Shannon Gallagher vs. Seikagaku Corporation

Motion for Summary JudgmentAdjudication

Cal. Super. - 4th Dist.July 6, 2015

H U R R E L L C A N T R A L L LL P LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Thomas C. Hurrell, State Bar No. 119876 E-Mail: thurrell@hurrellcantrall.com John V. McNulty, State Bar No. 290834 E-Mail: jmcnulty@hurrellcantrall.com Lisa Y. An, State Bar No. 242918 E-Mail: lan@hurrellcantrall.com HURRELL CANTRALL LLP 300 South Grand Avenue, Suite 1300 Los Angeles, California 90071 Telephone: (213) 426-2000 Facsimile: (213) 426-2020 Attorneys for Defendant, ZIMMER, INC. ELECTRONICALLY FILED Superior Court of California, County of Orange 05/02/2017 at 12:43:00 PM Clerk of the Superior Court By Nomi Lau, Deputy Clerk SUPERIOR COURT OF THE STATE OF CALIFORNIA COUNTY OF ORANGE, CENTRAL JUSTICE CENTER SHANNON GALLAGHER, Plaintiff, Vv. SEIKAGAKU CORPORATION, a Japanese corporation; ZIMMER, INC., a Delaware corporation; BRIGHT HEALTH PHYSICIANS OF PIH, a California corporation doing business as PIH HEALTH PHYSICIANS; ROBERT J. BOHR, M.D.; and DOES 1 through 20, Defendants. CASE NO. 30-2015-00796955-CU-MM-CJC DEFENDANT ZIMMER, INC.’S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF Assigned to Hon. Sheila Fell, Dept. C25 Filed concurrently with: 1. Separate Statement of Undisputed Material Facts; 2. Declaration of John V. McNulty; 3. Declaration of Hollace S. Rhodes; 4. Declaration of Seth Middleton; 5. [Proposed] Order; and 6. [Proposed] Judgment. Date: August 9, 2017 Time: 10:00 a.m. Dept.: C25 Reservation ID: 72581265 7/06/15 8/21/17 Action Filed; Trial Date; DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION THE ALTERNATIVE, SUMMARY ADJUDICATIO AND MOTION FOR SUMMARY JUDGMENT, OR, IN N OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 eo 0 Na AA Un sR W N M N O N O R N O N N N N N O N em em em e m p m e m mk mm e m p d Q 2 & Un A W N == O N D 00 N N RA W N = D TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on August 9, 2017, at 10:00 a.m., in Department "C25" of the Central Justice Center located at 700 Civic Center Drive West, Santa Ana, California 92701, Defendant ZIMMER, INC. (“Zimmer” or "Defendant") will move this Court for an order granting summary judgment in favor of Defendant and against Plaintiff SHANNON GALLAGHER (“Plaintiff”) for each of Plaintiff’s causes of action against Defendant pursuant to Code of Civil Procedure § 437(c), or alternatively, summary adjudication of issues. Summary judgment should be granted in favor of Defendant and against Plaintiff for the following reasons: As to Plaintiff's First Cause of Action for Strict Liability: I. Defendant is immune from suit for strict liability for injuries arising from Federal Food & Drug Administration (“FDA”) regulated Class III medical devices requiring a prescription from a physician. 2. Defendant cannot be held liable for strict liability based on design defect, as such claims are barred against suppliers of medical devices under California law. 3. Defendant cannot be held liable for strict liability based on manufacturing defect, as Defendant is only the distributor of the subject medical device. 4, Defendant cannot be held liable for strict liability based on warning defect, as this theory of liability can only be maintained under general negligence. As to Plaintiff’s Second Cause of Action for Negligence: 1. There is insufficient evidence to raise a triable issue of fact as to whether Defendant’s action(s) or omission(s) were the proximate cause of Plaintiff’s alleged injuries. 2. There is no evidence that Defendant is liable for Plaintiffs alleged injuries under a theory of negligent failure to warn due to the learned intermediary doctrine and Gel-One’s status as a FDA regulated Class III medical device. 3. There is no evidence that Defendant is liable for Plaintiff's alleged injuries under a negligent manufacturing defect theory. Di DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 Lo 0 9 A nN A W N = BN O N N N N N N N N e m e m em em mk md je m e d e d I A N nN A W N = S O N S N E W N Do This Motion is based upon this Notice, the attached Memorandum of Points and Authorities, the Declarations of John V. McNulty, Hollace S. Rhodes, and Seth Middleton, supporting exhibits, Defendant's Separate Statement of Undisputed Material Facts, this Court’s file, and upon such further evidence, both oral and documentary, as may be presented at or before the hearing on this Motion. DATED: May Z-,2017 HURRELL CANTRALL LLP orl he HOREALL Hn Ay Sh Attorneys for Defendant, ZIMMER, INC. 3 DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 hh A W N No 90 Na 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TABLE OF CONTENTS Page MEMORANDUM OF POINTS AND AUTHORITIES .....ooioiiieieeeceeeeeeeee e v 1 L INTRODUCTION. L..oiiiiiiireiciii cee sree eases eee te esas eset en sabes bs enn sna saese enn cone 1 II. STATEMENT OF UNDISPUTED MATERIAL FACTS. iiciiunnsnioninsussins sassssssssusssns sssasoiis 2 A. Background on Gel-One as a Regulated Class III Medical Device and Zimmer's Reels as a Distribuier of GeO. mum swam soos assmssmssssoamsm nise 2 B. Injection of Gel-One into Plaintiff's Knee on April 7, 2014. ....c.covevveniiininrnncnns 4 II. MOTION FOR SUMMARY JUDGMENT IS APPROPRIATE WHEN THERE ARE NO TRIABLE ISSUES OF MATERIAL FACT. ...ccoiiiitierininicetinieneereseveeec enna 5 IV. FEDERAL LAW PRE-EMPTS PLAINTIFF'S CLAIMS. o.oo 7 A. The Medical Device Amendments and FDA Regulatory Regime. ......ccccoocvivieiriceninecns 7 B. FDA Approval of Class III Medical Devices Through the PMA Process Preempts State Common Law Claims Concerning the Device’s Safety................... 9 C. Plaintiff’s Strict Liability and Negligence Claims are Preempted by the MDA. ............. 9 V. CALIFORNIA LAW BARS PLAINTIFF'S STRICT PRODUCTS LIABILITY CLAIM AGAINST ZIMMER. ....oiiiiiiiieiite eects sete eevee es 10 A. Plaintiff’s Claim for Strict Products Liability for Design Defects of Prescription- Only Medical Devices is Inapplicable..........cocovevieiiniencieree cesses 11 VI. THERE ARE NO TRIABLE ISSUES OF FACT CONCERNING PLAINTIFE’S NEGLIGENCE CLAIM AGAINST ZIMMER. iawn anemia ws 13 A. There Are No Triable Issues Of Fact Concerning A Negligent Failure To Warn Claim Because Zimmer Had No Duty To Warn Plaintiff. ............coccoociinins 13 B. There Are No Allegations Or Evidence Supporting a Cause of Action For Negligent Design Against ZIMIMEE. ....ccueiveeerireerioieriesiereeississsseresiesesseseseseessesaeseens 15 C. There Are No Triable Issues Of Fact For Manufacturing Defect Claim Under A Negligence Theory Against ZIMMET. ......c...couieerieiieiiiiieeieieceeeeee e e e e e esi ese evens 15 NH CONCLUSION miosis ssa eH A ARO A ARE ES 53 ARASH EASA 17 A- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 No 00 Na n t Ed W N N O N NN RN N N N N N m m e m e k je m mk mk mk e k pe d je w W 1 SN A W N = D S N 0 0 N t RAR W N = o TABLE OF AUTHORITIES Page CASES Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 853 ....c..ioiieerierriree reece 6 Armstrong v. Optical Radiation Corp.(1996) 50 Cal. App.4th at 587 .c.c.ovvvveiieiiiiiiicirccceieeee 9 Artiglio v. Superior Court (1994) 22 Cal. App.4th 1388, 1397 ...ooviiiiieieeeeceee veer 12 Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413,418 .....ccviiovieiieeeecrceeere ven 11, 16 Blanco v. Baxter Healthcare Corp. (2008) 158 Cal. App.4th 1039 ...ccovveiiiviiiieiiiieeecinesicse en 9 Bostick v. Flex Equip. Co. (2007) 147 Cal. App.4th 80, 87 ..c.ccvi ii, 12 Brown v. Superior Court (1988) 44 Cal.3d 1049, 1061 ......cveovrieiiieeee cerca passim Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1008 ......oooeveiiierceririirierecenecrereeeeee rees i 2 Crouse v. Brobeck, Phleger & Harrison (1998) 67 Cal.App.4th 1509, 1524.....ccoviviiieieiiiice 6 Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal. App.4th 779, 785 ooo 7 Garrett v. Howmedica Osteonica Corp. (2013) 214 Cal. App.4th 173, 190 ...c.ccovioiiniivniieircrrinen, 16 Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, 63 ...cccocceviievieriecrierireeeeiesieieens 11 Hufft v. Horowitz (1992) 4 Cal. APp.4th 8, 11 ...cciiiivreeiiiee eee teneeberer neseves 12, 16 Inre Coordinated Latex Glove Litigation (2002) 99 Cal. App.4th 594, 607......ccovcviiivvcrcinnnnne 16 Jessen v. Mentor Corp. (2008) 158 Cal. App.4th 1480, 1492 .....oovvevvvrieiiiireeeeee eee passim Jimenez v. Superior Court (2002) 29 Cal Ath 473; 4TT-478 .c...cocumssmasimismssisssrssamsassssasssssss ass 11 Jones v. P.S. Dev. Co. (2008) 166 Cal. App. 4th 707, 718 ...ccoiomiiiiiieiieteee erecta 6 Krasley v. Superior Court (1980) 101 Cal. App. 3d 425, 432 ooo, 6 Ladd v. County of San Mateo (1996) 12 Cal.4th 913, 917-918 ....oiiiiieie eee 13 Medtronic, Inc. v. Lohr (1996) S18 U.S. 470, 474 .....ccoiiiiiiiiiieeeeeeee ee 7,8,9 Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 478 ....cooveiiieiieeteeeeeeeeeeeee seen ne 10 Mirzada v. Department of Transportation (2003) 111 Cal. App.4th 802, 806-807 ........ccveevierecnnnee. 6 OL. Neil v. Crane Co. (2012) 53 Cal Atl 338, 347 rmsmmmemmmnnsrsmsemasmammsrs messmo 11 Plenger v. Alza Corp. (1992) 11 Cal. App.d4th 349, 360 .....cc.iivieivirieiriiericeiiee re se sr e 12 -ii- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S C U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 o w Na N n AR W N = N O R RN N N N O N N N e m e m e m ee d md em t fe d e d f d e d QR J S N Un hs WwW N e S $ C e N h BR W N e S Saelzler v. Advanced Grp. 400 (2001) 25 CalAth 763; TT5-T0...c.covnssswirsnivsssssvs sxssssinsansssssssssssssssssn 6 Scott v. CR. Bard, Inc. (2014) 231 Cal. App.4th 763 .....coiiiiiiiii cece, 11, 15 Scoft v. CIBA Vision Corp. (1995) 38 Cal. App. 307, 15. isan sass cos 7,9 Steele v. Collagen Corp. (1997) 54 Cal. App.4th 1474, 1488 cocoon 7,9, 10 STATUTES Cal Civ, Prac. Code § AB TEUOYZY ucum..5 5 555088 ee 55585.5 me htm in moi fr 5556580 G55 55 ANAS 5 ARREARS 6 Code Of Civil PFOCEAUFE § A3TC .ovoeeviiieieee ceric eects eevee esses sa eb ees ens sie sees eases anneanes 5 OTHER AUTHORITIES A] Co FB. Gp BBL MTN tiie tiie chats i i Sh eS i 8 21 CFR: G BOB. 1{d) cuties eee est s eases tenet estan eset teak ee bent e nares 8 21 TB :0, § BIE 500 5.0550700005 515 5-055. ins cmnmomsmmncs mmm marnsmsmmsc iim RGR RARA65 0 7 21 USC. § 300K coir atte be tabs ethers a eres 8 21 U.S.C §360€IAN2) werervereerersereeeseeeeeeeseseseese esses esessees sees s es seseessess esses esse sere essseeeees seers sseseesseens 7 -1ii- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 eo 0 Na A n t BR W N N N N N N N em em ee k em em t j m mm ed e k fe d RL ~~ S n A W N mE D O d N WN R W N = MEMORANDUM OF POINTS AND AUTHORITIES I. INTRODUCTION. This case arises from Plaintiff SHANNON GALLAGHER’S (“Plaintiff”) allegations that defendant ZIMMER, INC. (“Zimmer” or “Defendant”) is liable for a right knee infection that Plaintiff allegedly suffered as a result of co-defendant Dr. Robert Bohr injecting a single dose of Gel-One into Plaintiff's knee on April 7, 2014. Plaintiff contends that he sustained physical injuries and loss of past earnings as a result of the right knee infection and corresponding convalescence. Plaintiffs sets forth causes of action for strict liability and negligence against Zimmer, Gel-One is an injectable hyaluronate gel exclusively manufactured in Japan by Seikagaku Corporation (“Seikagaku”)' and distributed in the United States by Zimmer. It is a Federal Food & Drug Administration (“FDA”) approved and regulated Class III medical device used for the treatment of osteoarthritis of the knee and is only available to consumers via a physician’s prescription and administration. As will be shown, Zimmer respectfully submits that it is entitled to summary judgment or, in the alternative, summary adjudication on the following grounds. First, Plaintiff's state law claims for strict liability and negligence are both preempted by federal law. It is well-established in California that any state common law claims concerning the safety and effectiveness of an FDA approved Class III medical device, other than claims premised upon a violation of the device-specific FDA requirements, are preempted by the Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act. Here, Zimmer will establish that Gel-One is an FDA-approved and regulated Class III medical device that is only available through a physician’s prescription and subject to the requirements of the MDA. In addition, Plaintiff does not claim that Defendant violated any FDA requirements specifically relating to Gel-One. Because Plaintiff’s state law tort claims would impose liability by creating "In an Order dated J anuary 4, 2016, this Court dismissed Seikagaku on the grounds that the Court did not have personal jurisdiction over Seikagaku. (See Declaration of John V. McNulty [“McNulty Decl.”], 4 7). DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 Lo Le J a N nh EA W N N O O N N N N N O N N N ee e m mk em w k mm mm ee d e d e d WM XI A nN EA W N E D N N N EA W N = D requirements “different from” or “in addition to” the FDA’s requirements concerning Gel-One, both claims are barred by the express preemption provision for medical devices under 21 U.S.C. §360k(a). Therefore, Defendant is entitled to summary judgment on federal preemption grounds. Second, regardless of Plaintiff’s theory of products liability (design defect, manufacturing defect, or warning defect), his strict liability claim must be summarily adjudicated in Zimmer’s favor because: (1) Zimmer is only the distributor of Gel-One and therefore cannot be held liable under a manufacturing defect theory of liability; (2) California unequivocally bars strict liability claims based on design defect for suppliers of prescription drugs and medical devices [See Brown v. Superior Court (1988) 44 Cal.3d 1049, 1061]; and (3) a warning defect theory of liability can only be maintained under a general negligence theory. Third, Plaintiff's negligence claim must be summarily adjudicated because there is no duty to warn imposed upon Zimmer, as a supplier to Gel-One, to Plaintiff. In the prescription-only medical device context, the duty to warn a patient lies solely with the physician under the learned intermediary doctrine. See Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1008. Furthermore, there is no evidence that Zimmer negligently manufactured or handled the Gel-One unit at issue or that Defendant’s actions or omissions were a causal factor in Plaintiff's knee infection. Accordingly, Zimmer respectfully submits that it is entitled to summary judgment as to the case in its entirety, or in the alternative, summary adjudication of the issues discussed below. I. STATEMENT OF UNDISPUTED MATERIAL FACTS. A. Background on Gel-One as a Regulated Class III Medical Device and Zimmer’s Role as a Distributor of Gel-One. Gel-One is an injectable hyaluronate gel product used to treat osteoarthritis and other degenerative knee conditions. (Undisputed Material Fact [“UMF”] No. 1). Seikagaku is the exclusive manufacturer of Gel-One. (UMF No. 2). Pursuant to Federal Food and Drug Administration (“FDA”) regulation, no other manufacturer is permitted to manufacture Gel-One. (UMF No. 3). Seikagaku only manufactures Gel-One in facilities located in Japan. (UMF No. 4). Zimmer is a corporation incorporated in the State of Delaware. (UMF No. 5). Zimmer's D- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 o e Na S N hh RA W N - N O N N N N N N N N em p e mk em em em e m em e d 0 1 SN Nn EA W N E S O 0 a S N nn Ea W N = D business includes, but is not limited to, the marketing, sale, and distribution of pharmaceuticals and medical devices. (UMF No.6). Seikagaku and Zimmer are parties to a distributorship agreement, whereby Zimmer has the right to market, sell, and distribute Gel-One in the United States. (UMF No. 7). Pursuant to the distributorship agreement, Seikagaku delivers orders of Gel-One to Zimmer in Japan, and from there, Zimmer transports and distributes Gel-One in the United States. (UMF No. 8). Gel-One is an FDA regulated Class III medical device. (UMF No. 9). Class III medical devices are the most heavily regulated medical devices because Class III medical devices are those that support human life, sustain human life, or present an unreasonable risk of injury or illness when being used. (UMF No. 10). Because Class III medical devices are those that support human life, sustain human life, or present an unreasonable risk of injury or illness when being used, the IDA requires that each Class III medical device obtain specific FDA approval before it can be marketed and distributed for use. (UMF No. 11). In order to obtain approval from the FDA to market a Class III medical device, the manufacturer of the device, or other person or entity who developed or designed the device, must submit a pre-market approval (“PMA”) application with the FDA. (UMF No. 12). The approval process for a PMA application is the most stringent regulatory process employed by the FDA for medical devices. (UMF No. 13). When the FDA receives a PMA for a new Class III medical device, the FDA makes an in depth analysis of the supporting scientific, technical, and clinical data. (UMF No. 14). FDA approval of a PMA for a Class III medical device means that the FDA has determined that the device is safe and effective for its intended use and such safety and efficacy is supported by valid scientific evidence. (UMF No. 15). When the FDA denies a PMA, the corresponding device cannot be marketed. (UMF No. 16). Seikagaku submitted the PMA Application for Gel-One to the FDA on July 31, 2008. (UMF No. 17). Seikagaku was required to submit the PMA Application to the FDA due to Gel- One’s status as a Class III medical device. (UMF No. 18). Gel-One could not be marketed in the United States prior to FDA approval of the PMA for Gel-One. (UMF No. 19). The FDA’s Center _3- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 oo LL 9 A nN A W N N N N N N N N N N N N N DN N e m e m em em e m em e d e d e d ed QR J 4 Un A W N = O N N N R E W I N D for Devices and Radiological Health performed the Premarket Review of the PMA Application for Gel-One. (UMF No. 20). The FDA determined that Gel-One is safe and effective for the treatment of pain due to osteoarthritis of the knee and approved the PMA application for Gel-One on March 22, 2011, which is more than two years after Seikagaku submitted the application. (UMF No. 21). The FD&C Act requires that the FDA prepare a detailed summary of the safety and effectiveness data (“SSED”) on which its approval decision is based, and the FDA prepared an SSED for Gel-One. (UMF No. 22). In the letter approving Seikagaku’s Gel-One PMA Application, the FDA stated that “the sale and distribution of this device are restricted to prescription use in accordance with 21 CFR 801.109 and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (the act). The FDA has determines that this restriction on the sale and distribution is necessary to provide reasonable assurance of the safety and effectiveness of this device. Your device is therefore a restricted device subject to the requirements in section 502(q) and (r) of the act, in addition to the many other FDA requirements governing the manufacture, distribution, and marketing of devices.” (UMF No. 23). The FDA continues to regulate the design, manufacture, distribution, and marketing of Gel-One, as the FDA’s March 22, 2011 approval letter states: “Continued approval of this PMA is contingent upon the submission of periodic reports, required under 21 CFR 814.84, at intervals of one year (unless otherwise specified) from the date of approval of the original PMA.” The FDA's approval letter continues on state: “Before making any change affecting the safety or effectiveness of the device, you must submit a PMA supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39. All PMA supplements and alternate submissions (30-day notice) must comply with the applicable requirements in 21 CFR 814.39.” (UMF No. 24). To date, Gel- One remains a current and approved FDA Class IIT medical device. (UMF No. 25). B. Injection of Gel-One into Plaintiff’s Knee on April 7, 2014. Prior to April 2014, Plaintiff was experiencing pain in his right knee. (UMF No. 26). Plaintiff first went to Dr. Robert Bohr for treatment of his right knee pain in February of 2013. -4- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 No 0 N A A N hh BR W N N O N N N N N N N N E m em em je m md e d e d fe d pe @ N N N A W N = S Y N S N E W N ee © (UMF No. 27). Plaintiff went to see Dr. Bohr on March 31, 2014 specifically for treatment for the pain in Plaintiffs right knee. (UMF No. 28). At the appointment with Dr. Bohr on March 31, 2014, Dr. Bohr and Plaintiff discussed using Gel-One to treat Plaintiff’s right knee. (UMF No. 29). Plaintiff returned to Dr. Bohr’s office on April 7, 2014 to receive the Gel-One injection. (UMF No. 30). Dr. Bohr prescribed Gel-One to Plaintiff. (UMF No. 31). Prior to receiving the injection of Gel-One on April 7, 2014, Plaintiff executed an informed consent form for the Gel- One injection stating: “I have discussed the procedure listed above at length with my practitioner and I understand the options, risks, and benefits for treatment. I understand the common risks and complications which include, but are not limited to, anesthesia, bleeding, infection, damage to internal organs and scarring. I have had an opportunity to ask questions and have had all my questions answered. No guarantees were given or implied.” (UMF No. 32 [emphasis added]). On April 7, 2014, Dr. Bohr injected a single unit of Gel-One into Plaintiffs right knee. (UMF No. 33). No person, other than Dr. Bohr recommended that Plaintiff receive a Gel-One injection. (UMF No. 34). Dr. Bohr was the only person who injected Gel-One into Plaintiff’s right knee on April 7,2014. (UMF No. 35). II. A MOTION FOR SUMMARY JUDGMENT IS APPROPRIATE WHEN THERE ARE NO TRIABLE ISSUES OF MATERIAL FACT. Code of Civil Procedure § 437¢ provides in pertinent part: (@)(1) A party may move for summary judgment in an action or proceeding if it is contended that the action has no merit . . . (¢) The motion for summary judgment shall be granted if all the papers submitted show that there is no triable issue as to any material fact and that the moving party is entitled to a judgment as a matter of law . . . (H(1) A party may move for summary adjudication as to one or more causes of action within an action, one or more affirmative defenses, one or more claims for damages, or one or more issues of duty, if the party contends that the cause of action has no merit . . . (Cal. Civ. Proc. Code § 437¢). 5. DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 o e Na n y Ee W N = N O N N N N N N N N ee em je je m em em pe t e d je m e d 0 0 A dA W N = D Ne 0 d N N R W N e A defendant’s motion for summary judgment must be granted when the motion shows that there are no triable issues of material fact and that the defendant is entitled to judgment as a matter of law. (See Krasley v. Superior Court (1980) 101 Cal. App. 3d 425, 432). In bringing a motion for summary judgment or adjudication, the defendant has the burden of showing that the defendant has established an affirmative defense or that a plaintiff cannot establish one or more causes of action. (See Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 853; Cal. Civ. Proc. Code § 437¢(0)(2)). Once a defendant has met this burden, the burden then shifts to the plaintiff to show that triable issues of material fact exist concerning the defendant’s affirmative defense or the plaintiff's cause(s) of action. (See Aguilar, 25 Cal.4th at 855; Mirzada v. Department of Transportation (2003) 111 Cal.App.4th 802, 806-807). The plaintiff “cannot avoid summary judgment based on mere speculation and conjecture, but instead must produce admissible evidence raising a triable issue of fact.” (Jones v. P.S. Dev. Co. (2008) 166 Cal. App. 4th 707, 718 [citing Crouse v. Brobeck, Phleger & Harrison (1998) 67 Cal. App.4th 1509, 1524; see also Aguilar, 25 Cal.4th at 865). “The purpose of the law of summary judgment is to provide courts with a mechanism to cut through the parties’ pleadings in order to determine whether, despite their allegations, trial is in fact necessary to resolve their dispute.” (Id. at 843). In cases requiring causation, “[a] mere possibility of such causation is not enough; and when the matter remains on one of pure speculation or conjecture, or the probabilities are at best evenly balanced, it becomes the duty of the court to direct a verdict for the defendant.” (Saelzler v. Advanced Grp. 400 (2001) 25 Cal.4th 763, 775-76 [internal citations omitted]). As is shown below, Plaintiff cannot bring to bear any evidence of causation against Defendant in relation to Plaintiff's cause of action for negligence. And, importantly for this instant motion, a motion for summary judgment is the appropriate vehicle for the Court to determine the application of federal preemption to state law claims arising from the administration of FDA regulated Class III medical devices, like Gel-One. (See Jessen v. Mentor Corp. (2008) 158 Cal. App.4th 1480, 1492). Here, Plaintiff is unable to -6- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 w e e X N nn a 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 raise any triable issues of fact as to Defendant’s affirmative defense that Plaintiffs causes of action against Defendant are barred by federal preemption. IV. FEDERAL LAW PRE-EMPTS PLAINTIFF'S CLAIMS. Gel-One is a Class III medical device subject to federal preemption of any state or local requirements differing from or in addition to the federal regulations specific to Gel-One. As such, Plaintiff’s claims for strict liability and negligence against Zimmer are both preempted by federal law. (Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal. App.4th 779, 785) A. The Medical Device Amendments and FDA Regulatory Regime. The Medical Device Amendments (21 U.S.C. § 360c ef seq. )(“MDA”™) to the Federal Food, Drug, and Cosmetic Act (“FDCA”™) created a stringent {federal regulatory framework for medical devices, like Gel-One, in order to provide safe and effective medical devices for human use. (Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 474). The MDA classifies medical devices into three classes based upon the risk they pose, with Class III devices posing the greatest risk, and therefore, being subject to the most stringent controls. (21 U.S.C. § 360c; Medtronic, 518 U.S. at 476; Scott v. CIBA Vision Corp. (1995) 38 Cal. App. 307, 315). Before a Class II medical device can be brought to market, the manufacturer, or other entity that designed the device, must submit a pre-market approval application (“PMA”) to the FDA. (21 U.S.C. §360e(d)(2); Jessen v. Mentor Corp. (2008) 158 Cal. App.4th 1480, 1485-1486)(UMF No. 12). The FDA’s PMA review process is extremely rigorous, requiring the manufacturer to submit detailed safety and efficacy information, and the FDA spends an average of 1,200 hours on each PMA submission. (Medtronic, 518 U.S. at 477(UMF No. 13). Importantly, a Class III medical device’s labeling and warnings are subject to FDA regulation through the PMA process. (21 U.S.C. 360e(d)(2); Steele v. Collagen Corp. (1997) 54 Cal. App.4th 1474, 1488 [“FDA retains rigid control over the entirety of the labeling and packaging of class III products . . . the product's sponsor must submit a proposed label to the FDA for analysis and review prior to gaining PMA for the product.”]). The FDA must approve a Class III medical device before the device may be commercially distributed “to provide reasonable assurance of [its] safety and effectiveness.” (See 21 U.S.C. §§ Ps DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 eo 0 3 a N nh RAR W N = N O O N N N N N N N N em mm j m mk je k md j d fe d p d fe 0 J nh A W O N = S Y N S N N R W N ee 360c(a)(1)(C), 360e(d)(2); 21 C.F.R. § 870.3925(b); 21 C.F.R. § 814.1 et seq.)(UMF No. 11). Once the FDA has approved a PMA for a Class III medical device, the product can be sold in the U.S., but the product remains subject to the device-specific requirements and standards contained in the FDA approved PMA. (Jessen, 158 Cal. App.4th at 1486)(UMF Nos. 22-24). In fact, any changes to the manufacturing process, design, labeling, packaging, or indications for use of an FDA approved Class III medical device requires pre-approval by the FDA. (21 C.F.R. § 814.39). Most importantly, the MDA contains an express preemption provision, which provides in relevant part: “[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” (21 U.S.C. § 360k). In interpreting § 360k of the MDA, the FDA issued a regulation providing that “State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements.” (21 C.F.R. § 808.1(d).) A state law requirement may be “established by statute, ordinance, regulation, or court decision” (21 C.F.R. § 808.1(b) [emphasis added]). “Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the [MDA], the agency is uniquely qualified to determine whether a particular form of state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress, [citation] and, therefore, whether it should be pre-empted.” (Medtronic, 518 U.S. at 496.) And, “[t]he design, manufacture, and labeling of the device, as approved by the FDA as safe and effective after the device has undergone the PMA process, are the specific federal requirements giving rise to _8- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 Lo e e Na S N nn RA W N N O N O R N N N N N N N e e m e m em em je m md e d e m e d XR 0 A N BR W O N eM O O 00 N N R W N = D preemption. They constitute a federal regulatory standard of care.” (Steele, 54 Cal.App.4th at 1489.) Therefore, state common law claims may be preempted when there are specific FDA requirements for a medical device, like a specifically approved PMA. (Jessen, 158 Cal. App.4th at 1487-1488; Armstrong v. Optical Radiation Corp.(1996) 50 Cal.App.4th at 587). B. FDA Approval of Class 111 Medical Devices Through the PMA Process Preempts State Common Law Claims Concerning the Device’s Safety. Since the landmark Medtronic, Inc. v. Lohr Supreme Court case, California courts have consistently held that all state common law claims concerning the safety and effectiveness of an FDA approved medical device, other than claims premised upon a violation of the device specific FDA requirements/regulations, are preempted by the MDA. For instance, in Blanco v. Baxter Healthcare Corp. (2008) 158 Cal. App.4th 1039, a case concerning an FDA approved Class III heart valve device, the Court of Appeal upheld the trial court’s grant of the defendant’s motion for summary judgment on the grounds that the plaintiffs’ state common law claims for negligent manufacture, negligent failure to warn, strict product liability, and breach of implied warranty were all preempted by the MDA. (Blanco, 158 Cal. App.4th at 1060). The court in Blanco stated that while the Supreme Court in Medtronic had a fractured decision, “{ive Justices agreed ‘state common-law damages actions do impose ‘requirements’ and are therefore preempted where such requirements would differ from those imposed’ by the MDA” (Id. at 1054 [citing Medtronic, 518 U.S. at 509]; see also Steele, 54 Cal. App.4th at 1489 [Holding that “state requirements in the form of standards of care or behavior are preempted and cannot form the basis of a state common law claim for damages if they are different from or in addition to the specific federal requirements arising from the PMA process”]; Scott, 38 Cal. App.4th at 318-319 [“[r]ecent cases ... illustrate the complete preemptive effect of the PMA process on state law tort claims involving inadequate labeling or failure to warn”]). C. Plaintiffs Strict Liability and Negligence Claims are Preempted by the MDA. Here, Plaintiff’s two causes of action against Defendant for strict products liability and negligence are both state common law claims. Both claims are preempted by the MDA. Gel-One 9. DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P LO S A N G E L E S , CA LI FO RN IA 50 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 W I N n A W N = N O O N N O N N R N N N N em em je m em mm em pe w j m Je m e d RL N N N nn A W N = DS 9 0 N N N A W N = e is an FDA approved Class III medical device. (UMF Nos. 9, 21-25). The PMA for Gel-One was submitted for FDA review on July 31, 2008. (UMF No. 17). The PMA detailed the results of clinical trials supporting Gel-One’s safety and efficacy. (UMF Nos. 14, 15). After a stringent review process by a team of physicians, engineers, biocompatibility experts, statisticians, and other scientists, the FDA approved the PMA for Gel-One on March 22, 2011, nearly 3 years later. (UMF Nos. 15-22). In accordance with the FDA's regulations specific to Gel-One, Gel-One is only available to the public through a physician’s prescription. (UMF No. 23). In addition, at all relevant times Gel-One remained and continues to remain subject to FDA regulation and oversight. (UMF Nos. 24, 25). This evidence is sufficient to establish that Gel-One meets the requirements for federal preemption under the MDA. The burden of establishing preemption is on Defendant. (Steele, 54 Cal. App.4th at 1490). To meet this burden, Defendant must “prove, by way of its statement of undisputed facts, that [Gel-One] was designed, manufactured, and labeled according to the specifications approved by the FDA.” (Jessen, 158 Cal.App.4th at 1492 [citing Steele, 54 Cal. App.4th at 1490]). This burden can be met by submitting declarations demonstrating compliance with the FDA specifications. (Jessen, 158 Cal. App.4th at 1492). Here, Defendant has met its burden to establish preemption by presenting evidence that Gel-One is an FDA approved Class III medical device that is only available through a prescription. As such, Defendant respectfully requests that this Court dismiss each of Plaintiff’s causes of action against Defendant with prejudice. V. CALIFORNIA LAW BARS PLAINTIFE’S STRICT PRODUCTS LIABILITY CLAIM AGAINST ZIMMER. With a claim based on products liability, the plaintiff may seek recovery on one of two theories - strict liability in tort or negligence. (See Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 478). Products liability focuses responsibility for defects, whether negligently or non-negligently caused, on the manufacturer of the completed product. (/d. at 478-479). Thus, under the strict liability or negligence tort theories, the plaintiff must prove that a defect caused the injury. (See -10- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 Oo 0 N n AR W N N O N N N N N N N N E E ee j m em em t e d ml f e d e d RX 3 A Nn EA W N S Y N N N RA W N = e Scott v. CR. Bard, Inc. (2014) 231 Cal. App.4th 763). A product’s alleged defect may be either in the design or manufacture of the product, but, under a negligence theory, the plaintiff must also prove that the alleged defect was due to negligence of the defendant. (/d. at 479). The doctrine of strict products liability imposes strict liability in tort on the manufacturer of a defective product and others in the product's chain of distribution. (See Jimenez v. Superior Court (2002) 29 Cal.4th 473, 477-478; Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, 63). The purpose of the imposition of liability is to ensure that the loss is borne not by injured consumers but by manufacturers and others in the chain of distribution who are better able to reduce the risks of injury and can equitably distribute the loss to the consuming public. (See Jimenez, 29 Cal. 4th at 477-478). Strict products liability has been imposed under three separate theories: 1) manufacturing defects for defects arising from flaws in the manufacturing process; 2) design defects for defects in the design rendering a product unsafe; and 3) warning defects for inadequate warnings or failure to warn. (See O'Neil v. Crane Co. (2012) 53 Cal.4th 335, 347); Brown v. Superior Court (1988) 44 Cal.3d 1049, 1057). A product is defective in design if the benefits of the design do not outweigh the risk of danger inherent in the design (risk-benefit test), or if the product fails to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner (consumer expectations test). (See Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 418). Here, based upon Plaintiff’s allegations in the Complaint, Plaintiff brings his strict liability claim under the design defect theory. Plaintiff specifically alleges that “Gel-One was defective and unsafe for its intended purpose in that it contained bacteria and/or other organisms or material which were unsafe for injection into the human body and would cause severe physical injuries.” (Complaint § 15). A. Plaintiff’s Claim for Strict Products Liability for Design Defects of Prescription-Only Medical Devices is Inapplicable. Controlling California law unequivocally bars strict liability claims for design defect against manufacturers of medical devices available only through a physician’s prescription. (See -11- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN !A 80 07 1 e R S N nn A W N — mk j m md f m md ed AN nN BE W N = DO 17 18 19 20 21 22 23 24 25 26 27 28 Brown v. Superior Court (1988) 44 Cal.3d 1049.) The California Supreme Court in Brown v. Superior Court, held that a supplier” of prescription drugs cannot be strictly liable for a design defect and that the appropriate test for determining a prescription drug manufacturer's liability for a design defect involves an application of the ordinary negligence standard. (Id. at 1061). In a series of cases in the early 1990°s, California courts applied the exclusion of prescription drugs from strict liability for design defects to implanted medical devices prescribed by a doctor. (See Hufft v. Horowitz (1992) 4 Cal.App.4th 8, 11; Plenger v. Alza Corp. (1992) 11 Cal. App.4th 349, 360; Artiglio v. Superior Court (1994) 22 Cal.App.4th 1388, 1397). The court in Hufft held that, like prescription drugs, implanted medical devices are available only through the services of a physician and can alleviate pain and suffering, sustain life, or provide other important benefits. (Hufft, 4 Cal. App.4th at 18). But, as is true of prescription drugs, harm to some users from implanted medical devices is unavoidable. (Id At 18-19). The Court of Appeal in Artiglio concluded that this exemption from strict liability for design defects is categorical and not to be determined on a case-by-case basis. (Artiglio, 22 Cal.App.4th at 1395-1397). As the foregoing cases make clear, a plaintiff may not maintain a strict liability claim against the supplier of an implanted prescription medical device on the basis of an alleged design defect. Here, Plaintiff’s strict liability claim premised upon a design defect with Gel-One cannot be maintained. Gel-One is an FDA approved and regulated injectable medical device that is only available through a physician. (UMF Nos. 21-25). As a matter of public policy, the FDA has determined that Gel-One is a beneficial therapeutic when prescribed and administered by a physician. (UMF Nos. 21-25). Because Gel-One is a medical device that is only available through a prescription from a physician, Plaintiff cannot prevail on his claim for strict liability under a design defect theory. ? California law provides that strict liability tort regime applies to all material participants in the chain of distribution of an allegedly defective product, which includes the distributor. (Bostick v. Flex Equip. Co. (2007) 147 Cal.App.4th 80, 87). As the distributor of Gel-One in the United States, Defendant is an integral part of Gel-One’s supply chain, and therefore, the strict liability regime set forth in Brown and its progeny applies to Defendant. -12- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 o a aN Un A W 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 B. Manufacturing Defect and Warning Defect Claims Concerning Prescription Only Medical Devices are not Available Under Strict Products Liability. As noted above, Brown and its progeny held that a plaintiff cannot maintain a strict liability design defect cause of action regarding a prescription-only medical device, but a plaintiff may maintain a manufacturing and/or warning defect claim regarding a prescription-only medical device under a negligence cause of action. (Brown, 44 Cal.3d at 1069, fn. 12 [“Our conclusion does not mean, of course, that drug manufacturers are free of all liability for defective drugs. They are subject to liability for manufacturing defects, as well as under general principles of negligence, and for failure to warn of known or reasonably knowable side effects.”]). Thus, Plaintiff can still maintain a manufacturing defect or warning defect claim premised upon ordinary negligence, but as shown below, there are no issues of material facts concerning either theory. VI. THERE ARE NO TRIABLE ISSUES OF FACT CONCERNING PLAINTIFF'S NEGLIGENCE CLAIM AGAINST ZIMMER. The elements of a negligence cause of action are the existence of a legal duty of care, breach of that duty, and proximate cause resulting in injury. (See Ladd v. County of San Mateo (1996) 12 Cal.4th 913, 917-918). Here, there is no evidence, nor even allegations in the Complaint, showing that Defendant had a legal duty of care towards Plaintiff, that Defendant breached that duty, and that such breach was the proximate cause of Plaintiff’s alleged injuries. A. There Are No Triable Issues Of Fact Concerning A Negligent Failure To Warn Claim Because Zimmer Had No Duty To Warn Plaintiff. Plaintiff's negligent failure to warn (i.e. warning defect) claim against Defendant must be summarily adjudicated because Defendant had no duty to warn Plaintiff regarding any potential adverse effects of Gel-One. Because Gel-One is only available through a physician, a physician prescribing Gel-One to a patient has the exclusive duty to warn the patient regarding Gel-One’s potential adverse effects. a. The Learned Intermediary Doctrine. The California Supreme Court has held that “[m]anufacturers are strictly liable for injuries -13- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 eo ee J a nt a W N N O O N NN N N N N N N e m em e m em em em em em es RL 3 A n A W N e m o N 8 0 N N R W = D caused by their failure to give warning of dangers that were known to the scientific community at the time they manufactured and distributed the product{.]” (Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1108 [citing Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987, 1003). In the medical device context, California applies the “learned intermediary” doctrine, which provides that the duty to warn runs to the physician, not the patient. (See Carlin, 13 Cal.4th at 1112-13 [emphasis added]: see also Plenger. 11 Cal.App.4th at 362 [for prescription medical devices, the “consumer” was the physician]). California courts have extended the learned intermediary doctrine to implantable medical devices in addition to prescription drugs. (See e.g. Valentine v. Baxter Healthcare Corp. (1999) 68 Cal.App.4th 1467, 1483). “In the case of prescription drugs and implants. the physician stands in the shoes of the ‘ordinary user’ because it is through the physician that a patient learns of the properties and proper use of the drug or implant. Thus, the duty to warn in these cases runs to the physician, not the patient.” (Id). “The rationale of the foregoing rule is: (1) The doctor is intended to be an intervening party in the full sense of the word. Medical cthics as well as medical practice dictate independent judgment, unaffected by the manufacturer's control, on the part of the doctor. (2) Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it, and in his limited understanding he might actually object to the use of the drug. thereby jeopardizing his life. (3) It would be virtually impossible for a manufacturer to comply with the duty of direct warning, as there is no sure way to rcach the patient.” (Fogo v. Cutter Laboratories, Inc. (1977) 68 Cal.App.3d 744, 754-755 [citation omitted]). Here. the evidence shows that Zimmer was the distributor of Gel-One. (UMF No. 7-8). And, Gel-One is an FDA approved and regulated medical device that is only available through a physicians prescription. (UMF Nos. 21-25). Defendant Dr. Robert Bohr recommended and prescribed Gel-One to Plaintiff and subsequently injected the Gel-One into Plaintiff’s right knee on April 7, 2014. (UMF Nos. 29-35). Zimmer had no interaction whatsoever with Plaintiff concerning the recommendation, prescription, and administration of Gel-One in this case. As a -14- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 w w NN = oe Ww 3 NN W n 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 matter of law, Zimmer had no duty to warn Plaintiff regarding the Gel-One product, and therefore Plaintiff cannot prevail on a negligent failure to warn claim against Zimmer. B. There Are No Allegations Or Evidence Supporting a Cause of Action For Negligent Design Against Zimmer. In order to prevail on a negligent design claim, a product designer must fail to use the amount of care in designing the product that a reasonably careful designer would use in similar circumstances. (See Scott v. C.R. Bard, Inc. (2014) 231 Cal.App.4th 763, 778). As an initial matter, there are no allegations in the Complaint stating that Gel-One was designed in a negligent fashion. Nor are there any contentions in Plaintiff's discovery responses regarding a negligent design claim. Most importantly, Defendant did not design Gel-One, but rather, is the sole distributor of Gel-One in the United States. (UMF Nos. 2, 3, 7, 8). Therefore, a negligent design claim is inapplicable to Defendant because Defendant had no role in designing and manufacturing Gel- One. (UMF No. 2, 3). Seikagaku, which is not a party to this action, designed Gel-One as a Class III medical device and this design was subjected to a rigorous review by the FDA in order to ensure Gel-One’s safety and efficacy. (UMF Nos. 12-22). The FDA only permitted the sale of Gel-One after this review process, and the FDA mandated that Gel-One only be available through a physician. (UMF Nos. 21-23). Any subsequent changes to the design of Gel-One after the FDA'’s initial approval must also be reviewed by the FDA prior to being implemented. (UMF No. 24). As detailed in the Sect. III of this Motion, this heavily regulated design approval process is one of the marquee rationales for preempting state common law claims, like negligent design. The law simply does not permit common law tort claims attacking the design of FDA regulated Class III medical devices like Gel-One. C. There Are No Triable Issues Of Fact For Manufacturing Defect Claim Under A Negligence Theory Against Zimmer. As discussed above, while Plaintiff may not maintain a strict product liability claim against Defendant because Gel-One is a prescription-only medical device, he may maintain a -15- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P LO S A N G E L E S , C A L I F O R N I A 80 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 30 0 S O U T H G R A N D AV EN UE , SU IT E 13 00 ae ee a S n A W N = N O N N N N N N N N Em Em em me e k m d em mk je m RX 9 A N hn A W N = S D R d S n RAR W N = D manufacturing defect claim under a negligence theory. (See Brown, 44 Cal.3d at 1069; Huff, 4 Cal. App.4th at 19-20). A manufacturing defect exists when a product is produced in a substandard condition, and such a defect typically demonstrated by showing the product performed differently from other ostensibly identical units of the same product line. (See Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 429). Put another way, there is a manufacturing defect if the product, as manufactured, does not conform to the manufacturer's design. (See In re Coordinated Latex Glove Litigation (2002) 99 Cal. App.4th 594, 607). And, a manufacturing defect can only be the legal cause of a plaintiff's injury if the plaintiff can establish that the alleged “defect was a substantial factor in producing the injury.” (Garrett v. Howmedica Osteonica Corp. (2013) 214 Cal. App.4th 173, 190). Here, Plaintiff’s manufacturing defect claim under negligence cannot withstand scrutiny. First and foremost, Defendant has never manufactured Gel-One at any point in time. (UMF Nos. 2, 3). In fact, FDA regulations preclude Defendant from manufacturing Gel-One. (UMF No. 3). Therefore, Defendant cannot be liable for manufacturing defect. Moreover, there is absolutely no evidence, nor any allegations in the Complaint, showing that the Gel-One unit injected into Plaintiff’s knee on April 7, 2014 had a manufacturing defect. There is no evidence that the Gel-One unit at issue did not conform to Seikagaku’s FDA approved design for the product. Lastly, there is no evidence that the Gel-One unit issue performed differently than other Gel-One units. Simply put, there is no evidence that there was a manufacturing defect. Accordingly, Plaintiff cannot prevail on a manufacturing defect claim under general negligence against Defendant. 111 111] /1/ Il 117 111 _16- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 oo LL uO Sa nn A W N nN No no No no no no nN nN Jt Jk fo ) pk pd pk Jk Jd pk — NN & n t BEA W N = O N O NN S N N E W N = Oo VII. CONCLUSION. Based on the foregoing, Defendant Zimer, Inc. respectfully requests that this Court enter summary judgment in its favor and against Plaintiff Shannon Gallagher. In the alternative, Defendant respectfully requests summary adjudication on one or more of Plaintiff's claims against Defendant as determined by the Court. DATED: May Z 2017 HURRELL CANTRALL LLP By: —< SHA HOMAS C. HU LL LIS . AN OHN V. MCNULTY Attorneys for Defendant, ZIMMER, INC. =] 7s DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 LO S A N G E L E S , C A L I F O R N I A 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 eo 0 Nu Sa n t A W N BN O N N N O N N N N em em e m em em e m em e m e k e d WW N N N A W N E S 0 NN S N EA W O N - = oO PROOF OF SERVICE STATE OF CALIFORNIA, COUNTY OF LOS ANGELES At the time of service, I was over 18 years of age and not a party to this action. I am employed in the County of Los Angeles, State of California. My business address is 300 South Grand Avenue, Suite 1300, Los Angeles, California 90071. On May 2, 2017, I served true copies of the following document(s) described as DEFENDANT ZIMMER, INC.’S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF on the interested parties in this action as follows: SEE ATTACHED SERVICE LIST BY MAIL: I enclosed the document(s) in a sealed envelope or package addressed to the persons at the addresses listed in the Service List and placed the envelope for collection and mailing, following our ordinary business practices. I am readily familiar with Hurrell Cantrall’s practice for collecting and processing correspondence for mailing. On the same day that the correspondence is placed for collection and mailing, it is deposited in the ordinary course of business with the United States Postal Service, in a sealed envelope with postage fully prepaid. I declare under penalty of perjury under the laws of the State of California that the foregoing is true and correct. Executed on May 2, 2017, at Los Angeles, California. Yvont Sandoval -iv- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF H U R R E L L C A N T R A L L LL P 30 0 S O U T H G R A N D A V E N U E , SU IT E 13 00 LO S A N G E L E S , CA LI FO RN IA 90 07 1 T E L E P H O N E (2 13 ) 42 6- 20 00 No 0 a a t e W N N O O N O N N N N N N N em m a e s pe el mk e d es d be d pe ed e d 0 J SN RA W N mem D X N N N R W O N = D SERVICE LIST Gallagher v. Seikagaku Corp., et al. Case No. 30-2015-00796955-CU-MM-CJC Shannon Gallagher, Esq. In Pro Per Gallagher & Moore 2 Park Plaza #680 Irvine, CA 92614 (949) 955-2880 sgallagher@gallagherandmoore.com Mitzie L. Dobson Co-Counsel of Robert J. Bohr, M.D. and Shareholder Bright Health Physicians of PIH Bonne Bridges O’Keefe & Nichols 355 S. Grand Avenue, Suite 1750 Los Angeles, CA 90071-1562 Phone: (213) 480-1900 Fax: (213) 607-5588 mdobson@bonnebridges.com mruoccol{@bonnebridges.com Stephen M. Padilla, Esq. Counsel for Plaintiff Padilla & Associates 3020 Old Ranch Pkwy Ste 300 Seal Beach, CA 90740 Phone Number: (562) 799-5567 Fax Number: (562) 596-0900 smpadillas(@earthlink.net -Y- DEFENDANT ZIMMER, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT, OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION OF ISSUES; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF