United States District Court, D. Delaware
KATHLEEN M. FREED and RICHARD FREED, Plaintiffs,
ST. JUDE MEDICAL, INC., ST. JUDE MEDICAL S.C., INC., and ADVANCED NEUROMODULATION SYSTEMS, INC., d/b/a ST. JUDE MEDICAL NEUROMODULATION DIVISION, Defendants.
G. Culley, TYBOUT, REDFEARN & PELL, Wilmington, DE,
Attorney for Plaintiffs.
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;
Michael K. Brown, REED SMITH LLP, Los Angeles, CA, Attorneys
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' Second
Amended Complaint[, ]" filed pursuant to Federal Rule of
Civil Procedure 12(b)(6) (the "Motion"). (D.I. 42)
For the reasons that follow, the Court DENIES St. Jude's
BACKGROUND AND STANDARD OF REVIEW
Court here writes primarily for the parties, who are well
familiar with the issues in this case. The Court has
previously provided an overview of the relevant background
regarding this matter in its February 1, 2019 Memorandum
Opinion (hereinafter, "Freed IF), and
incorporates that summary herein by reference. (D.I. 34 at
2-5) The Court will only set out additional background facts
as needed, in light of the current case posture.
the Court granted-in-part and denied-in-part St. Jude's
Motion to Dismiss the First Amended Complaint
("FAC") in Freed II,  Plaintiffs filed
their Second Amended Complaint ("SAC") on April 9,
2019. (D.I. 39) In lieu of filing an Answer, on May 9,
2019, St. Jude filed the instant Motion. (D.I. 42) The Motion
was fully briefed on June 18, 2019, (D.I. 48), and the Court
heard oral argument on the Motion on October 8, 2019.
Court additionally incorporates by reference the legal
principles regarding motions to dismiss filed pursuant to
Federal Rule of Civil Procedure 12(b)(6), and those regarding
the legal doctrine of preemption, all of which were also set
out in Freed II. (D.I. 34 at 5-12)
Court will address St. Jude's arguments with respect to
Plaintiffs' negligent manufacturing claim and failure to
warn claim in turn.
respect to their negligent manufacturing claim, Plaintiffs
allege in the SAC that, inter alia: (1) St. Jude
manufactured and/or sold a variety of spinal cord stimulator
devices ("SCS device(s)") with components including
batteries that were defective and that caused injury to
patients like Mrs. Freed, (D.I. 39 at ¶ 83); (2) St.
Jude has conducted recall campaigns in the past for various
such devices and their components, including batteries,
(id, at ¶¶ 27, 84); and (3) St. Jude
manufactured and/or sold to Mrs. Freed an SCS device that was
adulterated or that was otherwise nonconforming with certain
identified good manufacturing practices ("GMPs")
required by the FDA, (id. at ¶¶ 81 (citing
21 U.S.C. § 351), 85; see also id, at ¶ 35
(citing 21 C.F.R. §§ 820.90(a), 820.100(a)(3)).
Importantly, Plaintiffs made these same allegations
in their FAC. (See, e.g., D.I. 19 at ¶¶
12, 16, 48, 50-52) Indeed, at oral argument, St. Jude's
counsel acknowledged that in substance, Plaintiffs'
negligent manufacturing claim in their SAC is the same as it
was in their FAC.
in the instant Motion, St. Jude asserts that Plaintiffs'
negligent manufacturing claim should now be dismissed with
prejudice for two reasons. First, St. Jude argues that the
recalls that Plaintiffs rely upon cannot support a viable
claim for negligent manufacturing, sufficient to survive the
affirmative defense of preemption, because those recalls
relate to prior devices (i.e., the Genesis and Eon family of
neurostimulator devices) with different FDA Premarket
Approvals ("PMAs") that predate the March 2014 PMA
for the Protege, the device at issue. (D.I. 43 at 9-11; D.I.
48 at 2-3) Second, St. Jude argues that Plaintiffs'
reliance on GMP regulations cannot serve as the basis for a
federal violation sufficient to survive preemption, because
such GMPs are vague and open-ended, and thus create standards
that are different from, or in addition to, those required by
federal requirements. (D.I. 43 at 15-16; D.I. 48 at 6-9) St.
Jude did not raise either of these arguments in its prior
Motion to Dismiss the FAC. (See D.I. 34 at 33 n.20;
D.I. 43 at 15 n.5; D.I. 48 at 9-10)
respond that these two arguments "should have been
raised in [Defendants'] Motion to Dismiss the FAC"
but were not, and therefore "have been waived by
Defendants" at this Rule 12(b)(6) stage. (D.I. 45 at ...