Court Opinion

ID: 4534823
Source: CourtListenerOpinion
Date Created: 2020-05-15 20:00:41.483103+00
Date Added: 2024-06-11T09:27:27.546518
License: Public Domain

NOT FOR PUBLICATION                           FILED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).

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      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.

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