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Date: 07-06-2020

Case Style:

Rexina Mize v. Mentor Worldwide, LLC

Case Number: B295829

Judge: Tangeman, J

Court: California Court of Appeals Second Appellate District, Division Six on appeal from the Superior Court, County of Los Angeles

Plaintiff's Attorney: Jennifer A. Lenze and Martin N. Buchanan

Defendant's Attorney: Mollie F. Benedict, Dustin B. Rawlin and Monee Takla Hanna

Description: This case is about preemption and causation:
whether the Medical Device Amendments (MDA) to the federal
Food, Drug, and Cosmetic Act (FDCA) preempt the state-law
products liability claims at issue here, and whether Rexina Mize
and her husband, Minh Nguyen, sufficiently pled causation to
survive Mentor Worldwide LLC’s demurrer to those claims. We
conclude that the tort claims in this case survive preemption
because they are “‘“‘premised on conduct that both (1) violates the
[MDA] and (2) would give rise to a recovery under state law even
in the absence of the [MDA].’”’ [Citation.]” (Glennen v. Allergan,
Inc. (2016) 247 Cal.App.4th 1, 11-12 (Glennen).) We further
conclude that Mize and Nguyen pled the requisite “‘causal
connection’” between their injuries and Mentor’s tortious acts to
2
survive a demurrer. (Rannard v. Lockheed Aircraft Corp. (1945)
26 Cal.2d 149, 156 (Rannard).) Because the trial court reached
contrary conclusions, we reverse.
FACTUAL AND PROCEDURAL HISTORY1
The Medical Device Amendments of 1976
Since 1976, the MDA has required the Food and Drug
Administration (FDA) to provide “detailed federal oversight” of
medical devices. (Rigel v. Medtronic, Inc. (2008) 552 U.S. 312,
316 (Rigel).) “The devices receiving the most federal oversight
are those in Class III.” (Id. at p. 317.) Such devices include those
that pose potentially unreasonable risks of illness or injury.
(Ibid.) Breast implants are assigned to Class III.
A Class III device must undergo premarket approval
to “provide reasonable assurance of its safety and effectiveness.”
(21 U.S.C.2 § 360c(a)(1)(C).) “Premarket approval is a ‘rigorous’
process.” (Rigel, supra, 552 U.S. at p. 317.) It includes
submission of an application that includes studies of the device’s
safety and effectiveness, a statement of its components and
principles of operation, a description of its manufacturing
methods, samples of the device, and proposed labels. (Id. at pp.
317-318.) The FDA will grant premarket approval “only if it
finds there is a ‘reasonable assurance’ of the device’s ‘safety and
effectiveness.’” (Ibid.) Once it does, “the MDA forbids the
1 The facts are taken from Mize and Nguyen’s third
amended complaint, which we accept as true in our review of the
trial court’s order sustaining Mentor’s demurrer. (Blank v.
Kirwan (1985) 39 Cal.3d 311, 318 (Blank).)
2 Further unlabeled statutory references are to title 21 of
the United States Code.
3
manufacturer to make . . . changes in design specifications,
manufacturing processes, labeling, or any other attribute that
would affect safety or effectiveness.” (Id. at p. 319.)
Before obtaining premarket approval, a Class III
device manufacturer may apply to use the device in clinical tests
pursuant to an investigational device exemption (IDE).
(§ 360j(g).) To qualify for an IDE, the manufacturer must submit
an application and investigational plan for the device. (See 21
C.F.R. §§ 812.20(b), 812.25.) The FDA must then determine that
the benefits to test participants and the knowledge to be gained
from the tests outweigh the device’s risks. (21 C.F.R. § 812.30.)
If the FDA approves an IDE application, few changes to the
investigational plan are permitted. (21 C.F.R. § 812.35(a)(1).)
Mentor’s MemoryGel breast implants
In the early 1990’s, Mentor applied for an IDE to
permit clinical testing of its MemoryGel silicone breast implants.
The FDA granted Mentor’s application and approved three
studies: an adjunct study for patients undergoing either breast
reconstruction after a mastectomy or breast implant revision,3
approved in July 1992; a core study, approved in August 1992;
and an IDE study, approved in August 2000.
In 1998, the FDA sued Mentor, alleging that the
company failed to meet manufacturing quality standards,
destroyed evidence of its implants’ high rupture rates, sold
contaminated implants, and failed to comply with FDA-mandated
design and materials specifications. The FDA and Mentor
entered into a consent decree to address the alleged violations,
which required the company to remedy the deficiencies, comply
3 Breast implant revision involves the removal or
replacement of existing breast implants.
4
with federal law, and adhere to good manufacturing practices. If
Mentor complied with the terms of the decree for five years, the
FDA would not oppose a petition to dissolve it.4
Mize’s breast implants
Two years after the FDA and Mentor finalized the
consent decree, Mize underwent a bilateral breast augmentation,
receiving MemoryGel breast implants as part of Mentor’s adjunct
4 The trial court took judicial notice of the consent decree
and its subsequent dissolution. We grant Mentor’s unopposed
request to judicially notice these documents and all others
properly noticed by the court below. (Rea v. Blue Shield of
California (2014) 226 Cal.App.4th 1209, 1223; see Evid. Code,
§ 459, subd. (a).)
Mentor also requests that we consider several additional
documents that were not presented to the court below: (1) five
documents, other than those cited above, attached to the request
for judicial notice, (2) pages 53 to 558 of the Respondent’s
Appendix, and (3) two documents attached to a declaration in
support of Mentor’s brief on appeal. We deny these requests. As
to the first set of documents, Mentor “puts forth no reason for its
failure to request [that] the trial court . . . take judicial notice of”
them. (Brosterhous v. State Bar (1995) 12 Cal.4th 315, 325-326.)
As to the second, though Mentor lodged these documents with the
trial court, it did not request that the court take judicial notice of
them. They are thus not a proper part of the record for review of
Mentor’s demurrer. (Cloud v. Northrop Grumman Corp. (1998)
67 Cal.App.4th 995, 999 [demurrer “attacks only defects disclosed
on the face of the pleadings or by matters that can be judicially
noticed”.]) As to the third, “documents not before the trial court
cannot be included as part of the record on appeal.” (Pulver v.
Avco Financial Services (1986) 182 Cal.App.3d 622, 632.) We
disregard all of these documents and the portions of Mentor’s
brief that cite to and rely on them. (Ibid.)
5
study. Mize did not meet the study’s criteria because she did not
need breast reconstruction or implant revision. She was unaware
she was participating in the study, and did not know that her
implants had not been approved for sale by the FDA.
After her breast augmentation, Mize began to
experience a variety of health problems, including chronic
fatigue, muscle and bone pain, joint swelling and stiffness,
memory loss, and numbness. Her vision deteriorated, and she
had to get prescription eyeglasses. She lost several business
opportunities and abandoned her music career. None of Mize’s
doctors connected her health problems to her implants.
Premarket approval
In August 2003, a federal court dissolved Mentor’s
consent decree with the FDA. Four months later, Mentor sought
premarket approval for its MemoryGel implants. The FDA
approved Mentor’s application in November 2006. As a condition
of approval, the FDA required Mentor to conduct six studies that
would document the safety and effectiveness of its implants and
answer questions the earlier clinical trials did not answer. As
part of these studies, Mentor had to submit adverse event
reports, either as individual medical device reports that would be
stored in the FDA’s publicly accessible Manufacturer and User
Facility Device Experience (MAUDE) database (for deaths and
unusual adverse events), or as postmarket spreadsheet reports
that would not be included in the database (for well-known or
expected adverse events, including implant rupture).
Mentor failed to properly perform the six studies. It
did not follow up with enough study participants and did not fully
report the myriad adverse events—such as silicone toxicity,
implant removal, autoimmune complaints, ruptures, and
6
inflammation—documented in the studies. According to Mize,
the FDA would have included the adverse events in the MAUDE
database had Mentor properly reported them.
The removal of Mize’s implants and ensuing lawsuit
In December 2016, an MRI revealed that Mize’s
breast implants had ruptured. She had them removed the
following month. After their removal, Mize’s mental clarity
improved. She no longer suffered from chronic fatigue, and no
longer needed her prescription eyeglasses.
Mize and Nguyen sued Mentor. In the third
amended complaint, Mize alleged causes of action for negligence
and negligence per se based on Mentor’s negligent failure to warn
and negligent manufacturing, strict products liability for failure
to warn, and strict products liability for manufacturing defects.
Nguyen alleged a derivative cause of action for loss of consortium.
In support of her manufacturing defect claims, Mize
alleged that Mentor: (1) manufactured its MemoryGel implants
in a manner that “differed from the specifications agreed to by
the FDA”; (2) “us[ed] materials and components [that] differed
from those approved by the FDA”; (3) “fail[ed] to follow good
manufacturing practices”; (4) “fail[ed] to properly meet the
applicable standard of care by not complying with applicable
federal regulations and . . . manufacturing protocols approved by
the FDA”; (5) distributed its implants “in violation of the terms of
the IDE and applicable federal law”; (6) “negligently
incorporat[ed] components and/or materials into its . . .
[i]mplants that could not stand up to normal usage and/or [that]
differed from those [that] were commercially reasonable and/or
fail[ed] to use the components and/or materials approved by the
FDA”; (7) “fail[ed] to exercise reasonable care in inspecting and
7
testing of the product”; (8) “fail[ed] to exercise reasonable care in
its manufacturing, quality control, and quality assurance
processes”; and (9) “was negligent in its recordkeeping and did
not disclose manufacturing flaws.”
In support of her failure-to-warn claims, Mize alleged
that Mentor breached its duty to report to the FDA, as part of the
IDE clinical tests and the six postapproval studies, “adverse
events similar to the injuries [she] suffered” despite having
“knowledge and possession of information” that its MemoryGel
implants were dangerous. Mentor also did not ensure that the
FDA-mandated studies were properly performed and did not
ensure follow-up with enough study participants. “Accordingly,
the information . . . the FDA [sought] regarding adverse events
and device failures was never gathered.” Had it been gathered
and reported, doctors would have seen and relayed it to Mize,
who would have then had her implants removed.
The demurrer
Mentor demurred to the complaint. It asserted that
Mize’s claims were preempted by federal law and insufficiently
pled, and that Nguyen’s claim failed because it was derivative of
his wife’s.
The trial court agreed with Mentor. As to the
manufacturing defect claims, the court found that they were
impliedly preempted because they “hinge[d] entirely on conduct
that allegedly violated federal law.” Even if they were not, the
allegations that underlay the claims all preceded the 1998
consent decree between Mentor and the FDA. But Mize did not
allege that her implants were manufactured prior to the decree.
And if they were manufactured after, the decree showed that
Mentor promised to change any faulty manufacturing practices.
8
To the extent Mize based her claims on Mentor’s alleged
noncompliance with IDE requirements, the complaint did not
specify how that noncompliance occurred, that it occurred prior to
her implant surgery, or how it “affected the manufacture of the
device implanted.”
As to the failure-to-warn claims, the trial court found
them expressly preempted because Mize did not allege that
Mentor’s failure to report adverse events violated any FDA
requirement. Even if she did, to succeed on her claims Mize had
to allege that “if Mentor had reported additional adverse
incidents [after she received her implants in] 2000, and if the
FDA had made such incidents public, and if [Mize’s] doctors had
been aware of such reports, [the] doctors might have provided an
earlier diagnosis leading to earlier surgery to remove the
implants,” reducing Mize’s damages. The trial court found she
did not do so.
The trial court impliedly rejected Mize’s negligence
per se claim since it was based on the same allegations as her
other claims. The court rejected Nguyen’s loss-of-consortium
claim as derivative of his wife’s. It sustained Mentor’s demurrer
without leave to amend.
DISCUSSION
Standard of review
“In reviewing the sufficiency of a complaint against a
general demurrer, we are guided by long-settled rules.” (Blank,
supra, 39 Cal.3d at p. 318.) “‘We treat the demurrer as admitting
all material facts properly [pled], but not contentions, deductions,
or conclusions of fact or law.’” (Ibid.) “‘We also consider matters
[that] may be judicially noticed.’” (Ibid.) “[W]e give the
complaint a reasonable interpretation, reading it as a whole and
9
its parts in their context.” (Ibid.) Our fundamental task is to
“determine whether the complaint states facts sufficient to
constitute a cause of action.” (Ibid.)
Preemption
Federal law is the “supreme [l]aw of the [l]and.”
(U.S. Const., art. VI, cl. 2.) State laws that conflict with federal
laws are preempted. (Murphy v. National Collegiate Athletic
Assn. (2018) __ U.S. __, __ [138 S.Ct. 1461, 1476].) Preemption
can be express or implied. (English v. General Electric Co. (1990)
496 U.S. 72, 78-79.) It is express if Congress defines “the extent
to which its enactments preempt state law.” (Id. at p. 78.) It is
implied if state law “regulates conduct in a field that Congress
intended the [f]ederal [g]overnment to occupy exclusively” or if it
“actually conflicts with federal law.” (Id. at p. 79.)
The MDA expressly preempts any state requirement
that: (1) “is different from, or in addition to, any requirement
applicable under [the FDCA],” and (2) “relates to the safety or
effectiveness of the device or to any other matter included in a
requirement applicable to the device under [the FDCA].”
(§ 360k(a).) The MDA “does not prevent a [s]tate from providing
a remedy for claims premised on a violation of FDA regulations,”
however, because “the state [requirements] in such a case
‘parallel,’ rather than add to, federal requirements.” (Riegel,
supra, 552 U.S. at p. 330.) A state requirement parallels a
federal requirement if the two are “‘“‘generally equivalent.’”’”
(Glennen, supra, 247 Cal.App.4th at p. 10.) But “[i]f state law
liability could be found notwithstanding compliance with the
federal requirements, those state law duties are not parallel to
the federal requirements.” (Ibid.) Claims seeking to enforce
those duties are expressly preempted. (Ibid.)
10
Alternatively, a plaintiff’s claim will be impliedly
preempted if it conflicts with the MDA’s enforcement scheme.
(Buckman Co. v. Plaintiffs’ Legal Committee (2001) 531 U.S. 341,
352 (Buckman).) Section 337(a) provides that “all . . . proceedings
for the enforcement, or to restrain violations, of [the MDA] shall
be by and in the name of the United States.” This provision
prohibits claims that “seek[] to enforce an exclusively federal
requirement that is not grounded in traditional state tort law.”
(Glennen, supra, 247 Cal.App.4th at p. 11, italics added.) Thus, if
an FDA requirement is “a critical element” of a plaintiff’s tort
claim, the claim conflicts with the MDA’s enforcement scheme
and is impliedly preempted. (Buckman, at pp. 352-353.)
Together, express preemption under section 360k(a)
and implied preemption under section 337(a) and Buckman
create a “‘“‘narrow gap’ through which a state-law claim must fit
to [survive] preemption.”’” (Glennen, supra, 247 Cal.App.4th at p.
11.) The claim must be based on “‘“conduct that violates the
[MDA],”’” but the plaintiff cannot be “‘“suing because the conduct
violates the [MDA].”’” (Id. at pp. 11-12, original italics.) Thus,
“‘“to survive preemption, [a] claim[] ‘must be premised on conduct
that both (1) violates the [MDA] and (2) would give rise to a
recovery under state law even in the absence of the [MDA].’”’
[Citation.]” (Id. at p. 12.)
Manufacturing defect
Mize first contends the trial court erred when it
concluded that: (1) the MDA impliedly preempts her
manufacturing defect claims, and (2) the complaint fails to link
the alleged defects in her implants to her injuries. We agree.
11
1. Preemption
Mize’s manufacturing defect claims are premised, at
least in part, on Mentor’s alleged failure to comply with
manufacturing requirements imposed by the FDA. But it does
not follow that the claims “hinge entirely on conduct that
allegedly violated federal law,” as the trial court concluded. Mize
does not seek to enforce any exclusively federal requirement; her
claims are predicated on violations of state tort law. (Cf. Jiminez
v. Sears, Roebuck, & Co. (1971) 4 Cal.3d 379, 384-387 [California
recognizes negligence and strict liability claims of manufacturing
defects].) That these tort theories “impose[] obligations identical
to those imposed by the [FDA] . . . does not substantively
transform [Mize’s] action into one seeking to enforce federal law.”
(Farm Raised Salmon Cases (2008) 42 Cal.4th 1077, 1095.) Her
lawsuit would exist regardless of whether the FDA or some other
federal or state agency imposed the obligations. (Id. at pp. 1095-
1096.) There is thus no conflict with section 337(a), and no
implied preemption under Buckman. (Ibid.; see, e.g., Mink v.
Smith & Nephew, Inc. (11th Cir. 2017) 860 F.3d 1319, 1330
[manufacturing defect claims not impliedly preempted]; Bass v.
Stryker Corp. (5th Cir. 2012) 669 F.3d 501, 513-514 (Bass)
[same]; Bausch v. Stryker Corp. (7th Cir. 2010) 630 F.3d 546, 556-
558 (Bausch) [same].)
Glennen, supra, 247 Cal.App.4th 1, on which Mentor
relies, is not to the contrary. In Glennen, the plaintiff’s claim was
based on the defendant’s alleged failure to train physicians how
to use its product, as the FDA required. (Id. at p. 20.) But “there
is no state law duty that requires a medical device manufacturer
to offer a physician training program.” (Ibid.) The claim thus
“‘exist[ed] solely by virtue of [FDA] requirements’” and was
12
impliedly preempted. (Ibid.) Here, in contrast, Mentor had a tort
duty, under California law, to manufacture its breast implants in
compliance with FDA requirements. (Armstrong v. Optical
Radiation Corp. (1996) 50 Cal.App.4th 580, 595 (Armstrong).)
Evraets v. Intermedics Intraocular, Inc. (1994) 29
Cal.App.4th 779 (Evraets) does not suggest there is no such duty,
as Mentor asserts. That case involved claims based on
inadequate testing, defective design, and failure to warn, not
manufacturing defects. (Id. at p. 787.) “It is axiomatic that cases
are not authority for propositions . . . not considered.” (California
Building Industry Association v. State Water Resources Control
Board (2018) 4 Cal.5th 1032, 1043.) More significantly, Evraets
predated the U.S. Supreme Court’s decision in Medtronic, Inc. v.
Lohr (1996) 518 U.S. 470, 497-502 (Lohr), which held that the
MDA does not preempt state-law claims based on manufacturing
defects. Thus, to the extent Evraets suggested otherwise, it is no
longer good law. (Armstrong, supra, 50 Cal.App.4th at p. 596, fn.
13.) Mize’s claims are not impliedly preempted.
2. Causation
“[U]nder either a negligence or strict liability theory
of products liability, to recover from a manufacturer a plaintiff
must prove that a defect caused [their] injury.” (Merrill v.
Navegar, Inc. (2001) 26 Cal.4th 465, 479.) This requires showing
“some substantial link or nexus” between the alleged defect and
the injury. (Saelzler v. Advanced Group 400 (2001) 25 Cal.4th
763, 778.) At the pleading stage, the plaintiff need only allege “‘a
causal connection’” between the two. (Rannard, supra, 26 Cal.2d
at p. 156.) “‘Ordinarily that is accomplished by implication from
the juxtaposition of the allegations of wrongful conduct and
harm.’” (Christensen v. Superior Court (1991) 54 Cal.3d 868, 900
13
(Christensen).) It is only “‘where the pleaded facts of negligence
and injury do not naturally give rise to an inference of causation
[that] the plaintiff must plead specific facts affording an inference
the one caused the others.’ [Citation.]” (Id. at pp. 900-901.)
Mize sufficiently pled her manufacturing defect
claims. She alleged that in the years leading up to her implant
surgery Mentor failed to meet FDA-imposed manufacturing
quality standards, destroyed evidence of its implants’ high
rupture rates, sold contaminated implants, and failed to comply
with FDA-mandated design and materials specifications. She
alleged that she later suffered a number of ailments that
subsided once her implants were removed. That juxtaposition
naturally gives rise to an inference that Mentor’s alleged
manufacturing defects caused her injuries. (Christensen, supra,
54 Cal.3d at pp. 900-901.)
The trial court improperly refused to make this
inference. As part of the 1998 consent decree between Mentor
and the FDA, Mentor promised to remedy its alleged violations,
comply with federal law, and implement good manufacturing
practices. To the court below, this promise broke any causal
connection between Mentor’s manufacturing conduct and Mize’s
defective implants. But a company’s promise to do something
does not establish that it did so. The FDA’s 2003 nonopposition
to the consent decree’s dissolution similarly does not defeat an
inference of causation; it merely shows that the FDA believed
that Mentor remedied the problems, not that it did.
The trial court also faulted Mize for insufficiently
pleading how Mentor failed to comply with IDE requirements or
how that failure affected the manufacture of her implants. The
court required too much of Mize at the pleading stage. Under
14
California law, a plaintiff may allege facts “in a conclusory
fashion if their knowledge of the precise cause of injury is
limited.” (Bockrath v. Aldrich Chemical Co., Inc. (1999) 21
Cal.4th 71, 80 (Bockrath).) That is particularly true where, as
here, the “‘defendant has superior knowledge of the facts.’” (Doe
v. City of Los Angeles (2007) 42 Cal.4th 531, 549-550.)
“[I]n the context of Class III medical devices,” such as
Mentor’s MemoryGel breast implants, “much of the critical
information is kept confidential as a matter of federal law.”
(Bausch, supra, 630 F.3d at p. 560.) “An injured patient,” like
Mize, thus “cannot gain access to that information without
discovery” (ibid.), and cannot “fairly be expected to provide a
detailed statement of the specific bases for her claim” (id. at p.
558). She should not be required to meet a pleading standard
that identifies specific IDE requirements breached by Mentor
based on information available only to Mentor and the FDA.
(Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4th 413, 436
(Coleman); see Bockrath, supra, 21 Cal.4th at p. 82 [plaintiff
could pursue claim despite lack of knowledge of specific cause of
injury]; Bass, supra, 669 F.3d at p. 511 [requiring allegations
about confidential manufacturing processes “make[s] pleading a
parallel [state] claim regarding defective manufacturing nearly
impossible”].) The trial court erred when it sustained the
demurrer to Mize’s manufacturing defect claims because she
could not meet that standard.
Failure to warn
Mize next contends the trial court erred when it
concluded that: (1) her failure-to-warn claims were expressly
preempted, and (2) she did not sufficiently plead that Mentor’s
15
failure to report adverse events to the FDA caused her injuries.
We again agree.
1. Preemption
Mize’s failure-to-warn claims are based on Mentor’s
breach of its duty to report information about adverse events to
the FDA. During clinical testing pursuant to an IDE, if a
manufacturer evaluates unanticipated adverse events, it must
“report the results of [that] evaluation to the FDA.” (21 C.F.R.
§ 812.150(b)(1).) If the manufacturer later wins premarket
approval of its device, it must report to the FDA whenever the
device “[m]ay have caused or contributed to a death or serious
injury” or when it “[h]as malfunctioned and . . . would be likely to
cause or contribute to a death or serious injury[] if the
malfunction were to recur.” (21 C.F.R. § 803.50(a).) “A claim
based on the failure to warn the FDA of adverse events is not
preempted to the extent state tort law recognizes a parallel duty.”
(Jacob v. Mentor Worldwide, LLC (C.D.Cal. 2019) 393 F.Supp.3d
912, 925; see also Stengel v. Medtronic, Inc. (9th Cir. 2013) 704
F.3d 1224, 1233 (Stengel).) California law recognizes a
manufacturer’s duty to warn the FDA of adverse events.
(Coleman, supra, 223 Cal.App.4th at pp. 428-429.) Mize’s failureto-warn claims are thus not expressly preempted. (Id. at p. 428.)
Mentor counters that Mize’s claims do not survive
preemption because the authority on which Coleman relied is no
longer good law. In reaching its conclusion that the MDA does
not preempt a failure-to-warn claim, the Coleman court relied
largely on the Ninth Circuit’s decision in Stengel, supra, 704 F.3d
1224. (Coleman, supra, 223 Cal.App.4th at pp. 428-429.) That
case concluded that: (1) a state-law tort claim based on a
manufacturer’s failure to warn the FDA of problems with its
16
product is not preempted if state law recognizes a parallel duty,
and (2) Arizona law recognizes such a duty. (Stengel, at pp. 1232-
1233.) The Arizona Supreme Court subsequently rejected
Stengel’s latter conclusion: “[E]stablished law does not recognize
a claim merely for failing to provide something like adverse event
reports . . . to a government agency.” (Conklin v. Medtronic, Inc.
(Ariz. 2018) 431 P.3d 571, 579.)
But that does not mean that Coleman is no longer
good law in California. Conklin did not reject the Stengel court’s
framework that a claim based on a manufacturer’s failure to
warn of adverse events is not preempted if state law recognizes a
parallel duty; it simply rejected the conclusion that Arizona law
recognizes such a duty. Unlike Arizona, California does recognize
a duty to report adverse events to the FDA. Coleman thus
remains good law.
The trial court employed a different rationale than
Mentor, concluding that Mize’s failure-to-warn claims were
expressly preempted because she did not show that Mentor’s
failure to report adverse events violated any FDA requirement.
In reaching this conclusion, the court adopted the reasoning of
the federal district court in Ebrahimi v. Mentor Worldwide
LLC (C.D.Cal., May 25, 2018, No. CV 16-7316-DMG (KSX)) 2018
WL 2448095. But Coleman was binding on the court below.
(Auto Equity Sales, Inc. v. Superior Court (1962) 57 Cal.2d 450,
455.) Ebrahimi was not. (Johnson v. American Standard,
Inc. (2008) 43 Cal.4th 56, 69.) Moreover, in her complaint Mize
alleged that Mentor failed to report adverse events to the FDA, as
it was required to do in both the IDE clinical tests and the
postapproval studies. Because these allegations are based on a
duty that is not “different from, or in addition to, any [FDA]
17
requirement,” Mize’s failure-to-warn claims are not expressly
preempted.
2. Causation
To prevail on her failure-to-warn claims, Mize “‘will
ultimately have to prove that if [Mentor] had properly reported
the adverse events to the FDA as required under federal law,
that information would have reached [her] doctors in time to
prevent [her] injuries.’ [Citation.]” (Coleman, supra, 223
Cal.App.4th at pp. 429-430.) But at this stage, Mize need only
allege “‘a causal connection’” between Mentor’s failure to report
and her injuries. (Rannard, supra, 26 Cal.2d at p. 156.) Here,
Mize alleged that if Mentor complied with the reporting duties
required in the IDE and postapproval studies, a fuller picture of
the adverse events associated with its MemoryGel implants
would have been available to the FDA, which would have in turn
made that information available to Mize’s doctors via the
MAUDE database. Mize’s doctors would then have
communicated that information to Mize, who would have had her
implants removed earlier. Assuming these allegations are true,
they allege a sufficient causal connection between Mentor’s
failure to report and Mize’s injuries.
Mentor counters that Mize has not shown that
information about adverse events would have reached her doctors
in time to prevent her injuries. We conclude that her allegations
are sufficient.
First, while Mentor was required to report adverse
events to the FDA, the evidence attached to its demurrer showed
that for adverse events associated with implant ruptures it could
submit spreadsheet reports that would not be included in the
MAUDE database. But this ignores that Mentor was required to
18
provide individual medical device reports—which could be
included in the database—whenever one of its implants
contributed to a person’s death.
Second, Mentor claims that even if it had submitted
individual medical device reports, the FDA had discretion to not
include those reports in the database. (21 C.F.R. § 803.9(a); see
also Pinsonneault v. St. Jude Medical, Inc. (D. Minn. 2013) 953
F.Supp.2d 1006, 1016 [adverse events not “automatically” made
public].) But because the FDA regularly publishes such
information in the database, it is reasonable to infer that it would
have done so here. (See, e.g., Hughes v. Boston Scientific
Corp. (5th Cir. 2011) 631 F.3d 762, 770, fn. 5; Rosen v. St. Jude
Medical, Inc. (N.D.N.Y. 2014) 41 F.Supp.3d 170, 187.)
Finally, Mentor claims that even if it submitted
individual medical device reports about implant ruptures, and
even if the FDA would have exercised its discretion to include
that information in the MAUDE database, there is no evidence
that Mize’s doctors consulted the database when making
decisions about her implants and their removal. But Mize alleges
otherwise, and further claims that her doctors would have told
her of the information in the database. It is reasonable to infer
that they did review the database and would have provided that
information to Mize. (See, e.g., Gravitt v. Mentor Worldwide,
LLC (N.D.Ill. 2018) 289 F.Supp.3d 877, 891.)
“‘One of the dangers of winning on demurrer is that
you are stuck, on appeal, with your opponent’s version of the
facts.’” (Silguero v. Creteguard, Inc. (2010) 187 Cal.App.4th 60,
64.) Here, Mize’s version of the facts is sufficiently pled to
demonstrate a causal connection between Mentor’s reporting
failures and her delayed decision to remove her implants.
19
Whether Mize can ultimately prove those facts is of no concern to
us here. (Ibid.) A demurrer “‘may not be turned into a contested
evidentiary hearing’” into the “‘truthfulness or proper
interpretation’” of the evidence. (Ibid.) Because the trial court’s
decision reflects such a consideration of the evidence, it
erroneously sustained Mentor’s demurrer to Mize’s failure-towarn claims.
Negligence per se
Mize contends the trial court erred when it dismissed
her negligence per se claim since it is based on the same
allegations as her manufacturing defect and failure-to-warm
claims. She is correct.
Under the doctrine of negligence per se, negligence
will be presumed if: (1) a person violated a statute or regulation,
(2) that violation injured another person or their property, (3) the
injury was of a type the statute or regulation was designed to
prevent, and (4) the person or property injured was of the class
the statute or regulation was designed to protect. (Evid. Code,
§ 669, subd. (a).) Federal statutes, such as the FDCA or MDA,
and federal regulations, such as those imposed by the FDA, may
provide the applicable state standard of care, satisfying the first
of these requirements. (DiRosa v. Showa Denko K.K. (1996) 44
Cal.App.4th 799, 807; see Coleman, supra, 223 Cal.App.4th at p.
433; Evraets, supra, 29 Cal.App.4th at pp. 791-792.) State-law
tort claims that attempt to enforce these standards are not
expressly preempted since the state requirements are identical to
federal requirements. (Evraets, at p. 792; see § 360k(a) [only
state requirements that are “different from, or in addition to”
FDCA requirements are preempted].) Nor are such claims
impliedly preempted when the plaintiff attempts to enforce state
20
requirements that parallel federal law.5 (Coleman, supra, 223
Cal.App.4th at pp. 432-433.)
Here, Mize alleged that Mentor violated the MDA
and FDA-imposed requirements. She also alleged that Mentor’s
manufacturing defects and its failure to properly report adverse
events to the FDA caused her injuries. These injuries are clearly
those the MDA and FDA regulations sought to prevent, and Mize
is in the class the FDA sought to protect. She may therefore
pursue her negligence per se claim. (Coleman, supra, 223
Cal.App.4th at p. 433.)
Loss of consortium
Finally, Nguyen contends the trial court erroneously
sustained Mentor’s demurrer to his loss-of-consortium claim
because it was derivate of his wife’s claims. He is correct.
Because Mize sufficiently pled valid, non-preempted causes of
action, Nguyen’s loss-of-consortium cause of action remains
viable. (Armstrong, supra, 50 Cal.App.4th at p. 597; see Hahn v.
Mirda (2007) 147 Cal.App.4th 740, 746 [loss of consortium claims
“stands or falls” based on whether spouse suffered actionable
injury].)
5 We disagree with the pre-Lohr and other non-California
cases cited by Mentor that hold otherwise.

Outcome: The judgment is reversed, and the matter is remanded to the trial court with directions to enter an order overruling the demurrer to the third amended complaint. Mize and Nguyen shall recover their costs on appeal.

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