ARCELIA SANDOBAL GOMEZ v. BAYER CORPORATION
Annotate this CaseNOT FOR PUBLICATION WITHOUT THE
APPROVAL OF THE APPELLATE DIVISION
This opinion shall not "constitute precedent or be binding upon any court ." Although it is posted on the
internet, this opinion is binding only on the parties in the case and its use in other cases is limited. R. 1:36-3.
SUPERIOR COURT OF NEW JERSEY
APPELLATE DIVISION
DOCKET NO. A-0680-18T4
ARCELIA SANDOBAL GOMEZ,
a/k/a ARCELIA SANDOBAL
and ARCELIA SANDOVAL,
Plaintiff-Appellant,
v.
BAYER CORPORATION, BAYER
HEALTHCARE, LLC, BAYER
ESSURE, INC., and
BAYER HEALTHCARE
PHARMACEUTICALS, INC.,
Defendants-Respondents,
and
BAYER A.G., ROBERT WOOD
JOHNSON UNIVERSITY
HOSPITAL, AMBULATORY
SURGICAL PAVILION AT
ROBERT WOOD JOHNSON,
and ROBERT M. SCHAEFER,
M.D.,
Defendants.
____________________________
Argued November 18, 2019 – Decided January 14, 2020
Before Judges Sabatino, Sumners and Geiger.
On appeal from the Superior Court of New Jersey, Law
Division, Middlesex County, Docket No. L-4930-17.
Neal M. Unger argued the cause for appellant (Neil M.
Unger, PC, attorneys; Neal M. Unger, of counsel and
on the briefs; Ronald L. Lueddeke, Jr., on the briefs).
Erika L. Maley (Sidley Austin LLP) of the Washington,
DC Bar, admitted pro hac vice, argued the cause for
respondents (DLA Piper, LLP, and Erika L. Maley,
attorneys; Jonathan F. Cohn (Sidley Austin LLP) of the
Washington, DC Bar, admitted pro hac vice, Brian J.
Pendleton, Jr., and Christopher M. Strongosky, of
counsel and on the brief; Kristin A. Pacio, on the brief).
PER CURIAM
Plaintiff Arcelia Sandobal Gomez appeals from the Law Division's
dismissal of all her claims for damages related to the implantation of a tubal
birth control device known as Essure. For the following reasons, we affirm.
I.
Essure is a permanently implanted birth control device that is not intended
to be removed. Unlike other marketed permanently implanted birth control
devices, insertion of Essure does not require a surgical incision. During the
implantation procedure, the doctor places flexible metallic coil inserts through
the vagina and cervix and into the fallopian tubes. The implanted Essure
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2
stimulates growth during the three months after implantation. The tissue build-
up is meant to create a physical barrier that permanently prevents sperm from
reaching the woman's eggs.
Essure was designed and initially manufactured by Conceptus, Inc. It was
subsequently manufactured, marketed, promoted, sold, and distributed by the
following "Bayer" organizations: (1) Bayer Essure, Inc., the device's
manufacturer; (2) Bayer Healthcare, LLC; (3) Bayer Healthcare
Pharmaceuticals, Inc.; (4) Bayer Corp., the American parent company of Bayer
Essure, Bayer Healthcare, and Bayer Healthcare Pharmaceuticals; and (5) Bayer
A.G., the German parent company of Bayer Corp. (collectively the Bayer
defendants). The Bayer defendants provided hysteroscopic equipment,
manufactured by a third-party, for use in implanting Essure. The Bayer
defendants also provided training to physicians in how to implant Essure using
the hysteroscopic equipment it supplied.
A. The Statutory and Regulatory Framework
Before 1976, "the introduction of new medical devices was left largely for
the States to supervise as they saw fit." Riegel v. Medtronic, Inc., 552 U.S. 312,
315 (2008). This led to inconsistent and inadequate state regulation of complex
medical devices. Id. at 315-16. Congress recognized that federal oversight was
A-0680-18T4
3
needed to prevent Americans from being "put at risk from the use of unsafe and
ineffective medical devices." S. Rep. 94-33, at 2 (1975).
To address these concerns, Congress enacted the Medical Device
Amendments of 1976 (MDA), 21 U.S.C. §§ 360c to 360m (2018), to the Food,
Drug and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 to 399i. The MDA was
aimed at both protecting the public and ensuring that "innovations in medical
device technology [were] not stifled by unnecessary restrictions." H.R. Rep. 94-
853, at 12 (1976). To effectuate those dual goals, Congress "swept back some
state obligations and imposed a regime of detailed federal oversight"
administered by the Food and Drug Administration (FDA). Riegel, 552 U.S. at
316. A key goal was to avoid the undue burden imposed by inconsistent state
regulation. H.R. Rep. 94-853, at 45. This led to the twofold approach
implemented by Congress—combining a comprehensive "system of federal
regulation over the introduction of new [medical] devices" to broad preemption
of state law that imposes "any different or additional state safety or effectiveness
requirements." Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 765 (3d Cir.
2018) (citing 21 U.S.C. §§ 360c to 360f, 360k).
The MDA contains an express preemption clause, which preempts any
state "requirement" affecting a medical device "(1) which is different from, or
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in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device under this chapter."
21 U.S.C. § 360k(a). However, states are not precluded "from providing a
damages remedy for claims premised on a violation of FDA regulations," if "the
state duties in such a case 'parallel,' rather than add to, federal requirements."
Riegel, 552 U.S. at 330 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 495
(1996)). Nevertheless, all enforcement actions under the MDA "shall be by and
in the name of the United States." 21 U.S.C. § 337(a). This section impliedly
preempts suits by private parties "for noncompliance with the medical device
provisions." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n.4
(2001).
The MDA "classifies medical devices in three categories based on the risk
that they pose to the public." Lohr, 518 U.S. a 476. Class III devices are subject
to "the most federal oversight," Shuker, 885 F.3d at 765 (quoting Riegel, 552 U.S. at 316-17), because they "presen[t] a potential unreasonable risk of illness
or injury," Buckman, 531 U.S. at 344 (alteration in original) (quoting 21 U.S.C.
§ 360c(a)(1)(C)(ii)(II)). "Before a new Class III device may be introduced to
the market, the manufacturer must provide the FDA with a 'reasonable
A-0680-18T4
5
assurance' that the device is both safe and effective." Lohr, 518 U.S. at 477
(citing 21 U.S.C. § 360e(d)(2)). This includes
"a detailed description of the proposed conditions of
use of the device," 21 U.S.C. § 360c(a)(3)(D)(i); a
sample label delineating the intended uses, 21 U.S.C. §
360e(c)(1)(F); and "full reports of all information,
published or known to or which should reasonably be
known to the applicant, concerning investigations
which have been made to show whether or not such
device is safe and effective[.]" 21 U.S.C. §
360e(c)(1)(A).
[Cornett v. Johnson & Johnson, 414 N.J. Super. 365,
386 (App. Div. 2010), aff'd in part and modified in part,
211 N.J. 362 (2012).]
The FDA may condition PMA "on adherence to performance standards,
restrictions upon sale or distribution, or compliance with other requirements.
The agency is also free to impose device-specific restrictions by regulation."
Riegel, 552 U.S. at 319 (citations omitted).
There are two paths to approval of Class III devices. Relevant here is
premarket approval (PMA) of devices that are so innovative there are no other
"substantially equivalent" devices. Cornett v. Johnson & Johnson, 211 N.J. 362,
389 (2012), abrogated on other grounds, McCarrell v. Hoffmann-La Roche, Inc.,
227 N.J. 569 (2017). Obtaining PMA is rigorous.
To obtain pre-market approval, a device
manufacturer must submit to the FDA full
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reports of all investigations relating to the
device's safety or effectiveness; a "full
statement of the components, ingredients,
and properties and of the principle or
principles of operation" of the device; a full
description of the manufacturing methods
and the facilities and controls used for the
device's manufacturing; references to any
performance standards applicable to the
device; samples of the device and any
component parts; examples of the proposed
labeling for the device; and other
information[.]
[Walker v. Medtronic, Inc., 670 F.3d 569,
572-73 (4th Cir. 2012) (quoting 21 U.S.C.
§ 360e(c)(1)).]
A device's labeling includes the Instructions for Use provided to physicians and
the Patient Information Booklet provided to patients.
When determining whether to grant PMA, the FDA "weig[hs] any
probable benefit to health from the use of the device against any probable risk
of injury or illness from such use." Riegel, 552 U.S. at 318 (quoting 21 U.S.C.
§ 360c(a)(2)(C)). The FDA will "grant[] [PMA] only if it finds there is a
'reasonable assurance' of the device's 'safety and effectiveness.'" Ibid. (quoting
21 U.S.C. § 360e(d)). The FDA may "approve devices that present great risks
if they nonetheless offer great benefits in light of available alternatives." Ibid.
A-0680-18T4
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PMA has important legal effects. It "incorporates an FDA finding that a
device is safe and effective under the conditions of use included on the label and
that the label is not false or misleading." Cornett, 211 N.J. at 381 (citing 21
U.S.C. § 360e(d)(1)(A)). PMA also imposes federal safety requirements that
preempt different or additional state requirements. Riegel, 552 U.S. at 321
(quoting 21 U.S.C. § 360k(a)(1)).
Once a device receives PMA, the manufacturer is prohibited, without FDA
approval, from making "changes in design specifications, manufacturing
processes, labeling, or any other attribute, that would affect safety or
effectiveness." Id. at 319. This prohibition includes adding warnings to the
label, "until it submits the proposed change as part of a supplemental PMA
application and obtains FDA approval." Cornett, 211 N.J. at 381 (citing 21
U.S.C. § 360e(d)(6)). Absent such FDA approval, the approved device must "be
made with almost no deviations from the specifications in its approval
application." Riegel, 552 U.S. at 323.
"After approval, the devices are subject to additional reporting
requirements." Cornett, 211 N.J. at 381 (citing U.S.C. § 360i(a)(1), (3)).
These include the obligation to: 1) inform the FDA of
new clinical investigations or scientific studies
concerning the device about which the manufacturer
know or reasonably should know, 21 C.F.R. §
A-0680-18T4
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814.84(b)(2); and 2) 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 if it
recurred, 21 C.F.R. § 803.50(a).
[Id. at 381-82 (citing Riegel, 552 U.S. at 319-20).]
The FDA may withdraw the device's PMA "based on newly reported
data," however, it "must withdraw approval if it determines that a device is
unsafe or ineffective under the conditions in its labeling." Riegel, 552 U.S. at
319-20 (citing 21 U.S.C. §§ 360e(e)(1), 360h(e)).
B. Premarket Approval of Essure
The FDA granted Essure PMA in 2002. After Essure's approval, and
before the device was implanted in plaintiff, two pertinent PMA supplements
regarding the device's labeling were approved by the FDA:
2012: patient and physician labeling updated to include
results of 5-year follow-up of subjects in Phase II and
pivotal trials and information on pregnancies that have
occurred in the commercial setting (that is, outside of
clinical trials).
2013: patient labeling updated to include risks of
chronic pain and device migration.
[FDA, Regulatory History: Essure Permanent Birth
Control, https://www.fda.gov/medical-devices/essure-
permanent-birth-control/regulatory-history (last
updated May 15, 2019) (last visited January 2, 2020).]
A-0680-18T4
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C. Implantation of Essure and Alleged Resulting Problems
On October 29, 2014, Robert M. Schaefer, M.D., implanted the Essure
device in plaintiff at the Ambulatory Surgical Pavilion at Robert Wood Johnson
(the Surgical Center). Plaintiff claims after implantation she "experience[d]
adverse reactions and side effects including . . . intermittent and severe
abdominal pain and chronic and abnormal vaginal bleeding" following
implantation. Plaintiff states she underwent approximately six months of
diagnostic testing and the removal of uterine polyps during the period from July
2015 until January 2016. Plaintiff ultimately underwent a hysterectomy on
January 13, 2016, to remove the Essure.
D. The Litigation
On August 17, 2017, plaintiff filed a nine-count complaint alleging the
following causes of action: medical malpractice (counts one and two);
negligence (count three); breach of express and implied warranties (count four);
gross negligence (count five); strict liability (count six); failure to warn (count
seven); fraud and misrepresentation (count eight); and violation of the Consumer
Fraud Act (CFA), N.J.S.A. 56:8-1 to -20 (count nine).
Plaintiff alleged the following parties committed medical malpractice:
Dr. Schaefer, the Surgical Center, and Robert Wood Johnson University
A-0680-18T4
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Hospital (the Hospital), the owner/operator of the Surgical Center. Dr. Schaefer
and the Hospital filed unopposed motions to dismiss the medical malpractice
claims with prejudice for failure to file an affidavit of merit. 1 The motions were
granted on March 29, 2018. Plaintiff does not appeal from those orders. On
April 26, 2018, a stipulation of dismissal with prejudice was entered as to the
Surgical Center. As a result, counts one and two were dismissed in their entirety
and only the products liability and related claims asserted against the Bayer
defendants (counts three through nine) remained.
The Bayer defendants moved to dismiss plaintiff's claims with prejudice
as preempted by federal law and for failure to state a claim upon which relief
may be granted. On August 31, 2018, the court granted the motion dismissing
all claims against the Bayer defendants with prejudice.
In its written statement of reasons, the motion court stated plaintiff's
claims were preempted. Noting that Essure received PMA, the court determined
the FDA had established requirements applicable to the device. It further
determined that "[p]laintiff's claims require a finding that issues relating to
1
A plaintiff who files suit against a physician or a hospital for medical
malpractice must provide the defendant with the affidavit of an appropriate
expert stating that the action has merit. N.J.S.A. 2A:53A-27. The affidavit must
be provided within the time limitations imposed by the statute. Ibid. Failure to
do so is "deemed a failure to state a cause of action." N.J.S.A. 2A:53A-29.
A-0680-18T4
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factors such as warnings should have been different from the federal
requirements." It further found that plaintiff failed "to show her claims fall
within [the] narrow exception to this preemption rule."
The motion court also concluded that the New Jersey Product Liability
Act (PLA), N.J.S.A. 2A:58C-1 to -11,
limits the types of theories that are permissible in a
products liability case such as design defects and
manufacturing defects. As a result, certain claims do
not fall within the PLA and are thus not permissible.
These include claims made by [p]laintiff for negligent
training and failure to report adverse events. As to the
issue of the failure to report adverse events, this [c]ourt
acknowledges that courts across the country are split.
However, this [c]ourt is guided by the New Jersey
Supreme Court decision of Cornett v. Johnson &
Johnson, 211 N.J. 362 (2012)[,] which ruled in part that
such claims are impliedly preempted. As to the claim
for manufacturing defect, this [c]ourt finds that
[p]laintiff has not sufficiently labeled what the
violation is as it relates to federal manufacturing
defects. The [c]ourt needs more than a flat allegation
to understand what the actual defective manufacture is
here as alleged by [p]laintiff. As a result, this [c]ourt
finds that [p]laintiff has not labeled the defect and how
it caused [p]laintiff's injuries, which would be
necessary to state a claim and possibly proceed past a
preemption analysis.
Since plaintiff's claims for medical malpractice were previously
dismissed, the dismissal of her claims against the Bayer defendants was a final
adjudication. This appeal followed.
A-0680-18T4
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Plaintiff raises the following points on appeal:
I. THERE IS A STRONG PRESUMPTION
AGAINST PREEMPTION UNDER NEW
JERSEY AND FEDERAL LAW.
II. THERE ARE VERY FEW MEDICAL DEVICE
PRODUCT LIABILITY ACTIONS
NATIONWIDE THAT FIND COMPLETE
PREEMPTION OF A PLAINTIFF'S CLAIMS.
III. PLAINTIFF'S CLAIMS ARE NOT
PREEMPTED.
A. Plaintiff's Manufacturing Defect And
Design Defect Claims Are Not Preempted.
B. Plaintiff's Breach Of Express Warranty
Claims Are Not Preempted.
C. Plaintiff's Fraudulent And Negligent
Misrepresentation And Breach Of Implied
Warranty Claims Are Contained Within
The Product Liability Act And Are Not
Preempted.
D. Plaintiff's Failure To Warn Claims Are Not
Preempted.
E. Plaintiff's Negligent Training Claims Are
Not Preempted.
IV. PLAINTIFF HAS PLED VALID CLAIMS FOR
RELIEF.
A. Plaintiff[] Has Sufficiently Pled Facts To
Show Causation And Reliance.
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B. Plaintiff Has Met The Pleading
Requirements Of [Rule] 4:5-8.
V. DEFENDANTS FAIL TO HOLD A VALID
PREMARKET APPROVAL UNDER THE
MEDICAL DEVICES AMENDMENTS TO THE
FOOD, DRUG & COSMETIC ACT AND
THEREFORE PLAINTIFF'S STATE LAW
CLAIMS ARE NOT PREEMPTED.
The primary issue presented on appeal is whether the MDA's express
preemption clause, 21 U.S.C. § 360k, bars plaintiff's state-law claims for
damages allegedly caused by a medical device given PMA by the FDA. The
secondary issue is whether plaintiff sufficiently pleaded any non-preempted
claims to avoid dismissal.
II.
"In considering a motion to dismiss under Rule 4:6-2(e), courts search the
allegations of the pleading in depth and with liberality to determine whether a
cause of action is '"suggested' by the facts." Rezem Family Assocs., LP v.
Borough of Millstone, 423 N.J. Super. 103, 113 (App. Div. 2011) (quoting
Printing Mart-Morristown v. Sharp Elecs. Corp., 116 N.J. 739, 746 (1989)). The
court should "ascertain whether the fundament of a cause of action may be
gleaned even from an obscure statement of claim, opportunity being given to
amend if necessary." Ibid. (quoting Di Cristofaro v. Laurel Grove Mem'l Park,
A-0680-18T4
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43 N.J. Super. 244, 252 (App. Div. 1957)). "For this purpose, 'all facts alleged
in the complaint and legitimate inferences drawn therefrom are deemed
admitted.'" Rieder v. State, Dep't of Transp., 221 N.J. Super. 547, 552 (App.
Div. 1987) (quoting Smith v. City of Newark, 136 N.J. Super. 107, 112 (App.
Div. 1975)).
"On appeal, we engage in a de novo review from a trial court's decision to
grant or deny a motion to dismiss filed pursuant to Rule 4:6-2(e)." Smith v.
Datla, 451 N.J. Super. 82, 88 (App. Div. 2017) (citing Rezem, 423 N.J. Super.
at 114). "We owe no deference to the trial court's conclusions." Rezem, 423 N.J. Super. at 114. We will uphold the dismissal if "the factual allegations are
palpably insufficient to support a claim upon which relief can be granted."
Rieder, 221 N.J. Super. at 552.
III.
In Reigel, the Court described the following two-part analysis for
determining whether a plaintiff's state law claims for harm caused by a PMA
device are preempted: "First, a court must determine whether the FDA has
imposed requirements for the device. Second, a court must determine whether
the common law claims are based on state requirements different from or in
addition to the federal requirements for the device." Cornett, 211 N.J. at 384
A-0680-18T4
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(citing Riegel, 552 U.S. at 321-22). "[T]o escape preemption, the state claim
premised on a violation of FDA regulations must be based on state common law
duties parallel to but not in addition to federal requirements." Id. at 385 (citing
Riegel, 552 U.S. at 330).
A plaintiffs' state-law claims for harm caused by a PMA device may also
be "impliedly pre-empted by" federal law. Buckman, 531 U.S. at 348. "[S]tate
law claims brought by individuals based on intentional misrepresentation to the
FDA during or after the PMA process are barred." Cornett, 211 N.J. at 385
(citing Buckman, 531 U.S. at 349 n.4). "[O]nly the federal government is
authorized to sue for failure to comply with the MDA provisions, including
providing false or misleading information." Ibid. (citing Buckman, 531 U.S. at
349 n.4). "Thus, regardless of how a plaintiff styles a state claim, if the claim
depends on the alleged violation of a federal requirement, it is functionally
equivalent to a claim grounded solely on the federal violation, and is impliedly
preempted." Cornett, 211 N.J. at 385 (citing Buckman, 531 U.S. at 352-53).
IV.
With those concepts in mind, we turn to New Jersey law regarding claims
for harm caused by an allegedly defective product. Such claims are generally
governed by the PLA. When our Legislature enacted the PLA, it "established
A-0680-18T4
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'one unified, statutorily defined theory of recovery for harm caused by a product,
and that theory is, for the most part, identical to strict liability.'" Dean v. Barrett
Homes, Inc., 204 N.J. 286, 294 (2010) (quoting In re Lead Paint Litig., 191 N.J.
405, 436 (2007)). The PLA is, thus, "remedial legislation," enacted to "establish
clear rules" in claims "for damages for harm caused by products, including
certain principles under which liability is imposed." McDarby v. Merck & Co.,
401 N.J. Super. 10, 97 (App. Div. 2008) (quoting Zaza v. Marquess & Nell, Inc.,
144 N.J. 34, 47-48 (1996)).
"A product liability action is defined as 'any claim or action brought by a
claimant for harm caused by a product, irrespective of the theory underlying the
claim, except actions for harm caused by breach of an express warranty.'"
Sinclair v. Merck & Co., 195 N.J. 51, 62 (2008) (quoting N.J.S.A. 2A:58C-
1(b)(3)). The PLA provides the following basis for liability:
A manufacturer or seller of a product shall be liable in
a product liability action only if the claimant proves by
a preponderance of the evidence that the product
causing the harm was not reasonably fit, suitable or safe
for its intended purpose because it: a. deviated from the
design specifications, formulae, or performance
standards of the manufacturer or from otherwise
identical units manufactured to the same manufacturing
specifications or formulae, or b. failed to contain
adequate warnings or instructions, or c. was designed
in a defective manner.
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[N.J.S.A. 2A:58C-2.]
In other words, a "prerequisite" for recovery under the PLA "is the existence of
a defective condition." Zaza, 144 N.J. at 49.
V.
A. Plaintiff's Claims For Negligence, Breach Of Implied
Warranty, Fraud And Misrepresentation, And Violations Of
The CFA
We first address plaintiff's claims for negligence (count three); breach of
implied warranties (count four); gross negligence (count five); fraud and
misrepresentation (count eight); and violation of the CFA (count nine). Plaintiff
argues those claims are not preempted by the MDA. We need not reach the issue
of whether those claims are preempted because, with the exception of plaintiff's
claim for negligent training, here, as in Cornett, "the PLA subsumed those
claims." Cornett, 414 N.J. Super. at 404.
"With the sole exception of its accommodation for breach of express
warranty, the PLA displaces all other causes of action 'for harm caused by a
product, irrespective of the theory underlying the claim[.]'" Ibid. (alteration in
original) (quoting N.J.S.A. 2A:58C-1(b)(3)). Put simply, the PLA
"encompass[es] virtually all possible causes of action relating to harms caused
by consumer and other products." Sinclair, 195 N.J. at 65 (quoting Lead Paint,
A-0680-18T4
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191 N.J. at 436-37). Consequently, breach of implied warranty is no longer "a
viable separate claim" for harm caused by a product. Cornett, 414 N.J. Super.
at 404 (quoting Tirrell v. Navistar Int'l, Inc., 248 N.J. Super. 390, 398 (App.
Div. 1991)). A separate claim for negligence is similarly precluded. Tirrell,
248 N.J. Super. at 398. Plaintiffs are likewise barred from asserting "separate
causes of action under the PLA and the CFA." McDarby, 401 N.J. Super. at 98.
See also Sinclair, 195 N.J. at 66 ("The language of the PLA represents a clear
legislative intent that, despite the broad reach we give to the CFA, the PLA is
paramount when the underlying claim is one for harm caused by a product.").
As such, except for plaintiff's negligent training claim, counts three, four, five,
eight, and nine were properly dismissed, irrespective of any preemption
analysis, because the claims are precluded by the PLA.
B. Plaintiff's Claims For Breach Of Express Warranty, Failure To
Warn, Negligent Training, And Manufacturing Defect
1. Breach of Express Warranty and Failure to Warn
We next address plaintiff's claims for breach of express warranties (count
four) and failure to warn (count seven). Plaintiff again argues her claims are not
preempted by the MDA. We affirm the dismissal of those claims because
plaintiff has not pleaded her claims with sufficient specificity to survive a
preemption analysis.
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If a plaintiff's state-law claim concerns the labelling of, or information
provided with, a PMA device, the possibility of preemption of that PLA claim
arises. Cornett, 211 N.J. at 387 (citing Kemp v. Medtronic, Inc., 231 F.3d 216,
236-37 (6th Cir. 2000)). PMA demonstrates the manufacturer established the
safety and effectiveness of the device for its approved uses. Ibid. The PMA
encompasses the device's label and instructions. Ibid. "The totality of the
approval represents a specific federal requirement." Ibid. (citing Kemp, 231
F.3d at 228).
Our Legislature acknowledged the primacy of federal regulation of
medical devices when it included a "rebuttable presumption of the adequacy of
labels and instructions in the PLA." Ibid. (citing N.J.S.A. 2A:58C-4).2
Accordingly, "a plaintiff asserting a failure to warn claim based on an inadequate
label or instructions" for a PMA device "has stricter pleading requirements." Id.
at 388. The "plaintiff must plead specific facts alleging 'deliberate concealment
or nondisclosure of after-acquired knowledge of harmful effects,' or
'manipulation of the post-market regulatory process.'" Ibid. (first quoting Rowe
v. Hoffman-La Roche, Inc., 189 N.J. 615, 626 (2007); then quoting McDarby,
2 N.J.S.A. 2A:58C-4 states: "If the warning or instruction given in connection
with a . . . device . . . has been approved . . . by the [FDA] under the [FDCA ,] a
rebuttable presumption shall arise that the warning or instruction is adequate."
A-0680-18T4
20
401 N.J. Super. at 63). The heightened pleading requirement "serves to permit
a determination whether a failure to warn claim is preempted by the MDA or is
a permissible parallel state claim." Ibid.
Cornett is instructive. In Cornett, the Court decided whether the state-law
claims asserted in forty-eight consolidated complaints constituted permissible
parallel claims or were preempted by Section 360k of the MDA. 211 N.J. at
368, 370. The named plaintiff, Billie Cornett, who suffered from coronary artery
disease and diabetes, had a Cypher® stent, a PMA device, implanted to treat his
heart condition. Id. at 368-70. Five months after the stent was implanted, a
blood clot formed near the site of the stent; Cornett suffered a subacute stent
thrombosis resulting in his death eleven days later. Id. at 368.
Cornett's widow and others filed suit against the defendants for the
injuries allegedly caused by Cypher® stents. Id. at 368, 370. The defendants
moved to dismiss the plaintiffs' claims as preempted by the MDA. Id. at 370.
The plaintiffs were given leave to file an amended complaint that asserted the
following nine causes of action: (1) strict liability for defective design; (2) strict
liability for defective manufacture; (3) strict liability for failure to warn; (4)
breach of implied warranty; (5) breach of express warranty; (6) consumer fraud;
(7) punitive damages; (8) wrongful death; and (9) loss of consortium. Ibid.
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The Court granted the defendants' motion to dismiss the amended
complaint as fully preempted by federal law. Cornett, 211 N.J. at 371. "[T]he
claimed express warranty was the patient information card and guide that the
FDA had specifically approved as part of [the Cypher® stent] label." Cornett,
414 N.J. at 383. Thus, a claim that the card and guide "failed to conform with
the materials expressly approved by the FDA . . . would be patently false.'" Id.
at 383-84 (alteration in original). Therefore, the motion court concluded the
plaintiffs' claim for breach of express warranty was "'nothing more than a
defective labeling/failure to warn claim, which is preempted' for a device
approved under the FDA's [PMA] regime." Id. at 384. It held the plaintiffs
alleged their claims were parallel to federal requirements merely to invoke the
exception to preemption but failed to set forth facts or legal authority that
demonstrated their claims were actually equivalent to the federal requirements.
Ibid. The motion court dismissed the plaintiffs' wrongful death, loss of
consortium and survivorship claims as "derivative of the strict liability and
breach of warranty claims it found expressly preempted." Id. at 405.
On appeal, we held the following claims were not preempted by federal
law: (1) manufacturing defect; (2) failure to warn, "to the extent that plaintiffs
based it on allegations of failure to satisfy federal requirements on disclosure ;"
A-0680-18T4
22
and (3) breach of express warranty, "to the extent that plaintiffs based it on
voluntary statements." Id. at 405. We determined "reversal of the Rule 4:6-2(e)
dismissal of th[o]se predicate claims compel[led] reinstatement of [the]
derivative claims for wrongful death, loss of consortium, and survivorship." Id.
at 406. We held the dismissal of the remaining claims – defective design, breach
of implied warranty, consumer fraud, and punitive damages – "was proper as
either federally preempted or precluded by the PLA itself." Ibid.
After the Court granted certification, the defendants withdrew their
challenge to the failure to dismiss the manufacturing defect claim. Cornett, 211 N.J. at 369 n.1. Accordingly, the Court did not decide the issue of whether the
plaintiffs' manufacturing defect claim was preempted; the opinion was limited
to whether the plaintiffs' failure to warn and breach of express warranty claims
were preempted by the MDA. Id. at 372 (citing Cornell v. Johnson & Johnson,
205 N.J. 317 (2011)).
The Court engaged in the following analysis of the plaintiffs' failure to
warn claim:
[T]he failure to warn claim relates to the duration of
post-implantation anti-platelet therapy and the lack of
comparative studies of the Cypher® stent and
alternative devices. This claim is nothing more than a
challenge to the adequacy of the information required
by the FDA during the PMA process and label approved
A-0680-18T4
23
by the [FDA, which] falls within the PLA rebuttable
presumption and the Riegel express preemption rule.
We affirm its dismissal.
Moreover, to the extent [the] claim is based
solely on a contention that defendants obtained [PMA]
only after submitting fraudulent representations to or
withholding material information from the FDA, this
claim falls squarely within the Buckman implied
preemption rule. We affirm its dismissal. So, too,
plaintiffs' failure to warn claim is preempted and
dismissed to the extent that it can be established solely
by evidence of fraud on the [FDA].
....
On the other hand, to the extent [the] plaintiffs' .
. . claim is based on other allegations of wrong-doing
apart from [the] defendants' failure to comply with FDA
disclosure requirements, it is not preempted. [The
plaintiffs alleged the] defendants withheld information
from the general public and the medical community
about the limitations . . . or safe use of the device,
including information that instructions for post-
implantation therapy were not part of the PMA process,
and misrepresented to the general public and medical
community that the Cypher® stent was non-
thrombogenic. As stated, this claim overcomes the
PLA rebuttable presumption of adequacy. [Perez v.
Wyeth Labs., Inc., 161 N.J. 1, 25 (1999).] Such a claim
falls within a traditional area of state concern and
regulation because fraud on the FDA is not an element
of the claim and it can be proved by evidence other than
by evidence of fraud on the FDA.
[Id. at 389-90 (footnotes omitted).]
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24
The Court determined the amended complaint, "read indulgently and in its
entirety," presented a "colorable" failure to warn claim that was not impliedly
preempted. Id. at 391. Nevertheless, the Court warned its decision came "at an
early stage in the proceedings" as the motion to dismiss was filed soon after the
plaintiffs filed their amended master complaint. Ibid. The Court instructed the
trial court that it "should not hesitate to grant" summary judgment, "if
appropriate." Consequently,
[i]f discovery reveals that the failure to warn claim is
nothing more than a private action to enforce FDA
statutes and regulations, or that plaintiffs' claim is no
more than a challenge to the approval of the device or
label, or that proof of fraud on the FDA is an element
of the[] claim, or that defendants' off-label promotional
activities fall within the MDA safe harbor . . . ."
[Ibid.]
Here, the following statement in plaintiff's complaint comprises her entire
failure to warn claim:
The Bayer defendants manufactured, distributed into
the stream of commerce, and/or marketed the defective
Essure device that was not reasonably fit, suitable or
safe for its intended purpose because Essure failed to
contain adequate warnings or instructions, was
designed in a defective manner, and such other defects
as continuing discovery and investigation may reveal.
A-0680-18T4
25
Plaintiff has not satisfied the heightened pleading requirement applicable to her
failure to warn claim. Accordingly, the motion court properly dismissed
plaintiff's failure to warn claim.
The MDA also preempts an express warranty claim based on the
information contained in FDA approved product labels and packaging inserts.
Id. at 392. "Like other state requirements that exceed federal requirements for
a PMA device, a state claim that allows liability for statements in the FDA-
approved label and other documentation is preempted." Cornett, 414 N.J. Super
at 403 (citing Riley v. Cordis Corp., 625 F. Supp. 2d 769, 787-88 (D. Minn.
2009)). The Supreme Court engaged in the following analysis of the plaintiffs'
breach of express warranty claim:
Following Riegel, generalized state common law
theories of liability, such as alleged in the [plaintiffs'
complaint], are precisely the types of claims preempted
by the MDA.
....
[T]o succeed on the breach of express warranty
claim, [the] plaintiffs must show . . . the label provides
inaccurate or insufficient information in spite of FDA
approval following the rigorous PMA process. Success
on this state law claim would inevitably impose greater
requirements than those already established by the
MDA. This claim is, therefore, preempted.
A-0680-18T4
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On the other hand, to the extent [the] plaintiffs
allege [the] defendants . . . deviated from the labeling
and instructions for use through voluntary statements .
. . in the course of its marketing efforts, this claim is
not preempted.
[Cornett, 211 N.J. at 392-93.]
The Court held the only aspects of the plaintiffs' breach of express warranty
claim that was not preempted were the "voluntary statements" by the defendants
that were "not approved . . . or mandated by the FDA about the use or
effectiveness of the product for on-label or off-label uses," "because federal law
requires any warranty statement to be truthful and accurate." Id. at 392 (citing
Cornett, 414 N.J. Super. at 404). When so "limited, an express warranty claim
based on state law does not impose additional requirements or obligations on
[medical device manufacturers] and is not preempted." Ibid. (citing Cornett,
414 N.J. Super. at 404).
Here, plaintiff's breach of express warranty claim is limited to the
following allegations:
43. [Bayer] expressly . . . warranted to the general
public, and to [plaintiff] in particular, that the . . .
Essure device was safe, merchantable, and fit for the
use for which it was intended.
44. [Bayer] breached the aforesaid warranties in that the
Essure device was unsafe, not of merchantable quality,
A-0680-18T4
27
and/or unfit for the purposes and use for which it was
intended.
45. Plaintiff, relied upon the warranties made by
[Bayer].
Once again, plaintiff did not plead her claim with sufficient specificity to survive
the motion to dismiss.
2. Negligent Training
We next address the dismissal of plaintiff's negligent training claim. We
find the Eastern District of Pennsylvania's decision in McLaughlin v. Bayer
Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016), to be persuasive authority. In
McLaughlin, the plaintiffs alleged Bayer was liable for negligent training
because it failed to (1) "abide by the FDA training guidelines," i.e., the plaintiffs
alleged Bayer provided "training [that was] different from that of the 'Physician
Training Manual[]'" approved by the FDA; (2) properly supervise the plaintiffs'
procedures; (3) provide the plaintiffs' implanting physicians with adequate
training on the use of the hysteroscopic equipment; and (4) "advise implanting
physicians of the adverse events and non-conforming product." Id. at 816
(alteration in original). The plaintiffs asserted Bayer's negligent training caused
their damages "insofar as the Essure device migrated from [their] fallopian tubes
and caused various complications." Ibid.
A-0680-18T4
28
The McLaughlin court engaged in the following analysis:
[A]t least to the extent that the claim alleges that Bayer
failed to abide by FDA-approved training
[requirements], the negligent training claim does not
seek to impose training requirements different from
those in the federal requirements and, thus, is not
expressly preempted on that basis but, rather, asserts a
permissible parallel claim. . . .
....
Reading the [c]omplaint in the light most
favorable to [the plaintiffs], it alleges that Bayer, by
training [the plaintiffs' implanting] physicians,
assumed a duty to do so non-negligently; that Bayer
breached that duty by failing to follow the FDA-
imposed training guidelines; and that [the plaintiffs']
injuries, all of which are alleged to have arisen from the
migration of the Essure device from [their] fallopian
tubes, were caused by Bayer's training deficiencies.
However, the [c]omplaint does not allege how Bayer's
training departed from the FDA-approved guidelines,
much less any facts that give rise to a recognizable
theory as to how any departure from the training
guidelines may have caused each [p]laintiff's Essure
device to migrate from her fallopian tubes.
[Id. at 816-17 (footnotes and citations omitted).]
As a result, the McLaughlin court dismissed the plaintiffs' negligent training
claims for failure to state a claim upon which relief can be granted because their
"bald allegations of both negligence and causation d[id] nothing more than posit
a 'sheer possibility that [Bayer] has acted unlawfully,' without setting forth a
A-0680-18T4
29
plausible claim of negligent training." Id. at 817-18 (alteration in original)
(quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
Here, plaintiff's entire negligent training allegation is contained in
paragraph forty of the complaint:
[Bayer] negligently failed to properly and/or
adequately train implanting health care providers on
how to use the Essure device and hysteroscopic
equipment provided for the procedure, failed to ensure
that ECTs were performed, failed to properly screen
physicians who were not competent or qualified to use
said Essure device and hysteroscopic equipment and
created an unreasonably dangerous plan of distribution
at the expense of Plaintiff's health and well-being.
Because plaintiff's negligent training claim is so insufficiently pleaded,
we are prevented from determining whether it is based upon any non-preempted
claim for relief. Id. at 818. Plaintiff does not allege Bayer's training departed
from the FDA-approved guidelines, much less how it departed from the
guidelines. Nor does she posit any theory as to how the allegedly negligent
training caused plaintiff's injury. For these reasons, the negligent training claim
was properly dismissed.
3. Manufacturing Defect
Lastly, even when read indulgently, plaintiff's complaint claim for "strict
liability," which we construe as a manufacturing defect claim, did not assert
A-0680-18T4
30
sufficient facts or a cognizable theory of liability to survive defendants' motion
to dismiss.
Manufacturers of PMA devices are:
required to follow the design controls process as
enumerated in 21 C.F.R. § 820.30. In addition to design
controls, the manufacturer must also comply with
manufacturing controls outlined at 21 C.F.R. §
814.20(b)(4) and § 820. These controls require the
manufacturer to submit to the FDA a complete
description of the methods used in, and the facilities
and controls used for, the manufacture, processing,
packing, storage, and where appropriate, installation of
the device.
[Cornett, 414 N.J. Super. at 386.]
A plaintiff's manufacturing defect claim that alleges the PMA device was
"adulterated due to failure to comply with federal regulations" is "not preempted
because a jury could find the defendants breached their duty of care to the
plaintiff and that the product was unreasonably dangerous without imposing
different or additional requirements." Id. at 398 (citing Hofts v. Howmedica
Osteonics Corp., 597 F. Supp. 2d 830, 836-37 (S.D. Ind. 2009)).
Plaintiff's complaint states:
55. The Essure devices manufactured, sold, promoted
and/or distributed by [Bayer] were, at the time they left
[the] control of [Bayer], defective products,
unreasonably dangerous for use, which were not fit,
suitable and/or safe for their intended use of
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31
contraception in otherwise healthy women resulting in
the injuries and damages to plaintiffs as stated above.
56. Plaintiff used the Essure device in the way [Bayer]
intended it to be used and in a manner which was
reasonably foreseeable by [Bayer].
57. Plaintiff's injuries and reliance upon [Bayer's]
misrepresentations and expertise were reasonably
foreseeable by [Bayer].
58. [Bayer] failed to warn Plaintiff of the risks inherent
in the insertion and function of the Essure device.
59. Plaintiffs therefore rely upon the doctrine of strict
liability in tort against [Bayer].
60. [Bayer is] strictly liable for plaintiff['s] injuries and
loss pursuant to [the PLA].
61. As the direct result of [Bayer's] conduct, [p]laintiff
suffered severe and permanent injuries. As a
consequence thereof, she has suffered great pain,
disability and mental anguish, and because of the
permanency of said injuries she will continue to suffer
in the future; moreover, she has suffered other injuries
to [p]laintiff's danger and detriment.
As with her negligent training claim, plaintiff fails to adequately state a
manufacturing defect claim. Plaintiff does not allege Bayer's manufacturing
process departed from the FDA-approved process, much less how it departed
from the approved process. In that regard, noticeably absent from the complaint
and plaintiff's opposing papers are any facts or allegations that the Essure
A-0680-18T4
32
implanted deviated from the design approved by the FDA. Nor does she posit
any theory as to how the allegedly defective manufacturing process caused her
injury. During oral argument before this court, plaintiff conceded that she had
no additional facts she could plead in support of her claims if she were permitted
to file an amended complaint. Given these circumstances, plaintiff's
manufacturing defect claim, comprised of mere bald assertions, was properly
dismissed.
VI.
In sum, the dismissal of plaintiff's complaint with prejudice is affirmed.
Plaintiff's claims for negligence (other than negligent training), breach of
implied warranties, fraud and misrepresentation, strict liability, and violations
of the CFA, are subsumed by the PLA. Cornett, 414 N.J. Super. at 404.
Plaintiff's claims for negligent training, breach of express warranties, and failure
to warn were properly dismissed due to plaintiff's failure to satisfy the "stricter
pleading requirements" applicable to claims for harm allegedly caused by PMA
devices. Cornett, 211 N.J. at 388. Plaintiff's claim for manufacturing defect
amounts to nothing more than an insufficient, factually unsupported, conclusory
allegation. During oral argument before this court, plaintiff acknowledged that
no additional facts would be added if she were permitted to file an amended
A-0680-18T4
33
complaint. The motion court properly concluded that even when read
indulgently, plaintiff has not sufficiently pleaded her claims to allow the court
to conduct a proper preemption analysis or to otherwise survive dismissal.
Dismissal of the complaint for "failure to state a claim upon which relief can be
granted" was appropriate. R. 4:6-2(e).
We are mindful of the large number of reported problems experienced by
women who had Essure birth control devices implanted. We are also aware of
the non-binding cases in other jurisdictions which reach a different conclusion
and which are not subject to New Jersey precedent. Our Supreme Court has
spoken on the subject of federal preemption and the stricter pleading
requirements pertaining to claims involving PMA devices, and we follow its
guidance here.
Affirmed.
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