Law

“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:

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:

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:

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:

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.

Thhi 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:

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:

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:

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.

“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:

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.