`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, DC
`
`Before the Honorable Bryan F. Moore
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN BOTULINUM TOXIN
`PRODUCTS AND PROCESSES FOR
`MANUFACTURING OR RELATING TO
`SAME
`
`Investigation No. 337-TA-1313
`
`RESPONDENTS’ RESPONSE COMPLAINANT’S MOTION IN LIMINE NO. 2
`TO EXCLUDE TESTIMONY AND EXHIBITS FROM THE INITIAL WITNESS
`STATEMENT OF JULIAN PARKHILL, PH.D. (RX-0005C) (Mot. No. 1313-029)
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`I.
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`INTRODUCTION
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`Pursuant to 19 C.F.R. §§ 210.37, and Ground Rule 6.4.3, 9, 13.6.6, Respondents Hugel
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`Inc., Hugel America, Inc. (collectively, “Hugel”), and Croma Pharma GmbH (“Croma”)
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`(together “Respondents”) respectfully submit this response to Complainant’s Motion in Limine
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`No. 2 to preclude Respondents’ expert Dr. Julian Parkhill from relying on certain exhibits and to
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`exclude the portions of Dr. Parkhill’s questions and answers and demonstratives that reference
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`those exhibits (“Compl. MIL 2”).
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`In order to streamline the issues, Respondents hereby withdraw the portions of Q/A 174
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`from Dr. Parkhill’s witness statement and RDX-0005C.014 that reference RX-0662 and RX-
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`0663 and the portions of Q/As 66 and 76 that reference RX-1060 and RX-1139 as shown in the
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`highlighted version of RX-0005C attached as Appendix A. A revised version of RDX-
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`0005C.014 is also attached as Appendix B. Medytox’s motion with respect to these Q/As is
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`therefore moot. However, these exhibits should remain available for Respondents to use on
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`1
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`cross-examination because they are proper cross exhibits. Nor has Medytox asked to strike the
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`exhibits themselves.
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`As Respondents have alerted Medytox and the Staff, the citation to RX-0823 in Q/A 41
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`of Dr. Parkhill’s witness statement is a typographical error; the reference should have been to
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`RX-0029C (Kyu Hwan Yang deposition designations).1 Respondents will correct this in Dr.
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`Parkhill’s amended witness statement along with updated citations to joint exhibits pursuant to
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`the attorney advisor’s request.
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`Finally, the ALJ should deny Complainant’s motion as it pertains to Q/As 167-168
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`referencing RX-1142 and Q/A 154 referencing RX-1173 and RX-1174 for the reasons set forth
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`below.
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`II.
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`ARGUMENT
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`The subject matter of Q/As 167-168—the likelihood of leaks or escapes of C. botulinum
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`and other laboratory strains into the environment—was disclosed in Dr. Parkhill’s expert report
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`and discussed extensively at his deposition. See, e.g., CX-0160C.0023, .0026-28 (Parkhill
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`Expert Report) at ¶¶ 89, 93-104; see, e.g., Appendix C (Parkhill Dep. Tr.) at 35:5-12, 36:9-37:9,
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`107:20-109:7, 109:22-112:1, 116:18-22, 130:12-131:4, 160:22-161:13, 163:16-165:13, 230:13-
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`24. RX-1142 is a review article discussing laboratory leaks published December 22, 2023.
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`Compl. MIL 2, at Ex. G. RX-1142 is powerful, independent evidence consistent with Dr.
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`Parkhill’s opinion that laboratory leaks are “not only possible, but ha[ve] demonstrably occurred
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`on many occasions.” CX-0160C.0025 (Parkhill Expert Report) ¶ 93. Because this review article
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`was published after Dr. Parkhill submitted his expert report and testified at deposition, Dr.
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`1 Dr. Parkhill cited the Yang deposition transcript in his expert report at paragraph 99, notes 82-
`83. See CX-0160C.0026 (Parkhill Report).
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`2
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`Parkhill could not have cited it on those occasions. Therefore, Dr. Parkhill’s discussion of RX-
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`1142 is neither untimely nor improper and should not be foreclosed by Ground Rule 13.6.6. See
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`Certain Kinesiotherapy Devices and Components Thereof, Inv. No. 337-TA-823, Order No. 38
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`(Aug. 20, 2012) at 5-6 (“the purpose of [a rule similar to Ground Rule 13.6.6] is to give the
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`opposing party notification in advance of the hearing of the issues to be contested and the
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`substance of any expert opinions on those issues. In so doing, the rule confines the issues for
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`hearing and avoids prejudicial surprises.”).
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`Medytox’s objection appears limited to Dr. Parkhill’s citation of RX-1173 and RX-1174
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`in the fourth paragraph of Q/A 154, as highlighted in Appendix A. The remaining portions of
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`Q/A 154 are not challenged—a tacit admission by Medytox that the general subject matter is
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`found in Dr. Parkhill’s expert report or deposition testimony. See Compl. MIL 2, at 5. The
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`challenged portion of Q/A 154 cites RX-1173 and RX-1174 as support for Dr. Parkhill’s
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`statement that “the odds of C. botulinum ending up in canned goods… is unfortunately
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`common.” RX-001C.0046. This opinion itself is not new—it is found in Dr. Parkhill’s expert
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`report. CX-0160C.0028 at ¶ 104 (“it is quite possible for laboratory stains of C. botulinum to be
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`released into the environment”); CX-1053C.0010 (Parkhill Decl.) at ¶ 30 (it “cannot be excluded
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`that CBFC26… was isolated from a contaminated food source”). Thus, Medytox was on notice
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`of and questioned Dr. Parkhill at deposition on this opinion. See, e.g., Appendix C at 163:16-
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`165:13.
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`Moreover, RX-1173 and RX-1174 are an excerpt of the U.S. Centers for Disease
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`Control’s website and a publicly available journal article concerning C. botulinum in canned
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`foods, respectively. Compl. MIL 2, at Exs. H, I. Medytox’s motion does not articulate how Dr.
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`Parkhill’s citation of publicly available documents to support previously disclosed opinions
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`3
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`creates any prejudice to Medytox. Accordingly, because Dr. Parkhill’s opinion was disclosed
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`and Medytox has not been prejudiced, Medytox’s request to exclude the challenged portion of
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`Q/A 154 should be denied. See Certain Movable Barrier Operator Systems and Components
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`Thereof, Inv. No. 337-TA-1209, Order No. 22 at 4 (March 28, 2023) (denying motion to exclude
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`because the challenged Q/As were “not substantially different” than the expert’s previous
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`opinions and there was no prejudice to movant); see also Certain Liquid Crystal Display
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`Devices, Including Monitors, Televisions, and Modules, and Components Thereof, Inv. No. 337-
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`TA-749, Order No. 26 at 1-2 (August 30, 2011) (“[a]n expert may provide more detail in his
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`witness testimony, as long as the opinion at issue is fairly disclosed.”).
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`Finally, Dr. Parkhill’s Q/As 154 and 167-168 are directly responsive to the new opinions
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`regarding laboratory leaks that Dr. Keim expressed for the first time in his witness statement.
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`See EDIS Doc. ID 812636 (Resp. Mot. in Limine No. 3) at 5-6 (seeking to exclude CX-
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`0002C.58-59 (Keim WS) at Q/A 176-179, 181-182). They are also responsive to Dr. Lenski’s
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`new opinion expressed for the first time at his deposition in response to questions from
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`Medytox’s counsel that Hugel’s lab leak theory is “implausible to the point that it’s…
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`impossible.” Appendix D (Lenski Dep.) at 236:2-9; see also CX-0003C.19 (Lenski WS) at Q/A
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`92-93.2
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`Thus, Medytox chose not to address Hugel’s laboratory leak arguments in expert reports
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`but rather raised new arguments in deposition and trial testimony and is now moving to preclude
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`2 Ground Rule 13.6.6 allows an expert’s trial testimony to include deposition testimony.
`Accordingly, Hugel did not move to exclude Q/As 92-93 from Dr. Lenski’s witness statement.
`However, to the extent the ALJ agrees with Medytox’s argument that it is improper to use
`redirect questioning at a deposition to introduce entirely new opinions (see Compl. Mot. in
`Limine No. 4, EDIS Doc. ID 812657, at 3-4, citing Certain Wireless Mesh Networking Prod. &
`Related Components Thereof, Inv. No. 337-TA-1131, Order No. 33 (Aug. 30, 2019)), these Q/As
`should be excluded.
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`4
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`Respondents’ experts from responding to those new arguments. Fairness demands that
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`Respondents have the opportunity to present evidence rebutting Medytox’s belatedly disclosed
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`arguments. See Certain Reduced Ignition Proclivity Cigarette Paper Wrappers and Products
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`Containing Same, Inv. No. 337-TA-756, Order No. 29 (Oct. 31, 2011) at 7-8 (denying
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`complainant’s motion to exclude documents because “fairness requires” that respondents be
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`allowed to respond to complainants’ “belatedly espoused” contentions and “it would be an
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`injustice to limit the evidence to the assertions [of] one party’s experts when there are…
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`legitimate opposing contentions.”). The opinions and evidence supporting those opinions that
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`Medytox seeks to exclude from Dr. Parkhill’s witness statement will be helpful to Your Honor’s
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`weighing of the competing expert opinions.
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`III.
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`CONCLUSION
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`For the foregoing reasons, Respondents respectfully request that the Administrative Law
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`Judge deny Complainant’s Motion in Limine No. 2 to exclude Dr. Parkhill’s testimony in Q/As
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`167-168 that references RX-1142 and Q/A 154 that references RX-1173 and RX-1174.
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`Regardless of the ALJ’s decision on Complainant’s motion, exhibits RX-0662, RX-0663, RX-
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`0823, RX-1060, RX-1142, RX-1173 and RX-1174 should remain on Respondents’ exhibit list
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`for potential use on cross-examination.
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`5
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`

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`
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`Dated: February 1, 2024
`
`Respectfully Submitted,
`
`/s/ Stephanie L. Roberts
`Eric S. Namrow
`Stephanie L. Roberts
`Kandis C. Gibson
`Min Woo Park
`Emily K. Burge
`Morgan, Lewis & Bockius LLP
`1111 Pennsylvania Ave, N.W.
`Washington, D.C. 20004-2541
`Telephone: (202) 739-3000
`Facsimile: (202) 739-3001
`
`Krista Vink Venegas, Ph.D.
`Zachary D. Miller
`Morgan, Lewis & Bockius LLP
`110 N. Wacker Dr.
`Chicago, IL 60606
`Telephone: (312) 324-1775
`Facsimile: (312) 324-1001
`
`Tae-Woong Koo, Ph.D.
`Morgan, Lewis & Bockius LLP
`1400 Page Mill Road
`Palo Alto, CA 94304
`Telephone: (650) 843-4000
`Facsimile: (650) 843-4001
`
`Daniel Zaheer
`Kobre & Kim LLP
`150 California Street
`San Francisco, CA 94111
`Telephone: (415) 582-4800
`
`Michael Kim
`Benjamin Sirota
`Martine Forneret
`Kobre & Kim LLP
`800 3rd Avenue
`New York, NY 10022
`Telephone: (212) 488-1200
`
`6
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`

`

`
`
`Zach Ruby
`Kobre & Kim LLP
`1919 M Street, NW
`Washington, DC 20036
`Telephone: (202) 664-1950
`
`Daniel Lee
`Naomi Yang
`Kobre & Kim LLP
`9F, Tower B, The-K Twin Towers
`50, Jong-ro 1-gil, Jongno-gu
`Seoul, 03142 South Korea
`Telephone: +82 2 369 1212
`
`Counsel for Respondents Hugel, Inc. and
`Hugel America, Inc.
`
`By: /s/ Goutam Patnaik
`Goutam Patnaik
`David J. Shaw
`Tuhin Ganguly
`DESMARAIS LLP
`1899 Pennsylvania Avenue, NW
`Suite 200
`Washington, DC 20006
`Telephone: (202) 451-4900
`
`Counsel for Respondent Croma Pharma
`GmbH
`
`7
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`

`

`CERTAIN BOTULINUM TOXIN
`PRODUCTS AND PROCESSES FOR
`MANUFACTURING OR RELATING TO
`SAME
`
`CERTIFICATE OF SERVICE
`
`Inv. No. 337-TA-1313
`
`I, Nina Armah, hereby certify that on February 8, 2024, copies of the foregoing
`RESPONDENTS’ RESPONSE COMPLAINANT’S MOTION IN LIMINE NO. 2
`TO EXCLUDE TESTIMONY AND EXHIBITS FROM THE INITIAL WITNESS
`STATEMENT OF JULIAN PARKHILL, PH.D. - PUBLIC VERSION were served as
`follows:
`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, S.W.
`Washington, D.C. 20436
`
`☒ Via EDIS
`☐ Via Hand Delivery
`☐ Via Overnight Delivery
`☐ First Class Mail
`☐ Not Served
`☒ Via EDIS
`☒ Via Email/Box Upload
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`☒ Via Email
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`
`☒ Via Email
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`
`The Honorable Bryan F. Moore
`Administrative Law Judge
`U.S. International Trade Commission
`500 E Street, S.W., Room 317
`Washington, D.C. 20436
`Moore1313@usitc.gov
`
`Megan Wantland, Esq.
`Office of Unfair Import Investigations
`U.S. International Trade Commission
`500 E Street, S.W., Room 317
`Washington, D.C. 20436
`Megan.Wantland@usitc.gov
`Jeffrey Hsu, Esq.
`Office of Unfair Import Investigations
`U.S. International Trade Commission
`500 E Street, S.W., Room 317
`Washington, D.C. 20436
`Jeffrey.Hsu@usitc.gov
`Irina Kushner
`ALJ Attorney Advisor
`U.S. International Trade Commission
`500 E Street, S.W., Room 317
`Washington, D.C. 20436
`Irina.Kushner@usitc.gov
`
`Brian Gold
`ALJ Attorney Advisor
`U.S. International Trade Commission
`500 E Street, S.W., Room 317
`Washington, D.C. 20436
`Brian.Gold@usitc.gov
`
`

`

`Counsel for Complainant Medytox Inc.
`S. Alex Lasher
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`1300 I Street NW, Suite 900
`Washington, DC 20005
`alexlasher@quinnemanuel.com
`
`Nina Tallon
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`1300 I Street NW, Suite 900
`Washington, DC 20005
`David Bilsker
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`50 California Street, 22nd Floor
`San Francisco, CA 94111
`
`James E. Baker
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue, 22nd Fl
`New York, NY 10910-1601
`
`John Rhie
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`4501-03 Lippo Centre, Tower One
`89 Queensway, Admiralty
`Hong Kong
`qe-medytox-itc1313@quinnemanuel.com
`Counsel for Respondent Croma Pharma GmbH
`Goutam Patnaik
`David J. Shaw
`Tuhin Ganguly
`Peter Zhu
`Delon Lier
`DESMARAIS LLP
`1899 Pennsylvania Avenue, NW
`Suite 400
`Washington, DC 20006
`CromaMedytoxService@desmaraisllp.com
`
`☒ Via Email
`☐ Via Hand Delivery
`☐ Via Overnight Delivery
`☐ First Class Mail
`☐ Not Served
`
`☒ Via Email
`☐ Via Hand Delivery
`☐ Via Overnight Delivery
`☐ First Class Mail
`☐ Not Served
`
`/s/ Nina Armah
` Nina Armah
`
`2
`
`

`

`Confidential
`
`Exhibits
`
` Redacted
`
`Entirely
`
`