Tammi Jacob et al v. Mentor Worldwide LLC et al, No. 2:2019cv01484 - Document 52 (C.D. Cal. 2019)

Court Description: ORDER DENYING PLAINTIFFS' MOTION TO REMAND AND GRANTING DEFENDANTS' MOTIONS TO DISMISS by Judge Andre Birotte Jr.: Plaintiffs' Motion to Remand 21 is DENIED. Defendants NuSil LLC and NuSil Technology LLC's Motion to Dismiss 23 is DENIED as moot. Defendant Mentor Worldwide's Motion to Dismiss 19 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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Tammi Jacob et al v. Mentor Worldwide LLC et al Doc. 52 1 JS-6 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 CENTRAL DISTRICT OF CALIFORNIA 10 TAMMI JACOB et al; 11 12 13 14 15 16 Case No. CV 19-01484-AB (PLAx) Plaintiffs, v. MENTOR WORLWIDE, LLC; NUSIL, LLC; NUSIL TECHNOLOGY, LLC; and DOES 1100, inclusive, ORDER DENYING PLAINTIFFS’ MOTION TO REMAND AND GRANTING DEFENDANTS’ MOTIONS TO DISMISS Defendant. 17 18 19 20 Before the Court are three motions filed by the Parties. 21 Defendants, Mentor Worldwide, LLC. (“Mentor”), NuSil LLC., and NuSil 22 Technology LLC (“NuSil”) filed motions to dismiss (Dkt. Nos. 19, 23). Plaintiffs 23 Tammi Jacob (“Jacob”), Kate Nunn (“Nunn”), Aluvia Solano (“Solano”), Mary 24 Watson (“Watson”), and April Zimmerman (“Zimmerman”) (collectively, 25 “Plaintiffs”) opposed the motions (Dkt. Nos. 34, 35), and Defendants replied (Dkt. 26 Nos. 37, 38). 27 Plaintiffs filed a Motion to Remand (Dkt. No. 21). Mentor opposed the motion 28 (Dkt. No. 33) and Plaintiffs replied (Dkt. No. 39). The Court heard oral argument on 1. Dockets.Justia.com 1 July 12, 2019 and took the motions under submission. For the following reasons, 2 Plaintiffs’ Motion to Remand is DENIED and Defendants’ Motions to Dismiss is 3 GRANTED. 4 I. BACKGROUND 5 This lawsuit revolves around injuries Plaintiffs allegedly suffered after 6 receiving surgical implants of Mentors’ MemoryGel Silicone Breast Implants 7 (“MemoryGel Implants”). Plaintiffs plead the following in their Complaint 8 (“Compl.,” Dkt. No. 1, Exhibit A). 9 A. The Parties 10 Jacob is a citizen and resident of Los Angeles County, California. Compl. ¶ 1. 11 Nunn is a citizen and resident of Collin County, Texas. Id. ¶ 2. Solano is a citizen 12 and resident of Bernalillo County, New Mexico. Id. ¶ 3. Watson is a citizen of Saline 13 County, Arkansas. Id. ¶ 4. Zimmerman is a citizen of Jackson County, Missouri. Id. 14 ¶ 5. 15 Mentor is a limited liability company incorporated in Delaware with its 16 principal place of business in Santa Barbara, California. Id. ¶ 6. Mentor 17 manufactured the MemoryGel Implants at issue. Id. ¶ 7. 18 19 NuSil LLC is a limited liability company incorporated in California with its principal place of business in Carpinteria, California. Id. ¶ 8. 20 NuSil Technology, LLC is a limited liability company incorporated in Delaware 21 with its principal place of business in Carpinteria, California. Id. ¶ 9. NuSil LLC and 22 NuSil Technology are silicone raw material suppliers and allegedly manufactured, 23 produced, supplied, and shipped the silicone used in the MemoryGel Implants. Id. ¶ 24 11. 25 B. FDA Regulation of Silicone Breast Implants 26 In 1976, Congress passed the Medical Device Amendments (“MDA”) to the 27 Federal Food, Drug, and Cosmetic Act (“FDCA”). Id. ¶ 41. Under the MDA, 28 medical devices, such as the MemoryGel Implants, are subject to three classifications 2. 1 and regulated accordingly. Id. ¶ 42. Class I devices require the least and most general 2 oversight, Class II devices are reviewed according to more stringent “special 3 controls,” and Class III devices receive the most oversight and require rigorous 4 premarket review and approval. Id. The Food and Drug Administration (“FDA”) 5 classified silicone breast implants as Class III devices. Id. ¶ 43. Accordingly, the 6 FDA requires manufacturers to meet certain requirements for Class III devices. Id. 7 On April 10, 1991, the FDA published a final regulation under Section 515(b) of the 8 FDCA requiring that manufacturers of silicone breast implants submit pre-market 9 approval (“PMA”) applications with data showing a reasonable assurance of safety 10 and effectiveness of the implants by July 9, 1991. Id. ¶ 44. 11 C. Mentor’s FDA Approval 12 In order to eventually seek PMA for its MemoryGel Implants, Mentor was 13 required to first provide the FDA with sufficient information regarding the safety and 14 efficacy of the medical device. Id. ¶ 51. On December 12, 2003, Mentor submitted a 15 request to the FDA for PMA for its MemoryGel Implants. Id. ¶ 67. On November 17, 16 2006, Mentor received approval subject to certain conditions. Id. ¶¶ 68. One of the 17 conditions imposed on Mentor required it to conduct six post-approval studies1 to 18 further characterize the safety and effectiveness of MemoryGel Implants. Id. ¶ 68. 19 D. Plaintiffs’ MemoryGel Procedures 20 Jacob was implanted with MemoryGel Implants in November 2006. Id. ¶ 21. 21 Jacob alleges that following implantation she developed pain and swelling of her 22 breasts, experienced fatigue, muscle pain, muscle weakness, joint pain, stiffness and 23 swelling, vision issues, light sensitivity, numbness, dizziness, nausea, memory loss, 24 shortness of breath, cognitive dysfunction, chest pain, migraines, itching, chronic sore 25 throats, night sweats, and hair loss. Id. ¶ 22. In July 2018, an MRI scan revealed 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. ¶ 69. 3. 1 Jacob’s right breast implant had ruptured; Jacob underwent a bilateral explantation of 2 her implants on August 6, 2018. Id. ¶ 23. After explantation, various defects were 3 found within Jacob’s right breast implant. Id. ¶ 24. 4 Nunn was implanted with MemoryGel Implants in December 2014 and 5 December 2015. Id. ¶ 25. Following the implantation, Nunn began to experience, 6 among other things, pain and swelling of the breasts, edema, and muscle pain. Id. ¶ 7 26. On September 17, 2018, Nunn underwent an explantation of her right breast 8 implant. Id. ¶ 27. A gel bleed/rupture was discovered during the procedure. Id. 9 After explantation, various defects were found within Nunn’s right breast implant. Id. 10 ¶ 28. 11 Solano was implanted with MemoryGel Implants for her left and right breast on 12 April 19, 2011 and August 9, 2011 respectively. Id. ¶ 30. Following implantation, 13 Solano developed a number of illnesses and symptoms. Id. ¶ 31. On December 13, 14 2016, Solano underwent an explantation of her ruptured left breast implant. Id. ¶ 31. 15 After explantation, various defects were found within Solano’s left breast implant. Id. 16 ¶ 32. 17 Watson was implanted with MemoryGel Implants in February 2012. Id. ¶ 33. 18 Following the implantation, Watson began to experience, among other things, fatigue, 19 muscle weakness, joint stiffness, shortness of breath, itching, dizziness, and night 20 sweats. Id. ¶ 34. On January 24, 2017, Watson underwent a bilateral explantation of 21 her implants. Id. ¶ 35. A gel bleed/rupture was discovered during the procedure. Id. 22 After explantation, various defects were found within Watson’s right breast implant. 23 Zimmerman was implanted with MemoryGel Implants on June 8, 2012. Id. ¶ 24 37. Following the implantation, Zimmerman began to experience, among other 25 things, fatigue, cognitive dysfunction, muscle pain and weakness, joint pain, stiffness, 26 and swelling, memory loss, shortness of breath, chest pain, nausea, dizziness, fevers, 27 numbness, vision issues, light sensitivity, silicone toxicity, hair loss, dry eyes, dry 28 mouth, chills, sore throat, skin rash, and a metallic taste in her mouth. Id. ¶ 38. In 4. 1 May 2017, an MRI scan revealed Zimmerman’s right breast implant had ruptured; 2 Zimmerman underwent explantation of her implants on June 21, 2017. After 3 explantation, various defects were found within Zimmerman’s right breast implant. 4 Id. ¶ 39. 5 E. This Action 6 On February 27, 2019, Plaintiffs filed a complaint in the Los Angeles County 7 Superior Court asserting causes of action for: (1) negligence/negligence per se; (2) 8 failure to warn; and (3) manufacturing defect. On February 28, 2019, Mentor filed a 9 notice of removal in this Court and then filed a motion to dismiss Plaintiffs’ complaint 10 pursuant to Federal Rule of Civil Procedure 12(b)(6). Plaintiffs filed a motion to 11 remand. 12 II. LEGAL STANDARD 13 A. Motion to Dismiss Under 12(b)(6) 14 Federal Rule of Civil Procedure 8 requires a plaintiff to present a “short and 15 plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. 16 Civ. P. 8(a)(2). Under Rule 12(b)(6), a defendant may move to dismiss a pleading for 17 “failure to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). 18 To defeat a motion to dismiss under Rule 12(b)(6), the complaint must provide 19 enough details to “give the defendant fair notice of what the . . . claim is and the 20 grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). 21 The complaint must also be “plausible on its face,” allowing the court to “draw the 22 reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft 23 v. Iqbal, 556 U.S. 662, 678 (2009). “The plausibility standard is not akin to a 24 ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant 25 has acted unlawfully.” Id. at 678. Labels, conclusions, and “a formulaic recitation of 26 the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. 27 When ruling on a Rule 12(b)(6) motion, “a judge must accept as true all of the 28 factual allegations contained in the complaint.” Erickson v. Pardus, 551 U.S. 89, 94 5. 1 (2007). But a court is “not bound to accept as true a legal conclusion couched as a 2 factual allegation.” Iqbal, 556 U.S. at 678 (internal quotation marks omitted). 3 B. Leave to Amend 4 Should a court dismiss certain claims, “[l]eave to amend should be granted 5 unless the district court ‘determines that the pleading could not possibly be cured by 6 the allegation of other facts.’” Knappenberger v. City of Phoenix, 566 F.3d 936, 942 7 (9th Cir. 2009) (quoting Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir. 2000) (en 8 banc)); see also Knevelbaard Dairies v. Kraft Foods, Inc., 232 F.3d 979, 983 (9th Cir. 9 2000) (“An order granting such a motion must be accompanied by leave to amend 10 unless amendment would be futile”). 11 C. Removal 12 Federal courts are courts of limited jurisdiction and possess only that 13 jurisdiction as authorized by the Constitution and federal statute. Kokkonen v. 14 Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). Under 28 U.S.C. § 1441(a), 15 a party may remove a civil action only if the district court has original jurisdiction 16 over the issues alleged in the state court complaint. There is a strong presumption that 17 the Court is without jurisdiction until affirmatively proven otherwise. See Fifty 18 Assocs. v. Prudential Ins. Co. of America, 446 F.2d 1187, 1190 (9th Cir. 1970). When 19 an action is removed from state court, the removing party bears the burden of 20 demonstrating that removal is proper. Gaus v. Miles, Inc., 980 F.2d 564, 566 (9th Cir. 21 1992). 22 Under the diversity statute, 28 U.S.C. § 1332, a federal district court has 23 original jurisdiction when the parties are completely diverse and the amount in 24 controversy exceeds $75,000. See 28 U.S.C. § 1332. Pursuant to 28 U.S.C. § 1441(a) 25 and (b), a defendant may remove an action from state court to federal court if the 26 diversity and amount in controversy requirements are satisfied. Under 28 U.S.C. § 27 1441(b)(2), “[a] civil action otherwise removable solely on the basis of the jurisdiction 28 under section 1332(a) of this title may not be removed if any of the parties in interest 6. 1 properly joined and served as defendants is a citizen of the State in which such action 2 is brought.” 28 U.S.C. § 1441(b)(2). 3 A non-diverse party may be disregarded for purposes of determining whether 4 jurisdiction exists if the court determines that the party’s joinder was “fraudulent” or a 5 “sham.” Ritchey v. Upjohn Drug Co., 139 F.3d 1313, 1318 (9th Cir. 1998). 6 “Fraudulent joinder” occurs, for the purpose of determining diversity jurisdiction, 7 where the plaintiff fails to state a cause of action against the resident defendant, and 8 the failure is obvious according to settled rules of the state. McCabe v. Gen. Foods 9 Corp., 811 F.2d 1336 (9th Cir. 1987). “But if there is a possibility that a state court 10 would find that the complaint states a cause of action against any of the resident 11 defendants, the federal court must find that the joinder was proper and remand the 12 case to the state court.” Grancare, LLC v. Thrower by & through Mills, 889 F.3d 543, 13 548 (9th Cir. 2018) (quotations omitted). 14 The defendant has a high burden of proof when establishing fraudulent joinder. 15 A removing defendant may present evidence to prove fraudulent joinder, but the 16 district court must resolve all disputed questions of fact in the plaintiff’s favor. See 17 Grancare, 889 F.3d at 549. Thus, a defense should not require “a searching inquiry 18 into the merits of the plaintiff's case, even if that defense, if successful, would prove 19 fatal.” Id. In this regard, “[r]emand must be granted unless the defendant shows that 20 the plaintiff would not be afforded leave to amend his complaint to cure [a] purported 21 deficiency” in its allegations against the non-diverse defendant. Padilla v. AT & T 22 Corp., 697 F. Supp. 2d 1156, 1159 (C.D. Cal. 2009) (quotations omitted). Ultimately, 23 “[f]raudulent joinder must be proven by clear and convincing evidence.” Hamilton 24 Materials, Inc. v. Dow Chem. Corp., 494 F.3d 1203, 1206 (9th Cir. 2007). 25 III. 26 DISCUSSION A. The Court Has Subject Matter Jurisdiction 27 This dispute raises two issues concerning the Court’s subject matter 28 jurisdiction. First, Plaintiff argues Section 1441(b)(2) precludes removal because 7. 1 NuSil LLC had not been served at the time of Mentor’s Notice of Removal. 2 Additionally, Defendants contend that complete diversity2 exists because NuSil LLC, 3 a California corporation, is fraudulently joined. The Court addresses each argument in 4 turn. 5 1. Section 1441(b) Does Not Prohibit Removal 6 Plaintiffs first argue that Section 1441(b) prohibits removal here because 7 Mentor removed to this Court before Plaintiffs had an opportunity to serve any of the 8 Defendants. Plaintiffs also argue the literal interpretation of Section 1441(b) promotes 9 gamesmanship on the part of removing defendants. 10 The forum defendant rule, articulated in Section 1441(b)(2), provides that “[a] 11 civil action otherwise removable solely on the basis of [diversity] jurisdiction . . . may 12 not be removed if any of the parties in interest properly joined and served as 13 defendants is a citizen of the State in which such action is brought.” 28 U.S.C. § 14 1441(b)(2). 15 This Court previously held that the above statute precludes removal only when 16 the in-state defendant has been both properly joined and properly served in the action 17 prior to removal. See Dechow v. Gilead Sci., Inc., 358 F. Supp. 3d 1051 (C.D. Cal. 18 2019) (“The text of § 1441(b)(2) is unambiguous,” and “[i]ts plain meaning precludes 19 removal on the basis of in-state citizenship only when the defendant has been properly 20 joined and served.”) 21 In Dechow, however, the Court also noted that there may be “absurd or bizarre 22 results” that prevent plaintiff from having the opportunity to exact service; in such 23 scenarios, the forum defendant rule may not apply. Id., at 1055. 24 The Court relied on Vallejo v. Amgen, Inc., 2013 WL 12147584 (C.D. Cal. Aug. 25 30, 2013) as an example of a possible instance of absurdity. In Vallejo, the defendants 26 27 28 2 There is no federal question jurisdiction in this matter as it does not touch upon any area of federal law. Thus this Court only has jurisdiction if all the requirements of diversity jurisdiction are satisfied. 8. 1 filed a notice of removal on diversity grounds before the Superior Court made the 2 summons available to plaintiff. On those facts, it was impossible for plaintiff to serve 3 defendants before removal. Id. This distinction required the Court to deviate from 4 adopting the literal interpretation of Section 1441(b)(2). Id. 5 Nothing before the Court suggests it was impossible for Plaintiffs to serve 6 Defendants before removal. Plaintiffs’ primary argument is that the short time (less 7 than 24 hours) between the time Plaintiffs filed their complaint and Defendants filed 8 their Notice of Removal made it impossible for Plaintiffs to serve Defendants. 9 Plaintiffs have not provided any indication that they were unable to serve Defendants 10 on the day of filing. The Court recognizes this rule may create a race to serve,3 but 11 absent any dispositive ruling regarding the forum defendant rule, the Court adopts the 12 plain meaning of statutory text. Section 1441(b)(2) does not bar Mentor’s removal 13 because NuSil LLC was not properly served at the time of removal. 14 2. NuSil LLC is Fraudulently Joined 15 Plaintiffs assert there is not complete diversity of citizenship because NuSil 16 LLC and Jacob are both California citizens. In their Complaint, Plaintiffs aver that 17 NuSil LLC manufactured a defective component of Mentor’s implants. In response, 18 Mentor contends that NuSil LLC was fraudulently joined in the action. 19 In a product liability action, a plaintiff must establish “that the defendant 20 produced, manufactured, sold, or was in some way responsible for the [defective] 21 product.” Garcia v. Joseph Vince Co., 84 Cal. App. 3d 868, 874 (1984) (quotations 22 omitted). Mentor argues that NuSil LLC was not involved with the production of the 23 silicone used in its MemoryGel implants. Specifically, Mentor argues NuSil LLC is a 24 holding company with no operations, and thus could not have participated in the 25 manufacture of Mentor’s allegedly defective implants. In support of this argument, 26 27 28 3 Indeed, the rule does nothing to prevent a party from dutifully reviewing a court’s docket, and promptly filing a notice of removal the moment a complaint is properly filed in order to dodge a state tribunal. 9. 1 Mentor submitted to the Court the Declaration of Scott Mraz (“Mraz Decl.”, Dkt. No. 2 42 Ex. C), an individual member of NuSil LLC since August 1, 2005. Mr. Mraz 3 declares that NuSil LLC (1) is a holding company that transacts no business of its own 4 and whose sole purpose is to hold stock for its members; (2) has not developed, 5 designed, manufactured, supplied, or distributed any products, including the silicone 6 or silicone gel used to manufacture breast implants; and (3) has no ownership interest 7 in or control over the plant, equipment, and supplies that are used to manufacture the 8 silicone raw materials used in breast implants. See Mraz Decl. ¶¶ 4-5, 13-14. 9 Plaintiffs also deposed Mr. Mraz. Under oath Mr. Mraz confirmed that NuSil LLC is 10 an investment holding company that played no role in producing or supplying any 11 products used in the manufacture of breast implants. (See Deposition of Scott Mraz 12 (“Mraz Dep.”) 13 Jacob produces evidence contrary to Mr. Mraz’s position and suggests there is a 14 triable issue. In 2013, NuSil LLC filed a Statement of Information with the Secretary 15 of State of California.4 The Statement of Information is a short, two-page document 16 which identifies NuSil LLC as a “Manufacturer of Silicone Products”. Mraz signed 17 that Statement of Information as CFO/President of NuSil. Under oath, Mraz testified 18 that he would have reviewed the document for accuracy before signing. 19 Mentor claims that the 2013 Statement of Information contained a clerical error 20 and points out that NuSil has since filed an amended statement of information wherein 21 it describes itself as an “Investment holding entity.” See Hanna Decl., Ex. A (Dkt. 22 No. 33-5). Mentor argues this corrected Statement of Information “conclusively 23 24 25 26 27 28 4 The Court GRANTS Plaintiffs’ request for judicial notice. Dkt. No. 40. 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). 10. 1 resolve[s]” the factual dispute this Court previously addressed in a related matter.5 2 Plaintiffs’ position is bolstered by the declaration and deposition testimony of Mr. 3 Mraz. 4 After a review of the amended Statement of Information and Mr. Mraz’s 5 testimony at deposition, the Court concludes that NuSil LLC did not manufacture 6 silicone and was not involved in the development of the MemoryGel Implant. NuSil 7 is not a proper defendant in this lawsuit as there is no possibility that Plaintiff could 8 recover under a theory of product liability against NuSil LLC. 9 3. Plaintiff’s Claims Are Properly Joined 10 Mentor argues in the alternative that Jacob should be severed from the lawsuit. 11 Rule 20 allows courts to join plaintiff’s claims that are substantially similar in order to 12 promote judicial economy, and reduce inconvenience, delay, and added expense. 13 Here, both the facts and legal theories of Jacob, as well as the other remaining 14 Plaintiffs are nearly identical. The primary distinction between Plaintiffs’ claims is 15 the state in which Plaintiffs underwent surgery. There are no other significant 16 distinctions for each Plaintiff’s claims.6 Nothing supports severing Jacob’s claims in 17 what accounts to judicial waste. 18 B. Motion to Dismiss 19 In support of their motions to dismiss, Defendants argue that Plaintiffs’ state- 20 law claims are expressly and impliedly preempted by the MDA. Because NuSil LLC 21 is not a proper party to this litigation, the Court will only consider arguments from 22 Mentor’s motion. Accordingly, NuSil LLC’s motion to dismiss is DENIED as moot 23 24 25 26 27 28 5 See Vieira v. Mentor Worldwide, LLC, et al., No. 2-18-cv-06502-AB (PLAx) (C.D. Cal. Aug. 23, 2018) 6 Mentor asserts that the difference in location, doctor conducting the procedure, and their understanding of the surgery are all significant and support severance. However, those differences appear minor when compared to the underlying background: each woman alleges she received defective breast implants and became ill as a result. 11. 1 since NuSil was fraudulently joined in this matter.7 Because Plaintiffs’ claims against 2 Mentor are preempted by the MDA, Mentor’s motion to dismiss is GRANTED. 3 1. There Is No Presumption Against Preemption That Applies Here 4 The Supremacy Clause of the Constitution provides that federal law preempts 5 state law. Art. VI. cl. 2. However, preemption analysis starts with the assumption 6 that state laws are not preempted unless it was intended by Congress. Rice v. Santa Fe 7 Elevator Corp., 331 U.S. 218, 230 (1947). Thus, legislative intent is the “ultimate 8 touchstone” of preemption analysis. Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 9 (1963). Congress’ intent to preempt state law may be expressed in the statute’s 10 language or implied in its statutory framework. Cipollone v. Liggett Group, Inc., 505 11 U.S. 504 (1992) (quoting Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977)). 12 When there is an express preemption provision, the court does “not invoke any 13 presumption against pre-emption but instead ‘focus[es] on the plain wording of the 14 clause, which necessarily contains the best evidence of Congress’ pre-emptive 15 intent.’” Puerto Rico v. Franklin Cal. Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) 16 (quoting Chamber of Commerce of U.S. v. Whiting, 536 U.S. 582, 594 (2011)). 17 Here, Plaintiffs claim Mentor’s motion does not overcome this presumption 18 against preemption because Mentor failed to establish that Congress intended to bar 19 redress for injuries caused by Defendants’ FDA violations. The Supreme Court in 20 Puerto Rico found that where there is an express preemption provision there is no 21 presumption against preemption. 136 S. Ct. at 1946. “[F]ocus on the plain meaning 22 of the clause which contains the best evidence of Congress’s pre-emptive intent.” Id. 23 It is well established that the MDA expressly preempts state requirements that 24 are “different from, or in addition to” federal requirements and that was the clear 25 intention of Congress. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Plaintiffs 26 27 28 7 Plaintiffs raise negligence per se arguments against NuSil LLC, however those arguments will not be addressed as they are inapplicable to the remaining parties. 12. 1 also cite to Medtronic, Inc., v. Lohr, 518 U.S. 470, 487 (1996) for the proposition that 2 it is 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 13. 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’ 14. 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 Nunn 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 15. 1 2 the predominant interest”). Here, Plaintiff Nunn resided in Texas at all relevant times—her alleged injuries 3 all occurred there. Texas has the greatest interest in the application of its law to 4 Nunn’s claims and its law therefore applies. Thus, Plaintiff Nunn is preempted from 5 making a failure to warn claim, because her home state of Colorado does not 6 recognize such claims. Moreover, Plaintiff Nunn cannot avoid preemption by arguing 7 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 their assertion. Plaintiffs have not explained how any purported 25 failure to report 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 16. 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 physicians relied on 13 information in the adverse-event database when 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 have Plaintiffs alleged any facts explaining how Mentor’s purported failure to report 22 adverse events from its post-approval studies somehow caused their injuries. 23 Plaintiffs failure to report claim, thus, fails for lack of proximate causation. 24 5. Plaintiffs’ Manufacturing Defect Claims Are Preempted 25 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. 17. 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 MemoryGel Implants violated the FDA’s manufacturing 16 requirements.” Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122, at *2 (C.D. 17 Cal. Dec. 27, 2018). Merely alleging that a defendant violated unspecified “law and 18 regulations” or produced a “noncomforming” device does not sufficiently establish 19 that the defendant violated a federal requirement. Instead a plaintiff must identify 20 specific regulatory violation at issue. In addition, Plaintiffs do not allege how any 21 violation caused their purported injuries; they simply conclude that causation exists 22 without providing any supporting explanation. More is needed. 23 24 6. Plaintiffs Fail To Explain How To Cure The Pleading Deficiencies 25 Valid reasons for denying leave to amend include undue delay, bad faith, repeated 26 failure to cure deficiencies by amendments previously allowed, undue prejudice, and 27 futility. Foman v. Davis, 371 U.S. 178, 182 (1962); see also Klamath-Lake Pharm. 28 Ass’n v. Klamath Med. Serv. Bureau, 701 F.2d 1276, 1292-93 (9th Cir. 1983) (holding 18. 1 that while leave to amend shall be freely given, the court need not allow futile 2 amendments). The Court denies leave to amend because Plaintiffs have not explained 3 how further amendment could cure the pleading deficiencies in their Complaint. 4 IV. 5 CONCLUSION For the foregoing reasons, Plaintiffs’ Motion to Remand is DENIED. Defendants 6 NuSil LLC and NuSil Technology LLC’s Motion to Dismiss is DENIED as moot. 7 Defendant Mentor Worldwide’s Motion to Dismiss is GRANTED as to each of 8 Plaintiffs’ claims. As amendment would be futile, Plaintiffs’ Complaint is 9 DISMISSED WITH PREJUDICE. 10 11 IT IS SO ORDERED. 12 13 14 15 Dated: August 1, 2019 _______________________________________ HONORABLE ANDRÉ BIROTTE JR. UNITED STATES DISTRICT COURT JUDGE 16 17 18 19 20 21 22 23 24 25 26 27 28 19.

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