Photo of Bexis

“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era.  To be very brief, Jurisfiction is the fictional police force for BookWorld, one of Fforde’s fictional universes.  Tuesday is a Jurisfiction agent (sometimes rather more than that).

“Jurisfiction,” unfortunately, is also something we see in our line of work, sometimes making us wonder whether the likes of Emperor Zhark, the Red Queen, and Pinky Perkins may have aliases who serve in the all-too-real judicial branches here in the States.  Jurisfiction is shorthand for a decision that gets a legal issue totally bollixed  – perhaps applying the UltraWord to the issue – allowing the user to control the plot, garbling it, and ultimately making all precedent useless.

We recently ran across a shining example of jurisfiction in the discussion of FDA warning letters found in Mihok v. Medtronic, Inc., ___ F. Supp.3d ___, 2015 WL 4722847 (D. Conn. Aug. 10, 2015).  Here’s what Mihok held on that subject:

The Complaint is rooted in FDA Warning Letters which state that [defendant] failed to comply with the CGMP regulations. . . .  While perhaps not dispositive on the issue, the FDA’s conclusions and interpretations of its own regulations are likely to receive a considerable degree of deference.  See, e.g., Conroy v. Dannon Co., Inc., No. 12 CV 6901(VB), 2013 WL 4799164, at *6 (S.D.N.Y. May 9, 2013) (stating that the FDA’s interpretations of its own regulations promulgated under title 21 “are ‘controlling unless plainly erroneous or inconsistent with the regulations’ or there is any other reason to doubt that they reflect the FDA’s fair and considered judgment”) (citing and quoting PLIVA, Inc. v. Mensing, ––– U.S. ––––, ––––, 131 S.Ct. 2567, 2575, 180 L.Ed.2d 580 (2011)); Dorsey v. Housing Auth. of Baltimore City, 984 F.2d 622, 632 (4th Cir. 1993) (finding district court abused its discretion in refusing to consider regulatory agency’s assessment of defendant’s compliance with agency regulations and noting that the district “court should welcome [the agency’s] appraisal of [the defendant’s] compliance with regulations, given its concern for deference to agency interpretations of its own regulations”). Indeed, it is precisely when a court is called upon to interpret the regulations, i.e., when they are ambiguous, and where their application to facts raises complex issues, that the court is most likely to defer to the FDA’s prior determinations.  See Wilson v. Frito-Lay N. Am., Inc., 961 F. Supp.2d 1134, 1142 (N.D. Cal. 2013) (noting that “an agency’s informal interpretation of its own ambiguous regulation is [typically] controlling” but declining to give “deference to two warning letters that the FDA sent” because neither party to the case “contended that the FDA regulations . . . [w]ere ambiguous, and the Court d[id] not find that they [we]re”); James T. O’Reilly, et al., 1 Food & Drug Admin. §4:56 (4th Ed. 2015) (“The FDA is allowed great deference in the interpretations of its own regulations…. The more complex the issue, the more scope is likely to be given for the FDA to draw the interpretations.”).

As to deference, Defendants cite a non-binding case, Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939 (E.D. Wisc. 2008), for the proposition that “a warning letter from the FDA is not considered a final agency action,” and contend that, as a result, “Plaintiffs’ allegations … raise legal questions as to the potential effects of various actions by a federal agency … [which] should be decided in a federal forum.”  The Second Circuit has not taken a position on whether an FDA Warning Letter is considered a final agency action.  Even if it is not, such letters may still be entitled to deference.  See Cmty. Health Ctr. v. Wilson-Coker, 311 F.3d 132, 138 (2d Cir. 2002) (“[E]ven relatively informal [agency] interpretations, such as letters from regional administrators, warrant respectful consideration” where the statute at issue is complex and the regulatory agency possesses “considerable expertise”) (citations and quotations omitted).  Regardless, they may serve as evidence of regulatory violations.  Gelber v. Stryker Corp., 788 F. Supp.2d 145, 155–56 (S.D.N.Y. 2011) (finding plaintiffs who provided FDA Warning Letters as evidence of violations of FDA regulations stated claims for manufacturing defects).

Mihok, 2015 WL 4722847, at *5-6 (citations not omitted, for once).  Under this analysis, there being no undecided FDA-related issue, Mihok was remanded to state court.

From beginning to end, that analysis is just backwards – or what the republican Brits in BookWorld might call an anagram for “restorative.”  Let’s start with the citations.  None of the citations in the first paragraph have anything to do with warning letters.  Conroy v. Dannon Co., 2013 WL 4799164 (S.D.N.Y. May 9, 2013), deferred to something called an “FDA Q & A,” which interpreted a regulatory stay published in the Federal Register – in other words, something that the FDA intended to be generally followed.  Id. at *6.  No warning letter of any sort there.  Conroy quoted general language from PLIVA v. Mensing, 131 S. Ct. 2567 (2011), about FDA deference.  Mensing was discussing the FDA’s formal litigation position, taken by the Department of Justice in an amicus curiae brief filed in that case at the express behest of the Supreme Court.  Id. at 2575.  Again, that brief took a position that the agency hoped would be accorded general application.  Dorsey v. Housing Auth. of Baltimore City, 984 F.2d 622 (4th Cir. 1993), didn’t deal with the FDA at all, but with “HUD’s 1992 Formal Utility Review.”  Id. at 627.  Note that word – “formal.”

No warning letters so far.  Which brings us to Wilson v. Frito-Lay, Inc., 961 F. Supp.2d 1134, 1142 (N.D. Cal. 2013), which refused to give any deference to two FDA warning letters.  Id. at 1142.  Mihok cited Wilson for dictum that FDA “informal” interpretation of “ambiguous” regulations should be “controlling unless plainly erroneous or inconsistent with the regulation.”  Id. The “non-binding” (just as binding as Dorsey or Wilson) contrary case, Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939 (E.D. Wisc. 2008), was not dictum, expressly rejecting the “position that the FDA letters express official FDA determination.”  There’s much more to Schering-Plough than the brief paraphrase in Mihok:

The FDA letters cited by [plaintiff] did not provide the defendants the opportunity for a hearing. . . .  Therefore, even if the FDA had purported to make an agency determination through the letters . . . such a determination would not have been in compliance with the explicit statutory requirements, the determination could not be considered an official agency determination to be afforded deference.

Indeed, several courts have recognized that letters such as those cited here do not constitute an official agency determination.  Furthermore, pursuant to 21 C.F.R. §10.85(k), “[a] statement or advice given by an FDA employee . . . is an informal communication that represents the best judgment of that employee at that time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.”  Id.

547 F. Supp.2d at 946-47 (five citations omitted – discussed below).  The only other warning letter case Mihok cites, Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011), is mischaracterized as standing for the proposition that FDA warning letters “may serve as evidence of regulatory violations.”  Gelber, however, is a Rule 12(b)(6) pleading case; all it really stands for is that warning letters may give a defendant “ample notice” of a “plausible” claim under TwIqbal.  788 F. Supp.2d at 156-57.

Finally, there’s Community Health Center v. Wilson-Coker, 311 F.3d 132 (2d Cir. 2002), deferring to a Medicaid administrator’s letter issued under regulations that specifically authorized that sort of “discuss[ion]” and “consult[ation]” on “questions regarding application of Federal policy.”  Id. at 138 (quoting 42 C.F.R. §430.14 (2002)).

In sum, Mihok does not cite a single case giving any sort of deference to an FDA warning letter.  There’s plenty of reasons for that, and we’ll start with the statute – the Food, Drug and Cosmetic Act (“FDCA”) itself.  The FDA is an administrative agency, so its powers have to be delegated by Congress.  The FDCA expressly gives the FDA authority to address “minor violations . . . by suitable written notice or warning.”  21 U.S.C. §336.  That’s where warning letters come from.  If the FDA is content to address some possible violation by letter, by definition it’s a “minor violation.”  It has to be, otherwise, by statute, the FDA has to resort to some other more robust enforcement tool.

What does the FDA itself have to say?  As already discussed, Mensing gave considerable deference to the FDA’s position when appearing in a brief filed by the Department of Justice with the Court.  Just such a Supreme Court brief was filed on behalf of the FDA in 2012 in a case called Holistic Candlers & Consumers Ass’n v. FDA (No. 11-1454).  It’s on Westlaw at 2012 WL 3991471, and those are the citations we’re going to use, but, if you’re looking to save money, you can read the same brief for free on the DoJ website, here.  The case involved, of all things, ear candles, but the appeal concerned precisely the point that Mihok rejected – that FDA warning letters are informal, tentative, and thus completely non-final.  The court of appeals had ruled exactly the opposite of Mihok on the significance of FDA warning letters:

FDA’s warning letters . . . neither mark the consummation of the agency’s decisionmaking process nor determine the appellants’ legal rights or obligations.  The letters plainly do not mark the consummation of FDA’s decisionmaking. . . .  FDA warning letters . . . giv[e] firms an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action. . . .  Nor do the letters represent a decision determining rights or obligations, or one from which legal consequences flow. . . .  [A] Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].  Although a warning letter communicates the agency’s position on a matter, it is only informal and advisory and does not commit FDA to taking enforcement action. . . .  In short, an FDA warning letter compels action by neither the recipient nor the agency.

Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940, 943-44 (D.C. Cir. 2012) (citation to the FDA’s regulatory procedures manual and quotation marks omitted).

The Holistic folks sought certiorari, and the Department of Justice opposed, telling the Supreme Court firmly that FDA warning letters, although providing notice to recipients and giving them the opportunity to respond informally, were not any sort of definitive agency determination of any legal matter:

If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action.  Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].”  FDA, Regulatory Procedures Manual, 4-1-1 (July 2012).  A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.”  Ibid.

FDA Holistic Candlers DoJ br., 2012 WL 3991471, at *5.  That’s one.

[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. . . .  Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.”  Regulatory Procedures Manual 4-1-1. . . .  Relatedly, the warning letters were not based on a formal and complete administrative record.  At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”

Id. at *9-10 (citation omitted) (emphasis original).  That’s two.

Nor did the warning letters finally determine the rights or obligations of petitioners . . . or trigger direct and appreciable legal consequences.  Rather, the letters “request[ed]” that petitioners “take prompt action” . . ., and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.”  The letters served only to communicate FDA’s position . . ., and to warn recipients about the possibility of future enforcement action.  See Regulatory Procedures Manual 4-1-1.  The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.”  Ibid.

Id. at *10-11 (citations and quotation marks omitted).  That’s three.

FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response.  Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review.

Id. at *14.  That’s four.  After the DoJ/FDA told the Supreme Court all this, the Court denied the Holistic folks’ petition for certiorariSee 133 S.Ct. 497 (2012).

So, if what was really going on in Mihok was Mensing-style deference to the FDA’s position, then “deference” should have required treating warning letters as:  “informal,” “advisory,” “not commit[ting] the FDA,” “not based on a formal and complete administrative record, “not final and binding,” “tentative,” not “finally determin[ing]” “rights or obligations,” “trigger[ing] no legal consequences,” “subject to further agency “evaluat[ion]” − a far cry from how they were characterized in Mihok.  Critically, that’s the FDA’s own characterization of a warning letter.  The Mensing deference language traces back to the “considered judgment” standard in Auer v. Robbins, 519 U.S. 452, 462 (1997), in which the Court was also dealing with a position taken in a legal brief filed on behalf of an agency.  We strongly doubt that Auer deference, or any other sort of deference, can legitimately be given to anything, such as FDA warning letters, when the very agency that issued them states so clearly and repeatedly that they are not binding, even (indeed, especially) on itself.

The FDA’s position is underscored by the regulatory procedures manual that the DoJ cited several times in its brief in Holistic Candlers. Turns out that, unlike the citations in Mihok, the manual says exactly what the DoJ told the Supreme Court it did.  “[I]t is the Food and Drug Administration’s (FDA’s) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action.  Warning Letters are issued to achieve voluntary compliance and to establish prior notice.”  FDA Regulatory Procedures Manual §4.1.1 (“Warning Letter Procedures”).  Warning letters “are based on the expectation that most individuals and firms will voluntarily comply.”  Id. “A Warning Letter is informal and advisory.  It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action.  For these reasons, FDA does not consider Warning Letters to be final agency action.” Id.

Furthermore, the FDA’s Regulatory Procedures Manual makes pretty clear is that warning letters are “not appropriate” if alleged violations are “repeated,” “continual,” “intentional,” “flagrant,” or “willful”; or if “[t]he violation presents a reasonable possibility of injury or death.” Id.  This confirms the first point we made above – that warning letters are only authorized by the FDCA for “minor violations,” not the kind of things that, in tort litigation, might bring punitive damages into play.

This is hardly all.  Mihok also cited (2015 WL 4722847, at *6) a book section, James T. O’Reilly, et al., 1 Food & Drug Admin. §4:56 (4th Ed. 2015).  That’s the treatise’s general FDA deference section, and like many of the cases Mihok cites, that section doesn’t say “boo” about warning letters.  However, other sections of the same treatise do.  Section 6:2 of the O’Reilly treatise, entitled “Warning letters—What they are and how to respond,” refutes practically everything stated in Mihok:

[A] warning letter is not “final agency action,” it is not a “finding” that warrants negligence per se liability action. . . .  A trial court denied a defendant’s request for judicial notice of an FDA warning letter sent to it regarding its Internet marketing.  Warning letters, even as supplemented by FDA’s Web site and the appellants’ conversations with FDA officials, do not constitute final agency action, and so a judicial review complaint is not cognizable under the APA and must be dismissed for failure to state a claim.  An FDA warning letter is not a final decision by the FDA and its position may change after further investigation. A warning letter does not constitute evidence in the record that the FDA has determined or will determine that a product’s mark is deceptive. . . .  FDA warning letters have not been judicially reviewable “final action” but some cases will suggest a basis for such a review.

O’Reilly, et al.,1 Food & Drug Admin. §6:2 (2015) (various footnotes omitted) (emphasis added).  Thus the same treatise states that warning letters are:  (1) “not final agency action,” (2) not anything that “warrants negligence per se,” (3) not subject to “judicial notice,” (4) subject to “change after further investigation,” and (5) not “evidence in the record that FDA has determined” anything.  And that’s just the most pertinent section of this treatise.  See also Id. §4:45 (“Statements of lower-level agency officials do not rise to the level of final agency action, even when they are contained in warning letters”); §10:17 (“FDA warning letters are insufficient evidence of how reasonable consumers would view the labels”); §15:73 (“an FDA warning letter did not support an inference of the requisite scienter,” quoting Avon Pension Fund v. GlaxoSmithKline PLC, 343 F. Appx. 671, 674 (2d Cir. 2009)); §26:130 (“a warning letter from the FDA is informal and advisory”).  Don’t look at us; we know O’Reilly has appeared as a plaintiff-side FDA expert, but that’s the treatise that Mihok chose to cite.

Finally, we turn to case law.  As we suspected from Mihok’s inability to come up with any warning letter precedent that actually stood for the propositions being advanced, courts are close to unanimous that warning letters aren’t “final” in any meaningful sense.  “[E]very court to consider the question has held that an FDA warning letter does not constitute ‘final agency action.’”  Cody Laboratories, Inc. v. Sebelius, 446 F. Appx. 964, 969 (10th Cir. 2011).  While warning letters may have helped push some complaints past the TwIqbal “plausibility” standard on Rule 12 motions to dismiss (see Gelber, supra), that’s about it.  We’ll start with Holk v. Snapple Beverage Corp., 575 F.3d 329 (3d Cir. 2009), where the defendant relied upon “several” FDA warning letters on a particular topic.  The court refused to defer to them:

We do not think these letters are sufficient to accord the policy the weight of federal law. . . .  Congress likely intended to give administrative action the effect of law when the agency adhered to a relatively formal administrative procedure tending to foster the fairness and deliberation that should underlie a pronouncement of such force. . . .  In this case, the deficiencies inherent in the process by which the FDA arrived at its policy . . . are simply too substantial to be overcome by isolated instances of enforcement. . . .  Both lack the formal, deliberative process.

Id. at 341-42 (citations and quotation marks omitted).  Thus, when the FDA “took steps to address the allegations by issuing warning letters . . . it did not take final action.”  Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013).  FDA “letters are not final agency action . . ., as there has been no final agency action, let alone action that has been or could be judicially reviewed.”  Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 586 F.3d 500, 508 (7th Cir. 2009) (affirming the “nonbinding” decision that Mihok shrugged off).  “[T]he type of informal letter issued by the FDA . . . does not constitute . . . formal or final agency action.”  Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 562-63 (9th Cir. 1992).  FDA warning letters are “informal communications.”  Professionals & Patients for Customized Care v. Shalala, 56 F.3d 592, 599 (5th Cir. 1995).  “Warning letters merely establish a dialogue between the FDA and the [addressee] and do not necessarily lead to further sanctions.”  Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1378 (9th Cir. 1983).  A warning letter “d[oes] not represent the FDA’s final word,” thus there is no “per se” rule requiring their disclosure in securities litigation.  Fire & Police Pension Ass’n v. Abiomed, Inc., 778 F.3d 228, 243 & n.9 (1st Cir. 2015).  Add the Holistic Candlers case quoted extensively above, and that’s a lot of directly-on-point court of appeals decisions discounting the adjudicative value of FDA warning letters.

The West Virginia Supreme Court of Appeals (not normally pro-defense in our experience), when faced with a verdict based on the purported collateral estoppel effect of “false and misleading” language contained in an FDA warning letter, decided that there was no such thing – because such letters had no finality.  That court said so nearly as many times as the FDA did in its Holistic Candlers brief:

The Appellants contend that the circuit court erred by giving preclusive effect to DDMAC’s determination that their [drug related] statements were false and misleading. They point out that, pursuant to the FDA’s own guidelines, warning letters are merely “informal and advisory” and do not constitute a final judgment of the FDA.  The Appellants further assert that, despite the circuit court’s finding to the contrary, they did not have the ability to administratively appeal the allegations contained in those warning letters and, thus, were never afforded the opportunity to defend against the FDA’s informal determinations.  This Court agrees.

State ex rel. McGraw v. Johnson & Johnson, 704 S.E.2d 677, 687 (W. Va. 2010) (footnote omitted).  That’s one.

Here, no preclusive effect can be given to the FDA’s determination that the statements and omissions in the [defendant’s statements] are false and misleading, because the FDA did not render a “final adjudication on the merits” on this issue, nor did the Appellants have an opportunity to fully and fairly litigate the question.

Id. at 688. That’s two.

Clearly, in issuing warning letters, the FDA is not acting pursuant to any adjudicatory authority, nor does it employ any due process procedures similar to those accorded defendants in courts of law.  Rather, in issuing a warning letter, the FDA, acting pursuant to its regulatory authority, attempts to remedy a perceived violation through informal means.  No hearing is provided prior to the issuance of the letters, nor is the recipient notified of the alleged violations. Indeed, the purpose of the warning letters is to provide such preliminary notification, thereby giving the alleged violator an opportunity to resolve the problem in an informal manner before actual adjudication takes place.  Accordingly, the warning letters cannot be considered quasi-judicial determinations by the FDA and, thus, are not subject to collateral estoppel under West Virginia law.

Id. at 689. That’s three.

Plenty of federal district court cases reach the same holdings.  In Von Koenig v. Snapple Beverage Corp., 713 F. Supp.2d 1066 (E.D. Cal. 2010), the court agreed with Holk, supra, concluding that an “informal” FDA policy, “arrived at without the benefit of public input or formal procedures” and enforced by warning letters, should not “be accorded the weight of federal law.”  Id. at 1075.

The fact that [defendant] eventually received the Warning Letter from the FDA does not change things.  The receipt of the Warning Letter . . . does not establish [defendant] “knew” that it was out of compliance with CGMPs. . . . [E]ven a warning letter from the FDA is “informal and advisory.”  While it reflected the FDA’s position on the matter, it did not commit the FDA to taking enforcement action.

In re Genzyme Corp., 2012 WL 1076124, at *10 (D. Mass. March 30, 2012) (citations omitted). Just because a warning letter states that a product is “adulterated” doesn’t mean that it is, because such letters are “an informal and advisory method that does not commit the FDA to taking enforcement action.”  In re Digitek Products Liability Litigation, 821 F. Supp.2d 822, 829 (S.D.W. Va. 2011).

“FDA warning letters are informal and advisory, and do not amount to an FDA action.”  CytoSport, Inc. v. Vital Pharmaceuticals, Inc., 894 F. Supp.2d 1285, 1294 (E.D. Cal. 2012).  “[T]he FDA warning letter is not a final decision by the FDA and its position may change after further investigation.”  Id. at 1296.  “There is nothing magical about [an FDA] warning letter. Although the language sounds ominous, it really is rather boilerplate.”  Anderson v. Abbott Laboratories, 140 F. Supp.2d 894, 902 (N.D. Ill. 2001). “[A]n FDA warning letter does not necessarily compel action by the recipient nor the agency, and does not represent a decision from which legal consequences would flow.”  Craig v. Twinings, Inc., 2015 WL 505867, at *7 (W.D. Ark. Feb. 5, 2015).  A “warning letter is not a ‘final agency action,’ but rather is “is a tentative or interlocutory action.”  Regenerative Sciences, Inc. v. FDA, 2010 WL 1258010, at *7 (D. Colo. March 26, 2010).  It “is correct that FDA warning letters are not binding.  As the FDA Regulatory Procedures Manual states, ‘A Warning Letter is informal and advisory.’”  Gitson v. Trader Joe’s Co., 2013 WL 5513711, at *10 (N.D. Cal. Oct. 4, 2013).  “[R]egardless of any warning letters that the FDA may have sent . . ., it is clear that the FDA has not completed this investigation.”  “FDA’s warning letters do not represent the consummation of FDA’s process, determine any legal rights or obligations, or affect plaintiffs’ legal rights.”  Cody Laboratories, Inc. v. Sebelius, 2010 WL 3119279, at *12 (D. Wyo. July 26, 2010), aff’d in pertinent part, 446 F. Appx. 964 (10th Cir. 2011).  “[R]egardless of any warning letters that the FDA may have sent to Defendants, it is clear that the FDA has not completed this investigation.”  Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 306 (C.D. Cal. 1996).  “It is well-settled . . . that an agency’s investigatory activity does not constitute final agency action.”  Genendo Pharmaceutical N.V. v. Thompson, 308 F. Supp.2d 881, 884 (N.D. Ill. 2003).  Thus, an “FDA letter is insufficient to establish a violation.”  Chan v. Orthologic Corp., 1998 WL 1018624, at *20 (D. Ariz. Feb. 5, 1998). “Regulatory letters . . . do not amount to final agency action” and “do not bind the agency to the views expressed in them.”  Clinical Reference Laboratory, Inc. v. Sullivan, 791 F. Supp. 1499, 1503-04 (D. Kan. 1992), aff’d in part & rev’d in part on other grounds, 21 F.3d 1026 (10th Cir. 1994).

Further, it’s hard to see how something so tentative could constitute admissible evidence.  Forget hearsay; most states have rules of evidence equivalent to Fed. R. Evid. 404(6) (“[e]vidence of other crimes, wrongs, or acts is not admissible” except for enumerated exceptions), and Rule 609 (governing when witnesses can be impeached with criminal “convictions”).  Thus, we believe that, in most jurisdictions, juries don’t get to hear about mere arrests or indictments for purported “crimes” in the absence of any conviction. By contrast, an FDA warning letter doesn’t even reach the formality of an indictment.  Rather, in the words of the O’Reilly treatise, “warning letters . . . pointedly tell the offending violator to ‘knock it off.’” 1 Food & Drug Admin. §6:1.  A mere warning is not substantive evidence of an “other wrong.”

For these reasons, a number of cases have excluded FDA warning letters and other informal FDA enforcement activity:  Last year in Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State, 432 S.W.3d 563 (Ark. 2014) (which we discussed here), the court reversed a substantial verdict in part because an FDA warning letter was improperly admitted:

“A Warning Letter is informal and advisory.  It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action.  For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued.” . . .  [F]or evidence to be admissible, it must be more probative than prejudicial. . . .  Here, the “Warning Letter” was highly prejudicial.  Reports issued by governmental agencies, because of their “official” nature, may well carry inordinate weight in the minds of jurors.

Id. at 579 (quoting FDA Regulatory Procedures Manual, other citations and quotation marks omitted) (note, the link on WL is broken).  See King v. Danek Medical, Inc., 37 S.W.3d 429, 441-42 (Tenn. App. 2000); Newman v. McNeil Consumer Healthcare, 2013 WL 4460011, at *17-18 (N.D. Ill. March 29, 2013); In re Viagra Products Liability Litigation, 658 F. Supp.2d 950, 966 (D. Minn. 2009); In re Seroquel Products Liability Litigation, 2009 WL 223140, at *4-5 (M.D. Fla. Jan. 30, 2009); Chan, 1998 WL 1018624, at *5; Summit Technology, Inc. v. High-Line Medical Instruments, Co., 933 F. Supp. 918, 934 & n.9 (C.D. Cal. 1996).  The Second Circuit, in a case not cited in Mihok, excluded an “interim” governmental report from evidence, concluding that non-final agency action would mislead a jury due to its having “an aura of special reliability and trustworthiness . . . not . . . commensurate with actual reliability.”  New York v. Pullman, 662 F.2d 910, 915 (2d Cir. 1981).  Ditto FDA warning letters.

In light of all of this precedent, we think that the funhouse-mirror view of FDA warning letters expressed in Mihok – that they are entitled to significant “deference” – is an outstanding example of jurisfiction – a fanciful view of the law unsupported even by the cited materials and contrary to both the FDA’s own position and to overwhelming precedent on all levels.