Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 1 of 19 PageID# 21569
`
`IN THE 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
`
`MEMORANDUM IN SUPPORT OF REYNOLDS’S MOTIONS IN LIMINE NOS. 1-3 TO
`EXCLUDE REFERENCES TO VUSE PRODUCTS AS ALLEGEDLY BEING ILLEGAL
`OR UNLAWFUL, REFERENCES TO YOUTH VAPING OR ALLEGED TARGETING
`OF VUSE PRODUCTS TO YOUTHS, AND REFERENCES TO THE ALLEGED
`HARMS OF VAPING
`
`

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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 2 of 19 PageID# 21570
`
`TABLE OF CONTENTS
`
`
`Page
`
`
`INTRODUCTION ......................................................................................................................... 1
`BACKGROUND ........................................................................................................................... 2
`LEGAL STANDARD .................................................................................................................... 5
`ARGUMENT ................................................................................................................................. 5
`I.
`THE COURT SHOULD EXCLUDE ANY REFERENCE TO ANY VUSE
`PRODUCTS AS ALLEGEDLY BEING ILLEGAL OR UNLAWFUL ........................... 5
`THE COURT SHOULD EXCLUDE ANY REFERENCE TO YOUTH VAPING
`OR ALLEGED TARGETING OF VUSE PRODUCTS TO YOUTHS ............................ 9
`THE COURT SHOULD EXCLUDE ANY REFERENCE TO THE ALLEGED
`HEALTH RISKS OF VAPING ....................................................................................... 12
`CONCLUSION ............................................................................................................................ 12
`
`II.
`
`III.
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`
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`-i-
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 3 of 19 PageID# 21571
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`
`Abbott Lab’ys v. Sandoz, Inc.,
`743 F. Supp. 2d 762 (N.D. Ill. 2010) .........................................................................................8
`
`Advanced Tech. Incubator, Inc. v. Sharp Corp.,
`No. 5:09-CV-135, 2010 WL 11451797 (E.D. Tex. Mar. 31, 2010) ......................................6, 8
`
`Am. Acad. of Pediatrics v. FDA,
`379 F. Supp. 3d 461 (D. Md. 2019) ...........................................................................................3
`
`Am. Acad. of Pediatrics v. FDA,
`399 F. Supp. 3d 479 (D. Md. 2019) ...........................................................................................3
`
`Am. Acad. of Pediatrics v. FDA,
`No. 8:18-cv-883, ECF 120-1 (D. Md. June 12, 2019) ...............................................................3
`
`Am. Acad. of Pediatrics v. FDA,
`No. 8:18-cv-883-PWG, ECF 197 (D. Md. Dec. 13, 2021) ........................................................7
`
`Am. Home Assurance Co. v. Merck & Co.,
`462 F. Supp. 2d 435 (S.D.N.Y. 2006)......................................................................................11
`
`Anderson v. WBMG-42,
`253 F.3d 561 (11th Cir. 2001) ...................................................................................................9
`
`Bilenky v. Ryobi Ltd.,
`No. 2:13CV345, 2014 WL 12591940 (E.D. Va. Oct. 22, 2014) .........................................8, 12
`
`In re C.R. Bard, Inc.,
`810 F.3d 913 (4th Cir. 2016) ...............................................................................................9, 12
`
`Scalia v. Med. Staffing of Am., LLC,
`No. 2:18CV226, 2020 WL 2832491 (E.D. Va. Mar. 18, 2020) ................................................5
`
`Smithfield Foods, Inc. v. United Food & Commercial Workers Int’l Union,
`No. 3:07CV641, 2008 WL 4610305 (E.D. Va. Oct. 14, 2008) ...........................................8, 12
`
`United States v. DesAnges,
`921 F. Supp. 349 (W.D. Va. 1996) ..........................................................................................10
`
`-ii-
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 4 of 19 PageID# 21572
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`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`United States v. Seko,
`No. 1:15CR301 (JCC), 2017 WL 1369070 (E.D. Va. Apr. 10, 2017) .....................................11
`
`United States v. Williams,
`445 F.3d 724 (4th Cir. 2006) ...................................................................................................10
`
`Wages & White Lion Invs., L.L.C. v. FDA,
`16 F.4th 1130 (5th Cir. 2021) ................................................................................................2, 7
`
`STATUTES, RULES, AND REGULATIONS
`
`81 Fed. Reg. 28,973 (May 10, 2016) (Deeming Rule) ....................................................................2
`
`21 U.S.C. § 387a(b) .........................................................................................................................2
`
`Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123
`Stat. 1776 (2009) ........................................................................................................................2
`
`Fed. R. Evid. 401 .........................................................................................................................5, 6
`
`Fed. R. Evid. 402 .............................................................................................................................5
`
`Fed. R. Evid. 403 .............................................................................................................................5
`
`OTHER AUTHORITIES
`
`CDC, About Electronic Cigarettes (E-Cigarettes) (Sept. 30, 2021),
`https://tinyurl.com/4cxrjfdu .......................................................................................................2
`
`Eunice Park-Lee et al., Notes from the Field: E-Cigarette Use Among Middle and
`High School Students — National Youth Tobacco Survey, United States, 2021,
`MMWR Morb. Mortal Wkly. Rep. (Sept. 30, 2021),
`https://tinyurl.com/yrzenz3f .......................................................................................................4
`
`FDA, Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS)
`and Other Deemed Products on the Market Without Premarket Authorization
`3 (rev. Apr. 2020), https://tinyurl.com/8j58axb7 ...................................................................3, 7
`
`-iii-
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 5 of 19 PageID# 21573
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`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`FDA, FDA Permits Marketing of E-Cigarette Products, Marking First
`Authorization of Its Kind by the Agency (Oct. 12, 2021),
`https://tinyurl.com/3m8t7b78.................................................................................................3, 4
`
`FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on New
`Enforcement Actions (Apr. 23, 2018), https://tinyurl.com/f7rrwxxc .........................................2
`
`Mitch Zeller, Perspective: FDA’s Progress on Tobacco Product Application
`Review and Related Enforcement, FDA (Sept. 9, 2021),
`https://tinyurl.com/4xhb5bjt ......................................................................................................4
`
`Sheila Kaplan, Juul to Pay $40 Million to Settle N.C. Vaping Case, New York
`Times (June 28, 2021)..............................................................................................................11
`
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`
`
`INTRODUCTION
`
`RAI Strategic Holdings, Inc. and R.J. Reynolds Vapor Company (collectively,
`
`“Reynolds”) respectfully move the Court for an order excluding all evidence and argument,
`
`whether presented on direct or cross-examination, and for impeachment or otherwise, concerning
`
`references to VUSE products as allegedly being illegal or unlawful, references to youth vaping or
`
`alleged targeting of VUSE products to youths, and references to the alleged health risks of vaping.
`
`Based on the evidence gathered during discovery, Reynolds anticipates that Altria Client Services
`
`LLC (“ACS”), Philip Morris USA, Inc. (“PM USA”), and Philip Morris Products S.A. (“PMP”)
`
`(collectively, “PM/Altria”) will attempt to raise these irrelevant issues in order to distract the jury
`
`from the questions it must decide and paint Reynolds and its VUSE products in a negative light.
`
`The Court should bar PM/Altria from raising these issues. First, these issues are
`
`completely irrelevant to any issue to be tried in this case. Specifically, they have no relevance to
`
`the issues of patent infringement, patent validity, damages, or any other substantive question
`
`before the jury. The jury in this case is tasked with deciding these patent questions, not with
`
`deciphering VUSE’s regulatory status or weighing the propriety of vape marketing or vape use.
`
`Second, even if these issues were relevant, their probative value would be substantially outweighed
`
`by the risks of unfair prejudice to Reynolds, misleading the jury, and the need for wasteful, time-
`
`consuming mini-trials on these collateral issues. Referring to VUSE as illegal and discussing
`
`alleged youth marketing and the alleged health risks of vaping would unfairly and inaccurately
`
`paint Reynolds in a negative light in front of the jury by misleadingly labeling VUSE’s regulatory
`
`status and indirectly attributing the actions of other vape manufacturers to Reynolds. And each of
`
`these issues would waste valuable time as each would result in its own mini-trial, confusing the
`
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`
`jury as to which issues it is tasked with deciding. The Court should exclude evidence and argument
`
`related to these issues.
`
`BACKGROUND
`
`At issue in this case are five patents PM/Altria allege cover Reynolds’s electronic nicotine
`
`delivery systems (ENDS, or e-cigarettes) products, called VUSE. Unlike combustible cigarettes,
`
`ENDS produce an aerosol by heating a liquid that contains nicotine. See CDC, About Electronic
`
`Cigarettes (E-Cigarettes) (Sept. 30, 2021), https://tinyurl.com/4cxrjfdu. As the U.S. Food and
`
`Drug Administration (“FDA”) has recognized, ENDS “provide a potentially less harmful
`
`alternative for currently addicted individual adult smokers.” FDA, Statement from FDA
`
`Commissioner Scott Gottlieb, M.D., on New Enforcement Actions (Apr. 23, 2018),
`
`https://tinyurl.com/f7rrwxxc.
`
`In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act
`
`(“TCA”), Pub. L. No. 111-31, 123 Stat. 1776 (2009), but the TCA did not originally cover ENDS.
`
`In 2016, invoking its authority under the Act to “deem” other “tobacco products” subject to the
`
`Act, 21 U.S.C. § 387a(b), FDA promulgated a rule deeming ENDS subject to the Act. See
`
`Deeming Rule, 81 Fed. Reg. 28,973, 28,975 (May 10, 2016). This meant that ENDS needed FDA
`
`authorization to be marketed, but by this time, millions of ENDS products were already on the
`
`market. See Wages & White Lion Invs., L.L.C. v. FDA, 16 F.4th 1130, 1134 (5th Cir. 2021). To
`
`solve this Catch-22, FDA delayed enforcement of the premarket review requirements for ENDS
`
`products already on the market, to give the agency time to design and implement an authorization
`
`pathway. 81 Fed. Reg. at 28,977. FDA also recognized that immediately ordering these products
`
`off the market would present “countervailing health concerns.” Id. at 29,014. As FDA’s Director
`
`later explained in sworn testimony, “[d]ramatically and precipitously reducing availability of
`
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`[ENDS products] could present a serious risk that adults, especially former smokers, who currently
`
`use ENDS products and are addicted to nicotine would migrate to combustible tobacco products.”
`
`See Am. Acad. of Pediatrics v. FDA, No. 8:18-cv-883, ECF 120-1, at ¶ 15 (D. Md. June 12, 2019).
`
`In 2019, a federal court invalidated FDA’s approach of withholding enforcement while
`
`manufacturers sought premarket clearance. Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461,
`
`498 (D. Md. 2019); see also Am. Acad. of Pediatrics v. FDA, 399 F. Supp. 3d 479, 487 (D. Md.
`
`2019). Pursuant to the court’s order, FDA then accelerated the application deadline by nearly two
`
`years, to September 9, 2020, and said that it intended to rule on applications submitted by that date
`
`within a year. FDA, Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and
`
`Other Deemed Products on the Market Without Premarket Authorization Revised (Apr. 2020),
`
`https://tinyurl.com/8j58axb7. FDA said that products with timely applications could remain on
`
`the market for up to one year while FDA was reviewing the applications. Id. FDA reiterated that
`
`its policy of allowing certain products furthered the public health by “maintaining availability of
`
`potentially less harmful options for current and former adult smokers who have transitioned or
`
`wish to transition completely away from combusted tobacco products.” Id. at 20. FDA also
`
`retained its case-by-case enforcement discretion even after that one-year period expired. Am.
`
`Acad. of Pediatrics, 399 F. Supp. 3d at 487. When the application deadline arrived, FDA had
`
`unexpectedly received applications for over 6.5 million products. As a result, the agency missed
`
`the one-year September 9, 2021 deadline, leaving applications for all major ENDS manufacturers
`
`undecided.
`
`To date, FDA has only granted marketing authorization to one ENDS product—Reynolds’s
`
`tobacco-flavored VUSE Solo. FDA, FDA Permits Marketing of E-Cigarette Products, Marking
`
`First Authorization of Its Kind by the Agency (Oct. 12, 2021), https://tinyurl.com/3m8t7b78. FDA
`
`
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`denied Reynolds’s application for non-tobacco- and non-menthol-flavors of VUSE Solo, but those
`
`products were not currently on the market. Applications for menthol-flavored VUSE Solo and for
`
`Reynolds’s other VUSE products remain under FDA review. FDA has not stated that Reynolds
`
`must stop selling those products that remain under FDA review. Instead, the agency has said,
`
`“Products for which no application is pending, including, for example, those with a Marketing
`
`Denial Order and those for which no application was submitted, are among our highest
`
`enforcement priorities.” See Mitch Zeller, Perspective: FDA’s Progress on Tobacco Product
`
`Application Review and Related Enforcement, FDA (Sept. 9, 2021) (emphasis added),
`
`https://tinyurl.com/4xhb5bjt. None of Reynolds’s currently marketed products fit that description.
`
`One of FDA’s main concerns throughout the PMTA process has been youth access to
`
`ENDS. Reynolds shares these concerns, which is why, unlike some other ENDS manufacturers,
`
`Reynolds adheres to rigorous standards to ensure its marketing is accurate and responsibly directed
`
`to adult tobacco consumers. It also imposes strict compliance policies on retailers to prevent
`
`underage purchases. And as a general matter, the most recent data show that, for the second year
`
`in a row, youth use of e-cigarettes overall is declining. See Eunice Park-Lee et al., Notes from the
`
`Field: E-Cigarette Use Among Middle and High School Students — National Youth Tobacco
`
`Survey, United States, 2021, MMWR Morb. Mortal Wkly. Rep. (Sept. 30, 2021),
`
`https://tinyurl.com/yrzenz3f (1.56 million fewer students used e-cigarettes in 2021).
`
`On December 10, 2021, the parties met and conferred regarding their proposed motion in
`
`limine topics, and Reynolds raised the topics of excluding evidence and argument regarding
`
`references to VUSE products as allegedly being illegal or unlawful, references to youth vaping or
`
`alleged targeting of VUSE products to youths, and references to the alleged health risks of vaping.
`
`The parties were unable to reach a resolution on these issues.
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`
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`LEGAL STANDARD
`
`“The purpose of a motion in limine is to allow a court to rule on evidentiary issues in
`
`advance of trial in order to avoid delay, ensure an even-handed and expeditious trial, and focus the
`
`issues the jury will consider.” Scalia v. Med. Staffing of Am., LLC, No. 2:18CV226, 2020 WL
`
`2832491, at *1 (E.D. Va. Mar. 18, 2020) (citation omitted). Relevant evidence is generally
`
`admissible. Fed. R. Evid. 402. Evidence is relevant if “it has any tendency to make a fact more
`
`or less probable than it would be without the evidence” and “the fact is of consequence in
`
`determining the action.” Fed. R. Evid. 401. But “[t]he court may exclude relevant evidence if its
`
`probative value is substantially outweighed by a danger of … unfair prejudice, confusing the
`
`issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative
`
`evidence.” Fed. R. Evid. 403.
`
`ARGUMENT
`
`I.
`
`THE COURT SHOULD EXCLUDE ANY REFERENCE TO ANY VUSE
`PRODUCTS AS ALLEGEDLY BEING ILLEGAL OR UNLAWFUL.
`
`The Court should preclude PM/Altria from referring to Reynolds’s VUSE products as
`
`illegal or unlawful because any such reference is factually inaccurate, irrelevant, and unfairly
`
`prejudicial to Reynolds. PM/Altria’s expert report makes clear that they intend to characterize
`
`Reynolds’s VUSE products as being illegal or unlawful under the TCA. Indeed, in her report,
`
`PM/Altria expert Stacy Ehrlich states that “all of the VUSE e-cigarettes are illegal.” (Amended &
`
`Supplemented Opening Expert Report of Stacy Ehrlich (4/26/2021) (“Ehrlich Rpt.”), attached as
`
`Exhibit 1, ¶ 162.) She makes similar claims multiple times throughout her report on the regulatory
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`-5-
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`history and status of e-cigarettes. (Ehrlich Rpt. ¶¶ 3, 22, 28, 31, 84.)1 In context, it is clear that
`
`Stacy Ehrlich is referring to FDA’s PMTA regulatory scheme—a scheme in which VUSE products
`
`(with the exception of tobacco-flavored VUSE Solo, the marketing of which has been authorized
`
`by FDA) have the same legal status as all other e-cigarette products that are still on the market and
`
`still under FDA review. That status is the continued ability to market products while FDA is
`
`reviewing applications for those products. Referring to VUSE products being “illegal,” especially
`
`when read in isolation, fails to account for the complex regulatory scheme at issue, and this Court
`
`should bar any such statements from being made to the jury.
`
`First, this is a patent case. The only issues that the jury will be called upon to decide are
`
`(i) whether Reynolds’s VUSE products infringe any of the patents asserted by PM/Altria; and (ii)
`
`whether those patents are invalid. The alleged “illegality” of VUSE products—which is just a
`
`pejorative and inaccurate way of saying that the marketing of these products (other than tobacco-
`
`flavored VUSE Solo) have not yet received FDA authorization—does not make either PM/Altria’s
`
`infringement claims or Reynolds’s invalidity defenses more or less probable. See Fed. R. Evid.
`
`401; Advanced Tech. Incubator, Inc. v. Sharp Corp., No. 5:09-CV-135, 2010 WL 11451797, at
`
`*10 (E.D. Tex. Mar. 31, 2010) (“Any probative value of allegations that Japanese companies
`
`generally engaged in illegal or inappropriate business conduct is irrelevant to issues of patent
`
`infringement, invalidity, or damages in the above-captioned case.”).2
`
`1 As discussed in Reynolds’s Motion to Exclude the Testimony of Stacy Ehrlich, this is
`hardly the only flaw in Ehrlich’s report. Indeed, her opinions are so devoid of scientific merit that
`she should be barred completely from testifying before the jury.
`2 And to the extent PM/Altria seeks to argue that the asserted patents allegedly assisted
`Reynolds in its efforts to submit PMTAs for the accused VUSE products for damages purposes,
`PM/Altria’s witnesses can make those points (subject to the Court’s rulings on Reynolds’s Motion
`in Limine No. 11, Reynolds’s Motion to Exclude the Testimony of Stacy Ehrlich, and Reynolds’s
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`
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`Second, even if the regulatory status of the VUSE products were relevant to any issue in
`
`this case (and it is not), that marginal relevance would be far outweighed by the clear and unfair
`
`prejudice to Reynolds if PM/Altria were allowed to refer to the accused products as “illegal,” as
`
`well as the unavoidable risk that such inflammatory rhetoric will confuse and mislead the jury.
`
`FDA’s regulatory scheme for e-cigarettes is a complex, detailed process. Indeed, the complexity
`
`of the scheme is highlighted by the fact that FDA is now facing legal challenges from dozens of
`
`manufacturers who attempted to navigate FDA’s scheme before ultimately having their
`
`applications denied. See Am. Acad. of Pediatrics v. FDA, No. 8:18-cv-883-PWG, ECF 197 at 2-3
`
`(D. Md. Dec. 13, 2021) (noting 48 legal challenges filed in the U.S. courts of appeals as of mid-
`
`December); cf. Wages & White Lion Invs., 16 F.4th at 1134-35 (noting the “onerous” PMTA
`
`application process and FDA’s shifting “regulatory goalposts” throughout that process). It is true
`
`that VUSE products other than tobacco-flavored VUSE Solo have yet to receive marketing
`
`authorization, but referring to VUSE products as illegal or unlawful to a lay jury without explaining
`
`the full regulatory context would be grossly misleading and would unfairly prejudice Reynolds.
`
`To a lay jury, terms like illegal or unlawful connote criminal action and imply that
`
`Reynolds is breaking the law. In fact, Reynolds is operating in the midst of a complex regulatory
`
`scheme pursuant to an FDA policy of “maintaining availability of [e-cigarettes as] potentially less
`
`harmful options for current and former adult smokers who have transitioned or wish to transition
`
`completely away from combusted tobacco products,” FDA, Enforcement Priorities, supra, at 20,
`
`and FDA has not stated given any indication that Reynolds needs to pull its currently marketed
`
`products off the market. Referring to VUSE products as illegal or unlawful in isolation also gives
`
`
`
`
`Motion to Exclude the Testimony of Paul Meyer) without referring to VUSE products as illegal or
`unlawful.
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`the incorrect impression that VUSE products’ legal status is somehow unique when, in fact, VUSE
`
`products are in the same boat as every other major e-cigarette manufacturer still awaiting FDA’s
`
`decisions on pending PMTAs.3 Thus, allowing PM/Altria to characterize Reynolds’s VUSE
`
`products as illegal or unlawful would unfairly paint Reynolds in a negative light. See, e.g.,
`
`Advanced Tech. Incubator, 2010 WL 11451797, at *10 (“Any probative value of allegations that
`
`Japanese companies generally engaged in illegal or inappropriate business conduct … is
`
`substantially outweighed by the dangers of unfair prejudice, jury confusion, and waste of time.”);
`
`Abbott Lab’ys v. Sandoz, Inc., 743 F. Supp. 2d 762, 773 (N.D. Ill. 2010) (barring party from using
`
`negative terms that would suggest Abbott’s “enforcement of patent rights is unfair or unlawful and
`
`improperly invit[es] the jury to view Abbott in a negative light”).
`
`
`
`And that misleading and negative characterization will stick with the jury until Reynolds
`
`is able to present its case. By that time, the damage will have been done—the jury will be
`
`prejudiced against Reynolds’s products and distracted from the real issues in the case. Moreover,
`
`allowing this evidence will result in a wasteful, time-consuming “mini-trial” on the “legality” of
`
`Reynolds’s VUSE products and the background of FDA’s complex regulatory scheme. Such
`
`“[t]rials within a trial” on collateral issues “are the prototypical dangers warned of by Rule 403’s
`
`‘confusing the issues’ and ‘undue delay.’” Bilenky v. Ryobi Ltd., No. 2:13CV345, 2014 WL
`
`12591940, at *7 (E.D. Va. Oct. 22, 2014) (citation omitted); see also Smithfield Foods, Inc. v.
`
`United Food & Commercial Workers Int’l Union, No. 3:07CV641, 2008 WL 4610305, at *2 (E.D.
`
`Va. Oct. 14, 2008) (“[E]vidence can be excluded under Rule 403 when it would ‘create a series of
`
`
`
`
`
`3 And such characterization fails to recognize the fact that tobacco-flavored Vuse Solo is
`the only ENDS product to be granted marketing authorization—i.e. Reynolds is the only ENDS
`manufacturer to have successfully navigated FDA’s scheme.
`
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 14 of 19 PageID# 21582
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`mini-trials’” (citation omitted)); see also, e.g., Anderson v. WBMG-42, 253 F.3d 561, 567 (11th
`
`Cir. 2001) (trial court has discretion to “prevent[] counsel from embarking on a lengthy
`
`examination of matters” that would “generate[] a mini-trial on collateral issues”). Debating these
`
`side issues here will take up valuable time and risk distracting the jury from the key patent issues
`
`it must decide. See In re C.R. Bard, Inc., 810 F.3d 913, 921-22 (4th Cir. 2016) (holding district
`
`court did not abuse its discretion by excluding evidence of disclosures to FDA because “having a
`
`‘mini-trial’” on “complex testimony about regulatory compliance” could “easily inflate the
`
`perceived importance of compliance and distract the jury from the central [design defect] question
`
`before it”).
`
`
`
`For these reasons, the Court should bar any reference to Reynolds’s VUSE products as
`
`being illegal or unlawful.
`
`II.
`
`THE COURT SHOULD EXCLUDE ANY REFERENCE TO YOUTH VAPING OR
`ALLEGED TARGETING OF VUSE PRODUCTS TO YOUTHS.
`
`The Court should also bar PM/Altria from referring to youth vaping or alleged targeting of
`
`VUSE products to youths, as these issues are unrelated to the matters that the jury must decide in
`
`this case (infringement and validity) and would unfairly prejudice Reynolds. PM/Altria has gone
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`to great lengths in its expert reports – including those of putative experts Stacy Ehrlich and Paul
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`Meyer – to highlight concerns over youth vaping, and to unfairly tie that issue to the VUSE
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`products. (Ex. 1 ¶¶ 128, 133-35; Amended & Supplemental Opening Expert Report of Paul K.
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`Meyer (4/26/2021), attached as Exhibit 2, ¶ 49.)4 Reynolds does not dispute, and indeed
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`wholeheartedly agrees, that use of tobacco products in any form by youths is a concern in this
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`4 PM/Altria’s experts then go on to tout the IQOS products as allegedly being less popular
`with underage tobacco consumers. As discussed in Reynolds’s Motion in Limine No. 11, evidence
`about the IQOS products is categorically irrelevant to the issues in this trial and should be barred.
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 15 of 19 PageID# 21583
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`country, and one that impacts Reynolds, PM/Altria, and every other company who markets or sells
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`tobacco products. But this patent trial is hardly the appropriate venue to dissect this complex,
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`multi-faceted, nationwide health concern.
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`First, there is no colorable argument that evidence about youth usage of VUSE products
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`(or any e-cigarettes) is relevant to the infringement or validity issues that the jury will decide in
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`this case. It is not. The patent claims at issue are directed to the components of an e-cigarette
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`device; they have nothing whatsoever to do with the marketing, sale, or use of that device by any
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`person, regardless of age. PM/Altria may claim that such evidence is relevant to damages, but that
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`too is wrong. The patent claims at issue are apparatus claims directed to e-cigarette devices; they
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`are agnostic about the end-user, old or young. Even if PM/Altria could argue that the patents relate
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`in some way to safety features (they do not), those features would benefit all users equally.
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`PM/Altria certainly does not argue that its own patented features make its claimed e-cigarette
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`device more attractive to youth users in particular. Absent such an argument, there is no
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`conceivable way in which evidence about youth use of the accused VUSE products could bear on
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`the value of the asserted patents for damages purposes.
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`Second, allowing PM/Altria to raise the issues of youth vaping or the alleged targeting of
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`VUSE products to youths will unfairly prejudice Reynolds by inflaming the jury and will result in
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`a waste of time that distracts from the core issues of this case. “Evidence is unfairly prejudicial
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`and thus should be excluded under Rule 403 ‘when there is a genuine risk that the emotions of a
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`jury will be excited to irrational behavior, and … this risk is disproportionate to the probative value
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`of the offered evidence.’” United States v. Williams, 445 F.3d 724, 730 (4th Cir. 2006) (citation
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`omitted); see also United States v. DesAnges, 921 F. Supp. 349, 359 (W.D. Va. 1996) (“Evidence
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`that tends to inflame the jury or lead to decisions based on emotion carries a greater danger of
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 16 of 19 PageID# 21584
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`unfair prejudice.”). There is no doubt that youth use of e-cigarettes and other tobacco products is
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`a concern in this country, and one that provokes strong feelings. This issue has been widely
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`covered in the media, is the subject of numerous lawsuits against the tobacco industry, and is
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`central to enacted or proposed legislation in virtually every state in the country. Indeed, Altria’s
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`JUUL line of vaping products has been at the forefront of such challenges. See, e.g., Sheila Kaplan,
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`Juul to Pay $40 Million to Settle N.C. Vaping Case, New York Times (June 28, 2021),
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`https://tinyurl.com/2mjv56w2 (attached as Exhibit 3). But the strong feelings that one might have
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`around youth use of vaping products, however justified, have no place in this trial. This sort of
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`evidence and argument has no purpose other than to turn the jurors against Reynolds and to
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`encourage them to decide the case on grounds completely unrelated to infringement or validity.
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`The Court should not allow it. See United States v. Seko, No. 1:15CR301 (JCC), 2017 WL
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`1369070, at *3 (E.D. Va. Apr. 10, 2017) (holding video showing defendant throwing money
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`inadmissible because prejudice arises from the videos’ ability to inflame the passions of the jury,
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`who may rightly or wrongly conclude that the money being thrown around by defendant originated
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`from the victim homeowners); see also Am. Home Assurance Co. v. Merck & Co., 462 F. Supp.
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`2d 435, 446 (S.D.N.Y. 2006) (granting Merck’s motion to exclude any reference to Vioxx in a trial
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`involving whether Merck was entitled to coverage under a transit insurance policy because “the
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`Vioxx litigation has received considerable public attention” and thus “repeated references to Vioxx
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`w[ould] prejudice the trier of fact”).
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`Beyond being inflammatory, allowing PM/Altria to raise youth vaping and alleged
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`targeting of VUSE products to youths would also result in a significant delay of trial proceedings
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`as both parties debated the truth of such claims. Allowing such evidence would turn the issue into
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`a “mini-trial,” taking time away from the substantive issues of the case and confusing jurors about
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`Case 1:20-cv-00393-LO-TCB Document 829 Filed 01/21/22 Page 17 of 19 PageID# 21585
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`what issues they must decide. This is yet another reason that such evidence should be barred. See
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`C.R. Bard, 810 F.3d at 921-22; Smithfield Foods, 2008 WL 4610305, at *2; Bilenky, 2014 WL
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`12591940, at *7.
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`III. THE COURT SHOULD EXCLUDE ANY REFERENCE TO THE ALLEGED
`HEALTH RISKS OF VAPING.
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`For the same reasons, the Court should also bar PM/Altria from introducing evidence or
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`argument about the alleged health risks of using e-cigarettes. PM/Altria includes allusions to such
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`risks in certain of its expert reports, but such evidence has no place in this trial. Whether e-cigarette
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`products have health risks, what those risks are, or how those risks compare to use of combustible
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`cigarettes have