United States: Implied Preemption And Monograph Drugs

Last Updated: December 13 2016
Article by James Beck

The Reed Smith blogging team has just returned from this year's annual ACI Drug & Medical Device Litigation conference. In addition to excessive amounts of eating, drinking, and socializing (now called "networking"), we kept our eyes open for new and interesting topics to blog about. We were not disappointed. We learned a lot more regarding preemption of claims involving non-prescription, over-the-counter ("OTC") drugs, particularly those governed by parts of the FDA's monograph system that we haven't considered much before.

We knew, of course, that OTC drug preemption is governed by 21 U.S.C. §379r, which contains not only an express preemption clause, but also a savings clause. Under the preemption clause, tort claims demanding warnings or other information that is "different from," "addition[al] to," or "otherwise not identical with" federal labeling requirements are preempted. However – and it's a great big however – the savings clause exempts "product liability" claims from preemption. Id. §379r(e). That doesn't mean that preemption covers nothing of interest to us. We've discussed at some length how many courts have considered non-personal injury claims to be outside the scope of the "product liability" saving language, and therefore precluded by express preemption. Most recently, we described a 2014 New Jersey case involving mouthwash that refused to apply a presumption against preemption to the express preemption clause, finding the presumption precedent "confused" and inapplicable. Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 374 & n.17 (S.D.N.Y. 2014).

But what about implied preemption by reason of conflict – specifically the impossibility preemption rationale adopted in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2468, (2013)? What we heard at the ACI conference sounded good enough to us that we thought we'd investigate it pass along what we found.

First, we've already blogged about the recent demise of the presumption against preemption in express preemption cases. See Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) ("because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption") (citation and quotation marks omitted). While not a good thing for implied preemption generally, this difference between implied and express preemption is also a vivid demonstration of the principle that express and implied preemption operate independently. As the Supreme Court previously held in one of our favorite cases:

Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision. . . . To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail . . . .

Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 352 (2001). See also: Spreitsma v. Mercury Marine, 537 U.S. 51, 65, 123 S.Ct. 518, 154 L.Ed.2d 466 (2002); Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000); Freightliner v. Myrick, 514 U.S. 280, 288-289 (1995). The combination found in §379r of preemption and savings clauses do not "create some kind of 'special burden'" that would "specially disfavor pre-emption." Geier, 529 U.S. at 870.

Mensing/Bartlett preemption, of course, depends on what we call the "independence principle."

[W]hen a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

Mensing, 564 U.S. at 623-24. Accord Bartlett, 133 S.Ct. at 2470 ("federal law prohibits generic drug manufacturers from independently changing their drugs' labels. Accordingly, state law imposed a duty on [defendant] not to comply with federal law"). That means in the OTC area, as elsewhere, there should be preemption if the defendants can't do what the plaintiffs are demanding without first going to the FDA.

First, let us point out that the rote response that "this product isn't a generic drug" is, to put it bluntly, garbage. Three Courts of Appeals have addressed this limitation, and all three have rejected it. Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016); Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir. 2015); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015). Numerous trial courts cited in our drug preemption cheat sheet have held likewise. Thus there is no doctrinal obstacle to Mensing/Bartlett implied impossibility preemption applying to OTC drugs. Sikkelee, after all, involved the design of airplane parts.

So the question devolves to whether an FDA tentative monograph for an OTC drug is something that, like Wyeth v. Levine, 555 U.S. 555 (2009), can be amended at will, or is it something, like the Mensing/Bartlett line of cases, that is cannot be deviated from without prior FDA approval. The "changes being effected" regulation that the Levine court found dispositive, 21 C.F.R. §314.70, is explicitly limited to "changes to an approved NDA." Since NDAs are not required for OTC drugs subject to the monograph system, that would appear to be out.

Rather, the FDA regulations pertaining specifically to OTC products require compliance with monographs without a similar exception.

An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the conditions contained in this part and in an applicable monograph is liable to regulatory action.

21 C.F.R. §330.1 (emphasis added). Labeling/warnings are, of course, part of this process. Id. at §330.10(a)(4)(v) (addressing labeling). As long as an OTC drug complies with "any" FDA monograph applicable to it, it is not subject to "regulatory action," but if it doesn't, the FDA can go after the manufacturer. This requirement to conform strictly to the monograph specifically extends to all labeling other than the "Indications" section:

The "Uses" section of the label and labeling of the product shall contain the labeling describing the "Indications" that have been established in an applicable OTC drug monograph or alternative truthful and nonmisleading statements. . . . Any other labeling under this subchapter and subchapter C et seq. of this chapter shall be stated in the exact language where exact language has been established and identified by quotation marks in an applicable OTC drug monograph or by regulation except as provided in paragraphs (i) and (j) of this section.

Id. at §330.1(c)(2) (emphasis added). Does this regulatory "exact language" mandate sound like generic "sameness" to you? It sure does to us.

Like generics, and unlike medical devices and biologics, there is no equivalent to the CBE provisions of §314.70 in §330.1. We looked at the exceptions stated in the above block quote from §330.1(c)(2), but neither of those provisions had anything to do with strengthening labels (only use of a variety of specific, quoted language). Particularly, while a monograph is pending, and therefore "tentative," new scientific information does not support CBE-style unilateral changes to the warnings. Rather, as with generic drugs, "new" information explicitly goes to the FDA for consideration:

New data and information submitted . . . prior to the establishment of a final monograph will be considered as a petition to amend the monograph and will be considered by the Commissioner only after a final monograph has been published in the Federal Register unless the Commissioner finds that good cause has been shown that warrants earlier consideration.

Id. §330.10(a)(7)(i)(v) (emphasis added).

The FDA hasn't been able to finalize all of these monographs due to limited resources, thus a number of OTC drugs are authorized for sale under "tentative" monographs. The FDA has explained this in a guidance document for "marketed unapproved drugs":

The Agency also was faced with resource challenges because it was receiving many applications for different OTC drugs for the same indications. Therefore, in 1972, the Agency implemented a process of reviewing OTC drugs through rulemaking by therapeutic classes. . . . This process involves convening an advisory panel for each therapeutic class . . . . These panel reports are then published in the Federal Register, and, after FDA review, tentative final monographs for the classes of drugs are published. The final step is the publication of a final monograph. . . . Drugs marketed in accordance with a final monograph are considered to be generally recognized as safe and effective. . . . Final monographs have been published for the majority of OTC drugs. Tentative final monographs are in place for virtually all categories of OTC drugs.

Draft Guidance: Marketed Unapproved Drugs – Compliance Policy Guide, 2003 WL 24014273, at *8 (FDA Oct. 15, 2003) (emphasis added). These "tentative" monographs are are only tentative in that they are subject to additional formal comments. See 21 U.S.C. §330.10(7). Tentative monographs "establish[] conditions under which a category of OTC drugs or specific OTC drugs are generally recognized as safe and effective and not misbranded." Id. §330.10(7)(i).

Compliance with all tentative OTC monographs is mandatory. Another FDA regulation addresses this situation:

Marketing of such a product [an OTC drug "under consideration by an OTC advisory review panel" "on or after May 11, 1972"] with a formulation or labeling not in accord with a proposed monograph or tentative final monograph also may result in regulatory action against the product, the marketer, or both.

21 C.F.R. §330.13(b)(2) (emphasis added). By regulation, therefore, the FDA can come after any OTC drug manufacturer that violates a "proposed" or "tentative final" monograph in either the design or labeling of a drug. As to OTC drugs subject to a tentative monograph, only "marketing under [the] specified conditions will be permitted." 21 C.F.R. §330.13 (d)(2)(i); see also 21 C.F.R. §300.14(h) (for OTC products submitted after 12/23/2016).

Some OTC drugs – acetaminophen, skin protectants (sunscreen, bug repellants, lip balm, and some other stuff), and internal analgesics and related products (which previously included acetaminophen) − have been the subject of specific regulatory actions. There's a 2015 guidance for acetaminophen, for example, that indicates that the FDA is planning to issue an actual regulation to address "liver damage associated with the use of . . . OTC pediatric oral liquid acetaminophen." Over-The-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen Guidance For Industry, 2015 WL 4711458, at *1 (FDA Aug. 1, 2015). In the meantime, "[m]any of these products are marketed under the OTC conditions stated in FDA's Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use." Id. (footnote omitted). This 2015 guidance goes on to list a variety of "recommended" steps that manufacturers can take, but "do not establish legally enforceable responsibilities . . . and should be viewed only as recommendations." Id.

Thus these products remain "marketed under" the footnoted document, which is the 1988 "Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph," 53 Fed. Reg. 46204 (FDA Nov. 16, 1988). So what is that, and can manufacturers deviate from it without getting prior FDA approval?

The 1988 tentative monograph is clear enough as to its status. It states that "the present document is designated as a 'tentative final monograph.' Its legal status, however, is that of a proposed rule." 53 Fed. Reg. at 46204. Thus, according to the FDA, "any OTC drug product subject to this monograph that is repackaged or relabeled after the effective date of the monograph must be in compliance with the monograph." Id. at 46205 (emphasis added). The FDA rejected the "conten[tion] that there is no statutory authority for the codification of exact words." Id. at 46208. "All other OTC drug labeling required by a monograph or other regulation (e.g., statement of identity, warnings, and directions) must appear in the specific wording established under the OTC drug monograph or other regulation." Id. (emphasis added). Elsewhere, the FDA spoke in terms of "requiring warning statements." Id. at 46213. It's a rather long document, but we find nothing in this tentative final monograph, published in the Federal Register, that suggests that manufacturers of OTC products subject to it are free to ignore it unilaterally. "The contents of the Federal Register shall be judicially noticed." 44 U.S.C.A. §1507.

As far as the other category, skin protectants the relevant guidance document does allow some unilateral changes, mostly to design:

Until we issue final rules for external analgesic and first aid antiseptic drug products, we do not intend to take enforcement action if an OTC drug product combines external analgesic or first aid antiseptic active ingredients identified in these tentative final monographs with applicable skin protectant active ingredients.

Draft Guidance For Industry Labeling OTC Skin Protectant Drug Products, 2008 WL 3549653, at *4 (FDA Aug. 1, 2008). As for warnings, this guidance states "[t]here are a few warnings that are required in the labeling of OTC skin protectant drug products." Id. at *6 (listing required warnings). One such product is sunscreen, and as to the the FDA has issued a final monograph. We discussed the preemptive effect of that monograph, here, and here, but all those cases were primarily express preemption and/or primary jurisdiction, the former because of the "product liability" issue we mentioned earlier.

Reviewing this material, it appears that Mensing/Bartlett preemption should apply to just about all warnings related to OTC products for which there is at least a tentative monograph. The same combination of a "sameness" requirement (the "exact language" mandate of §330.1(c)(2)) and absence of any CBE exception for "new" information (§330.10(a)(7)(i)(v)), exists for OTC products, as it does for generics. Even though denominated "tentative," the relevant documents are replete with threats of administrative action should they be deviated from during the (very long) interim period before they are to be finalized. They also use mandatory language – "must" and "required." There seems to be somewhat more leeway in the skin protection area, as described in the relevant guidance, but all the sunscreen cases so far have been fallen outside the "product liability" exception, and thus have turned on express preemption and §379(r).

Ever since the FDA began regulating OTC products, it has specifically allowed then to be regulated – and marketed – pursuant to this system of "tentative monographs" set out in 21 C.F.R. §330.10(a)(7). As described, while the FDA reserves the right to change the requirements of these monographs, in most instances the design and language of warnings therein specified cannot be unilaterally changed by regulated persons, and deviations from them are subject to FDA enforcement action. Plaintiffs may not like this system, but it is what it is. State law cannot ignore the basis on which these products have been sold for decades without putting manufacturers in an "impossible" position of being punished with liability for doing what the FDA requires them to do.

Nor, as a last resort, can state common-law posit that the tentative monograph system is a lousy system, doesn't result in "safe" products, and thus manufacturers cannot avoid liability, whether or not a particular requirement is mandatory. That would amount to telling FDA-regulated manufacturers that they cannot sell their products in accordance with the regulatory regime that the FDA has created. Such "stop selling" claims are themselves impliedly preempted:

We reject this "stop-selling" rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be "all but meaningless

Bartlett, 133 S. Ct. at 2477.

Finally, we would like to thank the drafters of this Drinker Biddle piece from 2012, in addition to the ACI material we saw the other day, for shaping our thinking in this post.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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James Beck
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