Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 1 of 20 PageID# 32813
`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 1 of 20 PagelD# 32813
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 2 of 20 PageID# 32814
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`Planet Depos0
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`We Make It Happen ™
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`Confidential
`Transcript of James Figlar, Ph.D.
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`Date: June 3, 2022
`Case: RAI Strategic Holdings, Inc. -v- Altria Client Services, LLC, et al.
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`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
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`

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`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
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` A P P E A R A N C E S
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`ON BEHALF OF RAI STRATEGIC HOLDINGS, INC. and
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`R.J. REYNOLDS VAPOR COMPANY:
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` MR. MICHAEL S. QUINLAN
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` JONES DAY
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` 901 Lakeside Avenue
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` Cleveland, Ohio 44114-1190
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` 216.586.3939
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` msquinlan@jonesday.com
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`ON BEHALF OF ALTRIA CLIENT SERVICES LLC; PHILIP
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`MORRIS USA INC.; and PHILIP MORRIS PRODUCTS S.A.:
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` MR. CLEMENT NAPLES
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` LATHAM & WATKINS, LLP
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` 1271 Avenue of the Americas
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` New York, New York 10020
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` IN THE UNITED STATES DISTRICT COURT
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` FOR THE EASTERN DISTRICT OF VIRGINIA
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` Alexandria Division
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`RAI STRATEGIC HOLDINGS, :
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`INC. and R.J. REYNOLDS :
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`VAPOR COMPANY, :
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` Plaintiffs/ :
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` Counterclaim Defendants, : Case No.
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` v. : 1:20-cv-00393-LO-TCB
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`ALTRIA CLIENT SERVICES LLC; :
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`PHILIP MORRIS USA INC.; and :
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`PHILIP MORRIS PRODUCTS S.A., :
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` Defendants/ :
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` Counterclaim Plaintiffs. :
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` CONFIDENTIAL
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` VIDEOTAPED DEPOSITION of JAMES FIGLAR, Ph.D.
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` Reported By: Michelle M. Yohler, CSR, RMR, CRR
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` (Continued)
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` A P P E A R A N C E S C O N T I N U E D
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`ALSO PRESENT:
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` Remote videotaped 30(b)(6) deposition of RAI
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`STRATEGIC HOLDINGS, INC., and R.J. REYNOLDS VAPOR
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`COMPANY by JAMES FIGLAR, Ph.D., held remotely
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`pursuant to notice before Michelle M. Yohler, CSR,
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`RMR, CRR, a certified shorthand reporter,
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`CSR No. 84-4531.
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`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
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` THE VIDEOGRAPHER: The court reporter
`today is Michelle Yohler representing Planet
`Depos.
` Would the court reporter please swear in
`the witness.
` (WHEREUPON, the witness was duly sworn.)
` JAMES FIGLAR, Ph.D.,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MR. NAPLES:
` Q Good afternoon for you, Dr. Figlar, is
`that right?
` A That is correct.
` Q You're still --
` A Good morning to you all.
` Q So you're still in Italy?
` A Correct.
` Q Can you tell me precisely when you retired
`from Philip Morris?
` A I never --
` MR. QUINLAN: Objection --
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` E X A M I N A T I O N S
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`WITNESS PAGE
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`JAMES FIGLAR, PH.D.
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` By Mr. Naples............................ 7
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` By Mr. Quinlan........................... 164
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` P R O C E E D I N G S
` (Technician read-on.)
` THE VIDEOGRAPHER: Here begins Recording
`Number 1 in the videotaped deposition of Dr. James
`Figlar in the matter of RAI Strategic Holdings,
`Inc., et al., versus Altria Client Services LLC,
`et al., held in the United States District Court
`for the Eastern District of Virginia, Alexandria
`Division, Case Number 1:20-cv-00393-LO-TCB.
` Today's date is June 3rd, 2022. The time
`on the video monitor is 6:54 a.m. Central U.S.
`Time.
` The videographer today is RJ Buckler,
`CLVS, representing Planet Depos.
` This video deposition is taking place
`remotely via Zoom.
` Would counsel please voice-identify
`themselves and state whom they represent.
` MR. NAPLES: Clement Naples for Philip
`Morris/Altria plaintiffs from Latham & Watkins.
` MR. QUINLAN: Mike Quinlan from Jones Day
`on behalf of Reynolds.
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`BY THE WITNESS:
` A I never retired from Philip Morris.
`BY MR. NAPLES:
` Q Let me reask the question.
` Can you tell me precisely when you retired
`from Reynolds?
` A In essence, the last day of December 2020.
`I guess my official date was maybe the second day
`of January 2021, but basically the end of the year
`2020.
`0
` Q Okay. And since you've retired, have you
`11
`continued to work for Reynolds?
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` MR. QUINLAN: Object to form.
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`BY THE WITNESS:
`14
` A For the purposes of this litigation that
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`began before my retirement and I agreed to be the
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`corporate representative for Reynolds for this
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`litigation, I have maintained a type of employment
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`for the sake of this case. So in that sense, yes.
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`But am I receiving regular compensation from
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`Reynolds? No, it's separate and apart solely for
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`this litigation.
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 5 of 20 PageID# 32817
`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`33
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`9 (33 to 36)
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`cigarettes, smokeless products, vapor products.
` So they -- I think the -- our thinking is
`the agency wants to make an overall decision on
`menthol products as it regards -- as it applies to
`tobacco products in total, and so we think they're
`going to probably make that decision, and then
`either move to deny or accept the menthol portions
`of those applications.
`BY MR. NAPLES:
` Q And what's your understanding of what the
`FDA's concern is about menthol products?
` MR. QUINLAN: Object to form.
`BY THE WITNESS:
` A Well, I mean, there certainly -- there
`have been scientific questions and calls from
`legislatures and public health groups that -- that
`menthol is potentially more harmful than -- than
`non-menthol products.
` Now, from a scientific perspective, I'm --
`my opinion is the science doesn't justify that,
`but, nonetheless, it is up to the agency to
`wrestle with those questions. And they're going
`36
`to have to come to a decision about whether or not
` Q Okay. And you said that for the Solo,
`they think it's appropriate or not appropriate to
`Ciro, and Vibe, the tobacco flavors have been
`have menthol in those products.
`cleared --
` A They have.
` We can offer up our opinion, we can talk
`about the science, but ultimately it's going to be
` Q -- isn't that right?
` A That's correct.
`up to the FDA at this point to make decisions on
`menthol.
` Q But the menthol flavors have not been
`BY MR. NAPLES:
`cleared?
` A They had -- they are still in review. So
` Q Is it your opinion that menthol is equally
`they haven't been denied; they are in -- they're
`as safe as non-menthol tobacco products?
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`still under review.
`
` A Yeah, I mean, my --
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` Q Do you know why the menthol flavors are
` MR. QUINLAN: Object to form.
`12
`still in review for the Vuse PMTAs?
`BY THE WITNESS:
`13
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` A Yeah, we --
` A My understanding of the science is menthol
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`products are no more dangerous than non-menthol
` MR. QUINLAN: Object to form.
`15
`products. They're no more -- in my opinion,
`BY THE WITNESS:
`16
` A -- talked a little bit about -- we talked
`they're no more addictive than non-menthol
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`a little bit about that. I mean, I don't -- I'm
`products. They do offer a different taste
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`not -- I don't work for the FDA, and I never have,
`profile.
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`but my understanding is the FDA is reviewing
` But, nonetheless, there are others in the
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`menthol in total for tobacco products. So that
`scientific community that don't agree with that.
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`would include everything -- right? -- burn-down
`And there is a lot of science that's been
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`888.433.3767 | WWW.PLANETDEPOS.COM
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`none of the Alto products had been cleared by the
`FDA, correct?
` A Alto? No. We had -- the day that I
`retired, there were no -- no vapor products or
`e-cigarette products had been cleared by the
`agency in total --
` Q Right.
` A -- they hadn't -- they hadn't authorized
`anything.
` Q So as of the date you retired, certainly
`the -- the Solo, the Vibe, the Ciro, and the Alto,
`none of those had been cleared by the FDA,
`correct?
`
` A The day that I -- that's correct.
` Q And you learned that they had
`been -- cleared at least, the Solo, the Vibe, and
`the Ciro -- after you retired; is that right?
`
` A Correct.
` Q And you said the Alto is still not
`cleared, correct?
` A Alto is still in scientific review is my
`understanding.
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`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`37
`generated on menthol, and the FDA is going to have
`to slog through all that and make a decision that
`they think is appropriate for the public so --
`BY MR. NAPLES:
` Q Does Reynolds --
` A -- so -- I'm sorry, that's basically --
`that's the gist of the situation, and that's in
`FDA's court now.
` Q Has Reynolds done any studies on who uses
`menthol products?
` A I think --
` MR. QUINLAN: Object to form --
`BY THE WITNESS:
` A -- we have --
` MR. QUINLAN: -- beyond the scope.
` Sorry, Dr. Figlar.
` THE WITNESS: That's okay. I should wait
`a little bit but I'm just kind of answering
`questions.
`BY THE WITNESS:
` A No, the -- Reynolds has done those
`studies. I mean, we have to do those studies for
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` The -- what -- the questions that Reynolds
`would be interested in and FDA is interested in is
`would a menthol -- so, for instance, would a Vuse
`menthol product be more likely to attract a smoker
`who has quit to come back and start using vapor
`products as a for-instance. FDA is intimately
`concerned about that.
` So we would conduct surveys to try to make
`those types of determinations and a series of
`other kind of social science questions that the
`FDA is interested in.
` So that's the kind of information where
`we'd be talking about collecting on menthol or,
`frankly, any other flavor that we wanted to try to
`get cleared through the FDA.
`BY MR. NAPLES:
` Q Did -- did Reynolds determine that youths
`are more likely to use menthol products than
`non-menthol products?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`
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`10 (37 to 40)
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`the purposes of the PMTAs.
` So FDA is interested and requires us
`through their guidance to understand who uses
`products. That's all part of the abuse liability
`testing that we have to do as a company. And as
`part of the abuse liability protocols that we go
`through when we do the PMTA applications. So we
`have to make those studies.
` And the FDA asks you those questions,
`right? I mean, they want to know who's more --
`who's more likely to use these products and why.
`And so you have to conduct that kind of work. So
`we have done -- we have done that.
`BY MR. NAPLES:
` Q And what was Reynolds' conclusion about
`who uses menthol products?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A I mean, I'm not sure what you're -- what
`you're asking me. I mean, people who use menthol
`products are people who like menthol.
`
`BY THE WITNESS:
` A Reynolds does not -- we don't test youth,
`and that is a -- we don't do any of our survey
`work with underage people. That is not part of
`our policies.
` What -- and it's a difficulty for
`Reynolds -- right? It's a difficulty for Altria
`as well. Because the FDA wants to know whether or
`not younger people, underaged people are going to
`use products. And so the problem for Reynolds
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`when it comes to that is we're not going to do
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`that research -- right? -- because we're not going
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`to talk to underage people.
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` So what we ask the FDA is we ask them:
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`Are you compelling us to ask these questions of
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`underage people?
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` And FDA said: No. No. We're not
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`compelling you.
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` But what the FDA allowed us to do in all
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`of our applications we do -- this is allow for a
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`young adult, cohorts of people, to represent
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`younger people. In other words, whether at the
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 7 of 20 PageID# 32819
`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`41
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` I just want to note that for the record
`BY MR. NAPLES:
`and objection, beyond the scope.
` Q Did Reynolds make any -- reach any
`BY THE WITNESS:
`conclusions about whether using its, kind of,
` A Can you -- can you rephrase your question,
`surrogate analysis for youth, whether youth are
`Counselor.
`more likely to use menthol than regular tobacco
` MR. NAPLES: Can I get the question read
`products?
`back, please.
` MR. QUINLAN: Object to form. Beyond the
` (WHEREUPON, the record was
`scope.
`read by the reporter.)
`BY THE WITNESS:
` A Again, my recollection of the data is the
`BY THE WITNESS:
`0
` A Not that I'm aware of. I mean, we're
`answer to that would be, no, that the likelihood
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`obviously aware of demographic information with
`was the same. Especially with regard to people's
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`regard to menthol cigarettes, non-menthol
`preferences going into the survey, right? So --
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`cigarettes, vapor products, et cetera, but we
`BY MR. NAPLES:
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`don't typically collect that information; that
` Q Understood. Let me pause you there for a
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`stuff is known in the literature. So --
`second, Dr. Figlar.
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`BY MR. NAPLES:
`
` A Okay.
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` Q So, Dr. Figlar, what --
` Q Did -- did Reynolds reach any conclusions
`18
` MR. QUINLAN: Objection. Objection.
`about whether any particular class of people is
`19
`Objection. Objection. Mr. Naples, I let you cut
`more likely to use menthol than regular tobacco
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`him off once. You've now cut him off again. The
`products?
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`witness was obviously not finished with his
` MR. QUINLAN: Object to form. And before
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`you answer, Dr. Figlar, Mr. Naples, we offered
`this deposition so that you could learn about the
`conversations that Dr. Figlar had with his
`colleagues. This isn't an opportunity for you to
`ask Dr. Figlar questions you could have asked him
`at his past two depositions.
` I'm going to give you leeway. I'm not
`trying to cut you off. I'm not trying to shut you
`down. But, as Dr. Figlar said, he's got to get on
`a plane tomorrow morning. You know, it's 2:00
`where he is, now 2:30. We're not going to go for
`eight hours today to have you ask whatever
`question you feel like you want to ask about
`whatever topic you feel like you want to ask him
`about.
` We offered him up so you can learn about
`the conversations. I've given you plenty of
`leeway so far. I just want to note for the record
`that we're not going to do this all day.
`Dr. Figlar is not going to stay here until
`10:00 p.m. his time. He's got to get ready to
`travel for this trial tomorrow.
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`time if it was 18 or 21-year-olds, so if we
`surveyed a group of 21-year-olds, we would be able
`to use that data as a -- as a substitute or a
`surrogate for underage people in terms of our
`applications and in terms of who would use
`products with the FDA.
` And so that's how we try to make those
`determinations, and that's what we have done when
`we try to look at who -- who would be using
`products, are these more likely to be used by
`younger people, older people, et cetera.
` And so that's why I think -- you know,
`personally I think the menthol question for FDA is
`a global question for them because if they thought
`that younger people were using, say, Vuse Solo
`menthol more than older people would, they would
`have just rejected the menthol portion of the
`application rather than keeping it in scientific
`review. Same for Ciro and same for Vibe.
` So I think -- I kind of think that's where
`the situation is, but we will see moving forward.
`
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`

`

`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`45
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`12 (45 to 48)
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`BY MR. NAPLES:
` Q But are you aware of any targeted
`advertising of menthol products to
`African-Americans by Reynolds?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A Currently, no, I don't know -- I don't
`know of any of that. And I'm not a marketing
`person, so no.
`BY MR. NAPLES:
` Q Historically are you aware of any targeted
`marketing of menthol products to African-Americans
`by Reynolds?
` MR. QUINLAN: Object to form.
` Mr. Naples, what are we doing here? I
`mean, we're talking about historical targeted --
`potential targeted marketing of African-American
`menthol combustible cigarette smokers?
` We are so far afield from the topics that
`Dr. Figlar is going to testify at this trial, that
`he's been designated as a 30(b)(6) topic on, that
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`answer. Dr. Figlar, if you could -- Mr. Naples,
`if you could please let Dr. Figlar finish his
`answers.
` Dr. Figlar, continue.
`BY THE WITNESS:
` A I mean, all I was going to say is
`we -- Reynolds is aware of the scientific
`literature on smoking demographics. We don't
`necessarily collect that information, but we're
`aware of studies that happen all throughout the
`United States and globally.
` So we're aware of the -- of what -- of
`what is talked about.
`BY MR. NAPLES:
` Q And what demographic information are you
`aware of with respect to the use of menthol
`tobacco products, Dr. Figlar?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A My understanding is that -- well, the
`current demographics in the U.S. is menthol
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`cigarettes are virtually more popular -- almost
`more popular than non-menthol cigarettes at this
`point. That has been moving in that direction for
`probably a couple of decades.
` Historically, African-Americans have
`leaned towards using menthol products more than
`non-menthol products. But all those demographics
`are -- are changing. But that's the -- that's
`kind of the current situation and the -- and the
`information that's available through scientific
`literature.
`BY MR. NAPLES:
` Q Does Reynolds market menthol products to
`African-Americans?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A We market our products to
`African-Americans, to Asian-Americans, to
`Caucasian-Americans, and we market our products to
`smokers, both menthol and non-menthol.
`
`
`are even relevant at all to this litigation. And
`this isn't what we offered him up for a
`deposition.
` So, again, I'm not telling you that you
`can't ask him questions about the conversations he
`had with his colleagues or reasonable follow-ups
`about those conversations, but now we're so far
`afield, how did we even get here?
` So, again, I object. We urge you to focus
`on the topics that are relevant to this deposition
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` So that's my objection.
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` MR. NAPLES: Can you read my question
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`back, please.
`14
` (WHEREUPON, the record was
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`read by the reporter.)
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`BY THE WITNESS:
`17
` A By -- look, by Reynolds, I'm not exactly
`18
`sure. Look, we're going back in history, tobacco
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`litigation history, and smoking and health
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`litigation stuff. I haven't thought about those
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 9 of 20 PageID# 32821
`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`49
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`13 (49 to 52)
`
`51
`menthol and non-menthol cigarettes in many of the
`cases I've testified in.
`BY MR. NAPLES:
` Q And you've testified in over 100 product
`liability actions involving cigarettes for
`Reynolds, correct?
` A I don't know if the number is that. I
`mean, I've done probably over 100 depositions. I
`think I have testified in about 40, 45 cases in
`person. The number --
` Q What's the -- sorry. Go ahead.
` A The number of individual cases, Counselor,
`I'm not -- I'm not sure what the number is.
` Q What's the difference between testifying
`in a case and having your deposition taken in a
`case?
`
` A Well --
` MR. QUINLAN: Object to form.
`BY THE WITNESS:
` A -- there's -- there's been many times
`where I've been deposed for cases but I don't get
`called to testify in person. That happened many
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` My understanding, or at least certainly
`the accusation is, all the companies have been
`accused of target-marketing of a variety of
`different groups.
` So, again, I'm not a marketing guy, and
`I'm not the one that would really be an expert on
`historical marketing of cigarettes, so you might
`have to go look somewhere else for those -- those
`answers.
`BY MR. NAPLES:
` Q Has Reynolds ever been accused of
`targeting African-Americans with menthol tobacco
`products?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A I'm pretty sure Reynolds and Altria and
`Lorillard and all of the historical companies have
`been accused of -- of target-marketing, whether
`it's to African-Americans or to youth marketing or
`all that stuff has been accused of the industry
`over the -- over the history.
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`BY MR. NAPLES:
`times. I've also --
`BY MR. NAPLES:
` Q Now, you've test- --
` A Of all the companies.
` Q You haven't -- sorry.
` A Sorry. I've also done wholesale
` Q You've testified in a number of product
`depositions for, like, all of Duval County for all
`liability cigarette litigations, correct?
` A As a scientist, yeah, but not as a
`the cases that would happen in Duval County. So,
`marketing expert. So I've talked about smoking
`you know, there's been a variety of those types of
`and health-related issues for a variety of trials,
`depositions.
`but I focused on smoking and health-related
` But not in every -- and sometimes the
`issues. I have not been the person that talks
`lawyers don't want to bring a company witness for
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`about marketing because I'm not a marketeer. So
`their particular case, but they'll run -- they'll
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`that's not my -- that's not my area of expertise.
`do a deposition and they'll play video in court as
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`opposed to having a person there.
` Q And did any of the product liability
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`
` So that's the difference.
`actions you testified in for Reynolds involve
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`menthol cigarettes?
` Q In those product liability cases, did any
`15
` MR. QUINLAN: Object to form. Beyond the
`of those involve flavored cigarettes?
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`scope.
` MR. QUINLAN: Object to form. Beyond the
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`BY THE WITNESS:
`scope.
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` A I think the answer to that is, yes,
`BY THE WITNESS:
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`they -- they had -- in almost every case, the
`
` A No. Not that I'm aware of, no.
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`smoking and health litigation, there's a -- a
` I mean, the subject would have come up,
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`smoker typically will claim that they smoked both
`but they didn't -- no one would have claimed that
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 10 of 20 PageID# 32822
`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`53
`
`they smoked a flavored cigarette for their
`liability case that I can recall.
` MR. NAPLES: Can we take a short
`five-minute break? I'm just -- someone's
`knocking. I just want to make sure -- there's,
`like, a whole thing going on outside this -- this
`conference room. I just want to deal with that.
` Or we can take a five, ten-minute break,
`whatever you guys want to do.
` THE WITNESS: That's fine.
` THE VIDEOGRAPHER: Okay. I'll bring us
`
`off.
` The time is 7:41. We're going off the
`record at the end of Recording 1.
` (WHEREUPON, a recess was had.)
` THE VIDEOGRAPHER: The time is 7:51.
`We're on the record at the start of Recording 2.
`BY MR. NAPLES:
` Q So, Dr. Figlar, I think you had said at
`the break that none of the cases you testified in
`involved flavored cigarettes; is that right?
`
` A Not -- not as --
`
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`BY THE WITNESS:
` A No, I'm not an expert, but I am a
`scientist, so I do have, you know, a decent
`understanding of physics and some engineering and
`obviously chemistry, so -- you know, I used to
`direct a group of about 400 people, which
`consisted of biologists, toxicologists, engineers,
`mathematicians, chemists, et cetera, so I have
`a -- I have a working knowledge of many fields of
`science.
`BY MR. NAPLES:
` Q Fair enough.
` Okay. But you're not an expert in fluid
`dynamics, right?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A I would not say I'm an expert in fluid
`dynamics, no.
`BY MR. NAPLES:
` Q Now, if the -- the Vuse products in this
`case were not cleared by the FDA, then Reynolds
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` MR. QUINLAN: Object to form.
`BY THE WITNESS:
` A -- the main subject that I recall, no.
`BY MR. NAPLES:
` Q Okay. Now, have you ever testified in a
`patent case?
` A Well, I testified in the ITC case, which
`is a patent case, so yes.
` Q Is that the only time you've ever
`testified in a patent case?
`
` A That I'm aware of, yeah.
` Q And you didn't serve as an expert in that
`case on infringement or validity, correct?
`
` A I don't think so, no.
` Q You never testified in any case a -- a
`patent -- any patent case as an expert in
`infringement or validity, correct?
`
` A Not in a patent case, no.
` Q You're not an expert in fluid dynamics,
`right?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`
`would have to take them off the market, correct?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A Well, again, I thought -- I guess with the
`exception of Alto, yes. But the Vuse products
`that, as I recall are in this case, Ciro, Vibe,
`and Solo have all been cleared. So Alto would be
`the only one that remains at large.
`BY MR. NAPLES:
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` Q Sure. Ciro, Vibe, and Solo have been
`11
`cleared by the FDA for sale, correct?
`12
` A They have. And as I recall from our
`13
`earlier depositions, those were the products that
`14
`were most -- of most interest in -- in these
`15
`cases, with maybe one exception.
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` But they were -- they were chiefly
`17
`involved, as I recall. I mean, you can correct
`18
`me, but that's what I remember.
`19
` Q I'm just asking you that -- just
`20
`confirming, the Ciro, the Vibe, and the Solo,
`21
`those have all been cleared for sale by the FDA,
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 11 of 20 PageID# 32823
`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
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`correct?
` A Correct. Alto has not, that is correct.
` Q Now, if the Vuse Ciro and Solo were not
`cleared by the FDA, Reynolds would not be able to
`sell them in the U.S., correct?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A That would be the law. That's the
`regulation, yeah, but that's -- obviously didn't
`happen, but that would be the case.
`BY MR. NAPLES:
` Q Now, Alto is not cleared yet, correct?
` A It is not cleared yet; that is correct.
` Q Now, if the FDA clears the Alto, Reynolds
`will be able to continue to sell it, correct?
` MR. QUINLAN: Object to form. Beyond the
`scope.
`BY THE WITNESS:
` A Well, they're able to sell it now and
`continue to sell it now because that's what FDA
`has stated with regard to enforcement discretion.
`58
`The products were on sale prior to the deadline,
`September of 2020, and FDA said they will not use
`their enforcement discretion for products that
`are -- that had lawfully filed a PMTA, which we
`did, within the deadline.
` So while the product is not -- they
`haven't rendered a conclusion on Alto yet, it is
`still able to be legally sold in the United
`States.
`BY MR. NAPLES:
` Q Understood.
` Now, if the FDA decides it's not going to
`clear the Alto for sale in the U.S., then Reynolds
`will have to take that product off the market,
`correct?
` MR. QUINLAN: Object to form.
`BY THE WITNESS:
` A That would be the law, correct.
`BY MR. NAPLES:
` Q So is it fair to say that, absent FDA
`clearance for the sale of these products, Reynolds
`has to take them off the market?
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` MR. QUINLAN: Object to form. Asked and
`answered at every depo you've taken of Dr. Figlar,
`and it's beyond the scope of this depo.
`BY THE WITNESS:
` A I'm not quite -- absent --
`BY MR. NAPLES:
` Q FDA --
` A -- I don't -- I'm not quite sure I
`understand how you worded that question.
` I mean, look, I think at the end of the
`day, if the FDA -- either the FDA is going to
`authorize the products to continue to be sold or
`they're not.
` If they do, Reynolds is going to continue
`to sell Alto. If they do not, then Reynolds
`will -- will go through their full process --
`okay? -- because they have due process with regard
`to, you know, asking for administrative review,
`blah, blah, blah, blah. But at the end of the
`day, if the FDA still refuses to authorize the
`product, they won't be able to sell it in the
`United States.
`
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` Q So absent FDA authorization, Reynolds
`cannot keep the Vuse products on the market,
`correct?
` MR. QUINLAN: Object to form.
`BY THE WITNESS:
` A No. No. They don't have authorization
`now. They have the -- FDA has not rendered a
`decision on Alto. The FDA says they will not
`exercise enforcement discretion on products that
`were legally sold in the United States if the
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` Reynolds did that so, therefore, the
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`14
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`15
`application. They have not rendered a decision on
`16
`the application so, therefore, Reynolds can
`17
`continue to sell that product until such a
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` Is that clear enough?
`20
`BY MR. NAPLES:
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` Q It is. It is. Sorry it's a bad question.
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`Case 1:20-cv-00393-LO-TCB Document 1273-1 Filed 06/06/22 Page 12 of 20 PageID# 32824
`Confidential
`Transcript of James Figlar, Ph.D.
`Conducted on June 3, 2022
`61
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`
`63
`
` So that's what you're trying to establish
`in these PMTAs is whether or not they're
`appropriate -- w