Canary v. Medtronic, Inc.

Filing 24

OPINION and ORDER re 17 granting in part defendant's MOTION to Dismiss Plaintiff's First Amended Complaint. The Court dismisses count I, II & III. Pltf may proceed w/draud claim asserted in ct IV of the lst amended complaint. Signed by District Judge Nancy G. Edmunds. (CBet)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION

JANET CANARY,
Case No. 16-11742
Plaintiff,
Honorable Nancy G. Edmunds
v.
MEDTRONIC, INC.,
Defendant.
/

OPINION AND ORDER GRANTING IN PART DEFENDANT’S
MOTION TO DISMISS PLAINTIFF’S FIRST AMENDED COMPLAINT [17]
In May of 2013, Plaintiff was implanted with a spinal cord stimulator manufactured by
Defendant Medtronic, Inc. Within a few days after this device was activated, Plaintiff
allegedly developed a severe allergic reaction and hives over her entire body, and she was
admitted to an intensive care unit at a local hospital. It was soon determined that
Defendant’s device had triggered Plaintiff’s allergies to latex and rubber, and the device
was removed in June of 2013. Based on this incident, Plaintiff has asserted state-law
product liability and fraud claims against Defendant, alleging that Defendant’s medical
device had manufacturing and design defects, that Defendant failed to provide adequate
warnings against the alleged defects in its device, and that Defendant’s representatives
made misrepresentations to Plaintiff about the safety of Defendant’s medical device.
Through the present motion filed on January 3, 2017, Defendant seeks the dismissal
of Plaintiff’s first amended complaint under Federal Rule of Civil Procedure 12(b)(6).1 In
1

Defendant previously filed a motion to dismiss Plaintiff’s initial complaint, but this
motion was resolved through a stipulated order authorizing Plaintiff to amend her

support of this motion, Defendant argues that Plaintiff’s product liability claims are
preempted by federal law, either expressly or by implication, and that Plaintiff also has
failed to adequately plead her state-law claims of product liability and fraud.
On April 12, 2017, the Court heard oral argument on Defendant’s motion. For the
reasons stated more fully below, the Court GRANTS IN PART AND DENIES IN PART
Defendant’s motion to dismiss, holding that Plaintiff’s product liability claims are expressly
preempted but that she may go forward with her claim of fraud.
I.

FACTS
The facts giving rise to this suit are set forth in Plaintiff’s first amended complaint, and

Plaintiff’s factual allegations are accepted as true for present purposes.

Defendant

Medtronic, Inc. designs, manufactures, markets, and sells a variety of medical devices,
including the PrimeAdvanced spinal cord stimulator at issue in this case. This product is
deemed a Class III medical device under federal law, and Defendant therefore had to
secure the approval of the federal Food and Drug Administration (“FDA”) before it could
market and sell this device. See 21 U.S.C. § 360c(a)(1)(C)(ii).2

complaint.
2

According to public records accompanying Defendant’s motion, Defendant obtained
premarket approval for a predecessor spinal cord stimulator back in 1984, and the FDA
granted premarket approval of the specific device involved in this case on July 7, 2006.
(See Defendant’s Motion, Ex. 1 (record of premarket approval of predecessor device);
Ex. 2 (record of premarket approval of device implanted in Plaintiff).) As Defendant
observes, although the records evidencing the FDA’s approval of Defendant’s device
are not part of the pleadings in this case, the Court “may consider public records without
converting a Rule 12(b)(6) motion into a Rule 56 [summary judgment] motion.” Jones v.
City of Cincinnati, 521 F.3d 555, 562 (6th Cir. 2008); see also Thorn v. Medtronic
Sofamor Danek, USA, Inc., 81 F. Supp.3d 619, 622-23 (W.D. Mich. 2015) (considering
a medical device’s premarket approval and its FDA-approved label in deciding a motion
to dismiss).
2

In February of 2008, Plaintiff Janet Canary was involved in a motor vehicle accident
and sustained serious injuries to her spine. Over the next few years, Plaintiff underwent
a number of fusion surgeries to address these injuries. Following these surgeries, Plaintiff’s
physicians recommended that she consider the implantation of a permanent spinal cord
stimulator to address her chronic neck and back pain.
As Plaintiff decided whether to pursue this course, she met on multiple occasions with
her doctors and one of Defendant’s representatives, identified in the complaint as “Violet.”
The first such meeting was held on June 11, 2012, and Plaintiff alleges that she informed
Violet on this occasion that “she had a latex and rubber allergy” and had experienced
“allergic reactions to materials used in [her] previous fusion surgeries.” (First Amended
Complaint at ¶ 18.) Plaintiff asserts that she also disclosed these allergic reactions in a
questionnaire provided to Defendant at this meeting. When Plaintiff asked Defendant’s
representative, Violet, whether “other patients have had allergic reactions to any of the
manufacturing materials and/or components in [Defendant’s] spinal cord stimulators,” Violet
responded that no patients had experienced such an allergic reaction, and she assured
Plaintiff that “a latex and rubber allergy did not prevent implantation of [Defendant’s] spinal
cord stimulators.” (Id. at ¶ 21.)
Based on these representations, Plaintiff agreed to a trial use of Defendant’s spinal
cord stimulator, and a physician implanted this trial device on October 11, 2012. In contrast
to a permanent implant, the majority of the trial device remained outside of Plaintiff’s body.
Although Plaintiff did not experience any allergic reactions during this trial, she notes that
the trial device “was only activated for less than six hours,” and was “implanted for less than
24 hours because it was accidentally pulled out of her back during the trial.” (Id. at ¶ 23.)
3

Plaintiff next met with her physician and Defendant’s representative, Violet, on April
24, 2013. Plaintiff again inquired about other patients who might have had allergic
reactions to the materials used in Defendant’s spinal cord stimulators, and Violet again
responded that there had been no such allergic reactions, and that a latex or rubber allergy
would not preclude the implantation of Defendant’s spinal cord stimulators. (See id. at ¶
24.) Accordingly, Plaintiff elected to go forward with the implantation of a permanent spinal
cord stimulator, and this procedure was scheduled for May 16, 2013.
On the date of this procedure, Plaintiff met once more with her physician and
Defendant’s representative, Violet. After Violet once again confirmed that no patients had
reported allergic reactions to the materials used in Defendant’s spinal cord stimulators and
that latex and rubber allergies were no barrier to the use of this device, Plaintiff went ahead
with the permanent implantation of Defendant’s PrimeAdvanced spinal cord stimulator.
On May 22, 2013, Plaintiff’s physician activated the device that had been implanted
a few days earlier. Within five hours, Plaintiff developed pruritus at the site of the device’s
lead and battery placement, and “[o]ver the next four days, she . . . developed hives over
her entire body.” (Id. at ¶ 28.) This allergic reaction got progressively worse over the next
few days, to the point that Plaintiff was admitted to the intensive care unit at a local hospital
from May 28 to May 31, 2013. Upon her discharge from the hospital, Plaintiff was
diagnosed with “contact dermatitis secondary to spinal cord stimulator with resulting
urticaria and pruritus.” (Id. at ¶ 34.)
While Plaintiff was in the midst of this severe allergic reaction, she called Defendant’s
representative, Violet, on May 26, 2013 and informed her of the various conditions from
which she was suffering following the activation of Defendant’s device, including “a fever,
4

vomiting, difficulty breathing, swelling of her hands and face,” and an outbreak of hives over
her entire body. (Id. at ¶ 29.) In response, Violet “only then informed [Plaintiff] that other
. . . patients had indeed [experienced] allergic reactions to manufacturing materials and/or
components of [Defendant’s] spinal cord stimulator, which included being covered in hives.”
(Id.) More specifically, Plaintiff alleges that Defendant’s device “contained latex and/or
rubber manufacturing materials and/or components,” and that Defendant’s representative,
Violet, was aware prior to the date of Plaintiff’s procedure that other patients had suffered
allergic reactions to these substances in Defendant’s device. (Id. at ¶¶ 30-31.)
On June 13, 2013, Plaintiff underwent another procedure to remove Defendant’s
device, and her physician subsequently informed her that another such device could not
be implanted due to her latex and rubber allergies.

Since her allergic reaction to

Defendant’s device, Plaintiff continues to suffer from a variety of symptoms, including
dermographism and hypersensitivity to products containing certain plastics, rubber, and
latex. In this suit, Plaintiff now seeks to recover for these injuries under three state-law
theories of product liability — manufacturing defect, design defect, and failure to warn —
and she also asserts a state-law claim of fraud arising from Defendant’s alleged
misrepresentations that its spinal cord stimulator was safe for use by patients with known
latex and rubber allergies.
II.

STANDARD OF REVIEW
Through its present motion, Defendant seeks the dismissal under Fed. R. Civ. P.

12(b)(6) of each of the claims asserted in Plaintiff’s first amended complaint. When
determining whether Plaintiff’s claims are subject to dismissal under Rule 12(b)(6) for
failure to state a claim, the Court must construe the complaint in a light most favorable to
5

Plaintiff and accept all well-pleaded factual allegations as true. League of United Latin
American Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007). However, “the tenet
that a court must accept as true all of the allegations contained in a complaint is
inapplicable to legal conclusions.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937,
1949 (2009).
Moreover, “[w]hile a complaint attacked by a Rule 12(b)(6) motion to dismiss does not
need detailed factual allegations, a plaintiff’s obligation to provide the grounds of his
entitlement to relief requires more than labels and conclusions, and a formulaic recitation
of the elements of a cause of action will not do.” Bell Atlantic Corp. v. Twombly, 550 U.S.
544, 555, 127 S. Ct. 1955, 1964-65 (2007) (internal quotation marks, alteration, and
citations omitted). Rather, to withstand a motion to dismiss, the complaint’s factual
allegations, accepted as true, “must be enough to raise a right to relief above the
speculative level,” and to “state a claim to relief that is plausible on its face.” Twombly, 550
U.S. at 555, 570, 127 S. Ct. at 1965, 1974. “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.” Iqbal, 556 U.S. at 678, 129 S. Ct. at 1949.
The Supreme Court has emphasized that this plausibility standard “is not akin to a
‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has
acted unlawfully.” Iqbal, 556 U.S. at 678, 129 S. Ct. at 1949. “[W]here the well-pleaded
facts do not permit the court to infer more than the mere possibility of misconduct, the
complaint has alleged — but it has not shown — that the pleader is entitled to relief.” Iqbal,
556 U.S. at 679, 129 S. Ct. at 1950 (internal quotation marks, alteration, and citation
omitted). If a plaintiff does "not nudge[] [her] claims across the line from conceivable to
6

plausible, [her] complaint must be dismissed." Twombly, 550 U.S. at 570, 127 S. Ct. at
1974.
III.

ANALYSIS
A. Plaintiff’s Product Liability Claims Are Expressly Preempted by Federal Law.
1. The Law Governing Defendant’s Preemption Challenge
As the principal argument advanced in its motion, Defendant contends that Plaintiff’s

state-law product liability claims are preempted by federal law, either expressly or by
implication. Before turning to the specific claims of preemption raised by Defendant in this
case, the Court finds it instructive to survey the law that governs this inquiry.
As the Supreme Court has observed, the federal Food, Drug, and Cosmetic Act
(“FDCA”), 21 U.S.C. § 301 et seq., has “long required FDA approval of the introduction of
new drugs into the market,” but until the 1970s, “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, 128 S. Ct. 999, 1002 (2008). This legal landscape changed with the
enactment of the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq.,
“which swept back some state obligations and imposed a regime of detailed federal
oversight.” Riegel, 552 U.S. at 316, 128 S. Ct. at 1003. The “new regulatory regime”
ushered in through the MDA “established various levels of [FDA] oversight for medical
devices, depending on the risks they present,” with Class I devices “subject to the lowest
level of oversight” and Class III devices receiving the most stringent regulatory scrutiny.
552 U.S. at 316-17, 128 S. Ct. at 1003.
The spinal cord stimulator at issue here is a Class III device, and it therefore was

7

subject to “a rigorous regime of premarket approval” before it could be sold. 552 U.S. at
317, 128 S. Ct. at 1004. To secure this approval, a manufacturer “must submit what is
typically a multivolume application” that “includes, among other things,” (i) “full reports of
all studies and investigations of the device’s safety and effectiveness that have been
published or should reasonably be known to the applicant,” (ii) a “full statement of the
device’s components, ingredients, and properties” and its “principles of operation,” (iii) a
“full description of the methods used in, and the facilities and controls used for, the
manufacture [and] processing” of the device, and (iv) “a specimen of the proposed labeling”
of the device. 552 U.S. at 317-18, 128 S. Ct. at 1004 (internal quotation marks and citation
omitted). “The FDA spends an average of 1,200 hours reviewing each application” for
premarket approval of a Class III device, and “grants premarket approval only if it finds
there is a reasonable assurance of the device’s safety and effectiveness.” 552 U.S. at 318,
128 S. Ct. at 1004 (internal quotation marks and citation omitted). In conducting this
inquiry, the agency “must weigh any probable benefit to health from the use of the device
against any probable risk of injury or illness from such use,” and this cost/benefit analysis
may lead to the approval of “devices that present great risks if they nonetheless offer great
benefits in light of available alternatives.” 552 U.S. at 318, 128 S. Ct. at 1004 (internal
quotation marks and citation omitted).
“Once a device has received premarket approval, the MDA forbids the manufacturer
to make, without FDA permission, changes in design specifications, manufacturing
processes, labeling, or any other attribute, that would affect safety or effectiveness.” 552
U.S. at 319, 128 S. Ct. at 1005. “If the applicant wishes to make such a change, it must
submit, and the FDA must approve, an application for supplemental premarket approval,
8

to be evaluated under largely the same criteria as an initial application.” 552 U.S. at 319,
128 S. Ct. at 1005.
Beyond setting forth these detailed standards for FDA approval of medical devices,
the MDA also includes an express preemption provision:
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(a).3 This provision has been construed as “establish[ing] a two-prong test
for determining if a state-law tort claim is preempted.” Hughes v. Boston Scientific Corp.,
631 F.3d 762, 767 (5th Cir. 2011). First, the Court must “determine whether the Federal
Government has established requirements applicable to” the particular device at issue.
Riegel, 552 U.S. at 321, 128 S. Ct. at 1006. If so, the Court then must inquire whether
Plaintiff’s product liability claims “are based upon [state-law] requirements with respect to
[Defendant’s] device that are ‘different from, or in addition to,’ the federal ones, and that
relate to safety and effectiveness.” 552 U.S. at 321-22, 128 S. Ct. at 1006 (quoting 21
U.S.C. § 360k(a)).
2. Plaintiff’s Conclusory Allegations of Violations of FDA Regulations Fail
to Save Her Product Liability Claims from Federal Preemption.

3

As observed by the Supreme Court, “[t]he exception contained in subsection (b) [of
this provision] permits the FDA to exempt some state and local requirements from preemption.” Riegel, 552 U.S. at 316, 128 S. Ct. at 1003.
9

Against this legal backdrop, the Court turns to the specific claim of express
preemption advanced in Defendant’s motion. The parties agree as to certain elements of
this preemption inquiry. First, it is undisputed that Defendant’s spinal cord stimulator
received the requisite FDA approval applicable to Class III devices. As noted earlier,
Defendant obtained premarket approval for a predecessor device back in 1984, and on July
7, 2006, the FDA granted premarket approval of the particular spinal cord stimulator
involved in this case. The parties further agree that by virtue of this FDA approval, the
federal government has established requirements applicable to Defendant’s spinal cord
stimulator. See Riegel, 552 U.S. at 322-23, 128 S. Ct. at 1007 (recognizing that the
premarket approval process mandated for Class III devices necessarily imposes federal
requirements upon the specific device addressed in this process). This leaves only the
question whether Plaintiff’s product liability claims rest upon requirements that “relate to the
safety or effectiveness of [Defendant’s] device” and are “different from, or in addition to,”
the requirements imposed on this device by the federal government. 21 U.S.C. § 360k(a).
If so, these claims are preempted.
As the Supreme Court has emphasized, the MDA’s express preemption provision
“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.” Riegel, 552 U.S. at 330, 128 S. Ct. at 1011 (internal quotation
marks and citations omitted). In her response to Defendant’s motion, Plaintiff suggests that
her product liability claims are properly viewed as “parallel” in this sense — that is, they rest
upon Defendant’s alleged breach of state-law duties derived from FDA regulations that
prohibit the distribution of adulterated or misbranded products and establish Current Good
10

Manufacturing Practices (“CGMPs”) that apply to all FDA-regulated medical devices.
Because Plaintiff’s first amended complaint identifies a whole host of FDA regulations and
CGMPs that Defendant allegedly violated, (see First Amended Complaint at ¶¶ 53-76),
Plaintiff contends that she has pled “parallel” claims of product liability that avoid express
preemption.
Defendant challenges the adequacy of Plaintiff’s pleading on two fronts. First,
Defendant points to cases broadly holding that the FDA’s CGMPs “are simply too generic,
standing alone, to serve as the basis for” a parallel product liability claim that survives the
MDA’s express preemption provision. In re Medtronic, Inc. Sprint Fidelis Leads Products
Liability Litigation, 592 F. Supp.2d 1147, 1157 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th
Cir. 2010); see also Horn v. Boston Scientific Neuromodulation Corp., No. CV409-074,
2011 WL 3893812, at *8-9 (S.D. Ga. Aug. 26, 2011); Ilarraza v. Medtronic, Inc., 677 F.
Supp.2d 582, 588 (E.D.N.Y. 2009). As one court has reasoned:
. . . [The CGMPs] are intended to serve only as an umbrella quality system
providing general objectives medical device manufacturers must seek to
achieve. 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 [its] particular safety and efficacy needs.
The intentionally vague and open-ended nature of the regulations relied upon is
the precise reason why 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. Accordingly, where, as here, a plaintiff relies on nothing more tha[n]
CGMP[]s in support of a parallel cause of action, preemption bars the claim.
Ilarraza, 677 F. Supp.2d at 588 (internal quotation marks and citations omitted).
Yet, as Defendant acknowledges — albeit only in a footnote — the Sixth Circuit has
11

squarely rejected the notion that a violation of a CGMP can never serve as the basis for
a parallel claim that avoids express preemption. See Howard v. Sulzer Orthopedics, Inc.,
No. 09-3406, 382 F. App’x 436, 440 (6th Cir. June 16, 2010). The plaintiff in that case,
Brian Howard, asserted product liability claims against Sulzer Orthopedics, the
manufacturer of a knee implant that failed when it was used in Howard’s body. Although
Sulzer adhered to an FDA-approved process in manufacturing this medical device, it
determined after complaints from thousands of patients that this process “left lubricating
machine oil on the implants” during manufacture, resulting in an implant that “failed to bond
with the [patient’s] bone.” Howard, 382 F. App’x at 438. Howard contended that Sulzer’s
failure to remove the lubricating oil from its knee implants during its manufacturing process
constituted a violation of the FDA’s CGMPs, but Sulzer pointed to the district court’s
decision in In re Medtronic, supra, 592 F. Supp.2d at 1157, as precluding Howard’s reliance
on the CGMPs as a basis for his product liability claims.
The Sixth Circuit held that one of Howard’s product liability claims could go forward,
explaining that the decision in In re Medtronic was distinguishable:
[T]he alleged violations in [In re Medtronic] were different from the ones here;
and moreover the plaintiff there did not even identify a specific GMP that he
thought had been violated. Howard, in contrast, has done that; and, as we
explain below, the particular GMP that he cites is not so vague as to be
incapable of enforcement. We thus reject Sulzer’s argument that the relevant
GMP is categorically unenforceable here.
Howard, 382 F. App’x at 440. In particular, Howard cited a CGMP providing that “[w]here
a manufacturing material could reasonably be expected to have an adverse effect on
product quality, the manufacturer shall establish and maintain procedures for the use and
removal of such manufacturing material to ensure that it is removed or limited to an amount
12

that does not adversely affect the device’s quality.” 382 F. App’x at 440 (quoting 21 C.F.R.
§ 820.70(h)).

The Sixth Circuit observed that the lubricating oil used in Sulzer’s

manufacturing process “falls within the definition of manufacturing material” that Sulzer was
obligated under the CGMP to remove from its medical device, and it concluded that
Howard’s product liability claim withstood preemption as a parallel claim resting on Sulzer’s
alleged violation of a sufficiently specific and enforceable CGMP. 382 F. App’x at 440-41.
As Defendant correctly observes, the Sixth Circuit’s unpublished decision in Howard
is not binding on this Court, and Defendant tersely suggests that Howard should be
rejected as “wrongly decided.” (Defendant’s Motion, Br. in Support at 21 n.10.) The Sixth
Circuit is not alone, however, in holding that a manufacturer’s violation of a CGMP may
serve as the basis for a parallel state-law claim that survives express preemption. In
Bausch v. Stryker Corp., 630 F.3d 546, 555 (7th Cir. 2010), for example, the Seventh
Circuit opined that there was no “sound legal basis” for distinguishing between claims
resting on “general requirements” such as CGMPs and claims derived from alleged
violations of “concrete, device-specific requirements.” The court explained:
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.” 21 U.S.C. §
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.” 21 C.F.R. § 820.1. “The failure to comply with any applicable
provision in this part [of the regulations] renders a device adulterated under
section 501(h) of the [FDCA]. Such a device, as well as any person responsible
for the failure to comply, is subject to regulatory action.” 21 C.F.R. § 820.1(c).
Defendants’ proposed distinction between concrete, product-specific
13

requirements and more general requirements would also leave injured patients
without any remedy for a wide range of harmful violations of federal law. The
FDA regulations contain many requirements that are not concrete or productspecific, yet which are obviously vital to producing safe and effective medical
devices. For example, the regulations require each manufacturer to “establish
and maintain procedures to prevent contamination of equipment or product by
substances that could reasonably be expected to have an adverse effect on
product quality,” 21 C.F.R. § 820.70(e), and to “establish and maintain
procedures for the use and removal” of manufacturing material (such as
lubricants or abrasives, or cleaning and disinfectant agents) “to ensure that it is
removed or limited to an amount that does not adversely affect the device’s
quality.” 21 C.F.R. § 820.70(h). If a patient were harmed by an implanted hip
replacement system that was contaminated, for example, by a production
worker’s blood or mucus or by a lubricant or abrasive that caused an infection
after implantation, that contamination would present a substantial claim for
violating requirements that are not “concrete” and “product-specific,” yet which
surely are essential for the manufacture of safe and effective medical devices for
implantation in the human body.
Bausch, 630 F.3d at 555 (citation omitted). Accordingly, the Seventh Circuit concluded that
the defendant manufacturer’s suggested distinction between general regulations and
product-specific requirements lacked support in either “the language of the [MDA’s]
preemption provision or . . . its purpose, to provide preemption for medical device
manufacturers to the extent they actually comply with stringent requirements of federal
law.” 630 F.3d at 556; see also Bass v. Stryker Corp., 669 F.3d 501, 511-12 (5th Cir. 2012)
(“The key distinction between complaints that are sufficient to withstand a motion to dismiss
and those that are not is not reliance on CGMPs, but rather the existence of a
manufacturing defect caused by a violation of federal regulations and allegations
connecting a defect in the manufacture of the specific device to that plaintiff’s specific
injury.”); Raab v. Smith & Nephew, Inc., 150 F. Supp.3d 671, 692 (S.D. W. Va. 2015)
(reasoning that “[v]iolations of the CGMP requirements are undoubtedly violations of federal
law,” and concluding that “CGMP-premised claims are not expressly preempted simply
14

because they rely on those regulations”); Cline v. Advanced Neuromodulation Systems,
Inc., 921 F. Supp.2d 1374, 1381 (N.D. Ga. 2012) (finding that a claim avoided express
preemption where the plaintiff “provide[d] more than conclusory assertions of CGMP
violations,” but “also allege[d] specific facts about when and how these violations occurred
in the manufacture of the specific device at issue”); Gelber v. Stryker Corp., 788 F. Supp.2d
145, 159 (S.D.N.Y. 2011).
This Court is persuaded by the reasoning in Howard and Bausch that a plaintiff’s
reliance on violations of CGMPs in support of a product liability claim does not categorically
dictate the express preemption of that claim. Rather, in determining whether such a claim
is preempted, the key questions are (i) whether the plaintiff has identified specific CGMPs
that the defendant device manufacturer has allegedly violated, see Howard, 382 F. App’x
at 440, and (ii) whether the plaintiff’s allegations, accepted as true, demonstrate that the
plaintiff was injured as a result of the manufacturer’s breach of a CGMP-based duty, see
Bass, 669 F.3d at 512; Cline, 921 F. Supp.2d at 1381-82. Accordingly, the Court rejects
Defendant’s contention that Plaintiff’s product liability claims should be dismissed as
expressly preempted due to their reliance on CGMPs as the source of the legal obligations
giving rise to those claims.
Yet, even accepting that Plaintiff may look to the FDA’s CGMPs in support of parallel
product liability claims that avoid express preemption, Defendant nonetheless insists that
the allegations of Plaintiff’s first amended complaint are insufficient to establish the requisite
causal connection between Defendant’s violation of a specific CGMP and a resulting device
defect that brought about Plaintiff’s injury. As Defendant observes, Plaintiff’s first amended
complaint does not focus on only one or a small handful of CGMPs that Defendant
15

allegedly violated in manufacturing the medical device at issue. Rather, over the course
of nine pages and nearly thirty paragraphs, Plaintiff recites a plethora of CGMPs and other
regulatory provisions to which Defendant allegedly was subject as it manufactured,
distributed, and otherwise exercised control over this device.

(See First Amended

Complaint at ¶¶ 47-73.) A number of courts have rejected this “laundry list” approach to
pleading a parallel claim arising from a manufacturer’s alleged violation of FDA regulations
or CGMPs. See, e.g., Ali v. Allergan USA, Inc., No. 12-115, 2012 WL 3692396, at *10-*11
(E.D. Va. Aug. 23, 2012); Ilarraza, 677 F. Supp.2d at 588-89; Parker v. Stryker Corp., 584
F. Supp.2d 1298, 1301-02 & n.5 (D. Colo. 2008).
Likewise, the allegations that follow Plaintiff’s lengthy recitation of purportedly relevant
CGMPs and regulatory duties are too vague and conclusory to satisfy the Twombly/Iqbal
standard of plausibility. Plaintiff asserts “[u]pon information and belief” that Defendant’s
medical device “failed to meet” the performance standards and other requirements
established in the FDA regulations, and that Defendant “failed to establish and maintain”
the appropriate CGMPs governing the manufacture and testing of its device. (First
Amended Complaint at ¶¶ 74-76.) Plaintiff then alleges that “[a]s a result of Defendant’s
failure to establish and maintain” the proper CGMPs, its “medical device was defective and
resulted in injuries to Plaintiff.” (Id. at ¶ 77.) As the courts have emphasized, a plaintiff
“cannot simply incant the magic words ‘[the defendant manufacturer] violated FDA
regulations’ in order to avoid preemption.” In re Medtronic, 592 F. Supp.2d at 1158; see
also Swisher v. Stryker Corp., No. 14-0028, 2014 WL 1153716, at *2 (W.D. Okla. March
14, 2014) (“[M]ore is required to make out a parallel claim than conclusory statements that
a defendant violated multiple regulations.”); Desai v. Sorin CRM USA, Inc., No. 12-2995,
16

2013 WL 163298, at *6 (D.N.J. Jan. 15, 2013) (finding that the plaintiff’s proposed
amended complaint lacked any factual allegations “as to how [the defendant] allegedly
violated federal regulations in its design or manufacture of” the device at issue); Parker,
584 F. Supp.2d at 1302 (explaining that the plaintiff’s complaint did not “provide any factual
detail to substantiate th[e] crucial allegation” that the defendant’s manufacturing processes
failed to comply with one or more FDA regulations). Nor can a plaintiff rely on conclusory
allegations alone, without any supporting factual details, to plead the requisite causal
connection between the defendant’s alleged violation of FDA regulations and a device
defect that resulted in the plaintiff’s injury. See, e.g., Ali, 2012 WL 3692396, at *11-*12;
White v. Stryker Corp., 818 F. Supp.2d 1032, 1039-40 (W.D. Ky. 2011); Ilarraza, 677 F.
Supp.2d at 588-89; Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 282-83 (E.D.N.Y.
2009). As in these other cases, the allegations put forward by Plaintiff here in support of
her product liability claims lack the factual content necessary to permit the plausible
inferences (i) that Defendant violated one or more FDA regulations in the manufacture of
its spinal cord stimulator, and (ii) that Plaintiff was injured as a result of these violations.
In an effort to overcome these pleading deficiencies, Plaintiff seeks to supply the
requisite specificity in her response to Defendant’s motion.4 In particular, Plaintiff contends
that her product liability claims qualify as parallel, and thus avoid express preemption under
the MDA, by virtue of their reliance on Defendant’s violation of a specific CGMP that
4

Notably, Plaintiff does not request in her response brief that she be granted leave to
further amend her complaint in order to more clearly specify the regulatory violations
that give rise to her product liability claims. Rather, she contends that the allegations of
her first amended complaint already identify these violations in sufficient detail to
preclude the dismissal of her product liability claims. (See Plaintiff’s Response Br. at
22-23.)
17

provides as follows:
Where a manufacturing material could reasonably be expected to have an
adverse effect on product quality, the manufacturer shall establish and maintain
procedures for the use and removal of such manufacturing material to ensure
that it is removed or limited to an amount that does not adversely affect the
device’s quality. The removal or reduction of such manufacturing material shall
be documented.
21 C.F.R. § 820.70(h). Plaintiff further cites the commentary accompanying the FDA
regulation that defines “manufacturing material,” in which the FDA explains that “some
components, such as natural rubber latex, contain allergenic proteins that must be reduced
or removed from the finished devices.” 61 Fed. Reg. 52,602, 52,610 (Oct. 7, 1996). As
Plaintiff observes, the Sixth Circuit relied on the “manufacturing material” regulation and
the FDA’s accompanying commentary in Howard, 382 F. App’x at 440-41, concluding that
the plaintiff in that case had stated a parallel product liability claim that withstood
preemption through his allegations that the defendant manufacturer violated this regulation
by failing to remove the lubricating oil used in the manufacture of its medical device. In
Plaintiff’s view, her allegations in this case likewise should be deemed sufficient to sustain
her parallel product liability claims against Defendant, where the CGMP set forth in 21
C.F.R. § 820.70(h) purportedly imposed upon Defendant the obligation to remove any
natural rubber latex from its spinal cord stimulator before this device was implanted in a
patient.
As Defendant correctly observes, however, the CGMP that dictates the removal of
potentially harmful manufacturing material does not assist Plaintiff in her attempt to plead
parallel product liability claims, because the silicone rubber found in Defendant’s spinal
cord stimulator cannot be characterized as “manufacturing material” subject to this CGMP.
18

The pertinent FDA regulation defines manufacturing material as “any material or substance
used in or used to facilitate the manufacturing process, a concomitant constituent, or a
byproduct constituent produced during the manufacturing process, which is present in or
on the finished device as a residue or impurity not by design or intent of the manufacturer.”
21 C.F.R. § 820.3(p). Yet, as illustrated by the public documents in the record describing
Defendant’s spinal cord stimulator, the silicone rubber in this device is not a “residue or
impurity,” but instead is expressly identified as among the materials that make up the
device’s connector block, grommets, and seals.

(Plaintiff’s Response, Ex. 1,

PrimeAdvanced Neurostimulator Implant Manual at 8.) Consequently, the rubber in
Defendant’s device is present “by design or intent of the manufacturer,” and not as “a
residue or impurity.” 21 C.F.R. § 820.3(p). As such, the rubber cited by Plaintiff as
allegedly triggering her allergic reaction is not “manufacturing material” that must be
removed or limited under the CGMP; rather, it fits comfortably within the regulatory
definition of a “component,” which encompasses “any raw material, substance, piece, part,
software, firmware, labeling, or assembly which is intended to be included as part of the
finished, packaged, and labeled device.” 21 C.F.R. § 820.3(c).
To be sure, the commentary accompanying the regulatory definition of “manufacturing
material” cites “allergenic proteins” in “natural rubber latex” as an example of a
“concomitant constituent” that must be reduced or removed from a device at the conclusion
of the manufacturing process. 61 Fed. Reg. 52,602, 52,610 (Oct. 7, 1996). In Plaintiff’s
view, this comment supports a reading of the “manufacturing material” CGMP as
mandating that Defendant remove all natural rubber latex from its spinal cord stimulator.
(See Plaintiff’s Response Br. at 18, 22.) At best, however, the FDA’s commentary indicates
19

that the allergic proteins contained in natural rubber latex would qualify in some
circumstances as a “residue or impurity” generated in the manufacturing process that must
be reduced or removed in accordance with the CGMP. This limited example does not
overcome the distinction, as expressly drawn in the FDA’s definition of manufacturing
material, between a “residue or impurity” and a substance that is present in a device “by
design or intent of the manufacturer.” 21 C.F.R. § 820.3(p).
Nothing in Plaintiff’s first amended complaint suggests that the manufacturing process
used by Defendant generated any such allergenic proteins as a residue or impurity that was
subject to removal under the CGMP. Nor has Plaintiff alleged that her injuries resulted
from a residue or impurity that Defendant failed to remove at the conclusion of its
manufacturing process. To the contrary, the manual for Defendant’s spinal cord stimulator
expressly discloses that parts of this device contain silicone rubber or silicone medical
adhesive, (see Plaintiff’s Response, Ex. 1, PrimeAdvanced Neurostimulator Implant Manual
at 8), and the intentional use of these materials in Defendant’s device disqualifies them
from consideration as “manufacturing materials” that must be reduced or removed from the
device. Accordingly, Plaintiff has failed to allege a violation of an FDA regulation or CGMP
that could support a parallel product liability claim that avoids preemption under the MDA.
Finally, even assuming that Plaintiff’s allegations were sufficient to establish a violation
of the CGMP that requires the reduction or removal of certain manufacturing materials, it
bears emphasis that this alleged violation would support only Plaintiff’s manufacturing
defect theory of product liability, and would not save her design defect and failure to warn
claims from express preemption. As Defendant points out, Plaintiff has alleged no facts
indicating that the design of the device implanted in her deviated in any respect from the
20

design approved by the FDA as part of its premarket approval process for Class III medical
devices. Accordingly, to prevail under a design defect theory, Plaintiff “would need to
establish that [Defendant’s] [d]evice should have been designed in a manner different than
that approved by the FDA.” Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp.3d 1021, 1040
(D. Haw. 2014); see also Aaron v. Medtronic, Inc., No. 13-301, __ F. Supp.3d __, 2016 WL
5242957, at *9 (S.D. Ohio Sept. 22, 2016); Hafer v. Medtronic, Inc., 99 F. Supp.3d 844, 861
(W.D. Tenn. 2015). As a number of courts have explained, such a “common law tort claim
that presupposes a Class III device should have been designed in a manner other than that
contemplated by its premarket approval is . . . expressly preempted by the MDA as
interpreted by Riegel.” Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012); see
also In re Medtronic, 623 F.3d at 1206; Aaron, __ F. Supp.3d at __, 2016 WL 5242957, at
*9-*10; Hafer, 99 F. Supp.3d at 861; Beavers-Gabriel, 15 F. Supp.3d at 1040.
Plaintiff’s failure to warn claim is expressly preempted on essentially the same
grounds. Plaintiff has not alleged that the specific device implanted in her lacked the
warning label approved by the FDA in the premarket approval process. This theory of
recovery, therefore, depends upon a showing that the FDA-approved warnings were
inadequate, and that Defendant was required under Michigan product liability law to provide
additional warnings beyond those required by the FDA. Yet, the Supreme Court has
emphasized that the MDA “[s]urely . . . would preempt a jury determination that the FDAapproved labeling for a [device] violated a state common-law requirement for additional
warnings.” Riegel, 552 U.S. at 329, 128 S. Ct. at 1011; see also In re Medtronic, 623 F.3d
at 1205; Aaron, __ F. Supp.3d at __, 2016 WL 5242967, at *7; Hafer, 99 F. Supp.3d at 860.
This is especially true where the FDA-approved labeling for Defendant’s spinal cord
21

stimulator expressly warns of the possibility that “the implanted materials could cause an
allergic or immune system response.” (Defendant’s Motion, Ex. C, User Manual at 23.)5
Accordingly, the Court concludes on this additional ground that Plaintiff’s design defect and
failure to warn claims are expressly preempted.6
B. Plaintiff Has Sufficiently Pled Each Element of a State-Law Claim of Fraud.
Apart from her three product liability claims, Plaintiff also has asserted a claim of
fraud, alleging that Defendant made misrepresentations to her that its spinal cord stimulator
was safe for use by patients such as Plaintiff with known allergies to rubber and latex. In
its present motion, Defendant seeks the dismissal of this claim for failure to allege one of
the required elements of a viable claim of fraud: namely, that Defendant, through its
representatives, made its alleged misrepresentations either with knowledge that they were
false or with reckless disregard for their truthfulness. The Court disagrees, finding that
Plaintiff’s allegations are sufficient to satisfy this element of her claim of fraud.
To sustain a claim of fraud under Michigan law, a plaintiff must establish each of the
following elements:
(1) the defendant made a material representation; (2) the representation was
false; (3) when the defendant made the representation, the defendant knew that
it was false, or made it recklessly, without knowledge of its truth as a positive
assertion; (4) the defendant made the representation with the intention that the
plaintiff would act upon it; (5) the plaintiff acted in reliance upon it; and (6) the

5

As noted earlier, in resolving Defendant’s Rule 12(b)(6) motion, the Court may
properly consider the FDA-approved label for Defendant’s device as a public record,
even though this label was not expressly incorporated into Plaintiff’s pleadings.
6

In light of the Court’s determination that Plaintiff’s product liability claims are
expressly preempted under the MDA’s preemption provision, the Court need not
address Defendant’s contention that these claims are impliedly preempted by the
FDCA.
22

plaintiff suffered damage.
M&D, Inc. v. McConkey, 231 Mich. App. 22, 585 N.W.2d 33, 36 (1998). Defendant
challenges the third of these elements, contending that Plaintiff has offered only
“conclusory allegations” that Defendant “had knowledge of other patients having allergic
reactions to manufacturing materials and/or components” of its spinal cord stimulators,” but
nonetheless advised Plaintiff that “implanting the Spinal Cord Stimulator in patients with a
latex and rubber allergy was safe and would not cause an allergic reaction.” (Defendant’s
Motion, Br. in Support at 25 (quoting First Amended Complaint at ¶¶ 44, 111).) In
Defendant’s view, these allegations do not suffice to establish that its representatives had
the requisite state of mind when they allegedly advised Plaintiff that Defendant’s device
was safe despite her allergies to latex and rubber.
The Court cannot agree. As Plaintiff observes, while “a party must state with
particularity the circumstances constituting fraud or mistake,” this same Federal Rule
provides that “[m]alice, intent, knowledge, and other conditions of a person’s mind may be
alleged generally.” Fed. R. Civ. P. 9(b). Thus, a plaintiff “must plead facts about the
defendant’s mental state, which, accepted as true, make the state-of-mind allegation
plausible on its face.” Republic Bank & Trust Co. v. Bear Stearns & Co., 683 F.3d 239, 247
(6th Cir. 2012) (internal quotation marks and citation omitted). In this case, Plaintiff’s
complaint recounts several meetings prior to the implantation of Defendant’s device at
which she (i) informed Defendant’s representative, Violet, that she had latex and rubber
allergies, (ii) specifically inquired whether other patients had experienced allergic reactions
to the manufacturing materials or components used in Defendant’s spinal cord stimulator,
and (iii) was told in response that there had been no such reports of allergic reactions and
23

that latex and rubber allergies did not preclude the use of Defendant’s device. (See First
Amended Complaint at ¶¶ 18-21, 24, 25.) Plaintiff further alleges that after Defendant’s
device was implanted in her and she developed a severe allergic reaction, she contacted
Violet and was “only then informed . . . that other previous patients had indeed had allergic
reactions to manufacturing materials and/or components of” Defendant’s spinal cord
stimulators. (Id. at ¶ 29.)
These allegations, accepted as true, support a plausible inference that Defendant’s
representative knowingly or recklessly provided false assurances to Plaintiff about the
safety of implanting Defendant’s device in patients with allergies to rubber or latex.
According to the complaint, within a few days after Defendant’s device was implanted in
Plaintiff, Defendant’s representative acknowledged her awareness that other patients had
developed allergic reactions to the manufacturing materials or components used in this
device. (See id.) It surely is plausible to infer that this representative did not suddenly
become aware of these prior instances of allergic reactions, but that she instead had
knowledge of these reactions when she met with Plaintiff just a few days earlier, on the
date of the procedure to implant Defendant’s device, and reiterated her claim that no other
patients had experienced allergic reactions to Defendant’s spinal cord stimulators. (See
id. at ¶ 25.) These specific allegations that Defendant’s representative denied a material
fact one day, only to admit this same fact just a few days later, are sufficient to raise an
inference that Defendant’s representative had the requisite knowledge that she was not
being truthful when she assured Plaintiff that Defendant’s device was safe for those with
rubber or latex allergies. It follows that Plaintiff may go forward with her claim of fraud.
IV.

CONCLUSION
24

For these reasons,
The Court hereby GRANTS IN PART AND DENIES IN PART Defendant’s motion to
dismiss Plaintiff’s first amended complaint.

(Dkt. 17.)

More specifically, the Court

DISMISSES Counts I, II, and III of the first amended complaint, but Plaintiff may proceed
with the fraud claim asserted in Count IV of her first amended complaint.
SO ORDERED.

s/Nancy G. Edmunds
Nancy G. Edmunds
United States District Judge
Dated: April 18, 2017
I hereby certify that a copy of the foregoing document was served upon counsel of record
on April 18, 2017, by electronic and/or ordinary mail.
s/Carol J. Bethel
Case Manager

25