United States District Court, D. Delaware
KATHLEEN M. FREED and RICHARD FREED, Plaintiffs,
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, Defendants.
G. Culley, TYBOUT, REDFEARN & PELL, Wilmington, DE,
Attorney for Plaintiff.
M. Rostocki and Benjamin P. Chappie, REED SMITH LLP,
Wilmington, DE; J. David Bickham, REED SMITH LLP, San
Francisco, CA; Lisa M. Baird, REED SMITH LLP, Miami, FL,
Attorneys for Defendants.
UNITED STATES MAGISTRATE JUDGE
Kathleen M. Freed and Richard Freed ("Plaintiffs"
or "the Freeds") bring this products liability
action against Defendants 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"
or "Defendants"). Presently before the Court is St.
Jude's "Motion to Dismiss Plaintiffs' Amended
Complaint[, ]" filed pursuant to Federal Rule of Civil
Procedure 12(b)(6) (the "Motion"). (D.I. 20) For
the reasons that follow, the Court GRANTS-IN-PART St.
Jude manufacturers a variety of medical devices, including
the Protege 16-Channel IPG Spinal Cord Stimulator Catalogue
Number 3789, Lot Number 4699346 (hereinafter, "the SCS
device"). (D.I. 19 (hereinafter, "First Amended
Complaint" or "FAC") at ¶ 7) The SCS
device is implanted in patients suffering from chronic lower
back and lower extremity pain. (Id.)
2001, following the submission of a premarket approval
("PMA") application and review, the United States
Food and Drug Administration ("FDA") issued an
approval for the commercial distribution of the Genesis and
Eon Family of Neurostimulation (IPG) Systems, manufactured by
St. Jude. (Id. at ¶ 8) In March 2014, the FDA
issued an approval to change the name of a device in this
family, the Eon Mini IPG, to the Protege Model 3789 (i.e.,
the SCS device). (Id. at¶ll)
Freed has suffered from chronic lower back and left lower
extremity pain since before October 17, 2014. (Id.
at ¶ 17) She has received various surgical and
non-surgical treatments providing only modest overall relief
of her pain. (Id.) On or about July 14, 2014, Mrs.
Freed underwent a trial placement of an SCS device.
(Id. at ¶ 18) A St. Jude representative was
present during the procedure, and this representative told
Mrs. Freed that she would be "very happy" with the
SCS device. (Id.) Mrs. Freed's physician
subsequently recommended that Mrs. Freed undergo surgery to
have an SCS device permanently implanted for management of
her chronic pain. (Id.) After conducting internet
research (including on St. Jude's website) regarding the
SCS device and alternative devices, Plaintiffs decided that
Mrs. Freed would proceed with permanent implantation of the
SCS device in her body. (Id.)
October 17, 2014, Mrs. Freed underwent the implantation
procedure at Christiana Hospital in Newark, Delaware.
(Id. at ¶ 19) Dr. Kennedy Yalamanchili
surgically implanted the neurostimulator and battery
components of the SCS device in the soft tissues of Mrs.
Freed's left buttocks. (Id.) A St. Jude
representative was present at Christiana Hospital during the
procedure. (Id.) Thereafter, Mrs. Freed met
regularly with representative(s) of St. Jude and her
physician(s) regarding the SCS device's performance.
(Id. at ¶ 20)
about June 12, 2015, Mrs. Freed underwent further exploratory
and fusion surgery on her lumbar spine by Dr. Yalamanchili at
Christiana Hospital. (Id. at ¶ 21) Shortly
thereafter, Dr. Yalamanchili prescribed the use of a bone
growth stimulator to assist the healing process.
Mrs. Freed began using the bone stimulator, she experienced
discomfort in her left buttocks where the neurostimulator and
battery components of the SCS device had been implanted.
(Id. at ¶ 22) The discomfort progressed such
that the SCS device began giving off severely painful
electrical shocks and a burning sensation throughout her left
buttocks. (Id.) Mrs. Freed stopped using the SCS
device. (Id.) On August 5, 2015 she went to the
Emergency Department at the Easton Hospital in Easton,
Maryland due to persistent severe burning pain in her left
buttocks. (Id.) Mrs. Freed spoke to a St. Jude
representative present at the Emergency Department.
Freed then consulted with Dr. Yalamanchili and a St. Jude
representative, and a medical decision was made to surgically
remove the SCS device. (Id. at ¶ 23) On August
17, 2015, Dr. Yalamanchili performed the surgery at the Upper
Bay Surgery Center in Elkton, Maryland. (Id.) A
representative of St. Jude was present, and took possession
of the neurostimulator and battery components that had been
removed. (Id.) Plaintiffs allege that Mrs. Freed has
experienced and will continue to experience severe pain and
suffering and emotional distress due to the implementation of
the SCS device into her body. (See, e.g., Id. at
filed a Complaint in the Superior Court of the State of
Delaware that was removed to this Court on August 11, 2017;
that Complaint asserted state law claims for injuries
allegedly sustained as a result of the implementation of the
SCS device. (D.I. 1) With the case now in this Court, St.
Jude moved to dismiss Plaintiffs' Complaint, arguing
that, inter alia, Plaintiffs' state law claims
are preempted by federal law. (D.I. 4; D.I. 5) On September
15, 2017, United States District Judge Mark A.
Kearney granted St. Jude's motion without
prejudice to Plaintiffs' ability to file an amended
complaint. Freed v. St. Jude Medical, Inc., CIVIL
ACTION NO. 17-1128, 2017 WL 4102583 (D. Del. Sept. 15, 2017)
(hereinafter, 'Treed i"). On that same
date, the parties jointly consented to the Court's
authority to conduct all proceedings in this case, including
trial, the entry of final judgment, and all post-trial
proceedings. (D.I. 18)
October 2, 2017, Plaintiffs filed the currently operative
First Amended Complaint ("FAC"). (D.I. 19) In the
FAC, Plaintiffs have asserted claims under Delaware law for
breach of express warranty (Count I), breach of implied
warranties of merchantability and fitness for a particular
purpose (Counts II and III, respectively), the manufacture
and/or sale of a dangerous chattel (Count IV), and loss of
consortium (Count V). (Id.) In lieu of filing an
Answer, on October 16, 2017, St. Jude filed the instant
Motion, (D.I. 20), arguing that: (1) Plaintiffs' claims
remain preempted by federal law; and (2) as to all of their
claims, Plaintiffs have not otherwise stated a plausible
claim for relief pursuant to Federal Rule of Civil Procedure
12(b)(6), (D.I. 21). The Motion was fully briefed on November
6, 2017. (D.I. 26)
STANDARD OF REVIEW
sufficiency of pleadings for non-fraud cases is governed by
Federal Rule of Civil Procedure 8, which requires "a
short and plain statement of the claim showing that the
pleader is entitled to relief[.]" Fed.R.Civ.P. 8(a)(2).
When presented with a Rule 12(b)(6) motion to dismiss for
failure to state a claim, a court conducts a two-part
analysis. Fowler v. UPMC Shadyside, 578 F.3d 203,
210 (3d Cir. 2009). First, the court separates the factual
and legal elements of a claim, accepting "all of the
complaint's well-pleaded facts as true, but
[disregarding] any legal conclusions." Id. at
210-11. Second, the court determines "whether the facts
alleged in the complaint are sufficient to show that the
plaintiff has a 'plausible claim for relief.'"
Id. at 211 (quoting Ashcroft v. Iqbal, 556
U.S. 662, 679 (2009)). A plausible claim does more than
merely allege entitlement to relief; it must also demonstrate
the basis for that "entitlement with its facts."
Id. Thus, a claimant's "obligation to
provide the 'grounds' of his' entitle[ment] to
relief requires more than labels and conclusions, and a
formulaic recitation of the elements of a cause of action
will not do[.]" Bell Atl. Corp. v. Twombly, 550
U.S. 544, 555 (2007). In assessing the plausibility of a
claim, the court must '"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.'"
Fowler, 578 F.3d at 210 (quoting Phillips v.
Cty. of Allegheny, 515 F.3d 224, 233 (3d Cir.
Freed I, as noted above, Judge Kearney granted St.
Jude's motion to dismiss the original Complaint without
prejudice to file an amended complaint. In doing so, he found
that the original Complaint did "not plausibly allege
the facts necessary to avoid federal preemption[.]"
Freed I, 2017 WL 41025 83, at * 1. In the instant
motion, St. Jude asserts that while the Freed I
decision "outlined the defects in the initial Complaint.
. . Plaintiffs' [FAC] still has not cured the fundamental
problems" and that preemption requires dismissal of
Plaintiffs' claims with prejudice. (D.I. 21 at 1-2)
Additionally, St. Jude asserts that Plaintiffs "still
have not [otherwise] adequately stated any claim under
[Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)]
and [Ashcroft v. Iqbal, 556 U.S. 662 (2009)], and
some of their causes of action must also be dismissed on
state law grounds." (Id. at 2)
Court will first set out the relevant law regarding federal
preemption as it relates to medical devices. Then, the Court
will assess whether Plaintiffs' amended claims in the FAC
warrant dismissal on the various grounds pressed by St. Jude.
is a concept based on the Supremacy Clause of the United
States Constitution. See Hillsborough Cty. v. Automated
Med. Labs., 471 U.S. 707, 712 (1985); Fellner v.
Tri-Union Seafoods, L.L.C., 539 F.3d 237, 242 (3d Cir.
2008). It provides that a conflicting state law will be
trumped by its federal counterpart. Hillsborough,
471 U.S. at 712-13; Fellner, 539 F.3d at 242-43.
Preemption may be express or implied. Shaw v. Delta Air
Lines, Inc., 463 U.S. 85, 95(1983).
in 1976, the Medical Device Amendments ("MDA") to
the Food, Drug and Cosmetic Act ("FDCA")
established the federal regulatory regime for medical devices
(an area that had previously been left to the states).
Riegel v. Medtronic, Inc., 552 U.S. 312, 315-16
(2008). Pursuant to the MDA, medical devices are classified
into three categories, depending on the risks that they
present. Id. at 316-17. Class III devices, like
those at issue in this case, receive the greatest amount of
federal oversight; they are devices used '"in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human
health, '" or that'"present a potential
unreasonable risk of illness or injury.'"
Id. at3l7 (quoting 21 U.S.C. §
360c(a)(1)(C)(ii)). The rigorous process of federal review
that new Class III medical devices undergo for the evaluation
of safety and effectiveness is known as "premarket
approval" (or PMA). 21 U.S.C. § 360e; Shuker v.
Smith & Nephew, PLC, 885 F.3d 760, 766 (3d Cir.
Class III device has received premarket approval, the
manufacturer is not permitted to change design
specifications, manufacturing processes or labeling that
would affect safety or effectiveness without permission from
the FDA. Riegel, 552 U.S. at 319 (citing 21 U.S.C.
§ 36Oe(d)(6)(A)(i)). A manufacturer seeking to make such
changes must submit an application for supplemental premarket
approval ("PMA Supplement") to the FDA; it must
then await approval pursuant to the same rigorous standard of
review that is applied during the initial PMA application
also imposes reporting requirements on manufacturers
following the PMA process. Manufacturers are required to
"inform the FDA of new clinical investigations or
scientific studies concerning the device which the applicant
knows of or reasonably should know of. .. and to report
incidents in which the device may have caused or contributed
to death or serious injury, or malfunctioned in a manner that
would likely cause or contribute to death or serious injury
if it recurred[.]" Id. (citing 21 C.F.R.
§§ 803.50(a), 814.84(b)(2)).
contains an express preemption provision. It provides that
state laws "which relate to the safety or
effectiveness of [a Class III medical] device" and are
"different from, or in addition to" federal
requirements under the MDA, are expressly preempted. 21
U.S.C. § 360k(a) ("Section 360k(a)" or
"Section 360k"); see also Shuker, 885 F.3d
at 767 ("The [MDA's] comprehensive and tiered
approval procedures for medical devices leave only limited
room for additional state regulation, especially considering
the statute contains a broad express preemption
provision."). Class III device manufacturers receive
express preemption protections because the devices have
undergone premarket approval, and thus such devices have been
found to satisfy federal requirements applicable to the
device. Shuker, 885 F.3d at 767; see also
Riegel, 552 U.S. at 318 ("The FDA spends an average
of 1, 200 hours reviewing each [Class III medical device
application], and grants premarket approval only if it finds
there is a 'reasonable assurance' of the device's
'safety and effectiveness[.]'") (quoting 21
U.S.C. § 36Oe(d)). In light of Section 36Ok(a), the
Supreme Court of the United States has construed the MDA as
protecting Class III device manufacturers from liability
under state law tort claims if the manufacturer has complied
with federal regulatory requirements. See Riegel,
552 U.S. at 323-24; see also, e.g., Williams v.
Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir. 2010)
("Generalized common law theories of liability ... are
precisely the type of claims the MDA sought to
preempt."); Millman v. Medtronic, Civil Action
No. 14-cv-1465, 2015 WL 778779, at *5 (D.N.J. Feb. 24, 2015)
("As stated by one court, 'Riegel is loud
and clear: if a manufacturer complies with the premarket
approval, it gets a free pass on [products liability and
implied breach of warranty] claims.'") (citation
"state laws are not shut out entirely" when it
comes to claims against Class III device manufacturers.
Shuker, 885 F.3d at 768. The MDA's express
preemption provision does not apply to "parallel"
claims-that is, to claims premised on state requirements that
merely incorporate federal requirements and therefore are not
"different from, or in addition to," federal
requirements. Id. (internal quotation marks and
citations omitted); see also Riegel, 552 U.S. at 330
(noting that Section 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") (quoting Medtronic, Inc. v.
Lohr, 518 U.S. 470, 495 (1996)); Hart v. Medtronic,
Inc., Civil Action No. 1:16-cv-05403 (JBS-AMD), 2017 WL
5951698, at *4 (D.N.J. Nov. 30, 2017) (explaining that
Riegel recognized that "claims alleging that a
manufacturer failed to adhere to the specifications imposed
by a device's premarket approval are not preempted... .
because they merely parallel federal requirements-that is,
they do not add to or differ from federal requirements, which
is the cornerstone of the MDA's medical device
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the
Supreme Court established a two-step form of analysis for
determining whether a claim is expressly preempted pursuant
to the MDA. 552 U.S. at 321-22. First, the court must
determine whether the FDA has established requirements
applicable to the medical device at issue. Here, that step is
not at issue, for it is undisputed that the SCS device is a
Class III device, and the Supreme Court has held that any
Class III device receiving PMA approval from the FDA will
satisfy this first step in the analysis. Id. at 322
("Premarket approval.. . imposes 'requirements'
under the MDA[.]"); Hart, 2017 WL 5951698, at
Second, the court must determine whether the plaintiffs'
state law claims relate to safety and effectiveness and
impose requirements that are "different from, or in
addition to" those imposed by federal law.
Riegel, 552 U.S. at 321-22 (internal quotation marks
and citation omitted). If they do, those claims are expressly
preempted. Mat 330.
parallel claim exception to preemption requires more than
just the use of certain terminology; a plaintiff "cannot
simply incant the magic words 'Defendant violated FDA
regulations' in order to avoid preemption."
Clements v. Sanofi-Aventis, U.S., Inc., 111
F.Supp.3d 586, 598 (D.N.J. 2015) (certain internal quotation
marks, brackets and citations omitted); see also Smith v.
Depuy Orthopaedics, Inc., Civil Action No. 11-4139
(JAP), 2013 WL 1108555, at *12 (D.N.J. Mar. 18, 2013)
("[B]road references to federal regulations in pleadings
are insufficient [to properly plead a parallel claim].")
(internal quotation marks and citations omitted). Rather, a
plaintiff must plead "facts showing action or inaction
in [the] defendants' efforts to take part in the PMA
process or implement its results." Smith, 2013
WL 1108555, at * 12 (internal quotation marks, brackets and
citation omitted). In sum, a "parallel claim," like
any other claim, is subject to the pleading standards of
Twombly and Iqbal. Hart, 2017 WL 5951698,
in addition to the MDA's express preemption clause, the
MDA provides that all actions to enforce FDA requirements
"shall be by and in the name of the United States."
21 U.S.C. § 337(a). In Buckman Co. v.
Plaintiffs' Legal Comm., 531 U.S. 341 (2001), the
Supreme Court construed this provision as barring suits by
private litigants "for noncompliance with the medical
device provisions." 531 U.S. at 349 n.4. To avoid
implied preemption under Buckman, a claim must
assert violation of a state tort duty that also violates some
FDA requirement. See Hughes v. Boston Sci. Corp.,
631 F.3d 762, 775 (5th Cir. 2011). That is, the conduct on
which the plaintiffs' claim is premised must be the type
of conduct that would traditionally give rise to liability
under state law, and that would give rise to liability under
state law even if the FDCA had never been enacted.
Yosowitz v. Covidien LP, 182 F.Supp.3d 683, 690
(S.D. Tex. 2016); see also, e.g., Bull v. St. Jude Med,
Inc., CIVIL ACTION NO. 17-1141, 2018 WL 3397544, at *9
(E.D. Pa. July 12, 2018) ("State law claims that allege
liability based on a common law tort theory and which
parallel federal law claims ... are not impliedly preempted
under Buckman"). If the defendant's conduct
is not of this type, then (regardless of how the plaintiff
has labeled the claim) the claim is impliedly preempted under
Buckman because the plaintiff is effectively suing
for a violation of the FDCA. Yosowitz, 182 F.Supp.3d
Analysis of the FAC's Claims
Freed I, Judge Kearney concluded that
Plaintiffs' state law claims, as alleged in the original
Complaint, were all expressly preempted by federal law
because they were all theories of liability relating to the
safety or effectiveness of the SCS device and Plaintiffs
failed to plead facts sufficient to show that the claims did
not impose requirements that were "different from, or in
addition to" those imposed by federal law. Plaintiffs
had conceded that their original Complaint failed to
reference specific federal regulations, but they had argued
that "their claims are parallel to federal requirements,
pointing [in their briefing] to federal regulations
pertaining to labeling and compliance with good manufacturing
practices post-approval[.]" Freed I, 2017 WL
4102583, at *6. But ultimately, Plaintiffs'
"fail[ure] to plead the Device failed to comply with a
federal regulation" doomed the claims of the original
the instant Motion, St. Jude contends that Plaintiffs'
FAC is "hardly different" from their original
Complaint. (D.I. 21 at 2) While St. Jude acknowledges that
Plaintiffs' FAC now cites to federal regulations, (D.I.
26 at 2), it asserts that Plaintiffs "still have not
'plausibly allege[d] the facts necessary to avoid federal
preemption[, ]'" (D.I. 21 at 2 (quoting
Freed I, 2017 WL 4102583, at *1); see also
D.I. 26 at 2-3). St. Jude also argues that Plaintiffs do not
otherwise plead sufficient facts to make out plausible claims
under the Twombly/lqbal pleading standard. For these
reasons, according to St. Jude, the FAC must be dismissed
with prejudice. (D.I. 21 at 1-2)
the Court will assess each of Plaintiffs' claims, in the
order they are listed in the FAC.
Breach of Express ...