In Corridor v. Walgreens Boot Alliance, Inc., the Supreme Courtroom of Washington thought-about an authorized query from the Northern District of Illinois on a difficulty of Washington state legislation. No. 102829-6, 2025 Wash. LEXIS 145 (Wash. Mar. 20, 2025). The underlying case, a proposed shopper safety class motion, entails the labeling of a sure over-the-counter cough syrups. We’ve got seen a number of instances like this, most frequently after they have been selected preemption. For fairly a while, in posts on a variety of instances, we’ve pushed two associated propositions: 1) a correct preemption evaluation ought to normally begin with figuring out if the asserted state legislation declare is cognizable as acknowledged earlier than coping with preemption; to do in any other case invitations reverse engineering a non-preempted declare past the scope of state legislation; and a couple of) when a federal courtroom is sitting in range, the Erie doctrine requires that the courtroom not substitute its judgment on what it thinks the state legislation present be. Taken collectively, these propositions favor the usage of licensed questions to first decide whether or not state legislation would offer the reduction plaintiffs search if not for the potential of preemption. So, we predict it made sense for the Northern District of Illinois to ask the Supreme Courtroom of Washington to find out how the protected harbor within the Washington shopper safety act utilized to plaintiffs’ OTC drug labeling claims earlier than deciding if these claims are preempted. We want it didn’t take three years to get this far, however, like arithmetic and assembling gadgets shipped in items, the order of operations issues. As a result of the precise determination from the Supreme Courtroom of Washington is so clearly mistaken, we must take solace within the order of operations. That and the way this declare is much more clearly preempted, which looks like the logical subsequent step.
The time period “protected harbor” has been utilized to numerous issues within the authorized and actual world. For a very long time, fights over off-label promotion turned on compliance with FDA’s protected harbors about when and the way requested off-label use info might be shared. State shopper safety acts, which may be worded so broadly as to make all kinds of benign conduct actionable, additionally typically embrace their personal protected harbors on when conduct that has been blessed by a governmental entity in some type or trend is deemed, nicely, protected. When the artist previously generally known as Bexis put collectively a checklist of those provisions eleven years in the past, we/he had this to say in regards to the Washington legislation that might turn into the main focus in Corridor:
Some state’s statutes exempt conduct in “compliance” with related governmental oversight, which we’re taking to imply “FDA,” laws (Alabama, Colorado, Delaware, Georgia, Hawaii, Illinois, Maine, Minnesota, Nebraska, Nevada, Ohio, Oregon). Different states exempt something “permitted” by the related regulatory physique (Arkansas, Connecticut, Indiana, Maine, Massachusetts, Montana, Nebraska, New Mexico, Ohio, Rhode Island, South Carolina, South Dakota, Utah, Wyoming). Some states qualify their protected harbors with modifying adverbs, equivalent to “particularly,” “expressly,” or “affirmatively” (Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, Utah). A broader formulation exempts something that’s authorities “regulated” (Alaska, Nebraska, Oklahoma). A narrower formulation exempts solely conduct “required” by the regulator (Florida, Idaho, Indiana, Ohio, Utah, Wyoming). One other variant is “licensed (with or with out adjectives) (Illinois, Michigan, Tennessee, Virginia), or alternatively “licensed or accredited” (Kentucky). Then there are New York (“topic to and complies with”), Washington (“permitted, prohibited or regulated”) and California (a common-law carve out for “enterprise practices which the Legislature has expressly declared to be lawful in different laws,” see Cel-Tech Communications, Inc. v. Los Angeles Mobile Phone Co., 973 P.2nd 527, 542 (Cal. 1999)), which don’t comply with anyone else’s sample.
With all due respect to the grouping within the prior put up, the protected harbor within the Washington shopper safety act, though actually poorly written, seems to distinguish based mostly on which governmental entity is offering oversight for the challenged exercise. It begins off by saying that the chapter doesn’t apply to “actions or transactions in any other case permitted, prohibited or regulated underneath legal guidelines administered by the insurance coverage commissioner of this state, the Washington utilities and transportation fee, [strangely missing conjunction] the federal energy fee.” Revised Code of Washington 19.86.170 (emphasis added; conjunction not equipped). It continues, with out punctuation or numbering, with “or actions or transactions permitted by every other regulatory physique or officer appearing underneath statutory authority of this state or america.” Id. (emphasis added;unusual ending colon transformed to a interval). Then comply with numerous exceptions and exceptions to exceptions that seem inapplicable to the obvious catchall for a federal regulator except the “actions and transactions [are] in reference to the disposition of human stays.” The licensed query in Corridor was whether or not, underneath this murky protected harbor, “labeling as ‘non-drowsy’ an over-the-counter antitussive containing dextromethorphan hydrobromide an ‘motion[ ] … permitted by … [a] regulatory physique … appearing underneath statutory authority … of … america’ such that this labeling determination falls throughout the statutory protected harbor?” We’re not positive that is the suitable query, however it isn’t actually the query the Supreme Courtroom of Washington answered.
The query of Washington legislation actually was what’s required for a protected harbor based mostly on a non-enumerated federal company equivalent to FDA. The query of utility and implication to the underlying proposed class, which was reserved by the Northern District of Illinois, was whether or not FDA’s actions with regard the labeling of the OTC cough syrups met the right protected harbor customary. A short detour to Corridor’s allegations in regards to the merchandise and FDA’s position is required. We are saying temporary partially as a result of the opinion clearly offered any incomplete, plaintiff-friendly view of FDA’s position; the concurrence has a considerably extra thorough examination of monographs, in addition to the historical past of the buyer safety act and its protected harbor provision. A deep dive into monographs and OTC drug regulation on the whole is past our scope right here, however we will say that the regulatory scheme relevant to plaintiffs’ concept is extra concerned than whether or not the relevant monograph instantly says merchandise with the actual lively ingredient at challenge within the case may be labeled “nondrowsy.” 2025 Wash. LEXIS 145, *3. The putative class rep purchased “one among these over-the-counter cough medicines”—presumably one labeled as “nondrowsy” though the category allegations cowl a number of merchandise with and with out the designation—allegedly grew to become “unexpectedly drowsy,” and sued as a result of “drowsiness is a identified facet impact of medicines containing dextromethorphan hydrobromide.” Id. at *2. This case, in fact, has all of the hallmarks of a lawyer-driven litigation with no actual goal however to drive a settlement over a non-issue that produced no accidents. The angle the legal professionals like is that the FDA monograph requires OTC cough syrups with diphenhydramine to return with a drowsiness warning, however doesn’t say if those with out diphenhydramine can determine themselves as nondrowsy.
For the Supreme Courtroom of Washington in Corridor, the protected harbor was interpreted narrowly to assist to “accomplish [the statute’s] useful functions of defending the buyer.” Id. at *5. That led it to learn the statutory provision “actions or transactions permitted” as requiring that “an company should take ‘overt affirmative actions particularly to allow the actions or transactions engaged in’ by the particular person or entity concerned in a Shopper Safety Act grievance.” Id. at *7 (emphasis added and inner quotation omitted). Noting that the statute states that specified regulatory entities are coated by the protected harbor based mostly on actions they “permitted, prohibited or regulated,” the distinction in phrasing for different regulatory entities means “that the legislature supposed the statutory protected harbor for actions regulated by nonenumerated businesses to be restricted to actions or transactions expressly permitted by the company.” Id. at *8-9. One downside with this evaluation is that states that needed to make a protected harbor be tied to actions “particularly,” “expressly,” or “affirmatively” permitted by a regulatory company, equivalent to Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, and Utah per our previous put up, truly used these adjectives within the drafting of their very own protected harbor provisions. Decoding “permitted” to imply the very same factor as “particularly permitted,” “expressly permitted,” and “affirmatively permitted” doesn’t make a lot sense, particularly on the subject of a regulatory scheme as sophisticated as applies to monograph OTC medicine.
Corridor went a step additional and concluded that “[a]s FDA has not particularly permitted labeling these over-the-counter medicine nondrowsy, that exercise falls exterior the statutory protected harbor.” Id. at *10. We will quibble with that conclusion, but it surely additionally clear that eradicating the phrase “particularly” from customary—that’s, making the usual match the statute—ought to result in the alternative conclusion. That is definitely not the primary time {that a} courtroom has contracted its protected harbor to permit a doubtful shopper safety case a few drug to proceed. Right here, nevertheless, the problem of whether or not the state legislation declare is preempted by the FDCA remains to be alive. Shopper safety claims will not be saved from specific preemption underneath 21 U.S.C. §379r, and the plaintiffs’ declare is Corridor is clearly based mostly on a state requirement that’s “totally different from or along with, or that’s in any other case not similar with” federal necessities. We might say meaning specific preemption is a slam dunk, however even dunks get blocked typically.
