Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Sikkelee v. Precision Airmotive Corp.

United States Court of Appeals, Third Circuit

October 25, 2018

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.

          Argued: July 11, 2018

          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

          David I. Katzman Bradley Stoll Katzman Lampert & Stoll Tejinder Singh Goldstein & Russell Counsel for Appellant

          Catherine B. Slavin Gordon & Rees Amy M. Saharia Kannon K. Shanmugam [ARGUED] Williams & Connolly Counsel for Appellees Textron Lycoming Reciprocating Engine Division and AVCO Corp.

          Kathleen L. Nastri Jeffrey R. White American Association for Justice Counsel for Amicus Appellant American Association for Justice

          Daryl E. Christopher Schmidt Kramer Counsel for Amicus Appellant Pennsylvania Association for Justice

          Lauren L. Haertlein General Aviation Manufacturers Association Counsel for Amicus Appellee General Aviation Manufacturers Association

          Before: SHWARTZ, ROTH, and RENDELL, Circuit Judges.

          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 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-CV-00886, 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 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 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 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 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 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 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 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 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 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 conflict-preempted 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 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. 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 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 383-84; 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 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; 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 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 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, 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 FDA-approved 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 608-09, 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. 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 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.

         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.

         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] 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.

         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 ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.