Case 3:21-cv-08814-JCS Document 1-1 Filed 11/12/21 Page 1 of 43
`Case 3:21-cv-08814-JCS Document1-1 Filed 11/12/21 Page 1 of 43
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`EXHIBIT 1
`EXHIBIT 1
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`Case 3:21-cv-08814-JCS Document 1-1 Filed 11/12/21 Page 2 of 43
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`null / ALL
`Transmittal Number: 23984213
`Date Processed: 10/28/2021
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`Notice of Service of Process
`
`Primary Contact:
`
`Byron Hayes
`Zimmer Holdings, Inc.
`345 E Main St
`Warsaw, IN 46580-2746
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`Electronic copy provided to:
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`Entity:
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`Entity Served:
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`Title of Action:
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`Document(s) Type:
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`Nature of Action:
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`Court/Agency:
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`Case/Reference No:
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`Jurisdiction Served:
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`Date Served on CSC:
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`Answer or Appearance Due:
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`Originally Served On:
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`How Served:
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`Sender Information:
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` Tina McCoy
` Chad Phipps
` Dona Reust
` Lisa Dunkin
` Justin Kashman
` Myka Fernandez
` Maureen Smith
`
`Zimmer Biomet Spine, Inc.
`Entity ID Number 3499674
`Zimmer Biomet Spine Inc.
`Jane Prather vs. Zimmer Biomet Spine Inc.
`Summons/Complaint
`Product Liability
`San Francisco County Superior Court, CA
`CGC-21-595350
`California
`10/26/2021
`20 Days
`CSC
`Regular Mail
`Synergist Law, P.C
`415-326-3708
`
`Information contained on this transmittal form is for record keeping, notification and forwarding the attached document(s). It does not
`constitute a legal opinion. The recipient is responsible for interpreting the documents and taking appropriate action.
`
`To avoid potential delay, please do not send your response to CSC
`251 Little Falls Drive, Wilmington, Delaware 19808-1674 (888) 690-2882 | sop@cscglobal.com
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`STATE BAR NO: 2$0437
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`FOR COURT USE ONLY
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`POS-015
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`ATTORNEY OR PARTY wITHOUT ATTORNEY:
`NAME: Saml Sedghanl
`FIRM NAME: SynerglSt Law P.C.
`STREETADDRESS: 1299 FOurth Street, Suite 301
`cITY: San Rafael
`TELEPHONE NO.: 415-326-3708
`E-MAILADDRESS: sami@synergistlaw.com
`ATTORNEY FOR (Name): Jane Prather
`SUPERIOR COURT OF CALIFORNIA, COUNTY OF San Francisco
`STREETADDRESS: 400 MCAIIISter St.
`MAILINGADDRESS: 400 MCAIIISter St.
`San FranclSCo, CA 94102
`CITYAND ZIP CODE:
`BRANCH NAME: CIVIc Center CoUrthOUse
`
`STATE: CA
`FAX NO. :
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`ZIP CODE: 94901
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`Plaintiff/Petitioner: Jane Prather
`Defendant/Respondent: Zimmer Biomet Spine Inc.
`
`NOTICE AND ACKNOWLEDGMENT OF RECEIPT—CIVIL
`
`CASE NUMBER:
`CGC-21-595350
`
`TO (insert name of parfy being served): Zimmer Biomet Spine Inc.
`
`NOTICE
`The summons and other documents identified below are being served pursuant to section 415.30 of the California Code of Civil
`Procedure. Your failure to complete this form and return it within 20 days from the date of mailing shown below may subject you
`(or the party on whose behalf you are being served) to liability for the payment of any expenses incurred in serving a summons
`on you in any other manner permitted by law.
`If you are being served on behalf of a corporation, an unincorporated association (including a partnership), or other entity, this
`form must be signed by you in the name of such entity or by a person authorized to receive service of process on behalf of such
`entity. In all other cases, this form must be signed by you personally or by a person authorized by you to acknowledge receipt of
`summons. If you return this form to the sender, service of a summons is deemed complete on the day you sign the
`acknowledgment of receipt below.
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`Date of mailing: 10/14/2021
`
`Sami Sedghani
`(TYPE OR PRINT NAME)
`
`
`~i
`
`~
`A
`(SIGNATURE OF SENDER
`
`
`ST NOT BE A PARTY IN THIS CASE)
`
`ACKNOWLEDGMENT OF RECEIPT
`
`This acknowledges receipt of (to be completed by sender before mailing):
`
`1. ~x A copy of the summons and of the complaint.
`Other (specify):
`2. 0
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`Civil Case Cover Sheet, Notice to Plaintiff of Case Management Conference, a copy of the
`Alternative Dispute Resolution (ADR) Information Package, Notice of Change of Address of Synergist Law
`
`(To be completed by recipient):
`
`Date this form is signed:
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`(TYPE OR PRINT YOUR NAME AND NAME OF ENTITY, IF ANY,
`ON WHOSE BEHALF THIS FORM IS SIGNED)
`
`(SIGNATURE OF PERSON ACKNOWLEDGING RECEIPT, WITH TITLE IF
`ACKNOWLEDGMENT IS MADE ON BEHALF OF ANOTHER PERSON OR ENTITY)
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`Form Adopted for Mandatory Use
`Judicial Council of California
`POS-015 [Rev. January 1, 2005]
`
`NOTICE AND ACKNOWLEDGMENT OF RECEIPT— CIVIL
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`Page 1 of 1
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`Code of Civil Procedure,
`§§ 415.30, 417.10
`www.courtinfo.ca.gov
`
`

`

`SUMMONS
`(CITACIOIV JUDICIAL)
`
`NOTICE TO DEFENDANT:
`(AVISO AL DEMANDADO):
`ZIMMER BIOMET SPINE INC AND DOES 1-10 INCLUSIVE
`
`YOU ARE BEING SUED BY PLAINTIFF:
`(LO ESTA DEMANDANDO EL DEMANDANTE):
`JANE PRATHER
`
`ave been sued. The court may decide against you wltnout your neing rneard unless you respo
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`FOR COURT USE ONLY
`(SOLO PARA USO DE LA CORTE)
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`be[ow.
`You have 30 CALENDAR DAYS after this summons and legal papers are served on you to file a written response at this court and have a copy
`served on the plaintiff. A letter or phone call will not protect you. Your written response must be in proper legal form if you want the court to hear your
`case. There may be a court form that you can use for your response. You can find these court forms and more information at the California Courts
`Online Self-Help Center (www.courtinfo.ca.gov/selfhelp), your county law library, or the courthouse nearest you. If you cannot pay the fi[ing fee, ask the
`court clerk for a fee waiver form. If you do not file your response on time, you may lose the case by defau[t, and your wages, money, and property may
`be taken without further warning from the court.
`There are other legal requirements. You may want to call an attorney right away. If you do not know an attorney, you may want to call an attorney
`referral service. If you cannot afford an attorney, you may be eligible for free legal services from a nonprofit legal services program. You can locate
`these nonprofit groups at the California Legal Services Web site (www.lawhelpcalifornia.org), the California Courts Online Self-Help Center
`(www.courtinfo.ca.gov/selfhelp), or by contacting your local court or county bar association. NOTE: The court has a statutory lien for waived fees and
`costs on any settlement or arbitration award of $10,000 or more in a civil case. The court's lien must be paid before the court will dismiss the case.
`iAVISO! Lo han demandado. Si no responde dentro de 30 dias, la corte puede decidir en su contra sin escuchar su version. Lea /a informacidn a
`continuaci6n.
`Tiene 30 DIAS DE CALENDAR/O despu6s de que le entreguen esta citacidn y papeles legales para presentar una respuesta por escrito en esta
`corte y hacer que se entregue una copia al demandante. Una carta o una llamada telefdnica no lo protegen. Su respuesta por escrito tiene que estar
`en formato legal correcto si desea que procesen su caso en la corte. Es posible que haya un formulario que usted pueda usar para su respuesta.
`Puede encontrarestos formularios de la corte y m6s informaci6n en el Centro de Ayuda de /as Cortes de Califomia (www.sucorte.ca.gov), en la
`biblioteca de leyes de su condado o en /a corte que le quede m6s cerca. Si no puede pagar la cuota de presentaci6n, pida al secretario de la corte que
`le dd un formulario de exencidn de pago de cuotas. Si no presenta su respuesta a tiempo, puede perder el caso por incumplimiento y la corte le podr6
`quitar su sueldo, dinero y bienes sin m Is advertencia.
`Hay otros requisitos legales. Es recomendable que llame a un abogado inmediatamente. Si no conoce a un abogado, puede Ilamar a un servicio de
`remisidn a abogados. Si no puede pagar a un abogado, es posib/e que cumpla con los requisitos para obtener servicios legales gratuitos de un
`programa de servicios legales sin fines de lucro. Puede encontrar estos grupos sin fines de lucro en el sitio web de Califomia Legal Services,
`(www.lawhelpcalifornia.org), en el Centro de Ayuda de /as Cortes de Califomia, (www. sucorte. ca. gov) o poni6ndose en contacto con la corte o e/
`colegio de abogados locales. AVISO: Por ley, /a corte tiene derecho a reclamar las cuotas y los costos exentos por imponer un gravamen sobre
`cualquier recuperacidn de $10, 000 6 mas de valor recibida mediante un acuerdo o una concesi6n de arbitraje en un caso de derecho civil. Tiene que
`pagar e/ gravamen de la corte antes de que la corte pueda desechar el caso.
`The name and address of the court is:
`(EI nombre y direccion de la corte es):
`400 McAllister Street
`San Francisco CA 94102-4515
`The name, address, and telephone number of plaintiffs attorney, or plaintiff without an attorney, is: (EI nombre, la direccidn y el numero
`de telefono del abogado del demandante, o del demandante que no tiene abogado, es):
`Sami Sedghani at Synergist Law P.C. (1 Sansome St Suite 3500, SF, CA 94104) 415-326-3708
`1
`DATE:
`Clerk, by
`(Fecha) ~(~021
`(Secretario) RONNIE OTERO
`/ ~~~~
`(For proof of service of this summons, use Proof of Service of Summons (form POS-010).)
`(Para prueba de entrega de esta citatidn use el formulario Proof of Service of Summons, (POS-010)).
`NOTICE TO THE PERSON SERVED: You are served
`as an individual defendant.
`as the person sued under the fictitious name of (specify):
`
`CASE NUMBER: (Nf]mero del Caso):
`
`Deputy
`(Adjunto)
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`[SEAL]
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`1. 0
`2.
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`3. x0 on behalf of (specify):
`under: Ox CCP 416.10 (corporation)
`CCP 416.20 (defunct corporation)
`~
`CCP 416.40 (association or partnership)
`0
`other (specify):
`0
`by personal delivery on (date):
`
`4. 0
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`SUMMONS
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`0
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`CCP 416.60 (minor)
`CCP 416.70 (conservatee)
`CCP 416.90 (authorized person)
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`Paae 1
`Code of Civil Procedure §§ 412.20, 465
`www.courts.ca.gov
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`Form Adopted for Mandatory Use
`Judicial Council of Califomia
`SUM-100 [Rev. July 1, 2009]
`
`

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`SAMI SEDGHANI, SBN 280437
`SYNERGIST LAW, P.C.
`One Sansome Street, Suite 3500-11
`San Francisco, CA 94104
`Tel: (415) 326-3708
`Email: sami@synergistlaw.com
`
`DANIEL AZIZI, SBN 268995
`DOWNTOWN L.A. LAW GROUP
`601 N. Vermont Ave.
`Los Angeles, CA 90004
`Tel: (213) 389-3765
`Fax: (877) 389-2775
`Email: Daniel@downtownlalaw.com
`
`Attorneys for Plaintiff,
`JANE PRATHER
`
`ELECTRONICALLI'
`FILED
`
`Superior Court of Californi
`County of San Francisco
`09/21/2021
`Clerk of the Court
`BY: RONNIE OTERO
`Deputy Cle
`
`SUPERIOR COURT OF THE STATE OF CALIFORNIA
`
`COUNTY OF SAN FRANCISCO
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`CGC-21-595$50
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`JANE PRATHER, an individual,
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`Case No:
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`Plaintiff,
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`(UNLIMITED CIVIL ACTION)
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`V.
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`ZIMMER BIOMET SPINE, INC., and
`DOES 1-10, inclusive.
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`Defendants.
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`COMPLAINT FOR PERSONAL INJURY
`AND DEMAND FOR JURY TRIAL
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`1. STRICT PRODUCT LIABILITY -
`MANUFACTURING DEFECT
`2. STRICT PRODUCT LIABILITY -
`DESIGN DEFECT
`3. STRICT PRODUCT LIABILITY -
`FAILURE TO WARN
`4. BREACH OF IMPLIED WARRANTY
`5. NEGLIGENCE
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`1
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`2
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`1
`COMPLAINT FOR PERSONAL INJORY /PRODUCT LIABILITY
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`1
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`Comes now Plaintiff JANE PRATHER and hereby complains and alleges as
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`2 I I follows:
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`3
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`4
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`5
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`6
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`SUMMARY OF THE ACTION
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`l.
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`This complaint brings claims against ZIMMER BIOMET SPINE, INC. ("ZBS"),
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`relating to a defective Mobi-C artificial disc ("Device") manufactured, and or designed
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`and or sold by ZBS which failed.;
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`7 2.
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`The Device placed in Plaintiff's body was designed, manufactured with a defect,
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`8
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`and breached their express and implied warranties, was defective and unreasonably
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`9 dangerous for its intended use because it deviated in one or more ways from the approved
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`10
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`11
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`12
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`specifications, manufacturing methods, or testing methods. Defendants were negligent in
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`the design, manufacture, and labeling of the Device and knew that its devices were failing
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`at an alarming and unacceptable rate and yet they continued to produce defective devices
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`13 knowing full well of the high risk of failure.
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`14 3.
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`The Device implanted in Plaintiff was designed, manufactured, and sold in
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`15 violation of federal
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`law and in violation of _ ZBS's federally-approved device
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`16
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`specifications. It contained a latent defect not disclosed to the Food and Drug
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`17 Administration ("FDA"), was adulterated, breached ZBS's express and implied
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`18 warranties, and was defective and unreasonably dangerous for its intended use. ZBS was
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`19 negligent in the design, manufacture, and labeling of the Device and was negligent in its
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`20 dissemination of product failures ;and issues with the Device.
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`21 4.
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`Defendants are liable to Plaintiff for all consequential damages Plaintiff has
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`22
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`23
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`incurred as a result of injuries to Plaintiff. Defendants are liable for Plaintiff's pain,
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`suffering, permanent disability, revision surgery, continued damage to her spine as a result
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`24 of the defective product, and subsequent surgery. Defendants are liable for any and all
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`25 other damages sustained by Plaintiff. Plaintiff demands a trial by jury.
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`26 5.
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`State law claims of negligence and strict liability in designing, manufacturing,
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`27 marketing, and distributing the Device is not preempted by Medical Device Amendments
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`28 I (MDA), even though the product is a class III device because the claims parallel federal
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`3
`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`1
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`2
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`requirements, it is not different from or in addition to the duties mandated by federal law,
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`and state law requirements imposed by negligence or strict liability are not specifically
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`developed with respect to medical devices. Federal Food, Drug, and Cosmetic Act, §§
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`510(k), 513(a)(1)(C), 515, as amended, 21 U.S.C.A. §§ 360(k), 360c(a)(1)(C), 360e; 21
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`5 C.F.R. § 886.4275. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). In Medtronic, a
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`6 majority of the court agreed that section 360k did not act as a bar. The court held that the
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`7
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`claims alleging defective manufacturing and labeling could proceed to the extent they
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`8 were based on a violation of Federal Laws which give rise to recovery under state law
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`9
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`10
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`11
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`12
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`even in the absence of the FDCA. These parallel state law claims are not preempted by
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`the FDCA.
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`6.
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`Plaintiff is thus suing for conduct that violates FDCA and State Law.
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`PARTIES
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`13 I fll
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`Plaintiff Jane Prather is an adult resident of California.
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`14 8.
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`Upon information and belief, Defendant ZBS is a Delaware corporation with its
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`15 principal place of business in 10225 Westmoor Dr, Colorado 90021 and is presently
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`16 qualified for the transaction of intrastate business in the State of California.
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`17 9.
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`The true names, identities, and capacities of those defendants designated as DOES
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`18 1 through 10, inclusive, and each of them, are unknown to Plaintiff, who sue said
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`19 defendants by such fictitiously designated names. Plaintiff is informed and believe and, on
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`20
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`the basis thereof, allege that each of the defendants designated herein as a DOE in some
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`21 way was legally responsible for the events herein alleged. Plaintiff will seek leave of
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`22 Court to set forth the true names, identities, and capacities of defendants designated as
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`23 DOES 1 through 10, inclusive when same has been ascertained.
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`24 10.
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`Collectively, ZBS and DOES lthrough 10 inclusive shall hereinafter be referred to
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`25
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`as "Defendants" or "All Defendants."
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`26 11.
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`Plaintiff is informed and believe and on the basis thereof alleges that Defendants
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`27 were responsible for the design, manufacturing, development, research, testing,
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`28
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`inspection, packaging, mass-production, advertisement, promotion, supply, distribution,
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`3
`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`1
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`sale, delivery, instructions on, warnings about, and labeling of the Device which injured
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`2 Plaintiff as described herein.
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`3
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`JURISDICTION AND VENUE
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`4 12.
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`The San Francisco Superior Court has jurisdiction over ZBS because it is a
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`5
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`corporation that has routine and continuous contact with the State of California by virtue
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`6 of the fact that it advertises and sells its products in this State, it recruits and employs
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`7
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`8
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`I individuals in this State and conducts business with its customers and business associates
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`in this state and it is registered to do business in this State.
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`9 13.
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`ZBS intentionally avails -itself of the benefits and protections of California law
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`10
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`11
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`such that the exercise of jurisdiction over it by the California courts is consistent with
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`traditional notions of fair play and substantial justice.
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`12 14.
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`Venue is proper in this Court pursuant to California Code of Civil Procedure
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`13 §395(a) in that none of the Defendants reside in California and Plaintiff has designated the
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`14
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`15
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`16
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`superior court of San Francisco as the county to try this case.
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`FACTUAL BACKGROUND
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`I. DISC REPLACEMENT
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`17 15.
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`The natural cervical intervertebral disc is a remarkable mechanical structure from
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`18
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`an engineering perspective. It has the ability to absorb a large compressive load while still
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`19 providing an impressive range of motion between the bones in the neck. Degenerative disc
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`20 disease, typically from repetitive stresses experienced during the normal aging process,
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`21
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`accounts for the large majority of operative conditions affecting the spine. The disease
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`22 progression
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`involves gradual weakening and thinning of the shock absorbing
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`23
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`24
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`intervertebral discs. The progressive changes in the discs can lead to a host of conditions,
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`including osteoarthritis, herniated disc, and spinal stenosis.
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`25 16.
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`Anterior cervical discectomy and fusion (ACDF) was historically the instrumented
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`standard of care for the treatment of cervical disc disease. ACDF surgery decompresses
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`the spinal nerves by removing the diseased cervical disc material, and then stabilizes the
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`26
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`27
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`28
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`4
`COIVIPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`1 vertebral segment by inserting bone grafts, interbody devices, and/or fixation systems
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`2
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`3
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`4
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`5
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`including screws and plates.
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`17. ACDF process eliminates the natural motion of treated segments, it is widely
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`accepted to induce hypermobility and heightened intradiscal pressures at adjacent levels
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`after surgery. Treatment with ACDF accelerates degeneration of adjacent spinal levels
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`6 post-surgery.
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`7
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`8
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`18.
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`Like fusion, cervical total disc replacement (cTDR) or artificial disc replacement
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`(ADR) removes the diseased cervical disc and restores the natural disc height,
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`9 decompressing the nerves causing pain. ADR devices are designed to maintain normal
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`10 spinal motion at the operated vertebral segments. By preserving segmental motion as well
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`11 as overall cervical spine biomechanics, cTDR has been shown to maintain preoperative
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`12 intradiscal pressures in adjacent segments.
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`13 19.
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`As the name implies, an artificial disc replacement ("ADR") is designed in such a
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`14 way that it imitates normal anatomy. Several artificial cervical discs have been developed
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`15 and are available as a surgical option to treat cervical disc problems that cause chronic
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`16 neck pain and other symptoms.
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`17 20.
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`The Mobi-C Cervical Disc (Mobi-C) (aka "Device") was first introduced outside
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`18 the United States (US) in November 2004 by LDR Spine, now part of Zimmer Biomet,
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`19 and has been implanted over 40,000 times. In 2006, LDR Spine initiated an
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`20 I Investigational Device Exemption (IDE) trial to obtain Food and Drug Administration
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`21 (FDA) approval for use of Mobi-C in the US.
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`22 21.
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`In 2013, Mobi-C got FDA approval for both one and two-level implantation. See
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`23 PMA P 110002 and P 110009.
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`24 22.
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`In 2015, FDA approved an update to the Mobi-C labeling to include five year
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`25 I clinical results.
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`26
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`II. TI€E MOBI-C O Device
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`27 23.
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`The Mobi-CO is a weight-bearing implant comprised of an ultra-high-molecular-
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`28 weight polyethylene (UHMWPE per ISO 5832-4) mobile insert sandwiched between two
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`~
`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`

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`1
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`2
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`3
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`spinal plates consisting of cobalt, chromium, molybdenum (CoCrMo per ISO 5832-12)
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`alloy with a titanium (per ASTM F1580) and hydroxyapatite (per ISO 13779) plasma
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`spray coating.
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`4 24.
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`The Mobi-C® UHMWPE mobile insert consists of a standard (symmetric) convex
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`5
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`6
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`7
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`8
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`spherical dome that is radiolucent. The mobile insert articulates with both the superior and
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`inferior device endplates, the inner contact surfaces of which are spherical and flat,
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`respectively. The bottom of the mobile insert contains a grooved feature to enhance
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`lubrication of the mobile insert and inferior endplate surfaces with bodily fluids.
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`9 25.
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`The mobile insert is self-centering on the inferior endplate. Each movement of the
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`10
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`superior plate induces the mobile insert to reposition on the inferior spinal plate, which
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`11 maintains the superior versus inferior vertebral alignment.
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`12 26.
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`The mobile insert is designed to articulate between the superior and inferior spinal
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`13 plates, which allows for multiaxial motion, including five independent degrees of freedom
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`14
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`that include two translational and three rotational.
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`15 27.
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`The Mobi-C® device is provided to surgeons pre-assembled in a sterile package
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`16
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`ready for use. All MobiC® components are sterilized using gamma radiation at a
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`17 minimum dose of 25 kGy.
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`18 28. When correctly manufactured without defects, the Mobi-C Prosthesis should
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`19 withstand the expected physiologic loads in the cervical spine without breakage.
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`20 29.
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`The Mobi-C Device is a class III medical device and received CE Mark approval
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`21
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`in 2004.
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`22 30.
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`Although the Medical Device Amendments ("MDA") established a separate
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`23
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`24
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`regime of premarlcet approval fo'r new Class III devices, it grandfathered many that were
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`already on the market. Devices sold before the MDA's effective date may remain on the
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`25 market until the FDA promulgates, after notice and comment, a regulation requiring
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`26 premarket approval. §§ 360c(f)(1), 360e(b)(1). A new device need not undergo premarket
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`27
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`approval if the FDA finds it is "substantially equivalent" to another device exempt from
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`28 premarket approval. § 360c(f)(1)(A).'
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`6
`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
`
`

`

`1
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`III.Federal Regulations that ZBS Was Required to Follow
`
`2 31. A device is deemed to be "adulterated" if, among other things, it fails to meet
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`3
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`established performance standards, or if the methods, facilities, or controls used for its
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`4 manufacture, packing, storage, or installation are not in conformity with federal
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`5
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`regulations pursuant to 21 U.S.C. § 351 and 21 C.F.R. Part 820.1(c).
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`6 32. A device is deemed to be misbranded if among other things, its labeling is false or
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`7 misleading in any particular way, or if it is dangerous to health when used in the manner
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`8
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`9
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`prescribed, recommended or suggested in the labeling thereof. See 21 U.S.C. § 352.
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`33.
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`ZBS is required to comply with applicable FDA regulations, including FDA
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`10
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`regulations relating to records and reports, in order to prohibit the introduction of inedical
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`11 devices that are adulterated or misbranded and to assure the safety and effectiveness of its
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`12 medical devices.
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`13 34.
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`Adverse events associated with a medical device must be reported to FDA within
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`14 30 days after the manufacturer becomes aware that a device may have caused or
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`15
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`16
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`contributed to death or serious injury, or that a device has malfunctioned and would be
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`likely to cause or contribute to death or serious injury if the malfunction was to recur.
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`17 Such reports must contain all information reasonably known to the manufacturer,
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`18
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`19
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`including any information that can be obtained by analysis, testing, or other evaluation of
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`the device, and any information in the manufacturer's possession. In addition,
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`20 manufacturers are responsible for conducting an investigation of each adverse event, and
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`21 must evaluate the cause of the adverse event. See 21 C.F.R. Part 803.50.
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`22 35. Manufacturers of inedical devices must also describe in every individual adverse
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`23
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`I event report whether remedial action was taken in regard to the adverse event, and
`24 whether the remedial action was reported to the FDA as a removal or correction of the
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`25 device. See 21 C.F.R. Part 803.52.
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`26 36. Manufacturers must report to the FDA in five business days after becoming aware
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`27
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`that a medical device reportable event necessitates remedial action to prevent an
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`28 unreasonable risk of substantial harm to the public health. Medical device reportable
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`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`1
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`2
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`events require the manufacturer to conduct a trend analysis that necessitates remedial
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`action to prevent an unreasonable risk of substantial harm to public health. See 21 C.F.R.
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`I Part 803.53
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`4 137
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`Device manufacturers must report promptly to the FDA any device corrections and
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`5
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`6
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`I removals, and maintain records of device corrections and removals. FDA regulations
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`require submission of a written report within ten working days of any correction or
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`removal of a device initiated by the manufacturer to reduce a risk to health posed by the
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`7
`8 device, or to remedy a violation of federal law caused by the device that may present a
`risk to health. The written submission must contain, among other things, a description of
`the event giving rise to the information reported and the corrective or removal actions
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`9
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`10
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`11
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`taken, and any illness or injuries that have occurred with use of the device, including
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`reference to any device report numbers. Manufacturers must also indicate the total number
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`12
`13 of devices manufactured or distributed which are subj ect to the correction or removal, and
`14 provide a copy of all communications regarding the correction or removal. See 21 C.F.R.
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`15 Part 806.10.
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`16 38.
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`FDA publishes all adverse event reports in a searchable Internet database
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`17
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`18
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`("MAUDE") that physicians and the general public can use, and if Defendants had
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`fulfilled their duty to report adverse events in a timely fashion as required under Federal
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`19 Law, the FDA would have issued its draft guidance before Plaintiff and his physician
`20 made the decision to implant the Device or in the alternative would not have identified the
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`21 defect sooner and explanted the device impeding any further permanent hearing
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`22 degradation.
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`23 39.
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`California law recognizes a duty to convey warnings through a third•parry (such as
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`24
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`25
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`the FDA) where that is the only available method to warn doctors and consumers. See
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`e.g., Persons v. Salomon North America, Inc. ( 1990) 217 Ca1.App.3d 168; 178.).
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`26 40.
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`Pursuant to federal regulations, the CGMPs require compliance with the following
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`27 quality system regulations:
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`28
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`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`1
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`2
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`3
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`4
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`5
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`6
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`13
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`14
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`15
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`a.
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`Manufacturers must meet design-control requirements, including without
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`limitation, conducting design verification and validation to ensure that devices
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`conform to defined use needs and intended uses;
`Manufacturers must establish purchasing controls to ensure that all
`b.
`purchased products, parts and components conform to specified requirements;
`in manufacturing and
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`Manufacturers must meet quality standards
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`C.
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`production;
`Manufacturers must establish and maintain procedures for implementing
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`d.
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`corrective actions and preventive actions;
`Manufacturers must investigate the cause of nonconforming product and
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`e.
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`take corrective action to prevent recurrence;
`Manufacturers are required to review and evaluate all complaints and
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`f.
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`determine whether an investigation is necessary;
`Manufacturers are also required to use statistical techniques where
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`g.
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`necessary to evaluate product performance.
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`16
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`See generally 21 C.F.R. Part 820.
`The CGMPs required that ZBS adequately validate all Devices by testing
`17 41.
`18 production lots under actual or simulated use conditions. 21 C.F.R. Part 820.30(g).
`The CGMPs required ZBS to investigate the cause of device failure in its implants
`19 42.
`and to take corrective action to prevent reoccurrences and to investigate clinical
`complaints from patients reporting erratic or non-functioning implants.
`As stated above, a manufacturer's failure to comply with CGMPs applicable to a
`22 43.
`device renders the device adulterated under the FDCA., 21 U.S.C. § 351(h); 21 C.F.R.
`23
`24 Part 820.1(c). Each introduction of an adulterated device into interstate commerce is a
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`20
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`21
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`25 violation of the FDCA. 21 U.S.C. § 331(a).
`A device is deemed adulterated if the methods used in, and the facilities and
`26 44.
`controls used for, its manufacture, packing, storage, and installation are not in conformity
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`27
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`28
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`11
`COMPLAINT FOR PERSONAL INJORY /PRODUCT LIABILITY
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`1 with CGMP requirements. Each introduction of an adulterated Device into interstate
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`2
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`commerce is a violation of federal law. 21 U.S.C. § 331(a).
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`3 45.
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`FDA regulations
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`require manufacturers
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`to submit Pre-Market Approval
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`4 Application ("PMA") supplements for changes that may affect the safety or effectiveness
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`5 of a device, including "[t]he use of a different facility or establishment to manufacture"
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`6
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`the device, and "[c]hanges in the performance or design specifications, circuits,
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`components, ingredients, principle of operation, or physical layout of the device." 21
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`7
`8 C.F.R. Part 814.39(a)(3) and (6). Such supplements are referred to as "180-day PMA
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`9
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`supplements."
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`Any change in specifications of the materials used in manufacture requires a 180-
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`10 46.
`11 day PMA supplement. A manufacturer may make a change to a device without filing a
`12 PMA supplement only if the change does not affect the device's safety or effectiveness
`and the change is reported to FDA in post-approval periodic reports. 21 C.F.R. Part
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`13
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`14 814.39(b).
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`15 47.
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`A device lacking necessary PMA approval (including approval of supplements) is
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`16 deemed adulterated. 21 U.S.C. § 351(f)(1)(B).
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`17 48.
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`Federal regulations require that a PMA supplement be submitted when
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`18 unanticipated adverse effects increases in the incidence of anticipated adverse effects, or
`19 device failures necessitate a labeling, manufacturing, or device modification. See 21
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`20 C.F.R. Part 814.39. ZBS did not submit a PMA supplement as required when the
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`21
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`incidence of adverse effects where higher than expected.
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`22 49.
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`After FDA has approved a PMA, an applicant must submit a PMA supplement for
`
`23
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`24
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`review and approval by FDA before making any change affecting the safety or
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`effectiveness of the device unless FDA has advised that an alternate type of submission is
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`25 permitted for a particular change. All changes must meet the requirements of the Quality
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`26 System regulation (current good manufacturing practices) under 21 CFR Part 820
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`including the design control requirements under §820.30. Changes for which an applicant
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`27
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`28
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`COMPLAINT FOR PERSONAL INJURY /PRODUCT LIABILITY
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`1 I I must submit a PMA supplement include, but are not limited to, the following types of
`changes if they affect the safety or effectiveness of the device:
`2
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`3
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`4
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`5
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`6
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`7
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`9
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`10
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`12
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`13
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`14
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`15
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`16
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`• new indication for use of the device;
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`•
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`labeling changes;
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`• the use of a different facility or establishment to manufacture, process, or
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`package the device;
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`• changes in manufacturing methods, or quality control procedures;
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`• changes in sterilization procedures;
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`•
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`•
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`changes in packaging;
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`changes in the performance or design specifications, circuits, components,
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`ingredients, principles of operation, or physical layout of the device; and
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`• extension of the expiration date of the device based on data obtained under a
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`new or revised stability or sterility testing protocol that has not been
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`approved by FDA. [If the protocol has been previously approved by FDA, a
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`supplement is not submitted but the change must be reported to FDA in the
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`postapproval periodic reports as described in §814.39(b).]
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`17 50.
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`Upon information and belief, ZBS failed to submitted design data and documents
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`18
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`relating to the use of changes in the manufacturing process, changes in sterilization
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`19 procedures and changes in its testing procedures for the Device after it had received the
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`20 original PMA approval.
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`21 51.
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`Upon information and belief, the specifications of the Device that injured Plaintiff
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`22 differed from those that the FDA had previously approved in one or more ways