One key point where implied preemption differs from express preemption is that express preemption is inherently limited by the language of the particular statute that contains the pertinent preemption clause, whereas general principles of implied preemption have broad application to all similar cases. Since the preemption of agency fraud claims recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was based entirely on implied preemption, Bexis has kept track of non-FDCA applications of Buckman implied preemption in his book. See § 5.02[c] n.294. Non-FDA-related findings that federal agency fraud claims are preempted include:
Farina v. Nokia, Inc., 625 F.3d 97, 104 (3d Cir. 2010) (FCC); Transmission Agency of Northern California v. Sierra Pacific Power Co., 295 F.3d 918, 932 n.10 (9th Cir. 2002) (FERC); Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-06 (9th Cir. 2002) (EPA); Murray v. Motorola, Inc., 982 A.2d 764, 770 n.6 (D.C. 2009) (FCC); McCall v. Pacificare, Inc., 21 P.3d 1189, 1199 n.9 (Cal. 2001) (Health Care Financing Administration); Timaero Ireland Ltd. v. Boeing Co., 2021 WL 963815 at *6-7 (N.D. Ill. March 15, 2021) (FAA); LCS Group v. Shire LLC, 2019 WL 1234848 at *6 (S.D.N.Y. March 8, 2019) (patent office); In re Volkswagen “Clean Diesel” Marketing, Sales Practices, & Products Liability Litigation, 264 F. Supp.3d 1040, 1054-55 (N.D. Cal. 2017) (EPA); Syngenta Crop Protectin v. Willowood, 2016 WL 6783628 at *1 (M.D.N.C. Aug. 12, 2016) (EPA); Giglio v. Monsanto Co., 2016 WL 1722859 at *3 (S.D. Cal. April 29, 2016) (EPA); Offshore Service Vessels, LLC v. Surf Subsea, Inc., 2012 WL 5183557 at *11-12 (E.D. La. Oct. 17, 2012) (Coast Guard); Ramirez v. E.I. Dupont De Nemours & Co., 2010 WL 3529509 at *2 (M.D. Fla. Sept. 3, 2010) (EPA); Lockwood v. Sheppard, Mullin, Richter & Hampton, LLP, 2009 WL 9419499 at *7 (C.D. Cal. Nov. 24, 2009) (patent office); Beck v. Koppers, Inc., 2006 WL 2228910 at *1 (N.D. Miss. April 7, 2006) (EPA); Hill v. Brush Engineered Materials, Inc., 383 F. Supp.2d 814, 822 (D. Md. 2005) (EPA, OSHA); Williams v. Dow Chemical Co., 255 F. Supp.2d 219, 232 (S.D.N.Y. 2003) (EPA); Morgan v. Brush Wellman, Inc., 165 F. Supp.2d 704, 722 (E.D. Tenn. 2001) (Dept. of Energy); Zwiercan v. General Motors Corp., 2002 WL 31053838, 58 Pa. D. & C.4th 251, 266 (Pa. Com. Pl. 2002) (NHTSA); Redelmann v. Alexander Chemical Corp., 2002 WL 34423377 (Ill. Cir. July 26, 2002) (EPA).
Now Buckman preemption is the centerpiece of In re Ford Motor Co. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation, ___ F.4th ___, 2023 WL 3029837 (6th Cir. April 21, 2023). Indeed, at least one aspect of Ford F-150 is favorable to Buckman preemption in a way that should be useful in the drug/device field.
Buckman, of course, needs little introduction to the readers of this Blog. Plaintiffs in the Bone Screw litigation alleged that a manufacturer “defrauded” the FDA by seeking clearance of one indication (long bones) while secretly intending to market a medical device solely for an off-label use (spinal). Buckman found that claim impliedly preempted because:
- Since “[p]olicing fraud against federal agencies” is not a “traditional” function of state law, no presumption against preemption applies. 531 U.S. at 347-48.
- The FDCA “ampl[y]” empowers the FDA to punish and deter fraud against itself. Id. at 348.
- State second-guessing of FDA submissions would disrupt “a somewhat delicate balance of statutory objectives,” id., and thus “inevitably conflict[s] with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.” Id. at 351.
- Second-guessing FDA submissions can also cause applicants “to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA’s evaluation of an application.” Id.
- The relevant statute provides “clear evidence that Congress intended that [it] be enforced exclusively by the Federal Government.” Id. at 352 (citation omitted).
- Express and implied preemption operate independently, so that implied preemption may apply when express preemption does not. Id.
- Agency fraud claims are not traditional torts, but rather “exist solely by virtue of the [statute’s] disclosure requirements.” Id. at 353.
- To escape implied preemption, a plaintiff must “rely on traditional state tort law which had predated the federal enactments in question.” Id.
- Where there is no private right of action, claims for which “the existence of these federal enactments is a critical element in [a plaintiff’s] case” are impliedly preempted. Id.
Enter Ford F-150. Plaintiffs alleged – on ostensibly state-law grounds: “claims of breach of contract, negligent misrepresentation, breach of express warranty, fraud, and unjust enrichment under the laws of every state,” id. at *4 – that the defendant “cheated on its fuel economy and emissions testing,” which they submitted to the Environmental Protection Agency, and which purportedly “led the [EPA] to provide an inaccurate fuel economy estimate to consumers,” who were members of that putative class action. 2023 WL 3029837, at *1.
That’s a fraud-on-the-EPA claim, and as the earlier list of agency fraud citations indicates, such claims are the most frequent non-FDA application of Buckman preemption. The key to preemption in Ford F-150 is that – as is usual with the FDA − the agency, not the defendant, had the final authority over the information (here, fuel economy figures) that consumers ultimately see.
In reviewing the data, the EPA may accept it, require additional manufacturer testing, or perform its own confirmatory testing. . . . [I]f an unacceptable discrepancy exists, the EPA may reject all fuel economy data submitted by the manufacturer until the cause of the discrepancy is determined and the validity of the data is established by the manufacturer. . . .
2023 WL 3029837, at *2 (citations and quotation marks omitted). EPA can impose a variety of severe civil and criminal penalties on anyone responsible for submission of false information. Id. at *3.
The fate of this entire litigation “beg[a]n and end[ed] with implied preemption” under Buckman. Id. at 5. As in Buckman, no presumption against preemption applied. Id. at *8 n.7 (pointing out that plaintiffs did not even advocate such a presumption). Buckman was the “seminal case,” and it has produced “a host of caselaw . . . addressing similar fraud-on-the-agency claims in the context of implied preemption.” Id. at *6. The Sixth Circuit had previously concluded that “‘Buckman teaches that state tort remedies requiring proof of fraud committed against [a federal agency] are foreclosed since federal law preempts such claims.’” Id. (quoting Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 966 (6th Cir. 2004)). Discussion of the aforementioned Kimmel and Farina decisions followed. Ford F-150, 2023 WL 3029837, at *7.
Ford F-150 unanimously held that “Buckman and its progeny apply with equal force here.” Id. The EPA’s supervision of mileage testing matched the FDA’s scheme for medical devices in its thoroughness. Id. It involved a similar “delicate balance of statutory objectives.” Id. at 8. As with implied FDCA preemption, the defendant manufacturer here could not avoid EPA’s oversight. “[U]ltimately, the fuel economy figure is the EPA’s own; it is not adopted or published unilaterally by [defendant] (or by any other manufacturer).” Id. at *7. The EPA, like the FDA, had “ampl[e]” power “to punish and deter fraud.” Id. at *8 (citation and quotation marks omitted).
Thus the fraud-on-the-EPA claims, as in Buckman, “inevitably conflict[ed] with” the relevant regulatory scheme. Id. at *8. Since, “the EPA accepted [defendant’s] testing information and published its estimate based on that information, plaintiffs’ claims essentially challenge the EPA’s figures.” Id. A jury would be asked “to decide whether [defendant’s] testing figures are correct or fraudulent,” which would “inescapably and impermissibly puts [it] into the EPA’s regulatory shoes.” Id. Plaintiffs cannot use state law “to rebalance the EPA’s objectives.” Id. “‘Allowing juries to perform their own risk-utility analysis and second-guess the [EPA’s] conclusion would disrupt the expert balancing underlying the federal scheme.’” Id. (quoting Farina, 625 F.3d at 126).
In sum, federal law provides how the EPA regulates fuel economy standards and what the EPA must balance in arriving at its own estimates. It similarly gives the EPA significant authority to investigate and deter fraud. State-law tort claims, like plaintiffs’, would skew this balance and permit juries to take the EPA’s place in determining whether fuel economy estimates are reasonable. Therefore, as with the claims and regulatory scheme in Buckman, plaintiffs’ claims are preempted as conflicting with federal law.
2023 WL 3029837, at *9.
The plaintiffs in Ford F-150 raised (2023 WL 3029837, at *9-10) the usual anti-preemption precedential suspects, most of which were prescription medical product cases: Wyeth v. Levine, 555 U.S. 555 (2009); Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984); Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013). None of those cases controlled. In Ford F-150, the “requirements” of the Energy Policy and Conservation Act created the reporting obligation, not state law. Thus, “[t]he existence of these federal enactments is a critical element in [plaintiffs’] case.” 2023 WL 3029837, at *10 (citation and quotation marks omitted). Unlike those cases, “[w]hile plaintiffs’ claims may be founded in part on state-law fraud principles, they are also necessarily premised on violations of federal law, namely a failure to follow the testing procedures set by the EPA.” Id. (emphasis original). Those claims “could not exist apart from federal law.” Id. Silkwood involved a statute that “disclaimed providing any remedy” for violations, unlike the “enforcement authority” conferred upon the EPA (and on the FDA). Id.
And the Mensing independence principle also applied, which similarly distinguished Ford F-150 from Levine:
[C]rucially, the regulatory scheme governing fuel economy standards requires the EPA to approve those figures and publish them as its own. . . . [I]t is the EPA’s responsibility to determine whether that data is “reasonable”; after doing so, the EPA adopts those figures. The EPA must give its own approval. . . . This renders Levine distinguishable, where the manufacturer was responsible for the contents of the drug’s label and could alter it unilaterally without agency approval.
Id. (citing PLIVA, Inc. v. Mensing, 564 U.S. 604, 609 (2011)). “The scheme at issue here is like that in Mensing – [defendant] has no authority to modify or update the fuel economy figures for its vehicles once the EPA has accepted those figures. It must go through the EPA.” 2023 WL 3029837, at *10.
Indeed, in one aspect, Ford F-150 does Buckman and its progeny one better. “[P]laintiffs attempt to rescue their case by arguing that [defendant] committed fraud on consumers, not just the agency.” Id. Unlike a number of courts applying Buckman in prescription medical product liability litigation, Ford F-150 recognized that, at bottom, this distinction was “immaterial.”
[T]hat distinction is immaterial . . . any fraud committed by [defendant] on consumers is a byproduct of alleged fraud committed on the EPA. One does not exist apart from the other. Consequently, plaintiffs’ claims for fraud on consumers exist solely because of the [statutory] requirements.
Id. (citation omitted). “Mere reliance on the EPA estimates, without making any further disclosures about a vehicle’s supposed real-world fuel economy, is not enough” to establish any sort of fraud or misrepresentation. Id. Thus, in this respect, our prescription medical product clients should be able to rely on Ford F-150 in refuting future “consumers, not the FDA” arguments about Buckman.
But those of us who play in the prescription medical product sandbox also need to be watching Ford F-150 for another reason. As good an application of Buckman as this decision is, it also could go to the United States Supreme Court. We have discussed at length in two recent prior posts – Logical Contradiction Doctrine: Buckman for Textualists, and Viewing Buckman as a Logical Contradiction Decision – that, between the antipathy of some of the conservative justices for so-called “purposes and objectives”/“obstacle” implied preemption, and the antipathy of liberal justices for preemption of state-law personal injury claims generally, Buckman as it was reasoned back in 2001 may no longer enjoy majority support on the current Supreme Court. While we think that much of Buckman, and all of its result, fits easily within the “logical contradiction” doctrine that has been articulated as a more conservative implied preemption alternative to “purposes and objectives”/“obstacle” implied preemption, we need to make sure that this alternative reasoning is put before the Court should it entertain a further appeal in Ford F-150.