Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30435 Page 1 of 62
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`LEV TSUKERMAN (SBN: 319184)
`ltsukerman@winston.com
`WILLIAM M. WARDLAW (SBN: 328555)
`wwardlaw@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`GEORGE C. LOMBARDI (pro hac vice)
`glombardi@winston.com
`BRIAN J. NISBET (pro hac vice)
`bnisbet@winston.com
`SARANYA RAGHAVAN (pro hac vice)
`sraghavan@winston.com
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile: (312) 558-5700
`
`CORINNE STONE HOCKMAN (pro hac vice)
`chockman@winston.com
`WINSTON & STRAWN LLP
`800 Capitol Street, Suite 2400
`Houston, TX 77002-2529
`Telephone: (713) 651-2600
`Facsimile: (713) 651-2700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
`Case No. 18-CV-00347-CAB-MDD
`NUVASIVE, INC., a Delaware
`
`corporation,
`DEFENDANTS’ CONSOLIDATED
`
`RESPONSE TO NUVASIVE’S
`OBJECTIONS TO DEFENDANTS’
`
`DECLARATIONS IN SUPPORT OF
`v.
`THEIR OPPOSITION TO NUVASIVE’S
`
`MOTION FOR SUMMARY
`ALPHATEC HOLDINGS, INC., a
`JUDGMENT
`Delaware corporation and
`
`ALPHATEC SPINE, INC., a
`Judge: Hon. Cathy Ann Bencivengo
`California corporation,
`Courtroom: 4C
`
`
`Defendants.
`
`Plaintiff,
`
` DEFENDANTS’ CONSOLIDATED RESPONSE TO NUVASIVE’S
`
`OBJECTIONS TO DEFENDANTS’ DECLARATIONS
`
`
`
`CASE NO. 18-CV-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30436 Page 2 of 62
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`Alphatec hereby responds to NuVasive’s objections to four declarations that
`
`Alphatec submitted in support of its opposition to NuVasive’s motion for summary
`judgment.
`
`In support of its opposition to NuVasive’s summary judgment motion (Doc. No.
`306), Alphatec attached supporting declarations from four Alphatec employees: (1)
`Kelli Howell (Doc. No. 306-1); Matt Curran (Doc. No. 306-8); Scott Robinson (Doc.
`No. 306-17); and Mike Aleali (Doc. No. 306-16). NuVasive then objected to portions
`of each declaration. See Doc. No. 311-15 (Objections to Howell Declaration); Doc. No.
`311-16 (Objections to Curran Declaration); Doc. No. 311-17 (Objections to Robinson
`Declaration); Doc. No. 311-18 (Objections to Aleali Declaration).
`
`The following chart details Alphatec’s responses to NuVasive’s objections to
`each of these declarations. Alphatec’s responses relating to the Howell declaration
`begin on page 2. Alphatec’s responses relating to the Curran declaration begin on page
`11. Alphatec’s responses relating to the Robinson declaration begin on page 24.
`Alphatec’s responses relating to the Aleali declaration begin on page 39.
`
`Dated: March 5, 2021
`
`WINSTON & STRAWN LLP
`
`
`
`By: /s/ Nimalka R. Wickramasekera
`NIMALKA R. WICKRAMASEKERA
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND
`ALPHATEC SPINE, INC.
`
`DEFENDANTS’ CONSOLIDATED RESPONSE TO NUVASIVE’S
`
`OBJECTIONS TO DEFENDANTS’ DECLARATIONS
`
`1
`
`CASE NO. 18-CV-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30437 Page 3 of 62
`
`
`DEFENDANTS’ RESPONSES TO PLAINTIFF’S SPECIFIC EVIDENTIARY OBJECTIONS
`TO DECLARATION OF KELLI HOWELL IN SUPPORT OF DEFENDANTS’ OPPOSITION TO
`PLAINITFF’S MOTION FOR PARTIAL SUMMARY JUDGMENT (IMPLANT PATENTS)
`
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`
`
`
`
`Defendants’ Response
`
`
`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.”
`
`
`
`
`
`
`
`
`
`
`
`2
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30438 Page 4 of 62
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`¶ 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 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.”
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`
`
`
`
`Defendants’ Response
`
`
`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.
`
`Sufficient foundation. Ms. Howell
`provides sufficient foundation for her
`assertions. She attests that she held
`various roles at NuVasive over an almost
`twenty-year career. Doc. No. 306-1 ¶¶
`2–3. She also attests that as a Clinical
`Research and Education Manager, she
`was “involved with NuVasive’s
`development and introduction of the
`XLIF procedure and accompanying
`lateral products, including … CoRoent
`implants.” Doc. No. 306-1 ¶ 4. To that
`end, Ms. Howell “created a spreadsheet
`that collected data” about NuVasive
`procedures, which she attached to her
`declaration as Exs. A and B. Doc. No.
`
`
`
`3
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30439 Page 5 of 62
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`¶ 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
`
`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
`
`
`
`4
`
`Defendants’ Response
`
`306-1 ¶ 4. Because she attests to creating
`the spreadsheet, she is in a position to
`discuss what it is and what it is not. For
`the same reason, Ms. Howell can attest to
`what the data she collected means and
`how it was prepared. At bottom, Ms.
`Howell has personal knowledge about
`the content reflected in that spreadsheet,
`which she created and falls squarely
`within her job responsibilities. NuVasive
`offers no evidence to the contrary.
`Indeed, NuVasive admits this
`spreadsheet shows that embodying
`CoRoent implants were publicly used in
`the United States before March 29, 2004.
`See Doc. No. 300-21 at 5.
`
`No hearsay objection. Ms. Howell
`never attests that she “derive[d] her
`knowledge regarding the alleged
`commercial use of the CoRoent XL
`implants from other NuVasive
`employees.” There is no out of court
`statement offered to prove the truth of the
`matter asserted. NuVasive’s objection
`thus fails.
`
`Sufficient foundation. Ms. Howell
`provides sufficient foundation for her
`assertions. She attests that she held
`various roles at NuVasive over an almost
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30440 Page 6 of 62
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`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
`procedures from NuVasive from other
`NuVasive employees, these are out of
`court statements offered to prove the
`truth of the matter asserted.
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`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 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.”
`
`Defendants’ Response
`
`twenty-year career. Doc. No. 306-1 ¶¶
`2–3. She also attests that as a Clinical
`Research and Education Manager, she
`was “involved with NuVasive’s
`development and introduction of the
`XLIF procedure and accompanying
`lateral products, including … CoRoent
`implants.” Doc. No. 306-1 ¶ 4. To that
`end, Ms. Howell “created a spreadsheet
`that collected data” about NuVasive
`procedures, which she attached to her
`declaration as Exs. A and B. Doc. No.
`306-1 ¶ 4. Because she attests to creating
`the spreadsheet, she is in a position to
`discuss what it is and what it is not. For
`the same reason, Ms. Howell can attest to
`what the data she collected means and
`how it was prepared. At bottom, Ms.
`Howell has personal knowledge about
`the content reflected in that spreadsheet,
`which she created and falls squarely
`within her job responsibilities. NuVasive
`offers no evidence to the contrary.
`Indeed, NuVasive admits this
`spreadsheet shows that embodying
`CoRoent implants were publicly used in
`the United States before March 29, 2004.
`See Doc. No. 300-21 at 5.
`
`No hearsay. Ms. Howell never attests
`that she “derive[d] her knowledge
`
`
`
`5
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30441 Page 7 of 62
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`Defendants’ Response
`
`regarding the alleged commercial use of
`the CoRoent XL implants from other
`NuVasive employees.” There is no out
`of court statement offered to prove the
`truth of the matter asserted. NuVasive’s
`objection thus fails.
`
`
`
`
`¶ 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” and
`“PEEK-XL” implants listed in the “IBI”
`column, which include implants
`dimensioned 18 mm (width) x 40 mm
`
`
`
`6
`
`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.
`
`Impermissible Hearsay [FRE 802].
`To the extent that Ms. Howell derives her
`knowledge whether the design of the
`implant changed from when the implant
`
`Sufficient foundation. Ms. Howell
`provides sufficient foundation for her
`assertions. She attests that she held
`various roles at NuVasive over an almost
`twenty-year career. Doc. No. 306-1 ¶¶
`2–3. She also attests that as a Clinical
`Research and Education Manager, she
`was “involved with NuVasive’s
`development and introduction of the
`XLIF procedure and accompanying
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30442 Page 8 of 62
`
`Defendants’ Response
`
`lateral products, including … CoRoent
`implants, and I documented aspects of
`the early procedures and uses of the
`lateral products.” Doc. No. 306-1 ¶ 4.
`Ms. Howell has established that she has
`the requisite foundation to attest to
`whether the design of an implant—one
`that she was involved in developing—
`changed. NuVasive offers no evidence
`to the contrary. Indeed, NuVasive admits
`this spreadsheet shows that embodying
`CoRoent implants were publicly used in
`the United States before March 29, 2004.
`See Doc. No. 300-21 at 5.
`
`No hearsay. Ms. Howell never attests
`that she “derive[d] her knowledge …
`from other NuVasive employees.” There
`is no out of court statement offered to
`prove the truth of the matter asserted.
`NuVasive’s objection thus fails.
`
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`was first introduced from other NuVasive
`employees, these are out of court
`statements offered to prove the truth of
`the matter asserted.
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`(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
`
`
`
`7
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30443 Page 9 of 62
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`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 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.”
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`Defendants’ Response
`
`
`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.
`
`Sufficient foundation. Ms. Howell
`provides sufficient foundation for her
`assertions. She attests that she held
`various roles at NuVasive over an almost
`twenty-year career. Doc. No. 306-1 ¶¶
`2–3. She also attests that as a Clinical
`Research and Education Manager, she
`was “involved with NuVasive’s
`development and introduction of the
`XLIF procedure and accompanying
`lateral products, including … CoRoent
`implants.” Doc. No. 306-1 ¶ 4. To that
`end, Ms. Howell “created a spreadsheet
`that collected data” about NuVasive
`procedures, which she attached to her
`declaration as Exs. A and B. Doc. No.
`
`
`
`8
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30444 Page 10 of 62
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`¶ 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
`
`
`
`
`
`9
`
`Defendants’ Response
`
`306-1 ¶ 4. Because she attests to creating
`the spreadsheet, she is in a position to
`discuss what it is and what it is not. For
`the same reason, Ms. Howell can attest to
`what the data she collected means, how it
`was prepared, and its intended purpose.
`At bottom, Ms. Howell has personal
`knowledge about the content reflected in
`the spreadsheet, which she created and
`falls squarely within her job
`responsibilities. NuVasive offers no
`evidence to the contrary. Indeed,
`NuVasive admits this spreadsheet shows
`that embodying CoRoent implants were
`publicly used in the United States before
`March 29, 2004. See Doc. No. 300-21 at
`5.
`
`No hearsay. Ms. Howell never attests
`that she “derive[d] her knowledge …
`from other NuVasive employees.” There
`is no out of court statement offered to
`prove the truth of the matter asserted.
`NuVasive’s objection thus fails.
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30445 Page 11 of 62
`
`NuVasive’s Objections
`(Doc. No. 311-15)
`
`Defendants’ Response
`
`
`Statement in Howell Declaration
`(Doc. No. 306-1)
`NuVasive’s Society of Lateral Access
`Surgery (“SOLAS”) were involved in these
`early procedures.”
`
`
`
`10
`
`
`
`
`
`
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30446 Page 12 of 62
`
`DEFENDANTS’ RESPONSES TO PLAINTIFF’S SPECIFIC EVIDENTIARY OBJECTIONS
`TO DECLARATION OF MATT CURRAN IN SUPPORT OF DEFENDANTS’ OPPOSITION TO
`PLAINITFF’S MOTION FOR PARTIAL SUMMARY JUDGMENT (IMPLANT PATENTS)
`
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`¶ 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 Senior Director of
`Technology Advancement at Alphatec
`Spine, Inc. (“Alphatec”). I have held this
`position since I joined Alphatec in
`December 2017. Before that, I worked for
`NuVasive, Inc. (“NuVasive”) from May
`2000 until November 2017. I was
`employed in a variety of research and
`development roles during my time at
`NuVasive, working as an engineer on
`numerous products, including, among
`others, NuVasive’s cervical, lumbar, and
`interbody products. My last title before
`leaving NuVasive was Senior Director of
`Global Engineering Services.”
`¶ 3: “NuVasive began developing what
`would become the CoRoent XL implant in
`early 2003. I was a lead design engineer on
`the CoRoent implant project. In 2003, the
`CoRoent implant-was-also referred to as a
`PEEK Cement Restrictor. “Cement
`Restrictor” is a regulatory term for the
`implant which became marketed as
`
`
`
`
`
`
`
`NuVasive’s Objections
`(Doc. No. 311-16)
`
`11
`
`Defendants’ Response
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30447 Page 13 of 62
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`CoRoent. NuVasive sometimes referred to
`the implant as PEEK-CR. All of these
`names-PEEK Cement Restrictor, PEEK-
`CR, and CoRoent- refer to the same
`implant family, and PEEK Cement
`Restrictor XL, PEEK CR-XL, PEEK CR-
`X, and CoRoent XL refer to the same
`implant. “XL” and “X” stand for Extra
`Large, which NuVasive labeled all Cement
`Restrictor, PEEK CR, and CoRoent
`implants that had a length of at least 40
`mm.”
`¶ 4: “NuVasive tasked me with being the
`lead engineer for the project, and in that
`capacity, I led the design and development
`of the CoRoent implant systems. Attached
`here as Exhibit A is a true and correct copy
`of an interoffice memo I received that
`announced my position as the “Project
`Leader” of the “development engineering
`efforts” of the PEEK Cement Restrictor
`product lines. NuVasive began
`developing this product because PEEK
`implants were available on the market
`at that time, but NuVasive did not yet
`offer PEEK implants.”
`
`NuVasive’s Objections
`(Doc. No. 311-16)
`
`Defendants’ Response
`
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr. Curran’s
`claims regarding the reason that NuVasive
`began developing the CoRoent implant. As
`such, his testimony regarding NuVasive’s
`motivations constitute speculation.
`
`Impermissible Hearsay [FRE 802].
`To the extent that Mr. Curran derives his
`knowledge of NuVasive’s reasons for
`developing CoRoent from conversations
`with other individuals at NuVasive, these
`are out of court statements offered to prove
`the truth of the matter asserted.
`
`Sufficient foundation. Mr. Curran
`provides sufficient foundation for his
`assertions. During his 17-year career at
`NuVasive, Mr. Curran worked on
`numerous products, including
`NuVasive’s interbody products. Doc.
`No. 306-8 ¶ 2. His last title was “Senior
`Director of Global Engineering
`Services.” Doc. No. 306-8 ¶ 2. Mr.
`Curran was a “lead design engineer on
`the CoRoent implant project” and in that
`capacity, he “led the design and
`development of the CoRoent implant
`systems.” Doc. No. 306-8 ¶¶ 3–4. Mr.
`Curran has thus established that he has
`the requisite foundation to attest to why
`NuVasive began developing the very
`implants that he led the design and
`development of.
`
`
`
`12
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30448 Page 14 of 62
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`
`NuVasive’s Objections
`(Doc. No. 311-16)
`
`¶ 5: “During the development phase of the
`CoRoent implant, I worked both
`independently and solicited feedback from
`consulting surgeons, the most influential
`and significant of whom was Dr. Luiz
`Pimenta, who had been developing a
`direct lateral procedure since 2001.
`
`Dr. Pimenta was the primary surgeon
`consultant who guided NuVasive’s
`efforts to develop the XLIF procedure
`and provided concepts, parameters,
`goals, ideas, guidance, and feedback on
`the XLIF instruments, including the
`implants.”
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr. Curran’s
`claims regarding when Dr. Pimenta began
`developing a direct lateral procedure.
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr. Curran’s
`claims regarding Dr. Pimenta’s role in
`developing XLIF.
`
`
`
`Defendants’ Response
`
`
`
`No hearsay. Mr. Curran never attests
`that he “derive[d] his knowledge … from
`conversations with other individuals at
`NuVasive.” There is no out of court
`statement offered to prove the truth of
`the matter asserted. NuVasive’s
`objection thus fails.
`
`Sufficient foundation. Mr. Curran
`provides sufficient foundation for his
`assertions. During his 17-year career at
`NuVasive, Mr. Curran worked on
`numerous products, including
`NuVasive’s interbody products. Doc.
`No. 306-8 ¶ 2. His last title was “Senior
`Director of Global Engineering
`Services.” Doc. No. 306-8 ¶ 2. Mr.
`Curran was the “lead design engineer on
`the CoRoent implant project” and in that
`capacity, he “led the design and
`development of the CoRoent implant
`systems.” Doc. No. 306-8 ¶¶ 3–4. In
`that capacity, he worked with Dr.
`Pimenta—the “primary surgeon
`consultant who guided NuVasive’s
`efforts to develop the XLIF
`procedure”—to solicit feedback on and
`to help design the CoRoent implant.
`Doc. No. 306-8 ¶¶ 5–6. As the person
`tasked with leading the design and
`
`
`
`13
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30449 Page 15 of 62
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`
`NuVasive’s Objections
`(Doc. No. 311-16)
`
`¶ 6: “As part of my job, I worked with Dr.
`Pimenta to implement his designs for the
`CoRoent implant. Dr. Pimenta’s main
`concern was designing an implant that
`would be stable in the disc space. I have
`attached here as Exhibit B a true and
`correct copy of my handwritten notes and
`an email between Dr. Pimenta, Pat Miles,
`and myself that highlights some of Dr.
`Pimenta’s contributions to the design of
`the implant. As illustrated in my
`handwritten notes, Dr. Pimenta stressed
`including anti-migration features in the
`implant See Ex. B at
`NUVA_ATEC0016561. At the time, we
`were aware of commercially available
`implants that were designed with ridges
`on the top and bottom surfaces of the
`implant, but Dr. Pimenta felt these
`designs did not fully resolve issues with
`the implants moving in the disc space
`
`Lack of Foundation [FRE 602].
`There is no foundation for Mr. Curran’s
`claims regarding Dr. Pimenta’s concerns
`or motivations with respect to
`development of the CoRoent implant.
`
`Impermissible Hearsay [FRE 802].
`To the extent that Mr. Curran derives his
`knowledge of Dr. Pimenta’s concerns or
`motivations with respect to development
`of the CoRoent implant from
`conversations with Dr. Pimenta, 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 Mr.
`Curran’s statements regarding the
`“commercially available implants” that he
`and Dr. Pimenta were aware of.
`
`
`
`
`14
`
`Defendants’ Response
`
`development of CoRoent implants, Mr.
`Curran has the requisite foundation to
`attest to who else was involved with this
`development. He also has the requisite
`foundation to attest to Dr. Pimenta’s
`work with NuVasive in developing the
`XLIF procedure, as well as Dr.
`Pimenta’s earlier work relating to lateral
`surgery.
`
`Sufficient foundation. Mr. Curran
`provides sufficient foundation for his
`assertions. During his 17-year career at
`NuVasive, Mr. Curran worked on
`numerous products, including
`NuVasive’s interbody products. Doc.
`No. 306-8 ¶ 2. His last title was “Senior
`Director of Global Engineering
`Services.” Doc. No. 306-8 ¶ 2. Mr.
`Curran was the “lead design engineer on
`the CoRoent implant project” and in that
`capacity, he “led the design and
`development of the CoRoent implant
`systems.” Doc. No. 306-8 ¶¶ 3–4. In
`that capacity, he worked with Dr.
`Pimenta—the “primary surgeon
`consultant who guided NuVasive’s
`efforts to develop the XLIF
`procedure”—to solicit feedback on and
`to help design the CoRoent implant.
`Doc. No. 306-8 ¶¶ 5–6. As the person
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30450 Page 16 of 62
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`once the implant was in its final position.
`Dr. Pimenta proposed adding “spikes” to
`the implant to increase stabilization. Id.
`These spikes would extend above and
`below the surface of the implant to grip
`the vertebrae and hold the implant in
`place in its final position in the disc
`space. Dr. Pimenta also suggested that the
`“[t]eeth [be] more aggressive” to further
`increase the stability of the implant. Id.
`These anti-migration features were
`implemented in the design of the CoRoent
`implant.”
`
`NuVasive’s Objections
`(Doc. No. 311-16)
`Impermissible opinion testimony by lay
`witness [FRE 701, 702].
`Mr. Curran was put forward only as a fact
`witness. His testimony regarding the
`clinical role of “teeth” and “spikes” on the
`surface of the implant is opinion testimony
`and thus impermissible.
`
`Furthermore, on their face, these opinions
`clearly are “based on scientific, technical,
`or other specialized knowledge within the
`scope of Rule 702.” FRE 701(c). Alphatec
`has not disclosed Mr. Curran as an expert
`witness under Federal Rule of Civil
`Procedure 26(a)(2)(C). So even if Mr.
`Curran were qualified to offer these
`opinions, the opinions should be excluded
`as not properly disclosed. Fed. R. Civ. P.
`37(c)(1). Alphatec has retained Dr. Sachs,
`a spine surgeon, as its technical expert. If
`Alphatec wished to put forward these
`opinions, it needed to do so through Dr.
`Sachs.
`
`Defendants’ Response
`
`tasked with leading the design and
`development of CoRoent implants, Mr.
`Curran has the requisite foundation
`based on his personal observations and
`perceptions to attest to Dr. Pimenta’s
`goals for and concerns relating to the
`design of the CoRoent implant, and his
`understanding of Dr. Pimenta’s goals
`and concerns. He also has the requisite
`foundation to attest to the commercially
`available implants that he and Dr.
`Pimenta were aware of.
`
`No hearsay. Mr. Curran’s assertion that
`“Dr. Pimenta’s main concern was
`designing an implant that would be
`stable in the disc space” is not offered to
`prove the truth of the matter asserted. It
`is instead offered to show the effect Dr.
`Pimenta’s concern had on Mr. Curran as
`he was designing and developing the
`CoRoent implant. Defendants also
`disagree that Mr. Curran’s assertion is
`subject to hearsay because Mr. Curran is
`simply describing his understanding of
`Dr. Pimenta’s concerns.
`
`Permissible lay witness testimony. Mr.
`Curran is not offering himself as an
`expert witness. He is instead testifying
`about the design and development of an
`
`
`
`15
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 312 Filed 03/05/21 PageID.30451 Page 17 of 62
`
`Defendants’ Response
`
`implant that he led the engineering
`efforts for. Mr. Curran is not making
`assertions using any specialized
`knowledge within the scope of expert
`opinion. And to the extent that Mr.
`Curran offers opinion testimony, he
`meets the requirements of FRE 701.
`
`
`
`
`Statement in Curran Declaration
`(Doc. No. 306-8)
`
`NuVasive’s Objections
`(Doc. No. 311-16)
`
`
`
`
`
`¶ 7: “While at NuVasive, I assisted in a
`supporting role with the company’s 510(k)
`submissions to the U.S. Food and Drug
`Administration (“FDA”) for the CoRoent
`implant. For example, I created the
`engineering drawings that were submitted
`with NuVasive’s 510(k) submissions for
`the Cement Restrictor and CoRoent
`System to the FDA. I have attached here as
`Exhibit C a true and correct copy of my
`drawings submitted with NuVasive’s June
`2004 510(k) submission for the CoRoent
`System.”
`¶ 8: “I also helped NuVasive formulate
`responses to the FDA’s questions and
`issues that arose during that submission. I
`have attached here as Exhibit D a true and
`correct copy of an email NuVasive
`received on August 10, 2004 from the
`FDA regarding “quest