other hand,

must point to admissible evidence that would be sufficient

to show all elements of a prima facie case under applicable substantive law.” Id.

“[T]he inquiry involved in a ruling on a motion for summary judgment or for a directed verdict necessarily implicates the substantive evidentiary standard of proof that

would apply at the trial on the merits.” Liberty Lobby,

Inc., 477 U.S. at 252. Thus, “[i]f the defendant in a run-ofthe-mill civil case moves for summary judgment or for a

directed verdict based on the lack of proof of a material

fact, the judge must ask himself not whether he thinks the

evidence unmistakably favors one side or the other but

whether a fair-minded jury could return a verdict for the

plaintiff on the evidence presented.” Id. “The mere existence of a scintilla of evidence in support of the plaintiff’s

position will be insufficient; there must be evidence on

which the jury could reasonably find for the plaintiff.” Id.

“The judge’s inquiry, therefore, unavoidably asks . . .

‘whether there is [evidence] upon which a jury can

properly proceed to find a verdict for the party producing

it, upon whom the onus of proof is imposed.’” Id. (quoting

Schuylkill & Dauphin Imp. Co. v. Munson, 81 U.S. 442,

447 (1871)). Summary judgment therefore is “where the

rubber meets the road” for a plaintiff, as the evidentiary

record at trial, by rule, will typically never surpass that

which was compiled during the course of discovery.

101a

“[A] party seeking summary judgment always bears

the initial responsibility of informing the district court of

the basis for its motion, and identifying those portions of

the pleadings, depositions, answers to interrogatories,

and admissions on file, together with the affidavits, if any,

which it believes demonstrate the absence of a genuine issue of material fact.” Celotex, 477 U.S. at 323 (internal

quotations omitted). “[R]egardless of whether the moving

party accompanies its summary judgment motion with affidavits, the motion may, and should, be granted so long

as whatever is before the district court demonstrates that

the standard for the entry of summary judgment, as set

forth in Rule 56(c), is satisfied.” Id.

Where the movant properly supports his motion, the

nonmoving party, to avoid summary judgment, must answer by setting forth “genuine factual issues that

properly can be resolved only by a finder of fact because

they may reasonably be resolved in favor of either party.”

Liberty Lobby, 477 U.S. at 250. For movants and nonmovants alike, the assertion “that a fact cannot be or is

genuinely disputed” must be supported by: (i) “citing to

particular parts of materials in the record” that go beyond

“mere allegations”; (ii) “showing that the materials cited

do not establish the absence or presence of a genuine dispute”; or (iii) “showing . . . that an adverse party cannot

produce admissible evidence to support the fact.” Fed. R.

Civ. P. 56(c)(1).

“When opposing summary judgment, the non-movant

may not rest upon mere allegations, but rather must ‘identify those facts of record which would contradict the facts

identified by the movant.’” Port Auth. of N.Y. and N.J. v.

Affiliated FM Ins. Co., 311 F.3d 226, 233 (3d Cir. 2002)

(Weis, J.). Moreover, “[i]f a party fails to properly support

102a

an assertion of fact or fails to properly address another

party’s assertion of fact as required by Rule 56(c), the

court may . . . consider the fact undisputed for purposes of

the motion.” Fed. R. Civ. P. 56(e)(2). On motion for summary judgment, “[t]he court need consider only the cited

materials, but it may consider other materials in the record.” Fed. R. Civ. P. 56(c)(3).

“[A]t the summary judgment stage the judge’s function is not himself to weigh the evidence and determine

the truth of the matter but to determine whether there is

a genuine issue for trial.” Liberty Lobby, 477 U.S. at 249.

“[T]here is no issue for trial unless there is sufficient evidence favoring the nonmoving party for a jury to return a

verdict for that party.” Id. “If the evidence is merely colorable . . . or is not significantly probative, summary judgment may be granted.” Id. at 249–50 (internal citations

omitted).

III. ANALYSIS

At first glance, this case appears to present puzzling

questions of conflict preemption and proximate cause in

the field of aviation. Yet, I have come to suspect that its

complexity, like that of a shimmering oasis in the eyes of

a weary wanderer, may be nothing more than a clever mirage flowing from strained interpretations of the law and

academic daydreams divorced from fa

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