Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 1 of 15 PageID# 29709
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`
`
`v.
`
`RAI STRATEGIC HOLDINGS, INC. and
`R.J. REYNOLDS VAPOR COMPANY,
`
`Plaintiffs and Counterclaim Defendants,
`
`
`
`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTS S.A.,
`
`Defendants and Counterclaim Plaintiffs.
`
`Case No. 1:20-cv-00393-LO-TCB
`
`
`REPLY IN SUPPORT OF REYNOLDS’S MOTION TO
`EXCLUDE THE TESTIMONY OF STACY EHRLICH
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`
`
`
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`Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 2 of 15 PageID# 29710
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ......................................................................................................................... 1
`ARGUMENT ................................................................................................................................. 2
`I.
`MS. EHRLICH’S OPINIONS ARE UNRELIABLE AND SHOULD BE
`EXCLUDED. ..................................................................................................................... 2
`A.
`Ms. Ehrlich’s Opinions Should Be Excluded As Not Supported By A
`Reliable Methodology And Not Based On Sufficient Facts Or Data. ................... 2
`Ms. Ehrlich’s Opinions Should Be Excluded As Speculative. .............................. 5
`B.
`MS. EHRLICH’S LEGAL OPINIONS SHOULD BE EXCLUDED. .............................. 7
`II.
`III. MS. EHRLICH’S DISCUSSION OF EXTRANEOUS TOPICS SHOULD BE
`EXCLUDED. ..................................................................................................................... 8
`CONCLUSION .............................................................................................................................. 9
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`i
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`TABLE OF AUTHORITIES
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`Page
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`
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`CASES
`
`Adalman v. Baker, Watts & Co.,
`807 F.2d 359 (4th Cir. 1986) .....................................................................................................7
`
`Daubert v. Merrill Dow Pharms., Inc.,
`509 U.S. 579 (1993) ...............................................................................................................6, 9
`
`ePlus, Inc. v. Lawson Software, Inc.,
`764 F. Supp. 2d 807 (E.D. Va. 2011), aff’d, 700 F. 3d 509 (Fed. Cir. 2012) ........................6, 7
`
`Kumho Tire Co. v. Carmichael,
`526 U.S. 137 (1999) ...................................................................................................................1
`
`Lance ex rel. Lance v. Lewisville Indep. Sch. Dist.,
`No. 4:11-cv-00032, 2012 WL 1668198 (E.D. Tex. May 11, 2012) ..........................................4
`
`Mobility Workx, LLC v. Cellco P’ship,
`No. 4:17-CV-00872, 2019 WL 5721814 (E.D. Tex. Nov. 25, 2019) ........................................6
`
`Rumsfeld v. United Techs. Corp.,
`315 F.3d 1361 (Fed. Cir. 2003)..................................................................................................7
`
`Shire Viropharma Inc. v. CSL Behring LLC,
`No. 17-414 CONSOLIDATED, 2021 WL 1227097 (D. Del. Mar. 31, 2021) ..........................5
`
`Touchcom, Inc. v. Berreskin & Parr,
`No. 1:07cv114 (JCC), 2010 WL 4393282 (E.D. Va. Oct. 29, 2010) .........................................7
`
`United States v. Barile,
`286 F.3d 749 (4th Cir. 2002) .....................................................................................................8
`
`United States v. Mallory,
`988 F.3d 730 (4th Cir. 2021) .................................................................................................3, 4
`
`United States v. Offill,
`666 F.3d 168 (4th Cir. 2011) .....................................................................................................8
`
`United States v. Wilson,
`484 F.3d 267 (4th Cir 2007) ......................................................................................................4
`
`
`
`ii
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`Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 4 of 15 PageID# 29712
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`TABLE OF AUTHORITIES
`(continued)
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`
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`Page
`
`
`Wickersham v. Ford Motor Co.,
`No. 9:13-cv-1192-DCN, 2016 WL 5349093 (D.S.C. Sept. 26, 2016).......................................7
`
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`iii
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`Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 5 of 15 PageID# 29713
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`INTRODUCTION
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`PM/Altria concedes that Ms. Ehrlich, the expert it proffered to opine on the value of the
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`patented technology to Reynolds’s PMTAs:
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`• did not review the technical portions of Reynolds’s PMTAs,
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`• does not know exactly what FDA considers in evaluating the applications,
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`• does not know how FDA would view the patented technology,
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`• does not know how much more likely PMT authorization may be based on the
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`patented technology, and
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`• did not quantify the purported value of the patented technology.
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`These concessions confirm that Ms. Ehrlich’s testimony should be excluded because it is
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`unreliable, not supported by a reasonable methodology, not supported by sufficient facts or data,
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`speculative, untethered to the facts of this case, and would have a greater potential to mislead than
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`to aid the jury.
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`PM/Altria seeks to have the Court set aside its gatekeeping function because of
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`Ms. Ehrlich’s “experiential expertise.” Dkt. 1016 at 5-8. But the Supreme Court confirmed in
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`Kumho Tire Co. v. Carmichael that a trial court’s gatekeeping obligation applies to all expert
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`testimony, even if that testimony is based on, for example, experiential knowledge. 526 U.S. 137,
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`147 (1999). Regardless of Ms. Ehrlich’s qualifications, her testimony should be excluded because
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`she did not review the technical portions of Reynolds’s PMTAs that are the subject of her opinions
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`and she conceded that “[t]here’s no way of knowing” to what extent the patented technology may
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`affect the chances of PMT authorization. Dkt. 877 at 5.
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`In addition, Ms. Ehrlich’s legal opinions regarding the alleged illegality of Reynolds’s
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`VUSE products are not the proper subject of expert testimony. And her testimony regarding topics
`1
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`such as youth vaping and PM/Altria’s IQOS product is not relevant to any issue proceeding to trial
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`and should be excluded.
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`ARGUMENT
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`I.
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`MS. EHRLICH’S OPINIONS ARE UNRELIABLE AND SHOULD BE
`EXCLUDED.
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`Contrary to PM/Altria’s arguments, Ms. Ehrlich’s opinions are unreliable and should be
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`excluded because they are not supported by a reliable methodology, are not based on sufficient
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`facts or data, and are speculative.
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`A. Ms. Ehrlich’s Opinions Should Be Excluded As Not Supported By A Reliable
`Methodology And Not Based On Sufficient Facts Or Data.
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`PM/Altria contends that Ms. Ehrlich’s opinions are reliable because they purportedly are
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`based on “experiential expertise.” Dkt. 1016 at 5-8. PM/Altria makes much ado about
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`Ms. Ehrlich’s experience as a “Harvard-trained” attorney in private practice counseling clients on
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`FDA regulations. Id. at 2-3. But regardless of Ms. Ehrlich’s experience, her opinions must be
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`based on a reliable methodology and supported by sufficient facts. They are not.
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`PM/Altria does not dispute that Ms. Ehrlich’s methodology consisted of (1) gaining an
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`understanding from PM/Altria’s technical experts that the patented technology generally relates to
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`the safety of the battery, e-liquid, and heater of e-cigarettes, (2) identifying these safety
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`characteristics as factors FDA considers in reviewing PMTAs, and (3) concluding that because it
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`is purportedly challenging to obtain authorization, any advantageous information supplied in
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`PMTAs is valuable. Dkt. 877 at 7-8.
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`Lacking from her methodology, however, was any evaluation of any increased likelihood
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`of FDA approving Reynolds’s PMTAs and MRTPAs for the VUSE products due to the patented
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`technology. This is critical as her opinions are directed to the purported regulatory benefit
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`2
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`Reynolds’s PMTAs and MRTPAs for the accused VUSE products receive from the patented
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`technology. Dkt. 877, Ex. 1 at ¶¶ 3, 4; Dkt. 1016 at 3. Tellingly, Ms. Ehrlich concedes that “there’s
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`no way to know exactly what FDA considers in issuing a PMTA authorization,” and that “[t]here’s
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`no way of knowing” to what extent the patented technology may affect the chances of PMT
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`authorization. Dkt. 877, Ex. 2 at 98:13-15; 206:20-207:5. Without knowing FDA’s methodology
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`or how the patented technology may increase the likelihood of authorization of Reynolds’s VUSE
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`products, Ms. Ehrlich’s opinions should be excluded. See United States v. Mallory, 988 F.3d 730,
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`742 (4th Cir. 2021) (“Mallory”) (finding district court did not abuse its discretion to exclude an
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`expert’s testimony as to “Medicare’s reimbursement code calculations, [because the expert] lacked
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`personal knowledge about Medicare’s precise methodology”).
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`Faced with Ms. Ehrlich’s admission that she does not know the methodology used by FDA
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`in authorization decisions, and controlling Fourth Circuit precedent, PM/Altria cites district court
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`decisions from other jurisdictions to argue that an “expert opinion need not be based on personal
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`knowledge.” Dkt. 1016 at 6-7. But PM/Altria misses the point. Although an expert’s opinion can
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`be based on facts made available to an expert to which she does not have personal knowledge, that
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`is distinct from the requirement that an admissible expert opinion must be based on a reliable
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`methodology. Here, Ms. Ehrlich concedes that she does not know FDA’s methodology in
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`evaluating PMTAs—whether through personal knowledge or otherwise. Thus, as the Fourth
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`Circuit has recently confirmed, such testimony should be excluded for lack of a reliable
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`methodology. See Mallory, 988 F.3d at 742.
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`Ms. Ehrlich’s opinions also should be excluded because they are not based on sufficient
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`facts. Despite opining on the purported value of the patented technology to Reynolds’s PMTAs
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`for the VUSE products, PM/Altria concedes that Ms. Ehrlich did not review the technical aspects
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`
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`of Reynolds’s PMTAs. Dkt. 1016 at 7. PM/Altria seeks to excuse this fatal shortcoming by
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`contending that she considered all “relevant” facts. Id. Yet what could be more relevant than the
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`actual PMTAs to which her opinions pertain? PM/Altria again attempts to hide behind Ms.
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`Ehrlich’s “experiential” experience. Id. at 8. But for an expert to testify based on experiential
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`experience, the expert’s opinion must be based on a review of the relevant facts, and the expert
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`must explain how she applied her experience to the facts. See, e.g., United States v. Wilson, 484
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`F.3d 267, 274 (4th Cir 2007) (“the district court must nonetheless require an experiential witness
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`to ‘explain how his experience leads to the conclusion reached, why his experience is a sufficient
`
`basis for the opinion, and how his experience is reliably applied to the facts’”); Lance ex rel. Lance
`
`v. Lewisville Indep. Sch. Dist., No. 4:11-cv-00032, 2012 WL 1668198, at *3 (E.D. Tex. May 11,
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`2012) (“A witness’ experience, studies and education, combined with a review of the relevant
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`materials can provide a reliable basis for expert testimony.”) (emphasis added). Without having
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`reviewed the technical portions of the PMTAs that are the subject of her opinions, Ms. Ehrlich
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`could not have done so.
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`Notably, Ms. Ehrlich testified that even if a product contains certain technology, if that
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`technology is not sufficiently demonstrated in the PMTA, it would not matter that the product
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`contains the technology because it would not improve the chances of authorization. Dkt. 877,
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`Ex. 2 at 162:4-165:11. Thus, by Ms. Ehrlich’s own admission, her failure to review the
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`applications and consider to what extent, if at all, the applications address the patented technology,
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`renders her opinions unreliable.
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`PM/Altria proffered Ms. Ehrlich as an FDA expert to testify regarding Reynolds’s PMTAs.
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`Her failure to review the very applications on which she opines warrants exclusion of her opinions.
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`Indeed, opining on PMTAs that she did not review would mislead, rather than aid, the jury.
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`B. Ms. Ehrlich’s Opinions Should Be Excluded As Speculative.
`PM/Altria strains to argue that Ms. Ehrlich’s opinions are not speculative in the face of her
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`admissions that she does not know exactly what FDA considers in issuing a PMT authorization,
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`she does not know how FDA would view the patented technology, and she does not how much
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`more likely PMT authorization may be based on the patented technology. Ms. Ehrlich’s
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`admissions, however, confirm that her opinions regarding the purported benefit from the patented
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`technology in obtaining PMT and MRTP authorization are speculative.
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`First, PM/Altria argues that Ms. Ehrlich’s opinions are not speculative because she stated
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`in her report that FDA “will” consider various features in evaluating Reynolds’s PMTAs.
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`Dkt. 1016 at 9. PM/Altria ignores, however, that Ms. Ehrlich conceded that there are “a million
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`different variables” that FDA considers and, significantly, she conceded that she does not know
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`how the patented technology would affect the likelihood of PMT authorization. Dkt. 877 at 5; id.,
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`Ex. 2 at 206:20-207:11. Thus, by her own admission, her opinion that the patented technology is
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`valuable to the authorization of Reynolds’s VUSE products is speculative.
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`Second, PM/Altria argues that Ms. Ehrlich’s opinions are not speculative merely because
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`she cannot speak to FDA’s state of mind. Dkt. 1016 at 10. PM/Altria argues that it would be
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`improper for Ms. Ehrlich to testify regarding FDA’s state of mind. Id. The case relied upon by
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`PM/Altria actually confirms the impropriety of Ms. Ehrlich’s testimony as it excluded the expert’s
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`testimony for addressing how a company was “likely” to act. Shire Viropharma Inc. v. CSL
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`Behring LLC, No. 17-414 CONSOLIDATED, 2021 WL 1227097, at *6 (D. Del. Mar. 31, 2021)
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`(“Mr. Lassman's report, however, crosses the line by repeatedly opining that ‘even in the absence
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`of ODE [Orphan Drug Exclusivity], it is likely that Shire would have discontinued development
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`of CINRYZE SC anyway based on other factors limiting its commercial value to Shire.’”)
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`(emphasis added). Similarly, Ms. Ehrlich’s opinions pertain to whether FDA is more likely to
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`authorize Reynolds’s VUSE products in view of the patented technology. Moreover, by Ms.
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`Ehrlich’s own admission, she does not know what FDA considers or how it would view the
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`patented technology. Dkt. 877, Ex. 1 at ¶ 146; id., Ex. 2 at 54:18-55:15, 56:14-17, 98:13-15,
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`135:18-23, 140:14-17, 140:19-141:4, 146:5-22, 164:18-165:11, 166:4-12. Thus, she concedes that
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`her opinions are speculative.
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`Third, PM/Atria argues that Ms. Ehrlich’s failure to articulate the purported value of the
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`patented technology is not improper because “mathematical precision in royalty calculations is not
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`required.” Dkt. 1016 at 11. But here, the question is not one of precision, as Ms. Ehrlich did not
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`provide any valuation whatsoever. Ms. Ehrlich did not even provide a royalty calculation. Instead,
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`she opined that the patented technology is “important” to the FDA review process, without
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`quantifying how much more likely PMT authorization may be due to the patented technology.
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`Dkt. 877, Ex. 1 at ¶ 3. The Mobility Workx case relied upon by PM/Altria confirmed that at the
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`Daubert stage, the expert must explain “why and generally to what extent the particular factor
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`impacts the royalty calculation.” Mobility Workx, LLC v. Cellco P’ship, No. 4:17-CV-00872, 2019
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`WL 5721814, at *16 (E.D. Tex. Nov. 25, 2019) (citation omitted). Ms. Ehrlich did not provide
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`any such explanation. She did not quantify in any way whether the patented technology may
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`provide a 1%, 100%, or some other increased likelihood of authorization. As her opinions would
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`only confuse and not aid the jury, they should be excluded. See ePlus, Inc. v. Lawson Software,
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`6
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`Inc., 764 F. Supp. 2d 807, 815 (E.D. Va. 2011) (excluding expert testimony providing for an
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`“unarticulated quantum of ‘higher’ royalty rate”), aff’d, 700 F. 3d 509 (Fed. Cir. 2012).1
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`II. MS. EHRLICH’S LEGAL OPINIONS SHOULD BE EXCLUDED.
`PM/Altria acknowledges that Ms. Ehrlich opines that the VUSE products are “illegal.”
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`Dkt. 1016 at 13. Yet PM/Altria argues that such an opinion is merely a “factual recitation of
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`FDA’s statement of policy,” rather than a legal opinion. Id. PM/Altria is wrong. Ms. Ehrlich’s
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`opinion regarding the purported illegality of Reynolds’s products is an impermissible legal opinion.
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`Ms. Ehrlich’s testimony goes well beyond merely reciting FDA policies. Ms. Ehrlich
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`purports to apply statutes, FDA regulations and policies, and case law to opine that Reynolds’s
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`VUSE products are illegal. Such an application is not a mere “factual recitation.” It is an
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`impermissible legal opinion. Adalman v. Baker, Watts & Co., 807 F.2d 359, 368 (4th Cir. 1986)
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`(where a party proffers an expert witness to testify on “the meaning and applicability of the
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`[relevant] laws to the transactions” at issue, the Fourth Circuit has found that such testimony “flies
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`squarely in the face of the precedent—and the logic of that precedent”), abrogated on other
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`grounds by Pinter v. Dahl, 486 U.S. 622 (1988); see also Rumsfeld v. United Techs. Corp., 315
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`F.3d 1361, 1369 (Fed. Cir. 2003) (expert testimony interpreting regulations is a legal issue that
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`should not be received, much less considered).
`
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`1 The other cases cited by PM/Altria also are inapposite. Wickersham pertained to an
`expert opinion on causation. Wickersham v. Ford Motor Co., No. 9:13-cv-1192-DCN, 2016 WL
`5349093, at *9 (D.S.C. Sept. 26, 2016). Touchcom related to an expert’s testimony on the
`increasing percentage of the use of a product, Touchcom, Inc. v. Berreskin & Parr, No. 1:07cv114
`(JCC), 2010 WL 4393282, at *3-4 (E.D. Va. Oct. 29, 2010), in stark contrast to Ms. Ehrlich’s
`testimony that she did not know how much more likely PMT authorization may be based on the
`patented technology.
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`7
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`Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 12 of 15 PageID# 29720
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`The cases cited by PM/Altria actually support exclusion of Ms. Ehrlich’s legal opinions.
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`In Offill, this Court precluded experts from testifying that conduct was “illegal.” United States v.
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`Offill, 666 F.3d 168, 173-74 (4th Cir. 2011) (reciting the district court’s statement that “I think the
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`Government has properly drawn the line in stating that they will not ask for any expert witnesses
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`to give opinions as to conduct being illegal manipulation, or that a party has acted unlawfully”).
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`The appellate court stated that this Court did not abuse its discretion in permitting expert testimony
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`on the general operation of securities law, without suggesting the party’s liability, as that permitted
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`the jury to determine the applicability of the law to the party. Id. at 176. In Barile, the court stated
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`that it is within the district court’s discretion to exclude expert testimony on terms that have
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`specialized legal meanings. United States v. Barile, 286 F.3d 749, 761 (4th Cir. 2002).
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`Not only does Ms. Ehrlich’s purported application of the law to Reynolds’s VUSE products
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`constitute an impermissible legal opinion, but referring to them as “illegal” would be grossly
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`misleading and unfairly paint Reynolds and its products in a negative light as explained in
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`Reynolds’s Motion in Limine No. 1. Dkt. 825. Ms. Ehrlich’s legal opinions should be excluded.
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`III. MS. EHRLICH’S DISCUSSION OF EXTRANEOUS TOPICS SHOULD BE
`EXCLUDED.
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`PM/Altria merely incorporates by reference its response to Reynolds’s motions in limine
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`in seeking to summarily refute whether Ms. Ehrlich’s testimony on extraneous topics, such as
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`youth vaping and PM’s IQOS product, should be excluded. Dkt. 1016 at 15. For the reasons
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`Reynolds explained in its Daubert motion and motions in limine, this testimony is not “sufficiently
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`tied to the facts of the case” and will not “aid the jury in resolving a factual dispute” at issue.
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`Daubert v. Merrill Dow Pharms., Inc., 509 U.S. 579, 591 (1993). Consequently, Ms. Ehrlich’s
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`irrelevant testimony should be excluded.
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`8
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`CONCLUSION
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`Reynolds respectfully asks this Court to grant Reynolds’s Motion to Exclude the Expert
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`Testimony of Stacy Ehrlich.
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`9
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`Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 14 of 15 PageID# 29722
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`
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`Dated: February 25, 2022
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`
`
`Stephanie E. Parker
`JONES DAY
`1221 Peachtree Street, N.E.
`Suite 400
`Atlanta, GA 30361
`Telephone: (404) 521-3939
`Facsimile: (404) 581-8330
`Email: separker@jonesday.com
`
`
`Anthony M. Insogna
`JONES DAY
`4655 Executive Drive
`Suite 1500
`San Diego, CA 92121
`Telephone: (858) 314-1200
`Facsimile: (844) 345-3178
`Email: aminsogna@jonesday.com
`
`William E. Devitt
`JONES DAY
`77 West Wacker
`Suite 3500
`Chicago, IL 60601
`Telephone: (312) 269-4240
`Facsimile: (312) 782-8585
`Email: wdevitt@jonesday.com
`
`Sanjiv P. Laud
`JONES DAY
`90 South Seventh Street
`Suite 4950
`Minneapolis, MN 55402
`Telephone: (612) 217-8800
`Facsimile: (844) 345-3178
`Email: slaud@jonesday.com
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
` /s/ David M. Maiorana
`David M. Maiorana (VA Bar No. 42334)
`Ryan B. McCrum
`JONES DAY
`901 Lakeside Ave.
`Cleveland, OH 44114
`Telephone: (216) 586-3939
`Facsimile: (216) 579-0212
`Email: dmaiorana@jonesday.com
`Email: rbmccrum@jonesday.com
`
`John J. Normile
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Telephone: (212) 326-3939
`Facsimile: (212) 755-7306
`Email: jjnormile@jonesday.com
`
`
`Alexis A. Smith
`JONES DAY
`555 South Flower Street
`Fiftieth Floor
`Los Angeles, CA 90071
`Telephone: (213) 243-2653
`Facsimile: (213) 243-2539
`Email: asmith@jonesday.com
`
`Charles B. Molster
`THE LAW OFFICES OF
`CHARLES B. MOLSTER, III PLLC
`2141 Wisconsin Avenue, N.W. Suite M
`Washington, DC 20007
`Telephone: (202) 787-1312
`Email: cmolster@molsterlaw.com
`
`Counsel for RAI Strategic Holdings, Inc. and
`R.J. Reynolds Vapor Company
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`10
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`Case 1:20-cv-00393-LO-TCB Document 1082 Filed 02/25/22 Page 15 of 15 PageID# 29723
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this 25th day of February, 2022, a true and correct copy of the
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`foregoing was served using the Court’s CM/ECF system, with electronic notification of such filing
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`to all counsel of record.
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`/s/ David M. Maiorana
`David M. Maiorana (VA Bar No. 42334)
`JONES DAY
`901 Lakeside Ave.
`Cleveland, OH 44114
`Telephone: (216) 586-3939
`Facsimile: (216) 579-0212
`Email: dmaiorana@jonesday.com
`
`Counsel for RAI Strategic Holdings, Inc. and
`R.J. Reynolds Vapor Company
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`