Freed et al v. St. Jude Medical, Inc. et al

Filing 16

MEMORANDUM. Signed by Judge Mark A. Kearney on 9/15/2017. (nmfn)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

KATHLEEN M. FREED, et al.

CIVIL ACTION

v.
NO. 17-1128
ST. JUDE MEDICAL, INC., et al.

MEMORANDUM
KEARNEY,J.

September 15, 2017

A patient suffering injury allegedly caused by a medical device approved by the Food and
Drug Administration must carefully plead her products liability claim to fit within the narrow
gap of claims where the federal approval does not preempt her state law products liability claim.
Her complaint is the governing document although we may take judicial notice of the federal
approvals. When the complaint does not plausibly allege the offending aspect of the approved
device is not covered by the federal approval nor plausibly allege how her claims are different
from or in addition to the federal requirements, we cannot find she avoids federal preemption.
Today, we review a complaint which does not plausibly allege the facts necessary to avoid
federal preemption but, subject to good faith obligations, the patient may be able to plead facts
necessary for a products liability claim not preempted by the federal approvals. In the
accompanying Order, we grant the device manufacturer's motion to dismiss the patient's
products liability claims without prejudice for the patient to timely file an amended complaint.

I. Pleaded Facts
Christiana Hospital doctors surgically implanted a neurostimulator and battery
components of a spinal cord stimulator device (the "Device") into the soft tissue of Kathleen
Freed's left buttocks to address chronic lower back and lower extremity pain. 1
The St. Jude Defendants 2 designed, manufactured, marketed, distributed, and/or sold the Device
for implantation in patients suffering from chronic lower back and lower extremity pain. 3 Mrs.
Freed did not receive information or warning of any defects, faults, or contraindications
regarding the Device. 4
Mrs. Freed alleges the Device "started giving off severely painful electrical shocks and a
burning sensation throughout the left buttocks." 5 Her doctors removed the Device. 6 Mr. and
Mrs. Freed then sued St. Jude alleging state law breach of express warranty, breach of the
implied warranty of merchantability and fitness for a particular purpose, manufacture or sale of
dangerous chattel, and loss of consortium.

II.

Analysis7

St. Jude moves to dismiss, arguing: federal law expressly and impliedly preempts the
Freeds' state law claims; the complaint fails to meet the pleading standards of Twombly and
Iqbal; the claims are barred by St. Jude's warranty disclaimer; and, the derivative loss of

consortium claim fails because the other claims fail. St. Jude additionally requests we take
judicial notice of Food and Drug Administration ("FDA") approval letters and the device's
Limited Warranty. 8

A. We take judicial notice of FDA approval letters only.
We first address St. Jude's request we take judicial notice of three exhibits: a November
21, 2001 FDA approval letter for the Device (Exhibit 1); a March 21, 2014 approval letter

2

supplementing the premarket approval application of the Device (Exhibit 2); and the Limited
Warranty for the Protege Device (Exhibit 3).9
Under Federal Rule of Evidence 201, we may take judicial notice of "a fact that is not
subject to reasonable dispute because it: (1) is generally known within the trial court's territorial
jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot
reasonably be questioned." 10 We may also consider "an undisputedly authentic document that a
defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the
document. " 11
The FDA approval letters "can be accurately and readily determined" from the FDA's
website, a source "whose accuracy cannot reasonably be questioned." The Freeds do not object
to the FDA approval letters or question the authenticity of these documents. 12 We take judicial
notice of St. Jude's Exhibits 1 and 2 because they are publically available on the FDA's website
and are indisputably authentic. 13
St. Jude argues we should also take judicial notice of the Limited Warranty for the
Device because it is a document upon which the complaint necessarily relies and is central to the
Freeds' breach of warranty claims. St. Jude argues the Limited Warranty cannot be reasonably
disputed.

We disagree.

Rule 201 allows judicial notice of a fact "that is not subject to

reasonable dispute" and where it can be "accurately and readily determined from sources whose
accuracy cannot be reasonably questioned." Unlike the FDA's website, we have nothing to
determine the source of this document and whether its accuracy "cannot be reasonably
questioned." We have only the Declaration of St. Jude's counsel swearing the Limited Warranty
is a "true and correct copy" of the Limited Warranty and "which [counsel is] informed and
believe accompanied the Protege Spinal Cord Stimulator used" by Mrs. Freed. 14

3

We cannot say the Limited Warranty submitted by St. Jude is an "undisputedly authentic
document" on which the Freeds base their claims. The Freeds object to the Limited Warranty,
arguing it is not subject to judicial notice at the pleading stage and it is not a document attached
to or referenced in their complaint. The Freeds concede they assert a breach of express warranty
claim, but argue they do not refer or rely on the disclaimer language. The Freeds' warranty
claims are based on St. Jude's marketing materials and we have no information the Limited
Warranty is part of its marketing materials. We will not take judicial notice of the Limited
Warranty (Exhibit 3).
B. The Medical Device Amendments and express preemption.
1. The FDA's premarket approval process for the Device.
The Medical Device Amendments of 1976 ("MDA") 15 requires FDA approval of medical
devices intended for human use, establishing levels of oversight for medical devices depending
on the risks they prevent. 16 Class III devices receive the most federal oversight, requiring a
"rigorous regime" of premarket approval. 17 The FDA grants premarket approval "only if it finds
there is a 'reasonable assurance' of the device's 'safety and effectiveness,"' after weighing "'any
probable benefit to health from the use of the device against any probable risk of injury or illness
from such use.'" 18 The Device is a Class III device. 19
On November 21, 2001, the FDA granted premarket approval for the Device subject to
certain conditions. 20 The conditions include approving labeling before commercial distribution
and "adverse reaction and device defect reporting" requiring the manufacturer to report to the
FDA any information concerning adverse reactions, side effects, injuries, or sensitivity reactions
attributable to the Device not addressed by the Device's labeling or addressed by the Device's
labeling but "occurring with unexpected severity or frequency.',zi

4

2. The MDA's express preemption provision.
The MDA expressly preempts state law claims challenging the safety and effectiveness of
a medical device granted premarket approval by the FDA]:
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. 22
The Supreme Court in Riegel defined the two steps we must use in deciding whether
federal law preempts state law claims regarding a Class III device: "(1) the Federal Government
has established requirements applicable to the device and (2) the plaintiffs claims are based on
state requirements related to safety and effectiveness that are 'different from, or in addition to'
the federal requirements. ,m
In the first step, we determine whether the FDA established requirements applicable to

the Device. If there are FDA requirements applicable to the Device, we must then determine
whether the Freeds' products liability claims are "different from, or in addition to" the FDA's
safety and effectiveness requirements for the Device. Our court of appeals cautions
"[g]eneralized common law theories of liability ... are precisely the type of claims the MDA
sought to preempt. " 24
3. Did the FDA establish requirements for the Device?
The FDA's approval of the Device identified its components: "the Model 3608 pulse
generator, the Model 3850 patient programmer, the Model 1232 programming wand and the
Model 1210 patient magnet." 25 The pulse generator implanted in Mrs. Freed is powered by an

5

internal battery. 26 The approval letter does not specifically mention the battery used to power the
pulse generator as a component of the Device.
St. Jude asserts the first prong of the Riegel test is "irrefutably met" because the FDA
granted premarket approval for the Device in its approval letter. The Freeds disagree. Although
they allege injuries caused by the "device" generally, the Freeds contend the battery is "primarily
at issue." The Freeds argue their allegations "relate (in large part) to the battery component" of
the Device, pointing to allegations of injury resulting from a warming and burning sensation and
electrical shocks emanating from the battery,

27

and "to the extent the battery component of the

[Device] caused injury, those allegations fall outside the scope of' the MDA's express
preemption provision. 28 It appears the Freeds continue to maintain both the Device and the
battery caused injury.
To support their theory the battery caused injury, the Freeds argue the FDA's approval
letter does not list the battery used to power the pulse generator as a component of the Device.
Although not pleaded, the Freeds contend the battery is separate and distinct from the Device
itself and is not the subject of the FDA's premarket approval process. The Freeds do not cite a
case where the battery in a spinal stimulation device is found to be separate from the Device,
specifically the pulse generator component.
The cases cited by the Freeds do not support their argument the battery component is not
expressly preempted. For example, in Michael v. Shiley, Inc., our court of appeals found all state
law claims preempted by the MDA except for the state law claims for express warranty based on
the manufacturer's packaging and fraud based on the manufacturer's advertising and
promotional materials sent to physicians. 29 Michael did not hold a component part of an FDA
approved device escapes the preemptive force of the MDA. The Court of Appeals for the Sixth

6

Circuit's decision in Jacobs v. E.l. Dupont de Nemours & Co. is inapposite. There, the court
addressed the specific question of whether a supplier of raw materials used in a medical device
can invoke MDA preemption. 30 Here, there is no allegation the battery is "raw material" and
outside the scope of MDA preemption. Similarly, Lake v. TPLC 31 does not support the Freeds'
argument. In Lake, the plaintiff brought claims for injury allegedly caused by a cardiac
pacemaker and pacemaker leads manufacturer by defendant Teletronics. The pacemaker
underwent the FDA's premarket approval process, while the leads underwent a more relaxed
premarket process where the FDA found the lead "substantially equivalent" to devices already
on the market. The court found claims involving the lead were not preempted by the MDA,
rejecting Teletronics' argument the premarket approval of the pacemaker should be considered
the equivalent to premarket approval of the leads, and thus preempted. The court found
Teletronics' argument "would seem to depend on the scope and scale and the evaluation of the
system."32
We are left with no allegations the battery underwent a separate review process from the
pulse generator to bring it outside the scope of MDA preemption.

Based on the allegations as

currently pleaded, we find the Device includes the battery and is subject to federal regulation and
the MDA's express preemption.
4. Are the Freeds' claims based on parallel federal requirements?

We next determine the second prong of the Riegel test - whether the Freeds' state law
claims impose requirements different from, or in addition to, federal requirements. Under the
second prong, the Freeds' claims will be preempted under the MDA "only to the extent that they
are 'different from, or in addition to,' the requirements imposed by federal law." 33 Preemption

7

does not apply where a state's law "parallels" federal requirements. 34 A "parallel" claim "must
show a link between a specific violation of an FDA regulation and the plaintiffs' injury."35
St. Jude argues none of the Freeds' state law claims parallel the federal scheme and they
otherwise fail to plead facts the Device failed to comply with federal requirements. The Freeds
concede their complaint "does not reference specific federal regulations" and ask for leave to
amend their complaint. Nevertheless, the Freeds argue their claims are parallel to federal
requirements, pointing to federal regulations pertaining to labeling and compliance with good
manufacturing practices post-approval raises questions whether St. Jude complied with federal
requirements. 36 The problem is the Freeds, by their own admission, fail to plead the Device
failed to comply with a federal regulation. 37

Restatement§ 388 claim.
The Freeds argue their claim under Delaware law for "manufacture or sale of dangerous
chattel" 38 in which they allege St. Jude breached its duty of care to Mrs. Freed for failing to
inform or warn of the Device's "dangerous propensity" runs parallel to federal regulations. The
Freeds do not allege St. Jude failed to report problems with the Device to the FDA as required by
federal regulation. Any additional warnings imposed by Delaware law would be expressly
preempted by the MDA. We distinguish cases allowing common law claims under§ 388 of the
Restatement of Torts outside the scope of federal preemption. For example, in Silver v.

Medtronic, Inc., the court found the MDA did not preempt a failure to warn claim based on
Pennsylvania's adoption of§ 388 of the Restatement. 39 In Silver, the manufacturer argued the
plaintiffs failure to warn claim expressly preempted to the extent it attempted to hold the
manufacturer liable for its alleged failure to warn outside the FDA's requirements. The court
rejected the manufacturer's preemption argument because plaintiffs failure to warn claim rested

8

on allegations the manufacturer failed to report problems with the device to the FDA as required
by federal regulation. The court found the claim did not seek to impose additional warning
requirements on the manufacturer, but ran parallel to FDA warning requirements. 40
Here, the Freeds do not allege St. Jude failed to comply with FDA regulation. We cannot
find their § 388 claim, as currently pleaded, is parallel to any federal regulation. 41
Breach of express warranty and implied warranties.

The Freeds argue the MDA's preemption provision does not apply to their breach of
express warranty claim because it arises from the parties' contract and the warranties are the
basis of their bargain with St. Jude. Under Delaware law, a claim for breach of express warranty
is based on state statute. 42
The Freeds rely on case law holding express warranties arise from the parties'
representations, not from operation of state law and, consequently, not preempted by the MDA.
For example, in Davenport v. Medtronic, Inc., the court found the MDA did not preempt
plaintiff's express warranty claim because plaintiff based his claim on a limited warranty
applicable to the device. 43 The court held "[t]he MDA preemption clause does not preempt an
express warranty claim based on a warranty that is a product of the parties' bargain because any
'requirements' imposed by the warranty are created by the warrantor and not imposed by state
law as required for MDA preemption."44 The Freeds cite McLaughlin v. Bayer Corp. to support
their argument. 45 McLaughlin is distinguishable on its facts. In McLaughlin, the court found the
MDA did not expressly preempt the breach of express warranty claim because the claim, as
pleaded, arose from alleged contracts between the parties. 46 We have no such allegations here.
Ultimately, the court found the complaint failed to sufficiently allege any circumstances "under
which each Plaintiff read or saw each particular warranty, or how that warranty came to be a

9

basis of each Plaintiffs bargain with Bayer." 47 The court dismissed the breach of express
warranty claim because it failed to allege a plausible breach of express warranty. 48
The Freeds do not plead the basis of their express warranty claim. In their response to
St. Jude's motion, the Freeds argue their complaint does not "refer to or rely upon the disclaimer
language" of the Limited Warranty, but do not clarify or explain the basis of the warranty
claim. 49 We cannot determine, based on the complaint and the Freeds' brief, whether their breach
of express warranty claim arises from state requirements or a contract between the parties. Even
if we found the Freeds' breach of express warranty claim arose from the Freeds' bargain with St.
Jude, there is nothing in the complaint plausibly alleging such a claim, including an allegation
the Freeds relied on the warranty, a required element under Delaware law. 50
The Freeds similarly fail to explain the basis of their breach of the implied warranties of
merchantability and fitness for a particular purpose. For the reasons explained in finding the
breach of express warranty defective, we find the implied warranties claim does not articulate
parallel claims.

Adulterated Device.
Finally, the Freeds argue the MDA "does not preempt claims that the implanted device
was adulterated." Class III devices not receiving premarket approval are "adulterated."

51

An

"adulterated" device is defined as one where "the methods used in, or the facilities or controls
used for, its manufacture, packing, storage, or installation are not in conformity with applicable
requirements." 52 FDA regulations prohibit the manufacturing, packaging, storing, labeling,
distribution, or advertising "in a manner that is inconsistent with any conditions to approval
specified in the [premarket approval] order for the device." 53

10

The Freeds argue their allegations of bums and shocks in the implant area and "the recall
campaign evidence" creates a reasonable inference the Device "was adulterated but nevertheless
made it through the manufacturing and quality control process regulated by the [premarket
process]." We disagree the complaint makes this allegation or that a reasonable inference of
adulteration could be drawn from the complaint. We will not allow "recall campaign evidence" presumably recall notices attached as exhibits to the Freeds' response - to amend the complaint.
The complaint simply fails to allege the Device is "adulterated." There are no allegations of how
the Device became adulterated in violation of federal regulation and we cannot determine the
contours of any adulteration claim. It is additionally unclear which of the Freeds' five state law
claims purport to articulate an adulteration claim to determine whether the state law claim or
claims are parallel to the federal scheme or are different from or add to the federal scheme for
purposes of our preemption analysis.
C. Implied preemption

St. Jude also argues even if the Freeds' claims survive express preemption, their claims
are impliedly preempted. The Freeds' response does not address the implied preemption
argument.
"Implied preemption is based on the fact that any suit to enforce the [Food, Drug, and
Cosmetic Act] 'shall be by an in the name of the United States."' 54 In Buckman Co. v. Plaintiffs'
Legal Comm., the Supreme Court held "fraud [on the FDA] claims exist solely by virtue of the

FDCA disclosure requirements" and are impliedly preempted by federal law as they "inevitably
conflict with the FDA's responsibility to police fraud consistently with the Administration's
judgment and objectives."55 St. Jude concedes the Freeds must allege parallel claims to survive
implied preemption, leaving only a "narrow gap" for conduct violating the Food, Drug and

11

Cosmetic Act but not because the conduct violates this act. 56 As set forth above, we cannot
determine whether the complaint as currently pleaded alleges parallel claims.

III.

Conclusion

The Freeds do not presently allege facts necessary to overcome federal preemption
arising from FDA's approval of the Device. They may be able to do so with an amendment. In
the accompanying Order, we grant St. Jude's motion to dismiss without prejudice to the Freeds
timely filing an amended complaint.

1

ECF Doc. No. 1-1 (Complaint) at ~ 10.

Id. at ~~ 7, 10. Defendants are St. Jude Medical, Inc., St. Jude Medical, S.C., Inc., Abbott
Laboratories, Inc., and Advanced Neuromodulation Systems, Inc. d/b/a St. Jude Medical
Neuromodulation Division (collectively, "St. Jude"). Id. at~~ 2-5. The Device sold by St. Jude
is the Protege 16-Channel IPG Spinal Cord Stimulator implanted in Mrs. Freed.
2

3

Id. at~7.

4

Id.

5

Id. at~ 13.

6

Id. at~ 14.

7

In deciding a motion to dismiss under Rule 12(b)(6), we accept all well-pleaded allegations in
the complaint as true and draw all reasonable inferences in favor of the non-moving party, but
we "are not compelled to accept unsupported conclusions and unwarranted inference, or a legal
conclusion couched as a factual allegation." Castleberry v. ST/ Group, 863 F.3d 259, 263 (3d
Cir. 2017) (quoting Morrow v. Balaski, 719 F.3d 160, 165 (3d Cir. 2013)). "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.'" Edinboro Coll. Park Apartments v. Edinboro Univ.
Found., 850 F.3d 567, 572 (3d Cir. 2017) (quoting In re Vehicle Carrier Serv. Antitrust Litig.,
846 F.3d 71, 79 n.4 (3d Cir. 2017)). A claim satisfies the plausibility standard when the facts
alleged "allow[] the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged." Maiden Creek Assoc., L.P. v. US. Dep't ofTransp., 823 F.3d 184, 189 (3d
Cir. 2016) (quotingAscroft v. Iqbal, 556 U.S. 662, 678 (2009)). While the plausibility standard is
not "akin to a 'probability requirement,"' there nevertheless must be more than a "sheer
possibility that a defendant has acted unlawfully." Iqbal, 556 U.S. at 678 (citing Twombly, 550
U.S. at 556). "Where a complaint pleads facts that are 'merely consistent with' a defendant's
12

liability, it 'stops short of the line between possibility and plausibility of entitlement to relief."'
Id. (quoting Twombly, 550 U.S. at 557).
Our Court of Appeals requires us to apply a three-step analysis under a 12(b)(6) motion: (1) "it
must 'tak[e] note of the elements [the] plaintiff must plead to state a claim;"' (2) "it should
identify allegations that, 'because they are no more than conclusions, are not entitled to the
assumption of truth;"' and, (3) "[w]hen there are well-pleaded factual allegations, [the] court
should assume their veracity and then determine whether they plausibly give rise to an
entitlement for relief." Connelly v. Lane Construction Corp., 809 F.3d 780, 787 (3d Cir. 2016)
(quoting Iqbal, 556 U.S. at 675, 679).
8

ECF Doc. Nos. 6, 7. We confine our analysis to the preemption question and will not address
St. Jude's arguments the complaint fails to meet pleading standards.
9

ECF Doc. No. 7.

10

Fed.R.Evid. 201(b).

11

Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993).

12

See ECF Doc. No. 14-1 at Exhibits 3, 4.

13

See Declaration of Brian M. Rostocklin in Support of Defendants' Request for Judicial Notice
at 1111 2, 3 (ECF Doc. No. 7). Courts in this District regularly take judicial notice of FDA records.
See e.g. Scanlon v. Medtronic Sofamor Danek USA, Inc., 61 F.Supp. 3d 403, 413 n. 16 (D.Del.
2014) (taking judicial notice of FDA document titled "Important Medical Information" available
on the FDA's website); Clements v. Sanofi-Aventis, U.S., Inc, 111 F.Supp. 3d 586, 592 n. 2 (D.
N.J. 2015) (taking judicial notice of FDA's premarket approval of Class III medical device);
Starks v. Coloplast Corp., No. 13-3872, 2014 WL 617130, at *1 n.3 (E.D. Pa. Feb. 18, 2014)
(taking judicial notice of public records of the FDA attached to defendant manufacturer's motion
to dismiss); In re Wellbutrin SR/Zyban Antitrust Litig., 281 F.Supp.2d 751, 755 n. 2
(E.D.Pa.2003) (taking judicial notice ofFDA's published reports posted on FDA's website).
14

ECF Doc. No. 7 at 11 4.

15

21 U.S.C. § 360 et seq.

16

Riegel v. Medtronic, Inc., 552, U.S. 312, 315 (2008). Medical devices fall into one of three
categories. 21 U.S.C. § 360c. Class I devices such as bandages and examination gloves are
subject to "general controls" and receive the lowest level of oversight. Riegel, 552 U.S. at 316.
Class II devices, such as powered wheelchairs and surgical drapes, are those which cannot be
classified as Class I because the general controls are "insufficient to provide reasonable
assurance of the safety and effectiveness of the device" and require "special controls" to provide
safety assurances including performance standards, post-market surveillance, and patient
registries. Id. at 316 -17.

13

17 Iid .
18

at 317.

Id. at 318 (quoting 21 U.S.C. §§ 360c(a)(2)(C), 360e(d)).

19

Although they do not plead it in their complaint, the Freeds assert "[t]here is no dispute that
the [Device] implanted in Mrs. Freed's body is a Class III device." ECF Doc. No. 14 at 6.
2

° FDA approval

is not alleged in the complaint. However, both parties attach the FDA's
November 21, 2001 approval letter to their briefing. The FDA issued its November 21, 2001
approval letter to Advanced Neuromodulation Systems, Inc. The Freeds allege Advanced
Neuromodulation Systems, Inc. is an entity doing business as St. Jude Medical Neuromodulation
Division. ECF Doc. No. 1 at~ 5. At the time the FDA issued its approval letter, the Device was
known as the Genesis Neurostimulation (IPG) System. See ECF Doc. No. 7-1, Exhibit 1. At
some point, the name of the Genesis device changed to the Eon Mini IPG. There is no
explanation by the parties how and when the device changed from the Genesis system to the Eon
Mini system. On March 21, 2014, the FDA issued an approval to change the name from the Eon
Mini systen to the Protege model used by Mrs. Freed. See ECF Doc. No. 7-1 at Exhibit 2.
21

See ECF Doc. No. 7-1 at Exhibit 1.

22

21 U.S.C. § 360k(a).

23

Williams v. Cyberonics, Inc., 388 F.App'x 169, 171 (3d Cir. 2010) (quoting Riegel, 552 U.S.
321-22)).

24

Williams, 388 F.App'x at 171 (citing Riegel, 552 U.S. at 325 and Horn v. Thoratec Corp., 376
F.3d 163, 173 (3d Cir. 2004)).
25

ECF Doc. No. 7-1, Exhibit 1.

26

ECF Doc. No. 14 at 3, n.3.

27

ECF Doc. No. 1 at~~ 13, 14.

28

ECF Doc. No. 14 at 13 (emphasis added).

29

46 F.3d 1316, 1319, 1325, 1329-30 (3d Cir. 1995). The passage cited by the Freeds supports
preemption. In Michael, the plaintiff argued the absence of specific regulations on heart valves
proves the lack of FDA regulation, a requirement for preemption. Our court of appeals disagreed,
finding the "absence of regulations relating specifically to hear valves is not dispositive as long
as the [Defendant's] valve was subject to 'any requirement applicable under [the MDA] to the
device."' 46 F.3d at 1324 (quoting 21 U.S.C. § 360k(a)(l)). The court found the valve subject to
MDA requirements. Id. The entire passage, excised by the Freeds, reads: "Even though these
generally applicable regulations do not rise to the level of specificity present in the case of some
other devices regulated by the FDA, we conclude that they present "specific requirements
applicable to a particular device under the act." 21 C.F.R. § 808.l(d). They therefore constitute
14

proper bases for pre-emption under§ 360k." Id. (emphasis added). The Freeds regrettably omit
this emphasized sentence in their argument.

67 F.3d 1219 (6 1h Cir. 1995). In Jacobs, the plaintiff brought a products liability action against
DuPont alleging injury resulting from Teflon used in an implant to replace her jaw joint. DuPont
manufactured Teflon and other entity manufacturer the implant. The Sixth Circuit held plaintiffs
claims were not preempted by the MDA because the FDA never issued regulations specific to
the jaw joint implant or even classified the device until years after plaintiff received her implant
and, as to the raw material argument, the language of the preemption provision in the MDA
applies only to medical devices, not raw materials. Id. at 1236. Jacobs is factually
distinguishable.
30

31

1 F.Supp. 2d 84 (D. Mass. 1998).

32 Iid .

at 86.

33

Riegel, 552 U.S. at 330 (quoting§ 360k(a)(l)).

34

Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996); Riegel, 552 U.S. at 330.

35

Clements v. Sanofi-Aventis, U.S., Inc., 111 F.Supp. 3d 586, 598 (D.N.J. 2015) (citations
omitted).

36

For example, the Freeds argue Mrs. Freed received "a non-conforming" Device which "raises
an issue as to whether Defendants complied with" federal good manufacturing practices
regulation. But the Freeds do not make these allegations.

38

The Freeds assert their claim in Count IV is based on the Restatement (Second) of Torts, § 388
- "Chattel Known to be Dangerous for Intended Use."
39

236 F.Supp. 3d 889, 899-900 (M.D. Pa. 2017).

40

Id. at 899-900.

41

Because we focus our analysis on whether the complaint as currently pleaded articulates a
parallel claim, we do not address St. Jude's argument the "manufacture or sale of dangerous
chattel" states a claim under Delaware law, including the "learned intermediary" argument.
42
Bell Sports, Inc. v. Yarusso, 759 A.2d 582,592 (De. 2000). The statute provides:
(1) Express warranties by the seller are created as follows:
(a)
Any affirmation of fact or promise made by the seller to the buyer which relates to the
goods and becomes part of the basis of the bargain creates an express warranty that the goods
shall conform to the affirmation or promise.
(b)
Any description of the goods which is made part of the basis of the bargain creates an
express warranty that the goods shall conform to the description.
15

(c)
Any sample or model which is made part of the basis of the bargain creates an express
warranty that the whole of the goods shall conform to the sample or model.
6 Del.C. § 2-313(1 ).
43

302 F.Supp.2d 419, 433 (E.D.Pa. 2004).

44

Id. (citing Steele v. Depuy Orthopaedics, Inc., 295 F.Supp. 2d 439, 455-56 (D.N.J. 2003)).

45

172 F.Supp. 3d 804 (E.D. Pa. 2016).

46

Id. at 823-24.

47

Id. at 824.

48

Id. at 823-24.

49

ECF Doc. No. 14 at 20, n.14.

50

Dilenno v. Libbey Glass Div., Owens-Illinois, Inc., 668 F.Supp. 373, 376 (D. Del. 1987).

51

21

52

Id. at§ 351(h).

53

21 C.F.R. § 814.80.

u.s.c. § 351(f).

54

Scanlon v. Medtronic Sofamor Danek USA, Inc., 61 F.Supp.3d 403, 410 (D.Del. 2014)
(quoting 21 U.S.C. §337(a)).
55

531 U.S. 341, 350, 353 (2001).

56

ECF Doc. No. 5 at 9, n.7 (quoting McLaughlin, 172 F.Supp. 3d at 815). As explained by the
court in McLaughlin, "Riegel and Buckman create a narrow gap through which a plaintiffs statelaw claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for
conduct that violates the FDCA (or else his claim is expressly preempted by §360k(a)), but the
plaintiff must not be suing because the conduct violates the FDCA (such a claim would be
impliedly preempted under Buckman). McLaughlin, 172 F.Supp.3d at 815 (quoting In re
Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 623 D.3d 1200, 1204 (8th Cir. 2010)).

16