Don’t Forget FDA Prosecutorial Discretion

We’ve blogged a lot about implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and in particular how the FDCA expressly bars private enforcement of purported violations of the Act.  That’s good – very good indeed – as far as it goes.  But what’s the point as a practical matter?

We think the point is how preemption protects Congress’ additional decision in the FDCA to grant the FDA almost unlimited discretion to prosecute, resolve, or excuse violations as the Agency sees fit.  Basically, the FDA’s exclusive enforcement authority reinforces those parts of the FDCA that confer upon the FDA the ability to select which violations of the FDCA to prosecute and which to settle administratively.  As the Court observed in Buckman, FDA has “complete discretion” in deciding “how and when [its enforcement tools] should be exercised” and must exercise that discretion “to achieve a somewhat delicate balance of statutory objectives.”  531 U.S. at 348.  Preemption and prosecutorial discretion go hand in hand.

The Supreme Court looked at this interplay some years earlier in Heckler v. Chaney, 470 U.S. 821 (1985), in which death row inmates tried to throw a monkey wrench into their sentences by seeking to force the FDA to prevent the use of certain drugs use in executions.  The FDA had exercised prosecutorial discretion to refuse to enforce the statute in this manner.  The Supreme Court affirmed the FDA’s right to determine for itself how to enforce the Act:

[A]n agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise.  Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency's overall policies, and, indeed, whether the agency has enough resources to undertake the action at all.  An agency generally cannot act against each technical violation of the statute it is charged with enforcing.  The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.

Id. at 831-32.

FDA administrative discretion has precluded contrary positions 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 could not urge upon a court an FDCA categorization that the FDA had not seen fit to impose.

We decline to find and do not believe that the district court 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 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.

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 the FDA had sent a warning letter, but not taken any stronger steps:

[I]t is apparent that the FDA has not yet determined whether to take action against [defendant].  In essence, the FDA has not yet determined how it 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 and enforcement of the relevant FDA regulation is not an issue properly decided “as an original matter by a district court.

Id. at 934 (footnote omitted); accord Summit Technology, Inc. v. High-Line Medical Instruments, Co., 922 F.Supp. 299, 306 (C.D. Cal. 1996) (“regardless of any warning letters . . . the FDA has not completed this investigation”; plaintiff “would force this Court to rule on the legality of Defendants’ conduct before the FDA has had a chance to do so”). See Wyeth v. Sun Pharmaceutical Industries, Ltd., 2010 WL 746394, at *4 (E.D. Mich. March 2, 2010) (“it is solely the FDA's duty to investigate and prosecute allegations 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., 1999 WL 811334, at *18 (Tex. Dist. June 7, 1999) (private plaintiffs may not “act as a 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 particularly important when a plaintiff attempts to sue over something that resulted in an FDA warning letter or other form of informal enforcement activity, and nothing more.  Inevitably the plaintiff is demanding some sort of severe sanction – a product recall, a revocation of approval, or at minimum a mandatory warning change – when the FDA declined to require anything of the sort.  This kind of knee-jerk over-prosecution by private plaintiffs is contrary to the express terms of the FDCA:

Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution . . . minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.

21 U.S.C. §336.  This is the FDCA section that authorizes warning letters in the first place.  E.g. FDA Enforcement Manual ¶410 (“Authority To Issue Warning Letters”) (2010).

As a result of §336, “[t]he FDC Act imposes no clear duty upon FDA to bring enforcement proceedings. . . .  Congress has not given FDA an inflexible mandate 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 . . . product is “adulterated,” in the abstract, means little other than that FDA could choose to initiate enforcement proceedings.  [Plaintiff] does not, and could not, point to any provision in the FDC Act requiring FDA to initiate enforcement action against every [product] falling within the Act’s definition of “adulterated.”  Rather, the Act makes clear that these enforcement decisions are vested, as they traditionally are, with the agency.

Community Nutrition Institute v. Young, 818 F.2d 943, 950 (D.C. Cir. 1987) (enforcing §336).  A plaintiff has no right to demand an enforcement 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 arguments that certain allegedly “adulterated” products should be removed from the markes.  The FDA, the court observed, “has not taken enforcement action to remove [the products] from the market.  It is for the FDA to exercise its discretion to 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 decide whether or not to pursue arguable violations mentioned in such letters.  The Agency has “rather broad discretion − broad enough undoubtedly to enable [it] to perform [its] duties fairly without wasting [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 Center Pharmacy v. Mukasey, 536 F.3d 383, 399 (5th Cir. 2008) (relying on §336 to hold that “the FDA is not required to seek to enjoin, prosecute or otherwise litigate ‘minor violations’ of the Act”); United States v. Goodman, 486 F.2d 847, 855 (7th Cir. 1973) (“[u]njustifiably harsh consequences of a completely literal enforcement are tempered by discretion given” to the FDA).

We think that defendants arguing preemption should remember to cite FDA prosecutorial discretion as one of the practical reasons why the Congress’ affirmative rejection of private enforcement (see Buckman and §337(a)) are properly given preemptive effect.  It’s one thing to state the rule, but something else again to explain in practical terms why preemption is appropriate when an injured plaintiff is waving an FDA warning letter around.  The best recent example we know of involving successful use of the §336 prong of FDA discretion has to be Zimmerman v. 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 FDA exception to the New Jersey punitive damages immunity statute was preempted.  Not only was that result plainly the law under the great weight of precedent, but it made eminent practical sense in light of Congress’ grant of prosecutorial discretion to the FDA – precisely what this plaintiff was trying to override with his civil action.  First, the court in Zimmerman determined:

In fact, the FDA is vested with considerable discretion in 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 the institution of libel or injunction proceedings, minor violations of this chapter whenever [FDA] believes that the public interest will be adequately served by a suitable written notice or warning.”  Id. §336.  Finally, courts have found the FDA's decision not to undertake certain enforcement actions to be non-reviewable.

Id. at *10.  Coming back to this point, Zimmerman recognized that claims requiring a finding of a violation, as opposed to a defect, represented attempts to usurp the FDA’s discretion whether to prosecute a particular claimed violation:

[T]he FDCA vests the FDA, not private litigants, with the exclusive authority to investigate and prosecute any suspected fraud or misrepresentation in connection with FDCA created disclosure requirements [and] accords the FDA considerable flexibility in how it chooses to address any fraud or misrepresentation in connection with the disclosure requirements. . . .  If a state claim requires a fact finder to make a separate determination that federal law contemplates may be made in parallel by both a state fact finder and a federal agency, courts are unlikely to find any obstacle to the enforcement of a federal statute. . . .

Id. at *13-14.  A violation claim that the FDA never saw fit to prosecute (and typically seeking 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’s statutory immunity provision poses an obstacle to the FDCA regulatory scheme because it requires a fact finder to make a determination that a federal law leaves exclusively to the agency. . . .  [T]he FDA has exclusive authority to decide whether a drug is safe and effective enough to be approved for sale in the United States and the flexibility to decide whether and what type of enforcement claim to bring against a drug manufacturer that breaches the FDCA-mandated disclosure duty owed to it during the NDA and post-approval processes  But the FDA has never found that [defendant] knowingly withheld or misrepresented information required to be submitted under the agency's regulations.

*          *          *          *

Simply put, Plaintiff's claim . . . requires a state 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 a different approval decision had it been provided with the correct or missing information.  Plaintiff's claim thus requires a fact finder to make these types of determinations as a matter of state law even though federal law makes such determinations the exclusive province of the FDA.

Id. at *15.  Not only did Zimmerman follow what the preemptive rule in Buckman was, but it relied upon express FDA discretion not to prosecute an arguable violation as a major reason why preemption was not just required, but was the only sensible result under the circumstances.

In Zimmerman the defendant won, not only by convincing the court that preemption was required by controlling case law – a ruling that could have been made in far fewer pages – but also by convincing the court that preemption was the only result that was practical and in line with the structure of the FDCA as a whole.  And critically, the preemption ruling in Zimmerman was in a drug, not a device case.  That's not easy after Levine.  Convincing the court that the defendant is right not only on the law but on policy as well was a key, if not the key to success.  This is the kind of in-depth argument needed to win preemption motions in drug cases in the current environment.  We commend it to our readers.