Nevolas v. Boston Scientific Corporation

Filing 45

ORDER granting 40 defendant's Motion to Dismiss Plaintiff's Second Amended Complaint (as more fully set out). Signed by Honorable Vicki Miles-LaGrange on 4/15/2016. (ks)

IN THE UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF OKLAHOMA
SUSAN NEVOLAS,

)
)
Plaintiff,
)
)
vs.
)
)
BOSTON SCIENTIFIC CORPORATION, )
)
Defendant.
)

Case No. CIV-15-894-M

ORDER
Before the Court is defendant’s Motion to Dismiss Plaintiff’s Second Amended Complaint,
filed February 29, 2016. On March 21, 2016, plaintiff filed her response, and on March 28, 2016,
defendant filed its reply.
I.

Introduction
Plaintiff has brought the instant action to recover damages for injuries she allegedly

sustained after she was implanted in September 2012 with a spinal stimulator, a/k/a The Precision
Spinal Cord Stimulator System (the “Precision System”), consisting of an Implantable Pulse
Generator (“IPG”), model SC-1010C, manufactured by defendant Boston Scientific Corporation.
The Precision System is a Class III Medical Device. Plaintiff alleges that the Precision System
suffers from one or more of the following manufacturing defects: (1) the devise battery was
defective causing it to overheat; (2) the device overheating could not be fixed by reprogramming;
and (3) the polymer separator inside the battery failed to permanently disable the battery once the
battery began to overheat. See Plaintiff’s Second Amended Complaint [docket no. 39] at ¶ 25.
Plaintiff further alleges that because of the defects, she was required to undergo an additional
surgery to remove the original device. Defendant now moves the Court to dismiss plaintiff’s Second
Amended Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6).

II.

Standard for Dismissal
Regarding the standard for determining whether to dismiss a claim pursuant to Federal Rule

of Civil Procedure 12(b)(6), the United States Supreme Court has held:
To survive a motion to dismiss, a complaint must contain sufficient
factual matter, accepted as true, to state a claim to relief that is
plausible on its face. 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. The plausibility standard is not akin to a “probability
requirement,” but it asks for more than a sheer possibility that a
defendant has acted unlawfully. Where a complaint pleads facts that
are merely consistent with a defendant’s liability, it stops short of the
line between possibility and plausibility of entitlement to relief.
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal quotations and citations omitted). Further,
“where 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.”
Id. at 679 (internal quotations and citations omitted). Additionally, “[a] pleading that offers labels
and conclusions or a formulaic recitation of the elements of a cause of action will not do. Nor does
a complaint suffice if it tenders naked assertion[s] devoid of further factual enhancement.” Id. at
678 (internal quotations and citations omitted). A court “must determine whether the complaint
sufficiently alleges facts supporting all the elements necessary to establish an entitlement to relief
under the legal theory proposed.” Lane v. Simon, 495 F.3d 1182, 1186 (10th Cir. 2007) (internal
quotations and citation omitted). Finally, “[a] court reviewing the sufficiency of a complaint
presumes all of plaintiff’s factual allegations are true and construes them in the light most favorable
to the plaintiff.” Hall v. Bellmon, 935 F.2d 1106, 1109 (10th Cir. 1991).

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III.

Discussion
Defendant asserts that plaintiff’s Amended Complaint should be dismissed for the following

two independent reasons: (1) because federal law expressly or impliedly preempts plaintiff’s claims
related to the Precision System, and (2) because plaintiff fails to plead sufficient facts under Federal
Rule of Civil Procedure 8 to plausibly support her negligence-based claims. Plaintiff contends that
her claims are not preempted by federal law and meet the pleading standard required by Rule 8.
It is undisputed that the Precision System is subject to the United States Food and Drug
Administration’s (“FDA”) intensive Premarket Approval (“PMA”) process and that the FDA
approved the Precision System. By passing the Medical Device Amendments of 1976 (“MDA”),
21 U.S.C. § 360, the United States Congress ceded exclusive regulatory authority over medical
devices to the FDA because it determined that satisfaction of the FDA’s PMA requirements are
adequate, as a matter of law, to safeguard the American public in its use of medical devices. The
MDA includes an express preemption provision that states:
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).1 In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the United States Supreme
Court employed a two-step analysis for determining whether state law claims are preempted under
§ 360k(a). First, the Supreme Court considered whether PMA of a medical device by the FDA

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The exception contained in subsection (b) permits the FDA to exempt some state and local
requirements from preemption.
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imposes federal “requirements” under the MDA. See Riegel, 552 U.S. at 321-23. The Court
concluded that PMA imposes federal “requirements” within the meaning of the MDA. See id. at
322-23. Second, the Supreme Court considered whether the state common law claims would impose
requirements “different from, or in addition to” the requirements imposed by the PMA process and
that relate to safety and effectiveness. See id. at 322-23. The Court concluded that the plaintiffs’
state common law claims for strict products liability, breach of implied warranty, and negligence
in the design, testing, inspection, distribution, labeling, marketing, and sale of the device would
impose requirements “different from, or in addition to” the requirements imposed by the PMA
process. Id. at 323. When determining whether a state requirement is “in addition to” the
requirements imposed by federal law, courts have found “[w]here a federal requirement permits a
course of conduct and the state makes its obligatory, the state’s requirement is in addition to the
federal requirement and thus is preempted.” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab.
Litig., 623 F.3d 1200, 1205 (8th Cir. 2010) (internal quotations and citation omitted).
However, the Supreme Court has made clear that “[s]tate requirements are pre-empted under
the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed
by federal law. § 360k(a)(1). Thus, § 360k 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.
In order for a state requirement to be parallel to a federal
requirement, and thus not expressly preempted under § 360k(a), the
plaintiff must show that the requirements are “genuinely equivalent.”
State and federal requirements are not genuinely equivalent if a
manufacturer could be held liable under the state law without having
violated the federal law.

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Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (8th Cir. 2011) (quoting McMullen v.
Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)) (emphasis in original). Further, “[t]o properly
allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that
have been violated.” Id. at 1301 (internal quotations and citation omitted). “Plaintiffs must also
allege a link between the failure to comply and the alleged injury.” Desabio v. Howmedica Osteonics
Corp., 817 F. Supp. 2d 197, 204 (W.D.N.Y. 2011).
In her response, plaintiff asserts that she has sufficiently pled parallel claims to survive
federal law preemption. Specifically, plaintiff alleges that her Second Amended Complaint alleges
the state common law and federal regulations she contends defendant violated and identifies the
precise failures of defendant to comply with the FDA-approved PMA specifications, and that at this
point in litigation, it is impossible for her to plead with further specificity given the limited amount
of information that is publicly available.
Having carefully reviewed plaintiff’s Second Amended Complaint, the Court finds that while
plaintiff has set forth some additional allegations in her Second Amended Complaint regarding
approved design standards for the Precision System, plaintiff has still failed to sufficiently state any
parallel claims to survive federal law preemption. Specifically, the Court finds that in plaintiff’s
Second Amended Complaint, the allegations, including the new allegations included in the Second
Amended Complaint, are still merely conclusory and are devoid of any real factual support. Plaintiff
in essence alleges, in a conclusory manner, that defendant violated the conditions of the FDA’s
approval and the general regulations applicable to Class III medical devices. For example, plaintiff
alleges:
25.
The Precision System Mr. Nevolas received was not
manufactured in strict compliance with the Approved Design
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Standards set forth above. The Approved Design Standards describe
the only acceptable end result of the manufacturing process for the
Precision System, and the Precision System Ms. Nevolas received
does not match that end result. Accordingly, the device Ms. Nevolas
received violates the conditions of the FDA’s approval and the
general regulations applicable to Class III medical devices.
Specifically, Ms. Nevolas’ Precision System suffers from one or
more of the following manufacturing defects:
a.
The device battery was defective causing it to
overheat;
b.
The device overheating could not be fixed by
reprogramming; and
c.
The polymer separator inside the battery failed to
permanently disable the battery once the battery began
t
o
overheat.
*

*

*

27.
Defendant violated the conditions of the FDA’s approval by
failing to adhere to the Good Manufacturing Practices (“GMPs”)
promulgated by the FDA which are mandatory requirements for all
Class III medical devices.
28.
Defendant violated 21 C.F.R. § 820.30 by failing to establish
and maintain procedures to control the design of the Precision
System. As a result, the Precision System Ms. Nevolas received did
not comply with the Approved Design Standards as set forth above,
causing the injuries set forth herein.
29.
Defendant violated 21 C.F.R. § 820.70 by failing to adhere to
federally mandated production and process controls. Had Defendants
adhered to the requirements of § 820.70, the Precision System Ms.
Nevolas received would have complied with the Approved Design
Standards, and Ms. Nevolas would not have suffered the injuries set
forth herein.
30.
Defendant violated 21 C.F.R. § 820.86 by failing to identify
acceptance criteria for the conformance or nonconformance of the
Precision System throughout the manufacturing, packaging, labeling,
installation, and servicing of the product. As a result, The Precision
System that Ms. Nevolas received was not identified as nonconforming and was allowed to be distributed and sold despite its
failure to adhere to the Approved Design Standards. Ms. Nevolas
suffered the injuries described herein due to this failure to identify
acceptance criteria for Ms. Nevolas’ Precision System.
31.
Defendant violated 21 C.F.R. § 820.90 by failing to establish
and maintain procedures to identify, document, evaluate, segregate,
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and dispose of products like the Precision System that Ms. Nevolas
received that do not conform to the Approved Design Standards. If
Defendants had complied with § 820.90, the device Ms. Nevolas
received would have been identified as nonconforming and would
have been offered for sale. As a result of Defendant’s failure, Ms.
Nevolas received a nonconforming Precision System and was injured
as set forth herein.
32.
Defendant violated the Manufacturer Reports Requirements
contained in 21 C.F.R. §§ 803.50, 803.52, 803.56, and 803.58 by
failing to report adverse injuries similar to those suffered by Ms.
Nevolas. Had Defendant reported these adverse events as required
by law, Ms. Nevolas and her doctors would have been able to make
an informed decision regarding the Precision System. Instead, Ms.
Nevolas was allowed to receive a device that did not comply with the
Approved Design Standards, causing Ms. Nevolas’ injuries as set
forth herein.
Second Amended Complaint at ¶¶ 25, 27-32.
The Court recognizes that individuals in plaintiff’s position are handicapped because “[i]n
the case of Class III medical devices, potentially valuable information related to PMA is kept
confidential as a matter of federal law and formal discovery may be required before a plaintiff can
fairly be expected to identify specific defects.” Comella v. Smith & Nephew, Inc., No. 13 C 1850,
2013 WL 6504427, at *3 (N.D. Ill. Dec. 11, 2013) (internal citation omitted). “However, more is
required to make out a parallel claim than conclusory statements that a defendant violated multiple
regulations.” Swisher v. Stryker Corp., No. CIV-14-0028-HE, 2014 WL 1153716, at *2 (W.D. Okla.
Mar. 14, 2014). The Court finds plaintiff’s conclusory allegations that defendant violated the
conditions of the FDA’s approval and the general regulations applicable to Class III medical devices
are insufficient to state a plausible parallel claim upon which relief can be granted.

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IV.

Conclusion
Accordingly, for the reasons set forth above, the Court GRANTS defendant’s Motion to

Dismiss Plaintiff’s Second Amended Complaint [docket no. 40] and DISMISSES plaintiff’s Second
Amended Complaint.
IT IS SO ORDERED this 15th day of April, 2016.

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