FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
NICOLE WEBER, No. 18-15212
Plaintiff-Appellant,
D.C. No.
v. 2:12-cv-02388-
SRB
ALLERGAN, INC.,
Defendant-Appellee. OPINION
Appeal from the United States District Court
for the District of Arizona
Susan R. Bolton, District Judge, Presiding
Argued and Submitted September 13, 2019
Pasadena, California
Filed October 11, 2019
Before: Johnnie B. Rawlinson, John B. Owens,
and Mark J. Bennett, Circuit Judges.
Opinion by Judge Owens
2 WEBER V. ALLERGAN
SUMMARY *
Medical Device Amendments / Preemption
The panel affirmed the district court’s summary
judgment in favor of Allergan, Inc. in plaintiff’s action under
Arizona law alleging that she suffered injuries when her
breast implants bled silicone into her body.
Through the Medical Device Amendments (“MDA”) to
the Food, Drug, and Cosmetic Act, Congress permitted the
Food and Drug Administration (“FDA”) oversight of
medical devices. In November 2006, the FDA provided
Class III pre-market approval for the implants.
The MDA expressly preempts state law regulation of
medical devices. The panel held that 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.
The panel held that plaintiff failed to show that Allergan
violated an FDA requirement. Specifically, the panel held
plaintiff failed to raise a genuine dispute of material fact that
Allergan violated a requirement of the FDA’s pre-market
approval. The panel further held that plaintiff had not shown
a violation of the FDA’s Current Good Manufacturing
Practices found in the Quality System Regulations
applicable to all medical devices. The panel concluded that
*
This summary constitutes no part of the opinion of the court. It
has been prepared by court staff for the convenience of the reader.
WEBER V. ALLERGAN 3
plaintiff failed to raise a genuine dispute of material fact that
Allergan violated a federal requirement for its Style 20
implant, which she must have for her state law claims to fit
through the narrow exception to MDA preemption.
COUNSEL
Alan C. Milstein (argued), Sherman Silverstein Kohl Rose
& Podolsky P.A., Moorestown, New Jersey, for Plaintiff-
Appellant.
GinaMarie Slattery (argued), Slattery Petersen, Tucson,
Arizona, for Defendant-Appellee.
OPINION
OWENS, Circuit Judge:
Nicole Weber appeals from the district court’s grant of
summary judgment in favor of Allergan, Inc. Weber sued
Allergan under state law alleging that she suffered injuries
when her breast implants bled silicone into her body. We
have jurisdiction under 28 U.S.C. § 1291, and we affirm.
I. BACKGROUND
A. Weber’s Health Problems
In December 2009, Weber underwent reconstructive
surgery after a double mastectomy and received Allergan’s
Natrelle Style 20 silicone breast implants. Weber then
suffered severe health problems, including significant vision
loss. In October 2011, Dr. Feng removed the implants and
opined that a silicone gel bleed from the implants caused
4 WEBER V. ALLERGAN
Weber’s health issues. According to a pathology report
ordered by Dr. Feng, Weber’s right implant had lost roughly
2.8% of its mass.
B. FDA Approval of the Style 20 Implants
In November 2006, the Food and Drug Administration
(“FDA”) provided Class III pre-market approval for the
implants. The Style 20 product label stated that, while
silicone could bleed out of intact breast implants, “Allergan
performed a laboratory test” in which “[o]ver 99% of the . . .
silicones . . . stayed in the implant,” and that “[t]he overall
body of available evidence supports that the extremely low
level of gel bleed is of no clinical consequence.” In
November 2008, the FDA inspected Allergan’s
manufacturing facility and concluded that the “procedures
seem to be adequate and it seems like no significant change
has been made to manufacturing.” According to Allergan,
Weber’s right implant passed testing and inspection to
ensure compliance with the FDA’s pre-market approval for
the Style 20 model.
C. Procedural History
Weber sued Allergan in 2012, and in 2016 filed a Third
Amended Complaint alleging claims under Arizona law for
(1) strict product liability (manufacturing defect); and
(2) negligence. 1 As part of discovery, Allergan deposed
Dr. Feng, Weber’s main expert. She testified that the 2.8%
mass bleed was a “departure from the manufacturer’s
specifications” and a “defect.” Dr. Feng admitted, however,
1
Prior to the Third Amended Complaint, the district court granted
Allergan’s motion to dismiss, but we reversed and remanded. See Weber
v. Allergan, Inc., 621 F. App’x 401 (9th Cir. 2015) (unpublished).
WEBER V. ALLERGAN 5
that she did not “know anything about specifications and
how that implant is manufactured” and had “no opinion”
about “whether or not Allergan violated any protocols for
manufacturing.”
After discovery, the district court granted Allergan’s
motion for summary judgment. The district court explained
that Weber’s evidence of her health problems coupled with
an implant bleed “more than twice the expected amount of
gel according to the product’s labeling” could have been
enough to survive summary judgment if Weber “was
required to show only that her implant malfunctioned or was
defective.” But, according to the district court, that was not
the relevant question. Rather, Weber needed to show that
Allergan “failed to follow the FDA’s regulations and
requirements set forth in its pre-market approval of the
Natrelle Style 20 implant.” Dr. Feng’s testimony did not
address that question, as her opinion “that the implant was
defective because it did not function properly is simply not
evidence that it was not manufactured according to pre-
market approval specifications.” Accordingly, “[e]vidence
of a malfunction, without more, is . . . insufficient to
withstand summary judgment” for Class III medical
devices. 2
II. DISCUSSION
A. Standard of Review
We review de novo a district court’s decision to grant
summary judgment. Folkens v. Wyland Worldwide, LLC,
882 F.3d 768, 773 (9th Cir. 2018). Summary judgment is
2
The district court did not reach whether any alleged manufacturing
defect caused Weber’s health problems, and neither do we.
6 WEBER V. ALLERGAN
only appropriate if there is no genuine dispute of material
fact, after viewing the evidence in the light most favorable
to the nonmoving party. Id.
B. Class III Medical Devices
The Food, Drug, and Cosmetic Act (“FDCA”) “has long
required FDA approval for the introduction of new drugs
into the market.” Riegel v. Medtronic, Inc., 552 U.S. 312,
315 (2008). Through the Medical Device Amendments to
the FDCA (“MDA”), Congress permitted FDA oversight of
medical devices. Id. at 316. The MDA established three
classes of medical devices, with Class III receiving the most
FDA scrutiny. Id. at 316–17. “In general, a device is
assigned to Class III if . . . [it] is ‘purported or represented to
be for a use in supporting or sustaining human life or for a
use which is of substantial importance in preventing
impairment of human health,’ or ‘presents a potential
unreasonable risk of illness or injury.’” Id. at 317 (quoting
21 U.S.C. § 360c(a)(1)(C)(ii)).
The FDA “rigorous[ly]” reviews Class III devices prior
to their reaching the market. Id. (quoting Medtronic, Inc. v.
Lohr, 518 U.S. 470, 477 (1996)). This includes a risk-
benefit assessment of the device and an analysis of the
adequacy of the manufacturer’s label. Id. at 318. The FDA
may “approve devices that present great risks if they
nonetheless offer great benefits in light of available
alternatives.” Id. “Once a device has received premarket
approval, the MDA forbids the manufacturer to make,
without FDA permission, changes in design specifications,
manufacturing processes, labeling, or any other attribute,
that would affect safety or effectiveness.” Id. at 319 (citing
21 U.S.C. § 360e(d)(6)(A)(i)).
WEBER V. ALLERGAN 7
C. State Law Claims and the MDA
The MDA expressly preempts state law regulation of
medical devices. It provides in relevant part:
[N]o State or political subdivision of a State
may establish or continue in effect with
respect to a device intended for human use
any requirement—
(1) which is different from, or in addition
to, any requirement applicable under this
chapter to the device, and
(2) which relates to the safety or
effectiveness of the device or to any other
matter included in a requirement
applicable to the device under this
chapter.
21 U.S.C. § 360k(a).
In Riegel, the Supreme Court held that § 360k preempted
state law claims challenging the safety and effectiveness of
a Class III medical device that had received pre-market
approval from the FDA. 552 U.S. at 321–25. Because FDA
pre-market approval constitutes federal “requirements,” the
MDA preempts state laws to the extent they impose
standards that are “different from, or in addition to,” those
federal requirements. Id. at 322–23 (quoting 21 U.S.C.
§ 360k(a)). However, the MDA does not preempt state law
requirements that “‘parallel,’ rather than add to, federal
requirements.” Id. at 330 (quoting Lohr, 518 U.S. at 495);
see also Stengel v. Medtronic Inc., 704 F.3d 1224, 1228 (9th
Cir. 2013) (en banc) (holding that “the MDA does not
preempt a state-law claim for violating a state-law duty that
8 WEBER V. ALLERGAN
parallels a federal-law duty under the MDA”); Perez v.
Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013) (recognizing
a “narrow” preemption exception for parallel state law
claims (citation omitted)). In other words, the MDA allows
state law claims against a manufacturer of a Class III medical
device only if they are “premised on a violation of FDA
regulations” relating to the device. Riegel, 552 U.S. at 330.
While “[t]he contours of the parallel claim exception
were not addressed in Riegel and are as-yet ill-defined,” In
re Medtronic, Inc., Sprint Fidelis Leads Products Liability
Litigation, 623 F.3d 1200, 1204 (8th Cir. 2010), the district
court in this case applied the same preemption analysis as
other courts in our circuit have: to proceed with a state law
claim relating to a Class III medical device, such as a product
liability or negligence claim, a plaintiff must show a
“violation of FDA regulations or requirements related to [the
device].” Erickson v. Bos. Sci. Corp., 846 F. Supp. 2d 1085,
1092 (C.D. Cal. 2011); see also Houston v. Medtronic, Inc.,
957 F. Supp. 2d 1166, 1174 (C.D. Cal. 2013). Other circuits
have similarly held that “to escape express preemption as a
parallel claim,” a plaintiff must show violation of an FDA
requirement applicable to the medical device. Shuker v.
Smith & Nephew, PLC, 885 F.3d 760, 776 (3d Cir. 2018);
see also, e.g., Bass v. Stryker Corp., 669 F.3d 501, 512 (5th
Cir. 2012); Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d
1296, 1301–02 (11th Cir. 2011).
We adopt this principle as well and hold that, for a state
law claim regarding a Class III medical device to survive
express preemption by the MDA, a plaintiff must establish
that the defendant violated an FDA requirement. As noted
above, the protocols and specifications established by the
FDA’s pre-market approval constitute such requirements.
See Riegel, 552 U.S. at 321–23. For example, if the FDA’s
WEBER V. ALLERGAN 9
pre-market approval “required 400 degree welds but the
manufacturer used a 300 degree welding process,” that could
show violation of an FDA requirement and establish a
parallel state law claim. In re Medtronic, 623 F.3d at 1207.
However, the FDA’s pre-market approval of the process
by which a Class III device is manufactured “does not
guarantee that every device manufactured in that process
will work.” Banner v. Cyberonics, Inc., No. 08-0741, 2010
WL 455286, at *4 (D.N.J. Feb. 4, 2010) (unpublished).
Rather, the FDA performs a cost-benefit analysis and may
approve devices knowing that they sometimes will fail. See
Riegel, 552 U.S. at 318, 325. When it enacted the MDA,
Congress struck a balance “in which it determined that the
benefit to the many of bringing potentially lifesaving, but
risky, medical devices to the public following the rigorous
process of FDA approval outweighed the cost to the few of
preempting common law claims based on different
standards.” Walker v. Medtronic, Inc., 670 F.3d 569, 572
(4th Cir. 2012). Thus, the MDA “provides immunity for
manufacturers of new Class III medical devices to the extent
that they comply with federal law, but it does not protect
them if they have violated federal law.” Bausch v. Stryker
Corp., 630 F.3d 546, 553 (7th Cir. 2010); see also Williams
v. Cyberonics, Inc., 654 F. Supp. 2d 301, 306 (E.D. Pa. 2009)
(“[A] plaintiff must make some showing that the medical
device was not manufactured in accordance with FDA
standards.”), aff’d, 388 F. App’x 169 (3d Cir. 2010)
(unpublished). And to survive MDA preemption, a plaintiff
cannot simply demonstrate a defect or a malfunction and rely
“on res ipsa loquitur to suggest only . . . ‘that the thing
speaks for itself.’” Funk v. Stryker Corp., 631 F.3d 777, 782
(5th Cir. 2011); see also Clark v. Medtronic, Inc., 572 F.
Supp. 2d 1090, 1094 (D. Minn. 2008) (rejecting reliance on
“res ipsa loquitur for the proposition that full compliance
10 WEBER V. ALLERGAN
would have resulted in a problem-free device”). Instead, 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.
D. Weber Failed to Show that Allergan Violated a
Federal Requirement
Weber’s dual attempts to demonstrate that Allergan
violated FDA requirements fall short. She first argues that
Allergan’s product label providing a bleed rate of less than
1% is an FDA pre-market approval requirement, relying
heavily on the dissent in the Fourth Circuit’s decision in
Walker.
In Walker, the plaintiff’s husband died when his
internally implanted pump, a Class III medical device,
administered a lethal overdose of pain medication. 670 F.3d
at 574–75. The plaintiff argued that the pump’s pre-market
approval materials’ statement that the pump had a flow
accuracy of “plus or minus 15 percent . . . became a part of
the federal requirements governing the device,” which the
defendant violated because the pump “allegedly infused an
amount of medication outside of these parameters.” Id.
at 578. However, the plaintiff conceded that the “pump was
designed, manufactured, and distributed in compliance with
the terms of the FDA’s premarket approval” and that “the
plus or minus 15 percent specification is not a formal
performance standard.” Id.
The Walker majority held that the plus or minus
15 percent specification did not create a federal requirement,
and therefore the plaintiff’s state law claims that the pump
failed to comply with this specification were preempted. Id.
at 578–81. “In short, nothing in the . . . pump’s premarket
WEBER V. ALLERGAN 11
approval application—which was approved in its entirety by
the FDA—purported that the device would always dispense
medication within the range of the plus or minus 15 percent
flow accuracy.” Id. at 580 (emphasis added). “Instead, the
plus or minus 15 percent specification reflects the . . .
pump’s output under optimal conditions, but subject to
numerous qualifiers that disclose the possibility of infusion
outside this range.” Id. “To the extent that [the plaintiff]
interprets the plus or minus 15 percent specification as a
guarantee of performance, she seeks to impose a more
demanding standard than that of the FDA, rather than a
parallel one.” Id.
In contrast, the dissent would have held that the plus or
minus 15 percent accuracy specification was indeed a federal
requirement, rather than a “mere aspirational figure,” and
therefore the plaintiff’s state law claims were not preempted
under the MDA. Id. at 581 (Wynn, J., dissenting). The
dissent reasoned that “[t]he FDA accepted [the] margin [for
error], based on [the] Pre-Market Approval application, to
be plus or minus 15 percent” and the plaintiff “alone should
[not] bear the burden of [the] malfunction” when the pump
“instead infused her husband with 258 percent of the
appropriate medication dosage, and this extreme overdose
killed him.” Id. at 585.
Here, Weber urges us to follow the Walker dissent, and
hold that the implant label’s statement that a laboratory test
showed that “[o]ver 99% of the . . . silicones . . . stayed in
the implant” was a requirement of the FDA’s pre-market
approval, rather than an “aspirational figure.” Id. at 581.
However, we agree with the Walker majority. There is no
indication that Allergan purported to the FDA that the
implant would “always” bleed less than 1%. Id. at 580. To
the extent Weber interprets the implant label’s statement “as
12 WEBER V. ALLERGAN
a guarantee of performance, she seeks to impose a more
demanding standard than that of the FDA, rather than a
parallel one.” Id.; see also Rankin v. Bos. Sci. Corp., No. 09-
177-KSF, 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010)
(holding that the manufacturer did not “violate[] some
federally imposed requirement or regulation” merely
because a balloon catheter with a rated burst pressure of
12 atmospheres allegedly ruptured at only 6 atmospheres
during a surgical procedure).
Weber also argues that Walker is different because there
the majority was “compelled to affirm” “[i]n light of [the
plaintiff’s] concession that the device was designed,
manufactured, and distributed in compliance with the terms
of its premarket approval,” id. at 571, a concession that
Weber never made. Yet she fails to show that Allergan
violated an FDA pre-market approval requirement.
Weber’s only evidence that Allergan did not comply
with the FDA’s pre-market approval is Dr. Feng’s opinion
that Weber’s right implant’s gel bleed exceeding the amount
specified by its product labeling constituted a “departure
from the manufacturer’s specifications” and a “defect.”
However, Dr. Feng’s opinion that the implant was defective
and malfunctioned is not evidence that Allergan deviated
from the FDA’s pre-market approved procedures. Res ipsa
loquitor is not enough to survive MDA preemption. See
Funk, 631 F.3d at 782; Clark, 572 F. Supp. 2d at 1094.
Dr. Feng conceded that she did not “know anything about
specifications and how that implant is manufactured” and
had “no opinion” about “whether or not Allergan violated
any protocols for manufacturing.” On the other hand,
Allergan provided evidence that Weber’s right implant was
inspected and complied with the FDA’s pre-market
approval. In sum, Weber failed to raise a genuine dispute of
WEBER V. ALLERGAN 13
material fact that Allergan violated a requirement of the
FDA’s pre-market approval.
Second, Weber argues that Allergan violated the FDA’s
Current Good Manufacturing Practices or “CGMPs,” found
in the Quality System Regulations applicable to all medical
devices, which “require each manufacturer to put in place
processes to test products for compliance with product
specifications, to check and document compliance with
product specifications before products are accepted for sale
and use, and to identify and control nonconforming
products.” Bausch, 630 F.3d at 556 (citing 21 C.F.R.
§§ 820.72–820.90).
We need not wade into the intercircuit disagreement
regarding whether a parallel claim demands that the federal
“requirement” must be “device-specific” (such as FDA pre-
market approval for a particular medical device) or may be
a general FDA regulation applicable to all medical devices
(such as the Current Good Manufacturing Practices). See,
e.g., Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1331 n.3
(11th Cir. 2017) (agreeing “with our sister circuits that there
is no ‘sound legal basis’ to distinguish these federal
requirements because the plain text of § 360k refers to ‘any
requirement’” (quoting Bausch, 630 F.3d at 555)); Bass,
669 F.3d at 511–13 (noting that “the circuits are not in
complete agreement as to what constitutes a sufficient
pleading with regard to a CGMP,” and holding that
allegations based on a CGMP were sufficient at the pleading
stage because at trial the plaintiff “will have to prove
violations of the more specific, FDA-approved PMA process
for this device”); Bausch, 630 F.3d at 554–55 (noting that
some federal courts have held that “the Quality System
Regulations and Current Good Manufacturing Practices are
14 WEBER V. ALLERGAN
too general to allow juries to enforce them,” but rejecting
that approach).
Here, even if more general FDA requirements are
sufficient, Weber has not shown a violation of the FDA’s
Current Good Manufacturing Practices. Again, the mere
evidence suggesting that her particular breast implant was
defective does not show that Allergan failed to comply with
the FDA’s Current Good Manufacturing Practices.
Likewise, evidence that some other implants produced by
Allergan were defective does not demonstrate
noncompliance. Cf. Erickson, 846 F. Supp. 2d at 1093
(stating that “product recalls do not create a presumption that
FDA requirements have been violated”).
Accordingly, the district court properly granted
summary judgment because Weber failed to raise a genuine
dispute of material fact that Allergan violated a federal
“requirement” for its Style 20 implant. 21 U.S.C. § 360k(a);
see also Riegel, 552 U.S. at 330; Stengel, 704 F.3d at 1228.
We are sympathetic to Weber’s health problems. However,
she has not shown a violation of an FDA requirement, which
she must for her state law claims to fit through the “narrow”
exception to MDA preemption. Perez, 711 F.3d at 1120
(citation omitted).
AFFIRMED. 3
3
Weber also requests that we reverse the district court’s cost award.
However, Weber “waived her right to appellate review of the cost award”
because she neither objected to Allergan’s bill of costs nor moved for
district court review of the clerk’s taxation of costs under Federal Rule
of Civil Procedure 54(d)(1). Mendiola-Martinez v. Arpaio, 836 F.3d
1239, 1262 (9th Cir. 2016).