The “fraud on the FDA” claim that the Supreme Court held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was actually the most extreme form of a private plaintiff second-guessing the result of an FDA process classifying a regulated product.  Plaintiffs claimed that, because of purported “fraud” in the §510(k) process, the FDA incorrectly cleared the orthopedic bone screw spinal fixation device at issue as a Class III medical device.  Id. at 344.  We describe the claim as “most extreme” because plaintiffs in Buckman didn’t claim that the device should have received some other classification, but that it shouldn’t have been approved for marketing and labeling for any classification at all.  Id. (“but for” the supposed fraud, “the FDA would not have approved the devices”).

The Supreme Court rejected that claim – held it preempted – for a number of reasons, chief of which is that how the FDA decides to classify the products it regulates was none of the plaintiffs’ business as Congress gave sole FDCA enforcement power to the government:

The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”  21 U.S.C. §337(a).

The FDA . . . has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.

This flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives. . . .  For example, with respect to Class III devices, the FDA simultaneously maintains the exhaustive PMA and the more limited §510(k) processes. . . .

Buckman, 531 U.S. at 349 & n.4.  It was solely FDA’s function to decide whether to require pre-market approval, as opposed to §510(k) clearance, as the method to market for that product and to determine what the resultant classification would be.

The extreme form of second-guessing of FDA classification decisions exemplified by the preempted claims in Buckman – that the product should have been rejected altogether – has largely fallen by the wayside after Buckman.  The Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), finding “stop-selling” claims (another theory challenging the presence of an FDA regulated product on the market) should have nailed that coffin shut.  Occasional False Claims Act suits (which, being brought under a federal statute aren’t subject to “preemption”), of the sort we blogged about here still happen, but not many state-law claims see the light of day.  See United States ex rel Dan Abrams Co. LLC v. Medtronic, Inc., 2017 WL 4023092, at *7 (C.D. Cal. Sept. 11, 2017) (“claims of fraud are disfavored if made by third parties who seek to second guess a decision by the FDA to certify a device”).  Cf. Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (warning claim based on product being “illegal” under FDCA preempted under Buckman) (applying New Jersey law).

But that doesn’t mean plaintiffs ever stopped trying to overturn FDA classification decisions in other, less blatant, ways.  One, which as we’ve discussed before hasn’t made much headway, is to attack the sufficiency of the information on which the FDA’s decision is based.  But that’s not all.  Plaintiffs fairly regularly claim that they know better than the FDA how regulated products should be classified under the Agency’s regulations.

We’ve been thinking about this aspect of Buckman ever since last year, when we blogged about the preemption-based dismissals in the related cases Borchenko v. L‘Oreal USA, Inc., 389 F. Supp.3d 769 (C.D. Cal. 2019), and Borchenko v. L‘Oreal USA, Inc., 2019 WL 3315289 (C.D. Cal. July 18, 2019).  We’ve discussed this type of case quite a few times, but our posts were about individual cases.  We’ve never researched this issue comprehensively before, and we’ve been meaning to.

In the two Borchenko cases, preemption barred plaintiffs from claiming that products the FDA had regulated as “cosmetics” should instead have been subject to regulation as “drugs.”  Classifications were for the FDA to decide, even if California state law provided a way for plaintiffs to enforce some FDCA aspects under the guise of its consumer protection statutes:

The fact that Plaintiff’s claim is technically brought under the UCL and the Sherman Law does not override the fact that Plaintiff explicitly requests relief which lies squarely within the province of the FDA.  There can be no state law cause of action if a plaintiff’s true goal is to privately enforce alleged violations of the FDCA.

389 F. Supp.3d at 773 (citations omitted).

So, we’ve decided to collect what else is out there.

Even before Buckman, this type of claim had been frowned on.  “A federal court may not “determine preemptively how a federal administrative agency will interpret and enforce its own regulations.”  Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990).  See PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997) (affirming dismissal; plaintiff’s “dogged insistence that [defendant’s] products are sold without proper FDA approval suggests . . . that [his] true goal is to privately enforce alleged violations of the FDCA”); Braintree Laboratories, Inc. v. Nephro-Tech, Inc., 1997 WL 94237, at *7 (D. Kan. Feb. 26, 1997) (“it is not for this court to interpret and apply the statutory definition of ‘dietary supplement’”).

We soon encountered the odd case of Amarin Pharma, Inc. v. International Trade Commission, 923 F.3d 959 (Fed. Cir. 2019), which we blogged about here, where the plaintiff tried to use the Lanham Act (another federal statute not subject to preemption) to claim that a product the FDA was regulating as a “dietary supplement” should instead be considered an “unapproved new drug.”  Id. at 967.  Relying on PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010), the federal circuit held that a plaintiff cannot challenge an in-force FDA classification:

As in PhotoMedex . . . affirmative FDA approval is not required in the dietary supplement context.  Instead, manufacturers self-police. . . .  [T]he FDA has not provided guidance as to whether the products at issue in this case should be considered “new drugs” that require approval.  Given this lack of guidance, we . . . therefore hold that a complainant fails to state a cognizable claim under [the Lanham Act] where that claim is based on proving violations of the FDCA and where the FDA has not taken the position that the articles at issue do, indeed, violate the FDCA.  Such claims are precluded by the FDCA.

Id. at 968 (citations omitted).

PhotoMedex involved another competitor’s claim that the defendant’s product required a separate device clearance that the defendant had not sought and the FDA had not required.  The court held that private litigants cannot challenge the FDA’s decisions (even when implicit) how to classify a product.

[Plaintiff] is not permitted to circumvent the FDA’s exclusive enforcement authority by seeking to prove that Defendants violated the FDCA, when the FDA did not reach that conclusion.  In a context where the statute and regulations place responsibility in the first instance on the manufacturer to determine whether its device is covered by a previous FDA clearance and permit marketing of the product without an affirmative statement of clearance by the FDA, it is impossible for [plaintiff] to prove that [defendant’s] device had not been cleared by the FDA when the FDA itself did not take that position.

Id. at 928.  For other similar Lanham Act claims, see Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting, Inc., 230 F. Supp.3d 1323, 1331 (N.D. Ga. 2016) (“the Court declines to determine whether the supplement at issue is a drug or whether its sale violated the FDCA”); Intra-Lock International, Inc. v. Choukroun, 2015 WL 11422285, at *7 (S.D. Fla. May 4, 2015) (“the mere fact that Defendants may be erroneously selling the Competing Device as a Class I device when it is more appropriately considered a Class II device, is a violation of the FDCA, not a violation of the Lanham Act”); JHP Pharmaceuticals, LLC v. Hospira, Inc., 52 F. Supp. 3d 992, 1004 (C.D. Cal. 2014) (“determination of whether a drug is ‘new,’ and whether it can be lawfully marketed under the FDCA, involves complex issues of history, public safety, and administrative priorities that Congress has delegated exclusively to the FDA”); Catheter Connections, Inc. v. Ivera Medical Corp., 2014 WL 3536573, at *5-6 (D. Utah July 17, 2014) (Lanham Act claim that defendant “is engaging in false advertising when it represents (or implies) that [its product] does not need FDA clearance independent of the 510(k) clearance letter the FDA [already] issued . . . is precluded by the FDCA”) (blogged about here); Healthpoint, Ltd. v. Stratus Pharmaceuticals, Inc., 273 F. Supp.2d 769, 787 (W.D. Tex. 2001) (“It is for the FDA to exercise its discretion to determine whether [the products] are on the market lawfully, whether it be because they are grandfathered or are exempt from the FDA pre-clearance process.”).

Note:  Much earlier in the Blog’s history, we wrote a post similar to this one on how to challenge Lanham Act claims that alleged un-preempted claims of fraud on the FDA.

While we were writing this article, we learned of Somers v. Beiersdorf, Inc., 2020 WL 1890575 (S.D. Cal. April 15, 2020) (blogged about here), in which the plaintiff’s allegations that a “cosmetic” lotion was really an illegally marketed “drug” were dismissed as preempted.  “Recognizing that the distinction between drugs and cosmetics is a difficult one, Congress gave the FDA the sole authority to police violations of the FDCA.”  Id. at *2 (citing §337(a)).

[Plaintiff] alleges, for example, that “Defendant engaged in illegal conduct . . . that resulted in its [product] being deemed a drug under FDA regulations, but did so without obtaining required FDA approval through the FDA NDA [New Drug Approval] process.”  There is no reasonable way to construe this allegation except as an attempt to privately enforce the FDCA, enforcement that has been committed by law to the FDA.

Id. at *3.  The Plaintiff’s argument based on California’s “Sherman Act” – a state FDCA analog – was rejected as “largely circular,”  Id. at *4.  “[A] drug can only be unlawful under the California statute if it violates the FDCA, and determining whether the California statute has been violated requires first determining whether the article is a drug under the FDCA.”  Id.

The plaintiff in Obermeier v. Northwestern Memorial Hospital, 134 N.E.3d 316, 335 (Ill. App. 2019), which we blogged about here, claimed that the defendant was liable under an informed consent theory because it “bore the direct responsibility for registering the [device] with the FDA and for ensuring that it was properly cleared or approved . . ., but that it did not do so.”  Id. at 335.  The defendant contended that an additional FDA registration was not required, id., but that didn’t matter since preemption precluded the plaintiff from challenging at all how the device was properly characterized under the FDCA:

Plaintiff’s theory, therefore, is that [defendant] failed to proceed through the proper regulatory pathway, ensuring that the [device] was properly cleared by the FDA.  This claim, however, is precluded by the Food, Drug, and Cosmetic Act (FDCA), which provides that such alleged violations are the exclusive domain of the FDA.

Id. (citations omitted).  See Midlothian Laboratories, L.L.C. v. Pamlab, L.L.C., 509 F. Supp.2d 1065, 1086 (M.D. Ala. 2007) (same result on claim challenging whether the product was actually generic; “any false-equivalency claim based on the fact that [defendant’s] product does not appear in [a list of generic products] is preempted by the FDA’s exclusive authority to approve products pursuant to the FDCA”), vacated in part other grounds, 509 F. Supp.2d 1095 (M.D. Ala. 2007).

Ostensibly state-law “mislabeling” claims were preempted under Buckman and “the FDA[’s] regulatory authority over the enforcement of the FDCA” in Elkind v. Revlon Consumer Products Corp., 2015 WL 2344134, at *9 (E.D.N.Y. May 14, 2015), which we blogged about here.  Plaintiff had “dispute[d] whether the [products] are subject to the FDCA’s regulation as cosmetics or over-the-counter drugs.”  Id. at *7.  However, certain other claims, “hing[ing] on the perceived intended use” of the product, survived dismissal when the court “assumed” they were “drugs.”  Id.

Similar claims – disputing whether the products at issue were cosmetics or drugs − were held preempted in Reid v. GMC Skin Care USA, Inc., 2016 WL 403497, at *9 (N.D.N.Y. Jan. 15, 2016).  Following this aspect of Elkind, the court held preempted plaintiff’s purported state-law claims challenging product classification:

Plaintiffs . . . assert that they are bringing their claims − not under the FDCA − but under [state] law.  The complaint, however, belies Plaintiffs’ assertion . . . alleg[ing] that: “The . . . Products are Misbranded Because their Labels Violate FDCA Regulations for Over-the-Counter Drugs” . . . “The . . . Products are Unapproved New Drugs;” and “Placing an unapproved new drug into the stream of commerce is an independent wrongful act. . . .” Therefore, to the extent the complaint alleges violations of the FDCA, because there is no federal private right of action to enforce the FDCA, those allegations are dismissed.

Id. at *10 (citing Buckman and Elkind, other citations omitted).

The plaintiff’s challenge to the defendant’s device classification in Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minn. 2011) (blogged about here), was rather complex – involving a §510(k) clearance for reprocessing of 68 devices and a defendant’s use of a “line extension” internally to extend that clearance to “sufficiently similar” devices.  Id. at 1138.  The preemption ruling in Kapps, however, was simple – under Buckman a private plaintiff cannot challenge how an FDA-regulated product is classified:

[E]ven if [plaintiff’s] failure-to-warn claim were viable under [state] law, it would be foreclosed by Buckman.  [Plaintiff’s] argument (as the Court understands it) is that, regardless of whether the [device] was defective . . ., [defendant] should have warned . . . that the catheter was not really FDA-approved. . . .  To allow [plaintiff] to recover on a failure-to-warn claim if the catheter was not in fact defective or unreasonably dangerous would amount to creating a cause of action for a violation of the FDCA. Such a cause of action is preempted under Buckman.

Kapps, 813 F. Supp.2d at 1153.

Similarly, in In re Alloderm® Litigation, 2015 WL 13780242 (N.J. Super. Law Div. Aug. 14, 2015), the plaintiffs asserted a claim, ostensibly under state law, that an article the FDA had classified as a “human tissue” should have been classified as a medical device.  Id. at *2.  The court excluded all evidence of this allegation because “the FDA has not classified [the product] . . . as a medical device, and has never required [defendant] to comply with the FDCA medical device regulations for such use.”  Id. at *4.  Because the FDA had not made such a classification, state law could not usurp the FDA’s authority.  “It is not for a jury to second-guess the actions or inactions of the FDA in rendering complex decisions about product classification.”  Id. (citations omitted).

Buckman has also barred plaintiffs from suing over whether a defendant’s alteration to a product was a “major change” that required a supplemental application to the FDA.

Obtaining supplemental premarket approval for a change in the [product’s] specifications might change those requirements, but failing to obtain that approval would not cause previously established requirements to simply evaporate. . . .  The only violation of federal regulations that [plaintiff] alleges is the failure to comply with procedures governing supplemental premarket approval of a device.

Vincent v. Medtronic, Inc., 221 F. Supp.3d 1005, 1010-11 (N.D. Ill. 2016) (citation omitted) (blogged about here).  Thus, “claims based solely on [defendant’s] noncompliance with the FDA’s supplemental premarket approval procedures . . .  are impliedly preempted.”  Id. at 1011.

Somewhat similarly, in a case from the same judicial district as Vincent, the plaintiff in Aquino v. C.R. Bard, Inc., 413 F. Supp.3d 770, 784 (N.D. Ill. 2019), filed a complaint claiming that a raw materials change required a supplemental FDA filing when the FDA itself said it didn’t.  Id. at 783-84.  In the face of an implied preemption, however, plaintiff hastily abandoned that claim.  Id. at 784 (although plaintiff’s complaint “spends considerable space on [those] allegations,” plaintiff now “argues . . . that her claims sound in negligence and strict liability”).  Even when preemption becomes “inapposite,” id., it still has deterrent effect.

A spate of litigation raising failure-to-supplement claims (in the wake of a particular FDA enforcement action to this effect) got nowhere.  Courts refused to allow private plaintiffs to argue that product changes for which the FDA had not required a supplemental clearance in fact required such a supplement.

[A] claim . . . for [defendant’s] failure to file or obtain a PMA Supplement . . . is impliedly preempted.  [The] failure to file a PMA Supplement is a violation of an administrative obligation, required . . . in FDCA regulations.  A state law claim seeking a remedy for this violation is a disguised claim to privately enforce the federal law, prohibited under 21 U.S.C. § 337(a).  Any derivative claim that the [device] was adulterated as a result of the failure to obtain a PMA Supplement is likewise preempted for the same reasons.

Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 685 n.20 (W.D. Ky. 2013) (blogged about here).

Plaintiffs’ negligence claims based on [defendant’s] failure to obtain supplemental PMA approval . . . are impliedly preempted.  PMA approval is an administrative requirement created by the FDA, not a substantive safety requirement of state law.  Claims premised on PMA approval are disguised fraud-on-the-FDA claims which are impliedly preempted.

Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *5 (W.D. Pa. Sept. 19, 2013) (citations omitted).  Accord Littlebear v. Advanced Bionics, LLC, 896 F. Supp.2d 1085, 1092 (N.D. Okla. 2012) (“the FDCA do not provide a private right of action. And no pre-existing state law duty existed requiring such supplemental approval”) (blogged about here, sort of); Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694, 696 (W.D. Tenn. 2011) (“claims premised on PMA approval are disguised fraud-on-the-FDA claims”) (blogged about here).  Cf. Otero v. Zeltiq Aesthetics, Inc., 2018 WL 3012942, at *3 (C.D. Cal. June 11, 2018) (Buckman preempted claim that it was tortious for a “cleared” §510(k) medical device manufacturer to call its product “approved”; “Plaintiffs’ theory ignores the significance of the FDA’s decision to classify [the product] as a Class II medical device.”).

Finally, the doctrine of primary jurisdiction has also been invoked in this situation.  Postponing a commercial express warranty claim that sought “to determine whether [the product] should be classified a drug” or as one of three types of dietary supplements, the court held that such a determination should be made by the FDA.  “Classification of a product is within the primary jurisdiction of the FDA.”  Imagenetix, Inc. v. Frutarom USA, Inc., 2013 WL 6419674, at *4 (S.D. Cal. Dec. 9, 2013).  “[W]hether [the product] should be classified a drug, dietary supplement, ODI or NDI[ is] an issue that should be left to the expertise of the relevant agency, the FDA.”  Id.

There, one more thing we’ve been meaning to do is now done.