Order After Hearing POSCal. Super. - 6th Dist.May 24, 2018\OOONONUIALQNH NNNNNNNMNHHHHHp-IHHx-H WNQKJ’IAUJN-‘OOWNQLh-PWNHO SupenorCo :. ‘ - mffiév Santa Clara /_ 1:6“! SUPERIOR COURT OF CALIFORNIA COUNTY 0F SANTA CLARA LAWRENCE HASHA, et al., Case No. 18-CV-328673 Plaintiffs, ORDER RE: DEMURRER vs. ARASH PADIDAR, et al., Defendants, The demuner by defendants Terumo Medical Corporation (“Terumg”) and St. Jude Medical LLC, formerly known as St. Jude Medical, Inc., to the third amended complaint (“TAC”) ofplaintiffs Lawrence Hasha (“Lawrence”) and Elena Hasha (collectively, “Plaintiffs”) came on for hearing before the Honorable Mary E. Arand on July 21, 2020, at 9:00 a.m. in Department 21.1 The matter having been submitted, the Court finds and orders as follows: ' At times, the Court refers to the parties by their first names for purposes of clarity. (See Rubenstein v. Rubenstein (2000) 81 CaI.App.4th 113 l, 1136, fi1. 1.) 1 ORDER RE: DEMURRER 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 \oooslamhmm Factilal and Procedural Background This action arises out of interventional radiology procedures performed on Lawrence by various doctors over the course of two days in March 2017. (TAC, 1H] FR-2, FR-S, IT-l, & GN- 1.) Plaintiffs allege that they did not consent to the procedures, they were misled as t0 Who would conduct the procedures, and the doctors failed t0 adequately treat and obtain care for Lawrence. (Id. at 1m FR-2, FR-3, FR-4, IT-I, & GN-l .) As a result, Plaintiffs suffered injuries. (Id. at 1H] 11, FR-6, IT-l, & GN-I.) Plaintiffs further allege that they were injured by defective Angio-Seal devices that were used in the procedures. (Id. at 1H Prod. L-l-Prod. L-12.) Based on the foregoing allegations, Plaintiffs filed the operative TAC against numerous defendants, including Terumo and St. Jude Medical LLC, alleging causes of action for: (1) fiaud; (2) violation of the Consumers Legal Remedies Act; (3) products liability; (4) battery; (5) breach of fiduciary duty; (6) negligence; (7) elder abuse and neglect; (8) negligence; and (9) negligent infliction of emotional distress. On March 5, 2020, Terumo and St. Jude Medical LLC (hereinafier collectively “Defendants”) filed the instant demurrer. Plaintiffs filed an opposition to the demurrer on June 10, 2020. On June 16, 2020, Defendants filed a reply. The demurrer originally proceeded to hearing on June 23, 2020, but was continued due to the illness ofPlaintiffs’ counsel to July 21, 2020. Discussion Defendants demur to the third cause 0f action ofthe TAC on the ground of failure to allege facts sufficient t0 constitute a cause of action. (See Code Civ. Proc., § 430. 1 0, subd. (6).) I. Request for Judicial Notice Defendants ask the Court to take judicial notice of matters reflected in: (1) the Food and Drug Administration (“FDA”) premarket approval (“PMA”) database listing for the Angio-Seal device; and (2) the FDA PMA approval database listing for changes to the Angio-Seal device. Defendants assert that matters reflected in the FDA PMA database listings for the Angio-Seal device are judicially noticeable under Evidence Code section 452, subdivisions (c) and (h). 2 ORDER RE: DEMURRER \OOOQONUIhUJNP-A NNNNNNNMNv-tp-Hr-nr-IHHHHH OOQQm-PWNFOWWQQMQWNHO The FDA PMA database listings for the Angio-Seal device are proper subjects ofjudicial notice under Evidence Code section 452, subdivision (c) as the FDA’s approval of the Angio- Seal device, and changes thereto, constitute official acts. (See Peeple v. Morales (2018) 25 Cal.App.5th 502, 5 12, fil. 7 [taking judicial notice of materials on an official government website, which discussed official acts].) In opposition, Plaintiffs object to Defendants’ request for judicial notice. However, Plaintiffs waived their objections to the request for judicial notice by failing to oppose the Court’s grant ofthe same judicial notice request in prior demurrer proceedings. (See Shuster v. BAC Home Loans Servicing, LP (2012) 211 Cal.App.4th 505, 5 12, fil. 4.) Accordingly, Defendants’ request for judicial notice is GRANTED. II. Legal Standard The function 0f a demurrer is to test the legal sufficiency of a pleading. (Trs. OfCapital Wholesale Elec. Etc. Fund v. Shearson Lehman Bros. (1990) 221 Cal.App.3d 617, 621.) Consequently, “ ‘[a] demurrer reaches only to the contents of the pleading and such matters as may be considered under the doctrine ofjudicial notice’ [citation].” (Hilltop PrOperties, Inc. v. State (1965) 233 Cal.App.2d 349, 353; see Code Civ. Proc., § 430.30, subd. (a).) “ ‘It is not the ordinary function 0f a demurrer to test the truth of the allegations [in the challenged pleading] or the accuracy with which [the plaintiff] describes the defendant’s conduct; . .. .’ [Citation.] Thus, ‘the facts alleged in the pleading are deemed to be true, however improbable they may be. [Citation.]’ [Citations.]” (Align Technology, Inc. v. Tran (2009) 179 Cal.App.4th 949, 958.) However, while “[a] demurrer admits all facts properly pleaded, [it does] not [admit] contentions, deductions or conclusions oflaw or fact.” (George v. Automobile Club ofSouthem California (201 1) 201 Cal.App.4th 1112, 1120.) III. Third Cause of Action Defendants argue the third cause of action fails t0 state facts sufficient to constitute cause of action under state law and fails to state facts sufficient to avoid preemption by federal law. In the third cause of action for products liability, Plaintiffs allege they were injured on or about March 7 through 9, 2017, by three Angio-Seal devices. (TAC, 1[ Prod. L-l .) Each of the 3 ORDER RE: DEMURRER OKOOOQQMAUJNH NNNNNNNNMHH-sp-IHH-np-np-IH mqom-KWNHOCOOQONLh-PWNH Angio-Seal devices bore a St. Jude Medical label and reference number. (Ibid.) The products contained a manufacturing defect, which caused each of the Angio-Seals t0 malfunction when installed in Lawrence “in such a manner as to come apart, migate downstream, obstruct profusion, and thereby proximately cause [Lawrence’s] arterial occlusion and right leg amputation.” (Id. at 1m Prod. L-2 & Prod. L-S.) The Angio-Seal devices were allegedly defective when they lefi Defendants’ control, and each 0f the Defendants knew the products would be purchased and used without inspection for defect. (1d. a; 1H] Prod. L-2 & Prod. L-4.) At the time of injury, the products were being used in the manner intended by Defendants. (Id. at 1] Prod. L-4.) Plaintiffs were allegedly purchasers of the products, “a user of the products, “a bystander t0 the use of the product,” and “a patient in whom product was deployed.” (Id. at 11 Prod. L-3.) Plaintiffs allege that their injuries were the proximate result 0f the strict liability of the Defendants who distributed, manufactured, and assembled the products. (Id. at 1H] Prod. L-4, Prod. L-7, Prod. L-9, Prod. L-l 1, & Prod. L-12.) Plaintiffs further allege that their injuries were the proximate result of the negligence of Defendants, who “owed a duty t0 [them] to manufacture safe, nondefective products.” (Id. at 11 Prod. L-6.) Defendants “negligently breached said duty by allowing the aforesaid Angio-Seals to be manufactured with the aforesaid dangerous defects." (Ibid) Plaintiffs’ third cause 0f action is for negligent and stn'ct product liability. (See Jiminez v. Sears, Roebuck & C0. (1971) 4 Cal.3d 379, 387 [in a products liability action, the plaintiff may assert liability under a theory of strict liability in tqn 0r 0n the theory 0f negligence]; accord Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 478 (Merrill).) “Strict product liability may be premised upon a theory 0f design defect, manufacturing defect or failure to warn.” (Chavez v. Glock. Inc. (2012) 207 Cal.App.4th 1283, 1302.) “ ‘The elements 0f a strict products liability cause of action are a defect in the manufacture or desigl of the product or a failure to warn, causation, and injury.’ [Citations.] More specifically, plaintiff must ordinarily show: ‘ ‘(1) the product is placed on the market; (2) there is knowledge that it will be used without inspection for defect; (3) the product proves t0 be defective; and (4) the defect causes injury....’ ’ [Citation.]” (Nelson v. Super. Ct. (2006) 144 Ca1.App.4th 689, 695, 4 ORDER RE: DEMURRER \OOONO‘M-hWNH NNNNNNNNNHHHHt-nr-Ir-Hr-Ap-A WNONLh-hMNHODmQONLh-hL-HNHO emphasis omitted; see also Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, 62.) Notably, duty is not an element of a claim for strict product liability. (Elsheref supra, 223 Cal.App.4th at pp. 463-64.) To adequately plead a negligence claim, a plaintiffmust allege that the defendant owed a legal duty, thdt the defendant breached the duty, and that the breach was a proximate or legal cause of the plaintiff’s injuries. (Merrill, supra, 26 Cal.4th at p. 477.) “Under a negligence theory, a plaintiffmust also prove ‘an additional element, namely, that the defect in the product was due to negligence of thé defendant.’ ” (1d. at p. 479.) Defendants initially contend that Plaintiffs fail to state a claim for strict product liability or negligence because Plaintiffs do not allege specific facts regarding the nature of the alleged manufacturing defect or the manner in which the Angio-Seal devices used in Lawrence deviated fiom the Angio-Seal design. Defendants do not cite any legal authority providing that Plaintiff must plead such facts in order to state a claim for strict product liability or negligence based on an alleged manufacturing defect. Because Defendants’ position is unsupported by legal authority, it is deemed t0 lack merit and requires no further discussion. (See Schaefl'er Land Trust v. San Jose City Council (1989) 215 Cal.App.3d 612, 619, fn. 2 (Schaejj’er) [“[A] point which is merely suggested by a party’s counsel, with no supporting argument or authority, is deemed to be without foundation and requires no discussion.”].) Next, Defendants assert that Plaintiffs fail t0 state a claim for negligence because Plaintiffs do not adequately allege the elements of duty and breach. In the third cause of action, Plaintiffs expressly allege that Defendants distn'buted, manufactured, and assembled the Angio- Seal devices. (TAC, 1H] Prod. L-4, Prod. L-7, Prod. L-9, Prod. L-l 1, & Prod. L-12.) Plaintiffs were allegedly purchasers 0f the products, “a user 0f the products, “a bystander to the use of the product,” and “a patient in whom product was deployed.” (Id. at 1] Prod. L-3.) The Angio-Seal devices contained the alleged manufacturing defect when they lefi Defendants’ control, and each ofthe Defendants knew the products would be purchased and used without inspection for defect. (Id. at 1m Prod. L-2 & Prod. L-4.) Plaintiffs further allege that Defendants owed them a legal duty “t0 manufacture safe, nondefective products” and Defendants “negligently breached said 5 ORDER RE: DEMURRER \OOOQOLh-PUJN 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 duty by allowing the aforesaid Angio-Seals to be manufactured with the aforesaid dangerous defects.” (Id. at 11 Prod. L-6.) Defendants do not discuss these allegations or cite any legal authority showing that these allegations are insufficient t0 plead the elements 0f duty and breach. Consequently, Defendants’ argument is not well-taken. (See Schaeffer, supra, 215 Ca1.App.3d at p. 619, fn. 2 [“[A] point which is merely suggested by a party’s counsel, with no supporting argument or authority, is deemed t0 be without foundation and requires no discussion.”].) Lastly, Defendants argue the third cause 0f action is preempted by federal law. The Angio-Seal line ofproducts are line of vascular closure devices used by surgeons to close arteries after certain medical procedures. (See Gomez v. St. Jude Medical Daig Div. Inc. (5th Cir. 2006) 442 F.3d 919, 924 (Gomez).) The FDA designates each Angio-Seal a Class III medical device, i.e., device which “present[s] ‘potential unreasonable risk of illness or injury’ or which [is] ‘purported 0r represented t0 be for use in supporting or sustaining human life 0r for use which is 0f substantial importance in preventing impairment 0fhuman health.’ ” (Id. at p. 928, quoting 21 U.S.C. 3600(a)(1)(C).) The Federal Food, Drug, and Cosmetic Act 0f 1938 (“FDCA”), as amended by the Medical Device Amendments of 1976 (“MDA”), “ “imposed a regime of detailed federal oversight’ including a ‘rigorous regime ofpremarket approval’ for class III medical devices.” (Coleman v. Medtro'm‘c, Inc. (2014) 223 Ca1.App.4th 413, 422 (Coleman).) Class III medical devices, such as the Angio-Seal devices, must obtain premarket approval from the FDA before they are put on the market. (See 21 U.S.C. 3606(d)(2).) The judicially noticeable matedals show that the FDA granted PMA for Angio-Seal devices under the MDA. (See also Gomez 442 F.3d at 926 [stating that Angio-Seal devices have obtained the approval of the FDA through the PMA procedure].) “The MDA expressly preempts any state law that imposes ‘with respect to a device intended for human use any requirement--[1]] (1) which is different from, 0r in addition t0, any requirement applicable under this chapter to the device, and [fl] (2) which relates t0 the safety or effectiveness of the device or t0 any other matter included in a requirement applicable to the device under this chapter.’ [Citation.]” (Coleman, supra 223 Ca1.App.4th at p. 423.) 6 ORDER RE: DEMURRER \och‘mhwmha NNNNNNNNpr-Ip-HHHHHHp-t OOQOUIAWNP-‘OOM‘QONUI#UJNF‘O The United States Supreme Court established a two-step fiamework for determining whether the MDA expressly preempts a state law claim. (Coleman. supra 223 Cal.App.4th at p. 423.) “First, the FDA must have established ‘requirements’ applicable to the particular medical device at issue.” (Ibid) Second, “state law claims are preempted if they impose requirements that relate to safety and effectiveness and are “different from, or in addition to” the requirements under federal law.” (Ibid.) “ State law requirements can be established by either statute or common law.” (Ibid.) “State law causes of action that provide ‘a damages remedy for claims premised on a violation ofFDA regulations’ are not expressly preempted if they ‘ “parallel,” rather than add to, federal requirements.’ ” (1bid.) “A state law cause of action for violation of the FDCA is barred under the doctrine of implied preemption if it is cognizable only by virtue of the provisions ofthe FDCA itself, rather than traditional state tort law.” (Coleman, supra 223 Cal.App.4th at p. 425.) In sum, “[i]n order to state a claim that avoids both express and implied preemption, a ‘H plaintif must be suing for conduct that violates the FDCA (or else his claim is expressly preempted .. ., but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted )” ’ [Citation] Stated differently, to survive both express and implied preemption, a state law cause of action ‘must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.’ [Citation.]” (Coleman, supra 223 Cal.App.4th at p. 427.) Here, only express preemption appears to be at issue. Turning to the two-part test for express preemption, the PMA requirements applicable to class III medical devices, like the Angio-Seal devices, satisfy the first prong of the test. (See Coleman, supra 223 Cal.App.4th at p. 424.) With reSpect to the second prong, Plaintiffs’ common law tort claim for strict product liability and negligence would impose a safety or effectiveness requirement on Angio-Seal devices. The question here is whether the claim seeks to impose a requirement that is different fiom or in addition to the requirements imposed by federal law. 7 ORDER RE: DEMURRER OOOONJQU‘I-hUJNH NNNNNNNNNH-An-AHHH-IHr-ar-t WMQMhWNHomeQM$WNH Courts are divided regarding the factual allegations that a plaintiff must plead to avoid preemption 0n the ground that the claim imposes requirements that relate t0 safety and effectiveness and are different from or in addition to the requirements under federal law. Some courts require the plaintiff to specifically plead that the state law claims are parallel t0 federal requirements by alleging facts showing that the defendant violated a particular federal specification referring to the device at issue. (See e.g‘, Walicki-Gables v. Arrow Intern, Inc. (1 1th Cir. 201 I) 634 F.3d 1296, 1301; Evraets v. Intermedics Intraocular, Inc. (1994) 29 Ca1.App.4th 779, 794.) Other courts have held that claims of negligence and strict liability for a defective product can survive preemption at the pleading stage based 0n general allegations that the defendant violated federal law. (See e.g., Bausch v. Stiyker Corp. (7th Cir. 201 0) 630 F.3d 546, 554, discussing 1n re Medtronic, Ina, Sprint Fidelis Leads Products Liability Litigation (8th Cir. 2010) 623 F.3d 1200, 1206 [“Plaintiffs primarily argue that the [district court] held them to an impossible pleading standard because the FDA’s specific federal manufacturing requirements are set forth in the agency’s PMA approval files that are accessible, without discovery, only to [the defendant] and to the FDA. This argument-which focuses 0n the timing 0f the preemption ruling-would have considerable force in a case where a specific defective Class III device injured a consumer, and the plaintiff did not have access t0 the specific federal requirements in the PMA prior to commencing the 1awsuit.”]; Coleman, supra, 223 Cal.App.4th at p. 436.) The Court is inclined t0 agree that, at the pleading stage, general allegations that the defendant violated federal law are sufficient. Nonetheless, Plaintiffs’ pleading does not include even general allegations regarding parallel claims. In the third cause of action, Plaintiffs do not allege that Defendants’ conduct violated the FDCA or that the Angio-Seal devices used in Lawrence were defective because they failed to comply with the manufactun'ng specifications required by the PMA granted by the FDA. Therefore, Plaintiffs have not alleged sufficient facts to survive preemption. 8 ORDER RE: DEMURRER \OOOleUl-hwmp-u NNNNNNNNN-‘HHu-av-fiHw-ab-n OOQONMAUJNHOWOO‘QONLh-bUJNHO Accordingly, the demurrer to the third cause of action is SUSTAINED, with 10 days’ leave t0 amend afier service of the sigled order. July ”127/, 2020 ”4‘4“?st Mary E. Arand Judge of the Superior Court 9 ORDER RE: DEMURRER SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA DOWNTOWN COURTHOUSE 191 NORTH FIRST STREET SAN JOSE, CALIFORNIA 951 13 CIVIL DIVISION RE: Lawrence Hasha et al vs Arash Radidar et al Case Number: 18CV328673 0f Sanfa Clara DEPUTY PROOF 0F SERVICE ORDER RE: DEMURRER was delivered t0 the parties listed below the above entitled case as set forth In the sworn declaration beiow. If you. a party represented by you or a witness to be called on behalf of that party need an accommodation under the American with Disabflities Act please contact the Coun Administrator's office at (408) 882-2700 or use the Court's TDD line (408) 882-2690 or the VoicelTDD California Relay Service (800) 735-2922. DECLARATION 0F SERVICE BY MAIL: l declare that | served this notice by enclosing a true copy in a sealed envelope addressed to each per50n whose name is shown betow and by depositing the envelope with postage fully prepaid in the United States Mail at San Jose. CA on July 24. 2020 CLERK OF THE COURT, by Donna 0'Hara Deputy cc: Stephen K Rose PO BOX 29393 San Francisco CA 94129 Elspeth Victoria Hansen Mayer & Brown LLP 2 Palo Alto Square #300 3000 El Camino Real Pan Alto CA 94306 Bradford J Hinshaw Hinshaw Marsh Stitl & Hinshaw LLP 12901 Saratoga Ave Saratoga CA 95070 CW-9027 REV 12/08/16 PROOF 0F SERVICE
