Bledsoe v. Medtronic, INC.

Filing 74

OPINION AND ORDER: The Court hereby GRANTS Defendant Medtronic, Inc.'s Motion for Summary Judgment 61 . The Court DIRECTS the Clerk of Court to enter judgment in favor of the Defendant Medtronic, Inc. and against the Plaintiff Kirk J. Bledsoe. Signed by Judge Theresa L Springmann on 10/13/2022. (Copy mailed to pro se party via certified # 7099 3400 0003 4511 2994). (jdb) Modified on 10/14/2022 to add certified info. (nal)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
HAMMOND DIVISION
KIRK J. BLEDSOE,
Plaintiff,
v.

CAUSE NO.: 2:18-CV-133-TLS

MEDTRONIC, INC.,
Defendant.
OPINION AND ORDER
This matter is before the Court on Defendant Medtronic, Inc.’s Motion for Summary
Judgment [ECF No. 61], which is fully briefed and ripe for ruling. For the reasons set forth
below, the Court grants the Defendant’s motion.
PROCEDURAL BACKGROUND
On November 3, 2017, Plaintiff Kirk J. Bledsoe, through counsel, filed a Complaint [ECF
No. 5] against Defendant Medtronic, Inc. The Plaintiff alleged two counts of negligence and one
count of strict liability, all under the Indiana Product Liability Act (IPLA), Ind. Code § 34-20-1-1
et seq. Compl. at 4–9, ECF No. 5. The Plaintiff claimed he suffered injuries as the direct and
proximate result of a defective, implantable SynchroMed® II infusion pump, model 8637-40,
which was manufactured, sold, and monitored by the Defendant. Id. at 1, 4.
The Defendant moved to dismiss the Plaintiff’s claims for failure to state claim. ECF No.
8. On January 3, 2020, the Court ruled on the motion to dismiss, beginning its analysis by
explaining that the IPLA permits three types of actions—failure to warn, design defect, and
manufacturing defect. ECF No. 24, p. 11. The Court dismissed the Plaintiff’s failure to warn and
design defect claims as preempted by the Medical Device Amendments (MDA) to the Food,

Drug and Cosmetic Act, 21 U.S.C. § 360k(a),1 but permitted the Plaintiff’s manufacturing defect
claim to move forward. ECF No. 24, p. 11–15. The Court held that, “to the extent the Plaintiff’s
Complaint alleges that his injuries were caused by a manufacturing defect in the production of
his medical device and that the defect was caused by a violation of the federal requirements, his
claim is properly pled and not preempted.” Id. at 15. The Court explicitly noted that, “[t]o prevail
on his claim, the Plaintiff will ultimately have to specify a violation of a particular federal
requirement and will have to prove that his injury was the direct and proximate cause of that
violation.” Id.
On April 28, 2021, the Defendant filed the instant Motion for Summary Judgment [ECF
No. 61] on the Plaintiff’s manufacturing defect claim. On May 27, 2021, the Plaintiff, who is
now proceeding pro se, filed a Response [ECF No. 69], and on June 9, 2021, the Defendant filed
a Reply [ECF No. 72]. On June 15, 2021, the Plaintiff filed a “Reply” [ECF No. 73] to the
Motion for Summary Judgment.
SUMMARY JUDGMENT STANDARD
Summary judgment is warranted when “the movant shows that there is no genuine
dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R.
Civ. P. 56(a). The movant may discharge this burden by “either: (1) showing that there is an
absence of evidence supporting an essential element of the non-moving party’s claim; or
(2) presenting affirmative evidence that negates an essential element of the non-moving party’s

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The MDA preemption provision states:
[N]o 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.
21 U.S.C. § 360k(a).

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claim.” Hummel v. St. Joseph Cnty. Bd. of Comm’rs, 817 F.3d 1010, 1016 (7th Cir. 2016)
(citation omitted). In response, the non-movant “must make a sufficient showing on every
element of his case on which he bears the burden of proof; if he fails to do so, there is no issue
for trial.” Yeatts v. Zimmer Biomet Holdings, Inc., 940 F.3d 354, 358 (7th Cir. 2019) (citing
Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)).
In ruling on a motion for summary judgment, a court must construe all facts and draw all
reasonable inferences in the light most favorable to the nonmoving party. Id. (citation omitted).
A court’s role “is not to sift through the evidence, pondering the nuances and inconsistencies,
and decide whom to believe. The court has one task and one task only: to decide, based on the
evidence of record, whether there is any material dispute of fact that requires a trial.” Waldridge
v. Am. Hoechst Corp., 24 F.3d 918, 920 (7th Cir. 1994) (citations omitted). Facts that are
outcome determinative under the applicable law are material for summary judgment purposes.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
FACTUAL BACKGROUND
The SynchroMed® II Infusion System is a Class III2 medical device that treats certain
medical conditions by delivering medication (e.g., baclofen or morphine sulfate) via an
implanted pump and catheter directly to the “intrathecal” area where fluid flows around the

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The United States Congress has established a regulatory regime for medical devices that classifies
devices by the level of risk they present. See Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008); see also
21 U.S.C. § 360c. Class III devices require the most oversight. Riegel, 552 U.S. at 317. These devices
include “replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators.” Id.
In Riegel, the United States Supreme Court described Class III devices as follows:
In general, a device is assigned to Class III if it cannot be established that a less stringent
classification would provide reasonable assurance of safety and effectiveness, and the
device is “purported or represented to be for a use in supporting or sustaining human life
or for a use which is of substantial importance in preventing impairment of human health,”
or “presents a potential unreasonable risk of illness or injury.”
Id. (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)).

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spinal cord. Glen Smythe Decl. ¶ 4, ECF No. 63-1. The U.S. Food and Drug Administration
(FDA) approved the SynchroMed® II Infusion System and its component parts for commercial
release via its Premarket Approval (PMA), PMA Supplement, and Annual Report processes. Id.
at ¶ 5. The FDA approves products for market release via a PMA or PMA Supplement only after
it is satisfied there is a reasonable assurance that the devices are safe and effective for their
intended uses and comply with the FDA-mandated requirements for approval. Id.
On November 5, 2004, the Plaintiff had implanted a Model 8637-40 SynchroMed® II
pump (serial number NGV004193N) and a Model 8731 intrathecal catheter (serial number
N001532131). Wade Linnertz Decl. ¶ 4, ECF No. 64. On June 14, 2011, the Plaintiff had
implanted a different Model 8637-40 SynchroMed® II pump (serial number NGV450625H). Id.
at ¶ 5. And on December 3, 2014, the Plaintiff had implanted a Model 8780 Ascenda® catheter
(serial number N505359002). Id. at ¶ 6.
The FDA granted PMA to the original SynchroMed® Infusion System via PMA 860004
on March 14, 1988. Smythe Decl. at ¶ 6. The FDA granted PMA to the Model 8637
SynchroMed® II pump via PMA 860004, Supplement 56, on September 12, 2003. Id. at ¶ 7. The
FDA granted PMA to the Model 8731 intrathecal catheter on October 11, 2002, via PMA
860004, Supplement 54, id. at ¶ 8, and to the Model 8780 Ascenda® catheter on May 2, 2012,
via PMA 860004, Supplement 125, id. at ¶ 9.
Since the FDA’s original approval of the SynchroMed® Infusion System in 1988
through the present date, the FDA has maintained oversight of the design, manufacture,
composition, labeling, warnings, marketing, sale, device tracking, and performance reporting for
the device, including the above-mentioned pumps, catheters, and their accompanying manuals
and documents. Id. at ¶ 10. The FDA has approved hundreds of supplements concerning the

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SynchroMed® II Infusion System, and it retains the authority to initiate proceedings to withdraw
approval should it deem any medical device unsafe or ineffective or determine that the medical
device’s potential risks outweigh its benefits. Id. The PMA for the SynchroMed® II Infusion
System, including all of the above-mentioned pumps and catheters, remains valid and has never
been withdrawn, revoked, or suspended. Id. at ¶ 11.
As a Class III, prescription-only medical device, the SynchroMed® II Infusion System is
subject to the FDA’s enhanced regulatory controls: the Quality Systems Regulations (QSRs) and
Current Good Manufacturing Practices (CGMPs) set forth in 21 C.F.R. Part 820 et seq. Linnertz
Decl. at ¶ 9. In compliance with the FDA’s QSR and CGMP regulations, Medtronic’s
manufacturing facilities created and follow a quality assurance program, written manufacturing
specifications and procedures, written procedures for acceptance, storage, and handling, and
written procedures for finished device inspection. Id. at ¶ 10.
During the assembly process, every SynchroMed® II Infusion System pump and catheter
undergoes testing and inspection to assure that it conforms to the FDA-approved design
requirements and specifications, including visual, mechanical, electrical, and dimensional
inspections and tests. Id. at ¶ 13. Medtronic only provides a SynchroMed® II pump or catheter
for sale if it has passed the tests and inspections compiled within the design specifications
established for the specific device. Id. If a device does not pass each test and inspection, the
device is not provided for sale. Id.
Medtronic produces a “traceability card” for each device it manufactures. Id. at ¶ 11. A
traceability card details information such as the device identification number or lot control
number, each manufacturing or inspection operation the device goes through, the specification or
policy controlling each operation, the identity of the technicians who performed each operation,

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the date of each step of the process, and the product labels and literature packaged with the
device. Id. at ¶ 12. The traceability card for the Plaintiff’s second pump demonstrates that his
SynchroMed® II Model 8637-40 (Serial number NGV450625H) was manufactured in
Medtronic’s Juncos, Puerto Rico manufacturing facility from May 3, 2011, through May 31,
2011; met all of Medtronic’s FDA-approved specifications; passed each quality assurance
inspection and test; and was packaged with the warnings and labeling approved by the FDA. Id.
at ¶ 18. The traceability cards for the Plaintiff’s second catheter demonstrate that his Ascenda®
Model 8780 (Serial number N505359002) was manufactured in Medtronic’s Sullivan Lake,
Minnesota manufacturing facility from October 9, 2014, through October 28, 2014; met all of
Medtronic’s FDA-approved specifications; passed each quality assurance inspection and test;
and was packaged with the warnings and labeling approved by the FDA. Id. at ¶ 19.
DISCUSSION
In support of its Motion for Summary Judgment, the Defendant argues three grounds
upon which the Plaintiff’s manufacturing defect claim fails. First, the Defendant argues the
Plaintiff failed to specify a violation of a particular federal requirement and prove that his injury
was the direct and proximate cause of that violation. See Bausch v. Stryker Corp., 630 F.3d 546,
558 (7th Cir. 2010) (explaining that the plaintiff may succeed on her state law manufacturing
defect claim “so long as she can show that she was harmed by a violation of applicable federal
law”). Second, the Defendant argues the Plaintiff has failed to show that the product deviates
from its intended design. See Piltch v. Ford Motor Co., 778 F.3d 628, 632–33 (7th Cir. 2015)
(“To demonstrate a manufacturing defect, the plaintiff must show that ‘the product deviates from
its intended design.’” (quoting Hathaway v. Cintas Corp. Serv., Inc., 903 F. Supp. 2d 669, 673
(N.D. Ind. 2012))). Third, the Defendant argues the Plaintiff has failed to disclose an expert

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witness to establish causation, which may be required when causation issues are complex. See
Myers v. Ill. Cent. R.R. Co., 629 F.3d 639, 642 (7th Cir. 2010) (“[W]hen there is no obvious
origin to an injury and it has multiple potential etiologies, expert testimony is necessary to
establish causation.” (internal quotation marks omitted)). The Court finds that the Plaintiff has
failed to present an issue of material fact as to whether the Defendant violated a particular federal
requirement. The Court, therefore, does not reach the Defendant’s subsequent arguments.
In evaluating the Plaintiff’s products liability claim, the Court must apply Indiana law.
See Officer v. Chase Ins. Life & Annuity Co., 541 F.3d 713, 715 (7th Cir. 2008) (“When sitting in
diversity, we must apply the substantive law of the state as we believe the highest court of that
state would apply it . . . .”). In Indiana, the IPLA governs all actions for products liability. See
Dague v. Piper Aircraft Corp., 418 N.E.2d 207, 212 (Ind. 1981) (“The Product Liability Act
expressly applies to all product liability actions sounding in tort, including those based on the
theory of negligence . . . .”); see also Ind. Code. § 34-20-1-1 (“This article 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; regardless of the substantive legal theory or theories upon
which the action is brought.”). The IPLA provides, in relevant part, that
a person who sells, leases, or otherwise puts into the stream of commerce any
product in a defective condition unreasonably dangerous to any user or consumer
or to the user’s or consumer’s property is subject to liability for physical harm
caused by that product to the user or consumer or to the user’s or consumer’s
property if:
(1) that user or consumer is in the class of persons that the seller should
reasonably foresee as being subject to the harm caused by the defective
condition;
(2) the seller is engaged in the business of selling the product; and
(3) the product is expected to and does reach the user or consumer without
substantial alteration in the condition in which the product is sold by the
person sought to be held liable under this article.
Ind. Code § 34-20-2-1.

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Notwithstanding the IPLA’s governance over Indiana product liability claims, the MDA
preempts state product liability requirements that are different from federal requirements. 21
U.S.C. § 360k(a). Specifically, the MDA preemption provision states:
[N]o 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.
Id.
The United States Supreme Court has outlined a two-part test to determine whether the
MDA preempts a state claim related to a particular medical device. See Riegel v. Medtronic, Inc.,
552 U.S. 312, 320–21 (2008). First, a court must determine whether the federal government has
established requirements particular to the device in question. Id. at 321. To satisfy this part of the
preemption test, the federal requirement must be specific to the device in question and not simply
reflect “‘generic concerns about device regulation generally.’” Id. at 322 (quoting Medtronic,
Inc. v. Lohr, 518 U.S. 470, 501 (1996)). Second, if the court finds that a federal requirement
exists, it must then determine whether the plaintiff’s claims rely upon a state law that imposes
requirements “different from, or in addition to” the applicable federal requirements and whether
the state law “relates to the safety or effectiveness of the device or to any other matter included
in a requirement applicable to the device.” Id. at 323 (quoting 21 U.S.C. § 360k(a)).
A claim for defective manufacture in violation of federal law is not expressly preempted
by the MDA. Bausch, 630 F.3d at 553. Since state requirements are preempted only to the extent
they are “different from, or in addition to” the relevant federal requirements, a claim premised on
a violation of FDA regulations would not be preempted. Riegel, 552 U.S. at 330 (“[Section]
360k(a) does not prevent a State from providing a damages remedy for claims premised on a

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violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal
requirements.” (quoting Lohr, 518 U.S. at 495)).
Accordingly, at the pleading stage, this Court held that the Plaintiff’s manufacturing
defect claim was not preempted by the MDA. ECF No. 24 at 14. The Court found that “the
complaint certainly alleges that his injuries were the direct and proximate result of the
Defendant’s negligence and that the Defendant’s negligence included, among other things,
failing to comply with the federal requirements.” Id. The Court continued, however, explaining
that, “[t]o prevail on his claim” beyond the pleading stage, the Plaintiff must “specify a violation
of a particular federal requirement and will have to prove that his injury was the direct and
proximate cause of that violation.” Id. at 15; see also Bausch, 630 F.3d at 558 (explaining that
the plaintiff may succeed on her state law manufacturing defect claim “so long as she can show
that she was harmed by a violation of applicable federal law”).
In the Plaintiff’s response to the instant motion for summary judgment, he has not argued
that the Defendant violated a particular federal requirement, nor has he produced evidence to that
effect. The Plaintiff argues that “[n]o company . . . makes perfect assemblies,” Pl. Resp. 11, ECF
No. 69; that Medtronic could not have total quality control, id.; and that Medtronic had several
issues with manufacturing at one of its plants, id. Additionally, the Plaintiff casts doubt on the
reliability of Medtronic’s quality control logbooks. Id. However, the Plaintiff has not supported
these arguments with any facts, documents, depositions, or declarations.
Meanwhile, the Defendant has offered documentation that the FDA approved its devices
through the pre-market approval process, and it provided evidence that the devices in question
passed each test designed to align them with FDA requirements. The Plaintiff, not having
established any facts in the record to support an inference that the Defendant violated a federal

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requirement applicable to its devices—a necessary element of the Plaintiff’s manufacturing
defect claim—has failed to present an issue of material fact that would require a trial.
CONCLUSION
For the reasons set forth above, the Court hereby GRANTS Defendant Medtronic, Inc.’s
Motion for Summary Judgment [ECF No. 61]. The Court DIRECTS the Clerk of Court to enter
judgment in favor of the Defendant Medtronic, Inc. and against the Plaintiff Kirk J. Bledsoe.
SO ORDERED on October 13, 2022.
s/ Theresa L. Springmann
JUDGE THERESA L. SPRINGMANN
UNITED STATES DISTRICT COURT

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