We think the point is how preemption protects Congress’additional decision in the FDCA to grant the FDA almost unlimited discretion toprosecute, resolve, or excuse violations as the Agency sees fit. Basically, the FDA’s exclusive enforcementauthority reinforces those parts of the FDCA that confer upon the FDA theability to select which violations of the FDCA to prosecute and which to settleadministratively. As the Court observed inBuckman, FDA has “complete discretion” in deciding “how and when [itsenforcement tools] should be exercised” and must exercise that discretion “toachieve a somewhat delicate balance of statutory objectives.” 531 U.S. at 348. Preemption and prosecutorial discretion gohand in hand.
The Supreme Court looked at this interplay someyears earlier in Heckler v. Chaney, 470 U.S. 821 (1985), in which deathrow inmates tried to throw a monkey wrench into their sentences by seeking toforce the FDA to prevent the use of certain drugs use in executions. The FDA had exercised prosecutorialdiscretion to refuse to enforce the statute in this manner. The Supreme Court affirmed the FDA’s right todetermine for itself how to enforce the Act:
[A]n agency decision not to enforce often involves acomplicated balancing of a number of factors which are peculiarly within itsexpertise. Thus, the agency must notonly assess whether a violation has occurred, but whether agency resources arebest spent on this violation or another, whether the agency is likely tosucceed if it acts, whether the particular enforcement action requested bestfits the agency's overall policies, and, indeed, whether the agency has enoughresources to undertake the action at all. An agency generally cannot act against eachtechnical violation of the statute it is charged with enforcing. The agency is far better equipped than thecourts to deal with the many variables involved in the proper ordering of itspriorities.
Id. at 831-32.
FDA administrative discretion has precluded contrarypositions taken by civil litigants on a number of occasions. In Sandoz Pharmaceuticals v.Richardson-Vicks, 902 F.2d 222 (3d Cir. 1990), a Lanham Act plaintiff couldnot urge upon a court an FDCA categorization that the FDA had not seen fit toimpose.
We decline to find and do not believe that the districtcourt had to find, either “as a matter of common sense” or “normal English,”that which the FDA, with all of its scientific expertise, has yet to determine. Because agency decisions are frequentlyof a discretionary nature or frequently require expertise, the agency should begiven the first chance to exercise that discretion or to apply that expertise.
Id. at 231. Likewise, plaintiff in Summit Technology,Inc. v. High-Line Medical Instruments, Co., 933 F. Supp. 918 (C.D. Cal.1996), wanted to exclude certain products from the market as “illegal.” The court refused to take that step where theFDA had sent a warning letter, but not taken any stronger steps:
[I]t is apparent that the FDA has not yet determinedwhether to take action against [defendant]. In essence, the FDA has not yet determined howit will interpret and enforce its own regulations with regard to this question,and the Court must therefore decline to usurp the FDA’s authority. Simply put, the proper interpretation andenforcement of the relevant FDA regulation is not an issue properly decided “asan original matter by a district court.
Id. at 934 (footnote omitted); accord SummitTechnology, Inc. v. High-Line Medical Instruments, Co., 922 F.Supp. 299,306 (C.D. Cal. 1996) (“regardless of any warning letters . . . theFDA has not completed this investigation”; plaintiff “would force this Court torule on the legality of Defendants’ conduct before the FDA has had a chance todo so”). See Wyeth v. Sun Pharmaceutical Industries, Ltd., 2010WL 746394, at *4 (E.D. Mich. March 2, 2010) (“it is solely the FDA's duty to investigate and prosecuteallegations of misbranding or adulterating drugs”); Montgomery County v.Leavitt, 445 F. Supp.2d 505, 512 (D. Md. 2006) (rejecting allegations of“selective” FDA enforcement; FDA’s “decision not to prosecute or enforce,whether through civil or criminal process, is . . . committed to [its]absolute discretion”); Baker v. Smith & Nephew Richards, Inc., 1999WL 811334, at *18 (Tex. Dist. June 7, 1999) (private plaintiffs may not “act asa prosecutor when the FDA has declined to accept that role”), aff’d mem.,2000 WL 991697 (Tex. App. July 20, 2000).
The FDA’s prosecutorial discretion is particularlyimportant when a plaintiff attempts to sue over something that resulted in anFDA warning letter or other form of informal enforcement activity, and nothingmore. Inevitably the plaintiff isdemanding some sort of severe sanction – a product recall, a revocation ofapproval, or at minimum a mandatory warning change – when the FDA declined torequire anything of the sort. This kindof knee-jerk over-prosecution by private plaintiffs is contrary to the expressterms of the FDCA:
Nothing in this chapter shall be construed as requiringthe Secretary to report for prosecution . . . minor violations of this chapterwhenever he believes that the public interest will be adequately served by asuitable written notice or warning.
21 U.S.C. §336. This is the FDCA section that authorizes warning letters in the firstplace. E.g. FDA EnforcementManual ¶410 (“Authority To Issue Warning Letters”) (2010).
As a result of §336, “[t]he FDC Act imposes noclear duty upon FDA to bring enforcement proceedings. . . . Congress has not given FDA an inflexiblemandate to bring enforcement actions against all violators of the Act.” Cutler v. Hayes, 818 F.2d 879, 893(D.C. Cir. 1987) (footnote citing §336 omitted). For example, every possible instance of“adulteration” does not demand vigorous enforcement action:
[A] conclusion that a particular . . . productis “adulterated,” in the abstract, means little other than that FDA couldchoose to initiate enforcement proceedings. [Plaintiff] does not, and could not, point toany provision in the FDC Act requiring FDA to initiate enforcement actionagainst every [product] falling within the Act’s definition of “adulterated.” Rather, the Act makes clear that theseenforcement decisions are vested, as they traditionally are, with the agency.
Community Nutrition Institute v. Young, 818F.2d 943, 950 (D.C. Cir. 1987) (enforcing §336). A plaintiff has no right to demand anenforcement outcome that the FDA has not imposed. In Healthpoint, Ltd. v. Ethex Corp.,273 F. Supp.2d 817 (W.D. Tex. 2001), the court rejected plaintiff’s argumentsthat certain allegedly “adulterated” products should be removed from themarkes. The FDA, the court observed, “hasnot taken enforcement action to remove [the products] from the market. It is for the FDA to exercise its discretionto determine whether [those products] are on the market lawfully.” Id. at 841 (citing §336 and Heckler).
Section 336 means that it’s for the FDA to decidewhether or not to pursue arguable violations mentioned in such letters. The Agency has “rather broad discretion − broadenough undoubtedly to enable [it] to perform [its] duties fairly withoutwasting [its] efforts on what may be no more than technical infractions.” United States v. Sullivan, 332 U.S.689, 694 (1948). “[P]otential sanctions,however, [are] just that − potential. They[are] at the discretion of the [FDA] to impose or not to impose.” Hoyte v. American National Red Cross,439 F. Supp.2d 38, 45 (D.D.C. 2006) (dismissing qui tam action under§336). .Accord Medical CenterPharmacy v. Mukasey, 536 F.3d 383, 399 (5th Cir. 2008) (relying on §336 tohold that “the FDA is not required to seek to enjoin, prosecute or otherwiselitigate ‘minor violations’ of the Act”); United States v. Goodman, 486F.2d 847, 855 (7th Cir. 1973) (“[u]njustifiably harsh consequences of acompletely literal enforcement are tempered by discretion given” to the FDA).
We think that defendants arguing preemption shouldremember to cite FDA prosecutorial discretion as one of the practical reasonswhy the Congress’ affirmative rejection of private enforcement (see Buckmanand §337(a)) are properly given preemptive effect. It’s one thing to state the rule, butsomething else again to explain in practical terms why preemption isappropriate when an injured plaintiff is waving an FDA warning letteraround. The best recent example we knowof involving successful use of the §336 prong of FDA discretion has to be Zimmermanv. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2012 WL 3848545 (D.Md. Sept. 5, 2012) (previously discussed here), in which the defendant convinced the court that the fraud on the FDAexception to the New Jersey punitive damages immunity statute waspreempted. Not only was that resultplainly the law under the great weight of precedent, but it made eminentpractical sense in light of Congress’ grant of prosecutorial discretion to theFDA – precisely what this plaintiff was trying to override with his civilaction. First, the court in Zimmermandetermined:
In fact, the FDA is vested with considerable discretionin how it chooses to deploy these enforcement tools. The FDCA provides that “[n]othing in [FDCA]shall be construed as requiring [FDA] to report for prosecution, or for theinstitution of libel or injunction proceedings, minor violations of this chapterwhenever [FDA] believes that the public interest will be adequately served by asuitable written notice or warning.” Id.§336. Finally, courts have found theFDA's decision not to undertake certain enforcement actions to benon-reviewable.
Id. at *10. Coming back to this point, Zimmerman recognized that claimsrequiring a finding of a violation, as opposed to a defect, representedattempts to usurp the FDA’s discretion whether to prosecute a particularclaimed violation:
[T]he FDCA vests the FDA, not private litigants, withthe exclusive authority to investigate and prosecute any suspected fraud ormisrepresentation in connection with FDCA created disclosure requirements [and]accords the FDA considerable flexibility in how it chooses to address any fraudor misrepresentation in connection with the disclosure requirements. . . . If a state claim requires a fact finder tomake a separate determination that federal law contemplates may be made inparallel by both a state fact finder and a federal agency, courts are unlikelyto find any obstacle to the enforcement of a federalstatute. . . .
Id. at *13-14. A violation claim that the FDA never saw fit to prosecute (and typicallyseeking a dramatically more Draconian sanction than anything the Agency ever contemplated)thus fell afoul of the “purposes and objectives” prong of implied preemption:
Plaintiff’s claim for punitive damages under New Jersey’sstatutory immunity provision poses an obstacle to the FDCA regulatory schemebecause it requires a fact finder to make a determination that a federal lawleaves exclusively to the agency. . . . [T]he FDA has exclusive authority to decidewhether a drug is safe and effective enough to be approved for sale in theUnited States and the flexibility to decide whether and what type ofenforcement claim to bring against a drug manufacturer that breaches theFDCA-mandated disclosure duty owed to it during the NDA and post-approvalprocesses But the FDA has never foundthat [defendant] knowingly withheld or misrepresented information required tobe submitted under the agency's regulations.
* * * *
Simply put, Plaintiff's claim . . . requires astate fact finder to determine what was required to be submitted to the FDA,whether it was submitted to the FDA and, whether the FDA would have made adifferent approval decision had it been provided with the correct or missinginformation. Plaintiff's claim thusrequires a fact finder to make these types of determinations as a matter ofstate law even though federal law makes such determinations the exclusiveprovince of the FDA.
Id. at *15. Not only did Zimmerman follow what the preemptive rule in Buckmanwas, but it relied upon express FDA discretion not to prosecute an arguable violation as a major reason whypreemption was not just required, but was the only sensible result under thecircumstances.
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