Loper Bright Enterprises v. Raimondo

James M. Beck*

I. Why It Made the List

For forty years, the “Chevron doctrine,” named after Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.,[1] put a judicial thumb on the scale in favor of administrative agency constructions of their organic statutes. The FDA enjoyed the benefit of such deference many times. An online search of judicial decisions in which the FDA was mentioned in the same paragraph as a Chevron citation produced well over 500 results.[2]

No longer. The Supreme Court overruled Chevron and expressly did away with the Chevron doctrine in Loper Bright Enterprises v. Raimondo, requiring courts reviewing agency actions essentially to ignore administrative interpretations and to give relevant statutes “the reading the court would have reached if no agency were involved.”[3] Loper Bright found support for this position in decisions reaching as far back as Marbury v. Madison’s famous declaration that “[i]t is emphatically the province and duty of the judicial department to say what the law is.”[4] But the linchpin of Loper Bright is its application of the Administrative Procedure Act (APA),[5] a statute that was not mentioned at all in Chevron.

Congress intended the APA to be “a check upon” administrative “excesses not contemplated in legislation creating” the relevant agencies.”[6] In pertinent part, the APA “delineates the basic contours of judicial review” of agency action.[7] It provides that “the reviewing court shall decide all relevant questions of law,” and shall “interpret constitutional and statutory provisions.”[8] The APA did not create any deferential review standard of the sort recognized in Chevron for legal questions, a sharp contrast to “judicial review of agency policymaking and factfinding,” which was “deferential.”[9] Since the APA was “designed to serve as the fundamental charter of the administrative state,” judicial Chevron deference to agency construction of “constitutional and statutory provisions” could not survive.[10]

A large part of what FDA (like other agencies) does is dependent on the terms of the Federal Food, Drug, and Cosmetic Act (FDCA), the agency’s often ambiguous organic statute.[11] Because of its likely impact on FDA over the coming years and decades, the Supreme Court’s decision in Loper Bright makes our list of the top (FDCA)-related cases of 2024 even though it does not directly involve the FDA.

II. Discussion of the Facts, Holding, and Rationale

Loper Bright adjudicated two initially unrelated challenges to federal administrative action. Both cases implicated the power of the National Marine Fisheries Service under the Magnuson-Stevens Fishery Conservation and Management Act (MSA)[12] to charge certain fishing operations in the American coastal “exclusive economic zone” for the cost of on-board observers to prevent overfishing.[13] The statutory interpretation question involved the scope of the “fishery management plans” authorized by the MSA. The statute expressly authorized assessment of observer costs against foreign-operated vessels, vessels allowed to take certain “limited access” species of fish, and vessels operating in the North Pacific Ocean.[14] The plaintiffs fished only in the Atlantic Ocean and were not within any of the three enumerated categories statutorily required to reimburse observational costs.[15] However, in 2013 the relevant fishery management council “proposed amending its fishery management plans to empower it to require fishermen to pay for observers if federal funding became unavailable.”[16] Such observers would cost “up to $710 per day, reducing annual returns to the vessel owner by up to 20 percent.”[17]

The plaintiffs/petitioners challenged agency power to expand recoupment of observer costs beyond the three areas specified by the MSA. The Loper Bright named plaintiffs lost in the trial court, which in an alternative holding, ruled that even assuming the MSA were “ambiguous,” the Chevron doctrine required summary judgment for the government because its interpretation of the statute was “reasonable.”[18] A divided court of appeals affirmed, holding, with respect to the Chevron doctrine, the district court correctly deferred to the government’s “reasonable interpretation of “not wholly unambiguous” statutory language.[19] A second set of similarly situated plaintiffs sued in a different district and also lost, with the district court also deferring to the government’s interpretation under the Chevron doctrine.[20] That court of appeals unanimously applied Chevron, as well as a general “‘default norm’ that regulated entities must bear compliance costs.”[21] Under Chevron, the agency interpretation did “not ‘exceed[] the bounds of the permissible.’”[22] The Supreme Court granted both certiorari petitions and consolidated the two cases.

As befitting a landmark opinion, Loper Bright opened with first-principles jurisprudence dating back to the early days of the Republic. The Chevron doctrine—that judges must “defer to the agency’s interpretation” of the agency’s “ambiguous” organic statute provided that interpretation “is based on a permissible construction”[23]—could not be squared with the judicial function itself. “[T]he final ‘interpretation of the laws’” is “‘the proper and peculiar province of the courts.’”[24] Thus, it has always been “‘emphatically the province and duty of the judicial department to say what the law is.’”[25] This view of statutory construction persisted through the New Deal.[26] Agency statutory interpretations were simply “‘a body of experience and informed judgment’” that courts “could ‘properly resort for guidance,’ even on legal questions,” provided they were “‘made in pursuance of official duty’” and reflected the agency’s “‘specialized experience.’”[27]

This broad history of judicial power was crystallized, in the administrative law context, by the 1946 enactment of the APA. This statute provided the “contours of judicial review” of administrative actions.[28] When “necessary . . . reviewing court[s] shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of . . . agency action.”[29] The APA requires courts to “hold unlawful and set aside agency action” that is not in accordance with law.”[30] Critically, the APA “prescribes no deferential standard for courts to employ in answering those legal questions.”[31] Conversely, “the APA “does mandate that judicial review of agency policymaking and factfinding be deferential.”[32]

Thus, Loper Bright held, the rule of judicial deference created in Chevron “cannot be squared with the APA.”[33] “[W]ithout mentioning the APA,” the Chevron decision imposed on judges in administrative law litigation a “second step”: when “‘the statute [was] silent or ambiguous with respect to the specific issue’” before a court, then the judge must “set aside the traditional interpretive tools and defer to the agency if it had offered ‘a permissible construction of the statute.’”[34] Thus, under Chevron, the agency’s interpretation of its organic statute would prevail even though it was “not the reading the court would have reached if the question initially had arisen in a judicial proceeding.”[35]

Such deference was improper both because it was contrary to the judicial review provisions of the APA and because it operated in derogation of the traditional judicial role to determine “what the law is.” Contrary to the APA’s requirement that courts decide all legal questions, the Chevron presumption required courts “to ignore, not follow, ‘the reading the court would have reached” exercising independent judgment “as required by the APA.”[36] “[S]tatutory ambiguities” were not “implicit delegations to agencies.”[37] Rather, “most statutory ambiguities” were likely “unintentional.”[38]

Instead of deferring to any other body, “[i]n an agency case as in any other,” the job of the courts is to find the “best reading” of the statute, ambiguous or not, and that “best reading” is the same regardless—“the reading the court would have reached if no agency were involved.”[39]

It therefore makes no sense to speak of a “permissible” interpretation that is not the one the court, after applying all relevant interpretive tools, concludes is best. In the business of statutory interpretation, if it is not the best, it is not permissible.[40]

Moreover, when statutory ambiguity exists “about the scope of an agency’s own power . . . abdication in favor of the agency is least appropriate.”[41] Thus, Chevron deference was a “grave[] err[or],” and Chevron was overruled.[42]

Neither the judicial function nor the APA, however, precludes statutes that authorize administrative agencies to exercise discretion. Loper Bright recognized that “Congress has often enacted such statutes” that “expressly delegate” to agencies “the authority to give meaning to . . . statutory term[s]” or to “fill up the details.”[43] Such statutes use terms “such as ‘appropriate’ or ‘reasonable’” to “leave[] agencies with [that] flexibility.”[44] Thus:

When the best reading of a statute is that it delegates discretionary authority to an agency, the role of the reviewing court under the APA is, as always, to independently interpret the statute and effectuate the will of Congress subject to constitutional limits.[45]

Courts do this “by recognizing constitutional delegations,” “fixing the[ir] boundaries,” and requiring “reasoned [administrative] decisionmaking”[46]

III.   Impact

Loper Bright will make it less difficult for anyone, but particularly members of the industries that FDA regulates, to challenge the agency’s interpretations of the FDCA.

Laboratory-Developed Tests

The first such decision doing so is American Clinical Laboratory Ass’n v. FDA (“ACLA”).[47] ACLA held that FDA’s interpretation of the FDCA’s definition of “medical device”[48] as giving the agency authority to regulate laboratory-developed tests as “medical devices” was not the “best” reading of the statute. Moreover, “Congress created a separate statutory and regulatory framework for laboratory test services,” the Clinical Laboratories Improvement Act (CLIA).[49] Thus:

The sequence of legislative enactments underpinning FDCA and CLIA reflects that Congress viewed (1) ensuring medical-device safety and effectiveness, and (2) ensuring laboratory-testing accuracy, as distinct problems requiring different regulatory solutions.[50]

ACLA criticized “FDA’s view of its authority to regulate laboratory-developed test services” as having “been a moving target for decades.”[51] For its part, Congress had considered legislation that would have explicitly conferred regulatory authority on FDA and also on a different agency, but neither bill passed—only legislation requiring formal FDA notice to Congress before seeking to regulate laboratory-developed tests.[52] FDA did so in 2023, with a proposed rule to regulate what the agency called “in vitro diagnostic products.”[53] That rule became final in May 2024, with “significant carveouts” based on FDA “enforcement discretion.”[54]

ACLA invalidated FDA’s rule under Loper Bright. Expansion of the FDCA’s definition of “device” to intangible laboratory test services was “foreclosed by the text, structure, and history of the FDCA and CLIA.”[55] “All the operative terms” of the FDCA’s definition of “device” “ordinarily refer to tangible, physical products,” which laboratory-developed tests were not.[56] “A laboratory-test process and methodology . . . is far afield from such tangible products.”[57] FDA exceeded its authority by “inventing new ‘definitions’ untethered to the statute” and “conflating” things (physical tools and professional services) that are “distinct.”[58] FDA’s position “implicate[d] limitless FDA oversight of all surgical procedures and physical examinations that use ‘devices.’”[59] Because that reading of “device” yielded “an extraordinary, expansive meaning with far-reaching consequences, rather than the ordinary and normal meaning” required by principles of statutory construction.[60] It would reach “medical practice,” which was “beyond the power” of the FDCA, and also governed by a separate statute—the CLIA.[61] “The more fundamental problem is that Congress has already considered the distinct issues raised by laboratory-developed test services . . . and chose to address those issues by vesting regulatory authority in” a different agency.[62]

Express Preemption of State Tort Litigation Involving Medical Devices

More decisions applying Loper Bright to FDA interpretations of the FDCA are inevitable. One potentially quite significant example is the FDA’s limitation of the express preemption clause in the Medical Device Amendments (MDA), 21 U.S.C. § 360k(a), which received an extra-textual gloss in Medtronic v. Lohr.[63] Lohr created a “device specificity” requirement that appears nowhere in § 360k(a).[64] Lohr likewise fashioned what it called so-called “parallel federal requirements” exception to preemption, also without any express statutory support.[65] The Lohr majority was “substantially informed by” 21 C.F.R. §808.1(d), an FDA regulatory interpretation of the “[m]eaning of ‘requirements applicable to a device’”[66] language in § 360k(a). Thus, § 801.1(d) involved precisely what Loper Bright did—an agency interpretation of statutory language. In creating these limits to the facially broad express preemption language of § 360k(a), Lohr invoked Chevron while giving to FDA’s statutory interpretation “substantial weight.”[67]

Device specificity: Lohr relied on § 801.1(d) for “the critical importance of device specificity in our (and the FDA’s) construction of § 360k.”[68] FDA’s limiting construction “supported” Lohr’s conclusion that “§360k(a) mandates pre-emption only where there is a conflict between a specific state requirement and a federal requirement ‘applicable to’ the same device”[69]

[T]he regulations provide that state requirements of “general applicability” are not pre-empted except where they have “the effect of establishing a substantive requirement for a specific device.” Moreover, federal requirements must be “applicable to the device” in question, and, according to the regulations, pre-empt state law only if they are “specific counterpart regulations” or “specific” to a “particular device.” The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.[70]

Parallel Claims: Applying § 808.1(d)(2) verbatim, with no independent analysis, Lohr also held, “regulations promulgated by the FDA expressly support the conclusion that §360k ‘does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.’”[71] The statutory scope of preemption under § 360k(a), however, expressly extends to state common-law requirements that are both “different from” and “in addition to” any safety-related FDA requirement.[72] Other than the Chevron-driven reliance on the FDA’s statutory interpretation, Lohr offers no basis for reading “in addition to” out of the statute in its discussion of what are now known as “parallel claims.” Elimination of Lohr’s judicially created specificity and parallel claim exceptions to § 360k(a)’s broad preemption language would significantly reshape prescription medical product liability litigation against medical device manufacturers.

Criminalization of Off-Label Speech

A second potential casualty of non-deferential judicial review of FDA statutory interpretation post-Loper Bright could be FDA’s long-running, but increasingly precarious effort to criminalize all speech by regulated entities concerning the benefits and risks of off-label uses of drugs, medical devices, and other regulated products that the agency has permitted to be marketed.[73] FDA’s justification for its off-label speech ban is multifaceted, and the first two steps involve statutory interpretation. First, the FDCA generally prohibits “misbranding” of drugs and devices.[74] Noticeably absent from these statutory definitions of misbranding is any reference to “intent.” Second, products marketed subject to FDA authorization (whether “approved,” “cleared,” or by any other process) are “misbranded” if the labeling does not include “adequate directions for use.”[75] The concept of “adequate directions for use,” however, was included primarily to regulate over-the-counter (OTC) products.[76] Prescription-only products cannot be made safe by “adequate directions for use,” which is why a physician’s prescription is required. Rather, prescription products are “not safe for use except under the supervision of a practitioner licensed by law to administer such drug.”[77] The FDCA provisions concerning adequate directions for use likewise contain no reference to “intended use” as FDA has defined it.[78]

The remaining two steps in FDA’s off-label speech ban rationale are regulatory. Third, FDA regulations limit “adequate directions for use” only to “the purposes for which it [the product] is intended.”[79] These passive-voice regulations do not specify whose “intent,” but reflect the FDCA’s focus on OTC products.[80] Indeed, both regulations can be read as embracing “common” off-label uses.[81] Fourth, and finally, FDA defines “intended use,” as “the objective intent” of the “persons legally responsible for the labeling” even though “objective” is nowhere found in the FDCA, and extend it to all “labeling claims, advertising matter, or oral or written statements.”[82] Finally, “[t]he intended uses of an article may change after it has been introduced into interstate commerce” if a regulated entity “offer[s]” it “for a purpose for which it is neither labeled nor advertised.”[83]

Thus, under FDA’s construction of the FDCA, a regulated entity’s truthful discussion of a prescription medical product’s risks and benefits when used off-label changes that product’s “intended use,” resulting in the product being “misbranded” for lacking “adequate directions for use”—despite the FDCA having no “intent” requirement, either for misbranding or product use, and “adequate directions for use” only being relevant to OTC products. Even before Loper Bright, courts have viewed this rationale skeptically. “While the FDCA makes it a crime to misbrand or conspire to misbrand a drug, the statute and its accompanying regulations do not expressly prohibit or criminalize off-label promotion.”[84]

Under Loper Bright, courts are charged with ascertaining the one “best reading” of the FDCA, “exercis[ing] their independent legal judgment” and as “if no agency were involved.”[85] It is certainly questionable whether FDA’s statutory interpretations underlying its off-label speech ban can meet such scrutiny. If FDA’s reading is “not the best, it is not permissible.”[86]

Product-Specific Marketing Decisions as Discretionary FDA Action

There are, however, limits to Loper Bright’s scope. In particular, the Court’s decision specifically acknowledged that Congress “often” “confer[s] discretionary authority on agencies, and that courts should “respect such delegations.”[87] Likewise, Loper Bright contrasted the lack of any “deferential standard” under the APA for statutory construction with the APA’s “mandate that judicial review of agency policymaking and factfinding be deferential.”[88] Thus, nothing in Loper Bright disturbs FDA’s exercise of its discretionary authority or subjects it to de novo judicial review. But what is within FDA’s discretion will undoubtedly be litigated in coming years.

One existing source of precedent on this question is how courts have applied the “discretionary function” exception to liability under the Federal Torts Claim Act.[89] The Supreme Court has addressed this issue once in the FDCA context. In Berkovitz v. United States,[90] FDA was not immune from a suit alleging (dubiously) that it had violated mandatory vaccine testing requirements.[91] Since those requirements were a mandatory prerequisite, FDA “has no discretion to issue a license without first receiving the required test data.”[92] But in the absence of such deviation “from mandated procedure,” a claimant could not simply denounce an agency decision to approve a product as “incorrect.”[93]

With Berkovitz as a starting point, courts have unanimously applied the discretionary function exception to preclude claims attacking FDA approval of drugs and medical devices. In a case in which this author participated, a claimant sued the United States, alleging that FDA had improperly cleared a medical device that was not, in fact, “substantially equivalent.”[94] Whether a medical device met that FDCA prerequisite was a discretionary function entrusted to FDA:

When §510(k) applications are brought before the FDA, regulators must decide what data and other information is relevant, what is reliable, and how much is sufficient. Certainly in weighing evidence and comparing medical devices in this manner, the FDA utilizes judgment and choice. Appellants’ suggestion that the FDA violated statutory and regulatory provisions is, in reality, a claim that the FDA’s judgment is wrong. Because substantial equivalence determinations as well as the manner in which those decisions get made are functions committed to the discretion of the FDA, we will not second guess their outcomes.[95]

Without exception, FDA decisions to allow prescription medical products to be sold have been considered discretionary.[96] The converse is also true—FDA decisions whether or not to remove products from the market are also discretionary.[97] Thus, it appears likely that product-specific FDA actions, absent highly unusual facts, will remain subject to deferential FDA review following Loper Bright.

*   James M. Beck is a Senior Life Sciences Policy Analyst at Reed Smith LLP.

[1]   467 U.S. 837 (1984).

[2]   On March 24, 2025, the search “467 U.S. 837 & (chevron /p (fda or food drug administration))” produced 539 results in the Lexis All Cases library.

[3]   603 U. S. 369, 400 (2024) (citation and quotation marks omitted).

[4]   5 U.S. 137, 177 (1803), quoted at 603 U.S. at 385.

[5]   5 U.S.C. §§551, et seq.

[6]   Loper Bright, 603 U.S. at 391 (citation and quotation marks omitted).

[7]   Id.

[8]   Id. (quoting 5 U.S.C. §706).

[9]   Id. at 392.

[10] Id. (citations and quotation marks omitted).

[11] The Supreme Court has frequently found sections of the FDCA to be ambiguous. See Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 412 (2012); FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159 (2000); Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 668 (1990); Young v. Community Nutrition Institute, 476 U.S. 974, 980 (1986).

[12] 16 U. S. C. §§1801, et seq.

[13] Loper Bright, 603 U.S. at 380

[14] Id.

[15] Id. at 381

[16] Id. at 381–82.

[17] Id. at 382.

[18] Id.

[19] Id. at 382–83 (citations omitted).

[20] Id. at 383.

[21] Id. at 384.

[22] Id. (citations omitted).

[23] Id. at 379–80 (quoting Chevron, 467 U.S. at 843).

[24] Id. at 385 (quoting The Federalist, No. 78, at 525 (J. Cooke ed. 1961)).

[25] Id. (quoting Marbury, 5 U.S. at 177).

[26] Id. at 386–88.

[27] Id. at 388 (quoting Skidmore v. Swift & Co., 323 U. S. 134, 139–40 (1944)).

[28] Id. at 391.

[29] 5 U.S.C. §706.

[30] Id. § 706(2)(a).

[31] Loper Bright, 603 U.S. at 392.

[32] Id. (emphasis in original). Subsection 706(2)(A) requires that agency policy making may only be overturned if “arbitrary, capricious, [or] an abuse of discretion.” And subsection 706(2)(E) requires sustaining “agency factfinding” when “unsupported by substantial evidence.”

[33] Id. at 396.

[34] Id. at 397 (quoting Chevron, 497 U.S. at 843 n.11).

[35] Id.

[36] Id. at 398–99 (quoting Chevron, 497 U.S. at 843 n.11).

[37] Id. at 399.

[38] Id. at 400.

[39] Id. (citation and quotation marks omitted).

[40] Id.

[41] Id. at 401.

[42] Id. at 400.

[43] 603 U.S. at 394 (citation and quotation marks omitted).

[44] Id. at 395 (quoting Michigan v. EPA, 576 U.S. 743, 752 (2015)).

[45] Id.

[46] Id. (citation and quotation marks omitted).

[47] 2025 U.S. Dist. Lexis 59869 (E.D. Tex. Mar. 31, 2025).

[48] 21 U.S.C. § 321(h)(1).

[49] Id. (referencing the Clinical Laboratories Improvement Acts of 1967 and 1988, codified at 42 U.S.C. § 263a).

[50] Id. at *15.

[51] Id. at *22.

[52] Id. at *22–23.

[53] Id. at *24–25.

[54] Id. at *27–29.

[55] Id. at 37.

[56] Id. at *40.

[57] Id. at *42.

[58] Id. at *44–45.

[59] Id. at *45.

[60] Id. at *46

[61] Id. at *54–55 (citation and quotation marks omitted).

[62] Id. at *61.

[63] 518 U.S. 470; see supra, at n.11.

[64] Id. at 498–502.

[65] Id. at 495.

[66] Id.

[67] Lohr, 518 U.S. at 496 (“The ambiguity in the statute − and the congressional grant of authority to the agency on the matter contained within it − provide a ‘sound basis,’ for giving substantial weight to the agency’s view of the statute.”) (citing Chevron; other citations omitted). As for the asserted “grant of authority,” even before Loper Bright, the Court had repudiated any deference to FDA views of the FDCA’s preemptive effect. PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 n.3 (2011) (“[W]e do not defer to an agency’s ultimate conclusion about whether state law should be pre-empted.”); Wyeth v. Levine, 555 U.S. 555, 576–77 (2009) (“we have not deferred to an agency’s conclusion that state law is pre-empted” because “agencies have no special authority to pronounce on pre-emption absent delegation by Congress”).

[68] 518 U.S. at 502.

[69] Id. at 498 (finding preemption “only” when FDA established “specific counterpart regulations or . . . other specific requirements applicable to a particular device.” (quoting § 808.1(d)).

[70] Id. at 500 (quoting § 808.1(d)).

[71] Id. at 496–97 (quoting § 808.1(d)(2)).

[72] 21 U.S.C. §360k(a)(1).

[73] See generally James M. Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1, 44–45 (2021).

[74] 21 U.S.C. § 331(a) (prohibiting “introduction or delivery for introduction into interstate commerce of any [regulated] product that is adulterated or misbranded.”); § 331(b) (same for “adulteration or misbranding of any [regulated] product, or cosmetic in interstate commerce”).

[75] 21 U.S.C. § 352(f).

[76] “To satisfy §352(f)’s requirement of providing ‘adequate directions for use,’ a drug’s label must provide ‘directions under which the layman can use a drug safely and for the purposes for which it is intended.’” United States v. Regenerative Sciences, LLC, 741 F.3d 1314, 1323–24 (D.C. Cir. 2014) (emphasis original).

[77] 21 U.S.C. § 353(b)(1)(A). Thus, a prescription product would be “presumptively misbranded,” labeled solely with “adequate directions for use.” Regenerative Sciences, 741 F.3d at 1234 (citation and quotation marks omitted). See, e.g., United States v. Articles of Drug, 625 F.2d 665, 673 (5th Cir. 1980) (a “prescription drug by definition . . . is unsuitable for self-medication”).

[78] The statute contains general references to products “intended for human use” and “intended for use in health care facilities” or “intended for use by health care professionals.” 21 U.S.C. §§ 353(e)(1)(A)(ii–iii), 353(f). It does not link “intent” to any particular product indications.

[79] E.g., 21 C.F.R. § 201.5 (for drugs) and 21 C.F.R. § 801.5 (for medical devices).

[80] Both regulations identically define “adequate directions for use” as “directions under which the layman can use a device safely and for the purposes for which it is intended.” Id.

[81] Under both regulations, “adequate directions for use” include “[s]tatements of all conditions, purposes, or uses for which such [product] is intended, including . . . conditions, purposes, or uses for which the [product] is commonly used”).

[82] 21 C.F.R. §§ 201.128; 801.4.

[83] Id.

[84] United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012). See also McCormick v. Medtronic, Inc., 101 A.3d 467, 485 (Md. App. 2014) (“On the basis of this web of statutes and regulations, the FDA takes the position that off-label promotion can constitute misbranding in violation of the FDCA” even though “[f]ederal law does not expressly define, or ban, off-label promotion”); Underwood v. Rhone-Poulenc Rorer Pharmaceuticals, Inc., 890 So.2d 429, 431 (Fla. App. 2004) (“nothing in the FDCA actually prohibits manufacturers from promoting off-label uses”); United States v. Facteau, 2020 WL 5517573, at *1 (D. Mass. Sept. 14, 2020); Nagel v. Smith & Nephew, Inc., 2016 WL 4098715, at *7 (D. Conn. July 28, 2016); Raab v. Smith & Nephew, Inc., 150 F. Supp.3d 671, 697 (S.D.W. Va. 2015); Thorn v. Medtronic, Sofamor Danek, Inc., 81 F. Supp.3d 619, 626 (W.D. Mich. 2015); Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592, 600 & n.3 (D. Vt. 2013), aff’d, 616 F. Appx. 433 (2d Cir. 2015); Mendez v. Shah, 28 F. Supp.3d 282, 292 (D.N.J. 2014).

[85] 603 U.S. at 400–01.

[86] Id. at 400.

[87] Id. at 404.

[88] Id.

[89] See 28 U.S.C. § 2680(a) (liability does “not apply” to “the exercise or performance or the failure to exercise or perform a discretionary function . . . , whether or not the discretion involved be abused”).

[90] 486 U.S. 531 (1988).

[91] Id. at 542 (allegations that FDA “issued a product license without first receiving data that the manufacturer must submit”). Berkovitz involved events occurring prior to the enactment of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10, et seq.

[92] Id.

[93] Id. at 544–45.

[94] See 21 U.S.C. 360c(i).

[95] In re Orthopedic Bone Screw Products Liability Litigation, 264 F.3d 344, 364 (3d Cir. 2001).

[96] See King v. U.S. FDA, 35 F. Appx. 511, 514 (9th Cir. 2002) (device pre-market approval); Owen v. FDA Office of Generic Drugs, 2021 WL 3883112, at *4 (W.D.N.C. Aug. 27, 2021) (generic prescription drug); Zammit v. Shire US, Inc., 2005 WL 8155121, at *1 (E.D. Mich. May 11, 2005) (branded prescription drug); Forsyth v. Eli Lilly & Co., 904 F. Supp. 1153, 1160 (D. Haw. 1995) (branded prescription drug); Bailey v. Eli Lilly Co., 607 F. Supp. 660, 662 (M.D. Pa. 1985) (branded prescription drug); Gray v. United States, 445 F. Supp. 337, 340 (S.D. Tex. 1978) (branded prescription drug).

[97] Seaside Farm, Inc. v. United States, 842 F.3d 853, 860 (4th Cir. 2016); Fisher Brothers Sales, Inc. v. United States, 46 F.3d 279, 285–86 (3d Cir. 1995) (en banc); Wiley v. United States, Dep’t of HHS, 2013 WL 537529, at *4–5 (D. Nev. Sept. 23, 2013); Gelley v. Astra Pharmaceutical Products, Inc., 466 F. Supp. 182, 186 (D. Minn. 1979).