1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 CENTRAL DISTRICT OF CALIFORNIA 10 MARY SEWELL et al; Case No. SA CV 19-01126-AB (PLAx) 11
Plaintiffs, 12 v. ORDER DENYING PLAINTIFFS’ 13 MOTION TO REMAND AND GRANTING DEFENDANTS’ MENTOR WORLWIDE, LLC; 14 MOTIONS TO DISMISS NUSIL, LLC; NUSIL 15 TECHNOLOGY, LLC; and DOES 1- 100, inclusive, 16
17 Defendant. 18
19 20 Before the Court are two motions filed by the parties. 21 On June 13, 2019 Defendants Mentor Worldwide, LLC. (“Mentor”), NuSil 22 LLC., and NuSil Technology LLC (“NuSil”) filed a motion to dismiss (Dkt. No. 12). 23 Plaintiffs opposed the motion (Dkt. No. 14). 24 Plaintiffs filed a Motion to Remand (Dkt. No. 15) and Defendants opposed the 25 motion (Dkt. No. 19). The Court deemed the matter appropriate for resolution without 26 oral argument, see Local Rule 7.15, and took the matter under submission on August 27 9, 2019. For the following reasons, Plaintiffs’ Motion to Remand is DENIED and 28 Defendants’ Motions to Dismiss is GRANTED. 1 I. BACKGROUND 2 This lawsuit revolves around injuries Plaintiffs allegedly suffered after 3 receiving surgical implants of Mentors’ MemoryGel Silicone Breast Implants 4 (“MemoryGel Implants”). Plaintiffs plead the following in their Complaint 5 (“Compl.,” Dkt. No. 1, Exhibit A). 6 A. The Parties 7 Mary Sewell and Tom Saunders are a married couple and citizens of Orange 8 County, California. Compl. ¶ 1. Carole Little is a citizen and resident of El Dorado 9 County, California. Id. ¶ 2. Julia Maceo is a citizen and resident of Sonoma County, 10 California. Id. ¶ 3. Aurora Victoria Corona Cattuzzo and Michael Anthony Cattuzzo 11 are a married couple and citizens of Sacramento County, California. Id. ¶ 4. Barbara 12 Johncke and Anders Johncke are a married couple and citizens of Fairfield County, 13 Connecticut. Id. ¶ 5. Marianne Curry and Joseph Zacharzuk Jr. are a married couple 14 and citizens of Maui County, Hawaii. Id. ¶ 6. Tracie Leach and Gregory Leach are a 15 married couple and citizens of Noble County, Indiana. Id. ¶ 7. Lenie Valerie is a 16 citizen of Johnson County, Kansas. Id. ¶ 8. Deborah Michelle Destasio and Joseph 17 Destasio are a married couple and citizens of Canadian County, Oklahoma. Id. ¶ 9. 18 Stacey Holder and Mark Clark Holden are a married couple and citizens of Oklahoma 19 County, Oklahoma. Id. ¶ 10. Sheila Mathis and Randy Mathis are a married couple 20 and citizens of Young County, Texas. Id. ¶ 11. Kristina Ruiz and Steve Ruiz are a 21 married couple and citizens of Utah County, Utah. Id. ¶ 12. 22 Mentor is a limited liability company incorporated in Delaware with its 23 principal place of business in Santa Barbara, California. Id. ¶ 13. Mentor 24 manufactured the MemoryGel Implants at issue. Id. ¶ 14. 25 NuSil LLC is a limited liability company incorporated in California with its 26 principal place of business in Carpinteria, California. Id. ¶ 15. 27 NuSil Technology, LLC is a limited liability company incorporated in Delaware 28 with its principal place of business in Carpinteria, California. Id. ¶ 16. NuSil LLC 1 and NuSil Technology are silicone raw material suppliers and allegedly manufactured, 2 produced, supplied, and shipped the silicone used in the MemoryGel Implants. Id. ¶ 3 18. 4 B. FDA Regulation of Silicone Breast Implants 5 In 1976, Congress passed the Medical Device Amendments (“MDA”) to the 6 Federal Food, Drug, and Cosmetic Act (“FDCA”). See generally FAC. Under the 7 MDA, medical devices, such as the MemoryGel Implants, are subject to three 8 classifications and regulated accordingly. Class I devices require the least and most 9 general oversight, Class II devices are reviewed according to more stringent “special 10 controls,” and Class III devices receive the most oversight and require rigorous 11 premarket review and approval. The Food and Drug Administration (“FDA”) 12 classified silicone breast implants as Class III devices. Id. Accordingly, the FDA 13 requires manufacturers to meet certain requirements for Class III devices. On April 14 10, 1991, the FDA published a final regulation under Section 515(b) of the FDCA 15 requiring that manufacturers of silicone breast implants submit pre-market approval 16 (“PMA”) applications with data showing a reasonable assurance of safety and 17 effectiveness of the implants by July 9, 1991. 18 C. Mentor’s FDA Approval 19 In order to eventually seek PMA for its MemoryGel Implants, Mentor was 20 required to first provide the FDA with sufficient information regarding the safety and 21 efficacy of the medical device. Id. ¶ 92. On December 12, 2003, Mentor submitted a 22 request to the FDA for PMA for its MemoryGel Implants. Id. ¶ 108. On November 23 17, 2006, Mentor received approval subject to certain conditions. Id. ¶ 109. One of 24 the conditions imposed on Mentor required it to conduct six post-approval studies1 to 25 further characterize the safety and effectiveness of MemoryGel Implants. Id.. 26
27 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 28 adjunct study. Id. 1 D. Plaintiffs’ MemoryGel Procedures 2 Sewell was implanted with MemoryGel Implants on January 3, 2006. Id. ¶ 28. 3 Sewell alleges that following implantation she experienced fatigue, muscle pain and 4 weakness, joint pain, swelling and stiffness, vision issues, light sensitivity, numbness, 5 skin rashes, dizziness, nausea, chronic sore throats, chest pain, migraines. Id. ¶ 29. 6 On March 13, 2017, Sewell underwent a bilateral explantation of her implants in 7 Newport Beach, California. Id. ¶ 30. A gel bleed/rupture of Sewell’s right implant 8 was discovered during the procedure. Id. After explantation, various defects were 9 found in Sewell’s implants. Id. ¶ 31. 10 Little was implanted with MemoryGel Implants in May 2007. Id. ¶ 33. 11 Following implantation, Little developed a number of illnesses and symptoms 12 including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, 13 memory loss, shortness of breath, cognitive dysfunction, chest pain, itching, nausea, 14 dizziness, numbness, vision issues, light sensitivity, skin rashes, night sweats, dry 15 eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 35. On February 27, 16 2017, Little underwent a bilateral explantation of her implants. Id. ¶ 36. A gel 17 bleed/rupture of Little’s implants was discovered during the procedure. Id. After 18 explantation, various defects were found within Little’s breast implants. Id. ¶ 37. 19 Maceo was implanted with MemoryGel Implants in December 2006. Id. ¶ 39. 20 Following implantation, Maceo developed a number of illnesses and symptoms 21 including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, 22 muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pain, 23 itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night 24 sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 40. On April 25 26, 2017, Maceo underwent a bilateral explantation. Id. ¶ 41. A gel/bleed rupture 26 was discovered during the procedure. Id. 27 Cattuzzo was implanted with MemoryGel Implants on May 21, 2007. Id. ¶ 43. 28 Following implantation, Cattuzzo developed a number of illnesses and symptoms, 1 including, among other things, rheumatoid arthritis, autoimmune disorders, fatigue, 2 joint pain and stiffness, muscle weakness, memory loss, itching, and allergies. Id. ¶ 3 44. On August 21, 2017, Cattuzzo underwent a bilateral explantation of her implants. 4 Id. ¶ 45. A gel bleed/rupture was discovered during the procedure. Id. After 5 explantation, various defects were found within Cattuzzo’s implants. Id. ¶ 46. 6 Johncke was implanted with MemoryGel Implants on February 7, 2008. Id. ¶ 7 47. Following implantation, Johncke developed a number of illnesses and symptoms, 8 among other things, arthritis symptoms, chronic fatigue, joint pain and stiffness, 9 fibromyalgia, muscle weakness, memory loss, cognitive dysfunction, debilitating 10 migraines, numbness, light sensitivity, night sweats, autoimmune disorders, and hair 11 loss. Id. ¶ 48. On August 25, 2017, Johncke underwent a bilateral explantation. Id. ¶ 12 49. A gel bleed/rupture was discovered. Id. After explantation, various defects were 13 found within Johnson’s right breast implant. Id. ¶ 50. 14 Curry was implanted with MemoryGel Implants on April 11 2007. Id. ¶ 51. 15 Following implantation, Curry developed a number of illnesses and symptoms 16 including, among other things, tremors and other central nervous system problems, 17 neurocognitive issues, fatigue, Hashimoto’s thyroiditis, endocrine system disorders, 18 vision problems, dry eyes, headaches, neck and shoulder pain, elbow and thumb pain, 19 breast pain, breathing difficulties, and articular problems. Id. ¶ 52. On May 5, 2017, 20 Curry underwent a bilateral explantation. Id. ¶ 53. A gel bleed/rupture was 21 discovered in Curry’s left breast implant. Id. After explantation, various defects were 22 found within Johnson’s right breast implant. Id. ¶ 55. 23 Leach was implanted with MemoryGel Implants in 2006. Id. ¶ 56. Following 24 implantation, Leach developed a number of illnesses and symptoms including, among 25 other things, rheumatoid arthritis, fatigue, joint pain and stiffness, muscle weakness, 26 memory loss, cognitive dysfunction, chest pain, itching, nausea, dizziness, numbness, 27 vision issues, light sensitivity, skin rashes, and hair loss. Id. ¶ 57. On March 20, 28 2017, Leach underwent a bilateral explantation. Id. ¶ 58. A gel bleed/rupture was 1 discovered in Curry’s left breast implant. Id. After explantation, various defects were 2 found within Curry’s implants. Id. ¶ 59. 3 Lenie was implanted with MemoryGel Implants on July 29, 2008. Id. ¶ 60. 4 Following implantation, Lenie developed a number of illnesses and symptoms 5 including, among other things, fatigue, muscle pain and weakness, joint pain, swelling 6 and stiffness, ocular migraines, memory loss, shortness of breath, dizziness, 7 numbness, vision issues, light sensitivity, skin rashes, and night sweats. Id. ¶ 61. On 8 September 26, 2017, Lenie underwent a bilateral explantation. Id. ¶ 62. A gel 9 bleed/rupture was discovered in Lenie’s left breast implant. Id. After explantation, 10 various defects were found within Lenie’s implants. Id. ¶ 63. 11 Destasio was implanted with MemoryGel Implants on September 6, 2007. Id. ¶ 12 64. Following implantation, Destasio developed a number of illnesses and symptoms 13 including, among other things, lupus, rheumatoid arthritis, fatigue, muscle weakness, 14 joint pain and stiffness, memory loss, itching, nausea, dizziness, vision issues, light 15 sensitivity, skin rashes, night sweats, dry eyes, and chronic pain. Id. ¶ 65. On 16 February 23, 2017, Destasio underwent a bilateral explantation. Id. ¶ 66. A gel 17 bleed/rupture was discovered in Destasio’s right breast implants. Id. After 18 explantation, various defects were found within Destasio’s implant. Id. ¶ 67. 19 Holden was implanted with MemoryGel Implants on August 27, 2013. Id. ¶ 68. 20 Following implantation, Holden developed a number of illnesses and symptoms 21 including, among other things, fatigue, muscle weakness, joint pain and stiffness, 22 memory loss, itching, skin rashes, autoimmune dysfunction, and hair loss. Id. ¶ 69. 23 On November 10, 2017, Holden underwent a bilateral explantation. Id. ¶ 70. A gel 24 bleed/rupture was discovered in Holden’s left breast implant. Id. After explantation, 25 various defects were found within Holden’s implants. Id. ¶ 71. 26 Mathis was implanted with MemoryGel Implants on January 7, 2007. Id. ¶ 71. 27 Following implantation, Mathis developed a number of illnesses and symptoms 28 including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, 1 muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pain, 2 itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night 3 sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 73. On May 4 16, 2017, Mathis underwent a bilateral explantation. Id. ¶ 74. A gel bleed/rupture 5 was discovered in Mathis’s left breast implant. Id. After explantation, various defects 6 were found within Mathis’s implants. Id. ¶ 75. 7 Ruiz was implanted with MemoryGel Implants on May 27, 2010. Id. ¶ 76. 8 Following implantation, Mathis developed a number of illnesses and symptoms 9 including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, 10 muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pain, 11 itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night 12 sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 77. On 13 December 27, 2016, Ruiz underwent a bilateral explantation. Id. ¶ 78. A gel 14 bleed/rupture was discovered during explantation. Id. After explantation, various 15 defects were found within Mathis’s implants. Id. ¶ 79. 16 Plaintiffs allege that the exposure to silicone gel due to the rupture and leakage 17 into their bodies caused significant injuries. Id. ¶ 80. Plaintiffs further allege they 18 would not have received MemoryGel Implants if they were aware of the true risks 19 associated with rupture rate and injury. Id. ¶ 81. 20 E. This Action 21 On June 6, 2019, Plaintiffs filed a complaint in the Orange County Superior 22 Court asserting causes of action for: (1) negligence/negligence per se; (2) failure to 23 warn; and (3) manufacturing defect. On June 6, 2019, Mentor filed a notice of 24 removal in this Court and then filed a motion to dismiss Plaintiffs’ complaint pursuant 25 to Federal Rule of Civil Procedure 12(b)(6). Plaintiffs filed a motion to remand. 26 II. LEGAL STANDARD 27 A. Motion to Dismiss Under 12(b)(6) 28 Federal Rule of Civil Procedure 8 requires a plaintiff to present a “short and 1 plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. 2 Civ. P. 8(a)(2). Under Rule 12(b)(6), a defendant may move to dismiss a pleading for 3 “failure to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). 4 To defeat a motion to dismiss under Rule 12(b)(6), the complaint must provide 5 enough details to “give the defendant fair notice of what the . . . claim is and the 6 grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). 7 The complaint must also be “plausible on its face,” allowing the court to “draw the 8 reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft 9 v. Iqbal, 556 U.S. 662, 678 (2009). “The plausibility standard is not akin to a 10 ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant 11 has acted unlawfully.” Id. at 678. Labels, conclusions, and “a formulaic recitation of 12 the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. 13 When ruling on a Rule 12(b)(6) motion, “a judge must accept as true all of the 14 factual allegations contained in the complaint.” Erickson v. Pardus, 551 U.S. 89, 94 15 (2007). But a court is “not bound to accept as true a legal conclusion couched as a 16 factual allegation.” Iqbal, 556 U.S. at 678 (internal quotation marks omitted). 17 B. Leave to Amend 18 Should a court dismiss certain claims, “[l]eave to amend should be granted 19 unless the district court ‘determines that the pleading could not possibly be cured by 20 the allegation of other facts.’” Knappenberger v. City of Phoenix, 566 F.3d 936, 942 21 (9th Cir. 2009) (quoting Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir. 2000) (en 22 banc)); see also Knevelbaard Dairies v. Kraft Foods, Inc., 232 F.3d 979, 983 (9th Cir. 23 2000) (“An order granting such a motion must be accompanied by leave to amend 24 unless amendment would be futile”). 25 C. Removal 26 Federal courts are courts of limited jurisdiction and possess only that 27 jurisdiction as authorized by the Constitution and federal statute. Kokkonen v. 28 Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). Under 28 U.S.C. § 1441(a), 1 a party may remove a civil action only if the district court has original jurisdiction 2 over the issues alleged in the state court complaint. There is a strong presumption that 3 the Court is without jurisdiction until affirmatively proven otherwise. See Fifty 4 Assocs. v. Prudential Ins. Co. of America, 446 F.2d 1187, 1190 (9th Cir. 1970). When 5 an action is removed from state court, the removing party bears the burden of 6 demonstrating that removal is proper. Gaus v. Miles, Inc., 980 F.2d 564, 566 (9th Cir. 7 1992). 8 Under the diversity statute, 28 U.S.C. § 1332, a federal district court has 9 original jurisdiction when the parties are completely diverse and the amount in 10 controversy exceeds $75,000. See 28 U.S.C. § 1332. Pursuant to 28 U.S.C. § 1441(a) 11 and (b), a defendant may remove an action from state court to federal court if the 12 diversity and amount in controversy requirements are satisfied. Under 28 U.S.C. § 13 1441(b)(2), “[a] civil action otherwise removable solely on the basis of the jurisdiction 14 under section 1332(a) of this title may not be removed if any of the parties in interest 15 properly joined and served as defendants is a citizen of the State in which such action 16 is brought.” 28 U.S.C. § 1441(b)(2). 17 A non-diverse party may be disregarded for purposes of determining whether 18 jurisdiction exists if the court determines that the party’s joinder was “fraudulent” or a 19 “sham.” Ritchey v. Upjohn Drug Co., 139 F.3d 1313, 1318 (9th Cir. 1998). 20 “Fraudulent joinder” occurs, for the purpose of determining diversity jurisdiction, 21 where the plaintiff fails to state a cause of action against the resident defendant, and 22 the failure is obvious according to settled rules of the state. McCabe v. Gen. Foods 23 Corp., 811 F.2d 1336 (9th Cir. 1987). “But if there is a possibility that a state court 24 would find that the complaint states a cause of action against any of the resident 25 defendants, the federal court must find that the joinder was proper and remand the 26 case to the state court.” Grancare, LLC v. Thrower by & through Mills, 889 F.3d 543, 27 548 (9th Cir. 2018) (quotations omitted). 28 The defendant has a high burden of proof when establishing fraudulent joinder. 1 A removing defendant may present evidence to prove fraudulent joinder, but the 2 district court must resolve all disputed questions of fact in the plaintiff’s favor. See 3 Grancare, 889 F.3d at 549. Thus, a defense should not require “a searching inquiry 4 into the merits of the plaintiff's case, even if that defense, if successful, would prove 5 fatal.” Id. In this regard, “[r]emand must be granted unless the defendant shows that 6 the plaintiff would not be afforded leave to amend his complaint to cure [a] purported 7 deficiency” in its allegations against the non-diverse defendant. Padilla v. AT & T 8 Corp., 697 F. Supp. 2d 1156, 1159 (C.D. Cal. 2009) (quotations omitted). Ultimately, 9 “[f]raudulent joinder must be proven by clear and convincing evidence.” Hamilton 10 Materials, Inc. v. Dow Chem. Corp., 494 F.3d 1203, 1206 (9th Cir. 2007). 11 III. DISCUSSION 12 A. The Court Has Subject Matter Jurisdiction 13 This dispute raises two issues concerning the Court’s subject matter 14 jurisdiction. First, Plaintiffs argue Mentor’s Notice of Removal is untimely. 15 Additionally, Defendants contend that complete diversity2 exists because NuSil LLC, 16 a California corporation, is fraudulently joined. The Court addresses each argument in 17 turn. 18 1. Mentor’s Removal Was Timely 19 Plaintiffs first argue that Mentor’s removal was untimely and improper because 20 it was not based on new grounds or new information. “[A] notice of removal may be 21 filed within 30 days after receipt by the defendant, through service or otherwise, of a 22 copy of an amended pleading, motion, order or other paper from which it may first be 23 ascertained that the case is one which is or has been removable.” 28 U.S.C. 1446. 24 The thirty-day period applies even to cases which have been previously been removed 25 and remanded, so long as the latter removal is “based on information not available at 26
27 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 28 diversity jurisdiction are satisfied. 1 the prior removal.” See Sweet v. United Parcel Serv., Inc., 2009 WL 1664644 at * 3 2 (C.D. Cal. June 15, 2009) (permitting subsequent removal and denying motion to 3 remand). 4 Mentor’s successive removal was timely and proper. On May 9, 2019, Edward 5 Scott Mraz, a member of NuSil LLC since August 1, 2005, was deposed. See Mentor 6 Notice of Removal (Dkt. No. 1). Mraz testified, among other things, that NuSil was a 7 holding company and had no involvement in the manufacturing of the implants.3 8 Plaintiffs argue Mraz’s deposition did not reveal additional facts to permit successive 9 removal. To the contrary, Mraz’s statements provided further clarity regarding the 10 status of NuSil LLC and its lack of involvement in the production of the silicone used 11 in Mentor’s MemoryGel Implants. After Mraz’s deposition, Defendants timely 12 removed on the basis of this new information. Accordingly, removal was timely and 13 the Court’s inquiry ends there. 14 2. NuSil LLC is Fraudulently Joined 15 Plaintiffs also assert there is not complete diversity of citizenship because NuSil 16 LLC and Sewell 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 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. During his deposition, Mraz 26 was asked questions regarding NuSil LLC’s corporate structure. Mraz Mraz 27
28 3 The substance of Mraz’s deposition is discussed below. 1 confirmed that NuSil LLC is an investment holding company that played no role in 2 producing or supplying any products used in the manufacture of breast implants. 3 Mraz clarified that the description of NuSil LLC as a manufacturer of silicone 4 products was a clerical error that was subsequently corrected on corporate filings. 5 Sewell 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. 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.” Mentor argues this corrected 14 Statement of Information “conclusively resolve[s]” the factual dispute this Court 15 previously addressed in a related matter.4 16 After a review of the amended Statement of Information and Mr. Mraz’s 17 testimony at deposition, the Court concludes that NuSil LLC did not manufacture 18 silicone and was not involved in the development of the MemoryGel Implant. NuSil 19 is not a proper defendant in this lawsuit as there is no possibility that Plaintiff could 20 recover under a theory of product liability against NuSil LLC. 21 B. Motion to Dismiss 22 In support of their motions to dismiss, Defendants argue that Plaintiffs’ state- 23 law claims are expressly and impliedly preempted by the MDA. Because Plaintiffs’ 24 claims against Mentor are preempted by the MDA, Mentor’s motion to dismiss is 25 GRANTED. 26
27 4 See Vieira v. Mentor Worldwide, LLC, et al., No. 2-18-cv-06502-AB (PLAx) (C.D. 28 Cal. Aug. 23, 2018) 1 1. There Is No Presumption Against Preemption That Applies Here 2 The Supremacy Clause of the Constitution provides that federal law preempts 3 state law. Art. VI. cl. 2. However, preemption analysis starts with the assumption 4 that state laws are not preempted unless it was intended by Congress. Rice v. Santa Fe 5 Elevator Corp., 331 U.S. 218, 230 (1947). Thus, legislative intent is the “ultimate 6 touchstone” of preemption analysis. Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 7 (1963). Congress’ intent to preempt state law may be expressed in the statute’s 8 language or implied in its statutory framework. Cipollone v. Liggett Group, Inc., 505 9 U.S. 504 (1992) (quoting Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977)). 10 When there is an express preemption provision, the court does “not invoke any 11 presumption against pre-emption but instead ‘focus[es] on the plain wording of the 12 clause, which necessarily contains the best evidence of Congress’ pre-emptive 13 intent.’” Puerto Rico v. Franklin Cal. Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) 14 (quoting Chamber of Commerce of U.S. v. Whiting, 536 U.S. 582, 594 (2011)). 15 Here, Plaintiffs claim Mentor’s motion does not overcome this presumption 16 against preemption because Mentor failed to establish that Congress intended to bar 17 redress for injuries caused by Defendants’ FDA violations. The Supreme Court in 18 Puerto Rico found that where there is an express preemption provision there is no 19 presumption against preemption. 136 S. Ct. at 1946. “[F]ocus on the plain meaning 20 of the clause which contains the best evidence of Congress’s pre-emptive intent.” Id. 21 It is well established that the MDA expressly preempts state requirements that 22 are “different from, or in addition to” federal requirements and that was the clear 23 intention of Congress. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Plaintiffs 24 also cite to Medtronic, Inc., v. Lohr, 518 U.S. 470, 487 (1996) for the proposition that 25 it is difficult to believe that Congress would remove all means of judicial recourse for 26 consumers injured by FDA approved devices. Contrary to Plaintiffs’ position, “this is 27 exactly what a pre-emption clause for medical devices does by its terms.” Riegel, 552 28 U.S. at 326. Therefore, the presumption against preemption does not apply here. 1 2. Plaintiffs Do Not Assert A Parallel Claim That Survives 2 Preemption 3 The MDA contains an express preemption provision that provides, as relevant 4 here: 5 “[N]o State . . . may establish or continue in effect with respect to a device 6 intended for human use any requirement— 7 (1) which is different from, or in addition to, any requirement applicable under 8 this Act to the device, and 9 (2) which relates to the safety or effectiveness of the device or to any other 10 matter included in a requirement applicable to the device under this chapter.” 11 21 U.S.C. § 360k(a). 12 The Supreme Court, in Riegel, applied a two-step analysis to determine whether 13 the MDA expressly preempts a state law claim within the meaning of § 360k(a). First, 14 a court must determine whether the FDA has established requirements applicable to 15 the particular medical device at issue. Riegel, 552 U.S. at 321-22. Second, a court 16 must determine whether the state law claims are based on state requirements that are 17 “different from, or in addition to” the federal requirements, and relate to safety and 18 effectiveness. Id. State “requirements” also include the state’s common-law legal 19 duties. Id. at 324-325 (“State tort law . . . disrupts the federal scheme no less than 20 state regulatory law to the same effect”). 21 However, the Supreme Court has made clear that “§ 360k does not prevent a 22 State from providing a damages remedy for claims premised on a violation of FDA 23 regulations; the state duties in such a case parallel, rather than add to, federal 24 requirements.” Id. at 330; see also Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 25 (9th Cir. 2013) (en banc) (“[T]he MDA does not preempt a state-law claim for 26 violating a state-law duty that parallels a federal-law duty under the MDA”). 27 In order for a state requirement to be parallel to a federal requirement, a 28 plaintiff must show that the requirements are “genuinely equivalent.” Houston v. 1 Medtronic, 957 F. Supp. 2d 1166, 1174 (C.D. Cal. July 30, 2013) (quoting Wolicki- 2 Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2001)). State and federal 3 requirements are not generally equivalent if a manufacturer could be held liable under 4 state law without having violated federal law. Id. at 1174. 5 The MDA also provides that all actions to enforce FDA requirements “shall be 6 by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court 7 interpreted that the provision “leaves no doubt that it is the Federal Government rather 8 than private litigants who are authorized to file suit for noncompliance with the 9 medical device provisions.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 10 349 n. 4 (2001). Thus, to avoid implied preemption, a cause of action must rely on 11 traditional state law and not be based solely on a violation of federal law. Id. at 353. 12 The Ninth Circuit has recognized that there is a “‘narrow gap’ through which a 13 state-law claim must fit to escape preemption.” Perez v. Nidek Co., Ltd., 711 F.3d 14 1109, 1120 (9th Cir. 2013). “The plaintiff must be suing for conduct that violates the 15 FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must 16 not be suing because the conduct violates the FDCA (such a claim would be impliedly 17 preempted under Buckman).” Id. at 1120 (emphasis in original) (citing In re 18 Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200, 1204) (8th Cir. 19 2010). To avoid preemption, a plaintiff must assert a state-law claim that is premised 20 on a violation of federal law but that is not based solely on such violation. Id. 21 Here, Plaintiffs allege Mentor violated federal laws and regulations that are 22 parallel to violations of California state law; however, Plaintiffs have not satisfied 23 their pleading burden. As an initial matter, the Court is not satisfied with Plaintiffs’ 24 argument that Mentor violated federal and state law by failing to report adverse events 25 to the FDA. These allegations are merely conclusory. Plaintiffs’ Complaint lacks any 26 reference to the specific adverse events that Mentor failed to report. Further, Plaintiffs 27 do not specifically allege that poor performance on post-approval studies is a violation 28 of federal law. Additionally, the Court rejects Plaintiffs’ claims that Mentor violated 1 federal regulations and state law by defectively manufacturing MemoryGel Implants. 2 Plaintiffs, in conclusory fashion, allege that Defendants’ MemoryGel Implant 3 specifications are inconsistent with federal regulations; however, Plaintiffs fail to 4 allege facts demonstrating that Defendants’ specifications are inconsistent or violative 5 of federal standards. In short, a plaintiff “cannot simply incant the magic words” that 6 a defendant violated FDA regulations to avoid preemption. Simmons v. Boston 7 Scientific Corp., 2013 WL 1207421 at *4 (C.D. Cal. Mar. 25, 2018) (quoting Wolicki- 8 Gables, 634 F.3d at 1301). Lastly, Plaintiffs fail to allege facts showing how any 9 federal violation caused their claimed injuries. Plaintiffs have not asserted a parallel 10 claim capable of surviving preemption. 11 Plaintiffs claim that “discovery is necessary” to provide a basis for their claims 12 but Plaintiffs cannot be permitted to engage in discovery when they have not met the 13 most basic pleading standards. Nothing in Plaintiffs’ allegations suggests discovery is 14 needed to resolve this Motion. 15 3. Plaintiffs Fail to Sufficiently Plead Failure to Report 16 The FDA requires device manufacturers to report any time its device “may have 17 caused or contributed to a death or serious injury.” 21 C.F.R. § 803.50(a). A claim 18 based on the failure to warn the FDA of adverse events is not preempted to the extent 19 state tort law recognizes a parallel duty. De La Paz v. Bayer Healthcare LLC, 159 F. 20 Supp. 3d 1085, 1096-97 (N.D. Cal. Feb. 2, 2016). However, a claim based on a 21 failure to warn physicians or patients of adverse events would be preempted. Id.; see 22 also Stengel, 704 F.3d at 1234. California law recognizes such a duty to warn. 23 Coleman v. Medtronic, Inc., 223 Cal.App.4th 413, 429 (2014). To state a failure to 24 warn claim under California law, a plaintiff “will ultimately have to prove that if [a 25 defendant] had properly reported the adverse events to the FDA as required under 26 federal law, that information would have reached [the plaintiff’s] doctors in time to 27 prevent [plaintiff’s] injuries.” Id. at 429-30 (quoting Stengel, 704 F.3d at 1234). 28 Here, Plaintiffs’ conclusory allegation that Mentor failed to comply with federal 1 requirements by not reporting adverse events is insufficient. Plaintiffs do not point to 2 any facts supporting their assertion. Plaintiffs have not explained how any purported 3 failure to report unspecified adverse events caused her injuries. In turn, Plaintiffs 4 allegations are based not on a failure to report actual adverse events from the post- 5 approval studies but rather on a purported failure to properly conduct those studies. 6 “The alleged technical defects in Mentor’s post-approval studies, however, do not 7 constitute adverse events.” Ebrahimi v. Mentor Worldwide LLC, 2018 WL 2448095, 8 at *3 (C.D. Cal. May 25, 2018). Plaintiffs cannot pursue a claim premised on a 9 counterfactual assumption that Mentor would have identified additional adverse 10 events if it had conducted the studies more adequately. Any such claim is 11 impermissibly speculative. Additionally, any claim premised on Mentor’s alleged 12 failure to conduct the post-approval studies adequately is impliedly preempted, 13 because there is no state law duty to conduct post-approval studies in the first 14 instance. 15 Furthermore, Plaintiffs failure to report a claim fails because they do not allege 16 facts showing that the FDA would have exercised its discretion to include additional 17 adverse events in its publicly-accessible adverse-event database had Mentor reported 18 the events. Nor do Plaintiffs allege facts showing that their physicians relied on 19 information in the adverse-event database when making decisions. Without such 20 facts, Plaintiffs cannot establish a causal nexus between their alleged injuries and 21 Mentor’s alleged failure to report. 22 Plaintiffs deduce that if Mentor had conducted follow-up with participants 23 enrolled in clinical studies that there would have been adverse event reports showing 24 heightened instances of rupture rates. No facts support the conclusion that additional 25 information from patients in post-approval studies would reveal additional adverse 26 events regarding ruptures or would result in the FDA requiring different labeling. Nor 27 have Plaintiffs alleged any facts explaining how Mentor’s purported failure to report 28 adverse events from its post-approval studies somehow caused their injuries. 1 Plaintiffs failure to report claim, thus, fails for lack of proximate causation. 2 4. Plaintiffs’ Manufacturing Defect Claims Are Preempted 3 For manufacturing defects claims to survive preemption, plaintiffs are required 4 to allege “that the manufacturing of the device both fell short of the FDA’s 5 requirement for manufacturing and—based on the same deficiency—was defectively 6 manufactured under California law.” Funke v. Sorin Group USA, Inc., 147 F. Supp. 7 3d 1017, 1026 (C.D. Cal. Nov. 24, 2015). The MDA provides that a device is 8 defective if “the methods used in, or the facilities or controls used for, its manufacture 9 . . . are not in conformity” with the FDA’s requirements for that device. 21 U.S.C. § 10 351(h). Next, to escape implied preemption, a plaintiff must allege that the 11 manufacturing defect caused her injuries. De La Paz, 159 F. Supp. 3d at 1094; see 12 also Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1092 (C.D. Cal. 2011) 13 (stating a plaintiff must establish a “causal nexus between the alleged injury and the 14 violation”). 15 Here, Plaintiffs claim that Mentor’s implants differed in some undefined way 16 from the manufacturing and design specifications mandated by the FDA as part of the 17 PMA; that Mentor used unidentified material and components that somehow differed 18 from those approved by the FDA; that Mentor violated unspecified provisions of 19 applicable federal regulations, including the FDA’s Quality System Regulations and 20 design control requirements under 21 C.F.R. 820.30. But Plaintiffs “fail[] to 21 adequately allege that the MemoryGel Implants violated the FDA’s manufacturing 22 requirements.” Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122, at *2 (C.D. 23 Cal. Dec. 27, 2018). Merely alleging that a defendant violated unspecified “law and 24 regulations” or produced a “noncomforming” device does not sufficiently establish 25 that the defendant violated a federal requirement. Instead a plaintiff must identify 26 specific regulatory violation at issue. In addition, Plaintiffs do not allege how any 27 violation caused their purported injuries; they simply conclude that causation exists 28 without providing any supporting explanation. More is needed. 1 5. Plaintiffs Fail To Explain How To Cure The Pleading 2 Deficiencies 3 Valid reasons for denying leave to amend include undue delay, bad faith, repeated 4 | failure to cure deficiencies by amendments previously allowed, undue prejudice, and 5 | futility. Foman v. Davis, 371 U.S. 178, 182 (1962); see also Klamath-Lake Pharm. 6 | Ass’n v. Klamath Med. Serv. Bureau, 701 F.2d 1276, 1292-93 (9th Cir. 1983) (holding 7 | that while leave to amend shall be freely given, the court need not allow futile 8 || amendments). The Court denies leave to amend because Plaintiffs have not explained 9 || how further amendment could cure the pleading deficiencies in their Complaint. 10 | IV. CONCLUSION 11 For the foregoing reasons, Plaintiffs’ Motion to Remand is DENIED. Defendant 12 | Mentor Worldwide’s Motion to Dismiss is GRANTED as to each of Plaintiffs’ 13 | claims. As amendment would be futile, Plaintiffs’ Complaint is DISMISSED WITH 14 | PREJUDICE. 15 16 | □□ □□ SO ORDERED. 17 oh 18 | Dated: August 27, 2019 19 HONORABLE ANDRE BIROTTE JR. UNITED STATES DISTRICT COURT JUDGE
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