United States District Court, C.D. California
ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY
D. WRIGHT, II UNITED STATES DISTRICT JUDGE
Anita Laux initiated this action against Defendant Mentor
Worldwide, LLC, on December 29, 2015, in Ventura County
Superior Court. (Compl., ECF No. 1-2.) On February 12, 2016,
Defendant removed this case to United States District Court
for the Central District of California. (ECF No. 1.) Before
the Court now is Defendant's Motion for Summary Judgment.
(Mot., ECF No. 59.) Having considered the parties'
submissions, and for the reasons that follow, the Court
GRANTS Defendant's Motion.
is a manufacturer of saline filled inflatable breast implants
(“Mentor Saline Breast Implants” or “breast
implants”). (Compl. ¶ 12.) On December
30, 2005, Plaintiff underwent surgery and Plaintiff's
doctor implanted Defendant's Mentor Saline Breast
Implants. (Id.) After the surgery, Plaintiff
allegedly began to suffer from, among other things, pain
throughout her body, respiratory congestion, severe fatigue,
and numbness. (Id. ¶ 16.)
2014, Plaintiff's doctors performed several tests that
revealed the presence of debris and bio-toxins from mold
inside of Plaintiff's breast implants. (See id.
¶¶ 18-19.) On May 23, 2014, Dr. Susan Kolb removed
Plaintiff's breast implants, and concluded that they were
leaking bilaterally. (Id. ¶ 20.) In June 2015,
Dr. Pierre Blais examined the explanted breast implants.
(Id. ¶ 23.) In his “Failure Analysis
Report, ” Dr. Blais concluded that the Mentor Saline
Breast Implants had defective valves, causing them to leak
bilaterally. (See Id. ¶¶ 23-30.) Dr. Blais
also opined that the leaking breast implants caused Plaintiff
to suffer from a variety of injuries, including: debilitating
bio-toxin disease, auto-immune disorders, respiratory
disease, and fibromyalgia. (Id. ¶ 30.)
Plaintiff brought this suit alleging that she has suffered
injuries as a result of Defendant's manufacturing
defects, negligence, and breach of warranty. (See
generally Compl.) Initially, Plaintiff was represented
by counsel, but that counsel later moved to withdraw-which
this Court granted. (ECF Nos. 44, 51.) Therefore, Plaintiff
is proceeding in this action pro se. (See ECF No.
55.) On August 4, 2017, Defendant moved to exclude the
opinions of Plaintiff's proffered experts and filed the
instant Motion for Summary Judgment on all of Plaintiff's
judgment is appropriate under Federal Rule of Civil Procedure
56 if the moving party demonstrates the absence of a genuine
issue of material fact and entitlement to a judgment as a
matter of law. Celotex Corp. v. Catrett, 477 U.S.
317, 322 (1986). A fact is material when, under the governing
law, the resolution of that fact might affect the outcome of
the case. Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 248 (1986). A dispute is genuine if “the evidence
is such that a reasonable jury could return a verdict for the
nonmoving party.” Id. at 249.
seeking summary judgment bears the initial burden to
establish the absence of a genuine issue of material fact.
Celotex, 477 U.S. at 323. To satisfy this burden,
the moving party may simply point to portions of pleadings,
admissions, answers to interrogatories and depositions which,
along with affidavits, show the absence of a genuine issue of
material fact. See Id. If the moving party satisfies
its burden, the nonmoving party must produce specific
evidence to show that a genuine dispute exists. Fed.R.Civ.P.
56(e). The Court draws all inferences in the light most
favorable to the nonmoving party. See T.W. Elec. Serv.,
Inc. v. Pac. Elec. Contractors Ass'n, 809 F.2d 626,
630-31 (9th Cir. 1987). However, the nonmoving party
“must do more than simply show that there is some
metaphysical doubt as to the material facts.”
Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 586 (1986) (footnote omitted). “If the
evidence is merely colorable, or is not significantly
probative, summary judgment may be granted.”
Liberty Lobby, 477 U.S. at 249-50 (citations
moves for summary judgment on Plaintiff's state-law
claims for: (1) manufacturing defect, (2) negligence, and (3)
breach of warranty. (Mot. 10.)
Federal Preemption Under the Medical Device Amendments of
1976 and Riegel v. Medtronics, Inc.
first contends that the Mentor Saline Breast Implant at issue
is a Class III device approved by the Food and Drug
Administration (“FDA”) through the premarket
approval process (“PMA process”), and thus,
Plaintiff's manufacturing defect and negligence claims
are expressly preempted by the Medical Device Amendments
(“MDA”), 21 U.S.C. §§ 360 et