Richardson et al v. Bayer HealthCare Pharmaceuticals Inc. et al

Filing 26

MEMORANDUM DECISION AND ORDER - IT IS ORDERED: 1. Plaintiffs Motion to Amend Amended Complaint (Dkt. 14 ) is GRANTED, and the Court has addressed the motion for judgment on the pleadings as it applies to the Second Amended Complaint. 2. Defendants M otion for Judgment on the Pleadings (Dkt. 13 ) is GRANTED IN PART and DENIED IN PART. All claims except those relating to Plaintiffs failure to warn allegations are dismissed. Plaintiffs are granted leave to amend the claims in the Second Amended Co mplaint regarding the failure to train the implanting physician in the use of the hysteroscopic equipment. Any amended complaint must be filed on or before 9/13/2016 (Amended Complaint due by 9/13/2016). Signed by Judge B. Lynn Winmill. (caused to be mailed to non Registered Participants at the addresses listed on the Notice of Electronic Filing (NEF) by (cjs)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO
BRIAN RICHARDSON and SUSAN
RICHARDSON, husband and wife,

Case No. 4:15-cv-00443-BLW
MEMORANDUM DECISION AND
ORDER

Plaintiffs,
v.
BAYER HEALTHCARE
PHARMACEUTICALS INC.,
CONCEPTUS, INC., ESSURE, ESSURE
PROMISE, and JOHN DOE
CORPORATIONS I-X,
Defendants.

INTRODUCTION
The Court has before it Defendants Bayer HealthCare Pharmaceuticals Inc. and
Bayer Essure Inc.’s (collectively, “Bayer”) Motion for Judgment on the Pleadings (Dkt.
13), and Plaintiffs Brian and Susan Richardson’s Motion to Amend/Correct Amended
Complaint (Dkt. 14). Bayer asserts that Plaintiffs’ state law claims are expressly and
impliedly preempted by federal law.
From a procedural standpoint, this case is a bit convoluted. Bayer provided
substantial briefing in support of their original Motion for Judgment on the Pleadings.
Plaintiffs’ only substantive “response” was their motion to amend the amended
complaint, which includes a copy of their Proposed Second Amended Complaint. See

MEMORANDUM DECISION AND ORDER - 1

Motion to Amend, Dkt. 14; Supplement to Motion to Amend, Dkt. 16. Plaintiffs’ Proposed
Second Amended Complaint is extensive, detailed, and almost brief-like, including at
least one case citation. Id. at ¶ 12. Plaintiffs’ actual “response” to the motion was a
simple one-page “brief” that cited their Proposed Second Amended Complaint.
Bayer then responded to Plaintiffs’ motion to amend with more substantial
briefing, essentially making the same arguments as to the Proposed Second Amended
Complaint that they made against the Amended Complaint. Plaintiffs failed entirely to
respond to Bayer’s opposition brief, which was filed on March 4, 2016. Plaintiffs’ failure
to respond to Defendants’ arguments has placed this Court in a somewhat difficult
position, particularly given the complexity of the legal arguments involved.
Rule 15 of the Federal Rules of Civil Procedure provides that leave to amend
“shall be freely given when justice so requires.” Fed.R.Civ.P. 15(a). In the interest of
efficiency and thoroughness, the Court will grant Plaintiffs’ Motion to Amend (Dkt. 14),
and will address Bayer’s arguments as they apply to the Second Amended Complaint.
Thus, the Court essentially has before it a second motion for judgment on the pleadings
or motion to dismiss the Second Amended Complaint. And the Court will note that
Plaintiffs have been given an opportunity to respond to Bayer’s arguments as they apply
to both complaints. Accordingly, to the degree the Court grants dismissal, the Court will
not give Plaintiffs yet another chance to amend – that right has already been granted by
allowing the Second Amended Complaint, which Plaintiffs filed after having the
opportunity to review Defendants’ briefs.

MEMORANDUM DECISION AND ORDER - 2

BACKGROUND
The Richardsons’ claims arose after Susan Richardson had the birth control
device, Essure, implanted in her fallopian tubes on or around December 27, 2011 to
prevent future pregnancies. Proposed Am. Complaint, at ¶ 4, Dkt. 16-1. About a year
later, Plaintiffs discovered that Susan was pregnant despite the procedure. Id. at ¶ 6. An
ultrasound later revealed that she was pregnant with twins. Id. Plaintiffs’ Second
Amended Complaint alleges ten state common-law causes of action asserting liability for
the negligent and defective manner in which Essure was “manufactured, designed,
formulated, tested, packaged, labeled, produced, created, made, constructed, assembled,
marketed, advertised, distributed and sold.” Id. at ¶ 75. Bayer is responsible for the
manufacturing and distribution of the Essure birth control device. Id. at ¶ 3.
Plaintiffs’ claims arise in the context of an extensive federal regulatory scheme.
Medical devices are regulated by the FDA pursuant to the Food, Drug, and Cosmetics
Act (“FDCA”) and the Medical Device Amendments of 1976 (“MDA”). 21 U.S.C. §
360c et seq. Pursuant to the MDA, Essure is conditionally designated as a Class III
medical device, which means its design, manufacturing process, and labeling underwent
the rigorous scrutiny of the FDA’s premarket approval process (“PMA”). See Second Am.
Compl. at ¶ 33, Dkt. 16; see also 21 U.S.C. § 360e. Essure’s “conditional” status is
conditioned on further trial testing, but the device is still regulated under the MDA
statutory scheme until such status is otherwise revoked. See Am. Compl. at ¶ 42. A device
is classified under Class III (and therefore subject to PMA) when the less stringent

MEMORANDUM DECISION AND ORDER - 3

classifications cannot provide reasonable assurance of its safety and effectiveness, and
the device is used either “in supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health” or it “presents a
potential or unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C).
A Class III device may only win PMA status and be marketed if the FDA finds,
based on detailed investigations into the safety and effectiveness of the device and its
labeling, that there is a “reasonable assurance of safety and effectiveness of [that]
device....” 21 U.S.C. § 360e(d); see also Riegel v. Medtronic, Inc., 552 U.S. 312, 317–18
(2008) (describing PMA in detail). The determination of the safety and effectiveness of a
device is made in part by “weighing any probable benefit to health from the use of the
device against any probable risk of injury or illness from such use.” 21 U.S.C.A. § 360c.
In addition to regulating the device’s actual design and application, the FDA must
approve its labeling, including whether it is false or misleading under § 360e(d)(1)(A),
and requires post-approval clinical investigations, scientific studies, and periodical
reports to the FDA. See 21 C.F.R. § 814.84(b)(2).
Because Essure is a Class III device subject to the FDA’s PMA process, all
relevant regulations under the FDCA and MDA are applicable. Bayer’s motion is based
on the assertion that Plaintiffs’ state law claims are both expressly and impliedly
preempted by the federal statutory scheme encompassed in the FDCA and the MDA.

MEMORANDUM DECISION AND ORDER - 4

LEGAL STANDARD
FRCP 8(a)(2) requires only “a short and plain statement of the claim showing that
the pleader is entitled to relief,” to “give the defendant fair notice of what the ... claim is
and the grounds upon which it rests.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555
(2007). While a complaint attacked by an FRCP 12(b)(6) motion to dismiss “does not
need detailed factual allegations,” it must set forth “more than labels and conclusions,
and a formulaic recitation of the elements of a cause of action will not do.” Id. at 555. To
survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted
as true, to “state a claim for relief that is plausible on its face.” Id. at 570. A claim has
facial plausibility when the plaintiff pleads factual content that allows the court to draw
the reasonable inference that the defendant is liable for the misconduct alleged. Id. at 556.
The plausibility standard is not akin to a “probability requirement,” but it asks for more
than a sheer possibility that a defendant has acted unlawfully. Id. Where a complaint
pleads facts that are “merely consistent with” a defendant's liability, it “stops short of the
line between possibility and plausibility of ‘entitlement to relief.’” Id. at 557.
Rule 15 of the Federal Rules of Civil Procedure provides that leave to amend
“shall be freely given when justice so requires.” Fed.R.Civ.P. 15(a). Indeed, while the
decision to grant leave to amend is within the Court's discretion, the Court “must be
guided by the underlying purpose of Rule 15 to facilitate decision on the merits rather
than on the pleadings or technicalities.” U.S. v. Webb, 655 F.2d 977, 979 (9th Cir.1981).

MEMORANDUM DECISION AND ORDER - 5

This “policy of favoring amendments to pleadings should be applied with extreme
liberality.” Id. (internal quotation marks omitted).
To determine “whether justice requires granting leave to amend,” courts consider
“the presence or absence of undue delay, bad faith, dilatory motive, repeated failure to
cure deficiencies by previous amendments, undue prejudice to the opposing party and
futility of the proposed amendment.” Moore v. Kayport Package Express, Inc., 885 F.2d
531, 538 (9th Cir.1989) (citing Foman v. Davis, 371 U.S. 178, 182 (1962)). “Generally,
this determination should be performed with all inferences in favor of granting the
motion.” Griggs v. Pace Am. Group, Inc., 170 F.3d 877, 880 (9th Cir.1999) (citing DCD
Programs, Ltd. v. Leighton, 833 F.2d 183, 186 (9th Cir.1987)). Nevertheless, the “general
rule that parties are allowed to amend their pleadings. . .does not extend to cases in which
any amendment would be an exercise in futility or where the amended complaint would
also be subject to dismissal.” Steckman v. Hart Brewing, Inc., 143 F.3d 1293, 1298 (9th
Cir.1998) (citations omitted). Futility alone can justify a court's refusal to grant leave to
amend. See Bonin v. Calderon, 59 F.3d 815, 845 (9th Cir.1995).
ANALYSIS
1.

Express and implied preemption under the MDA and FDCA
Under the MDA, many state law claims asserting liability for allegedly faulty

medical devices are expressly preempted by federal law. See 21 U.S.C. § 360k(a); see
also Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Additionally, even claims not
expressly preempted by the MDA may be impliedly preempted under the FDCA’s greater

MEMORANDUM DECISION AND ORDER - 6

enforcement scheme. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348
(2001).
A.

Express preemption under the MDA
Unless a state seeks a specific exemption available under the statute, the MDA

provides that no state may establish or enforce any requirement that is inconsistent with
those required federally:
(a) General rule
Except as provided in subsection (b) of this section, 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 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. In Riegel, the United States Supreme Court reaffirmed the
determination reached in Medtronic v. Lohr, 518 U.S. 470, 495 (1996) that the MDA’s
preemption provision is “substantially informed by the FDA regulation set forth at 21
C.F.R. § 808.1(d).” Riegel, 552 U.S. at 322 (citing Lohr, 518 U.S. at 495). Section
808.1(d) states that State laws are preempted “only when the Food and Drug
Administration has established specific counterpart regulations or there are other specific
requirements applicable to a particular device.” Id. (emphasis added). In addressing the
Riegel dissent’s concerns that the preemption provision will “remove all means of
judicial recourse for consumers injured by FDA-approved devices,” the majority
MEMORANDUM DECISION AND ORDER - 7

responded summarily that “this is exactly what a pre-emption clause for medical devices
does by its terms.” Riegel, 552 U.S. at 326 (citing dissent of Ginsburg, J. Id. at 337).
While the MDA’s preemption provision is broad, the Riegel court still recognized
that § 360k(a) “does not prevent a State from providing a damages remedy for claims
premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’
rather than add to, federal requirements.” Id. at 330. Thus, claims that are analogous to a
violation of the MDA regulations may not be expressly preempted so long as they also
violate a parallel state duty. See De La Paz v. Bayer Healthcare LLC, 2016 WL 392972
at *4 (N.D. Cal. Feb. 2, 2016). However, any claims which are asserted that may be
viewed as “in addition” to the FDA regulations will be preempted. Riegel, 552 U.S. at
330.
B.

Implied preemption under the FDCA
Even those “parallel claims” not expressly preempted directly under the MDA

may be impliedly preempted by the federal statutory enforcement scheme under the
FDCA, which provides that the exclusive mechanisms of enforcement must be brought
by the United States government, or alternatively on behalf of the States. See Buckman,
531 U.S. at 348; see also Perez v. Nidek Co., Ltd., 711 F. 3d 1109, 1119–20 (9th Cir.
2013). The FDA is solely responsible for investigating potential violations of the FDCA
(which the MDA is a subsection thereof). See 21 U.S.C §§ 332–34, 372. The Act
provides the FDA “with a range of enforcement mechanisms, such as injunction
proceedings, civil and criminal penalties, and seizure.” Perez, 711 F. 3d at 1119.

MEMORANDUM DECISION AND ORDER - 8

However, the FDCA precludes private enforcement of all relevant provisions, as “all such
proceedings for the enforcement, or to restrain violations, of [the Act] shall be by and in
the name of the United States.” 21 U.S.C. § 337(a). Whereas citizens may “petition the
FDA to take administrative action, 21 C.F.R. §§ 10.25(a) and 10.30, private enforcement
of the statute is barred.” Perez, 711 F. 3d at 1119.
In Buckman, plaintiffs brought state tort claims against a medical device
manufacturer for fraudulent misrepresentations the company had allegedly made while
obtaining approval from the FDA for the use of orthopedic “bone screws” – a Class III
device. Buckman, 531 U.S. at 343. Because the claims were based on alleged violations
of the MDA, rather than “additional state requirements,” the claims were not necessarily
preempted by the MDA’s express preemption provision. Id. at 348. Instead, the Court
found that the alleged fraud claims “exist solely by virtue of the FDCA disclosure
requirements” and as such, the plaintiff’s private cause of action was impliedly
preempted by the government enforcement requirement under 21 U.S.C. § 337(a). Id. at
353.
The Ninth Circuit applied Buckman to a claim against a generic medical device
manufacturer on a “fraud by omission” claim that the company improperly concealed the
fact that the FDA had not approved the device for a specific eye surgery procedure.
Perez, 711 F. 3d at 1112. After holding that the plaintiff’s claims were improper under
two different California state laws, the Ninth Circuit ultimately held that because “the
existence of these [FDCA regulations] is a critical element in [the plaintiff’s] case,” the

MEMORANDUM DECISION AND ORDER - 9

claims were preempted under the Buckman rationale. Id. at 1119. Thus, even those claims
that aren’t preempted under Riegel still must fall outside the Buckman preemption in
order to state a private cause of action.
C.

Most of the Richardsons’ claims are either expressly or impliedly preempted
The Ninth Circuit has expressly recognized that between the respective

preemptions under the Riegel and Buckman line of cases, there is only a “narrow gap
through which a state-law claim must fit to escape preemption by the FDCA.” Perez, 711
F. 3d. at 1120 (internal quotations omitted). Essentially, “the plaintiff must be suing for
conduct that violates the FDCA . . . but the plaintiff must not be suing because the
conduct violates the FDCA.” Id. Absent a stand-alone state law that precisely mirrors the
MDA, a plaintiff’s claim against a Class III medical device manufacturer for violations of
the MDA will likely be preempted.
The claims asserted in the Richardsons’ Second Amended Complaint fall into
three separate categories: 1) claims asserting that Essure’s design is defective or
unreasonably dangerous; 2) claims asserting defects in Essure’s manufacturing process;
and 3) claims asserting that Bayer misrepresented Essure’s safety and effectiveness or
failed adequately to warn of its risks. See Second Am. Compl. at ¶¶ 67–140, Dkt. 16; see
also Defs’ Opposition to Motion to Amend, at 9, Dkt. 22. All ten claims are for state
common-law torts based on the alleged “adulteration” of the Essure product per FDA
protocol, expressly citing the conditional PMA requirements. Second Am. Compl. at ¶ 50.
The majority of these claims are exclusively governed by FDCA regulations which are

MEMORANDUM DECISION AND ORDER - 10

therefore required to be challenged “. . . by and in the name of the United States.” 21
U.S.C. § 337(a).
The Richardsons’ claims are almost exactly the same as those brought by the
plaintiff against Bayer in De La Paz v. Bayer Healthcare LLC, 2016 WL 392972 (N.D.
Cal. Feb. 2, 2016), who had to have one of her fallopian tubes removed after
complications arose from the Essure device. Id. at *2. In De La Paz, the plaintiff also
brought suit against Bayer based on the “adulteration” of the Essure product under FDA
regulations. Id. at *3 (The plaintiff’s ten claims were for (1) manufacturing defect, (2)
design defect, (3) negligence, (4) failure to warn, (5) strict liability, (6) breach of implied
warranty, (7) breach of express warranty, (8) negligent misrepresentation, (9) fraudulent
misrepresentation, (10) fraudulent concealment). Id. In each instance, the De La Cruz
court held that the claims, as pleaded, were insufficient and had to be dismissed. Id. at
*7–11. In several instances, however, the De La Paz court also found that the facts
alleged could possibly afford relief, and the court dismissed some claims without
prejudice so to allow the plaintiff the opportunity to amend her complaint. Id.
Overwhelmingly, this Court agrees with the decision and analysis underlying the
De La Paz court’s decision to dismiss the plaintiff’s claims. However, some factors that
led the De La Paz court to allow the plaintiff leave to amend are inapplicable in this case,
and the Court must consider the facts of this case independently based on the evidence
and applicable law before it. The Court will therefore address each set of claims

MEMORANDUM DECISION AND ORDER - 11

individually. And as noted above, the procedural posture of this case also affects the
Court’s decision not to allow yet another amendment.
(1)

Plaintiffs’ First, Second, and Fifth Causes of Action are preempted by
the FDCA as they relate to alleged manufacturing and design defects

Plaintiffs’ first cause of action for “manufacturing defect,” second cause of action
for “design defect,” and fifth cause of action for strict liability (so far as it relates to the
alleged design and manufacturing defects) are entirely preempted, either expressly or
impliedly, by federal law under the FDCA. As a conditionally approved Class III medical
device, the manufacturing and design of Essure is solely under the authority of the FDA.
See Riegel, 552 U.S. at 330; see also Buckman, 531 U.S. at 353. Plaintiffs’ have not
asserted an independent state statutory scheme by which relief may be granted, but rather
rely on common-law tort claims. Therefore, insofar as Plaintiffs could seek liability for
conduct not encompassed in the FDCA, such claims for the manufacturing and design of
the Essure device is expressly preempted under 21 U.S.C § 360k(a). Alternatively,
insofar as the Richardsons seek liability for noncompliance with the FDCA requirements
regarding the manufacture and design of the product, such claims are impliedly
preempted under 21 U.S.C. § 337(a). Buckman, 531 U.S. at 348 (claims must be brought
“by and in the name of the United States”). Plaintiffs’ first, second, and fifth claims will
therefore be dismissed.

MEMORANDUM DECISION AND ORDER - 12

(2)

Plaintiffs’ Third Cause of Action is partially preempted by the FDCA,
and alternatively, has not been adequately pleaded to allege a proper
claim for Bayer’s alleged “failure to train”

Plaintiffs’ third cause of action is for negligence, suggesting Bayer “failed to use
reasonable care in designing Essure.” Second Am. Compl. at ¶ 83, Dkt. 16. Plaintiffs
specifically state six ways in which Bayer “failed to use reasonable care,”
a. Failed to properly and thoroughly test Essure before releasing the
system to market;
b. Failed to properly and thoroughly analyze the data resulting from the
premarketing tests of Essure;
c. Failed to conduct sufficient post-market testing and surveillance of
Essure;
d. Designed, manufactured, marketed, advertised, distributed, and
sold Essure to consumers, including Plaintiff, without an adequate
warning of the significant and dangerous risks of Essure and without
proper instructions to avoid the harm which could foreseeably occur as a
result of using the system;
e. Failed to exercise due care when advertising and promoting Essure;
and
f. Negligently continued to manufacture, market, advertise, and
distribute Essure after Defendants knew or should have known of its
adverse effects.
Second Am. Compl. at ¶ 83, Dkt. 16 (emphasis added).
The Richardsons’ negligence claims, as pleaded, are preempted for precisely the
same reasons as the first and second causes of action are preempted. All of the
manufacturing, marketing, advertising, warnings, and distribution of the Essure product
are approved per the conditional PMA process. See Riegel, 552 U.S. 312, 317–18. All

MEMORANDUM DECISION AND ORDER - 13

alleged negligence stems solely from a failure to adhere to FDA protocol, rather than an
independent state duty. As noted above, a claim that Defendant failed to comply with the
FDCA requirements must be brought under 21 U.S.C. § 337(a).
However, ¶ 10 of the Second Amended Complaint discusses alternative assertions
for negligence that fail for different reasons:
Plaintiff’s first cause of action is based on Defendants’ negligence in 1)
failing to adequately train Plaintiff’s implanting physician (‘the implanting
physician”); and 2) entrusting the implanting physician with specialized
hysteroscopic equipment she was not qualified to use. . . .
Second Am. Compl., at ¶ 10, Dkt. 16. In De La Paz, the court gave the plaintiff leave to
amend her complaint for the “failure to train” claim, because under California law, “if a
manufacturer undertakes to train physicians and fails to exercise reasonable care in that
undertaking, it may be held liable for harm caused to the patient.” De La Paz, 2016 WL
392972 at *8 (N.D. Cal. Feb. 2, 2016) (citing Scott v. C.R. Bard, Inc., 231 Cal.App. 4th
763, 774, 180 Cal.Reptr.3d 479 (2014)). But in this case, facts have not been pleaded (nor
is this Court aware of relevant law) sufficient to demonstrate that a manufacturer owes a
duty under Idaho law to train physicians. Absent an independent state law claim, the
Richardsons’ claim for failure to train is impliedly preempted. 21 U.S.C. § 337(a).
Similarly, Plaintiffs allege that Bayer “entrusted” physicians with “hysteroscopic
equipment” that “is not part of any CPMA.” Second Am. Compl., at ¶ 10, Dkt. 16. If the
equipment indeed is not regulated under the MDA, liability for such products would not
be expressly preempted. See 21 U.S.C § 360k. While there is no Idaho case law expressly
holding that a “failure to train” is a breach of a duty owed by manufacturers or
MEMORANDUM DECISION AND ORDER - 14

distributors under Idaho law, the Court is not prepared to foreclose the possibility of such
a claim at this point. However, as currently pled, the Second Amended Complaint does
not allege a causal connection between the Richardsons’ injuries and any improper use of
the equipment by the implanting physician. From this standpoint, the plaintiffs’ Second
Amended Complaint pleads facts that are “merely consistent with” a defendant's liability,
meaning it “stops short of the line between possibility and plausibility of ‘entitlement to
relief.’” Twombly, 550 U.S. at 557. Particularly given the deficit of argument provided by
the plaintiffs regarding this aspect of their Second Amended Complaint, the third cause of
action will also be dismissed, but with leave to amend.
(3)

Plaintiffs’ Fourth Cause of Action – Failure to Warn claim are not
preempted

Plaintiffs seek liability for a number of claims generally stemming from
allegations that Bayer failed to adequately warn of Essure’s risk to consumers. See
Second Am. Compl., ¶ 86–98, Dkt. 16. Plaintiffs argue that their claims “based entirely on
the express warranties made by Defendants to plaintiff[s]” are not preempted by the
MDA under Stengel v. Medtronic Inc., 704 F. 3d 1224, 1334 (9th Cir. 2013). Second Am.
Compl., ¶ 12, Dkt. 16.
In Stengel, the Ninth Circuit held that a negligent “failure to warn” claim against
an MDA product was not preempted under Arizona law. Id. There, the Stengel plaintiffs’
Proposed Amended Complaint alleged that Medtronic was negligent because it “had
become well aware of [ ] risks but had failed to inform the FDA, even though the MDA
required Medtronic to do so.” Id. at 1227. The Ninth Circuit specifically construed this
MEMORANDUM DECISION AND ORDER - 15

argument as a “failure to warn the FDA claim.” Id. at 1233. Construing the claim as a
“failure to warn the FDA” is important because the MDA requires the company to report
to the FDA about complications that arise through the device’s use (but not necessarily to
the doctors or ultimate users) – otherwise it would be an “additional” requirement that is
expressly preempted under §360k(a). See Riegel, 552 U.S. at 330; see also Stengel, 704
F. 3d at 1234 (Watford, J. concurring) (“claim on an alleged state law duty to warn
doctors directly would have been expressly preempted”).
To avoid preemption under Buckman however, the Stengel plaintiffs also needed
to show that Arizona law required the company to report to the FDA. Notably, Arizona
law provides for a duty to warn third parties if “there is reasonable assurance that the
information will reach those whose safety depends on their having it.” Id. (citing
Anguiano v. E.I. DuPont de Nemours & Co., 808 F. Supp. 719, 723 (D. Ariz. 1992)).
Provided Arizona’s broad scope of duty for a failure to warn claim, the court found that
the FDA was a “third party,” whom if reported to, “there is reasonable assurance that the
information will reach those whose safety depends on their having it.” Id. Thus in that
case, there was a “parallel” state claim that could be used to enforce duties that also arose
under federal law.
As applied to the Richardsons’ “Failure to Warn” claim against Bayer here, the
Richardsons’ Second Amended Complaint states:
Defendants were cited by the FDA and the Department of Health for (1)
failing to report and actively concealing 8 perforations which occurred as a
result of Essure; (2) erroneously using non-conforming material in the
manufacturing of Essure; (3) failing to use pre-sterile and post-sterile cages;
MEMORANDUM DECISION AND ORDER - 16

(4) manufacturing Essure at an unlicensed facility and (5) manufacturing
Essure for three years without a license to do so.
Second Am. Compl., at ¶ 16, Dkt. 16. Bayer was allegedly required to report at least 1)
the occurrence of the eight perforations and (2) the use of non-conforming material to the
FDA under 21 C.F.R. § 814.84(b)(2). In Idaho, a manufacturer may be liable under either
theory of strict liability or negligence for a failure to warn if “[1] the defendant has reason
to anticipate that danger may result from a particular use of his product and [2] fails to
give adequate warnings of such danger.” Puckett v. Oakfabco, Inc., 979 P.2d 1174, 1181
(Idaho 1998). Such danger must not have been so “open or obvious” that the user would
be on notice of the dangers presented. Id. Plaintiffs’ Second Amended Complaint, at least
on its face, has pleaded sufficient factual details that could plausibly support a “failure to
warn the FDA” claim. See id.
Citing these same FDA violations, the De La Paz court applied Stengel when it
allowed the plaintiff leave to amend her complaint for a “Failure to Report to the FDA”
claim. 2016 WL 392972 at *10 (N.D. Cal. Feb. 2, 2016). The De La Paz Court allowed
leave to amend in order for the plaintiff to “allege facts plausibly showing that if Bayer
had timely reported the perforations, the FDA would have required some enhancement to
the perforations warning already in place, which would have caused De La Paz to forego
the Essure procedure.” Id. The De La Paz court’s remand was similar to the Stengel
concurrence’s concern that the party had demonstrated causation, but found that such
information was not necessary at the pleading stage. See Stengel, 704 F. 3d at 1234–35
(Watford, J. concurring) (Plaintiff would ultimately need to prove causation “that
MEMORANDUM DECISION AND ORDER - 17

information [reported to the FDA] would have reached Mr. Stengel's doctors in time to
prevent his injuries”).
Idaho law contemplates that a “third party intermediary” may play a critical role in
adequately warning users of a foreseeably dangerous product. See Sliman v. Aluminum
Co. of America, 731 P.2d 1267, 1272 (Idaho 1986). As such a claim relates to third
parties, such as the FDA, the Idaho Supreme Court has relied on the Restatement
(Second) of Torts § 388 & Comment n (1965), as well as the Eighth Circuit decision in
Hopkins v. Chip-in-Saw, Inc., 630 F. 2d 616, 619 (8th Cir. 1980):
When a manufacturer can reasonably foresee that the warnings it gives to a
purchaser of its product will not be adequately conveyed to probable users
of the product, then its duty to warn may extend beyond the purchaser to
those persons foreseeably endangered by the product's use. Warnings given
to the purchaser do not necessarily insulate the manufacturer from liability
to injured users of the product.
Sliman, 731 P.2d at 1272 (quoting Hopkins, 630 F. 2d at 619) (emphasis added).
Therefore, under Idaho law a manufacturer of a product may have a duty to forewarn a
user of the product, regardless whether the user is the direct purchaser of the product or
not. Id. In the context of Class III medical devices, that should be construed to include
warnings and reports to the FDA. Just as under Stengel, Idaho law provides an
independent, but “parallel” remedy for the failure of a manufacturer of a MDA device to
properly report known dangers of its product to the FDA.
The Richardsons’ failure to warn claims differ from the “fraud-on-the-FDA”
claims at issue in Buckman because the Buckman fraudulent statements were made
“solely by virtue of the FDCA disclosure requirements” and thus are impliedly preempted
MEMORANDUM DECISION AND ORDER - 18

by the FDCA enforcement scheme. Buckman, 531 U.S. at 353. In contrast, the failure to
warn requirement merely “parallels” the requirement under 21 C.F.R. § 814.84(b), but is
actually derived from the independent duty to actively warn potential third-party users,
even through disclosure to regulatory bodies.
It must be noted, however, that the Richardsons have failed to allege facts that
tend to show the plaintiffs would have opted to “forego” the Essure procedure had the
information been disclosed to the FDA. See De La Paz, 2016 WL 392972 at *10 (N.D.
Cal. Feb. 2, 2016). But under Idaho law, there is no insinuation that “reliance” is a
necessary element required to plead a failure to warn claim. Instead, whether Bayer’s
disclosure to the FDA would have provided warning to the Richardsons is an element of
the warning’s “adequacy” under a failure to warn claim, which “is for the jury to
determine. See Sliman, 731 P.2d at 1272 (manufacturer must give an “adequate”
warning). Whereas the plaintiffs will ultimately have the burden of proving the
“inadequacy” of the FDA’s warnings, they have pleaded sufficient factual information to
survive the Defendants’ motion.
Just as the Ninth Circuit stated in Stengel, “we do not decide whether plaintiffs can
prevail on their state-law failure-to-warn claim. That question is not before us.” 704 F. 3d
at 1233. For these reasons, the Court will not dismiss claims three, four, and five as they
relate to Bayer’s alleged failure to warn.

MEMORANDUM DECISION AND ORDER - 19

(4)

Causes of Action six through ten are preempted by federal law

Plaintiffs sixth cause of action for breach of implied warranty, seventh cause of
action for breach of express warranty, eighth cause of action for negligent
misrepresentation, ninth cause of action for fraudulent misrepresentation, and tenth cause
of action for fraudulent concealment are all expressly and impliedly preempted by federal
law. All five claims are based upon Bayer’s alleged “designing, manufacturing,
marketing, formulating, testing, packaging, labeling, producing, creating, making[,]
constructing, assembling, advertising, and distributing of Essure.” Second Am. Compl., at
¶ 113, Dkt. 16. These are all affirmative actions taken by Bayer and disclosed to the FDA
for their review. As discussed in subsection (1) supra, all of the allegedly improper
conduct is based implicitly on duties that are imposed under the FDCA, and must
therefore be enforced soley by the FDA. See Riegel, 552 U.S. at 330; see also Buckman,
531 U.S. at 353.
The Court recognizes that it may initially seem counterintuitive that the warranty
and fraudulent misrepresentation claims are preempted, whereas the failure to warn
claims are not – particularly when the fraud by concealment claim addresses essentially
the same conduct as the failure to warn claim. However, the relevant FDCA reporting
requirements are instructive. Under 21 C.F.R. § 814.84(b), the FDA requires device
manufacturers to produce a “periodic report” relating to known risks, but it is ultimately
up to the FDA to require changes in the “packaging, labeling, producing, [et cetera]. . .”
that is the basis of the Richardsons’ warranty and misrepresentation claims. Second Am.

MEMORANDUM DECISION AND ORDER - 20

Compl., at ¶ 113, Dkt. 16. The FDA’s role in receiving reports under the MDA is passive,
whereas their role in approving the warranty-related conduct is active. Such is the
difference between a “parallel” duty under independent state law, and those duties that
exist solely due to the FDCA. This distinction is indicative of the “narrow gap” in the law
described by the Ninth Circuit in Perez. 711 F. 3d. at 1120.
Idaho law cannot require stronger duties than the FDA actively requires under the
MDA, even if the Court could presume some likelihood the FDA would require changes
to the warranties made by Bayer had it known of the allegedly non-disclosed risks. For
these reasons, causes of action six through ten are either expressly or impliedly
preempted by federal law. Bayer’s motion will be granted as to those claims.
ORDER
IT IS ORDERED:
1. Plaintiff’s Motion to Amend Amended Complaint (Dkt. 14) is GRANTED,
and the Court has addressed the motion for judgment on the pleadings as it
applies to the Second Amended Complaint.
2. Defendant’s Motion for Judgment on the Pleadings (Dkt. 13) is GRANTED
IN PART and DENIED IN PART. All claims except those relating to
Plaintiffs’ failure to warn allegations are dismissed. Plaintiffs are granted
leave to amend the claims in the Second Amended Complaint regarding the
failure to train the implanting physician in the use of the hysteroscopic

MEMORANDUM DECISION AND ORDER - 21

equipment. Any amended complaint must be filed on or before September 13,
2016.

DATED: August 30, 2016
_________________________
B. Lynn Winmill
Chief Judge
United States District Court

MEMORANDUM DECISION AND ORDER - 22