Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 1 of 21 PageID# 28765
`
`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`
`
`
`
`RAI STRATEGIC HOLDINGS, INC. AND
`R.J. REYNOLDS VAPOR COMPANY
`
`
`
`
`
`Plaintiffs and
`Counterclaim Defendants,
`
`v.
`
`
`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
`
`ORAL ARGUMENT REQUESTED
`
`
`
`
`
`
`
`
`
`PMI/ALTRIA’S OPPOSITION TO RJR’S MOTION TO EXCLUDE
`THE TESTIMONY OF STACY EHRLICH
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 2 of 21 PageID# 28766
`
`
` TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ...............................................................................................................1
`
`FACTUAL BACKGROUND ..............................................................................................2
`
`A.
`
`B.
`
`C.
`
`Ms. Ehrlich Is Undisputedly Qualified To Testify As An FDA Expert ..................2
`
`Ms. Ehrlich’s Opinions In This Case .......................................................................3
`
`The Development Of E-Cigarette Laws And Regulations ......................................3
`
`III.
`
`LEGAL STANDARDS .......................................................................................................4
`
`A.
`
`B.
`
`Admissibility Of Expert Testimony Under Federal Rule Of Evidence 702 ............4
`
`Admissibility Of Expert Testimony Based On Experiential Expertise ...................5
`
`IV.
`
`ARGUMENT .......................................................................................................................6
`
`A.
`
`B.
`
`C.
`
`D.
`
`Ms. Ehrlich’s Opinions Are Reliable And Will Help The Jury ...............................6
`
`Ms. Ehrlich’s Opinions Are Not Speculative ..........................................................9
`
`Ms. Ehrlich Does Not Offer Legal Opinions .........................................................12
`
`Ms. Ehrlich Does Not Offer Opinions On “Extraneous Topics” ...........................14
`
`V.
`
`CONCLUSION ..................................................................................................................15
`
`
`
`
`
`i
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 3 of 21 PageID# 28767
`
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Aloe Vera of Am. Inc. v. United States,
`No. 99-cv-01794, 2014 WL 3072981(D. Ariz. July 7, 2014) ..................................................... 6
`
`Am. Academy of Pediatrics v. FDA,
`No. PWG-18-883, Mem. (May 15, 2019) ................................................................................. 14
`
`Audio MPEG, Inc. v. Dell, Inc.,
`No. 15-cv-73, Dkt. 830 (E.D. Va. Aug. 28, 2017) ...................................................................... 9
`
`Belville v. Ford Motor Co.,
`919 F.3d 224 (4th Cir. 2019) ..................................................................................................... 11
`
`Bockelman v. BNSF Ry. Co.,
`No. 10-cv-1001, 2011 WL 5180382 (C.D. Ill. Oct. 28, 2011) .................................................... 6
`
`Crouch v. John Jewell Aircraft, Inc.,
`No. 07-cv-638, 2016 WL 157464 (W.D. Ky. Jan. 12, 2016) ...................................................... 8
`
`De Reyes v. Waples Mobile Home Park Ltd. P’ship,
`No. 16-cv-563, 2017 WL 4509869 (E.D. Va. Apr. 17, 2017) ............................................. 6, 7, 8
`
`ePlus, Inc. v. Lawson Software, Inc.,
`764 F. Supp. 2d 807 (E.D. Va. 2011), aff’d, 700 F. 3d 509 (Fed. Cir. 2012) ............................. 9
`
`Estate of Lance ex rel. Lance v. Lewisville Indep. Sch. Dist.,
`No. 11-cv-00032, 2012 WL 1668198 (E.D. Tex. May 11, 2012) ............................................... 5
`
`In re Zetia,
`No. 2:18-md-2836, 2021 WL 6690348 (E.D. Va. Aug. 16, 2021) .......................................... 6, 7
`
`Kirksey v. Schindler Elevator Corp.,
`No. 15-cv-0115, 2016 WL 5213928 (S.D. Ala. Sept. 21, 2016) ................................................. 5
`
`Kumho Tire Co. v. Carmichael,
`526 U.S. 137 (1999) .................................................................................................................... 5
`
`Mobility Workx, LLC v. Cellco P’ship,
`2019 WL 5721814 (E.D. Tex. 2019) ................................................................................... 11, 12
`
`Poly-Am., Inc. v. Serrot Int’l, Inc.,
`No. 300-cv-1457, 2002 WL 1996561 (N.D. Tex. Aug. 26, 2002) .............................................. 6
`
`ii
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 4 of 21 PageID# 28768
`
`Rembrandt Soc. Media, LP v. Facebook, Inc.,
`22 F. Supp. 3d 585 (E.D. Va. 2013) ............................................................................................ 7
`
`Shire Viropharma Inc. v. CSL Behring LLC,
`No. 17-cv-414, 2021 WL 1227097 (D. Del. Mar. 31, 2021) ..................................................... 10
`
`The Harvester, Inc. v. Rule Joy Trammell + Rubio, LLC,
`No. 09-CV-358, 2010 WL 2653373 (E.D. Va. July 2, 2010)...................................................... 5
`
`Touchcom, Inc. v. Berreskin & Parr,
`No. 7-cv-114, 2010 WL 4393282 (E.D. Va. Oct. 29, 2010) ................................................. 5, 11
`
`Travelers Cas. Ins. Co. of Am. ex rel. Palumbo v. Volunteers of Am. Ky., Inc.,
`No. 10-cv-301, 2012 WL 3610250 (E.D. Ky. Aug. 21, 2012) .................................................... 8
`
`U.S. v. Wilson,
`484 F 3d 267 (4th Cir. 2007) ............................................................................................... 5, 7, 8
`
`United States v. Barile,
`286 F. 3d 749 (4th Cir. 2002) .............................................................................................. 12, 13
`
`United States v. Mallory,
`988 F. 3d 730 (4th Cir. 2021) .................................................................................................... 11
`
`United States v. Offill,
`666 F. 3d 168 (4th Cir. 2011) ........................................................................................ 12, 13, 14
`
`VS Techs., LLC v. Twitter, Inc.,
`No. 2:11-cv-43, 2011 WL 4744572 (E.D. Va. Oct. 5, 2011) ...................................................... 8
`
`Westberry v. Gislaved Gummi AB,
`178 F. 3d 257 (4th Cir. 1999) ...................................................................................................... 9
`
`Wickersham v. Ford Motor Co.,
`No. 13-cv-1192, 2016 WL 5349093 (D.S.C. Sept. 26, 2016) ............................................... 6, 11
`
`Zak v. Facebook, Inc.,
`No. 15-cv-13437, 2021 WL 4481588 (E.D. Mich. Sept. 30, 2021) .......................................... 12
`
`OTHER AUTHORITIES
`
`21 U.S.C. § 387 ............................................................................................................................... 4
`
`FED. R. EVID. 702 .............................................................................................................. 4, 5, 8, 14
`
`
`
`
`iii
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 5 of 21 PageID# 28769
`
`
`I.
`
`
`
`INTRODUCTION
`
`The Court should deny RJR’s motion to exclude the opinions of PMI/Altria’s regulatory
`
`expert, Stacy Ehrlich. None of RJR’s four arguments provides a basis for exclusion.
`
`First, Ms. Ehrlich’s opinions are supported by a reliable methodology and based on
`
`sufficient facts and data. She anchors her opinions in her experiential expertise from decades of
`
`work before the U.S. Food and Drug Administration (“FDA”), relevant materials on which others
`
`in her field reasonably rely, input from PMI/Altria’s technical experts, and extensive record
`
`evidence. In light of the specialized e-cigarette industry at issue in this case, Ms. Ehrlich’s
`
`testimony is essential to help the jury understand what RJR describes as FDA’s “complex
`
`regulatory scheme.” Dkt. 825 at 6.
`
`
`
`Second, Ms. Ehrlich’s opinions are not speculative, far from it. RJR’s contrary arguments
`
`seek to impose requirements on Ms. Ehrlich’s testimony that contradict the law. For example, Ms.
`
`Ehrlich is not required to know FDA’s state of mind or be able to predict its actions. Nor is she
`
`required to quantify the value RJR receives from using PMI/Altria’s patented technology. At most,
`
`RJR’s criticisms go to weight, not admissibly, and are not grounds for exclusion.
`
`
`
`Third, Ms. Ehrlich does not offer legal opinions. The opinions that RJR seeks to exclude
`
`are FDA’s own characterizations of e-cigarettes or observations about the landscape of tobacco
`
`product regulation and related industry practices.
`
`
`
`Fourth, Ms. Ehrlich’s opinions are highly probative to multiple damages issues and,
`
`contrary to RJR’s argument, do not encompass “extraneous topics.” Mot. at 1. Since RJR’s
`
`argument merely rehashes the meritless positions that RJR advances in its Motion in Limine Nos.
`
`1-3, and 11 (Dkts. 825, 870), these arguments should be rejected for the reasons set forth in
`
`PMI/Altria’s oppositions to those motions.
`
`Ms. Ehrlich is undisputedly qualified, and her opinions are reliable, relevant, and will help
`
`1
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 6 of 21 PageID# 28770
`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 6 of 21 PagelD# 28770
`
`the jury decide hotly disputed issuesat trial. Thus, RJR’s motion should be denied.
`
`Il.
`
`FACTUAL BACKGROUND
`
`A.
`
`Ms. Ehrlich Is Undisputedly Qualified To Testify As An FDA Expert
`
`RJR does not challenge Ms. Ehrlich’s qualifications, nor could it. Ms. Ehrlich is a Harvard-
`
`trained lawyer with more than twenty-five years of experience in FDA regulation. Ex. A (Ehrlich
`
`Op.) 9 5-6. She has counseled numerousclients, including the Coalition of Independent Tobacco
`
`Manufacturers of America with which she worked to negotiate the small business provisions of
`
`the Family Smoking Prevention and Tobacco Control Act (“TCA”). Jd. § 7. Her FDA experience
`
`is extensive, encompassing rulemaking, guidance development,Po
`
`NS0 Eich Dep) «
`
`44:20-45:21; Ex. E (Ehrlich ITC Test.) at 1403:13-1404:10-11. Ms. Ehrlich experience provides
`
`unique insight into FDA’s policies and actions through cumulative exposure to confidential
`
`communications with FDA on behalf of clients.
`
`Ms.Ehrlich has served on the Board of Directors of the Food and Drug Law Institute and
`
`has consistently been ranked in The Best Lawyers in America© and Super Lawyers© for her FDA
`
`know-how. Ex. A (Ehrlich Op.) § 8; Ex. B (Ehrlich Webpage). She regularly lectures on tobacco
`
`product regulation, tackling such subjects as PMT compliance and youth use of e-cigarettes. Ex.
`
`A (Ehrlich Op.) § 8; Ex. B (Ehrlich Webpage). She also has authored chapters in FDA-related
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 7 of 21 PageID# 28771
`
`books, such as Food and Drug Law & Regulation, How to Work with the FDA and Insights into
`
`Working with FDA: Takeaways and Experiential Tips. Ex. B (Ehrlich Webpage).
`
`B. Ms. Ehrlich’s Opinions In This Case
`
`In this case, Ms. Ehrlich opines that RJR derives particular regulatory benefits from its
`
`infringement of the Asserted Patents because this technology strengthens RJR’s pending PMTAs
`
`and prospective MRTPAs for the accused VUSE e-cigarettes (“Accused Products”). Ex. A
`
`(Ehrlich Op.) ¶¶ 3-4; Ex. D (Ehrlich Dep.) 99:23-100:4, 103:2-105:8, 204:14-205:21.
`
`There can be no credible dispute that PMT authorization is extremely valuable (really,
`
`commercially essential) to RJR.
`
` Ex. F (Mody ITC Rpt.) at 99.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ITC Dep.) at 49:4-52:3.
`
` Ex. G (Figlar
`
`
`
` See, e.g., Ex. H (Aug. 2021 FDA
`
`PR); Ex. I (Figlar ITC Tr.) 99:11-16, 100:8-13. Should that occur, RJR would forego
`
`
`
` potential revenue. Ex. A (Ehrlich Op.) ¶¶ 3-4; see Ex. J (Meyer Op.) ¶ 486.
`
`The Development Of E-Cigarette Laws And Regulations
`
`C.
`
`The “Deeming Rule,” effective on August 8, 2016, gave FDA regulatory authority over e-
`
`
`
`cigarettes under the TCA and required that each e-cigarette earn PMT authorization before it can
`
`
`
`3
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 8 of 21 PageID# 28772
`
`be legally sold in the United States. 81 Fed. Reg. at 28975-76 (May 10, 2016); 21 U.S.C.
`
`§ 387a(b). Consequently, as FDA has explained, all e-cigarettes on sale as of August 8, 2016,
`
`were instantly rendered illegal. See Ex. K (Apr. 2020 FDA Guidance) at -4128. To blunt this
`
`harsh effect, FDA unveiled a compliance policy whereby companies could continue to sell any e-
`
`cigarettes already on the U.S. market as of August 8, 2016, until a specified deadline for submitting
`
`PMTAs. 81 Fed. Reg. at 28977-80. This policy, however, “did not confer lawful marketing status
`
`on new tobacco products being marketed without the necessary premarket authorization.”2 Ex. K
`
`(Apr. 2020 FDA Guidance) at -4122.
`
`
`
`PMT authorization has proven extremely difficult to earn. Out of millions of PMTAs
`
`reviewed, FDA has only authorized one e-cigarette, the VUSE Solo, and only partially – granting
`
`applications for tobacco-flavored VUSE Solos, but issuing ten marketing denial orders for other
`
`flavors of that model. Ex. L (FDA Slides) at 11, 14; Ex. M (Clissold Dep.) 36:3-6.
`
`
`
`
`
` See Ex. A (Ehrlich Op.)
`
`¶¶ 143-144; Ex. N (Clissold Rbt.) ¶¶ 29-31; Ex. M (Clissold Dep.) 38:17-39:2.
`
`III. LEGAL STANDARDS
`A.
`
`Admissibility Of Expert Testimony Under Federal Rule Of Evidence 702
`
`Expert testimony may be admitted if:
`
`(a) the expert’s scientific, technical, or other specialized knowledge will help the
`trier of fact to understand the evidence or to determine a fact in issue; (b) the
`testimony is based on sufficient facts or data; (c) the testimony is the product of
`reliable principles and methods; and (d) the expert has reliably applied the
`principles and methods to the facts of the case.
`
`FED. R. EVID. 702.
`
`
`2 All emphasis added unless otherwise noted.
`
`
`
`4
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 9 of 21 PageID# 28773
`
`
`
`Daubert provides “a “flexible” framework for evaluating expert opinions and, accordingly,
`
`the Court has “considerable leeway in deciding . . . how to go about determining whether particular
`
`expert testimony is reliable.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). “Where
`
`the expert’s qualifications are challenged, the test for exclusion is a strict one, and the purported
`
`expert must have neither satisfactory knowledge, skill, experience, training nor education on the
`
`issue for which the opinion is proffered.” The Harvester, Inc. v. Rule Joy Trammell + Rubio, LLC,
`
`No. 09-CV-358, 2010 WL 2653373, at *1 (E.D. Va. July 2, 2010). To be admissible, “[a] court
`
`need not determine that the expert testimony . . . is irrefutable or certainly correct.” Touchcom,
`
`Inc. v. Berreskin & Parr, No. 7-cv-114, 2010 WL 4393282, at *8 (E.D. Va. Oct. 29, 2010). In
`
`sum, “the rejection of expert testimony is the exception rather than the rule.” FED. R. EVID. 702
`
`advisory committee notes (2000 amendments).
`
`B.
`
`Admissibility Of Expert Testimony Based On Experiential Expertise
`
`Like many testifying experts, Ms. Ehrlich’s expertise is grounded in her professional
`
`experience. Because “Daubert principles do not bar an expert’s opinion as unreliable merely
`
`because it is grounded in personal knowledge or experience,” the use of experiential experts is
`
`widely accepted. Kirksey v. Schindler Elevator Corp., No. 15-cv-0115, 2016 WL 5213928, at *3
`
`(S.D. Ala. Sept. 21, 2016); see U.S. v. Wilson, 484 F 3d 267, 274 (4th Cir. 2007). Indeed, “[a]
`
`witness’ experience, studies and education, combined with a review of the relevant materials can
`
`provide a reliable basis for expert testimony.” Estate of Lance ex rel. Lance v. Lewisville Indep.
`
`Sch. Dist., No. 11-cv-00032, 2012 WL 1668198, at *3 (E.D. Tex. May 11, 2012). The Fourth
`
`Circuit has recognized that, “although ‘[e]xperiential expert testimony . . . does not rely on
`
`anything like a scientific method,’ such testimony is admissible under Rule 702.” The Harvester,
`
`Inc., 2010 WL 2653373, at *2. The experiential witness must simply “explain how [his]
`
`experience leads to the conclusion reached, why [his] experience is a sufficient basis for the
`5
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 10 of 21 PageID# 28774
`
`opinion, and how [his] experience is reliably applied to the facts.” De Reyes v. Waples Mobile
`
`Home Park Ltd. P’ship, No. 16-cv-563, 2017 WL 4509869, at *2 (E.D. Va. Apr. 17, 2017); see In
`
`re Zetia, No. 2:18-md-2836, 2021 WL 6690348, at *1 (E.D. Va. Aug. 16, 2021). Where, as here,
`
`an experiential expert is providing opinions relevant to damages, they are “not required to
`
`quantitatively assess the impact upon damages for [the] underlying summary to be reliable.” Aloe
`
`Vera of Am. Inc. v. United States, No. 99-cv-01794, 2014 WL 3072981, at *4 (D. Ariz. July 7,
`
`2014); see Wickersham v. Ford Motor Co., No. 13-cv-1192, 2016 WL 5349093, at *9 (D.S.C.
`
`Sept. 26, 2016).
`
`IV. ARGUMENT
`
`RJR provides no viable basis on which to grant its motion. Ms. Ehrlich’s opinions are
`
`reliable and apply her experiential expertise to a sound methodology to reach opinions that are
`
`closely tied to the facts of this case. She offers no legal opinions, but rather identifies and applies
`
`policies and conclusions FDA has made and communicated. And she does not opine on
`
`“extraneous topics,” but explains how RJR derives added regulatory value from infringing the
`
`Asserted Patents, which will help the jury assess the appropriate royalty damages.
`
`A. Ms. Ehrlich’s Opinions Are Reliable And Will Help The Jury
`
`RJR contends that Ms. Ehrlich’s opinions should be excluded because they are purportedly
`
`unreliable and not based on sufficient facts or data. Mot. at 7-12. Both arguments lack merit.
`
`First, RJR’s argument that Ms. Ehrlich’s opinions are unreliable because she somehow
`
`“lacks personal knowledge” of “the methodology used by the FDA in issuing a PMTA
`
`authorization” is legally and factually baseless. Mot. at 8, 13-14. “[I]t is clearly the case that an
`
`expert opinion need not be based on personal knowledge.” Bockelman v. BNSF Ry. Co., No. 10-
`
`cv-1001, 2011 WL 5180382, at *5 (C.D. Ill. Oct. 28, 2011); see Poly-Am., Inc. v. Serrot Int’l, Inc.,
`
`No. 300-cv-1457, 2002 WL 1996561, at *14 (N.D. Tex. Aug. 26, 2002) (holding that an expert
`
`
`
`6
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 11 of 21 PageID# 28775
`
`did not need to have personal knowledge about the practices of the companies on which he was
`
`opining for his opinions to be admissible).
`
`Instead, Ms. Ehrlich draws on her decades of FDA work
`
`
`
` complements that experience with a fulsome evaluation of documentary evidence on
`
`which experts in her field would reasonably rely, and then applies that knowledge and analysis to
`
`the record evidence. See Ex. A (Ehrlich Op.) ¶¶ 7-8, 57, 86-126, 167-173; Ex. D (Ehrlich Dep.)
`
`37:14-24, 39:22-40:13, 44:20-45:21. The use of experiential experts like Ms. Ehrlich is a widely
`
`accepted practice. See, e.g., U.S. v. Wilson, 484 F 3d at 274; Zetia, 2021 WL 6690348, at *6; De
`
`Reyes, 2017 WL 4509869, at *2.
`
`Second, RJR’s argument that Ms. Ehrlich’s “methodology is not reliable” because she
`
`allegedly “did not take into account pertinent facts and data” should be rejected. Mot. at 8. “[A]n
`
`expert’s reliance on some facts but not others is not always cause to exclude such testimony under
`
`Daubert” because “it is not the district court’s role under Daubert to evaluate the correctness of
`
`facts underlying an expert’s testimony.” Rembrandt Soc. Media, LP v. Facebook, Inc., 22 F. Supp.
`
`3d 585, 596 (E.D. Va. 2013). Regardless, Ms. Ehrlich considered all of the relevant facts, and
`
`none of the “pertinent facts” that RJR identifies shows that her methodology is unreliable.
`
`For example, RJR argues that Ms. Ehrlich did not review “the technical aspects of [RJR’s]
`
`PMTAs or the asserted patent claims.” Mot. at 2. No surprise. Ms. Ehrlich is a regulatory expert
`
`on FDA-related issues. See supra § II(A). She is not a technical expert and thus did not analyze
`
`the technical aspects of any issue in this case. Instead, she relied on PMI/Altria’s technical experts
`
`for her understanding of certain technical issues relevant to her opinions. Ex. D (Ehrlich Dep.)
`
`
`
`7
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 12 of 21 PageID# 28776
`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 12 of 21 PagelD# 28776
`
`10:3-13, 39:22-40:2, 42:25. Mot. at 8-9. Thisis entirely proper.’ See, e.g., Crouch v. John Jewell
`
`Aircraft, Inc., No. 07-cv-638, 2016 WL 157464, at *5 (W.D. Ky. Jan. 12, 2016); Travelers Cas.
`
`Ins. Co. ofAm. ex rel. Palumbo v. Volunteers ofAm. Ky., Inc., No. 10-cv-301, 2012 WL 3610250,
`
`at *6 (E.D. Ky. Aug. 21, 2012).
`
`As the Fourth Circuit has explained, there are “meaningful differences in how reliability
`
`must be examined with respect to expert testimony that is primarily experiential in nature as
`
`opposedto scientific.” U.S. v. Wilson, 484 F. 3d at 274. Although experiential expert testimony
`
`“does not rely on anything like a scientific method,” Federal Rule of Evidence 702 specifically
`
`contemplates that an expert may be qualified on his/her experiences, along with other knowledge,
`
`skill, training, or education. Jd. The expert simply must explain how his/her experiencesserve as
`
`a sufficient basis for the opinions offered, how that experience leads to the conclusions reached,
`
`and how he/she applied that experience to the facts of the case. Jd. Ms. Ehrlich has done exactly
`
`that, and, thus, her testimony fulfills the requirements of Federal Rule of Evidence 702.4 See §§
`
`II(A)-(B), II, supra. At most, the scope of Ms. Ehrlich’s review is a matter for cross-examination
`
`that goes to weight, not admissibility. See, e.g., De Reves, 2017 WL 4509869,at *2; VS Techs.,
`
`LLC v. Twitter, Inc., No. 2:11-cv-43, 2011 WL 4744572, at *7 (E.D. Va. Oct. 5, 2011).
`
`3 Unsurprisingly, RJR’s non-technical experts did the same. See, e.g.,
`
`
`
`4 RJR argues that Ms. Ehrlich’s opinions regarding RJR’s MRTPAsare unreliable, absent an
`analysis as to “how the patented technology may be addressed.” Mot. at 15. As discussed, Ms.
`Ehrlich need not provide any technical analysis for her opinions to be reliable. Moreover, her
`MRTPA-related opinionsare not speculative because she: (1) considered the patented technology
`(using input from PMI/Altria’s technical experts); (2) is undisputedly familiar with MRTP
`
`
`requirements; (3) understands that MRTPA and PMTAanalysis have similarities; and (4) has
`reviewed RJR 30(b)(6)
`testimon
`
`See Ex. A (Ehrlich Op.) 4 167-173.
`
`8
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 13 of 21 PageID# 28777
`
`The cases RJR relies on are inapposite. See Mot. at 9, 11. In Westberry v. Gislaved Gummi
`
`AB, the Fourth Circuit affirmed the admission of a medical expert’s testimony, finding that his
`
`“alleged failure to account for all possible alternative causes” of the patient’s problems did not
`
`render his opinions untrustworthy, invalid, or inadmissible. 178 F. 3d 257, 266 (4th Cir. 1999).
`
`In Audio MPEG, Inc. v. Dell, Inc., the court excluded a technical expert’s opinion because, “[a]side
`
`from listing the patents reviewed and briefly describing them,” the expert set out “no further facts
`
`or data.” No. 15-cv-73, Dkt. 830 at 16 (E.D. Va. Aug. 28, 2017). And in ePlus, Inc. v. Lawson
`
`Software, Inc., the court excluded a damages expert’s royalty opinions because they were based
`
`on questionable, minimally probative documents using speculative calculations “without
`
`explaining at all” how he reached his conclusions. 764 F. Supp. 2d 807, 815 (E.D. Va. 2011),
`
`aff’d, 700 F. 3d 509 (Fed. Cir. 2012). In contrast, Ms. Ehrlich relies on her experiential expertise,
`
`input from PMI/Altria’s technical experts, and extensive record evidence—all of which she
`
`reliably applied to the facts of the case. Ex. A (Ehrlich Op.) at Ex. 2. This is precisely the type of
`
`analysis that the experts in RJR’s cases failed to undertake.
`
`B. Ms. Ehrlich’s Opinions Are Not Speculative
`
`RJR contends that Ms. Ehrlich’s opinions are speculative. Mot. at 12-16. RJR is wrong,
`
`and, again, its criticisms go to the weight of her opinions, not their admissibility.
`
`First, the Court should reject RJR’s argument that Ms. Ehrlich’s limited use of the word
`
`“may” in her report somehow “confirms that her opinions are speculative.” Mot. at 13. RJR omits
`
`that, in every single paragraph of Ms. Ehrlich’s report that RJR cites,
`
`
`
`
`
` Ex. A (Ehrlich Op.) ¶¶ 86, 98, 102, 104, 109, 111, 115, 118, 124; see
`
`id. ¶ 130
`
`
`
` In addition,
`
`9
`
`
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 14 of 21 PageID# 28778
`
`(Ehrlich Dep.) 98:13-18, 100:24-101:2, 103:13-17, 105:3-8, 111:9-20, 133:15-21, 137:12-138:2,
`
`
`
` Id. ¶ 85; Ex. D
`
`138:22-139:19, 145:2-11, 159:3-16; see Shire Viropharma, 2021 WL 1227097, at *5.
`
`
`
`
`
`
`
`
`
`Second, RJR argues that Ms. Ehrlich’s opinions are speculative because she does not
`
`“know exactly what FDA considers” or how “FDA would view the patented technology.” Mot. at
`
`13. This argument invites legal error. It would effectively force Ms. Ehrlich to opine on FDA’s
`
`state of mind or guarantee FDA’s course of action, which, as RJR itself has argued to this Court,
`
`would be improper. Dkt. 885 at 18 (“Courts uniformly hold that expert testimony about … state
`
`of mind is inadmissible.”). RJR cites no case requiring Ms. Ehrlich to “know exactly what FDA
`
`considers” for her opinions to be admissible. None exists. Cf. Shire Viropharma Inc. v. CSL
`
`Behring LLC, No. 17-cv-414, 2021 WL 1227097, at *5 (D. Del. Mar. 31, 2021) (“It is well settled
`
`that experts may not provide testimony concerning the ‘state of mind’ … of defendants,
`
`corporations, regulatory agencies, and others.”).
`
`Ms. Ehrlich’s opinions properly reflect her experience, reliance on technical experts where
`
`appropriate, and analysis of relevant record evidence. See, e.g., Ex. D (Ehrlich Dep.) at 74:5-11,
`
`75:17-20. That she cannot and will not speak on behalf of FDA does not render her opinions ipse
`
`dixit; it affirms their reliability. See Mot. at 8. Grounded in her personal extensive experience,
`
`and informed by her analysis of the record evidence in this case, Ms. Ehrlich will describe the
`
`
`
`10
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 15 of 21 PageID# 28779
`
`regulatory benefits RJR receives from its infringement of the Asserted Patents due to that
`
`technology’s importance in PMT authorization for the Accused Products.
`
`The cases RJR relies on are easily distinguished. In United States v. Mallory, the Fourth
`
`Circuit affirmed the exclusion of an expert’s testimony “because her opinion did not rest on
`
`sufficient facts or data.” 988 F. 3d 730, 742 (4th Cir. 2021). And in Belville v. Ford Motor Co.,
`
`the Fourth Circuit affirmed the exclusion of an expert’s testing method that was “purely
`
`theoretical,” “did not reflect real-world results,” and had previously been “rejected by NASA and
`
`NHTSA.” 919 F.3d 224, 234 (4th Cir. 2019). In contrast, Ms. Ehrlich’s opinions are firmly
`
`grounded in voluminous facts and data from the record evidence, and informed by her decades of
`
`experience and relevant industry materials. See § II(A), supra. And her analytical methodology
`
`and approach have not been rejected by FDA or other agencies.
`
`Third, Ms. Ehrlich’s opinions are not speculative merely because she does not quantify the
`
`benefit that RJR derives from infringing the Asserted Patents. See Mot. at 14-16. “There is nothing
`
`in Daubert that requires an expert to rely on a quantifiable theory.” Wickersham, 2016 WL
`
`5349093, at *9. This is particularly true where, as here, an experiential expert is providing opinions
`
`that explain how and why that the infringer’s use of the patented technology is valuable, and then
`
`a qualified damages expert uses those opinions as one input into in his royalty calculation. In such
`
`an analysis, “the law remains clear; mathematical precision in royalty calculations is not required.”
`
`Mobility Workx, LLC v. Cellco P’ship, 2019 WL 5721814, at *16 (E.D. Tex. 2019); see Touchcom,
`
`2010 WL 4393282, at *4 (admitting testimony from an experiential expert on valuation of patented
`
`technology without requiring a specific percentage of value).5 Regardless, disputes about alleged
`
`
`5 RJR’s kitchen sink arguments include attacking the reasonable royalty analysis of Paul Meyer,
`PMI/Altria’s damages expert. See Mot. 15. Such arguments are irrelevant to this motion and
`11
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 16 of 21 PageID# 28780
`
`“arbitrary value assignments are better left to cross examination.” Mobility Workx, 2019 WL
`
`5721814, at *16; accord Zak v. Facebook, Inc., No. 15-cv-13437, 2021 WL 4481588, at *3 (E.D.
`
`Mich. Sept. 30, 2021) (“[D]isputes with an expert’s conclusion apportioning relative value among
`
`patents in a transaction go to the weight that should be afforded an expert’s opinion, not its
`
`admissibility.”).
`
`C. Ms. Ehrlich Does Not Offer Legal Opinions
`
`RJR contends that Ms. Ehrlich offers legal opinions. Mot. at 16-17. She does not. RJR’s
`
`argument rests on the false premise that, because Ms. Ehrlich’s opinions relate to an admittedly
`
`“complex regulatory scheme,” they must be legal in nature. Dkt. 825 at 6. Not so. As the Fourth
`
`Circuit has held, in cases where “the legal regime is complex and . . . testimony would be helpful
`
`in explaining it to the jury, the testimony may be admitted.” United States v. Offill, 666 F. 3d 168,
`
`175 (4th Cir. 2011) (permitting expert testimony on the specialized regime of U.S. Securities and
`
`Exchange Commission). Indeed, the Fourth Circuit has affirmed the admissibility of expert
`
`testimony addressing FDA’s premarket approval process for medical devices, which is similar to
`
`FDA’s PMT and MRTP authorization processes at issue in this case. See United States v. Barile,
`
`286 F. 3d 749, 761 (4th Cir. 2002) (“Opinion testimony on whether the data submitted [to FDA]
`
`in a 510(k) submission were reasonable would not merely state a legal conclusion and therefore is
`
`not excludable on the ground that it invades the province of the jury.”). Here, as in Offill, Ms.
`
`Ehrlich’s “specialized knowledge will assist the trier of fact to understand the evidence” and
`
`should be allowed. 666 F.3d at 175.6
`
`
`incorrect for the reasons explained in the opposition to RJR’s motion to exclude his opinions. See
`Dkt. 892.
`6 Even if the handful of statements that RJR points to are legal conclusions (and they are not), the
`Fourth Circuit has recognized that courts have “consistently” admitted such testimony where, as
`12
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 17 of 21 PageID# 28781
`Case 1:20-cv-00393-LO-TCB Document 1017 Filed 02/11/22 Page 17 of 21 PagelD# 28781
`
`None of RJR’s arguments shows otherwise. For example,PO
`
`SSii 2crecitationofEDA’s long
`
`standing conclusion, using FDA’s own terminology. See, e.g., Ex. P (FDA Sharpless Statement)
`
`at 6 (testifying before Congress that no e-cigarette “in the United States is on the marketlegally”):
`
`Ex. K (Apr. 2020 FDA Guidance) at -4121 (“[I]it is illegal to market any new tobacco product
`
`without premarket authorization.”);’ Ex. R (Jan. 2020 Azar Statement) (“HHS is taking a
`
`comprehensive, aggressive approach to enforcing the law passed by Congress, under which noe-
`
`cigarettes are currently on the market legally.”).Pe
`
`Po RJR fails to articulate any basis to support its superficial mischaracterization
`
`of Ms. Ehrlich’s undisputed factual recitation of FDA’s statement of policy. Mot. at 16-17.
`
`Likewise, Ms. Ehlch’s pinion regne
`I© See F<. (sich Op)
`
`here, the issues involve “highly technical legal issues”or “‘a specialized industry.” Offill, 666 F.3d
`at 175; see Barile, 286 F.3d at 760 n.7.
`7 “New tobacco products”are “those that were not commercially marketed in the United States as
`of Febru