United States: Guest Post – Design Defect Implied Preemption Is Not Just for Drugs

Last Updated: August 18 2017
Article by James Beck

Today's guest post is by long-time friend-of-the-blog, Dick Dean, of Tucker Ellis.  This post covers the preemption aspects of the recent (after remand from the Third Circuit) aviation decision in Sikkelee v. Avco.  If you're interested in this issue, we heartily commend the actual decision (which, we warn you, is quite lengthy), since in addition to its many significant legal rulings, it is studded with pungent language, mostly calling out and rejecting plaintiff's many off-the-wall arguments.  As always our guest poster deserves all the credit (and any blame) for the discussion that follows.

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At times one can tell from the very first paragraph of an opinion that what follows will be an interesting read.  Such is the case with Sikkelee v. Avco Corp., Case. No. 4:07-CV-00886, 2017 WL 3317545(M.D. Pa. Aug. 3, 2017), a case involving the death of a pilot during a crash at take-off:

A weightless innocence so often attends our daydreams of flight. As the American aviator John Gillespie Magee, Jr., loftily described it, pilots "dance [ ] the skies on laughter-silvered wings," soaring "high in the sunlit silence."   Sadly, it would seem that Magee's "high untrespassed sanctity of space" must belong to a universe far away from the dark origins and convoluted history of this case.

Id. at *1. From this ephemeral beginning, we are soon transported to the detailed world of federal aviation regulations and their interaction with design defect and implied preemption.

This case is indeed "convoluted."  The crash occurred in 2005, and suit was filed in 2007, alleging different legal theories that distill to claims of a poorly designed carburetor.  There were two district court decisions (by two different district judges) dismissing plaintiff's state law torts claims on grounds of field preemption before the case reached the Third Circuit in 2015.  Field preemption occurs where the subject matter of the law suit is so occupied by the federal government that there is no room for state activity.  It is rarely invoked and hardly ever found. [ed. note: we know of only one FDCA field preemption decision]  The factual underpinnings of field preemption in the aviation field was best summarized in a concurring opinion of Justice Jackson in a tax dispute, quoted by the Sikkelee Court in its recent decision:

As the late Honorable Robert H. Jackson, Associate Justice of the Supreme Court, once remarked, "Planes do not wander about in the sky like vagrant clouds.  They move only by federal permission, subject to federal inspection, in the hands of federally certified personnel and under an intricate system of federal commands."  Northwest Airlines v. State of Minnesota, 322 U.S. 292, 303 (1944).  Justice Jackson's observation sprang from "the national responsibility for regulating air commerce" and reinforced the notion that the "air is too precious as an open highway to permit it to be owned" by local interests.  Id.  "Local exactions and barriers to free transit in the air would neutralize its indifference to space and its conquest of time."  Id.

Id. at *2.

Relying on the breadth of the Third Circuit's decision in Abdullah v. American Airlines, 181 F.3d 363 (3d Cir. 1999) (holding that federal law preempts the field of aviation safety in the context of federal in-flight seat belt regulations versus state law negligence claims), the Sikkelee Court found preemption first at 731 F. Supp.2d 429 (M.D. Pa. 2010) and most recently at 45 F. Supp. 3d 431 (M.D. Pa. 2014).  The Third Circuit reversed the later decision, finding that state law design claims were not covered by the decision in AbdullahSikkelee v. Precision Auotmotive Corp., 822 F.3d 680 (3d Cir. 2016).  But it is also observed that the claims might be barred by implied preemption—noting that the design changes advanced by plaintiff necessarily might have required FAA approval and thus would be barred under Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, —U.S.—-, 133 S.Ct. 2466 (2013).  Indeed, it cited Mensing noting that where a party cannot "independently do under federal law what state law requires of it," the state law claim is preempted.  822 F.3d at 703.  It remanded for consideration of that issue. (See DDLaw April 22, 2016 post discussing the Third Circuit's suggestion that this claim might be conflict preempted).

On remand, the district court first examined the relevant FAA regulations noting "the FAA has littered the books with a maze of regulations not readily traversed by most laypersons."  2017 WL 3317545 at *2.  It observed that the first step in production of a new aircraft or aircraft engine is a "type certificate" confirming that the aircraft or its component is properly designed and manufactured.  Id. at *3.  It is an "onerous process requiring numerous submissions that precisely detail the specifications."  Id.  A type certificate holder may not independently change a type certificate's design details without first obtaining FAA approval.  Id. at *5-*6 (citing 14 C.F.R. §21.31).  The district court observed that the relevant test was whether federal regulations prevented the defendant from unilaterally doing what state law required, citing the Mensing test of independent action.  The court found that the alternate design theory advocated by plaintiff would have required approval by the FAA and was therefore conflict preempted.  It specifically cited the key language from Mensing establishing that the mere fact that defendant could have asked the agency to change its rules does not defeat preemption.

"To decide these cases," the PLIVA Court concluded, "it is enough to hold that when 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 preemption purposes."  Id. at 623–24.  Justice Thomas then noted that in regulatory preemption cases such as these, "the possibility of possibility"—that is, the possibility that the agency will approve a requested change—does not defeat conflict preemption.  Id. at 624.

2017 WL 3317545 at *24. More colloquially, if you have to ask, it is preempted.

The Sikkelee Court also made two other points familiar to the readers of this blog.  First, it noted that impossibility conflict preemption may be found even in the absence of express preemption.  Id. at *22.  Second, it recognized that impossibility preemption requires no inquiry into congressional intent.  Id.  The only question is whether there is a conflict between state and federal law.

When Mensing was decided, the first argument of the plaintiffs' bar (and one that is still run today) was that it was limited to generics.  That was clearly wrong based on the "any party" language of Mensing.  Cases like Yates v. Ortho-McNeil-Janssen Pharmaceutical, Inc., 808 F.3d 281 (6th Cir. 2015) and In re Celexa and Lexapro Marketing and Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), and many others [ed. note: see our preemption cheat sheet for the citations] have expanded the Mensing test to brand drug manufacturers' where regulatory approval was a predicate of the claim alleged.  Now the Mensing test has been appropriately applied to the federal aviation context.  With this decision, it can be said that Mensing applies generally—not just to generic drugs, or even just drugs at all.  In Mensing and Bartlett, "[c]onflict preemption did not turn on a drug maker's status as a brand-name or generic manufacturer per se."  Sikkelee, 2017 WL 3317545 at *31 n.26.  That is not a surprising conclusion, since this is how implied preemption is supposed to work, but it is nice to have this solid opinion building upon the Third Circuit's observations actually finding implied preemption in the aviation context.  Going forward, one needs to read any complaint involving relevant federal regulations with an eye on preemption: if the relief sought could not be undertaken unilaterally by the defendant in light of federal law or regulations the claim is preempted.

[Ed. note: we'd like to add one final point – about proximate cause. Sikkelee also recognized something we've observed about design changes too "minor" to require FDA pre-approval:  that such changes can't be causal in a product liability action. The same is true of "minor" design changes under the FAA:

If the alleged omission was a minor one, then by definition, it had no effect on the aircraft engine's structural strength, reliability, operational characteristics, or airworthiness. . . .  [T]he underlying claims are nothing more than state law tort actions, which require proximate causation.  If the alleged breach of duty had no appreciable effect on the engine's reliability, airworthiness, structure, or operation, then proximate cause cannot be met.

2017 WL 3317545 at *28 . Likewise, design changes too "minor" to affect a product's safety and effectiveness (the corresponding FDA standard), could not possibly be causal in a product liability action.]

This article is presented for informational purposes only and is not intended to constitute legal advice.

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