Nicole Vieira et al v. Mentor Worldwide, LLC et al, No. 2:2019cv04939 - Document 28 (C.D. Cal. 2019)

Court Description: ORDER DENYING PLAINTIFFS' MOTION TO REMAND AND GRANTING DEFENDANTS' MOTION TO DISMISS by Judge Andre Birotte Jr.: Plaintiffs' Motion to Remand 18 is DENIED. Defendant Mentor Worldwide's Motion to Dismiss 12 is GRANTED as to each of Plaintiffs' claims. As amendment would be futile, Plaintiffs' Complaint is DISMISSED WITH PREJUDICE. ( MD JS-6. Case Terminated. ) (gk)

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Nicole Vieira et al v. Mentor Worldwide, LLC et al Doc. 28 1 JS-6 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 CENTRAL DISTRICT OF CALIFORNIA 10 11 NICOLE VIEIRA, an individual; EMILIA BAROZZI, an individual; 12 Plaintiffs, 13 v. 14 MENTOR WORLWIDE, LLC; NUSIL, LLC; NUSIL TECHNOLOGY, LLC; and DOES 1100, inclusive, 15 16 17 18 Case No. CV 19-04939-AB (PLAx) ORDER DENYING PLAINTIFFS’ MOTION TO REMAND AND GRANTING DEFENDANTS’ MOTION TO DISMISS Defendants. 19 20 21 22 23 24 25 26 27 28 Before the Court are two motions filed by the Parties. Defendants Mentor Worldwide, LLC (“Mentor”), NuSil, LLC, and NuSil Technology, LLC (“NuSil Technology”) (collectively, “Defendants”) filed a Motion to Dismiss (“MTD,” Dkt. No. 12). Plaintiffs Nicole Vieira (“Vieira”) and Emilia Barozzi (“Barozzi”) (collectively, “Plaintiffs”) filed an opposition (“Opp’n.,” Dkt. No. 16) and Defendants filed a reply (Dkt. No. 17). The Court heard oral argument on July 12, 2019 and took the motion under submission. Plaintiffs filed a Motion to Remand (Dkt. No. 18). Mentor opposed the motion 1. Dockets.Justia.com 1 (Dkt. No. 24) and filed supplemental authority in support of their opposition (Dkt. No. 2 26). The Court took the motion under submission on July 31, 2019. For the following 3 reasons, Plaintiffs’ Motion to Remand is DENIED and Defendants’ Motions to 4 Dismiss is GRANTED. 5 I. BACKGROUND 6 This lawsuit revolves around injuries Plaintiffs allegedly suffered after 7 surgically receiving Mentor’s MemoryGel Silicone Breast Implants (“MemoryGel 8 Implants”). Plaintiffs plead the following in their First Amended Complaint (“FAC,” 9 Dkt. No. 1, Ex. A). 10 11 12 13 A. The Parties Vieira is a citizen and resident of Solano County, California. FAC ¶ 1. Barozzi is a citizen and resident of Arapahoe County, Colorado. Id. ¶ 2. Mentor is a limited liability company incorporated in Delaware with its 14 principal place of business in Santa Barbara, California. Id. ¶ 3. Mentor 15 manufactured the MemoryGel Implants at issue. Id. ¶ 4. 16 NuSil LLC is a limited liability company incorporated in California with its 17 principal place of business in Carpinteria, California. Id. ¶ 6. NuSil Technology is a 18 limited liability company incorporated in Delaware with its principal place of business 19 in Carpinteria, California. Id. ¶ 7. NuSil LLC and NuSil Technology are silicone raw 20 material suppliers and allegedly manufactured, produced, supplied, and shipped the 21 silicone used in the MemoryGel Implants. Id. ¶ 9. 22 23 B. FDA Regulation of Silicone Breast Implants In 1976, Congress passed the Medical Device Amendments (“MDA”) to the 24 Federal Food, Drug, and Cosmetic Act (“FDCA”). Id. ¶ 36. Under the MDA, 25 medical devices, such as the MemoryGel Implants, are subject to three classifications 26 and regulated accordingly. Id. ¶ 37. Class I devices require the least and most general 27 oversight, Class II devices are reviewed according to more stringent “special 28 controls,” and Class III devices receive the most oversight and require rigorous 2. 1 premarket review and approval. Id. The Food and Drug Administration (“FDA”) 2 classified silicone breast implants as Class III devices. Id. ¶ 38. Accordingly, the 3 FDA requires manufacturers to meet certain requirements for Class III devices. Id. 4 On April 10, 1991, the FDA published a final regulation under Section 515(b) of the 5 FDCA requiring that manufacturers of silicone breast implants submit pre-market 6 approval (“PMA”) applications with data showing a reasonable assurance of safety 7 and effectiveness of the implants by July 9, 1991. Id. ¶ 39. 8 C. Mentor’s FDA Approval 9 In order to eventually seek PMA for its MemoryGel Implants, Mentor was 10 required to first provide the FDA with sufficient information regarding the safety and 11 efficacy of the medical device. Id. ¶ 46. On December 12, 2003, Mentor submitted a 12 request to the FDA for PMA for its MemoryGel Implants. On November 17, 2006, 13 Mentor received approval subject to certain conditions. Id. ¶¶ 62-63. One of the 14 conditions imposed on Mentor required it to conduct six post-approval studies1 to 15 further characterize the safety and effectiveness of MemoryGel Implants. Id. ¶ 63. 16 D. Plaintiffs’ MemoryGel Procedures 17 Vieira was implanted with MemoryGel Implants on April 16, 2007. Id. ¶ 19. 18 Vieira alleges that following implantation she developed Hashimoto’s disease, 19 experienced fatigue, memory loss, hair loss, light sensitivity, skin rashes, vision 20 issues, numbness, dizziness, nausea, chronic sore throats, chest pain, migraines, joint 21 pain, stiffness and swelling, muscle pain and weakness.2 Id. ¶¶ 20-21. Vieira was 22 unaware as to what triggered her symptoms. Id. ¶ 21. Vieira’s injuries caused her to 23 be bedridden; she subsequently moved to her parent’s household in Vacaville, 24 25 26 27 28 1 The FDA required Mentor to conduct: the core study, the large post-approval study, the device-failure study, the focus-group study, the informed-decision study, and the adjunct study. Id. ¶ 64. 2 At the time of her implantation and during the onset of her symptoms, Vieira resided in Los Angeles County. Id. ¶ 21. 3. 1 California for home care. Id. ¶ 22. On June 27, 2016, Vieira underwent a bilateral 2 explantation of her implants in Los Angeles, California. Id. ¶ 23. A gel bleed was 3 discovered in the right implant during the procedure. Id. Within six months of 4 explantation, Vieira saw relief of approximately 80% of her symptoms and is now in 5 remission from her Hashimoto’s disease. Id. ¶ 24. 6 Barozzi received MemoryGel Implants on April 12, 2012. Id. ¶ 26. Barozzi 7 alleges that following implantation, she developed a rash on her chest and abdomen 8 along with dry eyes and mouth, experienced recurrent sore throats, ear infections, and 9 bladder infections. Id. ¶ 28. Barozzi’s pain increased over time. Id. Barozzi also 10 developed rheumatoid arthritis, experienced fatigue, joint pain and stiffness, muscle 11 weakness, memory loss, shortness of breath, cognitive dysfunction, chest pains, 12 itching, nausea, dizziness, numbness, vision issues, light sensitivity, night sweats, 13 metallic taste, poor wound healing, and hair loss. Id. ¶ 27. Barozzi was unaware as to 14 what caused her injuries. Id. ¶ 28. On August 2, 2016, Barozzi underwent a bilateral 15 explantation of her implants. Id. ¶ 29. A gel bleed was discovered during the 16 procedure. Id. ¶ 29. After explantation, various defects were found in Barozzi’s 17 implants. Id. ¶ 30. 18 E. This Action 19 Plaintiffs filed a FAC in the Los Angeles County Superior Court asserting 20 causes of action for: (1) negligence/negligence per se; (2) failure to warn; and (3) 21 manufacturing defect. Defendants filed a notice of removal in this Court and then 22 filed a motion to dismiss Plaintiffs’ FAC pursuant to Federal Rule of Civil Procedure 23 12(b)(6) for failure to state a claim. Plaintiffs filed a motion to remand. 24 II. LEGAL STANDARD 25 A. Motion to Dismiss Under 12(b)(6) 26 Federal Rule of Civil Procedure 8 requires a plaintiff to present a “short and 27 plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. 28 Civ. P. 8(a)(2). Under Rule 12(b)(6), a defendant may move to dismiss a pleading for 4. 1 2 “failure to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). To defeat a motion to dismiss under Rule 12(b)(6), the complaint must provide 3 enough details to “give the defendant fair notice of what the . . . claim is and the 4 grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). 5 The complaint must also be “plausible on its face,” allowing the court to “draw the 6 reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft 7 v. Iqbal, 556 U.S. 662, 678 (2009). “The plausibility standard is not akin to a 8 ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant 9 has acted unlawfully.” Id. at 678. Labels, conclusions, and “a formulaic recitation of 10 the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. 11 When ruling on a Rule 12(b)(6) motion, “a judge must accept as true all of the 12 factual allegations contained in the complaint.” Erickson v. Pardus, 551 U.S. 89, 94 13 (2007). But a court is “not bound to accept as true a legal conclusion couched as a 14 factual allegation.” Iqbal, 556 U.S. at 678 (internal quotation marks omitted). 15 B. Leave to Amend 16 Should a court dismiss certain claims, “[l]eave to amend should be granted 17 unless the district court ‘determines that the pleading could not possibly be cured by 18 the allegation of other facts.’” Knappenberger v. City of Phoenix, 566 F.3d 936, 942 19 (9th Cir. 2009) (quoting Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir. 2000) (en 20 banc)); see also Knevelbaard Dairies v. Kraft Foods, Inc., 232 F. 3d 979, 983 (9th 21 Cir. 2000) (“An order granting such a motion must be accompanied by leave to amend 22 unless amendment would be futile”). 23 C. Removal 24 Federal courts are courts of limited jurisdiction and possess only that 25 jurisdiction as authorized by the Constitution and federal statute. Kokkonen v. 26 Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). Under 28 U.S.C. § 1441(a), 27 a party may remove a civil action only if the district court has original jurisdiction 28 over the issues alleged in the state court complaint. There is a strong presumption that 5. 1 the Court is without jurisdiction until affirmatively proven otherwise. See Fifty 2 Assocs. v. Prudential Ins. Co. of America, 446 F.2d 1187, 1190 (9th Cir. 1970). When 3 an action is removed from state court, the removing party bears the burden of 4 demonstrating that removal is proper. Gaus v. Miles, Inc., 980 F.2d 564, 566 (9th Cir. 5 1992). 6 Under the diversity statute, 28 U.S.C. § 1332, a federal district court has 7 original jurisdiction when the parties are completely diverse and the amount in 8 controversy exceeds $75,000. See 28 U.S.C. § 1332. Pursuant to 28 U.S.C. § 1441(a) 9 and (b), a defendant may remove an action from state court to federal court if the 10 diversity and amount in controversy requirements are satisfied. Under 28 U.S.C. § 11 1441(b)(2), “[a] civil action otherwise removable solely on the basis of the jurisdiction 12 under section 1332(a) of this title may not be removed if any of the parties in interest 13 properly joined and served as defendants is a citizen of the State in which such action 14 is brought.” 28 U.S.C. § 1441(b)(2). 15 A non-diverse party may be disregarded for purposes of determining whether 16 jurisdiction exists if the court determines that the party’s joinder was “fraudulent” or a 17 “sham.” Ritchey v. Upjohn Drug Co., 139 F.3d 1313, 1318 (9th Cir. 1998). 18 “Fraudulent joinder” occurs, for the purpose of determining diversity jurisdiction, 19 where the plaintiff fails to state a cause of action against the resident defendant, and 20 the failure is obvious according to settled rules of the state. McCabe v. Gen. Foods 21 Corp., 811 F.2d 1336 (9th Cir. 1987). “But if there is a possibility that a state court 22 would find that the complaint states a cause of action against any of the resident 23 defendants, the federal court must find that the joinder was proper and remand the 24 case to the state court.” Grancare, LLC v. Thrower by & through Mills, 889 F.3d 543, 25 548 (9th Cir. 2018) (quotations omitted). 26 The defendant has a high burden of proof when establishing fraudulent joinder. 27 A removing defendant may present evidence to prove fraudulent joinder, but the 28 district court must resolve all disputed questions of fact in the plaintiff’s favor. See 6. 1 Grancare, 889 F.3d at 549. Thus, a defense should not require “a searching inquiry 2 into the merits of the plaintiff's case, even if that defense, if successful, would prove 3 fatal.” Id. In this regard, “[r]emand must be granted unless the defendant shows that 4 the plaintiff would not be afforded leave to amend his complaint to cure [a] purported 5 deficiency” in its allegations against the non-diverse defendant. Padilla v. AT & T 6 Corp., 697 F. Supp. 2d 1156, 1159 (C.D. Cal. 2009) (quotations omitted). Ultimately, 7 “[f]raudulent joinder must be proven by clear and convincing evidence.” Hamilton 8 Materials, Inc. v. Dow Chem. Corp., 494 F.3d 1203, 1206 (9th Cir. 2007). 9 III. 10 11 12 DISCUSSION A. Motion to Remand 1. Removal Was Timely And Proper “A notice of removal may be filed within 30 days after receipt by the defendant, 13 through service or otherwise, of a copy of an amended pleading, motion, order or 14 other paper from which may first be ascertained that the case is one which is or has 15 become removable.” 28 U.S.C. § 1446. There are two thirty-day periods for removal 16 and the “second thirty-day period . . . enters the picture only when . . . the original 17 complaint does not evidence its removability.” Kuxhausenn v. BMW Financial 18 Services NA LLC, 707 F.3d 1136, 1141 (9th Cir. 2013). “A second removal petition 19 based on the same grounds [as the first removal] does not ‘reinvest’ the court’s 20 jurisdiction.” Seedman v. U.S. Dist. Court for Cent. Dist. of California, 837 F.2d 413, 21 414 (9th Cir. 1988). Nevertheless, the second thirty-day period applies even to cases 22 which have previously been removed and remanded, so long as the latter removal is 23 “based on information not available at the prior removal.” See Sweet v. United Parcel 24 Serv., Inc., 2009 WL 1664644, at *3 (C.D. Cal. June 15, 2009). Successive removals 25 are also permissible if “the first remand was on grounds that subsequently became 26 incorrect.” Taylor v. Cox Commc’ns Cal., LLC, 673 F. App’x 734, 735 (9th Cir. 27 2016) (internal quotation marks omitted). 28 Here, Mentor’s successive removal was timely and proper as it was filed within 7. 1 thirty days of receipt of Mr. Mraz’s deposition transcript. Following the prior notice 2 of removal, Mr. Mraz’s deposition provided evidence that NuSil LLC is a holding 3 company and not a manufacture of silicone. Mr. Mraz’s deposition seriously 4 undermines Plaintiff’s argument that NuSil LLC is a properly named defendant and 5 belongs in the case. Plaintiffs were afforded the opportunity to test the sufficiency of 6 Mr. Mraz’s statements. See, e.g., Costa v. Cnty. Of Ventura, 680 F. App’x 545, 547 7 (9th Cir. 2017) (explaining that a party must be afforded opportunity to “test . . . 8 declarations through depositions”). Yet, Plaintiffs have not demonstrated that the 9 information contained in Mr. Mraz’s deposition is false. The Court is satisfied that 10 additional discovery will not change the fact that NuSil LLC was not in the 11 manufacture of silicone products and is an improperly named defendant. 12 13 2. NuSil LLC is Fraudulently Joined Plaintiffs assert there is not complete diversity of citizenship because NuSil 14 LLC and Vieira are both California citizens. In their Complaint, Plaintiffs aver that 15 NuSil LLC manufactured a defective component of Mentor’s implants. In response, 16 Mentor contends that NuSil LLC was fraudulently joined in the action. 17 In a product liability action, a plaintiff must establish “that the defendant 18 produced, manufactured, sold, or was in some way responsible for the [defective] 19 product.” Garcia v. Joseph Vince Co., 84 Cal. App. 3d 868, 874 (1984) (quotations 20 omitted). Mentor argues that NuSil LLC was not involved with the production of the 21 silicone used in its MemoryGel implants. Specifically, Mentor argues NuSil LLC is a 22 holding company with no operations, and thus could not have participated in the 23 manufacture of Mentor’s allegedly defective implants. In support of this argument, 24 Mentor submitted to the Court the Deposition of Scott Mraz (“Mraz Dep.”, Dkt. No. 1 25 Ex. M), an individual member of NuSil LLC since August 1, 2005. Mr. Mraz testified 26 that NuSil LLC (1) is a holding company that transacts no business of its own and 27 whose sole purpose is to hold stock for its members; (2) has not developed, designed, 28 manufactured, supplied, or distributed any products, including the silicone or silicone 8. 1 gel used to manufacture breast implants; and (3) has no ownership interest in or 2 control over the plant, equipment, and supplies that are used to manufacture the 3 silicone raw materials used in breast implants. See Mraz Dep. at 18:7-21, 40:8-12, 4 40:2-7. 5 Vieira produces evidence contrary to Mr. Mraz’s position and suggests there is 6 a triable issue. In 2013, NuSil LLC filed a Statement of Information with the 7 Secretary of State of California.3 The Statement of Information is a short, two-page 8 document which identifies NuSil LLC as a “Manufacturer of Silicone Products”. 9 Mraz signed that Statement of Information as CFO/President of NuSil. Under oath, 10 Mraz testified that he would have reviewed the document for accuracy before signing. 11 Mentor claims that the 2013 Statement of Information contained a clerical error 12 and points out that NuSil has since filed an amended statement of information wherein 13 it describes itself as an “Investment holding entity.” See Dkt. No. 1 Ex. N. Mentor 14 argues this corrected Statement of Information “conclusively resolve[s]” the factual 15 dispute this Court previously addressed in a related matter.4 Plaintiffs’ position is 16 bolstered by the declaration and deposition testimony of Mr. Mraz. 17 After a review of the amended Statement of Information and Mr. Mraz’s 18 testimony at deposition, the Court concludes that NuSil LLC did not manufacture 19 silicone and was not involved in the development of the MemoryGel Implant. NuSil 20 is not a proper defendant in this lawsuit as there is no possibility that Plaintiff could 21 recover under a theory of product liability against NuSil LLC. 22 /// 23 24 25 26 27 28 3 The Court GRANTS Plaintiffs’ request for judicial notice. Dkt. No. 1 Ex. N. The 2013 Statement of Information is a proper subject of judicial notice under Federal Rule of Evidence 201. A court may take judicial notice of matters of public record, and a California Statement of Information is a matter of public record. Khoury Invs. Inc. v. Nationwide Mut. Ins. Co, No CV 13-05415-MWF (Ex), 2013 WL 12140449, at *2 (C.D. Cal. Sept. 16, 2013). 4 See Vieira v. Mentor Worldwide, LLC, et al., No. 2-18-cv-06502-AB (PLAx) (C.D. Cal. Aug. 23, 2018) 9. 1 2 3 /// B. Motion to Dismiss Defendants argue that Plaintiffs’ state-law claims are expressly and impliedly 4 preempted by the MDA. Because Plaintiffs’ claims against Mentor are preempted by 5 the MDA, Mentor’s motion to dismiss is GRANTED. 6 7 1. There Is No Presumption Against Preemption That Applies Here The Supremacy Clause of the Constitution provides that federal law preempts 8 state law. Art. VI. cl. 2. However, preemption analysis starts with the assumption 9 that state laws are not preempted unless it was intended by Congress. Rice v. Santa Fe 10 Elevator Corp., 331 U.S. 218, 230 (1947). Thus, legislative intent is the “ultimate 11 touchstone” of preemption analysis. Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 12 (1963). Congress’ intent to preempt state law may be expressed in the statute’s 13 language or implied in its statutory framework. Cipollone v. Liggett Group, Inc., 505 14 U.S. 504 (1992) (quoting Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977)). 15 When there is an express preemption provision, the court does “not invoke any 16 presumption against pre-emption but instead ‘focus[es] on the plain wording of the 17 clause, which necessarily contains the best evidence of Congress’ pre-emptive 18 intent.’” Puerto Rico v. Franklin Cal. Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) 19 (quoting Chamber of Commerce of U.S. v. Whiting, 536 U.S. 582, 594 (2011)). 20 Here, Plaintiffs claim Defendants’ motion does not overcome this presumption 21 against preemption because Defendants failed to establish that Congress intended to 22 bar redress for injuries caused by Defendants’ FDA violations. The Supreme Court in 23 Puerto Rico found that where there is an express preemption provision there is no 24 presumption against preemption. 136 S. Ct. at 1946. “[F]ocus on the plain meaning 25 of the clause which contains the best evidence of Congress’s pre-emptive intent.” Id. 26 It is well established that the MDA expressly preempts state requirements that are 27 “different from, or in addition to” federal requirements and that was the clear intention 28 of Congress. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Plaintiffs also cite 10. 1 to Medtronic, Inc., v. Lohr, 518 U.S. 470, 487 (1996) for the proposition that it is 2 difficult to believe that Congress would remove all means of judicial recourse for 3 consumers injured by FDA approved devices. Contrary to Plaintiffs’ position, “this is 4 exactly what a pre-emption clause for medical devices does by its terms.” Riegel, 552 5 U.S. at 326. Therefore, the presumption against preemption does not apply here. 6 2. Plaintiffs Do Not Assert A Parallel Claim That Survives 7 Preemption 8 9 The MDA contains an express preemption provision that provides, as relevant here: 10 “[N]o State . . . may establish or continue in effect with respect to a device 11 intended for human use any requirement— 12 (1) which is different from, or in addition to, any requirement applicable under 13 this Act to the device, and 14 (2) which relates to the safety or effectiveness of the device or to any other 15 matter included in a requirement applicable to the device under this chapter.” 16 21 U.S.C. § 360k(a). 17 The Supreme Court, in Riegel, applied a two-step analysis to determine whether 18 the MDA expressly preempts a state law claim within the meaning of § 360k(a). First, 19 a court must determine whether the FDA has established requirements applicable to 20 the particular medical device at issue. Riegel, 552 U.S. at 321-22. Second, a court 21 must determine whether the state law claims are based on state requirements that are 22 “different from, or in addition to” the federal requirements, and relate to safety and 23 effectiveness. Id. State “requirements” also include the state’s common-law legal 24 duties. Id. at 324-325 (“State tort law . . . disrupts the federal scheme no less than 25 state regulatory law to the same effect”). 26 However, the Supreme Court has made clear that “§ 360k does not prevent a 27 State from providing a damages remedy for claims premised on a violation of FDA 28 regulations; the state duties in such a case parallel, rather than add to, federal 11. 1 requirements.” Id. at 330; see also Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 2 (9th Cir. 2013) (en banc) (“[T]he MDA does not preempt a state-law claim for 3 violating a state-law duty that parallels a federal-law duty under the MDA”). 4 In order for a state requirement to be parallel to a federal requirement, a 5 plaintiff must show that the requirements are “genuinely equivalent.” Houston v. 6 Medtronic, 957 F. Supp. 2d 1166, 1174 (C.D. Cal. July 30, 2013) (quoting Wolicki- 7 Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2001)). State and federal 8 requirements are not generally equivalent if a manufacturer could be held liable under 9 state law without having violated federal law. Id. at 1174. 10 The MDA also provides that all actions to enforce FDA requirements “shall be 11 by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court 12 interpreted that the provision “leaves no doubt that it is the Federal Government rather 13 than private litigants who are authorized to file suit for noncompliance with the 14 medical device provisions.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 15 349 n. 4 (2001). Thus, to avoid implied preemption, a cause of action must rely on 16 traditional state law and not be based solely on a violation of federal law. Id. at 353. 17 The Ninth Circuit has recognized that there is a “‘narrow gap’ through which a 18 state-law claim must fit to escape preemption.” Perez v. Nidek Co., Ltd., 711 F.3d 19 1109, 1120 (9th Cir. 2013). “The plaintiff must be suing for conduct that violates the 20 FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must 21 not be suing because the conduct violates the FDCA (such a claim would be impliedly 22 preempted under Buckman).” Id. at 1120 (emphasis in original) (citing In re 23 Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200, 1204) (8th Cir. 24 2010). To avoid preemption, a plaintiff must assert a state-law claim that is premised 25 on a violation of federal law but that is not based solely on such violation. Id. 26 Here, Plaintiffs allege Mentor violated federal laws and regulations that are 27 parallel to violations of California state law; however, Plaintiffs have not satisfied 28 their pleading burden. As an initial matter, the Court is not satisfied with Plaintiffs’ 12. 1 argument that Mentor violated federal and state law by failing to report adverse events 2 to the FDA. These allegations are merely conclusory. Plaintiffs’ Complaint lacks any 3 reference to the specific adverse events that Mentor failed to report. Further, Plaintiffs 4 do not specifically allege that poor performance on post-approval studies is a violation 5 of federal law. Additionally, the Court rejects Plaintiffs’ claims that Mentor violated 6 federal regulations and state law by defectively manufacturing MemoryGel Implants. 7 Plaintiffs, in conclusory fashion, allege that Defendants’ MemoryGel Implant 8 specifications are inconsistent with federal regulations; however, Plaintiffs fail to 9 allege facts demonstrating that Defendants’ specifications are inconsistent or violative 10 of federal standards. In short, a plaintiff “cannot simply incant the magic words” that 11 a defendant violated FDA regulations to avoid preemption. Simmons v. Boston 12 Scientific Corp., 2013 WL 1207421 at *4 (C.D. Cal. Mar. 25, 2018) (quoting Wolicki- 13 Gables, 634 F.3d at 1301). Lastly, Plaintiffs fail to allege facts showing how any 14 federal violation caused their claimed injuries. Plaintiffs have not asserted a parallel 15 claim capable of surviving preemption. 16 Finally, Plaintiffs claim that “discovery is necessary” to provide a basis for their 17 claims but Plaintiffs cannot be permitted to engage in discovery when they have not 18 met the most basic pleading standards. Nothing in Plaintiffs’ allegations suggests 19 discovery is needed to resolve this Motion. 20 21 3. Plaintiff Barozzi Cannot Assert a Failure to Report Claim “[A] federal court sitting in diversity applies the choice-of-law rules of the 22 forum” state. Narayan v. EGL, Inc., 616 F.3d 895, 898 (9th Cir. 2010). California 23 employs a “governmental interest analysis” to resolve choice of law issues. Offshore 24 Rental Co., Inc. v. Continental Oil Co., 22 Cal. 3d 157, 161 (1978). “California courts 25 have tended to apply the law of the place of the injured’s domicile, finding that state 26 has the greatest interest.” Kasel v. Remington Arms Co., 24 Cal App.3d 711, 734 27 (1972); see also Mazza v. Am. Honda Motor Co., 666 F.3d 581, 593 (9th Cir. 2012) 28 (confirming that under California’s choice of law rules, “the place of the wrong has 13. 1 2 the predominant interest”). Here, Plaintiff Barozzi resided in Colorado at all relevant times—her alleged 3 injuries all occurred there. Colorado has the greatest interest in the application of its 4 law to Barozzi’s claims and its law therefore applies. Thus, Plaintiff Barozzi is 5 preempted from making a failure to warn claim, because her home state of Colorado 6 does not recognize such claims. Moreover, Plaintiff Barozzi cannot avoid preemption 7 by arguing that California law applies, because California has no comparable interest. 8 9 10 4. The Remaining Plaintiffs Fail to Sufficiently Plead Failure to Report The FDA requires device manufacturers to report any time its device “may have 11 caused or contributed to a death or serious injury.” 21 C.F.R. § 803.50(a). A claim 12 based on the failure to warn the FDA of adverse events is not preempted to the extent 13 state tort law recognizes a parallel duty. De La Paz v. Bayer Healthcare LLC, 159 F. 14 Supp. 3d 1085, 1096-97 (N.D. Cal. Feb. 2, 2016). However, a claim based on a 15 failure to warn physicians or patients of adverse events would be preempted. Id.; see 16 also Stengel, 704 F.3d at 1234. California law recognizes such a duty to warn. 17 Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413, 429 (2014). To state a failure to 18 warn claim under California law, a plaintiff “will ultimately have to prove that if [a 19 defendant] had properly reported the adverse events to the FDA as required under 20 federal law, that information would have reached [the plaintiff’s] doctors in time to 21 prevent [plaintiff’s] injuries.” Id. at 429-30 (quoting Stengel, 704 F.3d at 1234). 22 Here, Plaintiffs’ conclusory allegation that Mentor failed to comply with federal 23 requirements by not reporting adverse events is insufficient. Plaintiffs do not point to 24 any facts supporting her assertion. Plaintiffs have not explained how any purported 25 failure to report the unspecified adverse events caused her injuries. In turn, Plaintiffs 26 allegations are based not on a failure to report actual adverse events from the post- 27 approval studies but rather on a purported failure to properly conduct those studies. 28 “The alleged technical defects in Mentor’s post-approval studies, however, do not 14. 1 constitute adverse events.” Ebrahimi v. Mentor Worldwide LLC, 2018 WL 2448095, 2 at *3 (C.D. Cal. May 25, 2018) . Plaintiffs cannot pursue a claim premised on a 3 counterfactual assumption that Mentor would have identified additional adverse 4 events if it had conducted the studies more adequately. Any such claim is 5 impermissibly speculative. Additionally, any claim premised on Mentor’s alleged 6 failure to conduct the post-approval studies adequately is impliedly preempted, 7 because there is no state law duty to conduct post-approval studies in the first 8 instance. 9 Furthermore, Plaintiffs’ failure to report a claim fails because they do not allege 10 facts showing that the FDA would have exercised its discretion to include additional 11 adverse events in its publicly-accessible adverse-event database had Mentor reported 12 the events. Nor do Plaintiffs allege facts showing that their treating physicians even 13 relied on information in the adverse event database making decisions. Without such 14 facts, Plaintiffs cannot establish a causal nexus between their alleged injuries and 15 Mentor’s alleged failure to report. 16 Plaintiffs deduce that if Mentor had conducted follow-up with participants 17 enrolled in clinical studies that there would have been adverse event reports showing 18 heightened instances of rupture rates. No facts support the conclusion that additional 19 information from patients in post-approval studies would reveal additional adverse 20 events regarding ruptures or would result in the FDA requiring different labeling. Nor 21 has Plaintiff Vieira alleged any facts explaining how Mentor’s purported failure to 22 report adverse events from its post-approval studies somehow caused her injuries. 23 Plaintiff Vieira’s failure to report claim, thus, fails for lack of proximate causation. 24 25 5. Plaintiffs’ Manufacturing Defect Claims Are Preempted For manufacturing defects claims to survive preemption, plaintiffs are required 26 to allege “that the manufacturing of the device both fell short of the FDA’s 27 requirement for manufacturing and—based on the same deficiency—was defectively 28 manufactured under California law.” Funke v. Sorin Group USA, Inc., 147 F. Supp. 15. 1 3d 1017, 1026 (C.D. Cal. Nov. 24, 2015). The MDA provides that a device is 2 defective if “the methods used in, or the facilities or controls used for, its manufacture 3 . . . are not in conformity” with the FDA’s requirements for that device. 21 U.S.C. § 4 351(h). Next, to escape implied preemption, a plaintiff must allege that the 5 manufacturing defect caused her injuries. De La Paz, 159 F. Supp. 3d at 1094; see 6 also Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1092 (C.D. Cal. 2011) 7 (stating a plaintiff must establish a “causal nexus between the alleged injury and the 8 violation”). 9 Here, Plaintiffs claim that Mentor’s implants differed in some undefined way 10 from the manufacturing and design specifications mandated by the FDA as part of the 11 PMA; that Mentor used unidentified material and components that somehow differed 12 from those approved by the FDA; that Mentor violated unspecified provisions of 13 applicable federal regulations, including the FDA’s Quality System Regulations and 14 design control requirements under 21 C.F.R. 820.30. But Plaintiffs “fail[] to 15 adequately allege that the Implants violated the FDA’s manufacturing requirements.” 16 Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122, at *2 (C.D. Cal. Dec. 27, 17 2018). Merely alleging that a defendant violated unspecified “law and regulations” or 18 produced a “noncomforming” device does not sufficiently establish that the defendant 19 violated a federal requirement. Instead a plaintiff must identify specific regulatory 20 violation at issue. In addition, Plaintiffs do not allege how any violation caused their 21 purported injuries; they simply conclude that causation exists without providing any 22 supporting explanation. More is needed. 23 6. Plaintiffs Fail To Explain How To Cure The Pleading Deficiencies 24 Valid reasons for denying leave to amend include undue delay, bad faith, repeated 25 failure to cure deficiencies by amendments previously allowed, undue prejudice, and 26 futility. Foman v. Davis, 371 U.S. 178, 182 (1962); see also Klamath-Lake Pharm. 27 Ass’n v. Klamath Med. Serv. Bureau, 701 F.2d 1276, 1292-93 (9th Cir. 1983) (holding 28 that while leave to amend shall be freely given, the court need not allow futile 16. 1 amendments). The Court denies leave to amend because Plaintiffs have not explained 2 how further amendment could cure the pleading deficiencies in their Complaint. As 3 Plaintiffs have had two opportunities to properly plead their claims, the Court 4 concludes that granting further leave to amend would be futile. See Cafasso v. Gen. 5 Dynamics C4 Sys., Inc., 637 F.3d 1047, 1058 (9th Cir. 2011) (“[T]he district court’s 6 discretion to deny leave to amend is particularly broad where plaintiff has previously 7 amended the complaint.”) (quoting Ascon Props., Inc. v. Mobil Oil Co., 866 F.2d 8 1149, 1160 (9th Cir. 1989)). 9 IV. 10 CONCLUSION For the foregoing reasons, Plaintiffs’ Motion to Remand is DENIED. Defendant 11 Mentor Worldwide’s Motion to Dismiss is GRANTED as to each of Plaintiffs’ 12 claims. As amendment would be futile, Plaintiffs’ Complaint is DISMISSED WITH 13 PREJUDICE. 14 15 IT IS SO ORDERED. 16 17 18 19 Dated: August 1, 2019 _______________________________________ HONORABLE ANDRÉ BIROTTE JR. UNITED STATES DISTRICT COURT JUDGE 20 21 22 23 24 25 26 27 28 17.

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