United States District Court, N.D. Indiana, South Bend Division
REPORT AND RECOMMENDATION
MICHAEL G. GOTSCH, SR. UNITED STATES MAGISTRATE JUDGE.
August 19, 2016, Defendants, St. Jude Medical, Inc. and
Pacesetter, Inc. (collectively, “St Jude”), filed
their Motion to Dismiss. On August 24, 2016, Plaintiffs, Ron
and Beverly Mikesell, filed their response in opposition to
St. Jude's motion. St. Jude's motion became ripe on
September 6, 2016, when St. Jude filed a reply brief. On
October 7, 2016, St. Jude's motion was referred to the
undersigned for a report and recommendation pursuant to 28
U.S.C. § 636(b)(1)(B), Fed.R.Civ.P. 72(b), and N.D. Ind.
L.R. 72-1(c). For the reasons stated below, the undersigned
recommends that St. Jude's motion be GRANTED. [DE
April 19, 2016, Plaintiffs filed their complaint raising four
claims-strict liability- manufacturing defect (Count I),
negligence in manufacturing (Count II), negligence per
se (Count III), and loss of consortium (Count IV).
Plaintiffs' claims are based on allegations that Mr.
Mikesell was injured as the result of manufacturing defects
in the St. Jude Riata and Riata ST Leads (“Riata
Leads” or “Leads”) implanted in him in 2005
as part of an implantable cardiac defibrillator
(“ICD”). [DE 6 at 1, ¶ 1]. The Riata
Leads, manufactured by St. Jude, are wires attached to ICDs
“that deliver signals that allow an [ICD] to detect
an abnormal heart rhythm and deliver a shock to help the
heart return to an appropriate rhythm.” In re
Medtronic, Inc., Sprint Fidelis Leads Prod. Liab.
Litig., 623 F.3d 1200, 1203 (8th Cir. 2010).
to Plaintiffs' complaint, St. Jude introduced its Riata
Leads, a Class III medical device, to the American market in
about 2002 after securing approval for its design,
manufacturing method, and labeling from the Food and Drug
Administration (“FDA”). Class III medical devices
“present a potential unreasonable risk of illness or
injury and therefore incur the FDA's strictest
regulation.” Buckman Co. v. Plaintiffs' Legal
Comm., 531 U.S. 341, 344 (2001) (quoting 21 U.S.C.
§ 360c(a)(1)(C)(ii)(II)) (internal quotations omitted).
Before they may enter the market, Class III medical devices
must undergo the rigorous premarket approval process
(“PMA”), designed to provide the consuming public
with “reasonable assurance that such device is safe
[and effective] under the conditions of use prescribed,
recommended, or suggested in the proposed labeling
thereof.” Id. (quoting 21 U.S.C. §
allege in their complaint that from January 2003 through
2010, after securing initial approval of the Leads through
the PMA process, St. Jude submitted multiple PMA Supplements
through which it sought and received approval to manufacture
additional models of Leads as well as to make modifications
to the original Riata Leads. [DE 6 at 5-7,
¶¶ 16-32]. Plaintiffs more specifically allege that
“St. Jude applied for over 27 manufacturing or process
changes to the Riata Leads” between 2005 and 2010 and
that “St. Jude failed to manufacture the Riata Leads
consistent with these approved changes, thereby creating a
defective product.” [Id. at 7, ¶ 32]. In
the section of their complaint entitled “Manufacturing
Defects with Regard to Riata Leads, ” Plaintiffs allege
that the defects resulting from St. Jude's alleged
failure to comply with the 27 manufacturing or process
changes violated the PMA and included “inconsistent
insulation diameters surrounding the electric conductors,
” [Id., ¶ 33], inconsistent application
of “a lubricious interface between the inner and outer
insulation, ” [Id. at 8, ¶ 36],
“reduced tensile strength of the silicone
insulation” as the result of “failure to comply
with approved methods of curing and sterilization during the
manufacture of the Leads, ” [Id., ¶ 37],
and “insecure crimps over the length of the Lead”
resulting from “failure to crimp with a controlled,
uniform, degree of force” [Id., ¶ 38].
also allege that St. Jude sent two advisories, one in 2010
and one in 2011, to doctors regarding the Riata Leads. St.
Jude acknowledges that on December 21, 2011, the FDA
reclassified St. Jude's advisories as a Class I Recall as
Plaintiffs alleged. [Id. at 10, ¶ 46; DE 11
at 9]. According to Plaintiffs, “the FDA indicated
that the reason for the recall was that ‘failures
associated with lead insulation abrasion on the St. Jude
[Riata Leads] may cause the conductors to become
externalized, ” which “may cause serious adverse
health causes [sic], including death.” [DE 6 at
10, ¶ 48].
assert that Mr. Mikesell “first learned that his Riata
[L]ead had been recalled on or about August 2014” and
that “[o]n October 03, 2014, [he] underwent invasive
surgery to remove and replace the defective Riata Lead of his
pacemaker.” [Id. at 2, ¶ 6]. Plaintiffs
further allege that “[a]s a result of the defect in his
Riata lead, [Mr. Mikesell] is now 100 percent dependent upon
his pacemaker when he formerly was only 40 percent dependent
upon his pacemaker.” [Id., ¶ 7].
strict liability-manufacturing defect claim (Count I) alleges
that “the defendant [sic]” was injured “as a
direct and proximate result of the manufacturing defect
resulting “because the actual manufacture of the Riata
Leads differs from the specifications set forth in the PMA
and the conditions for approval.” [Id. at 12,
¶¶ 56-61]. Through their negligence in
manufacturing claim (Count II), Plaintiffs allege that St.
Jude breached its duty to manufacture the Riata Leads
consistent with the PMA and conditions of approval and that
St. Jude's breach directly and proximately caused Mr.
Mikesell's injuries. [Id., ¶¶ 62-64].
Plaintiffs' negligence per se claim (Count III)
is based on St. Jude's alleged failure to comply with
twenty specific Federal Regulations and the Conditions of
Approval for the Leads, which allegedly were the direct and
proximate cause of Mr. Mikesell's injuries. [Id. at
13, ¶¶ 65-70]. And lastly in Count IV, Mrs.
Mikesell alleges that she “suffered and will continue
to suffer the loss of services and consortium of her
husband” as a direct and proximate result of the St.
Jude's negligence. [Id., ¶ 71].
instant motion to dismiss, St. Jude argues that Plaintiffs
have failed to state any claim. Specifically, St. Jude
contends that (1) Counts I and II fail to satisfy the Rule 8
pleading requirements and are also expressly pre-empted under
21 U.S.C. § 360k(a) [DE 11 at 17-27]; (2) Count
III is inadequately pleaded and is also impliedly pre-empted
because there is no private right of action to enforce the
FDCA [Id. at 27-31]; and (3) Count IV must be
dismissed with the other claims because it is dependent upon
them and cannot stand alone [Id. at 31-32].
Manufacturing Defect Claims: Count I (Strict Liability) and
Count II (Negligence in Manufacturing)
arising from Class III medical devices with premarket
approval are limited under the 1976 Medical Device Amendments
(“MDA”) to the Food, Drug, and Cosmetics Act
(“FDCA”). Specifically, 21 U.S.C. § 360k(a)
prohibits states from
establish[ing] or continu[ing] 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