Sara Ebrahimi v. Mentor Worldwide LLC ( 2020 )

NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS MAY 15 2020
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
SARA EBRAHIMI, No. 19-55103
Plaintiff-Appellant, D.C. No.
2:16-cv-07316-DMG-KS
v.
MENTOR WORLDWIDE LLC, MEMORANDUM*
Defendant-Appellee,
and
JOHNSON & JOHNSON SERVICES, INC,
Defendant.
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.
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 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 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 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).
2
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 FDA-
approved 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.
3