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Reynolds PM MO ITC IQOS Appeal 31 Mar 23
Reynolds PM MO ITC IQOS Appeal 31 Mar 23
v.
2022-1227
______________________
Holdings LLC, 980 F.3d 858, 863 (Fed. Cir. 2020)); see also
Singleton v. Wulff, 428 U.S. 106, 120 (1976) (“It is the gen-
eral rule . . . that a federal appellate court does not consider
an issue not passed upon below.”).
Philip Morris failed to raise this issue before the ALJ.
None of Philip Morris’s briefing before the ALJ addressed,
or even mentioned, the Commission’s statutory duty to
“consult with” HHS or the FDA. In fact, the ALJ directly
asked the parties for their “views about [his] authority un-
der 19 U.S.C. [§] 1337(b)(2), which instructs that the Com-
mission may consult with [HHS], and, by implication, the
[FDA],” J.A. 21372 (Hearing Tr. 1524:17–1524:21). But
counsel for Philip Morris responded that he had “absolutely
no objection whatsoever,” J.A. 21383 (Hearing
Tr. 1571:03–1571:08), to the ALJ’s authority to “consult
with any publicly-available information on the FDA’s web
site regarding any of the products that have been discussed
during [the] investigation.” J.A. 21372 (Hearing
Tr. 1524:22–1524:25). He then stated that he had “nothing
[further] to share on that.” J.A. 21384 (Hearing
Tr. 1574:18–1574:20). At no point during the hearing did
counsel for Philip Morris ask the ALJ to reach out to the
FDA or suggest that the ALJ had not properly “consulted
with” the FDA.
Philip Morris does not meaningfully dispute that it
failed to raise the issue of the Commission’s statutory duty
before the ALJ. As evidence of its efforts to “fairly alert”
the ALJ to the issue, Philip Morris points only to its coun-
sel’s statement that he had “nothing to share” regarding
the Commission’s duty at the evidentiary hearing before
the ALJ. Appellants’ Reply Br. 4–5; see also J.A. 21384
(Hearing Tr. 1574:18–1574:20). Instead, Philip Morris as-
serts that “notice to the Commission regarding the ‘consult
with’ issue was unnecessary prior to the” Commission’s fi-
nal determination. Appellants’ Reply Br. 4. We disagree.
Case: 22-1227 Document: 72 Page: 11 Filed: 03/31/2023
Id. at *31.
Mr. Alarcon also testified that the accused IQOS prod-
ucts include an electrical energy source in the form of a
printed circuit board (PCB) that is at least partially located
within the portion of the housing corresponding to the cap
and thus the “receiving end.” Id. (citing J.A. 20898–99
(Hearing Tr. 200:14–201:02)). The PCBs that Reynolds al-
lege correspond to the electrical energy sources are shown
below:
Case: 22-1227 Document: 72 Page: 35 Filed: 03/31/2023