1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 WILLIAM BRADLEY, Case No. 22-cv-00414-HSG

8 Plaintiff, ORDER GRANTING MOTION TO

REMAND AND DENYING REQUEST

9 v. FOR ATTORNEYS’ FEES

10 THOMAS P. SCHMALZRIED, M.D., et al., Re: Dkt. No. 15 11 Defendants.

12 13 Pending before the Court is Plaintiff William Bradley’s motion to remand. Dkt. No. 15 14 (“Mot.”). The Court finds this matter appropriate for disposition without oral argument and the 15 matter is deemed submitted. See Civil L.R. 7-1(b). For the reasons detailed below, the Court 16 GRANTS the motion to remand and DENIES the request for attorneys’ fees. 17 I. BACKGROUND 18 Plaintiff filed this product liability action in San Francisco County Superior Court in 19 March 2021. See Dkt. No. 1-3, Ex. 3 (“Compl.”). Plaintiff alleges that in December 2008, he 20 received a Pinnacle Hip System implant during a hip replacement surgery. See id. at ¶¶ 1, 60–62. 21 According to Plaintiff, his implant leaked toxic amounts of cobalt and chromium that damaged the 22 tissue and bone surrounding Plaintiff’s hip. See id. at ¶¶ 1, 38, 60–66. Plaintiff also contends that 23 the toxic metals may have accumulated in his vital organs. See id. at ¶ 62. Plaintiff eventually 24 had another surgery to remove the implant. See id. at ¶¶ 64–66. 25 Plaintiff alleges that several entities are responsible for the defective implant. First, 26 Plaintiff alleges that Defendants Johnson & Johnson; Medical Device Business Services, Inc.; 27 DePuy Synthes Sales, Inc.; and Johnson & Johnson Services, Inc. (the “J&J Defendants”) 1 Second, Plaintiff alleges that the remaining Defendants (the “Distributor Defendants”) helped the 2 J&J Defendants with the design, promotion, marketing, distribution, and sale of the implant.1 Id. 3 at ¶¶ 6, 13, 17–19, 21–26. 4 Plaintiff brings causes of action against all Defendants for strict product liability, 5 negligence, fraud, negligent misrepresentation, breach of implied warranties, and breach of 6 express warranty under California law. See id. at ¶¶ 67–111. The J&J Defendants removed this 7 action in January 2022, arguing that the Distributor Defendants were fraudulently joined and that 8 their California citizenship should therefore be disregarded for purposes of diversity jurisdiction. 9 See Dkt. No. 1 (“Notice of Removal”) at ¶¶ 9–19. Plaintiff now moves to remand the action back 10 to state court. See Mot. 11 II. LEGAL STANDARD 12 “Except as otherwise expressly provided by Act of Congress, any civil action brought in a 13 State court of which the district courts of the United States have original jurisdiction, may be 14 removed” to federal court. 28 U.S.C. § 1441(a). District courts have original jurisdiction over 15 civil actions between citizens of different states in which the amount in controversy exceeds 16 $75,000. See 28 U.S.C. § 1332(a)(1). To properly invoke diversity jurisdiction, the defendant 17 bears the burden of proving that the parties in the action are completely diverse, meaning that 18 “each plaintiff [is] of a different citizenship from each defendant.” Grancare, LLC v. Thrower by 19 & through Mills, 889 F.3d 543, 548 (9th Cir. 2018). 20 However, a district court may disregard a non-diverse party and retain federal jurisdiction 21 if the party resisting removal can show that the non-diverse party was fraudulently joined. See 22 Hunter v. Phillip Morris USA, 582 F.3d 1039, 1043 (9th Cir. 2009). The Ninth Circuit holds that 23 there are two ways to establish fraudulent joinder: “(1) actual fraud in the pleading of 24 jurisdictional facts, or (2) inability of the plaintiff to establish a cause of action against the non- diverse party in state court.” Grancare, 889 F.3d at 548 (quoting Hunter, 582 F.3d at 1044). 25 26 1 Specifically, the Distributor Defendants include Thomas P. Schmalzried, M.D.; Thomas P. 27 Schmalzried, M.D. A Professional Corporation; Pinnacle West Orthopaedics, Inc.; Gregory T. 1 In the absence of actual fraud, therefore, a defendant must “show[] that an individual 2 joined in the action cannot be liable on any theory.” Id. (quotations omitted) (alterations omitted). 3 “[I]f there is a possibility that a state court would find that the complaint states a cause of action 4 against any of the resident defendants, the federal court must find that the joinder was proper and 5 remand the case to the state court.” Id. (quotations omitted) (emphasis in original). In other 6 words, joinder is only fraudulent if it is “obvious according to the settled rules of the state that [the 7 plaintiff] has failed to state a claim against [the resident defendant].” See Hunter, 582 F.3d at 8 1046 (quotation omitted). 9 Courts have found fraudulent joinder “where a defendant presents extraordinarily strong 10 evidence or arguments that a plaintiff could not possibly prevail on its claims against the allegedly 11 fraudulently joined defendant,” including where “a plaintiff is barred by the statute of limitations 12 from bringing claims against that defendant.” Grancare, 889 F.3d at 548. By contrast, fraudulent joinder is not established where “a defendant raises a defense that requires a searching inquiry into 13 the merits of the plaintiff’s case, even if that defense, if successful, would prove fatal.” Id. at 548– 14 49 (citing Hunter, 582 F.3d at 1046). There is a “general presumption against fraudulent joinder,” 15 and defendants who assert that a party is fraudulently joined carry a “heavy burden.” Hunter, 582 16 F.3d at 1046. 17 18 III. DISCUSSION The parties agree that Distributor Defendants are all citizens of California. Compare 19 Compl. ¶¶ 5–6, 11–19, with Notice of Removal ¶¶ 13–16. Thus, because Plaintiff is also a 20 California citizen, the Distributor Defendants’ citizenships would ordinarily defeat federal 21 diversity jurisdiction. However, the J&J Defendants argue that all of Plaintiff’s claims against 22 Distributor Defendants “have no possibility of success under both federal and California law.” 23 Dkt. No. 29 (“Opp.”) at 2. As such, the J&J Defendants state that Distributor Defendants were 24 fraudulently joined and that their California citizenship should not defeat federal diversity 25 jurisdiction. Id. at 3. 26 Specifically, the J&J Defendants argue that Plaintiff has not established a cause of action 27 1 5–11. The Court is not persuaded. 2 The J&J Defendants argue that Plaintiff’s claims against the Distributor Defendants are 3 preempted—and therefore cannot possibly succeed—because federal law preempts such claims 4 against non-manufacturers of products approved by the Food and Drug Administration (“FDA”). 5 See id. at 5–11. The J&J Defendants rely on the Supreme Court’s opinions in PLIVA, Inc. v. 6 Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). 7 In both cases, the Supreme Court considered whether state law claims brought against generic 8 drug manufacturers were preempted by FDA drug regulations. The J&J Defendants suggest that 9 those holdings should apply with equal force to the medical device at issue here. See Opp. at 9– 10 11. 11 In Mensing, the Supreme Court held that FDA drug regulations preempt state failure-to- 12 warn claims against generic drug manufacturers because the regulations require the manufacturers 13 to use the same FDA-approved labels and warnings as the brand-name equivalents. See 564 U.S. 14 at 613–24. The Court explained that under the regulatory scheme, “brand-name and generic drug 15 manufacturers have different federal drug labeling duties.” Id. at 613. “A brand-name 16 manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its 17 label,” whereas “[a] manufacturer seeking generic drug approval, on the other hand, is responsible 18 for ensuring that its warning label is the same as the brand name’s.” Id. The Supreme Court 19 concluded that the generic manufacturers could not be held liable under state law because they did 20 not have the authority to change the drugs’ labels. Id. at 613–18. 21 Similarly, the Supreme Court in Bartlett held that FDA drug regulations preempt state 22 design defect claims against generic drug manufacturers that are based on the adequacy of a drug’s 23 warning label. Relying on Mensing, the Court reasoned that the manufacturers could not be held 24 liable because FDA regulations prevent the manufacturers from changing the composition of the 25 drug or its labels once it is approved by the FDA. See Bartlett, 570 U.S. at 482–87. In other 26 words, the Supreme Court reasoned that given the nature of the FDA regulations that apply to 27 generic drugs, the defendants in Mensing and Bartlett could not comply with both FDA 1 Neither Mensing nor Bartlett explicitly controls here. The J&J Defendants acknowledge 2 that the Pinnacle Hip System is not an FDA-approved drug like those at issue in Mensing and 3 Bartlett. See Opp. at 10–11. The FDA regulations that the Court considered in those cases are 4 thus inapplicable. The Pinnacle Hip System is a medical device that was approved under the 5 FDA’s clearance process under Section 510(k) of the Medical Device Act. Id. The J&J 6 Defendants concede that “the reasoning of Mensing has not yet been applied to distributors of 7 510(k)-cleared medical devices . . . .” Id. at 10. Nevertheless, they urge that its reasoning should 8 be extended to this context because the Distributor Defendants lacked control over the design and 9 labeling of the Pinnacle Hip System under Section 510(k). See id. at 12–14. 10 Contradicting Plaintiff’s allegations, the J&J Defendants state that the Distributor 11 Defendants “did not play any role in the manufacture or design of the Pinnacle Cup System.” See 12 id. at 7, n.2; see also Dkt. No. 29-1, Ex. 3 at ¶¶ 2–4; id., Ex. 6 at ¶¶ 14–18. The J&J Defendants 13 further suggest that Section 510(k) prohibited the Distributor Defendants from influencing the 14 design of or labels for the device. See Opp. at 10. None of the regulations that the J&J 15 Defendants cite, however, appear to prohibit distributors from altering the labels or packaging of 16 Section 510(k) medical devices. To the contrary, 21 C.F.R. § 807.20(a)(3) appears to contemplate 17 that parties may “[r]epackage[] or relabel[] a device.” Accord In re Stryker LFIT V40 Femoral 18 Head Prod. Liab. Litig., No. 17-CV-10829, 2017 WL 3815937, at *3–4 (D. Mass. Aug. 31, 2017). 19 Unlike the regulations at issue in Mensing and Bartlett, the Supreme Court has also 20 acknowledged that the Section 510(k) clearance process does not impose specific safety or design 21 requirements. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 478–79 (1996) (describing the Section 22 510(k) clearance process); see also 21 C.F.R. § 807.81 (describing premarket notification 23 submission requirements for devices under Section 510(k)). Rather, such devices may be 24 marketed “without further regulatory analysis” as long as the FDA concludes that they are 25 “substantially equivalent” to a pre-existing approved device. See id. (quotation omitted); see also 26 In re: DePuy Orthopaedics, Inc., No. 3:11-MD-2244-K, 2016 WL 6268090 at *3 (N.D. Tex. Jan. 27 5, 2016). It is simply not enough to claim that the Distributor Defendants lacked control over the 1 conflict exists between the FDA regulations and state labeling requirements. 2 Instead, the J&J Defendants rely heavily on Hall v. OrthoMidwest, Inc., 541 F. Supp. 3d 3 802, 808 (N.D. Ohio 2021). See Opp. at 10. Respectfully, the Court does not find persuasive 4 Hall’s brief analysis, which does not grapple with the language of the regulations or the Supreme 5 Court opinion in Medtronic. In Hall, the district court also declined to find preemption under 6 Mensing given the posture of the case and proceeded to evaluate the merit of the plaintiff’s state 7 law claims. See Hall, 541 F. Supp. 3d at 808–12. In any event, the Court agrees with those courts 8 which have held that ambiguity with respect to preemption must be resolved in favor of remand. 9 See, e.g., Sanghvi v. DJD Med., Inc., No. CV 21-11900-PBS, 2022 WL 363899, at *2 (D. Mass. 10 Jan. 11, 2022) (collecting cases); Marie v. Biomet, Inc., No. 3:16-CV-872 RLM-MGG, 2017 WL 11 2060655 (N.D. Ind. May 15, 2017); Fronczak v. Depuy Orthopaedics, Inc., No. 8:14-CV-2162-T- 12 30MAP, 2014 WL 5175857, at *3 (M.D. Fla. Oct. 14, 2014). 13 * * * 14 Accordingly, the Court finds that Defendants have failed to meet their “heavy burden” of 15 establishing fraudulent joinder.2 See Hunter, 582 F.3d at 1042. Because there is not complete 16 diversity of citizenship, the Court lacks subject matter jurisdiction and thus GRANTS the motion 17 to remand. 18 IV. REQUEST FOR ATTORNEYS’ FEES 19 Plaintiff asserts that the J&J Defendants’ argument is so frivolous that the Court should 20 award attorneys’ fees and costs for defending its motion to remand. Attorneys’ fees and costs are 21 only available under 28 U.S.C. § 1447(c) if the removing defendant “lacked an objectively 22 reasonable basis for seeking removal.” Martin v. Franklin Capital Corp., 546 U.S. 132, 141 23 (2005). Removal is not objectively unreasonable “solely because the removing party’s arguments 24 lack merit.” Grancare, 889 F.3d at 552. Here, Plaintiff urges that attorneys’ fees are appropriate 25

26 2 The J&J Defendants also argue that Dr. Schmalzried is fraudulently joined because Plaintiff cannot succeed on any of its state law claims against him. See Opp. at 11–16. As explained 27 above, however, the claims against the other Distributor Defendants are not preempted, and the 1 because other courts have previously rejected the J&J Defendants’ preemption argument. See 2 || Mot. at 13. Although the Court agrees that remand is appropriate under the circumstances, the 3 Court does not find that the J&J Defendants’ arguments were frivolous so as to warrant an award 4 || of attorneys’ fees, given the lack of any clearly controlling authority. The Court therefore 5 || DENIES Plaintiff's request for attorneys’ fees and costs. 6 V. CONCLUSION 7 The Court GRANTS the motion to remand and REMANDS the case to San Francisco 8 County Superior Court. The Clerk is directed to close the case. 9 IT IS SO ORDERED. 10 || Dated: 7/13/2022 11 Appel 3 bbl).

HAYWOOD S. GILLIAM, JR.

12 United States District Judge

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