Nicole Weber v. Allergan, Inc.

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).