PRECEDENTIAL

        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 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.
                     ______________

   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: October 25, 2018)

David I. Katzman
Bradley Stoll
Katzman Lampert & Stoll
100 West Big Beaver Road
Suite 130
Troy, MI 48084

Tejinder Singh [ARGUED]
Goldstein & Russell
7475 Wisconsin Avenue
Suite 850
Bethesda, MD 20814

      Counsel for Appellant




                              2
Catherine B. Slavin
Gordon & Rees
1717 Arch Street
Suite 610
Philadelphia, PA 19103

Amy M. Saharia
Kannon K. Shanmugam [ARGUED]
Williams & Connolly
725 12th Street, N.W.
Washington, D.C. 20005

      Counsel for Appellees Textron Lycoming
      Reciprocating Engine Division and AVCO Corp.

Kathleen L. Nastri
Jeffrey R. White
American Association for Justice
777 6th Street, N.W.
Suite 200
Washington, D.C. 20001

      Counsel for Amicus Appellant American Association
      for Justice

Daryl E. Christopher
Schmidt Kramer
209 State Street
Harrisburg, PA 17101

      Counsel for Amicus Appellant Pennsylvania
      Association for Justice




                             3
Lauren L. Haertlein
General Aviation Manufacturers Association
1400 K Street N.W.
Suite 801
Washington, D.C. 20005

      Counsel for Amicus Appellee General Aviation
      Manufacturers Association

                      ______________

                OPINION OF THE COURT
                    ______________


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), 

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

(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
Pennsylvania law. Sikkelee v. AVCO Corp. (Sikkelee III), 268




                              

(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-CV-00886, 

(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

                               A1

     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




                               5
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-320-D2C 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, Marvel-Schebler. 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 company

prior opinion in this case, Sikkelee II, 

, and the
District Court’s opinion, Sikkelee III, 

.
       2
         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




                               6
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


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 Steenholdt
v. FAA, 

, 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), 

, 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.




                              7
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 as to any action you may propose that will help in
alleviating this problem.” 

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


       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.




                                8
         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
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

       4
           Lycoming did not install the engine.




                                 9
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 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 state-law




                               10
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., 

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

(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 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), 

, 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 

.




                               11
        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,” 

(2) “Congress has not created a
federal standard of care for persons injured by defective
airplanes,” 

and (3) “the type certification process
cannot as a categorical matter displace the need for compliance
in this context with state standards of care,” 

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.”

We therefore vacated the grant of summary
judgment in Lycoming’s favor and remanded for further
proceedings. 

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 

,
and (2) there was no genuine dispute of material fact as to
either her negligence or strict liability claims, 

The District Court also reconsidered its earlier summary
judgment order, Sikkelee 

, and granted
summary judgment to Lycoming on Sikkelee’s claim that




                               12
Lycoming violated 14 C.F.R. § 21.3. Sikkelee IV, 

, at *2-3.

       Sikkelee appeals.

                              II5

                               A

       We exercise plenary review of the District Court’s
orders granting summary judgment. Sikkelee 

. 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, 

, 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 

. Preemption is an affirmative
defense on which Lycoming bears the burden of production
and persuasion. In re Vehicle Carrier Servs. Antitrust Litig.,

, 84 (3d Cir. 2017); El v. Se. Pa. Transp. Auth., 

, 237 & n.6 (3d Cir. 2007).

                               B

      Lycoming asserts Sikkelee’s claims are conflict-
preempted under the doctrine of impossibility preemption

       5
        The District Court had jurisdiction pursuant to 28
U.S.C. § 1332(a). We have jurisdiction pursuant to 28 U.S.C.
§ 1291.




                              13
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, 

, 399 (2012). We are nevertheless mindful that the
federal and state governments “possess concurrent
sovereignty” in some areas. Sikkelee 

. 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.” 

v. Levine, 

, 565 (2009)). This
presumption against preemption applies in the context of
aviation products liability law. 

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, 

683.6 We did not, however, decide whether conflict
preemption bars Sikkelee’s claims. See 

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 

.
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, 

, 620 (2011).




      6
          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 

. 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 

-99.
        7
          Because preemption is an affirmative defense, we
examine only the defense asserted before us. In re Vehicle
Carrier 

.




                              15
                                 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.

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., 

, 351, 384-433 (Pa. 2014).8
This requires a plaintiff to prove: “(1) that the product was

       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.




                                 16
defective; (2) that the defect was 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, 

, 881 (3d Cir.
1998) (citing Davis v. Berwind Corp., 

, 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”). 

, 387, 389.

       Pennsylvania law also recognizes a negligence cause of
action for products liability. See 

;
Phillips v. Cricket Lighters, 

, 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.” 

(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.




                              17
                                 3

        We next examine the federal regulations applicable to
the design of aircraft products. Congress has imposed federal
oversight of certain aspects of aviation. Sikkelee 

. 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.

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 

. “[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 

(emphasis
omitted).9 If the FAA determines that a product “is properly

       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 

(emphasis omitted).




                                 18
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 

(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; 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 

(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.” 

(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.’” 

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 

n.21; 14
C.F.R. pt. 43, app. A (listing major alterations and repairs).




                               19
Major changes require advance FAA approval and issuance of
an amended or supplemental type certificate. 49 U.S.C.
§ 44704(b); Sikkelee 

, 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; 

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 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 4-7 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




                              20
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 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,

(2011), and Mutual Pharmaceutical Co. v.
Bartlett, 

(2013). In contrast, Sikkelee relies on
the impossibility preemption standard articulated in Wyeth v.
Levine, 

(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 FDA-approved
design and warning labels as the brand-name manufacturer.
See 

, 486; 

-
13, 612 n.2. This is because the generic manufacturer is given

       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.




                               21
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, 

, 143-44 (3d Cir. 2017);
In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No.
II), 

, 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 

,
611-12. Generic drug manufacturers are required, under the
Food, Drug, and Cosmetic Act (the “FDCA”) and 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. 

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,

thus, it was impossible for the generic
company to change the warnings, 

        The Supreme Court reached the same conclusion in
Bartlett, where the manufacturer of a generic drug was sued for
an alleged design 

. 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.” 

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




                               22
its labeling are in conflict with federal laws that prohibit
manufacturers from unilaterally altering drug composition or
labeling.” 

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. 

490;

, 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 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 O-320 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.




                               23
        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 

. 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.” 

        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 brand-name manufacturers’ labels.11
       11
          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 manufactures 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




                               24
For Lycoming to be entitled to an impossibility-preemption
defense, it must present “clear evidence that the [FAA] would
not have approved a change.” 

.12 This
it cannot do.

      There is no evidence in the record showing that the FAA
would not have approved a change to the carburetor’s screws


allows the certificate holder to request permission to make a
minor or major change.
        12
           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 

33-36.
        We decline to adopt the rule Sikkelee proposes. As we
have noted, 

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 

.




                             25
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
“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., 

, 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




                               26
acquisition of a type certificate is merely a baseline
requirement.” Sikkelee 

. Thus, “in the
manufacturing context, the statutory language indicating that
these are ‘minimum standards,’ means what it says.” 

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
       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.”

(quoting FAA Letter Br. at 11; App.
1184). We concluded:

       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 . . . issuance of service bulletins to
       correct an issue that has come to the
       manufacturer’s attention . . . .

n.19 (citing FAA Letter Br. at 10-11, 12-13 n.2; App.
1183-86). 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




                              27
        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.




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.




                                28
                               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.” 

. 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., 

, 44-45 (3d Cir.
1980); Hamil v. Bashline, 

, 1287-88 (Pa. 1978);




                               29
D’Antona v. Hampton Grinding Wheel Co., 

, 310
(Pa. Super. Ct. 1973).

        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

(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., 

, 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)).




                              30
       Therefore, the District Court erred in granting
Lycoming summary judgment on Sikkelee’s state-law
claims.15
                            D

        Finally, Sikkelee argues the District Court erred in
granting Lycoming summary judgment on her failure-to-
notify-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. 

(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.

       15
          We note the District Court made repeated reference
to Sikkelee’s $2 million settlement with Kelly. Sikkelee 

, 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., 

(stating that because of this settlement,
“sympathy for unrealized pecuniary losses is not in order for
the Plaintiff here”).




                                31
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

; cf. Buckman Co. v. Plaintiffs’
Legal Comm., 

, 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 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.




                              32
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.

       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. Mensing2 and Mutual
Pharmaceutical Co. v. Bartlett3 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




1
  

(2009).
2
  

(2011).
3
  

(2013).
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 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

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.




                               2
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, 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

5
  

.
6
  21 C.F.R. § 314.70(c)(6)(iii).
7
  

.
8
  

9
  

.




                               3
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

       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

10
   

11
   

12
   See 

13
   

(emphasis added).
14
   

(emphasis added).




                              4
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

       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


15
   

16
   

17
   

18
   Id.
19
   

.




                              5
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 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, state-law claims imposing a duty to make a
different, safer product are preempted.          Crucially, the
question is not whether a manufacturer may ever alter its

20
   

21
   

at 488.
23
   

                               6
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 Fosamax24
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 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

24
   In re Fosamax (Alendronate Sodium) Prods. Liab. Litig.,

(3d Cir. 2017), cert. granted sub nom. Merck
Sharp & Dohme Corp. v. Albrecht, No. 17-290, 

(U.S. June 28, 2018).
25
   

26
   

, 555 U.S. at 571).




                               7
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 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

27
   Pub. L. No. 85-726, 72 Stat. 731.
28
   See 49 U.S.C. § 44704(a); 14 C.F.R. § 21.21.
29
   See 14 C.F.R. § 21.6.




                              8
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
manufacture 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


30
   14 C.F.R. § 21.15.
31
   14 C.F.R. § 21.21(b).
32
   Sikkelee v. Precision Airmotive Corp., 

, 684
(3d Cir. 2016).
33
   

U.S.C. § 44704(a)(1).
35
   Maj. Op. at 19.
36
   See 14 C.F.R. §§ 21.95, 21.97 (requiring FAA approval for
both minor and major changes).




                              9
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 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

37
   14 C.F.R. § 21.93.
38
   

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).
43
   Maj. Op. at 25 n.12.




                               10
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
      45
major.      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 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.

44
    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.
45
   14 C.F.R. § 21.93.
46
   14 C.F.R. § 21.113.
47
   14 C.F.R. § 21.97.
48
    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. Op. at 20. These regulations are not
directly applicable to an original manufacturer such as
Lycoming.




                             11
       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
Lycoming are conflict preempted. Lycoming, as the original
manufacturer of and type certificate holder for the O-320-
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

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/17
3006_Sikkeleev.Precision-Airmotive.mp3.




                              12
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
       The Majority disagrees, finding that Wyeth provides
the applicable standard and that we must thus consider

51
  Cf. 

.
52
   

(“[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 has established pre-emption.”).




                                13
whether 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 question for
impossibility is not whether a manufacturer has engaged in

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.




                              14
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,
major or minor.60 In fact, it would be logical to infer that
Lycoming and the FAA engaged in dialogue about bolt

57
   

.
58
   

59
   Maj. Op. at 26.
60
   See supra section II.




                             15
loosening 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 that such an answer supports a finding of
impossibility preemption and requires that our inquiry go no
further.


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 O-320 engine models between 1952 and
2003).




                             16
                            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.




                            17