Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30381 Page 1 of 8
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`WILSON SONSINI GOODRICH & ROSATI P.C.
`PAUL D. TRIPODI II (SBN 162380)
`ptripodi@wsgr.com
`WENDY L. DEVINE (SBN 246337)
`wdevine@wsgr.com
`NATALIE J. MORGAN (SBN 211143)
`nmorgan@wsgr.com
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: 323-210-2900
`Fax: 866-974-7329
`
`Hilgers Graben PLLC
`MICHAEL T. HILGERS (Pro Hac Vice)
`mhilgers@hilgersgraben.com
`575 Fallbrook Blvd, Suite 202
`Lincoln, NE 68521
`Telephone: 402-218-2106
`Fax: 402-413-1880
`
`Attorneys for Plaintiff NuVasive, Inc.
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware
`)
`CASE NO.: 18-cv-00347-CAB-MDD
`corporation,
`)
`
`
`)
`
`PLAINTIFF NUVASIVE, INC’S
`)
`OBJECTIONS TO
`
`)
`DECLARATION OF KELLI
`)
`HOWELL IN SUPPORT OF
`
`)
`DEFENDANTS’ OPPOSITION TO
`)
`NUVASIVE, INC.’S MOTION
`ALPHATEC HOLDINGS, INC., a
`)
`FOR PARTIAL SUMMARY
`Delaware corporation, and ALPHATEC
`)
`JUDGMENT
`SPINE, INC., a California corporation,
`)
`(IMPLANT PATENTS)
`
`)
`Defendants.
`)
`
`)
`Judge: Hon. Cathy Ann Bencivengo
`)
`Magistrate Judge: Mitchell D. Dembin
`)
`
`
`Plaintiff,
`
`v.
`
`
`Plaintiff NuVasive, Inc. (“NuVasive”) hereby objects to the Declaration of
`Kelli Howell in Support of Defendants’ Opposition to NuVasive, Inc.’s Motion for
`Partial Summary Judgment (Implant Patents). Doc. No. 306-1.
`
`
`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`- 1 -
`
`18-cv-00347-CAB-MDD
`
`

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`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30382 Page 2 of 8
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`NuVasive’s Objections
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`SPECIFIC EVIDENTIARY OBJECTIONS TO HOWELL DECLARATION
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`¶ 1: “I make the following statements
`based on personal knowledge and if
`called to testify to them, could and
`would do so.”
`¶ 2: “I am the Executive Vice President,
`Clinical Strategies at Alphatec Spine,
`Inc. (“Alphatec”). I have held this
`position since I joined Alphatec in
`March 2018. Before that, I worked for
`NuVasive, Inc. (“NuVasive”) from
`November 1999 until March 2018.”
`¶ 3: “I held various positions during my
`tenure at NuVasive. I began at
`NuVasive as a Project Manager in 1999.
`From August 2000 to July 2005, I
`worked as a Clinical Research and
`Education Manager. I then served as the
`Director of Clinical Resources from
`July 2005 to July 2011. From July 2011
`to April 2012, I was the Senior Director
`of Clinical Resources. I then became the
`Vice President of Research in April
`2012 and the Vice President of
`Research and Education in February
`2015. Finally, I was the Vice President
`of Research and Health Informatics
`from January 2017 to March 2018.”
`¶ 4: “As part of my role as a Clinical
`Research and Education Manager, I was
`involved with NuVasive’s development
`and introduction of the XLIF procedure
`and accompanying lateral products,
`including the MaXcess retractor and
`CoRoent implants, and I documented
`aspects of the early procedures and uses
`of the lateral products. For example, I
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`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`- 2 -
`
`18-cv-00347-CAB-MDD
`
`

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`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30383 Page 3 of 8
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`Statement in Howell Declaration
`(Doc. No. 306-1)
`created a spreadsheet that collected data
`about procedures I had been notified
`about in late 2003 through 2004.
`Attached here as Exhibits A and B are
`true and correct copies of the
`spreadsheet I created that tracked these
`early procedures.”
`¶ 5: “As the title of the spreadsheet
`indicates, I collected information on
`“MaXcess XLIF-90 Surgeries.” Ex. A
`at NUVA_ATEC000115139. At a high
`level, this spreadsheet shows 145
`commercial XLIF surgeries conducted
`by 20 different surgeons between
`January 2003 and December 2004 for
`which NuVasive products were used.
`See Id. at NUVA_ ATEC000115141.
`As explained in more detail below,
`certain of those products that were
`commercially used are the CoRoent
`XL implants.”
`
`¶ 6: “My goal in collecting this
`information was to assess the
`procedural utility of these early
`surgeries. This was not a formal
`study, nor was it a clinical trial, but
`rather post-market research on
`NuVasive’s early products. If
`NuVasive had conducted a clinical trial,
`I would have been aware of it. The
`hospital and surgeon would have
`purchased the implants for an XLIF
`procedure from NuVasive.1 Once I
`learned that the surgery had been
`performed, I worked in collaboration
`with the NuVasive representative who
`
`NuVasive’s Objections
`
`Lack of Foundation [FRE 602].
`There is no foundation or explanation
`of Ms. Howell’s claims regarding the
`“commercial XLIF surgeries” or use
`of the CoRoent XL implants.
`
`Impermissible Hearsay [FRE
`802].
`To the extent that Ms. Howell derives
`her knowledge regarding the alleged
`commercial use of the CoRoent XL
`implants from other NuVasive
`employees, these are out of court
`statements offered to prove the truth of
`the matter asserted.
`
`Lack of Foundation [FRE 602].
`There is no foundation for Ms.
`Howell’s claims regarding whether
`this was not a formal study or whether
`the hospital and surgeon would have
`purchased the implants for an XLIF
`Procedure from NuVasive.
`
`Impermissible Hearsay [FRE
`802].
`To the extent that Ms. Howell derives
`her knowledge regarding whether this
`was not a formal study or whether the
`hospital and surgeon would have
`purchased the implants for an XLIF
`
`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`- 3 -
`
`18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30384 Page 4 of 8
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`Statement in Howell Declaration
`(Doc. No. 306-1)
`was present at the surgery to collect
`procedural information regarding the
`surgery and the implants used in the
`surgery.”
`
`n.1 “Because the purpose of the spreadsheet
`was to gather information about the
`procedure, I did not collect any sales data for
`these transactions. The sales data for the
`transactions would be purchase orders either
`maintained by NuVasive or the hospital
`itself. This spreadsheet does not track all of
`the purchases made by hospitals or surgeons,
`but only the surgeries I was made aware of
`post-market.”
`¶ 7: “The columns show the procedural
`information I collected from each
`surgery. Id. at NUVA_ATEC0115139.
`For example, the “Hospital” column in
`the spreadsheet indicates the facility
`where the surgery occurred, and the
`“Training” column lists where the
`surgeon had been trained on the “XLIF”
`procedure. The “Retroper Access”
`column highlights whether two
`incisions were used in the
`retroperitoneal approach, as compared
`to a single incision. If two incisions
`were used, I referred to it as the
`“Pimenta approach.” Whether the
`surgeon employed one or two incisions,
`however, the procedure is considered an
`XLIF.”
`¶ 8: “The “IBI” column shows what
`interbody implant the surgeon used. The
`initial surgeries in 2003 were performed
`using an allograft spacer. At the end of
`2003 and through 2004, surgeons began
`using NuVasive “PEEK” and “PEEK-
`XL” interbody implants. The “PEEK”
`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`NuVasive’s Objections
`
`procedures from NuVasive from other
`NuVasive employees, these are out of
`court statements offered to prove the
`truth of the matter asserted.
`
`
`
`
`Lack of Foundation [FRE 602].
`There is no foundation for Ms.
`Howell’s claims regarding whether the
`design of the implant changed from
`when the implant was first introduced.
`
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`- 4 -
`
`18-cv-00347-CAB-MDD
`
`

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`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30385 Page 5 of 8
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`Statement in Howell Declaration
`(Doc. No. 306-1)
`and “PEEK-XL” implants listed in the
`“IBI” column, which include implants
`dimensioned 18 mm (width) x 40 mm
`(length) and 18 mm (width) x at least 45
`mm (length) (e.g., id. at lines 13-14),
`are the same implants that became
`marketed as CoRoent XL. For each
`procedure, I kept track of the implant
`dimensions as one of the uses of this
`spreadsheet was to identify the sizes of
`the most commonly used implants. I did
`not collect feedback, however,
`regarding the design of the implant. The
`design of the implant did not change
`from when the implant was first
`introduced.”
`¶ 9: “Further, during this time, the
`“PEEK” implants used in the
`procedures could have either been
`referred to as Cement Restrictor or
`CoRoent. Cement Restrictor is a
`labelling distinction that references the
`same product that was marketed as
`CoRoent XL. I have attached here as
`Exhibits C and D true and correct
`copies of correspondence and CoRoent
`sales sheets I received that show
`NuVasive’s decision to market the
`Cement Restrictor as CoRoent. As
`indicated by Exhibit C at
`NUVA_ATEC0341097 and Exhibit D
`at NUVA_ATEC0341113-15,
`NuVasive removed references to the
`Cement Restrictor on the sales sheet
`and replaced it with CoRoent. The
`product, however, is the same. For
`instance, looking at Exhibit C at
`NUVA_ATEC0341099 and Exhibit D
`at NUVA_ATEC0341115, you will see
`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`NuVasive’s Objections
`
`Impermissible Hearsay [FRE
`802].
`To the extent that Ms. Howell derives
`her knowledge whether the design of
`the implant changed from when the
`implant was first introduced from other
`NuVasive employees, these are out of
`court statements offered to prove the
`truth of the matter asserted.
`
`
`
`
`- 5 -
`
`18-cv-00347-CAB-MDD
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`

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`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30386 Page 6 of 8
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`NuVasive’s Objections
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`Lack of Foundation [FRE 602].
`There is no foundation for Ms.
`Howell’s claims whether NuVasive
`intended for the information in the
`spreadsheet to be confidential.
`
`Impermissible Hearsay [FRE
`802].
`To the extent that Ms. Howell derives
`her knowledge regarding whether
`NuVasive intended for the information
`in the spreadsheet to be confidential
`from other NuVasive employees, these
`are out of court statements offered to
`prove the truth of the matter asserted.
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`Statement in Howell Declaration
`(Doc. No. 306-1)
`that the “Restrictor” Extra Large and
`“CoRoent” Extra Large implant have
`the same product number. NuVasive
`had unique product numbers identifying
`each device. If the implant were
`different, the product number would
`also be different.”
`¶ 10: “No information collected in this
`spreadsheet was intended by
`NuVasive to be confidential. The
`information collected served as the
`basis for an article by Neil M. Wright
`titled, “XLIF - the United Stated
`Experience,” which was presented at
`the International Meeting on Advanced
`Spine Techniques (“IMAST”), a spine
`conference, in 2005. I have attached
`here as Exhibit E the abstract of that
`article and I also have attached here as
`Exhibit F a publicly available press
`release regarding the same.”
`
`¶ 11: “Further, I continued to rely on
`the spreadsheet after 2004 because it
`served a useful data point for how many
`surgeries had been completed during the
`introduction of XLIF and as a helpful
`reference to determine whether
`surgeons who joined NuVasive’s
`Society of Lateral Access Surgery
`(“SOLAS”) were involved in these
`early procedures.”
`
`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`- 6 -
`
`18-cv-00347-CAB-MDD
`
`

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`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30387 Page 7 of 8
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`Dated: February 26, 2021 WILSON SONSINI GOODRICH & ROSATI, P.C.
`
`By:
`Paul D. Tripodi II (SBN162380)
`Wendy L. Devine (SBN 246337)
`Natalie J. Morgan (SBN 211143)
`
`HILGERS GRABEN PLLC
`Michael T. Hilgers, pro hac vice
`
`Attorneys for Plaintiff NuVasive, Inc.
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`NUVASIVE INC.’S OBJECTIONS TO HOWELL
`DECL. ISO DEFS’ OPP’N TO MOT. FOR
`
`PARTIAL SUMMARY JUDGMENT
`
`- 7 -
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`18-cv-00347-CAB-MDD
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`

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`Case 3:18-cv-00347-CAB-MDD Document 311-15 Filed 02/26/21 PageID.30388 Page 8 of 8
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a true and correct copy of the foregoing
`document has been served on this date to all current and/or opposing counsel of
`record, if any to date, who are deemed to have consented to electronic service via
`the Court’s CM/ECF system per Civ.L.R. 5.4(d). Any other counsel of record will
`be served by electronic mail, facsimile and/or overnight delivery.
`I declare under penalty of perjury under the laws of the United States of
`America that the above is true and correct. Executed this 26th day of February 2021
`at San Diego, California.
`
`
`
`
`
`By: / s/ Arlene Apodaca
`ARLENE APODACA
`
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`CERTIFICATE OF SERVICE
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`18-cv-00347-CAB-MDD
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