NOT FOR PUBLICATION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 designation.

FILED

MAY 15 2020

MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS
2 

Sara Ebrahimi appeals from the district court’s judgment dismissing her 

action against Mentor Worldwide LLC (“Mentor”). Ebrahimi alleged a state law 

claim 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 Federal Drug Administration (“FDA”) under the premarket 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 Civil Procedure 12(b)(6). Puri 

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

the facts, we do not recount them here. We affirm.

The district court properly held that Ebrahimi’s state law manufacturing 

defect claim was expressly 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 premarket 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 sufficient 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 FDAapproved implants had some design specification or manufacturing requirement 

that would only allow an “extremely low level of gel bleed” with “no clinical 

consequence.” 

 While 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.