The opinion
Filed 4/29/16
CERTIFIED FOR PUBLICATION
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
FIRST APPELLATE DISTRICT
DIVISION ONE
ASHLEY GLENNEN,
Plaintiff and Appellant,
A145367
v.
ALLERGAN, INC., (San Francisco County
Super. Ct. No. CGC-12-524762)
Defendant and Respondent.
Plaintiff Ashley Glennen sued defendant Allergan, Inc. (Allergan),1 alleging she
suffered complications after Allergan’s LAP-BAND Adjustable Gastric Banding System
(Lap-Band) was surgically implanted in her body. She appeals from the judgment
rendered after the trial court sustained Allergan’s demurrer to her second amended
complaint (SAC) without leave to amend. She contends the court erred in concluding her
claim that Allergan failed to adequately train physicians in the use of the Lap-Band is
preempted by federal law. We affirm.
FACTUAL BACKGROUND AND PROCEDURAL HISTORY
We take the factual material from plaintiff’s SAC and from matters subject to
judicial notice. BioEnterics was a subsidiary of Inamed Corporation, a company that
merged with Allergan in 2006. In March 2000, BioEnterics applied for Food and Drug
Administration (FDA) premarket approval to manufacture and market the Lap-Band.
The Lap-Band “is designed to induce weight loss in severely obese patients by limiting
food consumption. The band’s slip-through buckle design eases laparoscopic placement
around the stomach, allowing the formation of a small gastric pouch and stoma.”
1
Plaintiff also sued two doctors and a surgical center. These defendants have since been
dismissed and are no longer parties to this lawsuit.
BioEnterics’ application was based on the Lap-Band’s designation as a Class III device
under the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA).
(52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq.)
BioEnterics received premarket approval for the Lap-Band on June 5, 2001. In the
letter notifying BioEnterics of this approval, the FDA indicated that the Lap-Band’s
labeling must “specify the requirements that apply to the training of practitioners who
may use the device as approved in this order . . . .” A brochure prepared by BioEnterics
provides that surgeons planning laparoscopic placement must, among other things,
“[h]ave extensive advanced laparoscopic experience . . .[;] [¶] [h]ave previous
experience in treating obese patients and have the staff and commitment to comply with
the long-term follow-up requirements of obesity procedures[;] [¶] [p]articipate in a
training program for the LAP-BAND System authorized by BioEnterics Corporation or
an authorized BioEnterics distributor (this is a requirement for use).” The brochure also
states that surgeons were required to be observed by “qualified personnel” during their
first band placements, to have the equipment and experience necessary to complete the
procedure via laparotomy if required, and to report on their personal experiences using
the device.2 Furthermore, the FDA approval letter obligated the manufacturer to “include
annual progress reports on the postapproval study that you agreed to conduct to gather
long-term safety and effectiveness data on the subject device. You agreed to continue
follow-up on subjects enrolled under protocol A and protocol B of your investigative
study. These post-approval subjects must be followed for a total of 5 years from the time
of implantation.” (Italics added.)
In January 2003, plaintiff underwent a surgical procedure to implant a Lap-Band.
The Lap-Band eventually eroded into both her stomach and her liver. The erosion into
the stomach caused a portion of her stomach to die. Additionally, the tubing attached to
the Lap-Band became entangled with her small intestine, resulting in the death of a
portion of her small intestine. The erosion into the liver caused the Lap-Band to become
2
The complete brochure drafted by the manufacturer and referenced by the FDA in its
approval letter is included in this record.
2
firmly adhered to her liver. During surgery to remove the Lap-Band she suffered a
massive hemorrhaging from her liver, causing her to experience profound hypotension
and systemic shock.3 As a result, plaintiff suffered brain damage.
In September 2012, more than nine years after the procedure, plaintiff filed a
complaint alleging several causes of action against Allergan and other defendants.
In December 2012, plaintiff filed a first amended complaint.
On April 12, 2013, plaintiff filed her SAC, alleging a single cause of action
against Allergan for negligence.
On July 9, 2013, the trial court granted Allergan’s demurrer to the SAC without
leave to amend.
On April 14, 2015, judgment after demurrer was entered in favor of Allergan.
Notice of entry of judgment was served on May 19, 2015. Plaintiff thereafter filed a
timely appeal.
DISCUSSION
I. Standard of Review
“ ‘We apply a de novo standard of review because this case was resolved on
demurrer [citation] and because federal preemption presents a pure question of law
[citation].’ [Citation.] ‘In ruling on a demurrer, the “allegations [of the complaint] must
be liberally construed, with a view to substantial justice between the parties.” ’ ”
(Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4th 413, 421–422 (Coleman).)
II. Federal Regulation of Class III Medical Devices
A. The Medical Device Amendments of 1976
This case, asserting injuries allegedly stemming from an FDA-approved medical
device, arises within a complex and highly regulated area of federal law pursuant to
which the contours of permissible private enforcement suits are carefully circumscribed.
The starting point is the federal Medical Device Amendments of 1976 (MDA), title 21
3
The SAC does not indicate when this surgery occurred.
3
United States Code section 360c et seq.,4 which imposed a “regime of detailed federal
oversight” over the market for medical devices. (Riegel v. Medtronic, Inc. (2008)
552 U.S. 312, 316 (Riegel).) Regulation of medical devices, an expansive field
encapsulating everything from “ ‘bedpans to brainscans’ ” (Medtronic, Inc. v. Lohr
(1996) 518 U.S. 470, 476 (Lohr)), had traditionally been left largely to state supervision.
However, rapid technological change and highly publicized instances of medical device
failure led many to doubt the ability of the “common-law tort system to manage the risks
associated with dangerous devices.” (Riegel, at p. 315.) In response to this “mounting
consumer and regulatory concern” (Lohr, at p. 476), Congress entered the field and
enacted the MDA, which “intentionally ‘swept back some state obligations’ in favor of
uniform federal regulation.” (Walker v. Medtronic, Inc. (4th Cir. 2012) 670 F.3d 569,
572, quoting Riegel, at p. 316.)
The MDA utilized a two-pronged approach to achieve its purpose. On the one
hand, it imposed an intricate regulatory scheme to increase oversight and promote
uniformity at the federal level. Correspondingly, as will be discussed below, it
eliminated the potential for state enforcement interference by enacting an express
preemption clause. (See § 360k.)
B. Classification System for Medical Devices
A key feature of the federal scheme is a graduated classification system designed
to tailor the level of FDA oversight to the safety risks posed by a given medical device;
the higher the safety risk, the more regulatory requirements apply. (See § 360c(a)(1).)
Class I devices present the lowest safety risk and accordingly are subject only to
“ ‘general controls,’ ” such as labeling requirements, imposed by the FDCA and the
regulations promulgated pursuant to its authority. (Riegel, supra, 552 U.S. at p. 316.)
Such devices need not adhere to device-specific regulations because general quality
controls, applicable to “all finished devices intended for human use” (21 C.F.R. § 820.1)
4
Unqualified section 360 et seq. numbers hereinafter refer to sections of title 21 of the
United States Code.
4
are “sufficient to provide reasonable assurance of the safety and effectiveness of the
device.” (§ 360c(a)(1)(A)(i).)
The safety and effectiveness of Class II devices cannot be guaranteed by these
generally applicable controls, and so these devices require further oversight, including
device-specific “special controls,” such as the promulgation of performance standards,
postmarket surveillance, patient registries, and the dissemination of guidelines.
(§ 360c(a)(1)(B).) Where not even such special controls can ensure the device’s safety,
and where the device is either useful in supporting or sustaining human life, substantially
important in preventing the impairment of human health, or presents an unreasonable risk
of illness or injury, the device is given a Class III classification. (§ 360c(a)(1)(C).)
Because of the risks associated with them, new Class III devices are required to go
through a premarket approval (PMA) process “to provide reasonable assurance of [their]
safety and effectiveness.” (Ibid.)
C. Premarket Approval Process
Premarket approval is a “ ‘rigorous process’ ” (Riegel, supra, 552 U.S. at p. 317),
designed to fully vet and secure safety and effectiveness before a new Class III device
may be introduced to the market. (Lohr, supra, 518 U.S. at p. 477.) The PMA process
for new devices is governed by section 360e, as well as regulations promulgated under its
authority. Where PMA is required, the device’s proponent must file with the FDA an
application providing a wide variety of information: reports of all investigations into the
safety and effectiveness of the device, a statement of its components, a full description of
the methods used to manufacture and produce the device, device samples, and specimens
of proposed labeling. (§ 360e(c)(1).) This application process typically requires a
“multivolume application.” (Riegel, at p. 317.) The FDA review of each submission
generally entails an average of 1,200 hours of study before possible approval. (Lohr, at
p. 477.) Within 180 days of receipt of such application, the FDA is required to make a
decision regarding approval. The FDA will grant premarket approval only if it finds that
there is “ ‘reasonable assurance’ ” of the device’s safety and effectiveness.
(§ 360e(d)(A)(ii); Riegel, at p. 318.)
5
The FDA has broad authority to condition its approval in a number of ways,
including requiring that the device meet formal performance standards (21 C.F.R.
§ 861.1(b)(3)), or any other postapproval requirement “necessary to provide reasonable
assurance, or continued reasonable assurance, of the safety and effectiveness of the
device.” (21 C.F.R. § 814.82(a)(9).) These postapproval requirements can include
restrictions on the sale, distribution, or use of the device, continuing reporting and
recordkeeping requirements, and requirements related to labeling and advertising of the
restricted device. (21 C.F.R. § 814.82(a)(1)-(3).)
Moreover, the FDCA and its accompanying regulations impose continuing
requirements on medical devices and their manufacturers after they receive PMA. These
include a general obligation to inform the FDA about the known adverse consequences of
the device. The rigorous oversight regime following approval also generally subjects
approved medical devices to continuing recording and reporting requirements, including
the obligation to inform the FDA of new clinical investigations or scientific studies
concerning the device of which the manufacturer knows or reasonably should know, and
the obligation to report incidents in which the device may have caused or contributed to
death or serious injury, or malfunctioned in a manner that would likely cause or
contribute to death or serious injury were it to recur. (§ 360i; 21 C.F.R. §§ 814.84(b)(2),
803.50(a); Riegel, 552 U.S. at p. 319.)
III. Federal Preemption.
The Supremacy Clause provides that the laws of the United States “shall be the
supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.” (U.S. Const., art. VI, cl. 2.) “Consistent with that [clause’s]
command, . . . state laws that conflict with federal law are ‘without effect. . .’ ”— they
are preempted. (Altria Group, Inc. v. Good (2008) 555 U.S. 70, 76, quoting Maryland v.
Louisiana (1981) 451 U.S. 725, 746.) Preemption can occur either expressly or
impliedly. Express preemption occurs when Congress “define[s] explicitly the extent to
which its enactments pre-empt state law.” (English v. General Electric Co. (1990)
496 U.S. 72, 78.) Implied preemption occurs: (1) when state law “regulates conduct in a
6
field that Congress intended the Federal Government to occupy exclusively[,]” or
(2) when state law “actually conflicts with federal law[,]” which exists “where it is
impossible for a private party to comply with both state and federal requirements,
[citation], or where state law ‘stands as an obstacle to the accomplishment and execution
of the full purposes and objectives of Congress.’ ” (Id. at p. 79.)
A. Express Preemption
The MDA contains an express preemption provision for medical devices, which
provides that “no 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 Act 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 Act.”
(21 U.S.C. § 360k(a) (§ 360(k)(a).) Thus, “the MDA expressly pre-empts only state
requirements ‘different from, or in addition to, any requirement applicable . . . to the
device’ under federal law.” (Riegel, supra, 552 U.S. at p. 321.)
In Riegel, the Supreme Court examined whether the MDA preempted state-law
claims regarding an allegedly defective medical device. In doing so, the court set forth a
two-part test to determine whether the state-law claim was preempted. Specifically, the
court held that preemption under section 360k(a) applies if (1) the federal government
established requirements applicable to the medical device in question, and (2) the state-
law claims concerning the device are based on requirements that are “ ‘different from, or
in addition to’ ” the federal requirements, and relate to the safety and effectiveness of the
device. (Riegel, supra, 552 U.S. at pp. 321–322.) The first prong is automatically
satisfied if the FDA authorizes commercial distribution of a Class III medical device
following the PMA process. (Id. at pp. 322–323.)
The Riegel court also affirmed that court’s earlier holding in Lohr, supra, 518 U.S.
470, that section 360k(a) “does not prevent a State from providing a damages remedy for
claims premised on a violation of FDA regulations” because “the state duties in such a
case ‘parallel,’ rather than add to, federal requirements.” (Riegel, supra, 552 U.S. at
7
p. 330.) The Ninth Circuit Court of Appeals has confirmed that “the MDA does not
preempt a state-law claim for violating a state-law duty that parallels a federal-law duty
under the MDA.” (Perez v. Nidek Co. (9th Cir. 2013) 711 F.3d 1109, 1117 (Perez),
quoting Stengel v. Medtronic, Inc. (9th Cir. 2013) 704 F.3d 1224, 1228 (en banc)
(Stengel), cert. denied by Medtronic Inc. v. Stengel (2014) ___ U.S. ___ [134 S.Ct. 2839,
189 L.Ed.2d 805].)5 In Wolicki-Gables v. Arrow International, Inc. (2011) 634 F.3d
1296, the Eleventh Circuit explained: “ ‘In order for a state requirement to be parallel to
a federal requirement, and thus not expressly preempted under section 360k(a), the
plaintiff must show that the requirements are “genuinely equivalent.” State and federal
requirements are not genuinely equivalent if a manufacturer could be held liable under
the state law without having violated the federal law.’ ” (Id. at p. 1300, quoting
McMullen v. Medtronic, Inc. (7th Cir. 2005) 421 F.3d 482, 489.) If state law liability
could be found notwithstanding compliance with the federal requirements, those state law
duties are not parallel to the federal requirements and will be preempted. (See Riegel,
552 U.S. at p. 328.)
B. Implied Preemption
Even if a plaintiff’s claim is not expressly preempted, it will be deemed impliedly
preempted if it conflicts with the FDCA’s enforcement scheme. Implied preemption
under the MDA bars claims seeking to enforce an exclusively federal requirement that is
not grounded in traditional state tort law. Claims not tied to state law tort duties are
essentially private actions to enforce the FDCA and are barred by 21 U.S.C. section
5
In Stengel, the court “clarified preemption law under the MDA.” (Stengel, supra,
704 F.3d at p. 1233.) There, the plaintiffs’ proposed negligence claim for failure to warn
the FDA about certain risks associated with a device was found not to be preempted
“insofar as the state-law duty parallels a federal-law duty under the MDA.” (Ibid.) In a
concurring opinion joined by six other judges, Judge Watford explained that had the
plaintiffs predicated their claim on a failure to warn doctors directly—an action not
required by FDA regulations—that claim would have been preempted because it would
have been an addition to the federal requirement. (Stengel, at p. 1234 (conc. opn. of
Watford, J.).)
8
337(a), a provision authorizing the federal government to enforce the MDA.6 “The FDA
is responsible for investigating potential violations of the FDCA, and the Act provides the
agency with a range of enforcement mechanisms, such as injunction proceedings, civil
and criminal penalties, and seizure. [Citations.] Although citizens may petition the FDA
to take administrative action, [citations], private enforcement of the statute is barred: ‘all
such proceedings for the enforcement, or to restrain violations, of [the Act] shall be by
and in the name of the United States.’ ” (Perez, supra, 711 F.3d at p. 1119.)
In Buckman Co. v. Plaintiffs’ Legal Committee (2001) 531 U.S. 341, 343
(Buckman), individuals who claimed to have been injured by the implantation of
orthopedic bone screws brought state tort claims alleging that the manufacturer’s
consultant had made fraudulent representations to the FDA while seeking approval to
market the screws. The court concluded claims that a device manufacturer had made
fraudulent representations to the FDA were “inherently federal in character” because the
relationship between the manufacturer and the FDA “originates from, is governed by, and
terminates according to federal law.” (531 U.S. at pp. 347.) The court held such “fraud-
on-the-FDA” claims were impliedly preempted (id. at p. 348) because they “exist solely
by virtue of the FDCA disclosure requirements” (id. at p. 353). Although common-law
claims for fraud are a traditional feature of state common law, the case at issue did not
implicate “ ‘federalism concerns and the historic primacy of state regulation of matters of
health and safety . . . .’ ” (Id. at p. 348, citing Lohr, supra, 518 U.S. at p. 485.) The court
observed that the consulting company’s “dealings with the FDA were prompted by the
MDA, and the very subject matter of [the company’s] statements were dictated by that
statute’s provisions.” (Buckman, at pp. 347–348.)
6
Title 21 United States Code section 337(a) provides, in part: “[A]ll such proceedings for
the enforcement, or to restrain violations, of this Act [21 USCS §§ 301 et seq.] shall be
by and in the name of the United States. . . .”
9
IV. Application
A. The Narrow Gap
“Together, express preemption and implied preemption identify a ‘ “narrow gap”
through which a state-law claim must fit to escape preemption.’ [Citation.] ‘The plaintiff
must be suing for conduct that violates the FDCA (or else his claim is expressly
preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates
the FDCA (such a claim would be impliedly preempted under Buckman).’ [Citations.]
Thus, to avoid preemption, a plaintiff must assert a state-law claim that is premised on a
violation of law, but that is not based solely on such violation.” (Beavers-Gabriel v.
Medtronic, Inc. (D. Hawaii 2014) 15 F.Supp.3d 1021, 1032.) Stated another way, “ ‘[i]n
order to survive preemption, such claims “must be premised on conduct that both
(1) violates the FDCA and (2) would give rise to a recovery under state law even in the
absence of the FDCA.” ’ ” (Scanlon v. Medtronic Sofamor Danek USA Inc. (D. Del.
2014) 61 F.Supp.3d 403, 411.)
B. Whether Plaintiff Has Alleged a Violation of the FDCA
1. Cases Finding State Law Claims that Parallel Federal Regulations
Applying this framework, we first consider whether plaintiff’s negligence claim is
expressly preempted under the test outlined in Riegel, supra, 552 U.S. 312. Plaintiff
asserts her negligence action parallels FDA regulations and is not preempted because it is
not “different from or in addition to” federal requirements. The cases she relies on,
however, are readily distinguishable on their facts.
Plaintiff first cites to Bausch v. Stryker (7th Cir 2010) 630 F.3d 546 (Bausch). In
that case, a plaintiff sued claiming she was injured by a hip replacement manufactured in
violation of federal law. (Id. at p. 549.) The court concluded her state law claim for
defective manufacture was not expressly preempted by section 360k(a). The court
reasoned that section 360k(a) provides immunity for manufacturers of Class III medical
devices to the extent that these manufacturers comply with federal law, but it does not
protect them if they have violated federal law. Thus, if a plaintiff can prove his or her
harm was caused by a violation of federal law, the state law claim would not impose on
10
manufacturers any requirement “ ‘different from, or in addition to, any requirement’ ”
imposed by federal law. Accordingly, the plaintiff’s manufacturing defect claim in
Bausch was not preempted. (Bausch, at p. 553.) In the present case, however, plaintiff
does not allege that the Lap-Band contained any manufacturing defects. Instead, she
asserts Allergan provided inadequate training to the surgeon who installed her Lap-Band.
Thus, Bausch is not on point.
Plaintiff next cites to Hughes v. Boston Scientific Corp. (5th Cir. 2011) 631 F.3d
762 (Hughes). There, the plaintiff sued after she was injured by a medical device
designed to treat excess uterine bleeding. (Id. at pp. 764–765.) The court found her state
law claim for failure to warn was not preempted “to the extent she asserts that [the
defendant] violated the state duty to warn by failing to accurately report serious injuries
and malfunctions of the [medical] device as required by the FDA’s [Medical Device
Reporting] regulations.” (Id. at p. 770.) Specifically, “[a] factfinder could infer that a
manufacturer’s failure to provide this information as required by FDA regulations is a
parallel violation of the state duty to provide reasonable and adequate information about a
device’s risks.” (Id. at pp. 770–771.) The court concluded such a claim “does not
impose additional or different requirements to the federal regulations, but is parallel to
the federal requirements.”7 (Id. at p. 771.) In the present case, plaintiff is not asserting a
state law failure to warn claim arising out of a failure to report serious injuries or
malfunctions as required by FDA regulations. Thus, Hughes is distinguishable.
Plaintiff also cites to Bass v. Stryker Corp. (5th Cir. 2012) 669 F.3d 501, 510
(Bass), another case in which the plaintiff, as in Bausch, alleged a state law
manufacturing defect claim regarding a hip replacement that malfunctioned and caused
injury. (Id. at p. 505.) The appellate court in Bass concluded the operative complaint
sufficiently pleaded parallel claims to the extent that the claims were based upon
7
The appellate court also found the plaintiff’s failure to warn claim was not impliedly
preempted under Buckman, supra, 531 U.S. 431, because it was not analogous to the
“fraud-on-the-FDA” theory that was at issue in Buckman. (Hughes, supra, 631 F.3d at
pp. 775–776.)
11
manufacturing defects resulting from violations of federal regulations. (Id. at p. 510.)
Again, no such claim is at issue here.
Finally, plaintiff relies on Stengel, supra, 704 F.3d 1109. Like Hughes, supra,
631 F.3d 762, Stengel is a failure to warn case. The device at issue in Stengel was a
surgically implanted spine pain pump. The manufacturer was allegedly aware of certain
risks at that time, but failed to report these risks to the FDA as was required by the MDA.
(Stengel, at p. 1227.) Citing Hughes and to Bausch, supra, 430 F.3d 546, the court in
Stengel concluded the plaintiff’s failure to warn claim rested “on a state-law duty that
parallels a federal-law duty under the MDA, as in Lohr[, supra, 518 U.S. 470].” (Stengel,
at p. 1233.) As such, the claim was not preempted. Again, plaintiff’s complaint
regarding the Lap-Band does not allege a failure to warn. Moreover, plaintiff does not
cite to any case in which a plaintiff has successfully maintained a state-law negligence
claim based on a manufacturer’s alleged failure to adequately train physicians in the use
of any medical device, let alone a Class III device that has undergone the PMA review
process.8
Plaintiff does not articulate any facts in the SAC tying Allergan’s alleged
negligence to her surgeon’s implantation of the Lap-Band device. Rather than discuss
specific features of the Allergan brochure and/or training protocols that were approved in
the extensive PMA review by the FDA, the SAC contains a narrative of what her surgeon
did incorrectly. However, physician error is not enough to support a claim against a
manufacturer for improper training or marketing of an approved Class III device. As was
noted by one court: “The only decision that has considered a failure-to-train claim in this
context held that claim survived preemption only to the extent the manufacturer failed to
8
Plaintiff also relies on two federal district court cases, and on Coleman. Eidson v.
Medtronic, Inc. (N.D. Cal. 2014) 40 F.Supp.3d 1202, 1223, concerned allegations of
fraud, negligent misrepresentation, strict liability failure to warn, negligent failure to
warn, loss of consortium. Hawkins v. Medtronic, Inc. (E.D. Cal. 2014) 62 F.Supp.3d
1144, 1147 concerned claims for fraud, failure to warn, misrepresentation, and
negligence. Coleman involved claims for failure to warn, negligence, and manufacturing
defect. (Coleman, supra, 223 Cal.App.4th at p. 421.) None of these cases involved a
failure to adequately train physicians in the use of the allegedly faulty device.
12
provide the training required by the premarket approval process.” (De La Paz v. Bayer
HealthCare LLC (N.D.Cal. 2016) 2016 U.S. Dist. LEXIS 13058, p. *23 (Alsup J.).) The
SAC here does not identify where the training provided by Allergan deviated from what
the FDA required.
In this regard we are concerned about the realities of the manufacturer/physician
distinction. We review below the several cases that have indicated the specific
procedures used in the practice of medicine by a professional are not part of the
manufacturer regulation process. (See post, pp. 21–22.) The PMA process does not
obligate Allergan and like manufacturers to follow their products into the surgery room.
As one commentator has observed in this regard: “The practice of medicine doctrine
traces its roots to the concept of federalism, the division of powers between the federal
government and the states. Historically, medical practice has been a local matter, largely
regulated through state licensure of healthcare professionals. Courts have concluded that
Congress recognized and supported this concept in its enactment of the FDCA.
[¶] . . . [¶] The practice of medicine doctrine was articulated explicitly in the FDAMA,
the most recent amendments to the FDCA. . . . [¶] . . . [¶] ‘Nothing in this Chapter shall
be construed to limit or interfere with the authority of a health care practitioner to
proscribe or administer any legally marketed device to a patient for any condition or
disease within a legitimate health care practitioner-patient relationship.’ ” (Smith,
Physician Modification of Legally Marketed Medical Devices: Regulatory Implications
Under the Federal Food, Drug, and Cosmetic Act (2000) 55 Food Drug L.J. 245, 251–
252, italics added, fns. omitted (citing 21 U.S.C. § 396).)
2. Plaintiff’s Claim Does Not Parallel Any Federal Regulation
In an apparent effort to align her claim with a violation of federal law, plaintiff’s
SAC alleges violations of several federal provisions contained in the FDA’s “Quality
System Regulation.” (21 C.F.R. § 820 et seq.) Because none of the regulations on which
she relies references any requirement to train physicians in the use of a medical device,
her allegations fail to state a parallel claim.
13
C. Current Good Manufacturing Practice Requirements
Medical devices in general, including Class III devices, are subject to the FDA’s
current good manufacturing practice (CGMP) requirements. (§ 360j(f); 21 C.F.R. § 820
et seq.). These CGMP requirements, promulgated under the authority of several MDA
provisions, are located within the Quality System Regulation, which applies to all
medical devices. (See 21 C.F.R. § 820.1.) The requirements are applicable to “any
finished device, as defined in this part, intended for human use.” (21 C.F.R.
§ 820.1(a)(2).) Though not sufficient to ensure the safety and effectiveness of Class III
devices, CGMP requirements are nonetheless applicable to such devices. (Bausch, supra,
630 F.3d 546 at p. 554.) This remains true, “[e]ven after PMA is granted” (Elmore v.
Smith & Nephew, Inc. (N.D. Ill. Apr. 19, 2013) No. 12 C 8347, 2013 WL 1707956,
p. *1).
The stated purpose of the CGMP requirements is to “govern the methods used in,
and the facilities and controls used for, the design, manufacture, packaging, labeling,
storage, installation, and servicing of all finished devices intended for human use.”
(21 C.F.R. § 820.1(a)(1).) To comply with CGMP requirements, a device manufacturer
must adopt a variety of procedures and controls relating to areas such as: (1) design
control, (2) quality assurance, (3) manufacturing and processing, (4) process validation,
(5) device inspection, and (6) corrective and preventive action. (21 C.F.R. §§ 820.1–
.250).
Courts “are not in complete agreement as to what constitutes a sufficient pleading
with regard to a CGMP.” (Bass, supra, 669 F.3d 501, 511–512, and cases cited.) Some
cases hold that CGMPs cannot be used as a basis for state law parallel claims: “It has
been recognized that these standards ‘are intended to serve only as “an umbrella quality
system” providing “general objectives” medical device manufacturers must seek to
achieve.’ [Citations.] These regulations are purposefully broad so as to apply to a broad
range of medical devices. The regulations are to be tailored by each manufacturer of a
device to apply to their particular safety and efficacy needs. [Citation.] The intentionally
vague and open-ended nature of the regulations relied upon is the precise reason why
14
they cannot serve as the basis for a parallel claim. Since these regulations are open to a
particular manufacturer’s interpretation, allowing them to serve as a basis for a claim
would lead to differing safety requirements that might emanate from various lawsuits.
This would necessarily result in the imposition of standards that are ‘different from, or in
addition to’ those imposed by the MDA—precisely the result that the MDA preemption
provision seeks to prevent. [Citations.] Accordingly, where, as here, a plaintiff relies on
nothing more than CGMP’s in support of a parallel cause of action, preemption bars the
claim.” (Ilarraza v. Medtronic, Inc. (E.D.N.Y. 2009) 677 F.Supp.2d 582, 588.)
Other courts appear to agree that CGMPs constitute generally applicable federal
“requirements.” For example, the court in Bausch, supra, 630 F.3d 546 stated: “Section
360k makes preemption a defense if a state seeks to impose on a manufacturer ‘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.’ [Citing § 360k(a).] We emphasize the phrase ‘any requirement.’ And federal
law is clear: for manufacturers of Class III medical devices, the Quality System
Regulations and Current Good Manufacturing Practices adopted by the FDA under its
delegated regulatory authority are legally binding requirements ‘under this chapter.’
[Citation.] ‘The failure to comply with any applicable provision in this part [of the
regulations] renders a device adulterated . . . . Such a device, as well as any person
responsible for the failure to comply, is subject to regulatory action.’ ” (Bausch, at
p. 555.)
D. CGMPs Do Not Apply to Physician Training Programs
Assuming CGMPs can form the basis of a “parallel” claim, we note that while
21 C.F.R. section 820.1(a)(1) indicates that CGMPs have broad application, the
regulations themselves operate in the context of product manufacturing: “Current good
manufacturing practice . . . requirements are set forth in this quality system regulation.
The requirements in this part govern the methods used in, and the facilities and controls
15
used for, the design, manufacture, packaging, labeling, storage, installation,[9] and
servicing of all finished devices intended for human use. The requirements in this part
are intended to ensure that finished devices will be safe and effective and otherwise in
compliance with the [FDCA].” (Italics added; see also Deka Internat. S.A. v. Genzyme
Corp. (1st Cir. Mass. 2014) 754 F.3d 31, 35 [“The FDA routinely conducts inspections
to determine if facilities are complying with Current Good Manufacturing Practices . . .
standards for biologics manufacturers.” (Italics added.)])
In her SAC, plaintiff alleges Allergan “failed to adopt and implement current good
manufacturing practices,” including failing “to adopt and implement a quality policy as
required by 21 C.F.R. § 820.20(a) and a quality system as required by 21 C.F.R. [§] 820.5
that were adequate and appropriate for the training of surgeons in implanting Lap-Bands
in compliance with the conditions imposed by the FDA in granting pre-market approval
for the Lap-Band.” She also asserts Allergan violated 21 Code of Federal Regulations
section 820.20(b)(2) by failing “to devote adequate resources to its Lap-Band surgeon
training program to ensure that surgeons who completed the program were skilled in the
implantation of Lap-Bands.” She further claims Allergan violated 21 Code of Federal
Regulations section 820.22 by failing to conduct adequate and appropriate quality audits
“to assure that its quality system for its Lap-Band training program was in compliance
with its established quality system requirements and to determine the effectiveness of its
quality system.” While these regulations could potentially support a negligence claim
based on a design or manufacturing defect, we see nothing in the language of these four
provisions to suggest that they are intended to address the quality of a manufacturer’s
physician training program.
21 Code of Federal Regulations section 820.5 provides: “Each manufacturer shall
establish and maintain a quality system that is appropriate for the specific medical
9
Plaintiff does not contend “installation” equates with the surgical implantation of a
device in a human body.
16
device(s) designed or manufactured, and that meets the requirements of this part.”10
(Italics added.) 21 Code of Federal Regulations section 820.20, by its terms, pertains to
“[m]anagement responsibility.” Subdivision (a) of that section states: “Management
with executive responsibility shall establish its policy and objectives for, and
commitment to, quality.[11] Management with executive responsibility shall ensure that
the quality policy is understood, implemented, and maintained at all levels of the
organization.”12 Section 820.20(b)(2) does contain a reference to training; however, it
pertains to the training of a manufacturer’s own personnel. It states that manufacturers
“shall provide adequate resources, including the assignment of trained personnel, for
management, performance of work, and assessment activities, including internal quality
audits, to meet the requirements of this part.” (Italics added.)
Finally, 21 Code of Federal Regulations section 820.22 provides, in part: “Each
manufacturer shall establish procedures for quality audits and conduct such audits to
assure that the quality system is in compliance with the established quality system
requirements and to determine the effectiveness of the quality system.” “Quality audit” is
defined as: “a systematic, independent examination of a manufacturer’s quality system
that is performed at defined intervals and at sufficient frequency to determine whether
both quality system activities and the results of such activities comply with quality
system procedures, that these procedures are implemented effectively, and that these
procedures are suitable to achieve quality system objectives.” (21 C.F.R. § 820.3(t).)
10
21 Code of Federal Regulations section 820.3(v) defines “quality system” as “the
organizational structure, responsibilities, procedures, processes, and resources for
implementing quality management.”
11
21 Code of Federal Regulations section 820.3(s) defines “quality” as “the totality of
features and characteristics that bear on the ability of a device to satisfy fitness-for-use,
including safety and performance.” (Italics added.)
12
21 Code of Federal Regulations section 820.3(u) defines “quality policy” as “the
overall intentions and direction of an organization with respect to quality, as established
by management with executive responsibility.”
17
Whatever else this regulatory language may mean, nothing suggests that it pertains to
training programs for surgeons who implant medical devices.13
Case law supports our conclusion that CGMPs apply to the manufacturing process
only. In Bass, the Fifth Circuit held the plaintiff could state a claim based on violation of
the CGMPs. In that case, part of a hip replacement had allegedly failed to attach
correctly due to impurities in the manufacturing process. The plaintiff asserted the
defendant manufacturer had violated the manufacturing or sterilization procedures that it
had adopted to fulfill the CGMPs. In that case, the court noted the FDA itself had found
the defendant in violation of the CGMPs, suggesting that the federal regulations “are not
so vague that they ‘[do] not spell out standards that the court could enforce.’ ” (Bass,
supra, 669 F.3d at p. 513.) The court held the plaintiff’s reliance, in part, on the CGMPs
did “not preclude him from having effectively alleged a parallel claim.” (Ibid.) Again,
the present case does not concern a defect occurring during the manufacturing process of
the Lap-Band. Plaintiff’s reliance on the CGMPs is therefore inapposite.
That the language of the CGMPs does not suggest the existence of any physician
training protocols is not surprising. As the court in Buckman observed, “the FDCA
expressly disclaims any intent to directly regulate the practice of medicine . . . .”14
(Buckman, supra, 531 U.S. at p. 351, italics added.) We also observe imposing
performance standards on the training of physicians in the use of a Class III device would
13
In the SAC, plaintiff also alleges the Lap-Band implanted in her violated section
502(q) of the 1976 Amendments, title 21 United States Code section 352(q), which
governs the FDA’s authority to regulate restricted device advertising. Under section
502(q), a restricted device is misbranded if its advertising is false or misleading in any
particular. She does not cite to any case allowing a private cause of action under this
section and our research has not located any such case.
14
In her reply brief, plaintiff cites section 360j(e)(1), which provides, in part, that the
FDA “may restrict the use of a device to persons with specific training or experience in
its use . . . unless the Secretary determines that such a restriction is required for the safe
and effective use of the device.” She asserts this statute operates to apply the quality
system regulation to physician training requirements. We disagree. The section merely
allows the FDA to impose device-specific restrictions by regulation. (See Riegel, supra,
552 U.S. at p. 319.) It does not reference any standards for the “specific training” that
persons using a restricted device must possess.
18
tend to increase the burden facing potential applicants. Plaintiff effectively seeks to write
in a new provision to the FDCA, namely, that medical device companies who are
required to provide training to physicians as a condition of premarket approval must
insure such training is designed to satisfy the standard of care applicable to medical
malpractice actions. We do not pass judgment on whether this would be a wise rule for
the FDA to adopt. It is sufficient for our inquiry that it has not done so. Just as
significant, the alleged inadequate training “relates to the safety or effectiveness” of the
Lap-Band. (See § 360k(a)(2).) In Riegel, supra, the court explained that premarket
approval “is federal safety review.” (Riegel, supra, 552 U.S. at p. 323.) It would
therefore appear that in granting premarket approval for the Lap-Band, the FDA
concluded Allergan had the ability to provide training such as to render the Lap-Band
safe and effective without the need for any further federal oversight of that training.
Stated differently, if Allergan’s training is inadequate, the matter is best addressed
under the FDA’s jurisdiction. We find support for this observation in Gomez v. St. Jude
Med. Daig Div. Inc. (5th Cir. 2006) 442 F.3d 919 (Gomez). In Gomez, the Fifth Circuit
Court of Appeal observed: “The FDA approved [the defendant’s] warnings and
instructions for physicians contained in the Instructions for Use . . . through the PMA
process. That process required the FDA to approve clinical studies and evaluate the
results, to specify the labeling requirements, and approve the label that issued. . . . [The
defendant’s] training requirements were also subjected to, and approved in, the PMA
process. To permit a jury to decide [the plaintiff’s] claims that the information, warnings,
and training material the FDA required and approved through the PMA process were
inadequate under state law would displace the FDA’s exclusive role and expertise in this
area and risk imposing inconsistent obligations on [the defendant]. The district judge
correctly found that [the plaintiff’s] state-law claims that [the defendant’s] labeling,
warning, information, and training were inadequate or incomplete are preempted.” (Id. at
p. 931.) In sum, we conclude plaintiff’s claim that Allergan failed to provide adequate
training to physicians with respect to the implantation of Lap-Bands is expressly
preempted under the FDCA because the claim does not parallel federal requirements.
19
E. Implied Preemption
Even if plaintiff’s allegations reflect actual violations of federal law, we conclude
her claim is subject to implied preemption. Plaintiff seeks to distinguish Buckman, supra,
531 U.S. 341, arguing that this case does not apply because she has not made any
allegations of fraud on the FDA. We do not read Buckman as being strictly limited to its
facts. (See, e.g., Gavin v. Medtronic, Inc. (E.D. La. July 19, 2013) No. 12-0851, 2013
WL 3791612, p. *17 [applying Buckman to a claim that the manufacturer promoted off-
label use ].) The rationale of Buckman is based on well-settled conflict preemption
principles: “In sum, were plaintiffs to maintain their fraud-on-the-agency claims here,
they would not be relying on traditional state tort law which had predated the federal
enactments in question. On the contrary, the existence of these federal enactments is a
critical element in their case. For the reasons stated above, we think this sort of litigation
would exert an extraneous pull on the scheme established by Congress, and it is therefore
pre-empted by that scheme.” (Buckman, at p. 353.)
Significantly, at least one California court has observed there is no state law duty
that requires a medical device manufacturer to offer a physician training program. In
Scott v. C.R. Bard, Inc. (2014) 231 Cal.App.4th 763 (Scott), the defendant was the
manufacturer of polypropylene mesh kits used to treat women with pelvic organ prolapse.
Unlike the present case, the FDA did not require the defendant to offer training and the
device was not subject to premarket review. However, as part of its marketing program,
the defendant voluntarily offered training to physicians using the device. (Id. at pp. 768–
769.) The plaintiff’s surgeon received this training before operating on the plaintiff. The
plaintiff sued the defendant for negligence when she suffered serious complications after
the device was surgically implanted in her. The jury was instructed on the theory of
negligent undertaking, and found the defendant liable for negligence. (Id. at pp. 774–
776, 777.) Within its opinion, the appellate court found the following jury instruction
was a correct statement of law: “ ‘The manufacturer of a prescription medical device has
no duty to train a physician in using its medical device. However, if a manufacturer
undertakes to train physicians and fails to exercise reasonable care in that undertaking, it
20
may be held liable for harm caused to third parties as a result of its negligent
undertaking.’ ”15 (Id. at p. 774, italics added.)
In the present case, it is undisputed that Allergan did not voluntarily undertake to
train physicians in the use of the Lap-Band. Instead, the FDA mandated this physician
training as a condition of its approval for the Lap-Band. Thus, the training program at
issue arose solely out of requirements imposed by the FDA. Under this set of facts,
plaintiff cannot allege a state law claim for negligent undertaking. To the contrary,
plaintiff’s claim for failure to adequately train physicians “exist[s] solely by virtue of the
FDCA . . . requirements” (Buckman, supra, 531 U.S. at p. 353) as set forth in the Lap-
Band’s PMA. Thus, the claim does not exist independently of the FDCA, and, like the
claims in Buckman, is impliedly preempted.
We find further support for our conclusion in a federal district court case applying
Maryland state law. Like the Lap-Band, the device at issue in Williams v. Smith &
Nephew, Inc. (2015) 123 F.Supp.3d 733 [“a ‘metal-on-metal hip resurfacing
prosthesis’ ”]) received PMA approval conditioned on, among other things, the provision
of “a training program for doctors using the BHR System.” (Id. at p. 737.) The district
court found the plaintiffs’ negligence claim for failure to implement an adequate training
program was impliedly preempted: “[Plaintiffs] do not suggest that Maryland law . . .
independently provides a remedy for the failure to ‘conduct a study on the learning curve
and training program of doctors in the United States . . . .’ Without a freestanding basis
in state law, such claims are impliedly preempted.” (Williams v. Smith & Nephew, Inc.,
at p. 747.)
More broadly, cases have held that medical device manufacturers are not
responsible for the practice of medicine. In Sons v. Medtronic Inc. (W.D. La. 2013)
915 F.Supp.2d 776 (Sons), the plaintiff alleged that the defendant “ ‘fail[ed] to properly
train, supervise, and/or equip the doctors and/or surgical techs responsible for
emplacement of their product,’ ‘fail[ed] to ensure that the pacemaker was properly
15
The court stated the principle as follows: “In general, there is no duty to take
affirmative action to assist or protect another.” (Scott, supra, 231 Cal.App.4th at p. 775.)
21
installed,’ ‘fail[ed] to provide a representative of [the defendant] at Plaintiff’s surgery,’
and ‘fail[ed] to provide a representative of [the defendant] to educate the physician
implanting the [defendant’s device].’ ” (Id. at p. 783.) The district court noted that even
if the claim was not expressly preempted under Riegel, supra, 552 U.S. 312, the plaintiff
had failed to state a cognizable claim: “It is well established that a medical device
manufacturer is not responsible for the practice of medicine.” (Sons, at p. 783.) The
district court relied on Swayze v. McNeil Laboratories, Inc. (5th Cir. 1987) 807 F.2d 464,
468, a case in which the appellate court had refused “to impose on a manufacturer a ‘duty
to intrude into the hospital operation as well as the doctor-patient relationship.’ ” (Sons,
at p. 783.) The Sons court further explained: “In affirming the trial court’s grant of
directed verdict in favor of a drug manufacturer on plaintiff’s negligence claims, the
[Swayze] court stated, ‘[i]t is both impractical and unrealistic to expect drug
manufacturers to police individual operating rooms to determine which doctors
adequately supervise their surgical teams . . . . ” (Ibid., citing Hall v. Horn Medical, LLC
(E.D. La. 2012) 2012 WL 1752546, p. *3 [finding it “patently unreasonable” for a
“seasoned neurosurgeon . . . to rely on a sales representative’s opinion about the type of
procedure that should be employed in operating on a patient’s spine.”].)
The record here does not reflect whether the FDA evaluated the adequacy of
Allergan’s Lap-Band training program during the PMA process. To the extent it did not,
this was a decision the FDA made at the time it approved the Lap-Band for use.
Plaintiff’s allegations that the training (which was concededly provided in this case) was
inadequate, goes beyond whatever the FDA did do, or chose not to do, in approving the
product. Because her allegations would “displace the FDA’s exclusive role and expertise
in this area” (Gomez, supra, 442 F.3d at p. 931), her claim is impliedly preempted.
In sum, but for the FDA’s requirement in the Lap-Band’s PMA that Allergan
provide training to physicians implanting the device, plaintiff would have no basis on
which to allege the facts underlying her present cause of action for negligence. Thus, her
claim is impliedly preempted under Buckman, supra, 531 U.S. 341.
22
DISPOSITION
The judgment is affirmed.
_________________________
DONDERO, J.
We concur:
_________________________
HUMES, P.J.
_________________________
BANKE, J.
A145367
23
Trial Court San Francisco County Superior Court
Trial Judge Hon. Ernest H. Goldsmith
Counsel for Plaintiff and Appellant Casey, Gerry, Schenk, Francavilla, Blatt &
Ashley Glennen Penfield LLP
Jeremy Robinson
Wendy M. Behan
Law Office of Mitchel J. Olson, J.D., M.D.
Mitchel J. Olson
Counsel for Defendant and Respondent King and Spalding LLP
Allergan, Inc. Ethan P. Davis
Jeffrey S. Bucholtz
Norton Rose Fulbright US LLP
Lesley Swanson
Jan Dodd
A145367
24