Minute OrderCal. Super. - 6th Dist.May 24, 2018SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER Lawrence Hasha et al vs Arash Radidar et al 18CV328673 Hearing Start Time: Hearing Type: 9:00 AM Hearing: Demurrer Date 0f Hearing: 07/21/2020 Comments: Heard By: Arand, MaryE Location: Department 21 Courtroom Reporter: - N0 Court Reporter Courtroom Clerk: Donna O'hara Court Interpreter: Court Investigator: Parties Present: Future Hearings: Exhibits: - No appearance. No one called t0 contest the Tentative Ruling. The tentative ruling is adopted. See below for ruling. Case Name: Lawrence Hasha, et al. v. Arash Padidar, et al. Case N0.: 18-CV-328673 Currently before the Court is the demurrer by defendants Terumo Medical Corporation (Terumo ) and St. Jude Medical LLC, formerly known as St. Jude Medical, |nc., t0 the third amended complaint (TAC ) 0f plaintiffs Lawrence Hasha ( Lawrence ) and Elena Hasha (collectively, Plaintiffs ).1 Factual and Procedural Background This action arises out of interventional radiology procedures performed 0n Lawrence by various doctors over the course oftwo days in March 2017. (TAC, FR-2, FR-5, |T-1, & GN-l.) Plaintiffs allege that they did not consent t0 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 FR-2, FR-3, FR-4, |T-1, & GN-l.) As a result, Plaintiffs suffered injuries. (Id. at 11, FR-6, |T-1, & GN-l.) Plaintiffs further allege that they were injured by defective Angio-Seal devices that were used in the procedures. (Id. at Prod. L-1-Pr0d. L12.) Based 0n the foregoing allegations, Plaintiffs filed the operative TAC against numerous defendants, including Terumo and St. Jude Medical LLC, alleging causes 0f action for: (1) fraud; (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 0f emotional distress. Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 1 0f 7 SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER On March 5, 2020, Terumo and St. Jude Medical LLC (hereinafter collectively Defendants ) filed the instant demurrer. Plaintiffs filed an opposition t0 the demurrer 0n June 10, 2020. On June 16, 2020, Defendants filed a reply. The demurrer originally proceeded t0 hearing 0n June 23, 2020, but was continued clue to the illness of Plaintiffs counsel t0 July 21, 2020. Discussion Defendants demur t0 the third cause 0f action 0f the TAC 0n the ground 0f failure t0 allege facts sufficient t0 constitute a cause 0f action. (See Code Civ. Proc., 430.10, subd. (e).) I. Request forJudicial Notice Defendants ask the Court t0 take judicial notice 0f matters reflected in: (1) the Food and Drug Administration ( FDA) premarket approval ( PMA ) database listing for the AngioSeaI device; and (2) the FDA PMA approval database listing for changes t0 the Angio-Seal 1 At times, the Court refers t0 the parties by their first names for purposes 0f clarity. (See Rubenstein v. Rubenstein (2000) 81 Cal.App.4th 1131, 1136, fn. 1.) device. Defendants assert that matters reflected in the FDA PMA database listings for the Angio-Seal device arejudicially noticeable under Evidence Code section 452, subdivisions (c) and (h). 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 0f the Angio-Seal device, and changes thereto, constitute official acts. (See People v. Morales (2018) 25 Cal.App.5th 502, 512, fn. 7 [takingjudicial notice 0f materials 0n an official government website, which discussed official acts].) In opposition, Plaintiffs object t0 Defendants request forjudicial notice. However, Plaintiffs waived their objections t0 the request forjudicial notice by failing t0 oppose the Court s grant 0f the same judicial notice request in prior demurrer proceedings. (See Shuster v. BAC Home Loans Servicing, LP (2012) 211 Cal.App.4th 505, 512, fn. 4.) Accordingly, Defendants request forjudicial notice is GRANTED. ||. Legal Standard Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 2 0f 7 SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER The function 0f a demurrer is t0 test the legal sufficiency ofa pleading. (Trs. Of Capital Wholesale Elec. Etc. Fund v. Shearson Lehman Bros. (1990) 221 Cal.App3d 617, 621.) Consequently, [a] demurrer reaches only t0 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 t0 test the truth 0f the allegations [in the challenged pleading] 0r the accuracy with which [the plaintiff] describes the defendant s conduct. . [Citation] Thus, the facts alleged in the pleading are deemed t0 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 of law or fact. (George v. Automobile Club 0f Southern California (2011) 201 Cal.App.4th 1112, 1120.) |||. Third Cause 0f Action Defendants argue the third cause 0f action fails t0 state facts sufficient t0 constitute cause 0f action under state law and fails t0 state facts sufficient t0 avoid preemption by federal law. In the third cause 0f action for products liability, Plaintiffs allege they were injured 0n 0r about March 7 through 9, 2017, by three Angio-Seal devices. (TAC, Prod. L-l.) Each of the Angio-Seal devices bore a St. Jude Medical label and reference number. (|bid.) The products contained a manufacturing defect, which caused each 0f the Angio-Seals t0 malfunction when installed in Lawrence in such a manner as t0 come apart, migrate downstream, obstruct profusion, and thereby proximately cause [Lawrence s] arterial occlusion and right leg amputation. (Id. at Prod. L-2 & Prod. L-5.) The Angio-Seal devices were allegedly defective when they left Defendants control, and each 0f the Defendants knew the products would be purchased and used without inspection for defect. (Id. at Prod. L-2 & Prod. L-4.) At the time 0f injury, the products were being used in the manner intended by Defendants. (Id. at Prod. L-4.) Plaintiffs were allegedly purchasers 0f the products, a user 0f the products, a bystander t0 the use 0f the product, and a patient in whom product was deployed. (Id. at 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 Prod. L-4, Prod. L-7, Prod. L-9, Prod. L- 11, & Prod. L-12.) Plaintiffs further allege that their injuries were the proximate result 0f the negligence 0f Defendants, who owed a duty t0 [them] to manufacture safe, nondefective products. (Id. at Prod. L-6.) Defendants negligently breached said duty by allowing the aforesaid Angio-Seals t0 be manufactured with the aforesaid dangerous defects. (|bid.) Plaintiffs third cause 0f action is for negligent and strict 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 0f strict liability in tort 0r 0n the theory 0f negligence]; accord Merrill v. Navegar, Inc. (2001) 26 Ca|.4th 465, 478 (Merrill).) Strict product liability may be premised upon a theory 0f design defect, manufacturing defect 0r failure t0 Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 3 0f 7 SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER warn. (Chavez v. Glock, Inc. (2012) 207 Cal.App.4th 1283, 1302.) The elements ofa strict products liability cause of action are a defect in the manufacture 0r design of the product or a failure to warn, causation, and injury. [Citations.] More specifically, plaintiff must ordinarily show: (1) the product is placed 0n 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 Cal.App.4th 689, 695, emphasis omitted; see also Greenman v. Yuba Power Products, Inc. (1963) 59 Ca|.2d 57, 62.) Notably, duty is not an element 0f a claim for strict product liability. (Elsheref, supra, 223 Cal.App.4th at pp. 463-64.) T0 adequately plead a negligence claim, a plaintiff must allege that the defendant owed a legal duty, that the defendant breached the duty, and that the breach was a proximate 0r legal cause 0f the plaintiff s injuries. (Merrill, supra, 26 Ca|.4th at p. 477.) Under a negligence theory, a plaintiff must also prove an additional element, namely, that the defect in the product was due t0 negligence 0f the defendant. (Id. at p. 479.) Defendants initially contend that Plaintiffs fail t0 state a claim for strict product liability 0r 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 from the Angio-Seal design. Defendants d0 not cite any legal authority providing that Plaintiff must plead such facts in order t0 state a claim for strict product liability 0r negligence based on an alleged manufacturing defect. Because Defendants position is unsupported by legal authority, it is deemed t0 lack merit and requires n0 further discussion. (See Schaeffer Land Trust v. San Jose City Council (1989) 215 Cal.App.3d 612, 619, fn. 2 (Schaeffer) [ [A] point which is merely suggested by a party s counsel, with no supporting argument 0r authority, is deemed to be without foundation and requires n0 discussion. ].) Next, Defendants assert that Plaintiffs fail t0 state a claim for negligence because Plaintiffs d0 not adequately allege the elements 0f duty and breach. In the third cause 0f action, Plaintiffs expressly allege that Defendants distributed, manufactured, and assembled the Angio-Seal devices. (TAC, Prod. L-4, Prod. L-7, Prod. L-9, Prod. L-ll, & Prod. L-12.) Plaintiffs were allegedly purchasers 0f the products, a user 0f the products, a bystander t0 the use 0fthe product, and a patient in whom product was deployed. (Id. at Prod. L-3.) The Angio-Seal devices contained the alleged manufacturing defect when they left Defendants control, and each 0f the Defendants knew the products would be purchased and used without inspection for defect. (Id. at 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 duty by allowing the aforesaid Angio-Seals to be manufactured with the aforesaid dangerous defects. (Id. at Prod. L-6.) Defendants d0 not discuss these allegations 0r cite any legal authority showing that these allegations are insufficient t0 plead the elements 0f duty and breach. Consequently, Defendants argument is not weII-taken. (See Schaeffer, supra, 215 Cal.App.3d at p. 619, fn. 2 [ [A] point which is merely suggested by a party s counsel, with n0 supporting argument 0r authority, is deemed t0 be without foundation and requires n0 discussion. ].) Lastly, Defendants argue the third cause 0f action is preempted by federal law. Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 4 0f 7 SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER The Angio-Seal line 0f products are line 0f vascular closure devices used by surgeons t0 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 ||| medical device, i.e., device which present[s] potential unreasonable risk 0f illness 0r injury 0r which [is] purported 0r represented t0 be for use in supporting 0r sustaining human life 0r for use which is 0f substantial importance in preventing impairment 0f human 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 0f 1976 ( MDA ), imposed a regime 0f detailed federal oversight including a rigorous regime 0f premarket approval for class ||| medical devices. (Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4th 413, 422 (Coleman).) Class ||| medical devices, such as the Angio-Seal devices, must obtain premarket approval from the FDA before they are put 0n the market. (See 21 U.S.C. 3606(d)(2).) The judicially noticeable materials 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 0f the FDA through the PMA procedure].) The MDA expressly preempts any state law that imposes with respect t0 a device intended for human use any requirement [] (1) which is different from, 0r in addition t0, any requirement applicable under this chapter t0 the device, and [] (2) which relates t0 the safety 0r effectiveness 0f the device 0r t0 any other matter included in a requirement applicable t0 the device under this chapter. [Citation] (Coleman, supra 223 Cal.App.4th at p. 423.) The United States Supreme Court established a two-step framework 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 t0 the particular medical device at issue. (|bid.) Second, state law claims are preempted if they impose requirements that relate t0 safety and effectiveness and are different from, 0r in addition t0 the requirements under federal law. (|bid.) State law requirements can be established by either statute 0r common law. (|bid.) State law causes 0f action that provide a damages remedy for claims premised 0n a violation 0f FDA regulations are not expressly preempted if they parallel, rather than add t0, federal requirements. (|bid.) A state law cause 0f action for violation 0f the FDCA is barred under the doctrine of implied preemption if it is cognizable only by virtue 0f the provisions 0f the FDCA itself, rather than traditional state tort law. (Coleman, supra 223 Cal.App.4th at p. 425.) In sum, [i]n order t0 state a claim that avoids both express and implied preemption, a plaintiff must be suing for conduct that violates the FDCA (0r 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, t0 survive both express and implied preemption, a state law cause 0f 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 0fthe FDCA. [Citation] (Coleman, supra 223 Cal.App.4th at p. 427.) Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 5 0f 7 SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER Here, only express preemption appears t0 be at issue. Turning t0 the two-part test for express preemption, the PMA requirements applicable t0 class ||| medical devices, like the Angio-Seal devices, satisfy the first prong 0f the test. (See Coleman, supra 223 Cal.App.4th at p. 424.) With respect t0 the second prong, Plaintiffs common law tort claim for strict product liability and negligence would impose a safety 0r effectiveness requirement 0n Angio-Seal devices. The question here is whether the claim seeks t0 impose a requirement that is different from 0r in addition t0 the requirements imposed by federal law. Courts are divided regarding the factual allegations that a plaintiff must plead to avoid preemption on the ground that the claim imposes requirements that relate t0 safety and effectiveness and are different from 0r in addition t0 the requirements under federal law. Some courts require the plaintiff t0 specifically plead that the state law claims are parallel to federal requirements by alleging facts showing that the defendant violated a particular federal specification referring t0 the device at issue. (See e.g., Wolicki-Gables v. Arrow Intern, Inc. (11th Cir. 2011) 634 F.3d 1296, 1301; Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal.App.4th 779, 794.) Other courts have held that claims 0f 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. Stryker Corp. (7th Cir. 2010) 630 F.3d 546, 554, discussing In re Medtronic, |nc., Sprint Fidelis Leads Products Liability Litigation (8th Cir. 2010) 623 F.3d 1200, 1206 [ Plaintiffs primarily argue that the [district court] held them t0 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 t0 [the defendant] and to the FDA. This argument which focuses 0n the timing of the preemption ruling would have considerable force in a case where a specific defective Class ||| device injured a consumer, and the plaintiff did not have access t0 the specific federal requirements in the PMA prior t0 commencing the lawsuit. ]; 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 0f action, Plaintiffs d0 not allege that Defendants conduct violated the FDCA or that the Angio-Seal devices used in Lawrence were defective because they failed t0 comply with the manufacturing specifications required by the PMA granted by the FDA. Therefore, Plaintiffs have not alleged sufficient facts t0 survive preemption. Accordingly, the demurrer t0 the third cause 0f action is SUSTAINED, with 10 days leave t0 amend after service of the signed order. The Court will prepare the order. Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 6 0f 7 SUPERIOR COURT OF CALIFORNIA COUNTY OF SANTA CLARA MINUTE ORDER - 00000 - Printed: 7/21/2020 07/21/2020 Hearing: Demurrer r 18CV328673 Page 7 Of 7