United States District Court, N.D. Indiana, Hammond Division
KIRK J. BLEDSOE, Plaintiff,
MEDTRONIC, INC., Defendant.
OPINION AND ORDER
THERESA L. SPRINGMANN CHIEF JUDGE
matter is before the Court on Defendant Medtronic, Inc.'s
Motion to Dismiss [ECF No. 8], filed on April 12, 2018. For
the reasons set forth below, the Court GRANTS in part and
DENIES in part Defendant Medtronic, Inc.'s Motion to
following facts are alleged in the Plaintiffs Complaint [ECF
No. 4]. On June 14, 2011, Plaintiff Kirk J. Bledsoe was
implanted with a SynchroMed II Programmable Implantable Drug
Infusion System (“SynchroMed Infusion
System”) to treat an unspecified medical condition.
Compl. ¶ 16, ECF No. 5. The SynchroMed Infusion System
is a medical device that is used to treat certain medical
conditions by delivering medication via an implanted pump and
catheter. Id. ¶ 2. Defendant Medtronic, Inc., a
Minnesota corporation, designs, manufactures, and sells the
SynchroMed Infusion System, including the system implanted in
the Plaintiff. Id. ¶¶ 3, 6, 16, 31.
Between March 2008 and March 2017, the Defendant issued ten
recalls on the SynchroMed Infusion System. Id.
¶¶ 13-15, 17-23.
January 2015, the Plaintiff underwent a series of evaluations
regarding his device at Methodist Hospital in Merrillville,
Indiana. Id. ¶ 25. During each of the
evaluations, a Medtronic representative was present.
Id. At no point during the January 2015 evaluations
was the Plaintiff informed of the recalls, and, based on the
series of evaluations, the Plaintiff was led to believe that
his device was in perfect working condition. Id. In
November 2015, the Plaintiff underwent another series of
implant evaluations at Methodist Hospital. Id.
¶ 26. At no point during the second series of
evaluations was the Plaintiff informed of the recalls to his
device, and he was, once more, led to believe his device was
working properly. Id.
December 7, 2015, the Plaintiff's device malfunctioned.
Id. ¶ 27. This malfunction resulted in the
Plaintiff requiring an emergency trip to the hospital for
immediate evaluation. Id. Again, a Medtronic
representative was present during the December 7, 2015
evaluation. Id. For a third time, the Plaintiff was
not informed of the recalls to his device and was led to
believe his device was working properly. Id.
December 29, 2015, the Plaintiff's device once again
malfunctioned. Id. ¶ 28. Due to the two
malfunctions, the Plaintiff was hospitalized from December
20, 2015, through January 4, 2016. Id. During the
Plaintiff's hospitalization, it was determined that the
motor on his device had stalled. Id. Again the
Plaintiff was evaluated by a Medtronic representative, who
advised him that the device had restarted and that no further
evaluation was needed. Id. The Plaintiff requested
an additional evaluation from the Medtronic representative,
but his request was denied. Id. At no point during
his hospitalization was the Plaintiff informed of the recalls
of his device. Id.
the next several months, the Plaintiff's device continued
to malfunction. Id. ¶ 29. Ultimately, the
device's motor stalled completely, resulting in a failure
of the Plaintiff's device. Id. On October 27,
2016, the Plaintiff's device was explanted. Id.
¶ 30. The Plaintiff claims that as a result of the
malfunction and removal of the device he has suffered and
continues to suffer substantial medical expenses, loss of
quality of life, severe and permanent pain and suffering, a
depreciated and impaired marital relationship, severe and
permanent physical impairment, and other damages.
Id. ¶ 33.
November 3, 2017, the Plaintiff filed his Complaint [ECF No.
5] in Porter County, Indiana, Superior Court, bringing claims
under the Indiana Products Liability Act and seeking relief
for unspecified injuries he sustained as a result of a
defective SynchroMed Infusion System. Id. ¶ 1.
On April 5, 2018, the Defendant removed this case to federal
court on the basis of diversity of citizenship. See
Notice of Removal, ECF No. 1. On April 12, 2018, the
Defendant filed the instant Motion to Dismiss [ECF No. 8]
requesting that the Court dismiss the Complaint pursuant to
Federal Rule of Civil Produce 12(b)(6) because it fails to
state a claim upon which relief can be granted. The Plaintiff
filed his Response in Opposition to Defendant's Motion to
Dismiss [ECF No. 13] on April 26, 2018, and the Defendant
filed its Reply Memorandum in Support of its Motion to
Dismiss on May 3, 2018 [ECF No. 14]. On July 9, 2019,
Defendant filed a supplement titled Additional Authorities
Supporting Defendant Medtronic Inc.'s Motion to Dismiss
[ECF No. 23].
motion to dismiss brought under Rule 12(b)(6)
“challenges the viability of a complaint by arguing
that it fails to state a claim upon which relief may be
granted.” Camasta v. Jos. A. Bank Clothiers,
Inc., 761 F.3d 732, 736 (7th Cir. 2014) (citing
Fed.R.Civ.P. 12(b)(6); Gen. Elec. Capital Corp. v. Lease
Resolution Corp., 128 F.3d 1074, 1080 (7th Cir.1997)).
The Court presumes that all well-pleaded allegations are
true, views these well-pleaded allegations in the light most
favorable to the Plaintiff, and accepts as true all
reasonable inferences that may be drawn from the allegations.
Reynolds v. CB Sports Bar, Inc., 623 F.3d 1143, 1146
(7th Cir. 2010). Surviving a Rule 12(b)(6) motion
“requires more than labels and conclusions . . .
[f]actual allegations must be enough to raise a right to
relief above the speculative level.” Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555 (2007). “A
claim has facial plausibility when the plaintiff pleads
factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct
alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009) (citing Twombly, 550 U.S. at 556).
Plaintiff asserts three counts against the Defendant, all of
which arise under Indiana law. Although not specified in each
count, the counts are necessarily brought pursuant to the
Indiana Products Liability Act (“IPLA”). See
Dague v. Piper Aircraft Corp., 418 N.E.2d 207, 212 (Ind.
1981) (“[I]t seems clear the legislature intended that
the [IPLA] govern all product liability actions, whether the
theory of liability is negligence or strict liability in
tort.”). Count 1 and Count 2 are both titled
“Negligence”; however, the counts are more aptly
described as a failure to warn claim (Count 1) and a design
and manufacturing defect claim (Count 2). Count 3 is a strict
Defendant, in the instant Motion, sets forth several reasons
why the Complaint should be dismissed: (A) the form of the
Complaint is improper under the IPLA; (B) the Complaint fails
to meet the Federal Rule of Civil Procedure 8(a) pleading
requirements; and (C) the Plaintiff's claims are
preempted by the Medical Device Amendments to the Food, Drug
and Cosmetic Act. The Court will address each argument in
Consolidation of Claims under the IPLA
Defendant contends that the Plaintiff's Complaint is
inconsistent with Indiana law because it details three
distinct counts, while the IPLA, regardless of the legal
theory, provides for a single cause of action. The IPLA
“governs all actions that are: (1) brought by a user or
consumer; (2) against a manufacturer or seller; and (3) for
physical harm caused by a product.” Ind. Code §
34-20-1-1. It is well established that the IPLA
“govern[s] all product liability actions, whether the
theory of liability is negligence or strict liability in
tort.” Dague, 418 N.E.2d at 212. Therefore, an
IPLA claim is properly brought under a single count in one
cause of action. Atkinson v. P&G-Clairol, Inc.,
813 F.Supp.2d 1021, 1023-24 (N.D. Ind. 2011) (citing cases).
Plaintiff agrees with the Defendant but contends that it is
sufficient that the Court “treat the claims as a
single, merged cause of action under [the] IPLA for
[purposes] of Defendant's motion to dismiss.”
Pl.'s Mem. in Supp. of Resp. in Opp'n to Def.'s
Mot. to Dismiss 6. The Plaintiff is correct. In cases where a
plaintiff has brought multiple claims under the IPLA-such as
the instant case-courts generally allow for the claims to be
merged into a single count. See, e.g.,
Atkinson, 813 F.Supp.2d at 1024; Am. Int'l
Ins. Co. v. Gastite, No. 1:08-CV-1360, 2009 WL 1383277,
at *4 (S.D. Ind. May 14, 2009). Considering that merging the
claims is more efficient than dismissing the Complaint and
waiting for the Plaintiff to file an amended pleading, the
Court will consider the Complaint to contain one count
alleging a cause of action under the IPLA.
Federal Rule of Civil Procedure 8(a) Pleading
Defendant next argues that the Complaint does not satisfy the
pleading requirements mandated by Federal Rule of Civil
Procedure 8(a)(2). 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.”
Plaintiff does not detail the facts of how his system
malfunctioned, the Complaint nevertheless alleges the
following: the Plaintiff was implanted with the SynchroMed
Infusion System; the Defendant designed, manufactured, and
sold the SynchroMed Infusion System; the Plaintiff's
SynchroMed Infusion System repeatedly malfunctioned; the
Plaintiff's SynchroMed Infusion System malfunctioned
because the Defendant negligently failed to comply with
applicable laws and regulations; the Plaintiff's
SynchroMed Infusion System was eventually removed due to
repeated malfunctions; the Plaintiff suffered injuries due to
the malfunction and removal of his SynchroMed Infusion
System; and the Plaintiff's injuries are the direct and