Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 1 of 28
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`SQUIRE PATTON BOGGS (US) LLP
`Erik Morrison, SBN 222071
` erik.morrison@squirepb.com
`Katja Wolf, SBN 344490
` katja.wolf@squirepb.com
`475 Sansome Street, Suite 1600
`San Francisco, California 94111
`Telephone:
`+1 415 954 0200
`Facsimile:
`+1 415 393 9887
`Attorneys for Defendants
`ZELTIQ AESTHETICS, INC.,
`ABBVIE INC., and ALLERGAN
`HOLDCO US, INC.
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`OAKLAND DIVISION
`
`PHORNPHAN LISA CHUBCHAI,
`Plaintiff,
`
`v.
`ABBVIE, INC.; ALLERGAN HOLDCO US,
`INC., f/k/a ALLERGAN PLC; ZELTIQ
`AESTHETICS, INC., and JOHN DOE
`CORPORATIONS 1-10.
`Defendants.
`
`Case No. 4:22-cv-06309-YGR
`DEFENDANTS’ NOTICE OF MOTION AND
`MOTION TO DISMISS PLAINTIFF’S
`COMPLAINT; MEMORANDUM OF POINTS
`AND AUTHORITIES IN SUPPORT THEREOF
`
`Judge: Yvonne Gonzalez Rogers
`
`January 10, 2023
`Date:
`2:00 PM
`Time:
`Crt. Rm. 1
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
`
`

`

`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 2 of 28
`
`NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT
`TO PLAINTIFF AND HER ATTORNEYS OF RECORD:
`NOTICE IS HEREBY GIVEN that on January 10, 2023, at 2:00 p.m. or as soon thereafter
`as counsel may be heard, before the Honorable Yvonne Gonzalez Rogers in Courtroom 1, located
`at the United States District Court for the Northern District of California, Oakland Division, 1301
`Clay Street, Oakland, CA 94612, Defendants AbbVie Inc. (“AbbVie”), Allergan HoldCo US, Inc.
`(“Allergan HoldCo”), Allergan Limited (formerly Allergan plc) (“Allergan Limited”), and Zeltiq
`Aesthetics, Inc. (“Zeltiq”) move to dismiss this case for failure to state a claim under Fed. R. Civ.
`P. 12(b)(6). This motion is based on this Notice of Motion and Motion, the concurrently filed
`Memorandum of Points and Authorities, and upon such other matters as may be presented to the
`Court at the time of the hearing.
`
`Dated: November 28, 2022
`
`Respectfully submitted,
`Squire Patton Boggs (US) LLP
`
`By: /s/ Erik Morrison
`Erik Morrison
`Attorneys for Defendants Zeltiq Aesthetics,
`Inc. and AbbVie Inc.
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 3 of 28
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`STATEMENT OF ISSUES TO BE DECIDED
`1. Whether Plaintiff’s FDCA-based claims (Counts 1 and 2 of the Complaint) are preempted
`by federal law.
`2. Whether Plaintiff has stated a plausible claim—whether sounding in strict liability,
`negligence, or fraud (Counts 3–7)—that Defendants failed to warn, misled, or concealed
`information from CoolSculpting providers.
`3. Whether California recognizes a cause of action for strict liability design defect.
`4. Whether Plaintiff has stated a plausible claim based on negligent design defect.
`5. Whether Plaintiff has stated a plausible claim for manufacturing defect.
`6. Whether Plaintiff’s claims for express warranty (Count 3), implied warranty (Count 4),
`negligent acts/omissions of agents (Count 6), and negligent misrepresentation and fraud
`(Count 7) are just repackaged failure-to-warn claims that should be dismissed for the same
`reasons her failure-to-warn claim fails.
`If reached, whether Plaintiff’s re-packaged failure-to-warn claims (Counts 3, 4, 6, and 7)
`independently fail to state a plausible claim.
`8. Whether Plaintiff’s “claim” for punitive damages (Count 8) should be dismissed because
`her other claims fail.
`
`7.
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 4 of 28
`
`TABLE OF CONTENTS
`
`Page
`
`STATEMENT OF ISSUES TO BE DECIDED ............................................................................. 3
`PROCEDURAL HISTORY ............................................................................................................ 1
`BACKGROUND ............................................................................................................................ 2
`ARGUMENT .................................................................................................................................. 4
`I.
`PLAINTIFF’S FDCA-BASED CLAIMS (COUNTS 1 AND 2) ARE
`PREEMPTED. .................................................................................................................... 4
`PLAINTIFF FAILS TO STATE A CLAIM FOR FAILURE TO WARN
`(COUNTS 3–7). .................................................................................................................. 6
`A.
`THE LEARNED INTERMEDIARY DOCTRINE APPLIES TO CLAIMS
`BASED ON MEDICAL WARNINGS. .................................................................. 7
`1.
`The learned intermediary doctrine applies under California law. ............... 7
`2.
`Federal law preempts any imposition of a duty to warn consumers. ........ 10
`PLAINTIFF PLEADS THAT ZELTIQ WARNED HER PROVIDER
`ABOUT THE RISK OF PH. ................................................................................. 11
`ANY CLAIM BASED ON THE DESIGN OF THE DEVICE FAILS. ........................... 13
`ANY CLAIM BASED ON A MANUFACTURING DEFECT FAILS. .......................... 14
`PLAINTIFF’S REPACKAGED WARNINGS-BASED CLAIMS ALSO FAIL
`INDEPENDENTLY. ......................................................................................................... 15
`A.
`PLAINTIFF’S EXPRESS-WARRANTY CLAIM (COUNT 3) FAILS. ............. 15
`B.
`PLAINTIFF’S CLAIM FOR BREACH OF IMPLIED WARRANTY
`(COUNT 4) FAILS. .............................................................................................. 16
`PLAINTIFF’S CLAIM FOR NEGLIGENT MISREPRESENTATION
`AND FRAUDULENT CONCEALMENT FAILS. .............................................. 16
`ZELTIQ IS NOT RESPONSIBLE FOR THE ACTIONS OF
`HEALTHCARE PROVIDERS (COUNT 6). ....................................................... 17
`PLAINTIFF’S PUNITIVE DAMAGES “CLAIM” (COUNT 8) SHOULD BE
`DISMISSED. ..................................................................................................................... 18
`CONCLUSION ............................................................................................................................. 19
`
`II.
`
`III.
`IV.
`V.
`
`VI.
`
`B.
`
`C.
`
`D.
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 5 of 28
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Federal Cases
`
`Aguirre v. Home Depot U.S.A., Inc.,
`No. 1:10-cv-00311, 2012 WL 3639078 (E.D. Cal. Aug. 23, 2012) ........................................ 15
`
`Anderson v. Jamba Juice,
`888 F. Supp. 2d 1000 (N.D. Cal. 2012) ................................................................................ 3, 4
`
`Andren v. Alere, Inc.,
`207 F. Supp. 3d 1133 (S.D. Cal. 2016) ................................................................................. 7, 8
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ............................................................................................................ 4, 14
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) ...................................................................................................... 4, 14, 15
`
`Borchenko v. L’Oreal USA, Inc.,
`389 F. Supp. 3d 769 (C.D. Cal. 2019)....................................................................................... 6
`
`Buckman v. Pls
`531 U.S. 341, 353 (2001) ...................................................................................................... 4, 5
`
`Carter v. Ethicon,
`No. 2:20-cv-1232-KJD-VCF, 2021 WL 1226531 (D. Nev. Mar. 31, 2012) ............................ 7
`
`Cates v. Zeltiq Aesthetics, Inc.,
`535 F. Supp. 3d 1222 (M.D. Fla. 2021), appeal pending, No. 21-12085 (11th
`Cir.) .................................................................................................................................. passim
`
`Daniels-Hall v. Nat’l Educ. Ass’n,
`629 F.3d 992 (9th Cir. 2010) ..................................................................................................... 3
`
`Davis v. HSBC Bank Nev., N.A.,
`691 F.3d 1152 (9th Cir. 2012) ................................................................................................... 3
`
`Donovan v. Centerpulse Spine-Tech Inc.,
`No. 03-CV-0376C, 2010 WL 1269751 (W.D.N.Y. Mar. 31, 2020), aff’d, 416
`F. App’x 104 (2d Cr. 2011) ..................................................................................................... 18
`
`Eidmann v. Walgreen Co.,
`522 F. Supp. 3d 634 (N.D. Cal. 2021) ...................................................................................... 3
`
`Elkins v. AbbVie, Inc.,
`No. 6:20-cv-01562 (M.D. Fla.) ................................................................................................. 1
`
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 6 of 28
`
`Ellis v. C.R. Bard, Inc.,
`311 F.3d 1272 (11th Cir. 2002) ............................................................................................... 18
`
`Faustino v. Alcon Labs., Inc.,
`No. CV 15-04145, 2015 WL 12839161 (C.D. Cal. Sept. 22, 2015) ....................................... 14
`
`Himes v. Somatics, LLC,
`2022 WL 989469 (9th Cir. Apr. 1, 2022) ................................................................................. 7
`
`Houston v. Medtronic, Inc.,
`957 F. Supp. 2d 1166 (C.D. Cal. 2013)........................................................................... 4, 5, 15
`
`Jacob v. Mentor Worldwide, LLC,
`393 F. Supp. 3d 912 (C.D. Cal. 2019)................................................................................... 1, 5
`
`Jager v. Davol Inc.,
`No. EDCV161424JGBKKX, 2017 WL 696081 (C.D. Cal. Feb. 9, 2017) ............................. 18
`
`Keegan v. Am. Honda Motor Co., Inc.,
`838 F. Supp. 2d 929 (C.D. Cal. 2012)..................................................................................... 15
`
`Loreto v. Procter & Gamble Co.,
`515 F. App’x 576 (6th Cir. 2013) ............................................................................................. 6
`
`Marroquin v. Pfizer, Inc.,
`367 F. Supp. 3d 1152 (E.D. Cal. 2019) ................................................................................... 12
`
`Martin v. Medtronic, Inc.,
`No. 115CV00994DADMJS, 2017 WL 4574160 (E.D. Cal. Oct. 13, 2017) ........................... 16
`
`McCartney v. U.S.,
`31 F. Supp. 3d 1340 (D. Utah 2014) ....................................................................................... 18
`
`Motus v. Pfizer Inc.,
`196 F. Supp. 2d 984 (C.D. Cal. 2001)........................................................................... 7, 11, 13
`
`Nw. Austin Mun. Util. Dist. No. One v. Holder,
`557 U.S. 193 (2009) ................................................................................................................ 10
`
`Oregon v. Bos. Sci. Corp.,
`No. 1:21-cv-01092, 2022 WL 1607960 (E.D. Cal. May 20, 2022) ........................................ 17
`
`PDK Labs, Inc. v. Friedlander,
`103 F.3d 1105 (2d Cir. 1997) .................................................................................................... 6
`
`PhotoMedex, Inc. v. Irwin,
`601 F.3d 919 (9th Cir. 2010) ..................................................................................................... 6
`
`Polley v. Ciba-Geigy Corp.,
`658 F. Supp. 420 (D. Alaska 1987) ......................................................................................... 18
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 7 of 28
`
`Pooshs v. Philip Morris USA, Inc.,
`904 F. Supp. 2d 1009 (N.D. Cal. 2012) .................................................................................. 13
`
`Rodman v. Otsuka Am. Pharm., Inc.,
`No. 18-cv-03732-WHO, -- F.3d --, 2020 WL 2525032 (N.D. Cal. May 18,
`2020), aff’d, No. 20-16646, 2021 WL 5850914 (9th Cir. Aug. 25, 2020) .............................. 12
`
`Rollins v. Dignity Health,
`338 F. Supp. 3d 1025 (N.D. Cal. 2018) .................................................................................. 10
`
`Sherman v. Stryker Corp.,
`No. SACV 09-224, 2009 WL 2241664 (C.D. Cal. Mar. 30, 2009) .......................................... 9
`
`Somers v. Beiersdorf, Inc.,
`467 F. Supp. 3d 934 (S.D. Cal. 2020) ....................................................................................... 6
`
`Sons v. Medtronic Inc.,
`915 F. Supp. 2d 776 (W.D. La. 2013) ..................................................................................... 18
`
`Tapia v. Davol, Inc.,
`116 F. Supp. 3d 1149 (S.D. Cal. 2015) ................................................................................... 16
`
`Torralbo v. Davol Inc.,
`No. 8:17-cv-00201, 2017 WL 8292477 (C.D. Cal. Apr. 12, 2017) ........................................ 16
`
`United States v. United Healthcare Ins. Co.,
`848 F.3d 1161 (9th Cir. 2016) ................................................................................................. 17
`
`Utts v. Bristol-Myers Squibb Co.,
`251 F. Supp. 3d 644 (S.D.N.Y. 2017), aff’d sub nom. Gibbons v. Bristol-Myers
`Squibb Co., 919 F.3d 699 (2d Cir. 2019) ................................................................................ 12
`
`Yastrab v. Apple Inc.,
`173 F. Supp. 3d 972 (N.D. Cal. 2016) .................................................................................... 17
`
`Zetz v. Bos. Sci. Corp.,
`398 F. Supp. 3d 700 (E.D. Cal. 2019) ....................................................................... 7, 9, 13, 17
`
`California Cases
`
`Adhoot v. CoolSculpting,
`No. BC656758, slip op. (Cal. Super. Ct. Feb. 4, 2019) .......................................................... 13
`
`Blanco v. Baxter Healthcare Corp.,
`158 Cal. App. 4th 1039 (Ct. App. 2008) ................................................................................. 16
`
`Carlin v. Superior Ct. of Sutter Cnty.,
`920 P.2d 1347 (Cal. 1996) ........................................................................................................ 4
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 8 of 28
`
`Cnty of Santa Clara v. Atl. Richfield Co.,
`137 Cal. App. 4th 292 (Cal. Ct. App. 2006) ........................................................................... 17
`
`Flores v. Liu,
`60 Cal. App. 5th 278 (2021).............................................................................................. 13, 18
`
`Garlock Sealing Techs., LLC v. NAK Sealing Techs. Corp.,
`148 Cal. App. 4th 937 (Cal. Ct. App. 2007) ........................................................................... 18
`
`Garrett v. Howmedica Osteonics Corp.,
`214 Cal. App. 4th 173 (2013).................................................................................................. 13
`
`Glennen v. Allergan, Inc.,
`202 Cal. Rptr. 3d 68 (Cal. Ct. App. 2016) .............................................................................. 18
`
`Glennen v. Allergan, Inc.,
`247 Cal. App. 4th 1 (2016).................................................................................................. 4, 13
`
`Lord v. Sigueiros,
`No. CV 040243, 2006 WL 1510408 (Cal. Super. Ct. Apr. 25, 2006) ...................................... 7
`
`Merrill v. Navegar, Inc.,
`28 P.3d 116 (Cal. 2001) .......................................................................................................... 14
`
`Rivas v. Safety-Kleen Corp.,
`98 Cal. App. 4th 218 (2002)...................................................................................................... 7
`
`Soule v. Gen. Motors Corp.,
`882 P.2d 298 (Cal. 1994) ........................................................................................................ 15
`
`Other State Cases
`
`Felix v. Hoffmann-LaRoche, Inc.,
`540 So. 2d 102 (Fla. 1989) ...................................................................................................... 18
`
`Greenwood v. Tehrani,
`No. 805111/2017, 2017 WL 4083099 (N.Y. Sup. Ct. Sept. 15, 2017) ................................... 18
`
`Federal Statutes
`
`21 U.S.C.
`§ 360k ...................................................................................................................................... 11
`
`21 U.S.C.
`§ 337(a) ................................................................................................................................. 5, 6
`§ 360k(a) ................................................................................................................................. 10
`
`FDCA .......................................................................................................................................... 5, 6
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 9 of 28
`
`Other Authorities
`
`21 C.F.R.
`§ 801.109 ................................................................................................................................. 10
`§ 803 .......................................................................................................................................... 5
`§ 807.97 ..................................................................................................................................... 5
`§ 820.30(a)(1)(2)(i) ................................................................................................................... 5
`§ 820.30(b) and (c) .................................................................................................................... 5
`§ 820.30(c), (d), (e), (f), and (g) ................................................................................................ 5
`§ 820.80(c) ................................................................................................................................ 5
`§ 820.100 ................................................................................................................................... 5
`§ 820.198 ................................................................................................................................... 5
`§ 878.4340(b) ...................................................................................................................... 8, 10
`
`21 CFR
`§ 801.109 ............................................................................................................................. 4, 10
`
`76 Fed. Reg. 6551-01, 6553 (Feb. 7, 2011) .................................................................................. 11
`
`CACI No. 1204 ............................................................................................................................. 14
`
`ce for Industry and
`FDA Staff, Class II Special Controls Guidance
`FDA, Guidan
`Document: Contact Cooling System for Aesthetic Use at 7 ,
`
`/https://www.fda.gov/media/79881
`
`
`
`download (Feb. 7, 2011) ................................................... 3
`
`Fed. R. Civ. P.
`Rule 8 ...................................................................................................................................... 14
`Rule 9(b).................................................................................................................................. 17
`Rule 12(b)(6) ............................................................................................................... 1, 3, 4, 19
`
`Federal Rule of Evidence 201(c)(2) ................................................................................................ 3
`
`https://www. com/coolsculptinghcp.
`
`
`media/
`1968/com1_us_user_manual___brz_101
`_tum_en2_l.pdf ......................................................................................................................................................................... 11
`
`
`Jalian et al., Paradoxical Adipose Hyperplasia After Cryolipolysis, 150 JAMA ........................ 12
`
`Singh et al., Paradoxical Adipose Hyperplasia Secondary to Cryolipolysis: An
`Underreported Entity? ........................................................................................................... 12
`
`Stefani et al., Adipose Hypertrophy Following Cryolipolysis ..................................................... 12
`
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 10 of 28
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`MEMORANDUM OF POINTS AND AUTHORITIES
`Defendants AbbVie Inc. (“AbbVie”), Allergan HoldCo US, Inc. (“Allergan HoldCo”),
`Allergan Limited (formerly Allergan plc) (“Allergan Limited”), and Zeltiq Aesthetics, Inc.
`(“Zeltiq”) move to dismiss Plaintiff’s Complaint for failure to state a claim under Rule 12(b)(6).1
`PROCEDURAL HISTORY
`Plaintiff Phornphan Chubchai was one of several putative members of a Class Action
`Complaint filed in the Northern District of California in May 2021. Class Action Compl. (ECF
`No. 1).; Am. Class Action Compl. (ECF No. 12) (dropping a putative class member) (3:21-cv-
`04099). That action—assigned to this Honorable Court—involved identical allegations against
`the same defendants as a prior-pending class action filed by the same lawyer in the Middle
`District of Florida. See Elkins v. AbbVie, Inc., No. 6:20-cv-01562 (M.D. Fla.). AbbVie moved to
`dismiss, or in the alternative to stay, the Amended Class Action Complaint on a number of
`grounds. Mot. to Dismiss Am. Compl. (ECF No. 17) (4:21-cv-04099). This Court granted
`Plaintiffs’ leave to file a second amended Class Action Complaint and entered a stay on
`November 3, 2021, to allow the action in the Middle District of Florida to proceed. ECF No. 36
`(4:21-cv-04099). On January 12, 2022, this Court lifted the stay following the putative class
`members’ decision to abandon their class claims, “leaving only claims which the plaintiffs bring
`in their individual capacity” (see ECF No. 39 (4:21-cv-04099)), and on January 25, 2022, AbbVie
`again moved to dismiss based on a lack of personal jurisdiction and, if reached, for failure to state
`
`1 As demonstrated in AbbVie and Zeltiq’s Notice of Removal and accompanying exhibits,
`Defendant Allergan HoldCo US, Inc. is fraudulently joined, is not a proper party to this litigation,
`and should be dismissed. See, e.g., Jacob v. Mentor Worldwide, LLC, 393 F. Supp. 3d 912, 922
`(C.D. Cal. 2019) (“Because [the fraudulently joined defendant] is not a proper party to this
`litigation, the Court will only consider arguments from [the proper defendant’s] motion.
`Accordingly, the [fraudulently joined defendant’s] motion to dismiss is DENIED as moot since
`[it] was fraudulently joined in this matter.”). Further, neither AbbVie Inc. (Zeltiq’s indirect parent
`corporation), nor Allergan HoldCo US, Inc. (a holding company), nor Allergan Limited (a
`holding company) designed or manufactured the CoolSculpting System that allegedly injured
`Plaintiff, nor are they “at home” in California. Thus, they are not subject to general or specific
`personal jurisdiction in California. Regardless, as this Court has already held, none of these
`defendants can be liable for Plaintiff’s claims against Zeltiq. See Chubchai v. AbbVie, Inc., -- F.
`Supp. 3d --, 2022 WL 1236877, at *3 (N.D. Cal. Apr. 21, 2022) (“[P]laintiffs primarily argue that
`the Court has specific jurisdiction over AbbVie because the company fully and completely
`merged with Zeltiq, Allergan plc, and Allergan, Inc., and has taken over all aspects of the
`CoolSculpting business . . . . This theory is incoherent and does not persuade that jurisdiction is
`proper.”).
`
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 11 of 28
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`a claim upon which relief could be granted. Mot. to Dismiss 2d Am. Compl. (ECF No. 41) (4:21-
`cv-04099). This Court granted AbbVie’s motion for lack of personal jurisdiction without reaching
`the merits of its arguments concerning failure to state a claim. Order Granting Def.’s Mot. to
`Dismiss (ECF No. 49 (4:21-cv-04099)).
`After retaining new counsel, Plaintiff re-filed her individual, personal injury action on
`July 22, 2022, in the Superior Court of California, Alameda County. ECF No. 1 (hereinafter
`“Compl.”). Defendants subsequently removed the case to the Northern District of California on
`October 20, 2022 (ECF No. 1), and the case was ultimately assigned to the Honorable James
`Donato. Reassignment Order Setting CMC (ECF No. 12). Defendants then filed an
`Administrative Motion to Consider Related Cases under Civil L.R. 3-11 (ECF No. 52 (4:21-cv-
`04099)), which was granted (ECF No. 54 (4:21-cv-04099)), and the case was transferred back
`before this Honorable Court (ECF No. 14).
`As with their prior iterations, Plaintiff’s claims fail to state a claim upon which relief can
`be granted, and they should be dismissed.
`BACKGROUND
`Zeltiq’s CoolSculpting System is an FDA-cleared class II prescription medical device.
`Compl. ¶¶ 30–31, 51. The device is indicated for the treatment of visible fat bulges in various
`parts of the body. Id. ¶ 51. It uses controlled cooling to target and freeze (thereby killing) fat cells
`under a patient’s skin, and the body removes those dead fat cells. Id. ¶ 27. The medical term is
`cryolipolysis. Id.
`Plaintiff underwent CoolSculpting in January 2018 at the medical offices of Ignacio
`Guzman, M.D. in Fresno, California. Id. ¶ 89. She alleges that she suffered paradoxical
`hyperplasia (PH),2 which she describes as “enlarged and sometimes hardened tissue masses that
`cause disfigurement.” Id. ¶ 43. The crux of her allegations is that “Defendants failed to
`appropriately and/or adequately warn all physicians, healthcare providers, and the public,
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`2 Plaintiff’s Complaint and various medical literature refer to the condition as both
`paradoxical hyperplasia (PH) and paradoxical adipose hyperplasia (PAH). The CoolSculpting
`User Manual has always referred to the condition as PH.
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
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`Case 4:22-cv-06309-YGR Document 16 Filed 11/28/22 Page 12 of 28
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`including Ms. Chubchai, of the risk of developing post-surgical growths, including but not limited
`to PAH, from the use of the CoolSculpting device.” Id. ¶ 114. But in the CoolSculpting User
`Manual that Plaintiff references in her Complaint (id. ¶¶ 157, 164, 166, 167), Zeltiq expressly
`warned healthcare providers of the rare but real risk that PH could occur following treatment and
`that the condition could require surgery to correct:
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`Rare Adverse Events
` Paradoxical hyperplasia: Visibly enlarged tissue volume within
`the treatment area, which may develop two to five months after
`treatment. Surgical intervention may be required.
`Ex. 1, CoolSculpting User Manual (Dec. 2016) at 5.3 In April 2021, a Florida federal court ruled
`in a virtually identical CoolSculpting case that “there was nothing inaccurate or misleading about
`[Zeltiq’s] warning that PH was a rare side effect causing visibly enlarged tissue volume that does
`not go away on its own and may require surgical intervention.” Cates v. Zeltiq Aesthetics, Inc.,
`535 F. Supp. 3d 1222, 1229 (M.D. Fla. 2021), appeal pending, No. 21-12085 (11th Cir.).
`Plaintiff also attempts to state claims against Zeltiq for allegedly failing to warn her—
`rather than her healthcare provider—about the risk of developing PH following CoolSculpting
`treatment. Compl. ¶¶ 54–68. But the CoolSculpting System is by law a prescription-only medical
`device. Ex. 2, FDA, Guidance for Industry and FDA Staff, Class II Special Controls Guidance
`Document: Contact Cooling System for Aesthetic Use at 7, https://www.fda.gov/media/79881
`/download (Feb. 7, 2011) (“FDA Special Controls”).4 Plaintiff’s CoolSculpting sessions were
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`3 The Court may “look beyond the pleadings without converting the Rule 12(b)(6) motion
`into one for summary judgment” at “documents whose contents are alleged in a complaint and
`whose authenticity no party questions, but which are not physically attached to the [plaintiff’s]
`pleading.” Davis v. HSBC Bank Nev., N.A., 691 F.3d 1152, 1160 (9th Cir. 2012) (citation
`omitted). The User Manual (Exhibit 1) is not only referenced in the Complaint but is also
`necessary to Plaintiffs’ claims, as it is a document provided to CoolSculpting practitioners that
`contains instructions and warnings. AbbVie requests that the Court take judicial notice of the
`User Manual under the incorporation-by-reference doctrine and under Federal Rule of Evidence
`201(c)(2).
`4 Publicly available documents on the FDA’s website are proper subjects for judicial
`notice. Daniels-Hall v. Nat’l Educ. Ass’n, 629 F.3d 992, 998–99 (9th Cir. 2010); see Eidmann v.
`Walgreen Co., 522 F. Supp. 3d 634, 642 (N.D. Cal. 2021) (“Documents published on
`government-run websites are proper for judicial notice given their reliability.”); Anderson v.
`Jamba Juice, 888 F. Supp. 2d 1000, 1003 (N.D. Cal. 2012) (taking judicial notice of documents
`from FDA’s website).
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`DEFS’ NTC. & MTN. TO DISMISS PLTF’S
`COMPLAINT; MEMO OF PTS. & AUTH.
`CASE NO. 4:22-CV-06309-YGR
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`“performed under the supervision of a physician, and she was informed of CoolSculpting’s risks
`by a physician.” Id. ¶ 90. For such devices, California law is clear: under the learned
`intermediary doctrine, the manufacturer’s duty to warn “runs to the physician, not to the patient.”
`Carlin v. Superior Ct. of Sutter Cnty., 920 P.2d 1347, 1354 (Cal. 1996) (emphasis omitted). If
`that were not enough, the FDA specifically exempted Zeltiq from any duty to warn lay patients,
`like Plaintiff, about the medical risks associated with the CoolSculpting System: “As a
`prescription device, under 21 CFR 801.109, the device is exempt from having adequate
`directions for lay use.” Ex. 2, FDA Special Controls at 7 (emphasis added).
`To the extent Plaintiff is attempting to state a claim based on a design or manufacturing
`defect, she has not alleged any such defect.
`Finally, although Plaintiff’s other claims are simply repackaged failure-to-warn claims,
`they would fail even if they were treated independently.
`ARGUMENT
`“A motion to dismiss under Rule 12(b)(6) tests the legal sufficiency of the claims alleged
`in the complaint.” Anderson, 888 F. Supp. 2d at 1002. And “[t]o survive a motion to dismiss, a
`complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is
`plausible on its face.” Id. (internal quotation marks omitted) (quoting Ashcrof