NOT FOR PUBLICATION FILED

UNITED STATES COURT OF APPEALS FEB 5 2021

MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS

FOR THE NINTH CIRCUIT

NICOLE VIEIRA; EMILIA BAROZZI, No. 19-56394

Plaintiffs-Appellants, D.C. No. 2:19-cv-04939-AB-PLA v.

MENTOR WORLDWIDE, LLC; et al., MEMORANDUM*

Defendants-Appellees.

Appeal from the United States District Court for the Central District of California Andre Birotte, Jr., District Judge, Presiding

Submitted February 3, 2021** Pasadena, California

Before: GOULD, OWENS, and VANDYKE, Circuit Judges.

Plaintiffs appeal from the district court’s judgment dismissing their action

alleging state law claims arising out of injuries they suffered after the implantation

of MemoryGel Silicone Breast Implants manufactured by Mentor Worldwide, LLC

(“Mentor”). The breast implants at issue are a Class III medical device approved

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3. ** The panel unanimously concludes this case is suitable for decision without oral argument. See Fed. R. App. P. 34(a)(2). by the Federal Drug Administration (“FDA”) under the pre-market approval

process of the Medical Device Amendments (“MDA”) to the Food, Drug, and

Cosmetic Act (“FDCA”). We review de novo a district court’s denial of a motion

to remand. Canela v. Costco Wholesale Corp., 971 F.3d 845, 849 (9th Cir. 2020).

We review de novo a district court’s dismissal for failure to state a claim pursuant

to Federal Rule of Civil Procedure 12(b)(6), and for abuse of discretion the denial

of leave to amend. Curry v. Yelp Inc., 875 F.3d 1219, 1224 (9th Cir. 2017). As the

parties are familiar with the facts, we do not recount them here. We affirm.

1. The district court properly denied Plaintiffs’ motion to remand. Mentor’s

removal was timely under 28 U.S.C. § 1446(b)(3) because the deposition transcript

of Scott Mraz revealed sufficiently new information about NuSil, LLC (“NuSil”)

to trigger the removal. See Fritsch v. Swift Transp. Co. of Ariz., LLC, 899 F.3d

785, 789 (9th Cir. 2018); Carvalho v. Equifax Info. Servs., LLC, 629 F.3d 876, 887

(9th Cir. 2010).

The district court properly determined that NuSil was fraudulently joined,

and therefore diversity jurisdiction existed. Fraudulent joinder may be established

“if a defendant shows that an ‘individual[] joined in the action cannot be liable on

any theory.’” Grancare, LLC v. Thrower ex. rel. Mills, 889 F.3d 543, 548 (9th Cir.

2018) (citation omitted). “Fraudulent joinder must be proven by clear and

convincing evidence.” Hamilton Materials, Inc. v. Dow Chem. Corp., 494 F.3d

2 1203, 1206 (9th Cir. 2007). Based on Mraz’s deposition testimony and the

amended Statement of Information, Mentor showed by clear and convincing

evidence that NuSil was not involved in manufacturing or supplying the silicone

used in Mentor’s allegedly defective implants, and thus there was no possibility

Plaintiffs could recover against NuSil. See DiCola v. White Brothers Performance

Prods., Inc., 69 Cal. Rptr. 3d 888, 897 (Ct. App. 2008).

2. The district court also properly dismissed Plaintiffs’ state law claims as

preempted by the MDA. The MDA expressly preempts state law claims unless

they are premised on a “parallel” federal requirement. See 21 U.S.C. § 360k(a);

Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008). Even if a state law claim is

not expressly preempted by the MDA, it may be impliedly preempted. See 21

U.S.C. § 337(a); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352-53

(2001). Thus, to escape preemption, a state law claim must fit through a “narrow

gap”: “The plaintiff must be suing for conduct that violates the FDCA (or else his

claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing

because the conduct violates the FDCA (such a claim would be impliedly

preempted under Buckman).” Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th

Cir. 2013) (citation omitted).

Plaintiffs’ failure to warn claims are primarily based on Mentor’s alleged

failure to report adverse events related to its MemoryGel Silicone Breast Implants

3 to the FDA. In states that recognize failure to report claims, such as California, a

manufacturer’s failure to report adverse events to the FDA can form the basis of a

parallel claim that survives preemption. See Stengel v. Medtronic Inc., 704 F.3d

1224, 1233 (9th Cir. 2013) (en banc); Coleman v. Medtronic, Inc., 167 Cal. Rptr.

3d 300, 311-12 (Ct. App. 2014).

Here, however, Plaintiffs fail to allege actual adverse events that Mentor did

not report to the FDA. Rather, Plaintiffs speculate that if Mentor had conducted its

post-approval studies differently (e.g., increased follow-up with participants), then

Mentor would have identified additional adverse events that it would have reported

to the FDA. These conclusory and speculative allegations are insufficient to state a

parallel failure to warn claim. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555

(2007). Moreover, to the extent Plaintiffs base their failure to warn claims on

Mentor’s alleged failure to properly conduct the post-approval studies, Plaintiffs’

claims are impliedly preempted because Plaintiffs do not identify a parallel state

law duty to conduct post-approval studies. In addition, to the extent Plaintiffs

argue that Mentor failed to warn them or their doctors directly, such claims are

preempted because there are no such federal requirements. See Stengel, 704 F.3d

at 1234 (Watford, J., concurring).

For their manufacturing defect claims to survive express preemption under

the MDA, Plaintiffs must allege that Defendants “deviated from a particular pre-

4 market approval or other FDA requirement applicable to the Class III medical

device.” Weber v. Allergan, Inc., 940 F.3d 1106, 1112 (9th Cir. 2019). They

“cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur

to suggest only . . . that the thing speaks for itself.” Id. (citation and internal

quotation marks omitted).

Here, Plaintiffs fail to allege that Defendants violated a particular FDA

requirement. For example, Plaintiffs vaguely allege that Mentor’s MemoryGel

Silicone Breast Implants contained unidentified materials that differed from those

approved by the FDA. Further, Plaintiffs’ mere allegations “suggesting that [their]

particular breast implant[s] w[ere] defective do[] not show that [Defendants] failed

to comply with the FDA’s Current Good Manufacturing Practices.” Id. at 1114.

While we are sympathetic to Plaintiffs’ health problems, they have not

sufficiently alleged a state law claim that squeezes through the “narrow gap” to

escape MDA preemption. Perez, 711 F.3d at 1120 (citation omitted).

3. Finally, the district court did not abuse its discretion by dismissing

Plaintiffs’ action without leave to amend based on its determination that any

amendment would be futile. See Ebner v. Fresh, Inc., 838 F.3d 958, 968 (9th Cir.

2016).

AFFIRMED.

5