Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/43

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Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 43 of 67 PageID 4465

(internal marks omitted). “That means a court cannot wave the ambiguity flag just because it found the regulation impenetrable on first read.” Id. If genuine ambiguity remains, the agency’s reading must still be “reasonable.” Id. And even if the regulation is genuinely ambiguous, the agency’s interpretation “must in some way implicate its substantive expertise.” Id. at 2417. Finally, an agency’s reading of a rule must reflect “fair and considered judgment” to receive Auer deference. Id. (internal marks omitted).

Here, Auer deference is not appropriate because “the language of [the] regulation is plain and unambiguous.” McCann v. Unum Provident, 907 F.3d 130, 144 (3d Cir. 2018). As explained, FDA’s definitions in prior rulemakings foreclose its interpretation of Subpart H. If there is any ambiguity in “serious or life-threatening illnesses,” the ordinary meaning principle resolves that ambiguity. See Bostock, 140 S. Ct. at 1825 (Kavanaugh, J, dissenting) (“The ordinary meaning principle is longstanding and well settled.”). “[C]ommon parlance matters in assessing the ordinary meaning” of a statute or regulation “because courts heed how most people would have understood the text.” Id. at 1828 (internal marks omitted). The word “illness” refers to “poor health; sickness,” or “a specific sickness or disease, or an instance of such.”[1] Merriam-Webster invokes the definition for “sickness” — “an unhealthy condition of body or mind.”[2] Likewise, a Wikipedia search for “illness” re-directs to the entry for “Disease,” which is defined as “a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury.”[3] Pregnancy, on the other


  1. Illness, Dictionary.com, https://www.dictionary.com/browse/illness (last visited Mar. 22, 2023); see also Bostock, 140 S. Ct. at 1766 (Alito, J, dissenting) (“Dictionary definitions are valuable because they are evidence of what people at the time of a statute’s enactment would have understood its words to mean.”).
  2. Illness, Merriam-Webster.com, https://www.merriam-webster.com/dictionary/illness (last visited Mar. 22, 2023).
  3. Disease, Wikipedia, https://en.wikipedia.org/wiki/Disease (emphasis added) (last visited Mar. 22, 2023).

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