NOT FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

SARA EBRAHIMI,

Plaintiff

- Appellant,

v.
MENTOR WORLDWIDE LLC,

Defendant

- Appellee,

and
JOHNSON & JOHNSON SERVICES, INC,

Defendant. No. 19

- 55103

D.C. No. 2:16

- cv
- 07316

- DMG

- KS

MEMORANDUM *

Appeal from the United States District Court for the Central District of California Dolly M. Gee, District Judge, Presiding
Submitted May 12, 2020 * * Pasadena, California
Before: COOK, ** * MURGUIA, and OWENS, Circuit Judges.

* 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).

*** The Honorable Deborah L. Cook, United States Circuit Judge for the U.S. Court of Appeals for the Sixth Circuit, sitting by des ignation. 

# FILED

MAY 15 2020

MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS2

Sara Ebrahimi appeals from the district court’s judgment dismissing her
action against Mentor Worldwide LLC (“Mentor”) . Ebrahimi alleged a state law

cl aim for strict product liability (manufacturing defect) arising out of injuries
Ebrahimi suffered after the implantation of silicone gel breast implants
manufactured by Mentor. The breast implants at issue are a Class III medical
device approved by the Fe deral Drug Administration (“FDA”) under the pre

market approval process of the Medical Device Amendments (“MDA”) to the
Food, Drug, and Cosmetic Act. We review de novo a district court’s dismissal for

failure to state a claim pursuant to Federal Rule of C ivil Procedure 12(b)(6). Puri

v. Khalsa , 844 F.3d 1152, 1157 (9th Cir. 2017). As the parties are familiar with

the fact s , we do not recount them here. We affirm.
The district court properly held that Ebrahimi’s state law manufacturing

defect claim was e xpressly preempted by the MDA. The MDA expressly preempts state law claims unless they are premised on a “parallel” federal requirement.
Riegel v. Medtronic, Inc. , 552 U.S. 312, 330 (2008) ; see also 21 U.S.C. § 360k(a)

. In other words, “ for a state law claim to survive express preemption under the
MDA, a plaintiff must show that the defendant deviated from a particular pre

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).3

Ebrahimi argues that she adequately alleged that Mentor violated the FDA’s
Current Good Manufacturing Practices or “CGMPs,” which “ establish [] basic
requirements applicable to manufacturers of finished medical devices .” 21 C.F.R.
§ 820 .1 ; see also Weber , 940 F.3d at 1113

- 14. Ebrahimi essentially contends that
the court can plausibly infer that Mentor must have violated at least one of the
FDA’s CGMPs by not catching her allegedly defective implants . However, even if
more general FDA requirements are suff icient for a parallel claim , mere allegations

“ suggesting that [Ebrahimi’s] particular breast implant [s] w[ere] defective do [] not

show that [Mentor] failed to comply with the FDA’s Current Good Manufacturing

Practices .” Weber , 940 F.3d at 1114. Further, contrary to Ebrahimi’s
characterization, Mentor’s Product Insert Data Sheet does not reflect that the FDA

approved implants had some design specification or manufacturing requirement
that would only allow an “extremely low level of gel bleed” with “no cli nical
consequence.”

W hile we are sympathetic to Ebrahimi’s health problems , she has not
sufficiently alleged that Mentor violated an FDA requirement when it

manufactured her implants. Accordingly, the district court properly dismissed

Ebrahimi’s state law manufacturing defect claim as expressly preempted by the

MDA.

AFFIRMED

.