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This post is about un-preempted fraud on the FDA claims and how to approach them….

“Heresy!” We hear you shout. “There’s no such thing as an unpreempted fraud on the FDA claim – at least one not brought by DoJ on behalf of the FDA itself. You guys have said so yourselves, in your discussion of preemption and “embedded” fraud on the FDA allegations.”
Yes we did.

We continue to believe every word of what we said about fraud on the FDA claims being preempted whether or not they constitute “causes of action” or something less than that. Substance should win out over form.

But some fraud on the FDA claims can’t be “preempted” because they’re not subject to the Supremacy Clause from which the preemption doctrine flows. We’re talking about fraud on the FDA claims that plaintiffs purport to bring under other federal statutes – chiefly the Lanham Act, RICO, and more recently, the False Claims Act. Because those are federal statutes, they can’t be “preempted” the way state-law claims were in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

That doesn’t mean that federal plaintiff’s skate, though.  Buckman bars fraud on the FDA claims, no matter what their purported statutory basis.  We just can’t call it “preemption” that’s the basis for dismissal.

It’s the other aspect of Buckman that requires dismissal of fraud on the FDA claims nominally brought under the auspices of a federal statute.  Buckman also makes absolutely clear that Congress did not intend that private individuals be permitted to enforce the FDCA, and thus did not intend that private persons raise fraud on the FDA allegations indirectly under the guise of other statutory claims. In short, private litigation of fraud on the FDA claims on any basis conflicts with the FDA’s exclusive administrative authority.

Actually, since drug and device companies have a long history of jockeying for commercial advantage under the Lanham Act, that statute produced a fair amount of law, even prior to Buckman as annoyed courts held that de facto private FDCA claims based upon another federal statute were precluded by the FDA’s exclusive jurisdiction.  Those decisions were not dependent upon any preemption precedent.

First, the basic principles. As Buckman recognized, the FDCA explicitly precludes private litigants from seeking to prosecute any statutory or regulatory violation:

Except as provided in subsection (b) of this section, all 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). This is probably our favorite all-time statutory section on this blog.  It “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.” Buckman, 531 U.S. at 349 n.4.

A lot of the justification for the preemption decision in Buckman is not preemption specific.  That means it’s equally applicable to the misuse of other federal statutes to bring FDCA-based claims as it is to analogous state-law attempts. For instance, there is the Court’s recognition that the FDA has “a variety of enforcement options that allow it to make a measured response to suspected fraud.” 531 U.S. at 349. Prosecutorial “flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives.” Id.; accord Heckler v. Chaney, 470 U.S. 821, 831 (1985) (FDCA frees the FDA to pursue whatever remedies the FDA thinks best fit the violation).  These propositions are not limited to arguments denominated “preemptive.”

Internally, the FDA has a “fraud policy” for investigating “acts such as submitting fraudulent applications, [and] making untrue statements of material facts” that “may call into question the integrity of some or all of the applicant’s submissions.” 56 Fed. Reg. 46191, 46199 (1991). Fraud can be – but is not necessarily –a basis for withdrawal of prior Agency approval. Id. at 46200.

Buckman discussed a number of ways that private fraud on the FDA claims generally impinge upon the FDA’s statutory authority to administer the FDCA in both legal and practical ways.

• Private litigants challenge practices and product approvals the FDA might considers legal and beneficial. 531 U.S. at 349-50 (describing attacks upon products with “accepted and necessary” off-label uses).

  • Private litigants seek different and more drastic penalties – usually monetary – than the FDA considers wise. “[F]raud-on-the-FDA claims inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.” Id. at 350.
  • Private FDA fraud litigants use “unpredictable civil liability” to create “burdens not contemplated by Congress in enacting the FDCA.” Those burdens “deter” and “discourage” manufacturers from seeking approval of “potentially beneficial” products. Id.
  • Private fraud-on-the-FDA litigation spills over into areas that “the FDCA expressly disclaims any intent to directly regulate.” Id. at 350-51.
  • Private litigants interpret the FDA’s disclosure regulations too rigorously, creating “an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA[].” Id. at 351.

For all of these reasons, the Court held that it was crucial to the FDA’s operation for the Agency to retain plenary authority over enforcement and product approval.

Thus, the numerous legal and policy reasons for rejecting private fraud-on-the-FDA claims are in no way unique to state-law – as opposed to federal-law – private actions:  (1) express statutory prohibition of private enforcement actions; (2) conflict with the FDA’s power to determine what products to approve for marketing; (3) inaccurate attacks upon legal conduct; (4) draconian damage demands; (5) deterrence of beneficial product submissions; (6) claims that exceed the scope of FDA regulatory authority; and (7) drowning the FDA in unwanted information.

We’ve never seen anything in the legislative history of these other federal statutes (Lanham Act, RICO, FCA) suggesting that Congress viewed them as a mechanism to allow private litigants to sue over alleged FDCA violations, contrary to §337(a). The legislative history should thus allow the normal canons of statutory construction to operate:  (1) that subsequent statutes/amendments are presumed harmonious with existing law; (2) that statutes capable of co-existence should be read to effectuate both; (3) disfavoring “absurd” results; and (4) disfavoring implied repeals.

That’s the prologue.  Now to the directly applicable law.
Attempts by private federal plaintiffs to do indirectly what they are not allowed to do directly – bring private FDCA-based causes of action (especially particular fraud on the FDA claims) – have gone on almost since the FDCA was enacted.  Ostensible private actions under other federal statutes have frequently been rejected by other federal courts as end runs around the FDA’s exclusive enforcement authority. Most notably there’s Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993), where the court considered fraud on the FDA claims dressed up both under the Lanham Act and as supposed “predicate acts” under RICO. The plaintiff in Mylan alleged that that FDA approval of several abbreviated new drug applications “had been obtained through ‘fraud’ and ultimately was withdrawn and that the data. . .had been ‘falsified.’” The claimed statutory wrong in Mylan was your typical broad fraud on the FDA attack – that the statute was violated simply from “the very act of placing a drug on the market.” Id. at 1139.

The Court in Mylan said “no way, José” to that attempt to allege fraud on the FDA under the Lanham Act and RICO – refusing to allow either of these federal statutes to be employed so as to reexamine whether FDA regulatory approval was fraudulently obtained:

Such a theory is, quite simply, too great a stretch under the Lanham Act. We agree with the defendants that permitting [plaintiff] to proceed on the theory that the defendants violated §43(a) merely by placing their drugs on the market would, in effect, permit [plaintiff] to use the Lanham Act as a vehicle by which to enforce the Food, Drug, and Cosmetic Act (“FDCA”) and the regulations promulgated thereunder. An attempt, by ingenious pleading, to escape one principle of law by making it appear that another not truly appropriate rule is applicable appears to have been attempted. [Plaintiff], in short, is not empowered to enforce independently the FDCA.

7 F.3d at 1139 (citation omitted). The court likewise “affirm[ed] a ruling that precludes [plaintiff] from relying on, as its sole basis for the predicate acts in its RICO counts, the theory that the FDA was defrauded.” Id. at 1137.

Mylan followed Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990), where the Third Circuit likewise refused to allow a plaintiff alleging an FDCA violation to hijack the Lanham Act. Any claim that would require a court “to determine preemptively how a federal administrative agency will interpret and enforce its own regulations” could not be brought under the Lanham Act. 902 F.2d at 231. Thus, a Lanham Act claim cannot turn on whether an FDA regulation was satisfied, because courts would be “usurp[ing]” the power of the FDA. The Sandoz court:

d[id] not believe that the district court had to find. . .that which the FDA, with all of its scientific expertise, has yet to determine. Because agency decisions are frequently of a discretionary nature or frequently require expertise, the agency should be given the first chance to exercise that discretion or to apply that expertise. . . . [Plaintiff’s] position would require us to usurp administrative agencies’ responsibility for interpreting and enforcing potentially ambiguous regulations.

902 F.2d at 231 (various stuff omitted). A plaintiff who complains of an FDCA violation “is free to petition the FDA to investigate,” but dissatisfaction with the FDA’s response “does not create a claim. . .under the Lanham Act.” Id. at 231 n.10; see CIBA Corp. v. Weinberger, 412 U.S. 640, 644 (1973) (“petitioner, having an opportunity to litigate the ‘new drug’ issue before the FDA and to raise the issue on appeal to a Court of Appeals, may not relitigate the issue in another proceeding”). Where the FDCA did not “directly” create a private right of action, the Lanham Act could not create one “indirectly.” Sandoz, 902 F.2d at 231.

It’s not just the Lanham Act and RICO. An ostensibly patent-related claim was dismissed on the same grounds in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2001). The claim was that a patent was used to mislead the FDA to get a drug included in the Agency’s “Orange Book” (this is generic drug stuff). The court shot down the case, following “the long line of cases precluding private rights of action under the [FDCA].”  Id. at 1332.

[Plaintiff’s] action here. . .is in essence an attempt to assert a private right of action for “delisting” under the [FDCA]. We see nothing in the Hatch-Waxman Amendments to alter the statement in §337(a) of the [FDCA] that “all 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) (1994). In a case in which neither the statute nor the legislative history reveals a congressional intent to create a private right of action for the benefit of the plaintiff, the inquiry is at an end.

268 F.3d at 1332 (citation and quotation marks omitted).

Numerous other courts agree with the two Mylan cases and Sandoz. These courts have restricted the private rights of action conferred by various federal statutes to preclude litigants from using those statutes to evade the FDCA’s express prohibition against private enforcement. See Minnesota Mining & Manufacturing Co. v. Barr Laboratories, Inc., 289 F.3d 775, 782-83 (Fed. Cir. 2002) (patent statute cannot be used to circumvent prohibition upon private FDCA enforcement); PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997) (Lanham Act claim that defendant’s “products [were] sold without proper FDA approval” dismissed as attempt “to privately enforce alleged violations of the FDCA”); In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *10 (D.N.J. July 10, 2009) (the “theory of injury is plainly an impermissible attempt by Plaintiffs to turn violations of the FDCA for off-label promotion into a private right of action under RICO”); In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F. Supp.2d 1282, 1289-90 (C.D. Cal. 2008) (“[a]llowing Plaintiffs to proceed on a theory that Defendants violated RICO by engaging in off-label promotion. . .would, in effect, permit Plaintiffs to use RICO as a vehicle to enforce the FDCA”); Schering-Plough Healthcare Products v. Schwarz Pharma, 547 F. Supp.2d 939, 943-44 (E.D. Wis. 2008) (FDA letters were not final; “ruling on the merits of [the] Lanham Act claim would require the court to usurp the FDA’s responsibility for interpreting and enforcing the agency’s regulations”); Photomedex, Inc. v. RA Medical Systems Inc., 2007 WL 3203039, at * 3 (S.D. Cal. Oct. 29, 2007) (“whether or not the regulatory agencies permitted Defendants to continue to manufacture and market their product, Plaintiff has no standing to assert its ‘fraud on the FDA claims” under the Lanham Act); Mylan Pharmaceuticals, Inc. v. Proctor & Gamble Co., 443 F.Supp.2d 453, 460 (S.D.N.Y. 2006) (“courts have rejected attempts, including under the Lanham Act, to create a private cause of action to challenge a manufacturer or distributor’s sale of an FDA approved drug for off-label use”); Pediamed Pharmaceuticals, Inc. v. Breckenridge Pharmaceutical, Inc., 419 F. Supp.2d 715, 726-27 (D. Md. 2006) (Lanham Act allegations involving “adulteration, mislabeling, and new drug applications” “require[] direct application of the FDCA, which only the FDA is entitled to enforce”); Rita Medical Systems, Inc. v. Resect Medical, Inc., 2006 WL 2038328, at *3-4 (N.D. Cal. July 17, 2006) (“the Lanham Act cannot be used as a circuitous route to challenge determinations of the FDA”; “this Court would not be able to consider a claim as to the veracity of those [§510(k)] representations without unduly converting the Lanham Act claim into a review of an FDA [device approval] action”); Schwarz Pharma, Inc. v. Breckenridge Pharmaceutical, Inc., 388 F. Supp.2d 967, 974-75 (E.D. Wis. 2005) (refusing to determine that drug “has not been proven to be a therapeutic equivalent,” and thus could not be substituted by pharmacies); Ethex Corp. v. First Horizon Pharmaceutical Corp., 228 F. Supp. 2d 1048, 1055 (E.D. Mo. 2002) (whether drug was properly classified as “generic” is the “type of claim [] better left to the FDA who has the expertise in enforcing and interpreting its own complicated regulations”); Robertson v. McGee, 2002 WL 535045, at *3 (N.D. Okla. Jan. 28, 2002) (FDCA’s “comprehensive enforcement scheme” is “incompatible with individual enforcement under [42 U.S.C.] §1983; purported civil rights claim is “more appropriately addressed by the FDA”); Healthpoint, Ltd. v. Ethex Corp., 273 F. Supp. 2d 817, 839-40 (W.D. Tex. 2001) (“what federal law does or does not require for [drugs] to be marketed legally requires the direct application and interpretation of FDA regulations. . . . It is for the FDA to exercise its discretion to determine whether [the drugs] are on the market lawfully”); Healthpoint, Ltd. v. Stratus Pharmaceuticals, Inc., 273 F. Supp. 2d 769, 787-88 (W.D. Tex. 2001) (same); Hoffman-La Roche Inc. v. Medisca, Inc., 1999 WL 123578, at *5 (N.D.N.Y. Mar. 3, 1999) (plaintiff’s “attempt to bootstrap unrecognizable claims of defendants’ [FDCA] and FDA noncompliance into a basis for source confusion under the Lanham Act must fail”); Eli Lilly & Co. v. Roussel Corp., 23 F. Supp. 2d 460, 477-78 (D.N.J. 1998) (Lanham Act claims that “rely on interpretations of FDCA provisions and regulations promulgated thereunder” dismissed); Inmuno Vital, Inc. v. Golden Sun, Inc., 49 F. Supp. 2d 1344, 1359 (S.D. Fla. 1997) (Lanham Act claims “fail as a matter of law because no private right of action exists to redress alleged violations of the FDCA”); Avon Products, Inc. v. S.C. Johnson & Son, Inc., 984 F. Supp. 768, 797 (S.D.N.Y. 1997) (“a Lanham Act plaintiff must prove that the defendant’s efficacy claims are literally false, not simply that they fail to meet current [FDA] licensing standards”); Braintree Laboratories, Inc. v. Nephro-Tech, Inc., 1997 WL 94237, at *6-7 (D. Kan. Feb. 26, 1997) (“because no private right of action exists under the [FDCA], a plaintiff may not use the Lanham Act as an alternative vehicle by which to seek redress for an FDCA violation”; whether product properly classified as a “dietary supplement” is “reserved solely for resolution by the FDA”); Summit Technology, Inc. v. High-Line Medical Instruments Co., 933 F. Supp. 918, 933 (C.D. Cal. 1996) (Lanham Act unapproved product allegation “would allow a private litigant to interfere with the FDA’s own investigatory time-table and prosecutorial decision-making,” and “would force the Court to rule directly on the legality of Defendants’ conduct before the FDA has had a chance to do so”); Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 305-06 (C.D. Cal. 1996) (same); Barr Laboratories, Inc. v. Quantum Mechanics, Inc., 1994 WL 1743983, at *10-11 (E.D.N.Y. Feb. 7, 1994) (claim that consumers were “falsely led to believe that the FDA had approved defendant’s drugs” dismissed); Grove Fresh Distributors, Inc. v. Everfresh Juice Co., 1989 WL 152670, at *3 (N.D. Ill. Nov. 29, 1989) (“[w]here Congress has precluded private causes of action under the FDCA, we find it difficult to justify the use of the FDCA to establish a crucial element of a private cause of action under the Lanham Act”).

There is an exception to the Buckman/Mylan/Sandoz rule, but it’s not one that is likely to affect a claim that actually raises fraud on the FDA issues. Cases hold that, even if a claim is somehow FDCA-related, it doesn’t run afoul of the FDA’s exclusive jurisdiction if the nature of the claim does not require the court to interpret any FDA regulation. The classic example of a case fitting into this exception is a false advertising claim that a product is FDA-approved when it actually isn’t.  Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 938-39 (8th Cir. 2005); see Solvay Pharmaceuticals, Inc., v. Global Pharmaceuticals, 298 F. Supp.2d 880, 884 (D. Minn. 2004) (same result concerning falsity of statement that drug was “generic”). That’s all well and good – as long the claim is “yes/no” like that. But once the plaintiff shifts from alleging “did the FDA approve” to “should the FDA have approved,” Alpharma, 411 F.3d at 939, then we’re back into the thicket of FDA regulations and the exception goes bye-bye. That’s because allegations of fraud on the FDA raise a large number of difficult questions that intrude directly upon administrative decision-making, such as:

  • Did the FDA intend its regulations to mean what a plaintiff contends they mean?
  • Did the FDA actually require the information that the plaintiff contends was fraudulently withheld?
  • Did the FDA rely on the allegedly fraudulent submission?
  • Was the allegedly fraudulent information actually material to the FDA’s determinations?
  • What different action would the FDA have taken, had it received the information the plaintiff claims the agency should have received?


Given these questions, it would be difficult to mistake a fraud on the FDA allegation for the kind of “was it approved or not” questions that can slide by the FDA’s exclusive jurisdiction without doing the Agency’s discretionary functions any serious damage.


Thus, that plaintiffs proceed under federal, rather than state, law does not give them any sort of free pass to conceal an action for purported FDCA violations in the trappings of a different cause of action. The FDA has sole and exclusive authority to regulate and approve drugs and medical devices as against other federal statutory claims. That’s why the FDA was created in the first place.