United States District Court, M.D. Pennsylvania
MEMORANDUM & ORDER
E. JONES III UNITED STATES DISTRICT JUDGE
pending before the Court is a motion to dismiss (the
“Motion”) filed by Defendants Medtronic, Inc,
Medtronic Puerto Rico Operations, Co, and Medtronic
Logistics, LLC. (collectively “Medtronic”)
(Doc. 9). Plaintiff Jason Silver brings seven counts against
Medtronic arising out of the alleged malfunction of a
Medtronic device, the SynchroMed II. (Doc. 1). The Motion has
been fully briefed (Docs. 11, 14, 15) and is therefore ripe
for our review. For the reasons that follow, the Motion shall
be granted in part and denied in part.
Jason Silver filed a Complaint against Medtronic on August
12, 2016. (Doc. 1). Plaintiff brings the following causes of
action arising out of the alleged malfunction of
Medtronic's product, the SynchroMed II Device (the
“Device”): manufacturing defect, failure to warn,
negligence, breach of express warranty, breach of implied
warranties, negligent misrepresentation, and violation of
Pennsylvania's unfair trade practices and consumer
accordance with the standard of review applicable to a motion
to dismiss, the following facts are derived from
Plaintiff's Complaint. (Doc. 1).
is a fifty-two year old man with diagnosed cervical
radiculopathy and cervicalgia. (Id., at ¶¶
10, 12). On December 7, 2012, Plaintiff had the Device,
comprised of a pump and an intrathecal catheter, implanted in
his abdomen. (Id., at ¶ 13). The Device is a
programmable drug infusion system that delivers medication
into the intrathecal space of the patient's spine.
(Id., at ¶¶ 22, 25). It is implanted and
remains under the skin. (Id., at ¶ 25).
several months after the Device was implanted,
Plaintiff's pain improved. (Id., at ¶14).
However, in the summer of 2014, the Device overdelivered pain
medication and caused Plaintiff severe pain, nausea, and lack
of mobility. (Id.). On August 12, 2014, Plaintiff
underwent a procedure to remove the Device due to its
malfunction. (Id., at ¶ 15).
Device is a Class III medical device approved by the Food and
Drug Administration (“FDA”) through the
Pre-Market Approval (“PMA”) process in 1988.
(Id., at ¶ 23). PMA is the FDA's process of
scientific and regulatory review to evaluate the safety and
effectiveness of Class III medical devices. (Id., at
¶ 29). The applicant must supply information to the FDA
in a PMA application. (Id., at ¶ 30). The
information includes: “a) device description, b)
clinical safety trials, c) methods of its product testing, d)
design of the device and specific manufacturing controls, e)
outcome evaluation, and f) proposed labeling.”
(Id.). Medtronic submitted a PMA application and the
Device was approved under PMA 860004. (Id., at
¶ 23). Since the original approval, the FDA has approved
many changes to the Device. (Id.). Following PMA
approval, the holder must comply with certain FDA
requirements and federal regulations, including those set out
in 21 C.F.R. § 801, et seq., 21 C.F.R. §
803, et seq., 21 C.F.R. § 814, et
seq., 21 C.F.R. § 806, et seq., 21 C.F.R.
§ 820, et seq., and 21 U.S.C. §§
351-52. (Id., at ¶¶ 31, 66). The holder
must also comply with specifications imposed during the PMA
process for the Device. (Id., at ¶ 66).
in 2006, the FDA issued Medtronic a series of warning letters
identifying federal manufacturing and quality control
violations at their manufacturing plants. (Id., at
¶ 32). On April 27, 2015, the U.S. Department of Justice
and U.S. Department of Health and Human Services filed a
complaint requesting a permanent injunction, leading to a
court ordered consent decree “imposing a moratorium on
the manufacture, sale, and distribution” of the Device.
warning letters issued by the FDA identified
“Significant Deviations” from Current Good
Manufacturing Practices (CGMPs), codified at 21 C.F.R. 820,
committed by Medtronic while manufacturing the Device.
(Id., at ¶ 36). The letters outlined specific
CGMPs that Medtronic failed to follow. (Id.). Due to
these deviations, the Device was found to be
“adulterated” or “misbranded.”
(Id., at ¶¶ 36, 37, 39). The FDA also
notified Medtronic on multiple occasions of several
manufacturing defects in the Device. (Id., at
¶¶ 41, 46). Since 2008, the FDA has issued nineteen
Class I recall actions for the Device to address federal
violations. (Id., at ¶ 48).
addition to manufacturing issues and violations of CGMPs, the
FDA notified Medtronic of the following failure to follow
“Regulatory approval was received for Supplement 136 to
PMA P860004 on December 15, 2011 to change the design of S.C.
Catheter models 8709 SC, 8731 SC, 8596 SC, and Revision Kit
model 8578 to mitigate a known field issue associated with
CAPA 1507-SC Catheter Occlusion. This design change was
implemented via ECO 12-00985, date March 6, 2012, and the new
revisions of Catheter models were released to the field in
September 2012. However, the previous S.C. catheter models
which do not conform to the current design have continued to
be distributed and have been attributed to 60 complaints of
catheter occlusion since September 2012.”
(Id., at ¶ 47).
April 27, 2015, the United States Department of Justice and
the United States Department of Health and Human Services
filed a complaint for a permanent injunction against
Medtronic with respect to manufacture of the Device.
(Id., at ¶ 52). The complaint alleges that
Medtronic is well aware that their practices violate the Act,
presumably referring to the CGMPs. (Id., at ¶
53). The complaint alleged that Medtronic continued to
violate 21 U.S.C. §§ 331(a) and (k) by introducing
adulterated devices into commerce. (Id., at ¶
56). On April 27, 2015, the Court signed a consent decree of
permanent injunction preventing the manufacture and
distribution of the Device. (Id., at ¶ 58).
According to Plaintiff, Medtronic continues to produce,
distribute, and sell the Device in violation of the consent
decree. (Id., at ¶ 60).
STANDARD OF REVIEW
considering a motion to dismiss pursuant to Rule 12(b)(6),
courts “accept all factual allegations as true,
construe the complaint in the light most favorable to the
plaintiff, and determine whether, under any reasonable
reading of the complaint, the plaintiff may be entitled to
relief.” Phillips v. Cty. of Allegheny, 515
F.3d 224, 231 (3d Cir. 2008) (quoting Pinker v. Roche
Holdings, Ltd., 292 F.3d 361, 374 n.7 (3d Cir. 2002)).
In resolving a motion to dismiss pursuant to Rule 12(b)(6), a
court generally should consider only the allegations in the
complaint, as well as “documents that are attached to
or submitted with the complaint, . . . and any matters
incorporated by reference or integral to the claim, items
subject to judicial notice, matters of public record, orders,
[and] items appearing in the record of the case.”
Buck v. Hampton Twp. Sch. Dist., 452 F.3d 256, 260
(3d Cir. 2006).
12(b)(6) motion tests the sufficiency of the complaint
against the pleading requirement of Rule 8(a). Rule 8(a)(2)
requires that a complaint contain a short and plain statement
of the claim showing that the pleader is entitled to relief,
“in order to give the defendant fair notice of what the
claim is and the grounds upon which it rests.” Bell
Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting
Conley v. Gibson, 355 U.S. 41, 47 (1957)). While a
complaint attacked by Rule 12(b)(6) motion to dismiss need
not contain detailed factual allegations, it must contain
“sufficient factual matter, accepted as true, to
‘state a claim to relief that is plausible on its
face.'” Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009). To survive a motion to dismiss, a civil plaintiff
must allege facts that “raise a right to relief above
the speculative level….” Victaulic Co. v.
Tieman, 499 F.3d 227, 235 (3d Cir. 2007) (quoting
Twombly, 550 U.S. at 555). Accordingly, to satisfy
the plausibility standard, the complaint must indicate that
defendant's liability is more than “a sheer
possibility.” Iqbal, 556 U.S. at 678.
“Where a complaint pleads facts that are ‘merely
consistent with' a defendant's liability, it
‘stops short of the line between possibility and
plausibility of entitlement to relief.'”
Id. (quoting Twombly, 550 U.S. at 557).
the two-pronged approach articulated in Twombly and
later formalized in Iqbal, a district court must
first identify all factual allegations that constitute
nothing more than “legal conclusions” or
“naked assertions.” Twombly, 550 U.S. at
555, 557. Such allegations are “not entitled to the
assumption of truth” and must be disregarded for
purposes of resolving a 12(b)(6) motion to dismiss.
Iqbal, 556 U.S. at 679. Next, the district court
must identify “the ‘nub' of the …
complaint - the well-pleaded, nonconclusory factual
allegation[s].” Id. Taking these allegations
as true, the district judge must then determine whether the
complaint states a plausible claim for relief. See
“a complaint may not be dismissed merely because it
appears unlikely that the plaintiff can prove those facts or
will ultimately prevail on the merits.”
Phillips, 515 F.3d at 231 (citing Twombly,
550 U.S. at 556-57). Rule 8 “does not impose a
probability requirement at the pleading stage, but instead
simply calls for enough facts to raise a reasonable
expectation that discovery will reveal evidence of the
necessary element.” Id. at 234.
moves for dismissal on four grounds: all claims are expressly
preempted by federal law, all claims are impliedly preempted
by federal law, certain claims are inadequately pleaded, and
Counts VI and VIII are barred by independent state law
grounds. (Doc. 11, p. 6). We will first analyze the federal
preemption issue and then discuss each count in turn.
Medical Device Amendments of 1976 (“MDA”),
codified at 21 U.S.C. § 360, et. seq.,
established a three-tiered classification system for medical
devices, arranged according to the risks presented.
Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008).
Class III devices receive the most stringent federal
oversight, which is why they are subject to the rigorous PMA
process. Id. “The FDA spends an average of 1,
200 hours reviewing each application, and grants premarket
approval only if there is ‘reasonable assurance' of
the device's ‘safety and effectiveness.'”
Id., at 318 (quoting 21 U.S.C. § 360(e)(d))
(internal citation omitted). The MDA “swept back some
state obligations and imposed a regime of detailed federal
oversight.” Id., at 316. In ...