Bird v. Globus Medical, Inc. ( 2020 )

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 FOR THE EASTERN DISTRICT OF CALIFORNIA 10 11 CHRISTINA BIRD, et al., No. 19-cv-1024-KJM-CKD 12 Plaintiffs, 13 v. ORDER 14 GLOBUS MEDICAL, INC., 15 Defendant. 16 17 Plaintiffs Christina and Clarence Bird bring this suit against defendant Globus 18 Medical, Inc., based on injuries Christina Bird alleges she suffered after the medical device 19 XPAND-S was used in her spinal surgery. Defendant moves to dismiss all of plaintiffs’ claims. 20 For the reasons below, the court GRANTS the motion in part and DENIES it in part. 21 I. BACKGROUND 22 On or about September 2, 2010, plaintiff Christina Bird underwent a surgery called 23 a corpectomy1 on the cervical region of her spine, which is the part of the spine that makes up the 24 neck. Not. of Removal, Ex. A ¶¶ 14–15, 19, ECF No. 1-1 (Compl.). As part of the surgery, her 25 1 According to plaintiffs, a “corpectomy” is “a complex procedure that consists of 26 removing the entire vertebral body (the box-shaped bones) as well as the discs above and below it and replacing them all with the same ‘dime-sized’ diameter (or footprint) device, but that is 27 longer in span (or taller) to match the taller height of the surgically removed vertebra.” Compl. ¶ 13. 28 1 surgeon inserted a device plaintiffs call “XPAND-S.” Id. ¶ 19. “XPAND-S” appears to be 2 plaintiffs’ name for the product XPAND in size small, or XPAND-Small. See Opp’n, ECF No. 13, 3 at 5; Reply, ECF No. 15, at 9. Though the parties agree the XPAND device was approved by the 4 FDA under a process called 510k clearance, they appear to dispute whether the XPAND in size 5 small was properly approved. Id. at 10; Opp’n at 7–8. 6 Roughly seven years after her surgery, Ms. Bird discovered the XPAND device had 7 moved out of its proper position in her spine, causing danger of paralysis and death. Compl. ¶ 20. 8 On March 22, 2019, Christina Bird and Clarence Bird filed an action in state court against the 9 manufacturer of the device, Globus Medical, Inc. for: (1) fraud by concealment, (2) negligence per 10 se, and (3) failure to warn. See generally Compl. Defendant removed the case to federal court on 11 the basis of diversity jurisdiction, Not. of Removal, ECF No. 1, at 2–3, and now moves to dismiss 12 all of plaintiffs’ claims, Mot., ECF No. 8-1. Plaintiffs oppose, ECF No. 13, and defendant has filed 13 a reply, ECF No. 15. In conjunction with its motion to dismiss, defendant also requests that the 14 court judicially notice documents from the FDA website, Def.’s Req. for Jud. Not., ECF No. 9, 15 which plaintiffs do not oppose. Plaintiffs also request the court judicially notice certain documents, 16 ECF No. 13-1, which defendant has not opposed. The court resolves the motion to dismiss and 17 related requests below. 18 II. REQUEST FOR JUDICIAL NOTICE 19 As part of defendant’s motion to dismiss, defendant argues XPAND-S is not one of 20 its products. Mot. at 7. In support of this argument, defendant requests the court judicially notice 21 five exhibits, all taken from the FDA website: (1) the FDA website page entitled “How to Find and 22 Effectively Use Predicate Devices (Ex. 1); (2) the FDA website page entitled “510(k) Submission 23 Process” (Ex. 2); (3) a document from the FDA website entitled “III. 510(d) Summary” submitted 24 by Globus Medical Inc. for the device “XPAND Corpectomy Spacer” (Ex. 3); an FDA website 25 page entitled “510(k) Premarket Notification” listing the results of the search “Applicant: globus” 26 and “Device Name: xpand” (Ex. 4); and (4) the FDA website page entitled “How to Prepare a 27 Traditional 510(k)” (Ex. 5). Defendant argues there is no question regarding the authenticity of the 28 exhibits, because they are “taken directly from the FDA’s own website.” Def.’s Req. for Jud. Not. 1 at 3–4 (citing, inter alia, Daniels-Hall v. National Educ. Ass’n, 629 F.3d 992, 998–99 (9th Cir. 2 2010) (“[It is] appropriate to take judicial notice of . . . information, as it was made publicly 3 available by government entities (the school districts), and neither party disputes the authenticity 4 of the web sites or the accuracy of the information displayed therein.”); In re Amgen Inc. Sec. Litig., 5 544 F. Supp. 2d 1009, 1023–24 (C.D. Cal. 2008) (taking judicial notice of drug labels “taken from 6 the FDA’s website”). Because all of defendant’s exhibits are from the FDA’s public website, and 7 plaintiffs do not oppose the request for judicial notice nor challenge the factual contents of 8 documents covered by the request, the court takes judicial notice of the contents of the exhibits, to 9 the extent the contents are factual. The court declines to take judicial notice of anything in the 10 exhibits that may be construed as a legal conclusion regarding, for example, the legal framework 11 surrounding the FDA’s approval process. See Fernandez v. Nevada, No. 3:06-CV-0628-LRH- 12 RAM, 2011 WL 3957612, at *2 (D. Nev. Sept. 6, 2011) (declining to take judicial notice of 13 proposed judicial fact because it “is a legal conclusion” and “the court could not . . . take judicial 14 notice of it”); Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069, 1077 (D. Or. 2013) (taking judicial 15 notice of “adjudicative facts” within FDA documents, but declining to judicially notice “other 16 content of the identified documents”). 17 Similarly, in support of their opposition, plaintiffs request judicial notice of: (1) the 18 results of a “search of the Federally [sic] maintained database for medical device manufacturers to 19 report adverse incidents for Globus XPAND, run on August 22, 2019” from the FDA website (Ex. 20 1); and (2) a copy of a brochure about the XPAND Corpectomy Spacer (Ex. 2). Pl.’s Req. for Jud. 21 Not. at 2. For the same reasons and in the same manner described above, the court judicially notices 22 plaintiffs’ Exhibit 1, as it is taken directly from a government website. However, plaintiffs do not 23 provide adequate information for the court to judicially notice Exhibit 2, particularly because the 24 court has no way of determining the origin of the document. Accordingly, the court declines to 25 judicially notice plaintiff's’ Exhibit 2. 26 III. LEGAL STANDARD 27 Under Rule 12(b)(6) of the Federal Rules of Civil Procedure, a party may move to 28 dismiss a complaint for “failure to state a claim upon which relief can be granted.” A court may 1 dismiss “based on the lack of cognizable legal theory or the absence of sufficient facts alleged under 2 a cognizable legal theory.” Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 1990). 3 Although a complaint need contain only “a short and plain statement of the claim 4 showing that the pleader is entitled to relief,” Fed. R. Civ. P. 8(a)(2), in order to survive a motion 5 to dismiss this short and plain statement “must contain sufficient factual matter . . . to ‘state a claim 6 to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell 7 Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). A complaint must include something more than 8 “an unadorned, the-defendant-unlawfully-harmed-me accusation” or “‘labels and conclusions’ or 9 ‘a formulaic recitation of the elements of a cause of action.’” Id. (quoting Twombly, 550 U.S. at 10 555). Determining whether a complaint will survive a motion to dismiss for failure to state a claim 11 is a “context-specific task that requires the reviewing court to draw on its judicial experience and 12 common sense.” Id. at 679. Ultimately, the inquiry focuses on the interplay between the factual 13 allegations of the complaint and the dispositive issues of law in the action. See Hishon v. King & 14 Spalding, 467 U.S. 69, 73 (1984). 15 In making this context-specific evaluation, this court must construe the complaint in 16 the light most favorable to the plaintiff and accept as true the factual allegations of the complaint. 17 Erickson v. Pardus, 551 U.S. 89, 93–94 (2007). This rule does not apply to “a legal conclusion 18 couched as a factual allegation,” Papasan v. Allain, 478 U.S. 265, 286 (1986), nor to “allegations 19 that contradict matters properly subject to judicial notice” or to material attached to or incorporated 20 by reference into the complaint, Sprewell v. Golden State Warriors, 266 F.3d 979, 988–89 (9th Cir. 21 2001) (citation omitted). A court’s consideration of documents attached to a complaint or 22 incorporated by reference or matter of judicial notice will not convert a motion to dismiss into a 23 motion for summary judgment. United States v. Ritchie, 342 F.3d 903, 907–08 (9th Cir. 2003) 24 (citation omitted). 25 IV. DISCUSSION 26 Defendant moves to dismiss all three claims in the complaint and plaintiffs’ request 27 for punitive damages. The court addresses each of defendant’s arguments in turn. 28 ///// 1 A. Plaintiff Clarence Bird 2 First, defendant asks the court to dismiss all the claims made on behalf of Clarence 3 Bird, because plaintiffs have not alleged any facts pertaining to Clarence Bird, including his 4 relationship to Christina Bird, nor any injury he has suffered as a result of defendant’s actions. Mot. 5 at 7. Defendant is correct. Accordingly, all claims made on behalf of Clarence Bird are 6 DISMISSED, but with leave to amend, if possible under Rule 11. See Fed. R. Civ. P. 11. The 7 court refers below to Christina Bird’s claims only. 8 B. Injury 9 Defendant argues the court should dismiss all of plaintiff’s claims, because plaintiff 10 has failed to allege any present injury. Mot. at 14 (citing Naeyaert v. Kimberly-Clark Corp., No. 11 ED-cv-17-00950-JAK (JPRx), 2018 WL 6380749, *8 (C.D. Cal. Sept. 28, 2018); Macy’s Cal., Inc. 12 v. Super. Ct., 41 Cal. App. 4th 744, 756 (1995) (physical injury for purposes of parasitic emotional 13 distress damages requires actual harm)). 14 However, plaintiff alleges the XPAND-S moved out of its proper position in 15 Christina Bird’s spine and, as a result, she “is under constant threat of imminent death or paralysis” 16 and it is “unsafe to remove the device.” Compl. ¶ 20. Plaintiff also alleges she “has suffered . . . 17 severe, lasting and debilitating physical and mental pain and suffering” and “has incurred medical, 18 hospital and related expenses” due to the XPAND-S moving out of position after her surgery. Id. 19 ¶¶ 31–32. Plaintiff’s allegation of physical pain and suffering is conclusory, and therefore 20 insufficiently pleaded. However, plaintiff’s medical costs are sufficient to show economic injury. 21 1. Emotional Distress 22 The court notes that plaintiff can recover damages for emotional distress or mental 23 suffering even if there is no physical injury. Naeyaert, 2018 WL 6380749, *8. However, if a 24 plaintiff suffers no physical injury, and bases her claim solely on a fear of future disease or physical 25 harm, plaintiff must show her fear “stems from a knowledge, corroborated by reliable or scientific 26 opinion, that it is more likely than not” the feared harm will occur. See Macy’s California, Inc., 27 41 Cal. App. 4th at 750 (analyzing injury from exposure to toxic substance that threatens cancer) 28 (citing Potter v. Firestone Tire & Rubber Co., 6 Cal. 4th 965 (1993)); see also Herbert v. Regents 1 of University of California, 26 Cal. App. 4th 782, 784 (1994) (applying this standard to fear of 2 AIDS/HIV infection). Under this standard, plaintiffs have not adequately pleaded mental pain and 3 suffering. Compl. ¶¶ 31–32. 4 2. Economic Injury 5 The “economic loss rule” defendant cites does not bar plaintiff from pleading 6 economic injury for plaintiffs’ fraud claim. “Under the economic loss doctrine, a plaintiff's tort 7 recovery of economic damages is barred unless such damages are accompanied by some form of 8 physical harm (i.e., personal injury or property damage).” In re Sony Gaming Networks & 9 Customer Data Sec. Breach Litig., 903 F. Supp. 2d 942, 961 (S.D. Cal. 2012). However, the 10 economic loss rule does not bar such damages “where he or she can allege personal injury or 11 damage to other property, that is, property other than the product itself.” Nada Pac. Corp. v. Power 12 Eng’g & Mfg., Ltd., 73 F. Supp. 3d 1206, 1221 (N.D. Cal. 2014) (internal quotation marks and 13 citation omitted). 14 The California Supreme Court has also held that a fraud claim was not barred by the 15 economic loss rule where the claim was based on allegations of misrepresentations that “risked 16 physical harm to persons.” Robinson Helicopter Co. v. Dana Corp., 34 Cal. 4th 979, 991 n.7 17 (2004). Under this holding, plaintiff has sufficiently pleaded injury for her fraud claim. 18 Generally, liability for plaintiff’s negligence per se claim and negligence based on 19 failure to warn is “limited to damages for physical injuries and recovery of economic loss is not 20 allowed” unless plaintiff pleads “(1) personal injury, (2) physical damage to property, (3) a ‘special 21 relationship’ existing between the parties, or (4) some other common law exception to the rule[.]” 22 Kalitta Air, L.L.C. v. Cent. Texas Airborne Sys., Inc., 315 F. App’x 603, 605 (9th Cir. 2008) 23 (quoting J’Aire Corp. v. Gregory, 24 Cal. 3d 799 (1979)). Because plaintiff does not argue this 24 point nor is it apparent plaintiff has pled any of these elements, purely economic damages are 25 insufficient to plead injury for plaintiff’s negligence claims and therefore plaintiff’s negligence per 26 se claim and failure to warn claim are DISMISSED with leave to amend. 27 ///// 28 ///// 1 C. Pre-emption 2 A complex legal framework dictates whether state law causes of action are 3 preempted under the Medical Device Amendment (MDA) to the federal Food, Drug, and Cosmetics 4 Act (FDCA), Medical Device Amendments of 1976, § 2(a), 21 U.S.C. § 360k(a). A colleague 5 aptly described that framework in Hawkins v. Medtronic, Inc., 62 F. Supp. 3d 1144, 1150 (E.D. 6 Cal. 2014), explaining: 7 [T]he MDA contains express and implied preemption provisions which provide only a ‘narrow gap’ through which a state-law claim 8 must fit to escape preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly 9 preempted by § 360k(a)[2]), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be 10 impliedly preempted under Buckman [Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001)]). 11 12 Id. (emphasis in original) (citing, inter alia, Hawkins v. Medtronic, Inc., No. 1:13-CV-00499 AWI 13 SK, 2014 WL 346622, at *5 (E.D. Cal. Jan. 30, 2014); Perez v. Nidek Co., Ltd., 711 F.3d 1109, 14 1120 (9th Cir. 2013)). Where a state requirement related to a medical device is “different from, or 15 in addition to” the federal requirements, a claim for a violation of that state requirement is 16 preempted by § 360k; however, § 360k does not preempt state claims “arising out of the violation 17 of state-law duties that ‘parallel’ duties arising under the FDCA.” Alton, 970 F. Supp. 2d at 1081 18 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996)). For a state duty to be “parallel” to the 19 federal requirement, “the plaintiff must show that the requirements are ‘genuinely equivalent,’” 20 21 2 The MDA’s express preemption provision states, in relevant part: 22 [N]o State or political subdivision of a State may establish or 23 continue in effect with respect to a device intended for human use any requirement— 24 (1) which is different from, or in addition to, any requirement 25 applicable under this chapter to the device, and 26 (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 27 this chapter. 28 21 U.S.C. § 360k(a). 1 meaning the state duty does not “add to” the federal requirement. Martin v. Medtronic, Inc., 2 32 F. Supp. 3d 1026, 1034 (D. Ariz. 2014) (quoting Wolicki–Gables v. Arrow Int’l, Inc., 634 F.3d 3 1296, 1300 (11th Cir. 2011)). Claims that “exist solely by virtue of the FDCA . . . requirements” 4 are impliedly preempted, Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001), 5 because the MDA requires any action to enforce the provisions of the FDCA “be by and in the 6 name of the United States,” 21 U.S.C. § 337(a). 7 Defendant only argues plaintiffs’ claims are impliedly preempted because they 8 “exist solely by virtue of the existence and alleged violation of regulations under the FDCA 9 requiring FDA premarket approval or clearance for the sale of medical devices.” Mot. at 16. 10 According to defendant, “Plaintiffs’ fraud by concealment and failure to warn claims are premised 11 on Globus’ alleged non-disclosure concerning the scope of the FDA’s 510k clearance” and 12 “[p]laintiffs’ negligence claim is based upon an alleged illegal off-label marketing of the device”; 13 the claims are therefore preempted. Id. Because defendant does not argue the claims are expressly 14 preempted, the court addresses only implied preemption. 15 The Ninth Circuit cases of McClellan v. I-Flow Corp., 776 F.3d 1035, 1040 (9th 16 Cir. 2015) and Perez are instructive, as they address implied preemption of claims similar to those 17 made here. In Perez, the Ninth Circuit found plaintiff’s fraud by omission claim was expressly 18 preempted, because it “exist[ed] solely by virtue of the FDCA . . . requirements,” and was therefore 19 “an attempt to privately enforce the FDCA.” Perez, 711 F.3d at 1109, 1117, 1119. There, the claim 20 “rest[ed] solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Id. 21 at 1119–20. By contrast, in McClellan, the Ninth Circuit held plaintiff’s claim that defendant 22 “negligently failed to warn that its pain pump should not be used in intra-articular spaces such as 23 the glenohumeral joint” was not preempted because it “did not arise solely by virtue of the MDA,” 24 the allegations occurred “outside the context of the regulatory process” and they did not “usurp the 25 exclusive federal enforcement power over the MDA.” McClellan, 776 F.3d at 1037, 1041. 26 1. Failure to Warn 27 Plaintiffs’ failure to warn claim (claim 3) is more closely analogous to the claim in 28 McClellan than Perez. First, the claim does not appear to be based on anything defendant did or 1 did not do related to its communications with the FDA; in other words, the alleged acts occurred 2 “outside the context of the regulatory process.” McClellan, 776 F.3d at 1041. Second, the claim 3 does not exist “solely by virtue of the FDCA . . . requirements,” but could exist independently of 4 any FDCA requirements, because it is based, inter alia, on defendant’s failure to warn “that the 5 device was not safe for use in the cervical spine” and “that the majority of patients in whom the 6 device has been implanted in the cervical spine have suffered from subsidence of the device 7 following the surgery . . . .” Compl. ¶ 60. In other words, even if the FDCA did not exist, plaintiff 8 could still conceivably formulate her failure to warn claim. Therefore, the failure to warn claim is 9 not preempted, based on the reasoning in McClellan. 10 2. Fraud by Concealment 11 Plaintiffs’ fraud by concealment claim (claim 1) appears to implicate Perez; but, 12 upon closer review, it too survives preemption. The claim is based in part on the allegation that 13 defendant “conceal[ed] that neither the XPAND-S or any other corpectomy cage has ever been 14 approved [by the FDA] for use in the cervical spine,” Compl. ¶ 22, similar to the claim in Perez. 15 See Perez, 711 F.3d at 1118–19. However, plaintiffs further allege defendant intentionally created 16 “the false impression in the medical community that XPAND-S was properly cleared for use by the 17 FDA and had established its safety and efficacy.” Compl. ¶ 23. This pleading describes an 18 “omission that tends to render false [defendant]’s off-label promotion of [XPAND-S],” which “both 19 violates the FDCA and is a basis for fraud liability under California law,” Hawkins, 62 F. Supp. 3d 20 at 1155. Like the negligence claim in Hawkins, to the extent plaintiffs’ fraud by concealment claim 21 is, a “based on misrepresentations made during off-label promotion”; it is “not impliedly 22 preempted, because [the] claim is rooted in traditional state tort law and exists regardless of the 23 FDCA.” Id. at 1154–55 (alterations and internal quotation marks omitted) (quoting Coleman v. 24 Medtronic, Inc., 223 Cal. App. 4th 413, 433–34 (2014), as modified (Feb. 3, 2014)); see also Alton, 25 970 F. Supp. 2d at 1097–98 (plaintiff’s fraud claim not preempted because allegations sufficient to 26 state claim “independently of the FDCA or of any other federal law”). Therefore, plaintiffs’ fraud 27 by concealment claim is also not preempted. 28 ///// 1 4. Negligence Per Se 2 Lastly, plaintiffs’ negligence per se claim (claim 2) is based on the allegation that, 3 by “manufactur[ing] and provid[ing] an unapproved or uncleared corpectomy cage to Plaintiff’s 4 physician and intend[ing] it to be implanted during Plaintiff’s cervical spine surgery,” defendant 5 violated California Health and Safety Code section 111550, which regulates the sale of “new” 6 medical devices, and is therefore negligent per se. Compl. ¶¶ 39–41. In other words, defendant’s 7 alleged violation of the FDCA constituted a violation of a state law, which was negligent. In Stengel 8 v. Medtronic Inc., 704 F.3d 1224, 1232 (9th Cir. 2013), the Ninth Circuit analyzed a claim for 9 failure to warn based on the allegation defendant “failed to comply with its duty under federal law” 10 to warn the FDA about known risks, and therefore “it breached its ‘duty to use reasonable care’ 11 under Arizona negligence law.” Id. The court found the claim was not preempted because the 12 claim “rests on a state-law duty that parallels a federal-law duty under the MDA.” Id. at 1233. 13 Because plaintiffs’ negligence per se claim is also based on a state law duty that appears to parallel 14 federal law,3 it also is not preempted by the MDA. 15 D. Fraud by Concealment (Claim 1) & Rule 9 Specificity 16 Federal Civil Procedure Rule 9(b) provides, in relevant part, that “[i]n alleging fraud 17 or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” 18 Fed. R. Civ. P. 9(b). “That is, the allegations must be sufficiently specific ‘to give defendants 19 notice of the particular misconduct which is alleged to constitute the fraud . . . so that they can 20 defend against the charge and not just deny that they have done anything wrong.’” Alton, 21 970 F. Supp. 2d at 1105 (quoting Semegen v. Weidner, 780 F.2d 727, 731 (9th Cir. 1985)). Rule 22 9(b) generally requires the plaintiff identify “the who, what, when, where, and how of the 23 misconduct charged.” Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003) 24 (internal quotation marks and citation omitted); see also Houston v. Medtronic, Inc., 25 3 Defendant does not make the argument that the California law on which this claim is 26 based is not “genuinely equivalent,” to federal regulations, or that it adds to the federal requirement. Martin, 32 F. Supp. 3d at 1034 (quoting Wolicki–Gables, 634 F.3d at 1300). 27 Because defendant has the burden to show the claim is preempted, the court concludes the state law is parallel to the federal requirements in the absence of evidence or argument to the contrary. 28 1 957 F. Supp. 2d 1166, 1180 (C.D. Cal. 2013) (dismissing fraud-based claims for failure to allege 2 “specific contents” of defendants’ alleged misrepresentations). Rule 9(b)’s heightened pleading 3 standard applies to plaintiff’s fraud by concealment claim. See Hawkins, 62 F. Supp. 3d at 1155 4 (applying Rule 9(b) pleading standard to claims for fraudulent misrepresentation and fraud in 5 inducement). 6 Plaintiffs’ fraud by concealment claim is premised on the allegation, based on 7 information and belief, that: 8 Defendant conspired with physicians to fraudulently coerce patients into undergoing experimental cervical spine surgery with an 9 unapproved/uncleared corpectomy cage. Defendant also subsidized physicians to write articles in scientific journals regarding their use 10 of the XPAND-S in the cervical spine while concealing the financial relationship between Defendant and the physicians and also 11 concealing that neither the XPAND-S or any other corpectomy cage has ever been approved for use in the cervical spine. 12 13 Compl. ¶ 22. As a result, plaintiffs allege, “many surgeons who use the XPAND-S and similar 14 devices in cervical surgeries are unaware that they are using a device that has not been properly 15 cleared by the FDA,” which ultimately caused plaintiff Christina Bird to undergo her surgery and 16 suffer injury. Id. ¶¶ 24–26. Plaintiffs’ allegations do not identify any specific surgeons or “articles 17 in scientific journals,” nor any timeline whatsoever. While perhaps sufficient to suggest “how” 18 defendant may have committed fraud by concealment and “what” was concealed, the complaint 19 does not provide defendant with notice of “who . . . when, [and] where.” Vess, 317 F.3d at 1106. 20 Without knowledge of which physicians were involved in defendant’s alleged conspiracy, for 21 example, defendant can do nor more to defend itself than “just deny that [it has] done anything 22 wrong.’” Alton, 970 F. Supp. 2d at 1105 (quoting Semegen, 780 F.2d at 731).4 23 Plaintiffs have not met Rule 9(b)’s heightened pleading standard for their fraud by 24 concealment claim, and the claim is DISMISSED with leave to amend. 25 ///// 26 4 Even if the court were to consider the brochure attached to plaintiffs’ request for judicial 27 notice in support of their opposition, the result is unchanged, as it is unclear how the brochure supports plaintiff’s fraud claim. See Pls.’ Req. for Jud. Not., Ex. 2, ECF No. 13-1, at 8–9. 28 1 E. Failure to Warn (Claim 3) & the Learned Intermediary Doctrine 2 Plaintiffs’ third claim alleges defendant failed to adequately “provide a warning” 3 “that the device, or any similar device, had never been approved for use in the cervical spine,” “that 4 the device was not safe for use in the cervical spine,” “that the majority of patients in whom the 5 device has been implanted in the cervical spine have suffered from subsidence of the device 6 following the surgery,” Compl. ¶ 60, and “plaintiff would not have underwent [sic] the surgery with 7 the XPAND-S device had Plaintiff received the appropriate warnings,” id. ¶ 62. 8 Defendant correctly points out that California applies the “learned intermediary” 9 doctrine, which provides that a medical device manufacturer “satisfies its duty to warn when it 10 provides adequate warnings to the prescribing physician, as opposed to the patient.” Zetz v. Bos. 11 Sci. Corp., 398 F. Supp. 3d 700, 706 (E.D. Cal. 2019); see also Brown v. Superior Court, 44 Cal. 12 3d 1049, 1061–62 n.9 (1988). However, plaintiffs’ allegations can fairly be read to state defendant 13 failed to provide any warnings at all, to either plaintiffs or to the physicians. See Compl. ¶¶ 60–63. 14 Defendant’s argument that the learned intermediary doctrine requires dismissal of plaintiffs’ third 15 claim is unavailing, except to the extent the claim is based on a duty of defendant to warn plaintiffs 16 directly. 17 F. Punitive Damages 18 California Civil Code section 3294 provides for punitive damages for a violation of 19 state law: 20 In an action for the breach of an obligation not arising from contract, where it is proven by clear and convincing evidence that the 21 defendant has been guilty of oppression, fraud, or malice, the plaintiff, in addition to the actual damages, may recover damages for 22 the sake of example and by way of punishing the defendant. 23 Cal. Civ. Code § 3294(a). While plaintiffs ultimately must meet the substantive standard requiring 24 “oppression, fraud, or malice” in order to obtain punitive damages, the Federal Rules of Civil 25 Procedure impose no requirement of particularity to support a claim of punitive damages based on 26 malice at the pleading stage. See Woods v. Davol, Inc., No. 16-CV-02616-KJM-CKD, 2017 WL 27 3421973, at *8 (E.D. Cal. Aug. 9, 2017) (citation omitted). 28 ///// 1 Under Federal Rule of Civil Procedure 9(b), “malice, intent, knowledge, and other 2 conditions of the mind may be alleged generally.” In this circuit, plaintiffs need not plead “any 3 particularity in connection with an averment of intent, knowledge or condition of the 4 mind.” Walling v. Beverly, 476 F.2d 393, 397 (9th Cir. 1973) (citations omitted). Although some 5 district courts in this circuit “have found that conclusory assertions of fraud, malice, and oppression 6 were insufficient under the heightened pleading standard of Twombly and Iqbal for punitive 7 damages,” Singh v. Amguard Ins. Co., No. CV 16-618 PSG (AJWX), 2016 WL 7469641, at *4 8 (C.D. Cal. Apr. 1, 2016) (citing Kelley v. Corrections Corporation of America, 750 F. Supp. 2d 9 1132, 1147–48 (E.D. Cal. 2010)), the court here is persuaded by the reasoning in Singh: those cases 10 that have found fraud, malice and oppression may be alleged generally under Rule 9(b) “better 11 harmonize the pleadings standards for punitive damages with the general pleading standards of 12 Rules 8 [General Rules of Pleading] and 9(b).” Id. (citing Keiper v. Victor Valley Transit Auth., 13 No. CV 15–00703 BRO SPX, 2015 WL 3929641, at *7 (C.D. Cal. June 25, 2015); Rees v. PNC 14 Bank, N.A., 308 F.R.D. 266, 273–74 (N.D. Cal. 2015)). Therefore, “in federal court, a plaintiff 15 may include a ‘short and plain’ prayer for punitive damages that relies entirely on unsupported and 16 conclusory averments of malice or fraudulent intent.” Taheny v. Wells Fargo Bank, N.A., No. CIV. 17 S-10-2123-LKK, 2011 WL 1466944, at *4 (E.D. Cal. Apr. 18, 2011) (citations omitted); see 18 also Somera v. Indymac Fed. Bank, FSB, No. 2:09CV01947 FCD DAD, 2010 WL 761221, at *10 19 (E.D. Cal. Mar. 3, 2010) (“Under federal pleading standards, defendant’s argument that plaintiff 20 must plead specific facts to support allegations for punitive damages is without merit.”). 21 Plaintiffs’ claims provide sufficient support for her request for punitive damages. 22 Plaintiffs allege defendant intentionally concealed the fact that the XPAND-S had not been 23 properly approved by the FDA and “subsidized physicians to write articles in scientific journals 24 regarding their use of the XPAND-S in the cervical spine,” creating the impression in the medical 25 community that the device was safe even though “there have never been any scientific studies on 26 the safety and efficacy of using these devices in the cervical spine.” Opp’n at 21; see also Compl. 27 ¶¶ 18, 22–24. These allegations support the inference that defendant was aware of the probable 28 dangerous consequences of allowing the device to be used in the cervical spine, yet willfully 1 failed to avoid such consequences by concealing facts from the medical community. See Jager v. 2 Davol Inc., EDCV 16-1424 JGB (KKx), 2016 WL 6157942, at *7 (C.D. Cal. Oct. 20, 2016) 3 (denying motion to dismiss where plaintiffs alleged defendants failed to provide accurate 4 information and warning to healthcare community so as to dissuade physicians from surgically 5 implanting Kugel Patch); Tapia v. Davol, Inc., No. 15CV179-GPC (JLB), 2015 WL 6828660, at 6 *8 (S.D. Cal. Nov. 6, 2015) (same). 7 G. Existence of XPAND-S 8 Lastly, defendant argues the court should dismiss plaintiffs’ complaint because the 9 XPAND-S “does not exist,” relying on search results from the FDA’s website indicating no product 10 entitled “XPAND-S” is associated with “globus” in the FDA’s database. Mot. at 13 (citing Def.’s 11 Req. for Jud. Not., Ex. 4). However, plaintiff provides a printout from an FDA database that tracks 12 adverse events reported by medical device manufacturers that suggests the “XPAND Small” or a 13 product with a very similar name, is associated with Globus. Pl.’s Req. for Jud. Not., Ex. 1 (listing 14 “XPAND SMALL VBR” and “XPAND CORPECTORMY SPACER SMALL 12/14”); see also 15 Ritchie, 342 F.3d at 907–08 (a court may “consider certain materials [such as] . . . matters 16 of judicial notice—without converting the motion to dismiss into a motion 17 for summary judgment.”). Because it is clear through the parties’ briefing, the judicially noticed 18 materials, and the court’s discussion with defense counsel at hearing, that “XPAND-S” simply 19 refers to XPAND Small, defendant is on notice of the device at issue. Plaintiffs’ imprecise 20 nomenclature does not warrant dismissing the complaint; however, plaintiffs may correct the name 21 in any first amended complaint. 22 ///// 23 ///// 24 ///// 25 ///// 26 ///// 27 ///// 28 ///// 1 V. CONCLUSION 2 For the foregoing reasons the court GRANTS defendant’s motion to dismiss 3 plaintiffs’ fraud by concealment. The claim is DISMISSED with leave to amend. 4 The court also GRANTS defendant’s motion to dismiss all claims brought by 5 plaintiff Clarence Bird. Those claims are also DISMISSED with leave to amend. 6 The motion to dismiss is otherwise DENIED. 7 Plaintiff SHALL file any amended complaint within fourteen (14) days. 8 This order resolves ECF Nos. 8, 9, and 13. 9 IT IS SO ORDERED. 10 DATED: August 18, 2020. 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28