Fussy v. RTI Surgical

• Court: District Court, E.D. California
• Decided: August 6, 2025
• Docket: 1:21-cv-01307
• Status: Unknown

Opinion

1 2 3 4 5 UNITED STATES DISTRICT COURT 6 EASTERN DISTRICT OF CALIFORNIA 7 8 KARIN FUSSY, Case No. 1:21-cv-01307-KES-CDB

9 Plaintiff, FINDINGS AND RECOMMENDATIONS TO GRANT DEFENDANT’S MOTION TO 10 v. DISMISS WITHOUT LEAVE TO AMEND

11 RTI SURGICAL, (Doc. 25)

12 Defendants. ORDER STRIKING UNSIGNED MOTION FOR JUDGMENT 13 (Doc. 57) 14 ORDER VACATING SCHEDULING 15 CONFERENCE

16 (Doc. 60)

17 14-DAY DEADLINE

18 19 Pending before the undersigned is the motion of Defendant RTI Surgical, Inc. 20 (“Defendant”), to dismiss the first amended complaint of Plaintiff Karin Fussy (“Plaintiff”), filed 21 on May 17, 2022. 1 (Doc. 25). Plaintiff, proceeding pro se, filed an opposition to the motion on 22 May 31, 2022. (Doc. 28). Defendant filed a reply on June 10, 2022. (Doc. 29). The undersigned 23 deems the motion suitable for resolution without hearing and oral argument. See E.D. Cal. Local 24 Rule 230(g). For the reasons set forth below, the undersigned will recommend Defendant’s motion 25 to dismiss be granted without leave to amend. 26 /// 27

1 On May 14, 2025, the assigned district judge referred the pending motion to dismiss to the 1 I. BACKGROUND2 2 Plaintiff, proceeding pro se, initiated this action with the filing of a complaint on March 17, 3 2021, in the Kern County Superior Court, case number BCV-21-100589. (Doc. 1-1). Defendant 4 removed the action to this Court on August 27, 2021. (Doc. 1). On September 2, 2021, Defendant 5 filed a motion to dismiss the complaint. (Doc. 4). Plaintiff filed an untimely opposition on 6 November 17, 2021. (Doc. 16). The Court granted the motion to dismiss on April 14, 2022, finding 7 that Plaintiff had failed to cognizably allege any manufacturing defect claim, design defect claim, 8 failure to warn claim, or negligence claim, and provided Plaintiff leave to amend. See (Doc. 22). 9 On April 27, 2022, Plaintiff filed her first amended complaint. (Doc. 24). 10 According to the allegations in the first amended complaint, in 2012, Plaintiff underwent 11 spine surgery to fix a damaged disk. (Doc. 24 at 6). During this operation, the operating surgeon 12 used a “Pedicle Screw Rod and Screw Fixation System” (the “Pedicle System”) to stabilize 13 Plaintiff’s spine. Plaintiff alleges that the Pedicle System used for her surgery was manufactured 14 by Defendant. She alleges that the “surgery was excessive, the screws shifted and impeded on 15 Plaintiff’s spine” causing significant pain as well as nerve damage, and that this was a “direct result 16 of the [Pedicle System] manufactured by RTI Surgical.” Plaintiff alleges that her claim is that the 17 Pedicle System “permanently crippled Plaintiff causing her to lose the ability to be employed.” Id. 18 Plaintiff seeks $10,000,00 in compensatory damages and $20,000,000 in punitive damages. Id. at 19 6-7. 20 Regarding manufacturing defects, Plaintiff states alleges that the “intention of the product 21 was to stabilize the spine during fusion even though it was not FDA approved for the spine at the 22 time of surgery” with the Pedicle System to then be removed. Plaintiff asserts that knowing “that 23 this product causes neurological issues and nerve damage” hinders its usability, causing it to be 24 liable under a manufacturing defect. Plaintiff includes an excerpt from a newspaper article, 25 discussing pedicle screws generally, which she asserts is from the Washington Post, dated April 26 18, 1995. Id. at 8. 27

2 References to Plaintiff’s first amended complaint are to the CM/ECF-assigned page 1 Regarding design defects, Plaintiff alleges that the FDA approval of the Pedicle System 2 came “almost [five] full years after Plaintiff’s surgery,” and thus it was “not reasonably safe” at the 3 time of the surgery. Id. at 9. The first amended complaint recites a quote from Menges v. Depuy 4 Motech, Inc., 62 F. Supp. 2d 817 (N.D. Ind. 1999), which purports to summarize the allegations by 5 the plaintiff in that case, which appear somewhat similar to Plaintiff’s allegations here (i.e., that the 6 pedicle screw device was not FDA-approved). She further alleges that, under a consumer 7 expectation test, the typical consumer would not choose to use this product knowing of the potential 8 risks. (Doc. 24 at 9). Plaintiff alleges that the Pedicle System, not having FDA approval for use 9 on the spine, renders the product “‘not reasonably safe.’ The possible benefit does not outweigh 10 the potential risk.” She asserts that, during her three follow-ups post-surgery (on March 28, 2012; 11 May 16, 2012; and November 30, 2015), she complained of pain, leg weakness, slurred speech, 12 and reduced stability. According to her allegations, the physician stated the Pedicle System could 13 not cause such issues and sent Plaintiff for a neurological examination. Upon Plaintiff’s request 14 for removal of the Pedicle System, the physician informed Plaintiff the product was intended to be 15 permanent and insurance would not cover removal. Plaintiff alleges that the fact that the physician 16 “was an owner in the company makes him an extension of the manufacturer and the deception 17 creates an unsafe product.” She states that the Pedicle System “manufactured by [Defendant] were 18 presented with the issues and potential dangers of their product and failed to warn the Plaintiff 19 making [Defendant] liable under Design Defect.” Id. at 10. 20 Regarding failure to warn, Plaintiff asserts that the learned intermediary doctrine is rendered 21 inapplicable here because “the physician was an owner in the company and therefore that makes 22 him an extension of the company. Therefore, his lack of warning to the patient is valid.” Plaintiff 23 alleges that the physician, in the operative report, states the “patient is aware that this procedure 24 may not meet expectations” and warnings of the possibility of “neurological issues” or “symptoms 25 being worse were not presented to the Plaintiff … the original use was intended to be temporary” 26 and, upon seeking removal, Plaintiff was “told that it was a permanent fixation not meant to be 27 removed” and that the Pedicle System was not the issue. Id. at 11. Plaintiff alleges she was never 1 Post article dated April 18, 1995, concerning a survey where surgical patients reported they had not 2 been told the “screws were experimental.” Id. She includes what appears to a screenshot of a 3 portion of an article titled “Pedicle Screws for Spinal Fusion,” by Peter Ullrich, dated January 20, 4 2004, stating that the “screws and rods … may be safely removed” once no longer needed but “most 5 surgeons do not recommend removal unless the pedicle screws cause discomfort for the patient 6 (5% to 10% of cases).” Id. at 12. 7 Plaintiff alleges that Defendant had a duty to manufacture safe and effective medical 8 devices, Plaintiff’s injuries are a direct result of their Pedicle System, and the “negligence of 9 [Defendant’s] actions caused a breach of duty putting the Plaintiff in harms [sic] way.” Id. She 10 alleges the treatment was needless and excessive and believes the “surgery was done as an 11 experiment in order to be used as an example of the [Pedicle System’s] success” in order to obtain 12 FDA approval. Id. at 12-13. 13 II. GOVERNING AUTHORITY 14 A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) tests a complaint’s 15 sufficiency and asks a court to dismiss a plaintiff’s complaint for failing “to state a claim upon 16 which relief can be granted.” Fed. R. Civ. P. 12(b)(6); N. Star Int’l v. Ariz. Corp. Comm’n., 720 17 F.2d 578, 581 (9th Cir. 1983) (citing Peck v. Hoff, 660 F.2d 371, 374 (8th Cir. 1981)). A complaint 18 may be dismissed as a matter of law either for lack of a cognizable legal theory or the absence of 19 sufficient facts alleged under a cognizable legal theory. Balistreri v. Pacifica Police Dep’t, 901 20 F.2d 696, 699 (9th Cir. 1990) (citing Robertson v. Dean Witter Reynolds, Inc., 749 F.2d 530, 533- 21 34 (9th Cir. 1984)). 22 To survive a motion to dismiss under Rule 12(b)(6), a complaint must provide sufficient 23 factual matter to state a claim to relief that is plausible on its face. Ashcroft v. Iqbal, 556 U.S. 662, 24 678 (2009); see Fed. R. Civ. P. 8(a)(2) (a complaint must contain a short and plain statement of the 25 claim showing that the pleader is entitled to relief). A complaint satisfies the plausibility 26 requirement if it contains sufficient facts for the court to “draw [a] reasonable inference that the 27 defendant is liable for the misconduct alleged.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 1 When considering a Rule 12(b)(6) motion to dismiss for failure to state a claim, the court 2 must accept as true all factual allegations put forth in the complaint and construe all facts and 3 inferences in favor of the non-moving party. Erickson v. Pardus, 551 U.S. 89, 94 (2007) (citations 4 omitted); Hebbe v. Pliler, 627 F.3d 338, 340 (9th Cir. 2010). The complaint need not include 5 “detailed factual allegations,” but must include “more than an unadorned, the-defendant- 6 unlawfully-harmed-me accusation.” Iqbal, 556 U.S. at 678 (citations omitted). The Court is “not 7 ‘required to accept as true allegations that contradict exhibits attached to the Complaint or matters 8 properly subject to judicial notice, or allegations that are merely conclusory, unwarranted 9 deductions of fact, or unreasonable inferences.’” Seven Arts Filmed Entm’t, Ltd. v. Content Media 10 Corp. PLC, 733 F.3d 1251, 1254 (9th Cir. 2013) (quoting Daniels-Hall v. Nat’l Educ. Ass’n, 629 11 F.3d 992, 998 (9th Cir. 2010)). Further, while factual allegations are accepted as true, legal 12 conclusions are not. Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 555). 13 Finally, courts must construe pro se pleadings liberally and hold such pleadings to a less 14 stringent standard than those drafted by attorneys. Boag v. MacDougall, 454 U.S. 364, 365 (1982) 15 (per curiam); see Hughes v. Rowe, 449 U.S. 5, 9 (1980) (“It is settled law that the allegations of [a 16 pro se litigant’s complaint] ‘however inartfully pleaded’ are held ‘to less stringent standards than 17 formal pleadings drafted by lawyers . . .’” (quoting Haines v. Kerner, 404 U.S. 519, 520 (1972))). 18 A court should dismiss a pro se complaint without leave to amend only if “it is absolutely clear that 19 the deficiencies of the complaint could not be cured by amendment.” Akhtar v. Mesa, 698 F.3d 20 1202, 1212 (9th Cir. 2012). 21 III. DISCUSSION 22 First, Plaintiff filed a “motion for judgment” on May 19, 2025, wherein she requests the 23 Court to rule on the pending motion to dismiss. (Doc. 57). The Court will construe Plaintiff’s 24 motion as, more properly, a motion to expedite. See Castro v. United States, 540 U.S. 375, 381– 25 82 (2003) (explaining that courts may recharacterize a pro se motion to “create a better 26 correspondence between the substance of a pro se motion’s claim and its underlying legal basis”). 27 This Court does not have an expedited calendar. As of the date of this order, the undersigned 1 presides over more than 800 civil cases. While the Court regrets the delays in the litigation of this 2 action, they are unavoidable given the tremendous judicial resource emergency experienced 3 throughout this District. 4 Further, Plaintiff’s motion is unsigned. As the Court advised in both its Informational Order 5 (Doc. 3-5 at 2; citing Local Rule 131 & Fed. R. Civ. P. 11(a)) and Order Striking Unsigned Pleading 6 (Doc. 43 at 2), each document submitted for filing must include the original signature of the filing 7 party. As a general rule, all documents submitted without the required signature(s) will be stricken 8 from the record. Plaintiff has been cautioned of this twice before. (Doc. 21 at 1 n.1; Doc. 43 at 2). 9 Thus, the Court will strike Plaintiff’s motion for judgment. (Doc. 57). Plaintiff is again directed 10 to refamiliarize herself with and adhere to the Local Rules of this Court; failure to comply with 11 those rules or Court orders may result in the imposition of sanctions. 12 Second, Defendant states in its motion to dismiss that the Pedicle System at issue here was 13 “cleared for marketing and sale in the U.S. by the [FDA] pursuant to the agency’s 510(k) or 14 ‘substantial equivalence’ process.” (Doc. 25 at 3). Plaintiff does not dispute this, except regarding 15 the time of her surgery in 2012, and includes in her first amended complaint text that she asserts is 16 from an “[a]announcement from the FDA published [January 24], 2017,” stating that “pedicle 17 screw systems became classified as a Class II/special controls device by the FDA” effective 18 December 30, 2016. (Doc. 24 at 12; Doc. 28 at 2). As such, preemption is not at issue here. See 19 Hobus v. Howmedica Osteonics Corp., 699 F. Supp. 3d 1122, 1138 n.12 (D. Or. 2023), aff’d, No. 20 23-3528, 2025 WL 25694 (9th Cir. Jan. 3, 2025); see also Merancio v. Smith & Nephew, Inc., No. 21 1:15-CV-00807-DAD-EPG, 2017 WL 2257124, at *6 n.7 (E.D. Cal. May 23, 2017). 22 Turning to the motion to dismiss (Doc. 25), the undersigned will discuss each of Plaintiff’s 23 claim in turn below. 24 A. Manufacturing Defect Claims 25 Pursuant to California law, a “manufacturing or production defect is readily identifiable 26 because a defective product is one that differs from the manufacturer’s intended result or from other 27 ostensibly identical units of the same product line. For example, when a product comes off the 1 Engineering Co., 20 Cal. 3d 413, 429 (1978). Such a claim provides that “a suitable design is in 2 place, but that the manufacturing process has in some way deviated from that design.” In re 3 Coordinated Latex Glove Litigation, 99 Cal. App. 4th 594, 613 (2002). “A plaintiff pursuing a 4 manufacturing defect claim must identify/explain how the product either deviated from the 5 manufacturer’s intended result/design or how the product deviated from other seemingly identical 6 models; therefore, a bare allegation that the product had ‘a manufacturing defect’ is an insufficient 7 legal conclusion.” Zetz v. Boston Sci. Corp., 398 F. Supp. 3d 700, 707–08 (E.D. Cal. 2019) (citing 8 Lucas v. City of Visalia, 726 F. Supp. 2d 1149, 1155 (E.D. Cal. 2010)). 9 In dismissing Plaintiff’s original complaint, the Court instructed Plaintiff that if she 10 intended to assert a manufacturing defect claim, she would be required to advance “allegations 11 identifying and explaining how the pedicle screws either deviated from defendant’s intended 12 result/design or how the screws deviated from other identical products.” (Doc. 22 at 4). However, 13 in the first amended complaint, Plaintiff again fails to set forth allegations supporting a 14 manufacturing defect claim. Plaintiff does not provide how the Pedicle System either deviated 15 from the Defendant’s intended result or design, nor how the Pedicle System deviated from other 16 products. Plaintiff appears to concede in her opposition to Defendant’s motion that her allegations 17 support a design defect rather than manufacturing defect, stating that the “manufacturer knew the 18 screws were defective and continued to sell them … Therefore, the product did ‘differ’ from 19 [Defendant’s] intended design, the defect was in the design itself …” (Doc. 28 at 4, 8). 20 Accordingly, Plaintiff again fails to adequately allege a manufacturing defect claim under 21 California law in her first amended complaint. 22 B. Design Defect Claims 23 California law provides two separate tests for establishing that a product design is 24 defective. “A product is defective in design if the benefits of the design do not outweigh the risk 25 of danger inherent in the design (risk-benefit test), or if the product fails to perform as safely as an 26 ordinary consumer would expect when used in an intended or reasonably foreseeable manner 27 (consumer expectations test).” Garrett v. Howmedica Osteonics Corp., 214 Cal. App. 4th 173, 1 plaintiff to prove design defect and do not serve as defenses to one another.” McCabe v. Am. 2 Hondo Motor Co., Inc., 100 Cal. App. 4th 1111, 1121 (2002). 3 However, California law precludes strict liability for design defects by manufacturers of 4 prescription medical devices, including implanted devices such as the Pedicle System at issue 5 here. See Garrett, 214 Cal. App. 4th at 182 (finding “an exemption from design defect strict 6 products liability for all implanted medical devices that are available only through the services of 7 a physician”). “[T]he appropriate test for determining a prescription [medical device] 8 manufacturer’s liability for a design defect involves an application of the ordinary negligence 9 standard.” Under that standard, “a manufacturer is liable for a design defect only if it failed to 10 warn of a defect that it either knew or should have known existed.” Id. (citing Brown v. Superior 11 Court, 44 Cal. 3d 1049, 1057 (1988)). 12 In dismissing Plaintiff’s original complaint, the Court instructed Plaintiff that if she 13 intended to assert a design defect claim, she would be required to advance “allegations identifying 14 what aspect of the pedicle screws’ design made them defective or how defendant failed to warn 15 about said defect.” (Doc. 22 at 4-5). However, in the first amended complaint, Plaintiff again fails 16 to set forth any assertions supporting a design defect claim. The case of Menges v. Depuy Motech, 17 Inc., cited by Plaintiff in her opposition, is inapplicable here as the Menges court applied Wisconsin 18 law. 61 F. Supp. 2d 817, 823 n.2 (N.D. Ind. 1999). Here, under governing California law, strict 19 liability is precluded on a design defect claim. Regarding the applicable ordinary negligence 20 standard, Plaintiff does not provide how the Pedicle System’s design made it defective nor how 21 Defendant failed to warn of any such defect, as further discussed below in subsections (C) and (D). 22 Accordingly, Plaintiff again fails to adequately allege a design defect claim under California 23 law in her first amended complaint. 24 C. Failure to Warn Claims 25 Pursuant to California law, a failure-to-warn claim may be pled under either a theory of 26 negligence or a theory of strict liability. Hannan v. Boston Sci. Corp., No. 19-cv-08453-PJH, 2020 27 WL 2128841, at *6 (N.D. Cal. May 6, 2020). “A plausible claim for a failure to warn should 1 danger was substantial, and that the danger was known or reasonably knowable, or explain how 2 any warning that was given was inadequate.” Marroquin v. Pfizer, Inc., 367 F. Supp. 3d 1152, 3 1161 (E.D. Cal. 2019) (citing Lucas, 726 F. Supp. 2d at 1156 n.1). 4 “California’s learned intermediary doctrine holds that a manufacturer of prescription drugs 5 or medical devices satisfies its duty to warn when it provides adequate warnings to the prescribing 6 physician, as opposed to the patient … The learned intermediary doctrine applies to implanted 7 medical devices … and it covers failure to warn claims under both the strict liability theory and the 8 negligence theory.” Zetz, 398 F. Supp. 3d at 706-707 (citations omitted); see Motus v. Pfizer Inc. 9 (Roerig Div.), 358 F.3d 659, 661 (9th Cir. 2004) (“[Defendant] is obligated to warn doctors, not 10 patients, of potential side-effects associated with its pharmaceutical products[.]”). 11 “The learned intermediary doctrine, as this rule is known, has been extended in California 12 to implantable medical devices in addition to prescription drugs … In the case of prescription drugs 13 and implants, the physician stands in the shoes of the ‘ordinary user’ because it is through the 14 physician that a patient learns of the properties and proper use of the drug or implant. Thus, the 15 duty to warn in these cases runs to the physician, not the patient.” Bigler-Engler v. Breg, Inc., 7 16 Cal. App. 5th 276, 319, 213 (2017) (quotations omitted; citing Valentine v. Baxter Healthcare 17 Corp., 68 Cal. App. 4th 1467, 1483 (1999)). “In the case of medical prescriptions, if adequate 18 warning of potential dangers of a drug has been given to doctors, there is no duty by the drug 19 manufacturer to insure that the warning reaches the doctor’s patient for whom the drug is 20 prescribed.” Stevens v. Parke, Davis & Co., 9 Cal. 3d 51, 65 (1973) (quotations omitted; citing 21 Love v. Wolf, 226 Cal. App. 2d 378, 395 (1964)). 22 A plaintiff who brings a claim “based on a failure to warn must prove not only that no 23 warning was provided or the warning was inadequate, but also that the inadequacy or absence of 24 the warning caused the plaintiff’s injury.” Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1238 25 (9th Cir. 2017). 26 In dismissing Plaintiff’s original complaint, the Court instructed Plaintiff that if she 27 intended to assert a failure to warn claim, she would be required to advance allegations identifying 1 capacity defendant knew about that danger.” (Doc. 22 at 6-7). In the first amended complaint, 2 Plaintiff again fails to allege that Defendant did not adequately warn the prescribing physician. 3 Plaintiff once more provides sparse allegations that suggest that a physician prescribed the spine 4 surgery Plaintiff received and also prescribed using Defendant’s Pedicle System to hold Plaintiff’s 5 spine in place. (Doc. 1-1 at 11; Doc. 24 at 6). As the Court informed Plaintiff in its prior order 6 granting Defendant’s motion to dismiss the initial complaint, Plaintiff must allege “(1) defendant 7 did not warn plaintiff’s doctors of the risks associated with the pedicle screws or the warning was 8 inadequate, and (2) that the inadequacy or absence of the warning caused plaintiff’s injuries.” (Doc. 9 22 at 7; quotations and citations omitted). 10 Plaintiff pleads no such facts. Rather, she alleges that the physician who conducted the 11 operation was an “owner” of Defendant and, therefore, an extension of the manufacturer, 12 presumably then requiring Defendant to warn Plaintiff directly. Plaintiff provides no citations to 13 any supporting authority for such a proposition and the Court cannot locate any. See Kamlade v. 14 LEO Pharma Inc., No. 1:21-CV-00522-DAD-EPG, 2022 WL 358429, at *5 (E.D. Cal. Feb. 7, 15 2022) (“Finally, even if a design defect claim was asserted, plaintiff has cited no cases holding that 16 the learned intermediary doctrine does not apply to such claims.”); see also Sidhu v. Bayer 17 Healthcare Pharms. Inc., No. 22-CV-01603-BLF, 2022 WL 17170159, at *4 (N.D. Cal. Nov. 22, 18 2022) (collecting cases). 19 Accordingly, Plaintiff again fails to adequately allege a failure to warn claim under 20 California law in her first amended complaint. 21 D. Negligence Claims 22 Pursuant to California law, “under either a negligence or a strict liability theory of products 23 liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury … Under 24 a negligence theory, a plaintiff must also prove an additional element, namely, that the defect in the 25 product was due to negligence of the defendant.” Higginbottom v. Dexcom, Inc., 744 F. Supp. 3d 26 1058, 1083 (S.D. Cal. 2024), motion to certify appeal denied, No. 24-CV-0195-WQH-BLM, 2024 27 WL 4547017 (S.D. Cal. Oct. 22, 2024) (citing Merrill v. Navegar, Inc., 26 Cal. 4th 465, 479 1 causation, and damages. Therefore, a product is not negligently designed so long as the 2 manufacturer took reasonable precautions in an attempt to design a safe product or otherwise acted 3 as a reasonably prudent manufacturer would have under the circumstances.” Lin v. Solta Med., 4 Inc., 760 F. Supp. 3d 926, 944 (N.D. Cal. 2024) (quotations omitted; citing Howard v. Omni Hotels 5 Mgmt. Corp., 203 Cal. App. 4th 403, 428 (2012) & Barker, 20 Cal. 3d at 434). 6 In the first amended complaint, Plaintiff again fails to advance allegations explaining how 7 the product created the alleged danger. Plaintiff states that her “permanent nerve damage” was a 8 direct result of the Pedicle System (Doc. 24 at 12), but Plaintiff fails to assert facts regarding how 9 Defendant’s actions are connected to any purported defects in the product. Plaintiff’s only other 10 contention is that the Pedicle System was not approved for spinal stabilization by the FDA at the 11 time of the surgery. However, this alone does not support a negligence claim. See Perez v. Nidek 12 Co., 711 F.3d 1109, 1115 (9th Cir. 2013) (explaining that “‘off-label’ usage of medical devices … 13 is an accepted and necessary corollary of the FDA’s mission to regulate [in the area of medical 14 devices] without directly interfering with the practice of medicine”) (citations omitted); see also 15 Carson v. Depuy Spine, Inc., 365 F. App'x 812, 815 (9th Cir. 2010) (“The [Food, Drug, and 16 Cosmetics Act] expressly protects off-label use … In addition, the Supreme Court has emphasized 17 that off-label use by medical professionals is not merely legitimate but important in the practice of 18 medicine.”) (citations omitted). 19 Accordingly, Plaintiff again fails to adequately allege a negligence claim under California 20 law in her first amended complaint. See Higginbottom, 744 F. Supp. 3d at 1084 (finding that 21 “Plaintiff fails to allege nonconclusory allegations identifying what aspect of the insulin pump’s 22 design made it defective or how any such defect resulted from Tandem’s negligence.”) 23 In sum, even liberally construing the allegations in the first amended complaint, the 24 undersigned finds Plaintiff fails to state a claim against Defendant upon which relief may properly 25 be granted. The undersigned therefore will recommend the Court grant Defendant’s motion to 26 dismiss. 27 E. Punitive Damages 1 obligation—including products liability actions … —where it is proven by clear and convincing 2 evidence that the defendant has been guilty of oppression, fraud, or malice[.]” Hill v. Novartis 3 Pharm. Corp., No. 1:06-CV-00939-AWI, 2012 WL 967577, at *2 (E.D. Cal. Mar. 21, 2012) 4 (citations omitted). California Civil Code § 3294, subdivision (c) states that: “(1) ‘Malice’ means 5 conduct which is intended by the defendant to cause injury to the plaintiff or despicable conduct 6 which is carried on by the defendant with a willful and conscious disregard of the rights or safety 7 of others. (2) ‘Oppression’ means despicable conduct that subjects a person to cruel and unjust 8 hardship in conscious disregard of that person’s rights. (3) ‘Fraud’ means an intentional 9 misrepresentation, deceit, or concealment of a material fact known to the defendant with the 10 intention on the part of the defendant of thereby depriving a person of property or legal rights or 11 otherwise causing injury.” Cal. Civ. Code § 3294(c). 12 Plaintiff has failed to allge any facts establishing oppression, fraud, or malice. As Plaintiff 13 fails to state a claim in her first amended complaint, it follows that her request for punitive damages 14 based on those same assertions fails. See Funke v. Sorin Grp. USA, Inc., 147 F. Supp. 3d 1017, 15 1028 (C.D. Cal. 2015) (dismissing punitive damages claim where claims of “design, manufacture, 16 and warnings” related to medical device had been dismissed). 17 F. Leave to Amend 18 Rule 15 provides that “leave [to amend] shall be freely given when justice so requires.” 19 Fed. R. Civ. P. 15(2). However, district courts are only required to grant leave to amend if a 20 complaint can be saved. Lopez v. Smith, 203 F.3d 1122, 1129 (9th Cir. 2000). When a complaint 21 cannot be cured by additional facts, leave to amend need not be provided. Doe v. United States, 58 22 F.3d 494, 397 (9th Cir. 1995). 23 Plaintiff has already been granted leave to amend. However, Plaintiff’s first amended 24 complaint fails to correct the deficiencies set forth in the Court’s order dismissing her initial 25 complaint. See (Doc. 22, discussed supra). Given the facts and circumstances of Plaintiff’s claims 26 as recounted above, the undersigned finds that further leave to amend Plaintiff’s claims would be 27 futile and, accordingly, recommends that Defendant’s motion to dismiss be granted without leave 1 leave to amend is particularly broad where court has afforded plaintiff one or more opportunities 2 to amend his complaint); see also Ismail v. Cnty. of Orange, 693 Fed. Appx. 507, 511-12 (9th Cir. 3 2017) (“A pro se complaint may be dismissed with prejudice when ‘it is absolutely clear that the 4 deficiencies of the complaint could not be cured by amendment.’”) (quoting Rosati v. Igbinoso, 791 5 F.3d 1037, 1039 (9th Cir. 2015)). 6 IV. CONCLUSION AND RECOMMENDATION 7 For the foregoing reasons, IT IS HEREBY ORDERED that: 8 1. Plaintiff’s motion for judgment (Doc. 57) is STRICKEN. 9 2. The scheduling conference set for September 23, 2025 (Doc. 60), is VACATED, to be 10 reset as necessary following resolution of the instant motion to dismiss. 11 And the undersigned RECOMMENDS that: 12 1. Defendant’s motion to dismiss (Doc. 25) be GRANTED. 13 2. Plaintiff’s first amended complaint (Doc. 24) be DISMISSED without leave to amend. 14 These Findings and Recommendations will be submitted to the U.S. District Judge assigned 15 to this case, pursuant to the provisions of 28 U.S.C. § 636(b)(l). Within 14 days after being served 16 with a copy of these Findings and Recommendations, any party may file written objections with 17 the Court. Local Rule 304(b). The document should be captioned, “Objections to Magistrate 18 Judge’s Findings and Recommendations” and shall not exceed 15 pages without leave of Court 19 and good cause shown. The Court will not consider exhibits attached to the Objections. To the 20 extent any party wishes to refer to any exhibit(s), that party should reference the exhibit in the 21 record by its CM/ECF document and page number, when possible, or otherwise reference the 22 exhibit with specificity. Any pages filed in excess of the 15-page limitation may be disregarded by 23 /// 24 /// 25 /// 26 /// 27 /// 1 the District Judge when reviewing these Findings and Recommendations under 28 U.S.C. 8 2 | 636(b)U)(C). A party’s failure to file any objections within the specified time may result in the 3 | waiver of certain rights on appeal. Wilkerson v. Wheeler, 772 F.3d 834, 839 (9th Cir. 2014). 4 | IT IS SOORDERED. >| Dated: _ August 5, 2025 | hwrnrD Pr 6 UNITED STATES MAGISTRATE JUDGE 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 14