Nevolas v. Boston Scientific Corporation

Filing 37

ORDER granting 25 defendant's Motion to Dismiss Plaintiff's Amended Complaint and dismissing plaintiff's Amended Complaint. However, as it is possible plaintiff may be able to correct the pleading deficiencies, the Court grants plaintiff leave to file a second amended complaint by February 15, 2016. (as more fully set out). Signed by Honorable Vicki Miles-LaGrange on 1/28/2016. (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 Amended Complaint, filed
December 7, 2015. On December 28, 2015, plaintiff filed her response, and on January 11, 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 PRECISION SPINAL CORD
STIMULATOR, Model SC-1010C (“Stimulator”), manufactured by defendant Boston Scientific
Corporation. The Stimulator is a Class III Medical Device. Plaintiff alleges that the Stimulator
malfunctioned because it was defective and the defect caused the Stimulator to run hot and/or
overheat and/or operate at abnormally high temperatures. See Plaintiff’s Amended Complaint
[docket no. 18] at ¶¶ 15-16. Plaintiff further alleges that because the defect could not be corrected
by “reprogramming,” she was required to undergo an additional surgery to remove the original
device. Defendant now moves the Court to dismiss plaintiff’s 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).

2

III.

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

two independent reasons: (1) because federal law expressly preempts plaintiff’s claims related to
the Stimulator, 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 Stimulator is subject to the United States Food and Drug
Administration’s (“FDA”) intensive Premarket Approval (“PMA”) process and that the FDA
approved the Stimulator. 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

1

The exception contained in subsection (b) permits the FDA to exempt some state and local
requirements from preemption.
3

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.

4

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 Amended Complaint alleges the state
common law and federal regulations she contends defendant violated 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 Amended Complaint, the Court finds that plaintiff has
failed to state any parallel claims to survive federal law preemption. Specifically, the Court finds
that in her Amended Complaint, plaintiff simply makes numerous conclusory allegations, devoid
of any factual support, that defendant violated in unspecified ways various federal regulations and
federal manufacturing requirements. For example, plaintiff alleges:
33.
The device which was required to be removed and replaced
in August 2013 malfunctioned (as defined by 21 CFR § 803.3(k)).
The malfunction occurred as a result of the negligence of the
Defendant in the design, manufacture, testing, selection/supervision
of suppliers or otherwise failing to manufacture the device as
required by the FDA.
34.
Because of manufacturing defects, the device implanted in
Plaintiff was defective and hazardous to patients including, but not
limited to, Plaintiff.
35.
Defendant failed to follow the established protocol for
manufacturing the device in violation of 21 CFR § 814.80.

5

36.
The quality control requirements and/or current good
manufacturing practice requirements for the manufacturing of the
device were not followed by Defendant in violation of 21 CFR § 820.
37.
The Defendant was negligent per se in choosing to not
following the applicable FDA requirements for the proper
manufacturing of the device.
*
*
*
40.
The Defendant was negligent in choosing to not warn
consumers, medical professionals and the FDA of the defects in the
device which caused it to malfunction, rendered it defective and
caused/contributed to injuries and damages to the consuming public
including, but not limited to the Plaintiff. Defendants’ actions in this
regard were intentional and deliberate, all in violation of FDA
requirements including, but not limited to 21 CFR §§ 803, 860.
Plaintiff’s Amended Complaint at ¶¶ 33-37, 40.
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 allegations that defendant was required to follow nonspecific federal regulations and current good manufacturing practice requirements, which are
applicable to all manufacturers of all medical devices, are insufficient to state a plausible parallel
claim upon which relief can be granted. “Allowing a plaintiff to plead non-specific regulations as
a basis for a parallel claim is inconsistent with the Supreme Court’s reasoning in Riegel, as well as
the pleading requirements articulated in Twombly [and] Iqbal.” Gross v. Stryker Corp., 858 F. Supp.
2d 466, 495 (W.D. Pa. 2012).
6

IV.

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

Dismiss Plaintiff’s Amended Complaint [docket no. 25] and DISMISSES plaintiff’s Amended
Complaint. However, as it is possible plaintiff may be able to correct the pleading deficiencies, the
Court GRANTS plaintiff leave to file a second amended complaint by February 15, 2016.
IT IS SO ORDERED this 28th day of January, 2016.

7