KUBICKI et al v. MEDTRONIC, INC. et al

Filing 165

MEMORANDUM OPINION GRANTING in part and DENYING in part 133 Medtronic's Motion for Summary Judgment and GRANTING 134 Unomedical's Motion for Summary Judgment. Signed by Judge Ketanji Brown Jackson on 2/5/2018. (lckbj1)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
)
JOHN KUBICKI & KAREN KUBICKI, )
on behalf of CAROLINE KUBICKI,
)
)
Plaintiffs,
)
)
v.
)
)
MEDTRONIC, INC., et al.,
)
)
Defendants.
)
)

Civil No. 12-cv-734 (KBJ)

TABLE OF CONTENTS
I.

INTRODUCTION ................................................................................................ 1

II. FACTS RELATED TO CAROLINE AND HER INJURIES ................................ 5
A.

The Hypoglycemic Event .......................................................................... 5

B.

The Medtronic Paradigm Insulin Pump Model MMT-522 And
The Medtronic MiniMed Paradigm Quick-set Infusion Set,
Model MMT-396 ..................................................................................... 8
1. The Design And Operation Of These Medical Devices ....................... 8
2. The Approval, Manufacturing, And Marketing Of These Medical
Devices ............................................................................................... 12

C.

Infusion Set Recalls In 2009 And 2013 ................................................... 14
1. 2009 Return And Replace Recall Of The “Lot 8” Batch ................... 14
2. 2013 Paradigm Infusion Set Recall .................................................. 15
3. 2013 FDA Warning Letter ............................................................... 17

III. PROCEDURAL HISTORY ................................................................................ 19
A.

The Initial Pump-Related Legal Action The Plaintiffs
Brought Against Medtronic Alone ......................................................... 19

B.

Plaintiffs’ Amended Complaint, Which Adds Unomedical
And Claims That Relate Specifically To The Infusion Set ...................... 21

C.

Medtronic’s And Unomedical’s Motions For Summary
Judgment ............................................................................................... 24

IV. LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT ........... 25
V. RULING ON CAUSATION ............................................................................... 26

A.

The Record Evidence Thus Far Submitted Is Not Sufficient
To Warrant Granting Summary Judgment To Defendants On
Causation Grounds ................................................................................ 28

B.

The Parties Will Be Permitted To Revisit The Causation
Question After Expert Discovery Is Completed ...................................... 33

VI. RULING ON TIMELINESS .............................................................................. 34
A.

The Law Pertaining To Timeliness: Statutes Of Limitations,
The Discovery Rule, And The Relation Back Doctrine ........................... 35
1. The Discovery Rule ......................................................................... 36
2. The Relation Back Doctrine ............................................................. 37

B.

Plaintiffs Could Have Discovered Their Claims Against
Unomedical Regarding The MMT-396 Infusion Set Near The
Time Of Caroline’s Injury; Therefore, The Infusion Set
Claims That Plaintiffs Belatedly Asserted Against
Unomedical Are Untimely ..................................................................... 39
1. Caroline’s Insulin-Delivery Device Is A Multifaceted Medical
Product, And The Manufacturers Of The Various Components Are
Clearly Identified ................................................................................ 40
2. Plaintiffs Rely On Dissimilar Cases To Support Their Contention That
Their Infusion Set Claims Accrued In 2013 ......................................... 44
3. The Relation Back Doctrine Does Not Save The Infusion Set-Related
Claims Against Unomedical ................................................................ 48

C.

VII.

Plaintiffs’ Infusion Set Claims Against Medtronic Relate
Back To Their Preexisting MMT-522 Pump Claims Against
That Defendant, And Thus Are Deemed Timely ..................................... 51

RULING ON PREEMPTION ......................................................................... 54
A.

The Law Pertaining To Classification Of Medical Devices
And The Express And Implied Preemption Of State Law
Claims Under The Medical Device Amendments To The
Food, Drug And Cosmetics Act ............................................................. 57
1. The MDA’s Device-Classification Scheme ...................................... 57
2. Express Preemption Of State Law Claims Under the MDA ............... 60
3. Implied Preemption Of State Law Claims Under the MDA ............... 64

B.

With One Exception, The MDA Expressly Preempts All Of
The Kubickis’ MMT-522 Pump Claims .................................................. 66
1. State Law Claims Pertaining To The MMT-522 Pump Are Subject To
The MDA’s Express Preemption Provision Because That Device Was
Approved Pursuant To The FDA’s Premarket Approval Process .......... 67

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2. Plaintiffs Have Not Established That Their Pump-Related State Law
Claims Are Genuinely Equivalent To Specific Federal Law
Requirements ...................................................................................... 71
a. . The CGMPs and general labeling and instruction regulations that
Plaintiffs cite are insufficient to support a parallel
state law claim asserting a design, manufacturing, or
labeling defect, or a breach of warranty ....................................... 74
b. Plaintiffs have not identified a genuinely equivalent parallel state
law claim pertaining to Medtronic’s failure to report
events to the FDA ....................................................................... 82
C.

The Implied Preemption Doctrine Does Not Bar Plaintiffs’
Claims Against Medtronic For The Allegedly Negligent
Design, Manufacture, And Labeling Of The MMT-396
Infusion Set, And The Claims Based On Medtronic’s
Alleged Failure To Warn Consumers About That Product
Also Survive ......................................................................................... 88

VIII. RULING ON THE LEARNED INTERMEDIARY DOCTRINE, THE
KUBICKIS’ INFUSION SET WARRANTY CLAIM, AND PUNITIVE
DAMAGES ..................................................................................................... 92
A.

Medtronic Is Not Entitled To Summary Judgment With
Respect To The Failure To Warn Claims On The Basis Of
The Learned Intermediary Doctrine ....................................................... 93

B.

Medtronic Is Entitled To Summary Judgment On Plaintiffs’
Breach Of Express Warranty Claim Because The Statements
On Which Plaintiffs Rely Do Not Create An Actionable
Warranty ............................................................................................... 97

C.

While Medtronic Is Entitled To Summary Judgment On
Plaintiffs’ Stand-Alone Punitive Damages Claim, It Is
Premature To Foreclose Punitive Damages As A Remedy .................... 101

IX. CONCLUSION ................................................................................................. 102

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MEMORANDUM OPINION
I.

INTRODUCTION
This complex products-liability action arises out of a tragic event in the life of

Caroline Kubicki, a Type-I diabetic who began using a mechanical pump and an
associated infusion set to administer the insulin necessary to manage her diabetes when
she was 12 years old. Caroline was 19 and a sophomore at George Washington
University (“GW”) in early September of 2007, when she experienced severe
hypoglycemia in her dormitory room and suffered a traumatic brain injury as a result of
the low blood sugar levels. Caroline currently resides in a group home in a persistent
vegetative state, and her parents, John and Karen Kubicki (“Plaintiffs” or “the
Kubickis”), have filed the instant lawsuit against the company that designed and
manufactured the insulin pump and a component of the associated infusion set that
Caroline was using at the time of the incident—Medtronic, Inc.—along with certain of
its subsidiaries, Medtronic Diabetes and Medtronic MiniMed, Inc. (collectively,
“Medtronic”). The Kubickis have also sued Unomedical Devices SA de CV, the
manufacturer and assembler of the infusion set, and one of that company’s affiliates,
Unomedical A/S (collectively, “Unomedical”).
The Kubickis’ amended complaint contains 25 state law claims that concern two
medical devices: the Medtronic MiniMed Paradigm® Insulin Pump Model MMT-522
(“the MMT-522 Pump”) and the Medtronic MiniMed Paradigm® Quick-set Infusion
Set, Model MMT-396 (“the MMT-396 Infusion Set”). (See Second Am. Compl. (“2nd
Am. Compl.”), ECF No. 124, ¶¶ 6, 20.) The complaint’s myriad claims can generally
be grouped into five categories. The first five counts (hereinafter referred to as “the

negligence claims”) generally allege that the defendants committed common law
negligence with respect to the design and manufacturing of both the MMT-522 Pump
and the MMT-396 Infusion Set, and that defendants breached both the duty to provide
adequate consumer instructions, labels, and warnings with respect to these devices, and
the duty to take “reasonable care in documenting, logging, investigating, and reporting
to the FDA” public complaints about these devices. (Id. ¶ 91; see id. ¶¶ 88–117
(Counts I–V).) Counts VI through X cast similar allegations as common law “strict
liability” claims (see, e.g., id. ¶ 149 (contending that defendants “sold the [insulindelivery devices] to Ms. Kubicki in a defective condition what was unreasonably
dangerous to consumers”); see also id. ¶¶ 118–152 (Counts VI–X)), while Counts XI
through XV (hereinafter the “express warranty claims”) assert that each defendant
breached an express warranty upon which Caroline, her parents, and her physicians
relied (see id. ¶¶ 153–203). The final two groups of claims in the complaint (the
“failure to warn” claims) allege that the defendants failed to warn users and the FDA
“of the foreseeable harm associated with the use” of the insulin-delivery devices (id.
¶ 205; see id. ¶¶ 204–253 (Counts XVI–XX)), and that the Kubickis are entitled to
“punitive damages” because each defendant company “acted maliciously, willfully,
wantonly, and recklessly without regard to the safety of others” (id. ¶ 262; see id.
¶¶ 254–263 (Counts XXI–XXV)). To date, the parties have completed fact discovery—
but not expert discovery—in this matter, and Plaintiffs have pared down the charges
against Unomedical, such that the only claims remaining against the Unomedical
defendants are the failure to warn claims that appear in the complaint both as separate

2

claims and as part of the negligence and strict liability theories. (See Mot. Hr’g Tr.,
ECF No. 152, at 5:5–6:1 (Nov. 3, 2016).)
Before this Court at present are two motions for summary judgment that
Medtronic and Unomedical have filed. (See Medtronic Mot. for Summ. J. or, in the
Alternative, for Partial Summ. J. (“Medtronic’s MSJ”), ECF No. 133; Unomedical Mot.
for Summ. J. (“Unomedical’s MSJ”), ECF No. 134.) 1 Plaintiffs oppose these motions,
but have not cross-moved for summary judgment. (See Pls.’ Opp’n to Defs.’ Mots. for
Summ. J. (“Pls.’ Opp’n”), ECF No. 141.) Medtronic first argues that Plaintiffs cannot
establish the requisite causation because, among other things, the existing record
evidence definitively establishes that Caroline was not wearing her insulin pump at the
time of the hypoglycemic incident. 2 In addition, Medtronic also maintains that the
Kubickis’ common law tort and express warranty claims are entirely preempted and/or
barred by the applicable statutes of limitations (see Mem. in Support of Medtronic’s
Mot. for Summ. J. or, in the alternative, for Partial Summ. J. (“Medtronic’s Mem.”),
ECF No. 133-1, at 31–62), and Medtronic further contends that, because the record
contains no evidence of intentional wrongdoing, it is entitled to summary judgment on
the punitive damages counts (id. at 63–70). Unomedical’s motion for summary
judgment argues that the failure to warn claims it faces are untimely and impliedly

1

Page numbers cited herein, except for transcript and deposition citations, refer to those that the
Court’s electronic case-filing system automatically assigns.

2

Medtronic’s motion for summary judgment references an expert declaration from Helena W. Rodbard,
M.D., FACP, MACE, which sets forth Dr. Rodbard’s expert opinion regarding various other potential
causes of Caroline Kubicki’s injuries. (See Decl. of Helena W. Rodbard (“Rodbard Decl.”), ECF No.
133-6.) Because the parties have yet to engage in expert discovery, this Court previously granted
Plaintiffs’ motion to strike the portions of this declaration (and related briefing) that suggest possible
alternative causes of Caroline’s hypoglycemic event. (See Min. Order of Apr. 8, 2016.)

3

preempted, and it also presses the same causation and punitive damages arguments that
Medtronic makes. (See Mem. in Support of Unomedical’s Mot. for Summ. J.
(“Unomedical’s Mem.”), ECF No. 134-1, at 25–34, 37–47.)
This Court has carefully parsed the defendants’ myriad summary judgment
arguments regarding causation, timeliness, preemption, and other issues, along with the
prior written ruling of the Court that resolved the Medtronic defendants’ initial motion
to dismiss. See Kubicki v. Medtronic, No. 12cv0734, 2013 WL 1739580 (D.D.C. Mar.
21, 2013). As explained fully below, this Court now concludes that Medtronic’s
Motion for Summary Judgment must be GRANTED IN PART AND DENIED IN
PART, and that Unomedical’s Motion for Summary Judgment must be GRANTED in
full. In sum, this Court has determined that neither defendant is entitled to summary
judgment on causation grounds at this point in the litigation (prior to expert discovery),
but that summary judgment can and will be entered in Unomedical’s favor on the basis
of the statute of limitations. The Court will also grant summary judgment to Medtronic
with respect to certain claims in the complaint—i.e., all claims that pertain to the
MMT-522 Pump (with the exception of Plaintiffs’ manufacturing defect claim) and the
failure to report claims that relate to the MMT-396 Infusion Set—because federal law
either expressly or impliedly preempts such claims. In addition, the Court will grant
Medtronic’s motion for summary judgment on Plaintiffs’ breach of warranty claim
because the statements on which Plaintiffs predicate their claim do not create an
actionable warranty. The Court will also grant Medtronic’s motion for summary
judgment with respect to Plaintiffs’ stand-alone claim for punitive damages, because
D.C. law does not recognize such a claim, but the Court finds that any ruling on the

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availability of punitive damages as a remedy is premature prior to the completion of
expert discovery. This Court sees no other basis for granting summary judgment in
Medtronic’s favor with respect to the remaining infusion set claims (negligent design,
manufacture, and labeling, and failure to warn) at this time. However, Medtronic can
seek summary judgment on causation grounds upon the parties’ completion of expert
discovery.
A separate Order consistent with this Memorandum Opinion will follow.
II.

FACTS RELATED TO CAROLINE AND HER INJURIES
A.

The Hypoglycemic Event

Caroline was diagnosed with Type I diabetes at the age of six, and was first
prescribed an insulin pump in March of 2001, at age 12, after she had experienced
difficulty controlling her blood glucose levels with self-administered insulin shots.
(See Medtronic’s Stmt. of Undisputed Material Facts (“Medtronic’s Stmt. of Facts”),
ECF No. 133-2, ¶¶ 13–14, 17; see also Pls.’ Stmt. of Genuine Issues of Material Fact
(“Pls.’ Stmt. of Facts”), ECF No. 138-70, ¶¶ 8–9) (noting that Caroline had experienced
three hypoglycemic events prior to receiving a prescription for the insulin pump in
2001).) 3 In October of 2006, Caroline’s physician, Dr. Paresh Dandona, prescribed
Caroline the MMT-522 Pump and the MMT-396 Infusion Set that are at issue in this
case. (See Dep. of John Kubicki (“J. Kubicki Dep.”), Ex. E to Decl. of Michael K.
Brown (“Brown Decl.”), ECF No. 133-5 at 67–92, at 114:6–14.) Nearly one year

3

The pancreas of an individual with Type I diabetes is unable to produce insulin, which is a hormone
that allows the body to process glucose. (See Medtronic’s Stmt. of Facts, ¶ 1.) Type I diabetics rely on
daily doses of insulin to control their levels of blood glucose and to prevent hypoglycemia (blood
glucose levels that are too low) and hyperglycemia (blood glucose levels that are too high). (See id.
¶¶ 1, 3.)

5

later—sometime between the late evening of September 8, 2007, and the early morning
of September 9, 2007—Caroline experienced the hypoglycemic event that gives rise to
the claims at issue here. (See Unomedical’s Stmt. of Material Facts as to Which There
Is No Genuine Issue (“Unomedical’s Stmt. of Facts”), ECF No. 132-10, ¶ 34.)
Although there are gaps in the timeline, the following basic facts are undisputed.
Caroline and her roommate, Magdelena Posthumus, were together in their shared dorm
room on GW’s campus from approximately 7:00 p.m. to 10:30 p.m. on the evening of
September 8, 2007. (See Dep. of Magdelena E. Posthumus (“Posthumus Dep.”), Ex. G
to Brown Decl., ECF No. 139-1 at 68–82, at 58:4–59:2.) During that time, Posthumus
observed Caroline napping, waking and eating a bowl of cereal, and then returning to
bed. (See id.) The various data points that Caroline’s parents were able to retrieve
from Caroline’s pump and glucometer indicate that Caroline’s blood sugar level was 77
mg/dL at approximately 7:02 p.m., and that Caroline gave herself six units of insulin at
approximately 8:30 p.m. (See Dep. of Karen Kubicki (“K. Kubicki Dep.”), Ex. F to
Brown Decl., ECF No. 133-5 at 94–106, at 129:20–130:8; J. Kubicki Dep. at 212:3–24;
see also Handwritten Glucometer Readings, Ex. 21 to K. Kubicki Dep., ECF 133-5, at
117.) Posthumus left the dorm for a couple of hours beginning at around 11:00 p.m.,
and Caroline was sleeping both when Posthumus left and when she returned around
12:30 a.m. (See Posthumus Dep. at 60:3–61:20.) At 8:00 a.m. the following morning,
Posthumus discovered Caroline in distress in her bed; Caroline was foaming at the
mouth and was otherwise unresponsive. (See Medtronic’s Stmt. of Facts ¶ 28.)
Posthumus immediately notified a resident advisor, Siobhan Chapman, who in
turn notified another resident advisor, Rebecca Barloon. (See Dep. of Rebecca Barloon

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(“Barloon Dep.”), Ex. 1 to Pls.’ Opp’n, ECF No. 138-3, at 42:21–23.) Posthumus also
called 911 and reported that Caroline was unconscious and vomiting. (See GW Police
Dep’t Incident Report, Ex. 11 to Pls.’ Opp’n, ECF No. 138-13, at 2.) Emergency
personnel responded, and when they checked Caroline’s blood sugar, it registered at 20
mg/dL—an extraordinarily low level. (See DCFEMS Incident Report, Ex. 13 to Pls.’
Opp’n, ECF No. 138-15, at 3.) The paramedics gave Caroline an emergency injection
of glucose, and then transported her to GW Hospital, where doctors administered
further glucose; however, none of these efforts changed Caroline’s condition. (See id.;
GW Hosp. Recs., Ex. 2 to Pls.’ Opp’n, ECF No. 138-4, at 6.) At GW Hospital, a CT
head scan revealed that Caroline was suffering from “diffuse cerebral edema.” (GW
Hosp. Recs. at 2.) 4 Caroline now resides in a nursing facility in a persistent vegetative
state, with no realistic possibility of recovery. (See Mot. Hr’g Tr. at 9:23–10:8.)
The readings that Plaintiffs were able to recover from Caroline’s glucometer
showed that Caroline’s insulin levels had fluctuated in the days leading up to her
injury—from a low of 43 mg/dL to a high of 568 mg/dL. (See Handwritten Glucometer
Readings.) The full set of data could not be recovered from the MMT-522 Pump’s
memory because Mr. Kubicki removed the battery from the pump after a Medtronic
customer service representative told him that doing so would not impact the data saved
on the device. (See Tr. of Tele. Call, Ex. 17 to Pls.’ Opp’n, ECF No. 138-19, at 9.)
The parties conducted joint non-destructive testing of Caroline’s pump, which did not

4

“A CT scan is a computed tomography scan, also referred to as a CAT scan or computed axial
tomography scan. The CT scan generates a three dimensional image of the inside of an object from a
large series of two-dimensional X-ray images taken around a single axis of rotation.” McCarty v.
Astrue, Civ. No. 08–432, 2008 WL 4922323, at *6 n.11 (M.D. Pa. Nov. 13, 2008).

7

reveal any defects. (See Pls.’ Opp’n at 67–68.) 5 The MMT-396 Infusion Set that
Caroline was using was discarded at an unknown time shortly after Caroline’s injury,
and therefore the parties were not able to conduct any testing on that device. (See K.
Kubicki Dep. at 322:14–325:16.)
In the days after the hypoglycemic event, the Kubickis began gathering
information in an attempt to determine what had caused Caroline’s blood sugar to drop
so low. Their efforts included speaking to Caroline’s treating physicians at GW
Hospital, one of whom suggested to the Kubickis that they preserve and test the MMT522 Pump because it appeared that Caroline had suffered an insulin overdose. (See J.
Kubicki Dep. at 23:25–25:13.) The Kubickis collected and retained Caroline’s medical
supplies, including the packaging materials for the discarded infusion set, and they
consulted with an attorney approximately five weeks after the incident. (See id. at
22:22–23:18.)
B.

The Medtronic Paradigm Insulin Pump Model MMT-522 And
The Medtronic MiniMed Paradigm Quick-set Infusion Set,
Model MMT-396
1.

The Design And Operation Of These Medical Devices

The MMT-522 Pump is an FDA-regulated, insulin-pumping medical device that a
patient wears outside her body. The device both monitors the patient’s blood glucose
levels and delivers insulin at rates that the patient programs. (See Decl. of Donna
Twisdom (“Twisdom Decl.”), ECF No. 35-4, ¶ 3.) The MMT-522 Pump and the MMT-

5

The only reported abnormality was the pump’s registering of an alarm code for “A45 Alarm after
Prime/A33 Test.” (Pls.’ Opp’n at 19.) The record does not reveal what this alarm code means, but
Plaintiffs represent that they “have reason to believe that it is triggered based on the amount of insulin
delivered by the Insulin Pump.” (Id. at 19 n.7.)

8

396 Infusion Set work together as a system, and appear as follows when attached to a
patient:

Generally speaking, the insulin pump works by delivering background insulin
throughout the day according to the “basal rate” that the user sets, and the user can also
give herself a dose of insulin (called a “bolus”) on demand when she eats. (See Mot.
Hr’g Tr. at 59:21–60:21.) A cylindrical reservoir housed in the pump contains the insulin
itself, and the insulin is delivered to the body through the infusion set. The infusion
set, which is a separate medical device, consists of a thin plastic tube that has a tubing
connector—called a “p-cap”—at one end; the p-cap connects the tube to the insulin
reservoir. (See Decl. of Rabi Gharabli (“Gharabli Decl.”), ECF 132-1, ¶ 10.) On the
other end of the tube, there is a small needle that the user inserts into her body. (See
id.)
Notably, when the pump’s insulin reservoir needs to be refilled, the user must
follow a number of steps carefully to accomplish this goal successfully. Specifically,
the user must disconnect the infusion set from her body; remove the empty reservoir

9

from the pump; fill a new reservoir with insulin from an insulin vial; rewind the pump;
insert the new reservoir into the pump; and push insulin through to the infusion set—all
before reattaching the infusion set to her body. (See User Guide, Ex. B to Twisdom
Decl., ECF No. 35-4, at 66–72.) The portion of the manual instructing users on how to
fill the reservoir, disconnect the vial, and attach the infusion set in 2007 (when Caroline
was injured) is reproduced below:

(Id. at 67.) Significantly for present purposes, when removing the vial from the
reservoir, the user is required to keep the reservoir upright, and she must ensure that the
inside of the p-cap connector and the top of the reservoir are not wet when they are
reconnected. (See infra Part II.C.3.)

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The design and operation of the infusion set’s p-cap connecter is at the center of
the products-liability claims in this case. As Medtronic describes it, this particular
connector is a marvel of biomedical mechanical engineering:
[it] contains four small one-way vent openings which provide
airflow to equalize the pressure in the reservoir compartment
with the surrounding atmospheric pressure. The p-cap vent
openings are covered by a polytetrafluoroethylene (“PTFE”)
membrane that allows air to flow in and out of the
compartment thus eliminating any pressure differential
between the insulin reservoir and the end of the infusion set
(such as may be created when completing a manual prime of
the pump or during a rapid and dramatic change in altitude).
(Medtronic’s Mem. at 17 (citations omitted).) Notably, the p-cap’s vent covering is
comprised of two different materials: the PFTE membrane is only on the topside, while
the underside (the part of the p-cap that touches the reservoir) is comprised of
polyester. (See Dep. of Mark Curtis (“Curtis Dep.”), Ex. 22 to Pls.’ Opp’n, ECF No.
138-24, at 211:7–19.)
Medtronic purportedly adopted this vented p-cap design for its insulin pumps so
that the pump can be watertight. (See Dep. of Susan McConnell Montalvo (“McConnell
Dep.”), Ex. 20 to Pls.’ Opp’n, ECF No. 138-22, at 43:17–44:14, 49:15–20, 53:5–9.)
The proper functioning of the vents is key to ensuring that the reservoir maintains
appropriate internal pressure and that the pump delivers insulin at the appropriate rates.
(See id. at 49:17–20; 94:22–95:19.) If the pressure inside the reservoir is too high
(which can occur if the vents are blocked), the stopper in the pump will push insulin
into the infusion set in order to achieve pressure equilibrium, even if the pump is not
programmed to deliver that insulin, resulting in an unscheduled delivery of insulin.
(See id. at 94:2–4; 96:6–19.)

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2.

The Approval, Manufacturing, And Marketing Of These
Medical Devices

The MMT-522 Pump and MMT-396 Infusion Set are two of a number of medical
devices that Medtronic markets for the management of diabetes. In June of 1999, the
FDA approved a PMA Application that Medtronic submitted for a precursor device—
the Guardian Continuous Glucose Monitoring System, which consisted of a Guardian
RT sensor and an external machine that measured and recorded an individual’s glucose
levels. See PMA Application No. P980022, Summary of Safety & Effectiveness Data 6;
see also infra Part VII.A.1 (discussing the FDA’s “premarket approval” (“PMA”)
process). This system did not include an insulin pump as a component.
Medtronic first released its “Paradigm” insulin pump system into the market in
2001, and it received 510(k) approval for its Paradigm MMT-515 Insulin Pump in May
of 2004. See 510(k) Premarket Notification. 7 Thereafter, in October of 2005,
Medtronic sought “approval for modifications to the MMT 515/715 external insulin
pump and to the Guardian RT sensor to enable the pump to accept data from the sensor,
and to enable the sensor to communicate directly to the pump.” (Ex. A. to Decl. of
Mark Faillance (“PMA Approval”), ECF No. 35-5, at 9.) The FDA approved this new,
combined system, known as the Paradigm Real Time System, through a PMA
Supplement on April 7, 2006. (See Decl. of Mark Faillance (“Faillance Decl.”), ECF

6

Available at https://www.accessdata.fda.gov/cdrh_docs/pdf/P980022B.pdf.

7

Available at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040676

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No. 35-5, ¶ 8.) The pump component of this approved device is the Paradigm MMT522. 8
The FDA cleared the MMT-396 Infusion Set, including the vented p-cap
connector that is at the center of this case, on June 7, 2001, through the 510(k)
clearance process. (See Decl. of Mark O’Donnell (“O’Donnell Decl.”), ECF No. 133-3,
¶ 8.) Medtronic designed and manufactured the p-cap connector, while Unomedical,
which owns the 510(k) for the MMT-396 Infusion Set, designed and manufactured all
the other components of the MMT-396 Infusion Set. (See id. ¶¶ 8–9.) Printed on the
exterior of the MMT-396 Infusion Set packaging is the notation, “Assembled for
Unomedical AS in Mexico,” (Packaging Photos, Ex. 61 to Pls.’ Opp’n, ECF No. 13863, at 2), and Unomedical’s name also appears on the instruction sheet for the MMT396 Infusion Set (Infusion Set Instructions, Ex. F to Gharabli Decl., ECF No. 134-3, at
22), as well as on the individual MMT-396 Infusion Sets themselves (Mot. Hr’g Tr.
73:19–74:6).
Unomedical’s role with respect to the p-cap was limited to the assembling of its
MMT-396 Infusion Set tubing with the p-cap that Medtronic provided. (See
Unomedical’s Stmt. of Facts ¶ 29.) Unomedical then provided the assembled MMT-396
Infusion Set to Medtronic, which Medtronic in turn sold to users in connection with its
line of Paradigm insulin pumps, including the MMT-522 Pump. (See id. ¶ 30;
O’Donnell Decl. ¶ 9.) The MMT-522 Pump and MMT-396 Infusion Set are

8

Medtronic claims that the FDA advised it to proceed through the PMA Supplement process rather
than the 510(k) process because “creation of a new pump that incorporated a continuous glucose
monitoring system software was a significant change, and the new pump would not be substantially
equivalent to any existing or pre-amendment device.” (Faillance Decl. ¶ 7.)

13

prescription-only devices (see Medtronic’s Stmt. of Fact, ECF No. 131-2, ¶¶ 7, 9),
which means that the devices are “available to the public only through a physician and
are to be [used] only under a physician’s supervision[.]” MacPherson v. Searle & Co.,
775 F. Supp. 417 , 422 (D.D.C. 1991).
C.

Infusion Set Recalls In 2009 And 2013
1.

2009 Return And Replace Recall Of The “Lot 8” Batch

On June 29, 2009, approximately 22 months after Caroline’s injury, Medtronic
issued a recall for the “Lot 8” batch of its Paradigm infusion sets because of a possible
manufacturing defect. Specifically, Medtronic determined that a silicone lubricant used
during manufacturing could clog the vents in the p-cap of the infusion sets in the
impacted lot, and thus could cause the pump to deliver too much or too little insulin.
(See Lot 8 Recall Notice, Ex. 26 to Pls.’ Opp’n, ECF No. 138-28.) Patients with
impacted infusion sets were instructed not to use them and to return the sets to
Medtronic for replacements. (See id.) The MMT-396 Infusion Set that Caroline had at
the time of her injury did not come from Lot 8 and therefore would not have been part
of this recall. (See Medtronic’s Resp. to Pls.’ Fourth Set of Reqs. for Produc., Ex. 28 to
Pls.’ Opp’n, ECF No. 138-30 at 4.)
In connection with the Lot 8 recall, Medtronic issued a “Questions & Answers”
sheet in which it stated that all other Medtronic infusion sets were safe to use. (See
Questions & Answers Regarding the “Lot 8” Quick-set Induction Set Recall, Ex. 27 to
Pls.’ Opp’n, ECF No. 138-29, at 2–3.) Medtronic made no mention of Unomedical—
which had manufactured the parts of the infusion set other than the p-cap and had
assembled the infusion sets, as explained above—in the documents associated with this
recall.
14

2.

2013 Paradigm Infusion Set Recall

Four years after the Lot 8 recall, on June 7, 2013, Medtronic issued a broad
“Class I recall” of its Paradigm infusion sets, including the MMT-396 Infusion Set that
Caroline had owned at the time of her injury. (See Infusion Sets Recall Notice (“2013
Recall Notice”), Ex. 18 to Pls.’ Opp’n, ECF No. 138-20, at 2.) Unlike the Lot 8 recall,
this recall did not involve replacement of the recalled device; rather, Medtronic
provided more information to users, explaining in the recall announcement that there
was a risk of under- or over-delivery of insulin if the top of the insulin reservoir or the
inside of the p-cap becomes wet while the user is refilling the reservoir with insulin.
(See id.) The impetus for this recall was Medtronic’s discovery (first through viewing
videos uploaded on YouTube) that some users were holding the insulin reservoir
horizontally when refilling it, which can result in fluid touching the inside of the p-cap
and blocking the vents. (See E-Mail from S. Schriever (June 11, 2013), Ex. 57 to Pls.’
Opp’n, ECF No. 138-59, at 2.) In the notification sent to pump users in connection with
the recall, Medtronic specifically instructed users to ensure that the insulin vial is
upright when removing it from the reservoir in order to prevent liquid transfer to the pcap, and it also declared that users should ensure that the reservoir tip and p-cap are dry
before connecting them. (See Letter from Shirajul Karim (June 10, 2013) (“Dear User
Letter”), Ex. 29 to Pls.’ Opp’n, ECF No. 138-31, at 2-3.) The recall notice identified
Unomedical A/S as one of the manufacturers of the recalled infusion sets. (See 2013
Recall Notice at 2.)
The pictures from the safety notification, which were issued to remind users
about the correct way to refill the reservoir, are reproduced below.

15

Hold insulin vial upright when removing reservoir.

Make sure these are dry when connecting.
(Dear User Letter at 2–3.)
In the context of the instant litigation, Medtronic characterizes the issue that led
to the 2013 infusion set recall as a “temporary blocked vent,” and it asserts that “[t]he
precise sequence of events required for the temporary blocked vent to occur (spilled
fluid on the interior of the p-cap connector, saturation of all four vents, and excess
pressure building) make it a rare occurrence.” (Medtronic’s Mem. at 29.) Medtronic
further maintains that it is even more unlikely that a temporary blocked vent will injure
an infusion set user, because the user should have detached the pump and infusion set
from herself while the reservoir was being refilled. (See id. at 29–30.) Medtronic
claims that it has received fewer than 100 complaints per year from users regarding
temporary blocked vents (out of approximately 425,000 pump users), and that it
“implemented [the 2013 recall as a] voluntary field corrective action” after “becoming
16

aware of the sequence of events that could le[a]d to a temporary blocked vent[.]” (Id.
at 29–30.)
3.

2013 FDA Warning Letter

On September 19, 2013, the FDA issued a formal “warning” letter to Medtronic
following an inspection of Medtronic’s Northridge, California office. (See Ex. 55 to
Pls.’ Opp’n (“2013 Warning Letter”), ECF No. 131-3.) This warning was purportedly
based on the agency’s finding that Medtronic had violated certain rules known as the
“current good manufacturing process regulations” (“CGMPs”) with respect to its
Paradigm insulin pumps (including the MMT-522 model pumps) in a number of ways.
(Id. at 2.) 9 The FDA cited various deficiencies, including Medtronic’s “[f]ailure to
establish and maintain procedures for implementing corrective and preventative action,
as required by 21 C.F.R. 820.100(a)[,]” (id. at 3); “failure to identify actions needed to
correct and prevent recurrence of the Paradigm Insulin Infusion Pumps (MMT-5XX,
7XX) device failure” (id.); and “failure to review and evaluate all complaints to
determine whether an investigation is necessary and to maintain a record that includes
the reason no investigation was made and the name of the individual responsible for the
decision not to investigate when no investigation is made” (id. at 5). The FDA also
announced the agency’s conclusion that, due to the 13 different CGMP violations the
that agency had found, Paradigm insulin pumps dating back to 2002 qualify as
“adulterated” under 21 U.S.C. § 351(h), and also “misbranded under section 502(t)(2)

9

CGMPs are general regulations that the FDA has promulgated which govern “the methods used in,
and the facilities and controls used for, the design, manufacture, packaging, labeling, storage,
installation, and servicing of all finished devices intended for human use.” 21 C.F.R. § 820.1(a)(1).

17

of the Act.” (Id. at 2, 15.) None of the 13 CGMP violations that are discussed in the
warning letter pertain to the temporary-block-vent condition of the MMT-396 Infusion
Set that the Kubickis allege in their complaint. 10
Notably, in the text of its 2013 letter to Medtronic, the FDA expressly
admonished Medtronic for its reporting failures. (See id. at 25–26 (asserting that
Medtronic’s “Paradigm Insulin Infusion Pumps are misbranded . . . in that your firm
failed or refused to furnish material or information respecting the device that is required
by or under the [MDA]” regarding incidents where users reportedly received an
overdose of insulin from the pump).) 11 The FDA further faulted Medtronic for not
“establish[ing] internal systems that provide for timely and effective indication,
communication, and evaluation of events that may be subject to [medical device
reporting] requirements[,]” and for not “establish[ing] internal systems that provide for
a standardized review process to determine when an event meets the criteria for
reporting under this part.” (Id. at 26.)

10

One potentially similar defect identified in the FDA warning letter is a failure to take corrective
action regarding “overlay leaks . . . which could cause moisture ingress into the pump and pump
failure.” (2013 Warning Letter at 3.) However, the root cause of these leaks is identified as the
“ultrasonic window welding process [which] causes initiation of stress-cracks, thus causing adverse
effects to the finished device.” (Id. at 4.) And Plaintiffs do not contend that Caroline’s injury was
caused by any such “overlay leak.” Similarly, the 2013 Warning Letter faults Medtronic for failing to
review and investigate pump-related complaints properly, citing as examples a pump where “the keypad
overlay had weak adhesive bond at locations[;]” two pumps with “loose motor support disk[s;]” and one
pump with “faulty FSR (gold).” (Id. at 7.) None of the cited examples involved the failure to
investigate temporary blocked vent problems.
11
The FDCA bars both the misbranding of any medical device in interstate commerce, and the
introduction of any misbranded device into interstate commerce. 21 U.S.C. § 331(a), (b). The statute
delineates a number of ways in which a medical device can be deemed misbranded, including where the
product labeling is defective, see id. § 352 (b), (c), where the device was manufactured in an
unregistered facility, see id. § 352 (o), or where a manufacturer or importer has failed to comply with
adverse event reporting requirements, see id. § 352(t).

18

III.

PROCEDURAL HISTORY
A.

The Initial Pump-Related Legal Action The Plaintiffs Brought
Against Medtronic Alone

On September 2, 2010, the Kubickis filed a lawsuit against Medtronic on
Caroline’s behalf in the Superior Court of the District of Columbia. (See Brown Decl.
¶ 3.) That complaint was dismissed without prejudice after the parties entered into a
tolling agreement, and when the agreement expired, the Kubickis initiated the instant
lawsuit by refiling their complaint against Medtronic in Superior Court. (See id.) Their
initial complaint asserted claims for negligence, strict liability, misrepresentation,
fraud, breach of express and implied warranties, violation of the District of Columbia
Deceptive Trade Practices Act, and failure to warn under Restatement of Torts § 388,
based on Caroline’s use of the “Medtronic MiniMed Paradigm® Insulin Pump Model
MMT-522.” (See Compl., Ex. A to Notice of Removal, ECF No. 1, ¶ 4.) This initial
complaint did not contain any specific allegations pertaining to the MMT-396 Infusion
Set. (See generally id.)
Medtronic removed the complaint to federal court on May 8, 2012. (See Notice
of Removal, ECF No. 1-2.) 12 Shortly after removal, Medtronic filed a motion to
dismiss the Kubickis’ complaint, asserting that Plaintiffs had failed to plead their
claims sounding in fraud with particularity; that their implied warranty claims were
duplicative of their strict liability claims; and that the doctrines of express and implied
preemption barred all of the claims. (See Medtronic Mot. to Dismiss, ECF No. 4.) The
Court granted this motion in part, dismissing without prejudice the Kubickis’ fraud-

12
U.S. District Judge Colleen Kollar-Kotelly presided over this case until it was transferred to the
undersigned in July of 2013.

19

based claims, as well as their implied warranty claims. See Kubicki v. Medtronic, No.
12cv0734, 2013 WL 1739580, at *1 (D.D.C. Mar. 21, 2013). However, the Court
rejected Medtronic’s contention that the remaining claims in the complaint should be
dismissed on either express or implied preemption grounds. Id. at *9–11. 13
With respect to express preemption, the Court found that the Kubickis had
“assert[ed] violations of the requirements set forth by the FDA as the cause of the
alleged defects and ensuing violation of District of Columbia law[,]” such that the state
law claims survived a challenge under Rule 12(b)(6). Id. at *8. However, in so
holding, the Court kept the door open for Medtronic to renew its express preemption
challenge following discovery, noting that “[w]hile the Court finds Plaintiffs’ pleading
sufficient to pass muster at this motion to dismiss stage, the Court does expect that as
this action proceeds, Plaintiffs will refine their claims to more specifically articulate the
parallel relationship between the alleged common law duties and the federal
requirements.” Id. at *9.
As for implied preemption, the Court rejected Medtronic’s preemption argument
on the grounds that Plaintiffs were not seeking to assert claims based on violation of
FDA regulations (which the Supreme Court has found improper), but instead were
pleading claims under “‘traditional state tort law.’” Id. at *11 (quoting Buckman
Company v. Plaintiffs’ Legal Committee, 531 U.S. 341, 352 (2001)).

13
See infra Part VI.A.2 and VI.A.3 for a discussion of the doctrines of express and implied
preemption.

20

B.

Plaintiffs’ Amended Complaint, Which Adds Unomedical And
Claims That Relate Specifically To The Infusion Set

The Kubickis filed an amended complaint on January 10, 2014. (See Am.
Compl., ECF No. 51.) With leave of Court and over Medtronic’s objection (see Pls.’
Mot. for Leave to Amend the Compl., ECF No. 38; Medtronic Opp’n to Pls.’ Mot. for
Leave to Amend the Compl., ECF No. 41), the Kubickis’ amended complaint included
Unomedical as a defendant, and also, for the first time in the course of the litigation,
made specific allegations regarding defects in the MMT-396 Infusion Set. (See Am.
Compl. ¶ 27.) 14 Medtronic and Unomedical then filed pre-discovery dispositive
motions related to the amended complaint, which this Court denied on January 14,
2015; the Court instructed the parties instead to proceed to engage in fact discovery,
and it provided both defendants with the opportunity to file either an answer or an
omnibus motion addressing all issues regarding the legal sufficiency of the complaint in
response to a second amended complaint that the plaintiffs proposed to file after
discovery. (See Order Revising Schedule for Pretrial Proceedings, ECF No. 111.)
On July 31, 2015, after the scheduled period of fact discovery ended, the
Kubickis filed a second amended complaint, which is the operative complaint for the
purpose of the instant motions. (See 2d Am. Compl.). As noted above, this complaint
asserts causes of action for negligence (Counts I–V), strict liability (Counts VI–X),
breach of express warranties (Counts XI–XV), failure to warn (Counts XVI–XX), and
punitive damages (Counts XXI-XXV). (See generally id.) There are multiple counts

14

Plaintiffs also added Flextronics International USA, Inc, as a defendant in their amended complaint,
alleging that the company was involved in the manufacture and/or sale of the Infusion Set (see Am.
Compl. ¶ 11), but later voluntarily dismissed the claims against Flextronics (see Stip. of Dismissal as to
Flextronics Int’l USA, Inc., ECF No. 69).

21

pertaining to each theory of liability because each theory is asserted separately against
each of the five entities named as defendants in the complaint (Medtronic, Inc.,
Medtronic Diabetes, Medtronic MiniMed Inc., Unomedical Devices SA de CV, and
Unomedical Devices A/S, respectively). (See generally id.) The claims against
Medtronic pertain to both the MMT-522 Pump and the MMT-396 Infusion Set (see id.
Counts I–III, VI–VIII, XI–XIII, XVI–XVIII, XXI–XXVIII, while the claims against
Unomedical pertain only to the MMT-396 Infusion Set (see id. Counts IV–V, IX–X,
XIV–XV, XIX–XX, XXIV–XXV).
Notably, the Kubickis’ negligence claims against Medtronic allege that
Medtronic violated various duties in connection with the company’s design and
marketing of the MMT-522 Pump and MMT-396 Infusion Set, including:


“[the D]uty to act with reasonable care in designing the
MiniMed Insulin Pump and Paradigm Infusion Sets
[which] parallels the federal requirements set forth in 21
C.F.R. § 820.30 et seq. related to design controls[]” (id.
¶ 89);



“[the D]uty to act with reasonable care in providing
adequate instructions for use, labeling and warnings for
the MiniMed Insulin Pump and Paradigm Infusion Sets
[which] parallels the federal requirements set forth in 21
C.F.R. § 801, et seq. and 21 U.S.C. § 352[]” (id. ¶ 90);



“[the D]uty to act with reasonable care in documenting,
logging, investigating, and reporting to the FDA and the
public any complaints it received from users concerning
instances of unintended overdelivery of insulin in the
MiniMed Insulin Pump and Paradigm Infusion Sets
[which] parallels the requirements set forth in 21 C.F.R.
§ 820, et seq. and 21 C.F.R. 803, et seq[]” (id. ¶ 91); and



“[the D]uty to act with reasonable care in manufacturing
the MiniMed Insulin Pump and Paradigm Infusion Sets

22

[which] parallels the requirements set forth in 21 C.F.R.
§ 820, et seq” (id. ¶ 92).
(See also id. at ¶¶ 95–98, 101–04.) The Kubickis assert these same alleged negligent
breaches of duty with respect to Unomedical regarding the MMT-396 Infusion Set.
(See id. ¶¶ 107–10, 113–16.)
As for their strict liability claims against Medtronic, which are asserted under the
Restatement of Torts § 402A, the Kubickis allege that Medtronic sold “MiniMed Insulin
Pumps and Paradigm Infusion Sets to Ms. Kubicki in a defective condition that was
unreasonably dangerous to consumers such as Ms. Kubicki[]” due to the inadequate
labeling, inadequate instructions for priming and filling, inadequate warnings
concerning the devices’ potential to cause an unintended overdelivery of insulin,
improper design in violation of FDA design control regulations, improper manufacture
in violation of FDA CGMPs, and failure to provide notice of complaints and adverse
events. (Id. ¶¶ 121, 128, 135.) The Kubickis make identical allegations against
Unomedical with respect to the MMT-396 Infusion Set. (See id. ¶¶ 142–49.)
The Kubickis’ breach of warranty claims assert that Medtronic breached an
express warranty allegedly set forth in the product packaging that the MMT-522 Pump
would be free from “defects in materials and workmanship for a period of four years
from the date of purchase[,]” (id. ¶ 158), as well as the express guarantee that the
MMT-396 Infusion Set would be free from “defects in materials and workmanship for a
period of up to three days from the date the packaging of the individual infusion set was
opened” (id. ¶ 160). Plaintiffs further allege that Medtronic had “warranted in
advertising and promotional materials” that the MMT-522 Pump and MMT-396
Infusion Set were “safe for use because the company had modified the design from

23

previous models to move the pressure-venting component from the insulin pump to the
infusion set . . . [and] that this [design modification] would make the updated models of
the devices safer than the previous versions and other models on the market by
preventing vent blockage[,]” and that Medtronic had breached this warranty. (Id. ¶ 162;
see also id. at ¶¶ 164–85.) Plaintiffs likewise assert that Unomedical breached the
three-day warranty that it offered on the MMT-396 Infusion Set, in addition to the
promotional warranty that the design changes made the device safer. (See id. ¶¶ 191–
93, 200–02.)
C.

Medtronic’s And Unomedical’s Motions For Summary
Judgment

Medtronic and Unomedical have each moved for summary judgment with respect
to Plaintiffs’ Second Amended Complaint. (See Medtronic’s MSJ; Unomedical’s MSJ.)
Medtronic makes three overarching arguments, each of which would dispose of this
case in its entirety: (1) there is no evidence of causation (Medtronic’s Mem. at 21–31),
(2) Plaintiffs’ claims are expressly and impliedly preempted (see id. at 31–45), and (3)
the statute of limitations bars Plaintiffs’ claims (see id. at 45–53). Medtronic further
argues that Medtronic is entitled to summary judgment on the punitive damages claim
because the record contains no evidence of intentional wrongdoing. (See id. at 58–60.)
Unomedical asserts that it is entitled to summary judgment on the basis of the statute of
limitations and implied preemption (Unomedical’s Mem. at 25–26; 44–47), and it also
seeks summary judgment on Plaintiffs’ punitive damages claims, arguing that its
alleged misconduct is not sufficiently outrageous or egregious to state a claim for
punitive damages (see id. at 49–50).

24

This Court held a hearing on these motions on November 3, 2016, during which
Plaintiffs represented to the Court that they were abandoning all of the claims against
Unomedical except for the failure to warn claims that are brought under both the
negligence and strict liability theories. (See Mot. Hr’g Tran. at 5:5–6:1.)
IV.

LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT
The standard that applies to motions for summary judgment brought under

Federal Rule of Civil Procedure 56 is clear beyond cavil. A court must grant summary
judgment to the movant if the moving party “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). “A fact is material if it ‘might affect the outcome of the suit under the
governing law,’ and a dispute about a material fact is genuine ‘if the evidence is such
that a reasonable jury could return a verdict for the nonmoving party.’” Steele v.
Schafer, 535 F.3d 689, 692 (D.C. Cir. 2008) (quoting Anderson v. Liberty Lobby, Inc.,
477 U.S. 242, 248 (1986)).
The moving party has the burden of demonstrating the absence of a genuine
dispute as to any material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).
Once the moving party has met this burden, the non-moving party must “designate
‘specific facts showing that there is a genuine issue for trial.’” Id. at 324 (quoting Fed.
R. Civ. P. 56(e)). Although the Court must view the evidence in the light most
favorable to the non-moving party and draw all reasonable inference in that party’s
favor, see, e.g., Grosdidier v. Broad. Bd. of Governors, Chairman, 709 F.3d 19, 23
(D.C. Cir. 2013) (citation omitted), the non-moving party must show more than “[t]he
mere existence of a scintilla of evidence in support of” his or her position, Anderson,

25

477 U.S. at 252. That is, in order to advance to trial, “there must be evidence on which
the jury could reasonably find” for the non-moving party. Id. Thus, the non-moving
party “may not rest upon mere allegation or denials of his pleading but must present
affirmative evidence showing a genuine issue for trial.” Laningham v. U.S. Navy, 813
F.2d 1236, 1241 (D.C. Cir. 1987) (internal quotation marks and citation omitted).
V.

RULING ON CAUSATION
As explained, Medtronic’s summary judgment brief opens with an argument that

it maintains disposes of this entire case: that the record contains insufficient evidence
to support a jury finding that either the MMT-522 Pump or the MMT-396 Infusion Set
actually caused Caroline’s injuries, and thus there is no genuine dispute of fact
regarding the causation element, which pertains to all of Plaintiffs’ claims. (See
Medtronic’s Mem. at 31–32.) 15 To be specific, Medtronic insists that the record
evidence indisputably demonstrates that Caroline was not connected to her insulin pump
at the time of her hypoglycemic incident, which means that the pump and infusion set
could not possibly have caused her injury. (See id. at 35.) And Medtronic offers
various alternative causes for the precipitous drop in Caroline’s blood sugar level—
such as “inadequate monitoring of blood sugar levels, hypoglycemia unawareness,
inadequate food intake, excessive exercise, dosing error by the patient, or some
combination of these things[,]” (id.)—to bolster its causation argument, as laid out in an
affidavit from Helena W. Rodbard, M.D., FACP, MACE, one of Medtronic’s retrained
expert witnesses (see Rodbard Decl.).

15

As noted above, Unomedical has adopted Medtronic’s arguments regarding causation (see
Unomedical’s Mem. at 10 n.1), and therefore the analysis in this section of the Memorandum Opinion
applies to Unomedical’s request for summary judgment on causation grounds as well.

26

This Court has already found that, by offering Dr. Rodbard’s assessment of
potential alternative causes for Caroline’s injuries prior to the parties’ formal entry into
the expert-discovery phase of this litigation, Medtronic has jumped the gun. (See Min.
Order of Apr. 8, 2016 (holding that “Medtronic’s submission of an expert declaration
(and related argument) regarding causation is premature”).) As a result, the Court
previously granted Plaintiffs’ motion to strike the causation-hypothesis-related portions
of Dr. Rodbard’s declaration, as well as the parts of Medtronic’s summary judgment
brief that rely on the stricken parts of the declaration. (See id.) Thus, today, this Court
considers only whether Defendants are entitled to summary judgment on causation
grounds based on what the (admittedly incomplete) record that is now before this Court
reveals.
As explained below, this Court finds that the record is such that a genuine
dispute currently exists regarding the material question of whether Caroline was, in
fact, connected to her insulin pump at the time of the hypoglycemic incident, which
means that summary judgment is inappropriate at this time. However, the Court will
permit Defendants to renew their causation arguments following the close of the
forthcoming period of expert discovery. 16

16

Thus, today’s causation ruling pertains only to what the current record demonstrates regarding the
issue of whether Caroline was connected to the pump when the hypoglycemic incident occurred. The
statements that Medtronic makes to suggest that (a) Caroline did not experience a temporary blocked
vent even if she was connected to the pump, and (b) such a blockage could not have caused her injury
in any event (see Medtronic’s Mem. at 37–39), have not been squarely presented as a basis for the
instant request for summary judgment, nor could they be, given that expert discovery is still pending.
Therefore, the instant Memorandum Opinion addresses only one aspect of Defendants’ causationrelated contentions—i.e., that Caroline was not in fact connected to the insulin pump at the time of her
injury—and should not be construed more broadly. (See Min. Order of Apr. 8, 2016 (preserving for
current consideration only “the portions of Medtronic’s brief [relating to causation] that argue that
there is no evidence that Caroline Kubicki was wearing her insulin pump at the time of her underlying
injury”).)

27

A.

The Record Evidence Thus Far Submitted Is Not Sufficient To
Warrant Granting Summary Judgment To Defendants On
Causation Grounds

As Medtronic itself acknowledges, “[b]ecause [Caroline] was alone for a
significant portion” of the evening of September 8, 2007, “we are left with an
incomplete picture of exactly what happened to [her].” (Medtronic’s Mem. at 21–22.)
Nevertheless, Medtronic maintains that it is entitled to summary judgment at this
juncture, because, in its view, what we do know from the facts that the parties have
gathered thus far indicates that Caroline was not actually using her insulin pump and
the associated infusion set at the time of her hypoglycemic event. (Id. at 35.) The
centerpiece of Medtronic’s causation claim is the deposition testimony of Caroline’s
roommate (Magdelena Posthumus) that the MMT-522 Pump was “not attached to
[Caroline]” when Posthumus discovered Caroline in distress on the morning of
September 9, 2007, but instead was laying on Caroline’s desk. (See Medtronic’s Mem.
at 22 (“According to Ms. Posthumus, when she discovered Ms. Kubicki at 8:00 a.m., the
MMT-522 Pump was not attached to Ms. Kubicki.” (citing Posthumus Dep. at 20:5–12,
20:20–23, 67:24–68:22, 70:5–13)) (emphasis omitted); see also Medtronic’s Stmt. of
Facts ¶ 29.) In addition, Medtronic points to Posthumus’s statement to the 911
dispatcher, made shortly after she discovered her roommate, that Caroline, “‘ha[d]
something that’s supposed to attach to her body but it’s not attached[,]’” and that
Posthumus did not know whether Caroline “‘took it out herself[.]’” (Medtronic’s Mem.
at 22 (quoting 911 Call Transcript, Ex. W to Brown Decl., ECF No. 133-5, at 221) (first
alteration in original).)
Medtronic further maintains that the police officers who responded to the scene
reported that Posthumus had told them that Caroline “‘carried around a device that
28

periodically dosed medication into her body’” and that “‘there was no indication that
the device was attached’” to Caroline’s body when Posthumus discovered her. (Id.
(quoting Police Report, Ex. V to Brown Decl., ECF No. 133-5, at 214).) Caroline’s
medical records also appear to indicate that the responding paramedics “‘found [the]
insulin pump disconnected’” on Caroline’s desk, but that, in the paramedics’ view, it
was “‘unclear’” whether Posthumus “‘did this when [Caroline was] found
unresponsive[.]’” (Id. (quoting GWU Medical Records, Ex. U to Brown Decl., ECF No.
133-5, at 209) (first alteration in original).)
Plaintiffs vociferously dispute Medtronic’s contention that the pump was
detached from Caroline’s body (see Pls.’ Stmt. of Fact ¶ 1), characterizing Posthumus’s
testimony as “equivocal and unreliable” (Pls.’ Opp’n at 55), and noting that not only
had Posthumus failed to recall certain details about the insulin pump (id. at 59 (citing
Posthumus Dep. at 133:3–25)), she did not even remember the fact that she had called
911 on the morning in question (id. (citing Posthumus Dep. at 131:10–16)). Plaintiffs
further argue that Posthumus had been out late with her friends on the evening of
September 8, 2017, “and it is unclear whether she was consuming alcohol, affecting her
memory and cognition the following morning.” (Id.) Plaintiffs also point out that
Posthumus testified that Caroline was wearing pajamas and that Posthumus could not
rule out the pump being underneath Caroline’s sleep clothes; that Posthumus did not
notice the location of the pump on the desk until several minutes had passed, during
which time numerous people had entered and left the dorm room; and that she did not
know when the pump was placed on the desk. (See id. at 59–60 (citing Posthumus Dep.
at 134:5–13, 160:19–21, 163:12–14).)

29

The Kubickis further maintain that, far from establishing that Caroline was not
using the pump on the night in question, Caroline’s medical records actually support the
contention that Caroline was, in fact, connected to her pump. For instance, Plaintiffs
read Caroline’s hospital records to state that Caroline’s pump was covered in vomit, and
they argue that the pump “could not feasibly have been covered with pink vomit unless
it was with Caroline at the time she suffered her acute hypoglycemic injury.” (Id. at 61
(citing GWU Hosp. Records, ECF No. 138-4, at 4).) Plaintiffs also point to other
statements in Caroline’s medical records that suggest that it was Posthumus who
removed the pump from Caroline’s body (id. at 61 (citing GWU Hosp. Records at 4)),
or that Caroline had removed the pump herself on the morning of September 9 (id. at 61
(citing GWU Hops. Records at 6)). Plaintiffs also note that a resident advisor had
recalled seeing an small plastic box on Caroline’s body while Caroline was unconscious
in her bed (id. at 61–62 (citing Barloon Dep. at 59, 96:18–25, 89:25–93:23, 97:8–15)),
and that a paramedic has removed a “sticker” attached to Caroline’s abdomen, which
they surmise was the “the adhesive attached to her infusion set” (id. at 62 (citing
Humphrey Dep. at 46:21–47:10, 59:8–15)). Additionally, when deposed, both of the
Kubickis testified that it simply was not Caroline’s practice to take her pump off at
night. (See id. (citing J. Kubicki Dep. at 418:2–4; K. Kubicki Dep. at 395:15–21).)
In response, Medtronic insists that the Kubickis “mischaracteriz[e]” the evidence
(Reply in Support of Medtronic’s Mot. (“Medtronic’s Reply”), ECF No. 145, at 11), and
it provides detailed, alternative characterizations of the deposition testimony and
medical records at issue (id. at 10–14). Moreover, Medtronic reiterates that “[t]he only
testimony concerning what Ms. Kubicki was doing on the evening in question came

30

from Posthumus, who testified Ms. Kubicki was asleep when Posthumus left for the
evening and remained in that state from the time Posthumus returned to her dorm and
read a book for an hour to when she awoke and discovered Ms. Kubicki in distress the
following morning.” (Medtronic’s Reply at 15 (citing Medtronic Mem at 22).)
This Court has no doubt that the instant record is not sufficient to establish
indisputably that Caroline was not connected to her insulin pump on the night in
question, because there is evidence the points in both directions, and because the issue
primarily turns on Ms. Postumus’s recollection of events, as Medtronic appears to have
acknowledged. It is well established that “[c]redibility determinations, the weighing of
the evidence, and the drawing of legitimate inferences from the facts are jury functions,
not those of a judge at summary judgment.” Barnett v. PA Consulting Grp., Inc., 715
F.3d 354, 358 (D.C. Cir. 2013) (citation omitted). And, indeed, this Court’s role in
deciding a motion for summary judgment is not to “determine the truth of the matter,
but instead [to] decide only whether there is a genuine issue for trial.” Id.
As this Court views the current record, there is evidence from which a reasonable
jury could conclude either that the insulin pump was involved in Caroline’s injury
because it was attached to her on the night in question (see, e.g., GWU Hosp. Records
at 4, 6; Barloon Dep. at 59, 96:18–25, 89:25–93:23, 97:8–15) or that the insulin pump
had nothing to do with Caroline’s injury because it was laying on her desk unused at the
time that Postumous discovered Caroline (see, e.g., Posthumus Dep. at 20:5–12, 20:20–
23, 67:24–68:22, 70:5–13; 911 Call Transcript). Drilling down even farther, it appears
that, even if the jury were to conclude that the pump was on Caroline’s desk, the
causation question would not be entirely resolved, because the current record does not

31

explain when or how Caroline’s insulin pump ended up there. Based on the existing
record evidence, then, a jury could only reasonably infer that the pump was placed on
the desk sometime between 8:30 p.m. on the evening of September 8th—when Caroline
gave herself six units of insulin (see K. Kubicki Dep. at 129:20–130:8)—and the
morning of September 9th—when emergency personnel took Caroline to the hospital.
Within this key block of time is a substantial period for which no competent individual
can provide eyewitnesses testimony, because Posthumus was out with friends from
10:30 p.m. the evening of September 8th until 12:30 a.m. the following morning, and
was asleep thereafter. Thus, Posthumus’s testimony does not go far enough in
answering the question of whether the pump did or did not contribute to Caroline’s
injury, even if it is deemed credible, which means that expert opinion regarding whether
the factual circumstances reflected in the record indicate that Caroline was actually
using the allegedly defective pump within the pertinent timeframe on the night of
September 8th and the morning of September 9th is likely to be necessary.
Consequently, the current testimony and documentary evidence are simply not
sufficient to establish that there is no issue of fact for trial with respect to the material
issue of whether Caroline was using her insulin pump at the time of her injury. If
nothing else, it is patently obvious that the parties’ volley of competing evidentiary
interpretations and witness-credibility assessments raise more causation questions than
the record presently answers, and these lingering questions are plainly ones that a
jury—and not this Court—must resolve. See In re Fort Totten Metrorail Cases Arising
Out of Events of June 22, 2009, 895 F. Supp. 2d 48, 70 (D.D.C. 2012) (noting that
“proximate causation is ordinarily a question of fact for the jury. . . . [and] that it is

32

only the exceptional case in which questions of proximate cause pass from the realm of
fact to one of law” (internal quotation marks and citations omitted)); see also Boodoo v.
Cary, 21 F.3d 1157, 1161 (D.C. Cir. 1994) (“The court may not substitute its judgment
for that of the jury: it neither assesses witness credibility nor weighs evidence.”
(citation omitted)); Ferebee v. Chevron Chem. Co., 736 F.2d 1529, 1536 (D.C. Cir.
1984) (finding that, where there was conflicting evidence regarding causation, court
properly submitted the question to jury).
B.

The Parties Will Be Permitted To Revisit The Causation
Question After Expert Discovery Is Completed

To be clear: this Court’s ruling on causation is a relatively narrow one, in that it
pertains only to the pending motions for summary judgment. (See supra n.16.) The
Court anticipates that the parties will undertake expert discovery in this matter (see
Order Revising Schedule for Pretrial Proceedings, ECF No. 11, at 1–3 (setting schedule
for fact discovery and initial motions, and providing that “[i]f any claims remain after
this Court rules on the dispositive motions, the Court will schedule an additional period
of expert discovery in preparation for trial”)), and in complex medical product liability
cases such as this one, expert testimony regarding causation is ordinarily indispensable
under District of Columbia law. See, e.g., Otis Elevator Co. v. Tuerr, 616 A.2d 1254,
1260 (D.C. 1992) (noting the necessity of expert testimony “when recovery is sought
for permanent injuries or where there are complicated medical questions related to
causation of such injuries”) (citations omitted); see also Baltimore v. B.F. Goodrich
Co., 545 A.2d 1228, 1231 (D.C. 1988) (explaining that expert testimony is necessary to
establish causation in cases involving “medically complicated” claims with “multiple
and/or preexisting causes”) (citations omitted).

33

As detailed below, the Court is permitting certain claims against Medtronic to
proceed (see infra Part VII.B, VII.C)), and therefore, the Court will issue a separate
order that requires the parties to submit a joint proposed schedule for a period of expert
discovery to commence forthwith. Once this expert discovery period has concluded, the
Court will permit Medtronic to renew and supplement its request for summary judgment
on the issue of causation.
VI.

RULING ON TIMELINESS
Turning to another major argument that Medtronic and Unomedical raise in the

context of their motions for summary judgment—timeliness—the Court notes that the
parties do not dispute that Plaintiffs’ product-liability claims for negligence, strict
liability, and failure to warn are subject to the three-year statute of limitations laid out
in D.C. Code § 12-301. (See Medtronic’s Mem. at 55; Unomedical’s Mem. at 25; Pls.’
Opp’n at 63.) See also D.C. Code § 12-301(8) (actions “for which a limitation is not
otherwise specially prescribed” must be brought within three years “from the time the
right to maintain the action accrues”). And the parties also appear to agree that the
Kubickis’ claims as they relate to the MMT-522 Pump are timely. (See Medtronic’s
Mem. at 55.) The statute of limitations dispute is over whether the tort claims that
pertain to the MMT-396 Infusion Set—which were first introduced into this litigation
on November 19, 2013, six years after Caroline’s injury—are time-barred. (See id. at
55–62; Unomedical’s Mem. at 25–34; Pls.’ Opp’n. at 63–76; Pls.’ Mot. for Leave to
File the First Am. Compl., ECF No. 38.) For the reasons explained below, this Court
finds that the infusion set-related tort claims that the Kubickis have brought against
Unomedical are not timely, because such claims could have (and should have) been

34

discovered shortly after Caroline’s injury in 2007, and Unomedical had no notice of the
infusion set claims against it until the Kubickis filed an amended complaint, six years
after the injury occurred. However, the infusion set-related tort claims against
Medtronic are not time-barred, because these otherwise untimely claims concerning the
MMT-396 Infusion Set relate back to the timely claims that the Kubickis had filed
against Medtronic concerning the MMT-522 Pump.
A.

The Law Pertaining To Timeliness: Statutes Of Limitations,
The Discovery Rule, And The Relation Back Doctrine

A statute of limitations is the legislatively prescribed time period (usually a
period of years) within which an authorized legal claim must be filed. See Statute of
Limitations, Black’s Law Dictionary (10th ed. 2014) (defining statute of limitations);
see also Rudder v. Williams, 47 F. Supp. 3d 47, 52 (D.D.C. 2014) (“‘Statutes of
limitations . . . represent a pervasive legislative judgment that it is unjust to fail to put
the adversary on notice to defend within a specified period of time and that the right to
be free of stale claims in time comes to prevail over the right to prosecute them.’”
(quoting United States v. Kubrick, 444 U.S. 111, 117 (1979) (alteration in original))).
Claims that are brought beyond the statutory time period are ordinarily barred. See
Untalasco v. Lockheed Martin Corp., 249 F. Supp. 3d 318, 323 (D.D.C. 2017) (“[T]he
general rule that one can glean from [precedent] is that courts should apply the [District
of Columbia] statute of limitations strictly, even though barring actions often seems
arbitrary and inequitable.” (internal quotation marks, citation, and emphasis omitted)).
However, when a plaintiff files a timely legal action regarding an injury, and then later
seeks to assert a potentially out-of-time claim in the context of an amended complaint,
two independent and alternative concepts can apply to permit such an amendment: “the

35

discovery rule” (which considers when the plaintiff knew or should have known of the
potential claim), see Bussineau v. President & Directors of Georgetown Coll., 518 A.2d
423, 425 (D.C. 1986), and “the relation back doctrine” (which considers the connection
between the old claim and the new one to determine whether the defendant knew or
should have known of the claim), see Meijer, Inc. v. Biovail Corp., 533 F.3d 857, 866
(D.C. Cir. 2008). The contours of each of these doctrines is laid out below.
1.

The Discovery Rule

The discovery rule alters the typical understanding of when the statute of
limitations starts to run, (i.e., when it “accrues.”) It is well established that, “[w]here
the fact of an injury can be readily determined, a claim accrues for purposes of the
statute of limitations at the time the injury actually occurs.” Colbert v. Georgetown
Univ., 641 A.2d 469, 472 (D.C. 1994) (citations omitted). But, if the injury is not
apparent, and/or if the causal link between tortious conduct and injury is not
immediately clear, District of Columbia courts apply the “discovery rule[,]” which
holds that the statute of limitations begins to run not on the date that the injury
happened, but “‘when the plaintiff has knowledge of (or by the exercise of reasonable
diligence should have knowledge of) (1) the existence of the injury, (2) its cause in fact,
and (3) some evidence of wrongdoing.’” Lee v. Wolfson, 265 F. Supp. 2d 14, 17
(D.D.C. 2003) (quoting Bussineau, 518 A.2d at 425); see also Colbert, 641 A.2d at 473
(holding that plaintiff’s claim for medical malpractice did not accrue until she
“discovered or reasonably should have discovered all of the essential elements of her
possible cause of actions”) (quotation marks and citation omitted).
The District of Columbia Court of Appeals has made clear that, per the discovery
rule, “the statute of limitation[s] for negligence begins to run at such time a prospective
36

plaintiff gains inquiry notice that wrongdoing may be involved.” Bussineau, 518 A.2d
at 427–28. This means that what a plaintiff knows, or should have known, about the
defendant’s potential fault is key. Id. Nevertheless, the statute of limitations will be
deemed to run even if the plaintiff does not fully comprehend the extent to which a
potential defendant may have caused the injury. See Baker v. A.H. Robins Co., 613 F.
Supp. 994, 996 (D.D.C. 1985). Furthermore, a plaintiff who has suffered an injury must
act reasonably and diligently to investigate the possibility of a claim, and a litigant is
deemed to have inquiry notice of a claim that he should have discovered by exercising
this reasonable diligence. See id. at 996; see also Reeves v. Eli Lilly & Co., 368 F.
Supp. 2d 11, 21 (D.D.C. 2005) (emphasizing that the reasonableness of an investigation
is evaluated under an objective standard). Put another way:
In every case, the plaintiff has a duty to investigate matters
affecting her affairs with reasonable diligence under all of the
circumstances. Once the plaintiff actually knows, or with the
exercise of reasonable diligence would have known, of some
injury, its cause-in-fact, and some evidence of wrongdoing,
then she is bound to file her cause of action within the
applicable limitations period, measured from the date of her
acquisition of the actual or imputed knowledge.
Diamond v. Davis, 680 A.2d 364, 381 (D.C. 1996). In the context of the discovery rule,
it is the defendant’s burden to show that the plaintiff has not acted with reasonable
diligence. See Smith v. Brown & Williamson Tobacco Corp., 108 F. Supp. 2d 12, 17
(D.D.C. 2000).
2.

The Relation Back Doctrine

Federal Rule of Civil Procedure 15(c) “governs when an amended pleading
‘relates back’ to the date of a timely filed original pleading and is thus itself timely
even though it was filed outside an applicable statute of limitations.” Krupski v. Costa

37

Crociere S. p. A., 560 U.S. 538, 541 (2010). Rule 15(c) addresses three instances where
relation back is appropriate; Plaintiffs here rely on the second of the three: where “the
amendment asserts a claim or defense that arose out of the conduct, transaction, or
occurrence set out—or attempted to be set out—in the original pleading.” Fed. R. Civ.
P. 15(c)(1)(B). (See Pls.’ Opp’n at 74 (“The allegations concerning the Infusion Set
‘arise out of the same conduct’ alleged in the original complaint and Plaintiffs have not
introduced any new legal theories since their original complaint.” (quoting Fed. R. Civ.
P. 15(c)(1)(B))).)
Significantly for present purposes, the relation-back doctrine and the discovery
rule both generally pertain to knowledge of the claim; however, these doctrines address
different parties. The discovery rule focuses on the knowledge of the plaintiff, while
the relation back doctrine focuses on whether a defendant has had fair notice of the
plaintiff’s claim. Compare Lee, 265 F. Supp. 2d at 17 (holding that the statute of
limitations begins to run under the discovery rule when a plaintiff knows, or should
know, of an injury, its causation, and some wrongdoing on the part of the defendant)
with Meijer, Inc., 533 F.3d at 866 (“The underlying question is whether the original
complaint adequately notified the defendants of the basis for liability the plaintiffs
would later advance in the amended complaint.”); Hartley v. Wilfert, 931 F. Supp. 2d
230, 233 (D.D.C. 2013) (explaining that, for purposes of the relation back doctrine,
“notice to the defendant is relevant to the inquiry”); see also, e.g., Dover v. Medstar
Wash. Hosp. Ctr., 989 F. Supp. 2d 57, 59, 61–62 (D.D.C. 2013) (holding that claims for
violations of D.C.’s overtime statute did not relate back to timely claims for intentional
interference with prospective advantage and economic expectancy, intentional

38

misrepresentation, and defamation because of defendants’ lack of notice of the alleged
wage payment violations). Ultimately, “[s]o long as the original and amended
[complaints] state claims that are tied to a common core of operative facts, relation
back will be in order.” Mayle v. Felix, 545 U.S. 644, 664 (2005).
B.

Plaintiffs Could Have Discovered Their Claims Against
Unomedical Regarding The MMT-396 Infusion Set Near The
Time Of Caroline’s Injury; Therefore, The Infusion Set Claims
That Plaintiffs Belatedly Asserted Against Unomedical Are
Untimely

Plaintiffs first named Unomedical as a defendant, and made associated claims
arising from Unomedical’s manufacture of the MMT-396 Infusion Set, on January 10,
2014—more than six years after Caroline’s hypoglycemic event. (See Am. Compl.) In
response to the timeliness objection that both Medtronic and Unomedical raise in their
summary judgment motions, Plaintiffs insist that their newly-asserted infusion set
claims are not time-barred, because Plaintiffs “could not have conceivably connected
Caroline Kubicki’s severe hypoglycemic injury” to a defect or malfunction in the
MMT-396 Infusion Set prior to June 2013 Paradigm Infusion Set recall. (Pls.’ Opp’n at
65; see also id. at 66 (“[T]he public was not made aware of the role of the Infusion Set
in the over-delivery of insulin until June 7, 2013, when the Class I recall concerning the
temporary vent block condition was issued.” (citation omitted)).) This Court rejects the
Kubickis’ contention that their product-liability claims arising from the MMT-396
Infusion Set accrued only as of June 2013, and that prior to that date they could not
possibly have discovered that the infusion set—and its manufacturer, Unomedical—
might have been the cause of Caroline’s injuries, for the following reasons.

39

1.

Caroline’s Insulin-Delivery Device Is A Multifaceted
Medical Product, And The Manufacturers Of The Various
Components Are Clearly Identified

First of all, as explained in Part II.B, supra, a mechanical insulin-delivery pump
is a complex medical device that has many intricate parts, even to the lay observer. In
the wake of Caroline’s injury, basic due diligence in evaluating the suspected source of
the alleged insulin overdose would have led a reasonable plaintiff to discover relatively
quickly that Caroline’s insulin-delivery device has various components; moreover, a
reasonable plaintiff certainly would have surmised that any one of the device’s various
components could have been responsible for Caroline’s injury. Indeed, the record
establishes that the Kubickis understood at the time of Caroline’s injury that the MMT522 Pump and the MMT-396 Infusion Set worked together to provide insulin to
Caroline (see J. Kubicki Dep. at 85:3-9; K. Kubicki Dep. at 324:3-16), which makes it
all the more unreasonable for Plaintiffs to have filed an initial complaint that only
contained claims related to an alleged defect in one component of Caroline’s insulindelivery device (the MMT-522 Pump).
The fact that Karen Kubicki may have subjectively believed that the potentially
defective insulin-delivery product was a unitary object (see K. Kubicki Dep. at 324:3–
16 (asserting that she considered the pump and infusion set as “one [and] the same”)) is
of no moment. As explained, the applicable standard of knowledge for the purposes of
the discovery rule is an objective one, see Baker, 613 F. Supp. at 996, and given the
totality of the facts and circumstances here, (including those that would have been
uncovered by a diligent investigation), it is clear to this Court that an objectively
reasonable plaintiff would have readily discovered that the pump and the infusion set
were distinct components of the Caroline’s insulin-delivery device, especially after one
40

of Caroline’s physicians specifically expressed to the Kubickis a concern about the fact
that Caroline’s MMT-396 Infusion Set had been discarded after the injury. (See K.
Kubicki Dep. at 322:6-7 (acknowledging that the doctor had told them “you would want
everything that [Caroline] was using” in trying to figure out what happened); see also
id. at 322:14–23, 324:3–16.) And even without such pointed statements from persons
with knowledge of the device in question, a reasonable plaintiff would have at least
consulted the packaging materials that accompanied the seemingly defective medical
device, and thereby would have discovered that the infusion set tubing that delivers
insulin to the body was packaged separately from the potentially defective mechanical
pump—another indisputable marker of a separate piece of medical equipment.
Plaintiffs’ contention that, as laypeople, they could not possibly have known that
a defect in the p-cap valve of the MMT-396 Infusion Set caused Caroline’s injury
before the recall in June of 2013 (see Pls.’ Opp’n at 66) misses the mark entirely,
insofar as it suggests that the statute of limitations does not accrue on a productsliability claim until the plaintiff has sufficient information to make specific allegations
with respect to causation. Quite to the contrary, it is well established that, while a
plaintiff must have “knowledge of wrongdoing to commence the statute of
limitation[s,]” Bussineau, 518 A.2d at 432 n.11, he need not “have certain knowledge of
causation[,]” Dawson, 543 F. Supp. at 1334. Thus, it was sufficient that the Kubickis
suspected wrongdoing related to the mechanism by which insulin went from the MMT522 Pump’s reservoir, through the infusion set, and into Caroline’s body—even if they
did not understand the precise failure mode—and they had developed this suspicion by
at least the year 2010. This Court has no doubt that, under such circumstances, a

41

reasonable plaintiff would have discovered, and presumably raised, tort claims that
pertain to all of the components of that allegedly faulty insulin-delivery system.
In this case, there is an additional wrinkle: the Kubickis’ unreasonable failure to
assert timely product-liability tort claims relating to a key component of Caroline’s
insulin-delivery device also means they failed to identify Unomedical, and to include
that company as a defendant in this action in a timely fashion. Again, while Karen
Kubicki may not have actually known that there was another company involved in the
manufacture of the medical device that she suspected caused Caroline’s injury (see Pls.’
Opp’n at 68 (referencing Karen Kubicki’s statement that she “did not know who made
the Infusion Set and only thought that Medtronic was involved”)), and in this Court’s
view, an objectively reasonable plaintiff would easily have discovered at the time of
Caroline’s injury that a potential tort claim arising from the MMT-396 Infusion Set
existed and was assertable against that product’s manufacturer. What is more, the
product packaging and instructions related to the MMT-396 Infusion Set clearly state
that the MMT-396 Infusion Set was “Assembled in Mexico for Unomedical A/S”
(Packaging Photos; Infusion Set Instructions), and Unomedical’s name also appears on
the MMT-396 Infusion Set itself (Mot. Hr’g Tr. 73:19–74:6.), which makes the
Kubickis’ failure to conduct even the most minimal investigation all the more obvious
here.
In any event, there is no question that the Kubickis had an obligation to conduct
an investigation into all of the potential sources of the product that they suspected was
the cause of Caroline’s injury. They were certainly aware that someone had
manufactured all of the components of the device in question; thus, they were on

42

“inquiry” notice that medical-device manufacturers had a role in making Caroline’s
infusion set, and should have looked into whether any companies other than Medtronic
were involved. See Berkow v. Lucy Webb Hayes Nat’l Training Sch. for Deaconesses &
Missionaries Conducting Sibley Mem’l Hosp., 841 A.2d 776, 781 (D.C. 2004) (noting
that “a plaintiff’s knowledge of one defendant’s misconduct will ‘create inquiry notice
of claims against a potential co-defendant . . . if (1) a reasonable plaintiff would have
conducted an investigation as to the co-defendant, and (2) such an investigation would
have revealed some evidence of wrongdoing[,]’” and holding that plaintiff’s knowledge
of one doctor’s misdiagnosis of him placed him on inquiry notice of claims against
other doctors who allegedly contributed to the misdiagnosis (quoting Cevenini v.
Archbishop of Wash., 707 A.2d 768, 773 (D.C. 1998) (alteration in original))).
This all means that nothing about the circumstances here persuades this Court
that it was reasonable for the Kubickis to forego an investigation of all of the potential
producers of the various parts of Caroline’s insulin-delivery device when they
undertook to bring a timely products-liability lawsuit in 2010. It is undisputed that the
MMT-396 Infusion Set works together with the MMT-522 Pump, and even setting aside
the obvious indications on the packaging materials and the device itself that a company
other than Medtronic was involved with the manufacture of that component, a
reasonable plaintiff would have investigated the origins of the device in question, and
such investigation would have revealed that Unomedical had a sufficient connection to
the manufacturing of the MMT-396 Infusion Set to warrant naming Unomedical as a codefendant in the 2010 complaint. See also 21 C.F.R. § 803.3(1) (FDA regulations
defining manufacturer as “any person who manufactures, prepares, propagates,

43

compounds, assembles, or processes a [medical] device”). In other words, although the
Kubickis were intent upon suing Medtronic based on their concerns about the operation
of the insulin pump, the company that the manufactured the infusion set—a component
of Medtronic’s insulin-delivery device—was readily ascertainable by the public at the
time of Caroline’s injury, and should have been known to Plaintiffs as well, long before
to the 2013 Recall.
2.

Plaintiffs Rely On Dissimilar Cases To Support Their
Contention That Their Infusion Set Claims Accrued In 2013

The functional connection between the MMT-522 Pump and the MMT-396
Infusion Set, and the fact that the Kubickis suspected a defect in Caroline’s insulindelivery system immediately but chose to file a timely action against only one of the
companies involved in the manufacture of the components of that system, differentiates
this case from Lee v. Wolfson, 265 F. Supp. 2d 14 (D.D.C. 2003), on which Plaintiffs
rely. The plaintiff in Lee sued for damages as a result of injuries that she suffered when
an unattended vehicle in a parking garage struck her. Notably, after testing showed no
issues with the parking break mechanism, Lee’s complaint alleged that the cause of her
injury was human error in either failing to set the parking brake or inadvertently
releasing it, id. at 16, and consistent with this theory, Lee initially named the owner of
the rolling car and the parking garage as defendants, id. The National Highway Traffic
Safety Administration subsequently issued a recall to correct a defect in the parking
brake design, which prompted Lee to seek to amend her complaint to add the car’s
manufacturer, id. at 16–17, and the Court authorized the amendment as timely. In
finding that Lee’s claims against the manufacturer did not accrue until the recall notice
issued, the Lee court held that “plaintiff here cannot automatically be expected to know

44

that wrongful conduct on the part of [the manufacturer] might have caused the release
of the [rolling car’s] parking brake at the time of her injury, particularly when no defect
in the parking brake was revealed during the investigation of the accident by the police
or plaintiff’s expert.” Id. at 18.
Here, by contrast, the Kubickis’ initial claim of wrongdoing concerned an
alleged product-related defect pertaining to the insulin-infusion system that Caroline
used (otherwise they could not have in good faith sued Medtronic). And having
suspected a problem with that system, it was incumbent upon the Kubickis to conduct a
reasonable inquiry into all of the possible components of that system in a timely
fashion. See Diamond, 680 A.2d at 381; see also Colbert, 641 A.2d at 472–73 (holding
that “[w]here the fact of an injury can be readily determined, a claim accrues for
purposes of the statute of limitations at the time the injury actually occurs[,]” but
“[w]here the relationship between the fact of injury and the alleged tortious conduct
may be obscure,” the claim accrues when the plaintiff “knew or should have known that
she had suffered injury as a result of the defendants’ negligence”). In other words, the
instant case is substantially different from Lee, because while the plaintiff in Lee lacked
fair notice of any wrongdoing with respect to the parking brake system of the car that
had injured her and was instead proceeding on a human-error tort theory, the Kubickis
suspected a product defect from the outset, and therefore, had the obligation to examine
timely all of the aspects of the allegedly defective product for statute of limitations
purposes.
A more analogous case is Colarossi v. Schmid Laboratories, Inc., 830 F. Supp.
230 (D.N.J. 1993), in which the court found that a claim against a manufacturer of

45

intrauterine devices (“IUDs”) was untimely under District of Columbia law. The
plaintiff in Colarossi learned from her doctor in 1978 that her IUD might have caused
an infection that led to permanent injuries. Id. at 237. The court found that her claim
accrued at that point in time, noting that “[f]aced with permanent injury and [a]
statement by her doctor that her IUD may have been the cause, wrongdoing by someone
was more than a hypothetical possibility and the wrongdoing element was met.” Id.
(alterations, internal quotation marks, and citation omitted); see also id. at 236 (“The
wrongdoing element does not, however, require that the plaintiff know the identity of
the party responsible for the injury.”). In the alternative, the court found that the claim
accrued no later than 1986, which was when the plaintiff learned of, and participated in,
litigation related to Dalkon Shield IUDs. Id. at 237. Notably, the Colarossi plaintiff
made a critical mistake in connection with that litigation: she failed to review her own
medical records to determine the specific manufacturer of the IUD that she had used,
and as a result, she only sued the manufacturer of Dalkon Shield IUDs, not the
manufacturer of the brand of IUD that was identified in her medical records. Id. When
the plaintiff later learned of her error and tried to sue the correct manufacturer, the
court pegged 1986 as the latest possible accrual date because, at that point, “not only
was [the plaintiff] aware of the possibility of wrongdoing, she took affirmative action to
obtain legal redress.” Id.; see also id. (faulting plaintiff for failing to exercise due
diligence because she failed to examine her medical records before initiating suit).
So it is here. The Kubickis knew of potential wrongdoing on the part of the
manufacturers of Caroline’s insulin-deilvery system in 2007, when Caroline suffered
her injury and when her treating physician advised them that Caroline’s insulin-delivery

46

system (consisting of the MMT-522 pump and MMT-396 Infusion Set) could be the
cause. (See J. Kubicki Dep. at 23:25–25:13.) And even if it was reasonable for the
Kubickis to fail to make a connection between the insulin-deilvery system and potential
wrongdoing in 2007, they undeniably had made that connection by the time they filed a
lawsuit against Medtronic in 2010, which means that, at the very latest, their productliability claims accrued in 2010 (see Brown Decl. ¶ 3), four years before they undertook
to litigate tort claims specifically pertaining to the MMT-396 Infusion Set.
The 2009 Lot 8 recall—through which Medtronic recalled certain MMT-396
Infusion Sets from a particular manufacturing lot but provided public assurances that all
other lots were safe and effective (see 2009 Recall Notice, Ex. 18 to Pls.’ Opp’n, ECF
No. 138-28, at 1)—has no bearing on the aforementioned analysis of the accrual of the
Kubickis’ claims. Plaintiffs assert that Medtronic’s safety assurances with respect to
non-Lot 8 infusion sets “led Plaintiffs to not consider the MMT-396 Infusion Set as a
potential cause in fact.” (Pls.’ Opp’n at 70.) But, if anything, the 2009 recall notice
would have spurred a reasonable plaintiff to inquire further regarding this component of
the Caroline’s insulin-deilvery system, because in the context of the Lot 8 recall,
Medtronic expressly identified a particular fault mechanism in the MMT-396 Infusion
Set that could result in the over-delivery of insulin, i.e., the blocking of air vents in the
tubing connector. (See Questions & Answers Regarding the “Lot 8” Quick-set Infusion
Set Recall, Ex. 27 to Pls.’ Opp’n, ECF No. 138-29, at 3; see also 2009 Recall Notice at
1 (explaining, specifically, that Lot 8 MMT-396 Infusion Sets potentially had a
manufacturing defect that “may not allow the insulin pump to vent air pressure properly

47

[which] could potentially result in the device delivering too much or too little insulin
and may cause serious injury or death.”)
Thus, armed with the general knowledge that blockage of the infusion set air
vents could lead to an over-delivery of insulin, and believing that Caroline was injured
as the result of an over-delivery of insulin, an objectively reasonable plaintiff would by
no means have felt “reassured” by Medtronic’s assertions; instead, she would have even
more vigorously investigated, and pursued, tort claims against any entity that had
played a role in the manufacture of Caroline’s MMT-396 Infusion Set, including
Unomedical. 17
3.

The Relation Back Doctrine Does Not Save The Infusion
Set-Related Claims Against Unomedical

Plaintiffs have invoked the “relation back” doctrine to maintain that, even if this
Court concludes that the amended complaint’s claims related to the MMT-396 Infusion
Set are untimely because those claims could have been discovered long before Plaintiffs
filed the amended complaint, the infusion set claims should nevertheless be deemed
timely. (See Pls.’ Opp’n at 74.) To support this argument, Plaintiffs cite to Federal
Rule of Civil Procedure 15(c)(1)(B), which provides that an amended pleading relates
back to the date of the original pleading when “the amendment asserts a claim or
defense that arose out of the conduct, transaction, or occurrence set out—or attempted
17
The holdings of the cases that Plaintiffs cite to support their contention that they “justifiably relied
on Defendants to provide information about the safety risks of their products[,]” (Pls.’ Opp’n at 70),
are inapposite. The court in Diamond, for example, noted that it could take into account the existence
of a “confidential or fiducial relationship between the plaintiff and defendant” in determining whether
the plaintiff rightfully relied on representations the defendant made. 680 A.2d at 381. No such
fiduciary or confidential relationship exists in this case. Nor is this a circumstance where there is a
latent product defect that only becomes evident after the limitations period had run. See, e.g.,
Ehrenhaft v. Malcolm Price, Inc., 483 A.2d 1192, 1202 (D.C. 1984). Here, the injury itself was
immediately evident, and Plaintiffs unquestionably had knowledge of the insulin-deilvery system’s
potential role in Caroline’s injury by at least 2010.

48

to be set out—in the original pleading[.]” Fed. R. Civ. P. 15(c)(1)(B). In this regard,
Plaintiffs argue that “the Second Amended Complaint does not introduce any new legal
theories into this litigation, but instead only amplifies the original factual allegations to
include the Infusion Set” (Pls.’ Opp’n at 75 (emphasis added) (internal citations and
quotation marks omitted)). Be that as it may, this Court concludes that the infusion setrelated claims against Unomedical cannot be considered to relate back to the original
complaint for statute of limitations purposes, for the following reasons.
It is clear beyond cavil that relation back under Rule 15(c)(1)(B) is permissible
only if the defendant had “sufficient notice of the facts and claims giving rise to the
proposed amendment” prior to the expiration of the statute of limitations. United States
v. Hicks, 283 F.3d 380, 388 (D.C. Cir. 2002). Thus, the general rule is that “new
parties, either plaintiffs or defendants, cannot be added to an action by amendment after
the applicable limitations period has expired[,]” 6A Charles A. Wright, et al., Federal
Practice & Procedure § 1498 (3d ed. 2017), because a new defendant typically would
not be aware of the claims, having not been named in the original suit. Rule
15(c)(1)(C) alters this general rule, but it allows the addition of a new party if Fed. R.
Civ. P. 15(c)(1)(B) is satisfied and if the party to be added “(i) received such notice of
the action [within the time allotted for service of the original complaint] that it would
not be prejudiced in defending on the merits; and (ii) knew or should have known that
the action would have been brought against it, but for a mistake concerning the proper
party’s identity.” Fed. R. Civ. P. 15(c)(1)(C); see also Bayatfshar v. Aeronautical
Radio, Inc., 934 F. Supp. 2d 138, 144 (D.D.C. 2013) (an amendment adding a new party
relates back to the prior complaint “‘when the requisite notice and identity of interests

49

showings’” that Rule 15(c)(1)(C) requires are made (quoting Stoppelman v. Owens, 580
F. Supp. 944, 946 (D.D.C. 1983))).
Thus, “relation back under Rule 15(c)(1)(C) depends on what the party to be
added knew or should have known, not on the amending party’s knowledge or its
timeliness in seeking to amend the pleading.” Krupski, 560 U.S. at 541 (emphasis
added); see also Philogene v. Dist. of Columbia, 864 F. Supp. 2d 127, 133 (D.D.C.
2012) (“This Circuit has explained that the purpose of [Rule 15(c)(1)(C)] is to ‘avoid
the harsh consequences of a mistake that is neither prejudicial nor a surprise to the
misnamed party.’” (quoting Rendall-Speranza v. Nassim, 107 F.3d 913, 918 (D.C. Cir.
1997))); see, e.g., Placide Ayissi-Etoh v. Mae, 49 F. Supp. 3d 9, 13–14 (D.D.C. 2014)
(holding that amendment adding individual capacity claims to employment
discrimination suit did not relate back under Rule 15(c)(1)(C) to original complaint
alleging corporate capacity claims where record “strongly support[ed] an inference that
the individual [d]efendants did not have notice” of potential for individual capacity
claims, such that the amendment “would be highly prejudicial”). Consequently, “[a]
potential defendant who has not been named in a lawsuit by the time the statute of
limitations has run is entitled to repose—unless it is or should be apparent to that
person that he is the beneficiary of a mere slip of the pen, as it were.” RendallSperanza, 107 F.3d at 918.
The Kubickis here have presented no evidence that contradicts Unomedical’s
contention that it was not aware of this litigation until 2014. (See Decl. of Rabi
Gharabit, Ex. D to Unomedical’s Reply, ECF No. 142-5, ¶ 4.) Nor is this a
circumstance where the omission of Unomedical was due to clerical error or confusion

50

about closely-related corporate entities. Cf. Krupski, 560 U.S. at 554–55 (concluding
that the district court erred in denying relation back where the corporate defendant that
plaintiff sought to add under Rule 15(c)(1)(C) was related to named defendant, had
“constructive notice” of the original complaint within the Rule 4(m) period, and should
have known that it would have been named in the original complaint but for plaintiff’s
mistake about which corporate entity was the proper defendant); Miller v. Holzmann,
Civil Action No. 95-1231, 2007 WL 778599, at *2–3 (D.D.C. Mar. 6, 2007) (holding
that an amended complaint adding a new defendant related back to prior complaint
where all defendants were closely-related members of the same corporate family and
represented by the same counsel and the newly-named defendant should have known
that it was the intended defendant all along). Indeed, the Kubickis did not make any
specific product-defect allegations regarding the MMT-396 Infusion Set—the only
portion of the insulin-delivery system to which Unomedical had any connection—until
2014, and Unomedical therefore would have no reason to suspect before that time that it
could be subject to liability for Caroline’s injuries. This lack of notice undoubtedly
forecloses the Kubicki’s reliance on the relation back doctrine to render timely their tort
claims against Unomedical. See, e.g., Meijer, Inc., 533 F.3d at 866.
C.

Plaintiffs’ Infusion Set Claims Against Medtronic Relate Back
To Their Preexisting MMT-522 Pump Claims Against That
Defendant, And Thus Are Deemed Timely

As a party to the original action, Medtronic stands in markedly different shoes
than Unomedical does, as far as the Kubicki’s infusion set claims are concerned. As
explained above, Federal Rule of Civil Procedure 15(c)(1)(B) specifically contemplates
the circumstances under which an amendment to a pleading “relates back to the date of
the original pleading” for the purpose of the statute of limitations, and unlike the
51

infusion set claims against Unomedical (which had nothing to relate back to because
Unomedical was not named in the original complaint), the relation-back question with
respect to the MMT-396 Infusion Set claims that Plaintiffs have belatedly brought
against Medtronic is whether these claims “arose out of the conduct, transaction, or
occurrence” laid out in Plaintiffs’ initial pleading, Fed. R. Civ. P. 15(c)(1)(B), such that
Medtronic had “been put on notice regarding the claim . . . raised by the amended
pleading[,]” 6A Charles A. Wright, et al., Federal Practice & Procedure § 1497 (3d ed.
2017).
Not surprisingly, Medtronic says ‘no’: it argues that the initial complaint
provided no notice of the potential infusion set claims, and that “[t]he addition of an
entirely new device as a potential cause of Ms. Kubicki’s injuries is a ‘substantial’
alteration to this case and provides Plaintiffs with an entirely new legal theory for why
Ms. Kubicki was injured.” (Medtronic’s Mem. at 62.) Elsewhere in its brief, however,
Medtronic acknowledges that “the MMT-522-Pump and MMT-396 Infusion Set worked
together to deliver insulin[,]” such that one component of the system would be useless
for insulin-delivery without the other. (Id. at 61.) In addition, Medtronic does not
dispute the fact that both medical devices are sold under Medtronic’s name, and are
components of the same system that Medtronic markets for use to deliver insulin to
consumers. (See Product Photos, Ex. 61 to Pls.’ Opp’n, ECF 138-63, at 2; Infusion Set
User Guide, Ex F. to Decl. of Michael Wallace, ECF No. 133-4, at 12 (“The Quick-set
is indicated for the subcutaneous infusion of medicine, including insulin, from a
Paradigm infusion pump and reservoir.”); Pump User Guide, Ex. 24 to Pl.’s Opp’n, ECF

52

No. 138-26, at 4 (instructing user to “insert the infusion set into your body as described
in the next section.”).)
Thus, Medtronic’s insistence that it had no notice of any potential claims arising
from the design or operation of Caroline’s infusion set is unpersuasive. The initial
complaint clearly alleges that Caroline was injured when she received an overdose of
insulin as a result of being connected to the MMT-522 Pump. (See Compl. ¶¶ 14 (“A
number of technical problems have been reported with the use of insulin pumps
including, but not limited to, the pumps’ delivery of too much insulin resulting in
hypoglycemia.”); 16 (“On or about September 9, 2007, Caroline Kubicki. . . was found
to be unresponsive and unarousable by her roommate as a result of her malfunctioning
MiniMed Insulin Pump.”); 72 (“If Caroline had known the true facts concerning the
risks of the use of the MiniMed Insulin Pump, in particular, the risk of significant
hypoglycemic event with anoxic brain injury, she would not have used the product.”).)
Consequently, Medtronic knew from the outset that the company was facing timely
allegations of product-related deficiencies that had allegedly caused a serious injury,
and the subsequent addition of even more specific allegations regarding another
component of the insulin-delivery device in question—the MMT-396 Infusion Set—
does not give rise to “an entirely new legal theory[,]” as Medtronic argues.
(Medtronic’s Mem. at 62.) Instead, it is reasonably clear that Plaintiffs’ amendment
merely refines the theory of liability that Plaintiffs had already pled in their timely
complaint. See Hicks, 283 F.3d at 388 (concluding that, where an amended complaint
“amplif[ies] the facts already alleged,” the amended complaint relates back to the initial
complaint); Jones v. Ottenberg’s Bakers, Inc., No. 13-814, 2013 WL 6119322, *3

53

(D.D.C. Nov. 21, 2013) (holding that an amended complaint relates back to the original
complaint if the “amended complaint is logically related to, and seeks recovery for, the
same acts alleged in the initial complaint”).
In short, as explained above, the relation back doctrine deems timely an
otherwise untimely amendment to a complaint when the defendant had adequate notice
of the claims that are subsequently added, and this Court is confident that such is the
case with respect to the Kubicki’s infusion set claims against Medtronic. Given the
allegations of the original complaint and the interrelation between the pump and the
infusion set in delivering insulin to users, Medtronic knew or should have known from
Plaintiffs’ initial allegations that infusion set claims existed and may yet be asserted,
and Medtronic can hardly be heard to complain that it was not sufficiently alerted to a
potential problem with MMT-396 Infusion Set and the p-cap valve in particular, when
these components play a crucial role in ensuring that the pump delivers insulin at the
correct rate and when the Kubickis’ core allegation was over-delivery of insulin to a
pump-user. Therefore, although the claims in Plaintiffs’ complaint concerning the
MMT-396 Infusion Set were not asserted timely in the first instance, this Court
concludes that these otherwise time-barred claims relate back to the timely claims
regarding the MMT-522 Pump that Plaintiffs brought against Medtronic in the initial
complaint, and as a result, these claims against Medtronic are deemed timely for statute
of limitations purposes.
VII.

RULING ON PREEMPTION
The thorniest legal issue that Medtronic raises as grounds for dismissal of the

Kubickis’ claims is preemption—a doctrine that has its roots in the Supremacy Clause

54

of the U.S. Constitution. See Gade v. Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 108
(1992) (“[U]nder the Supremacy Clause, from which our pre-emption doctrine is
derived, any state law, however clearly within a State’s acknowledged power, which
interferes with or is contrary to federal law, must yield.” (internal quotation marks and
citation omitted)). As relevant here, Congress has vested the Food and Drug
Administration (“FDA”) with the authority to regulate medical devices; consequently,
state law legal claims that pertain to such devices implicate questions of both express
preemption and implied preemption. As a general matter, express preemption occurs
when a federal statute explicitly sets forth the particular circumstances in which state
law claims cannot be maintained. See Waterview Mgmt. Co. v. FDIC, 105 F.3d 696,
700 (D.C. Cir. 1997). By contrast, as relevant here, “[i]mplied preemption occurs . . .
where the scheme of federal regulation is sufficiently comprehensive to make
reasonable the inference that Congress left no room for supplementary state
regulation[,]” Armstrong v. Accrediting Council for Continuing Edu. & Training, 168
F.3d 1362, 1369 (D.C. Cir. 1999) (internal quotation marks and citation omitted), which
renders state law claims that seek merely to enforce federal duties effectively barred.
See Buckman, 531 U.S. at 352.
Medtronic argues that Section 360k(a) of the Medical Device Amendments to the
Food, Drug, and Cosmetic Act (“FDCA”) expressly preempts the Kubickis’ MMT-522
Pump claims, and furthermore, that the claims in the Kubickis’ complaint pertaining to
both components of Medtronic’s insulin-deilvery system (the pump and the MMT-396
Infusion Set) are impliedly preempted because the Kubickis are seeking to enforce FDA
regulations rather than attempting to vindicate independent state law duties. (See

55

Medtronic’s Mem. at 44–55.) The Kubickis have myriad responses to Medtronic’s
preemption contentions (see Pls.’ Opp’n at 36–53), including the argument that there is
no express preemption of their MMT-522 Pump claims because the state laws on which
the claims are based track the federal requirements (see id. at 38–40), and the implied
preemption doctrine is inapplicable because the complaint asserts stand-alone state law
claims that do not usurp the FDA’s enforcement authority (see id. at 51–53).
The parties’ arguments are largely based on established law concerning the
express and implied preemption of state law claims involving medical devices—law
that is “charitably speaking, utterly conflicted[,]” In re Medtronic, Inc. Sprint Fidelis
Leads Prod. Liab. Litig., 592 F. Supp. 2d 1147, 1150 (D. Minn. 2009)—and as
explained below, the parties’ various contentions yield mixed results. In sum, this
Court concludes that all of the claims pertaining to the MMT-522 Pump are expressly
preempted, with the exception of one narrow aspect of the claim alleging a pumprelated manufacturing defect, and that none of the claims pertaining to the MMT-396
Infusion Set are impliedly preempted, except for one claim that pertains to Medtronic’s
allegedly tortious failure to report adverse events to the FDA. What remains, then, is a
single manufacturing defect claim concerning the MMT-522 Pump, as well as almost all
of the claims against Medtronic that pertain to the MMT-396 Infusion Set; these will be
the claims at issue during the forthcoming period of expert discovery.

56

A.

The Law Pertaining To Classification Of Medical Devices And
The Express And Implied Preemption Of State Law Claims
Under The Medical Device Amendments To The Food, Drug
And Cosmetics Act
1.

The MDA’s Device-Classification Scheme

In 1976, Congress responded to “a bevy of state laws regulating medical devices
largely enacted due to the failure of the Dalkon Shield contraceptive in the 1970s,” id.
at 1150, by enacting the Medical Device Amendment (“MDA”) to the Federal Food,
Drug and Cosmetics Act (“FDCA”), 21 U.S.C. §§ 301–399h. In essence, the MDA
expanded the regulatory scope of the FDCA to include medical devices. See In re
Medtronic, 592 F. Supp. 2d at 1150–51 (citing 21 U.S.C. § 360k). As amended, the
FDCA “classifies medical devices in three categories based on the risk that they pose to
the public[,]” Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 (1996), with Class III being
reserved for those devices that pose the most significant risk of illness or injury to
users. 18 “The [MDA] makes Class III the default category for new (that is, post–1976)
medical devices,” Ivy Sports Med., LLC v. Burwell, 767 F.3d 81, 83 (D.C. Cir. 2014),
and it requires that such devices be subjected to a rigorous and time-consuming
premarket approval (“PMA”) process, during which a manufacturer must prove to the
FDA that the device is both safe and effective, see Lohr, 518 U.S. at 477; see also
Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008) (noting that the PMA process

18

Class I devices “present no unreasonable risk of illness or injury . . . and are subject only to
minimal regulation by ‘general controls.’” Lohr, 518 U.S. at 477 (quoting 21 U.S.C. § 360c(a)(1)(A)).
Class II devices are “potentially more harmful[,]” and are subject to federal performance regulations
known as “‘special controls[,]’” though the FDA need not approve the marketing of Class II devices in
advance. Id. (quoting 21 U.S.C. § 360c(a)(1)(B)). Class III devices are those that either “presen[t] a
potential unreasonable risk of illness or injury,” or are “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[.]” Id. at 477 (quoting 21 U.S.C. § 360c(a)(1)(C)) (quotation marks
omitted).

57

typically requires a manufacturer to submit a multi-volume application). When it
analyzes the device-related application that manufacturers submit, “the FDA must
weigh the ‘probable benefit to health from the use of the device against any probable
risk of injury or illness from such use.’” In re Medtronic, 592 F. Supp. 2d at 1150
(quoting 21 U.S.C. § 360c(a)(2)(C)). And pursuant to this calculus, the FDA “may thus
approve devices that present great risks if they nonetheless offer great benefits in light
of available alternatives.” Riegel, 552 U.S. at 318.
Notably, once the FDA has granted premarket approval to a device, the
manufacturer generally may not make changes to the design, labeling, manufacturing
process, or any other aspect of the device without further FDA approval. See id. at 319;
see also id. at 323 (“[T]he FDA requires a device that has received premarket approval
to be made with almost no deviations from the specifications in its approval application,
for the reason that the FDA has determined that the approved form provides a
reasonable assurance of safety and effectiveness.”). “If the applicant wishes to make
such a change, it must submit, and the FDA must approve, an application for
supplemental premarket approval, to be evaluated under largely the same criteria as an
initial application.” Id. (citing § 360e(d)(6), 21 C.F.R. § 814.39(c)). Furthermore, a
PMA device manufacturer also has certain post-approval reporting duties, including the
obligation to report to the FDA all known incidents in which the device “(1) [m]ay have
caused or contributed to death or serious injury, or (2) [may have] malfunctioned and
. . . would be likely to cause or contribute to death or serious injury, if the malfunction
were to recur[.]” 21 CFR § 803.50(a). Such reporting must take place within 30 days of

58

when the manufacturer “receive[s] or otherwise become[s] aware of [the] information.”
Id.
In recognition of the fact that the lengthy PMA process can substantially delay
the introduction of improvements to existing medical devices, “the [MDA] . . . permits
devices that are ‘substantially equivalent’ to pre-existing devices to avoid the PMA
process.” Lohr, 518 U.S. at 478 (quoting 21 U.S.C. § 360e(b)(1)(B)). To be
substantially equivalent to a pre-existing Class I, II, or III medical device, “the new
device must have the same intended use as the predicate device, and either (i) have the
same technological characteristics as the predicate device or (ii) be shown to be as safe
and effective as the predicate devices.” Ivy Sports, 767 F.3d at 83 (quoting 21 U.S.C.
§ 360c(i)(1)(A) (internal quotation marks omitted). The FDA has a process for
conducting a substantial equivalence review—known as the “§ 510(k) process”—which
is triggered when a manufacturer who intends to introduce a new medical device into
the market submits to the FDA a “premarket notification” that “states the new device’s
intended use, identifies the predicate devices to which the new device is substantially
equivalent, and offers a proposed classification.” Id. at 83 (citing 21 C.F.R. § 807.87).
It is important to recognize that “[t]he § 510(k) notification process is by no
means comparable to the PMA process; in contrast to the 1,200 hours necessary to
complete a PMA review, the § 510(k) review is completed in an average of only 20
hours.” Lohr, 518 U.S. at 478–79 (citation omitted). This is in large part because,
while the PMA process focuses on the safety and efficacy of a device, the § 510(k)
process focuses only on whether the new device is equivalent to an existing device. Id.
at 493. Thus, “‘[t]he attraction of substantial equivalence to manufacturers is clear.

59

[Section] 510(k) notification requires little information, rarely elicits a negative
response from the FDA, and gets processed very quickly.’” Id. at 479 (quoting Robert
Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs
Another Step in the Right Direction, 43 Food Drug Cosm. L.J. 511, 516 (1988)) (second
alteration in original). Consequently, the abbreviated § 510(k) process has become the
route by which the vast majority of new medical devices—including Class III devices,
which by definition pose the highest level of risk to the patient—enter the marketplace.
See id.; see also Riegel, 552 U.S. at 1004 (“In 2005, for example, the FDA authorized
the marketing of 3,148 devices under § 510(k) and granted premarket approval to just
32 devices.”).
2.

Express Preemption Of State Law Claims Under the MDA

Manufacturers who opt to engage in the expensive and time-consuming PMA
process with respect to new medical devices get the benefit of express statutory
protection from certain state law claims relating to the device. See 21 U.S.C. § 360k(a);
Lohr, 518 U.S. at 492–94. In this regard, section 360k(a) of Title 21 of the U.S. Code
states (in relevant part) that
[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). The reach of this express exemption clause has been extensively
litigated over the past three decades, and as a result, the Supreme Court has established

60

a two-part test that courts must use when evaluating whether state law claims fall within
the scope of 21 U.S.C. § 360k(a). See Riegel, 552 U.S. at 321–22. Pursuant to the
prescribed analysis, courts must consider, first, “whether the Federal Government has
established requirements applicable to” the device, and second, “whether the
[plaintiff’s] common-law claims are based upon [state] requirements with respect to the
device that are ‘different from, or in addition to,’ the federal ones, and that relate to
safety and effectiveness.” Id. (quoting 21 U.S.C. § 360k(a)).
It is by now well established that the FDA’s affirmative grant of premarket
approval to a medical device through the PMA review process satisfies the first prong
of this two-part inquiry. Id. at 322–23 (noting that premarket approval “imposes
requirements under the MDA” because “the FDA requires a device that has received
premarket approval to be made with almost no deviations from the specifications in its
approval application” (internal quotation marks omitted)). By contrast, if a device has
been approved through the less-arduous Section 510(k) substantial equivalence process,
the first part of the Supreme Court’s express preemption test does not apply. See Lohr,
518 U.S. at 493–94; see also Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466, 469 (D.
Mass. 2012) (explaining that “medical devices entering the market pursuant to the
§ 510(k) process are not subject to specific federal requirements under the MDA,
because those devices receive less scrutiny from the FDA”). 19

19

Per the Supreme Court’s reasoning, the FDA’s Section 510(k) substantial equivalence process “is
focused on equivalence, not safety[,]”Lohr, 518 U.S. at 493 (emphasis in original; internal quotation
marks and citation omitted); therefore, when the FDA grants marketing approval through the substantial
equivalence review process, it does not actually “require” that the device at issue “take any particular
form for any particular reason” as is necessary to trigger express preemption, id. at 493 (internal
quotation marks omitted). The Lohr Court further concluded that permitting state law claims to
proceed with respect to devices that have only undergone substantial equivalence review as opposed to
PMA review is consistent with congressional intent. See id. at 494 (explaining that “[t]here is no

61

With respect to the second prong of the express preemption inquiry, the Supreme
Court has held that state common law claims for negligence, strict liability, and breach
of warranty, among other things, qualify as “requirements. . . with respect to devices”
for the purpose of the MDA’s express preemption clause. Riegel, 552 U.S. at 324, 327.
Thus, current express preemption disputes in the medical-device context often involve
the issue of whether the asserted state common law claims effectively impose
obligations on manufacturers that are “different from, or in addition to” the federal
requirements. Id. at 321 (quoting § 360k(a)(1)); see, e.g., Cupek v. Medtronic, Inc., 405
F.3d 421, 424–25 (6th Cir. 2005); In re Medtronic, Inc., 592 F. Supp. 2d at 1156–65;
see also Duggan, 840 F. Supp. 2d at 469 (commenting that “[m]any state common law
claims impose duties with respect to devices that are “different from, or in addition to”
federal requirements, satisfying the preemption test’s second prong” (citations
omitted)).
It is important to underscore the fact that, as the MDA has been interpreted, the
express preemption clause does not afford the manufacturer of a PMA-approved
medical device absolute immunity from all device-related lawsuits arising under state
law, but only those that are based on requirements that differ from, or augment, the
federal requirements. See Hughes v. Boston Sci. Corp., 631 F.3d 762, 767 (5th Cir.
2011) (“[A] manufacturer is not protected from state tort liability when the claim is
based on the manufacturer’s violation of applicable federal requirements.”). This

suggestion in either the statutory scheme or the legislative history that the § 510(k) exemption process
was intended to do anything other than maintain the status quo with respect to the marketing of existing
medical devices and their substantial equivalents[,]” and “[t]hat status quo included the possibility that
the manufacturer of the device would have to defend itself against state-law claims of negligent
design”).

62

means 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.” Riegel, 552 U.S. at 330 (citations
omitted). However, “[p]laintiffs cannot simply incant the magic words ‘[the
manufacturer] violated FDA regulations’ in order to avoid preemption.” In re
Medtronic, 592 F. Supp. 2d at 1158. Rather, for such a “parallel” claim to survive, a
plaintiff must (1) point to specific federal requirements that the manufacturer violated;
(2) specifically identify a state law claim that is parallel to the federal requirements, and
(3) causally connect the simultaneous violations of federal and state law and to the
alleged injury. See Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1214 (W.D.
Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015).
Thus, while it is the device manufacturer’s burden to invoke the MDA’s express
preemption clause based on the FDA’s premarket approval of the device at issue, see
Bruesewitz v. Wyeth LLC, 562 U.S. 223, 251 n.2 (2011) (noting that federal preemption
is an affirmative defense which a defendant must invoke and establish in the first
instance), once the defendant does so, the burden shifts to the plaintiff to establish that
the state law claims it seeks to maintain are truly parallel to the federal requirements at
issue, and that the alleged breach of these parallel duties caused the plaintiff’s injury,
cf. Carter v. Novartis Consumer Health, Inc., 582 F. Supp. 2d 1271, 1287–88 (C.D. Cal.
2008) (applying burden shifting framework to an FDCA express preemption clause
relating to prescription drugs). And it is in the context of demonstrating that the state
law claims are not expressly preempted because the state law duty is “genuinely
equivalent” to the applicable federal law requirements for a device, Wolicki–Gables v.

63

Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (internal quotation marks and
citation omitted), that the plaintiff must specify the particular federal requirement at
issue, identify the truly parallel state law claim, and establish the requisite causation.
See McAfee v. Medtronic, Inc., No. 12-cv-417, 2016 WL 2588807, at *1 (N.D. Ind. May
5, 2016); see also Wolicki–Gables, 634 F.3d at 1300 (explaining that “[s]tate and
federal requirements are not genuinely equivalent if a manufacturer could be held liable
under the state law without having violated the federal law” (quoting McMullen v.
Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)).
3.

Implied Preemption Of State Law Claims Under the MDA

Unlike express preemption, the doctrine of implied preemption does not rest on
the provisions of a statute; instead, it necessarily follows from the legislature’s intent to
confer all regulatory authority to a federal body. For example, the FDCA vests the
FDA with exclusive authority to investigate potential violations of medical device
requirements, regardless of whether the FDA has approved the device through the
rigorous PMA process or the less onerous § 510(k) substantial equivalence process.
See, e.g., Martin v. Medtronic, Inc., No. 15-cv-0994, 2017 WL 825410, at *9 (E.D. Ca.
Feb. 24, 2017) (finding that doctrine of implied preemption barred warranty claim
relating to PMA-approved device); Jones v. Medtronic, Inc., 89 F. Supp. 3d 1035, 1046
(D. Ariz. 2015) (noting that implied preemption is available where device is approved
through the 510(k) process)). Thus, a plaintiff’s attempt to enforce federal requirements
in the context of private litigation (even a suit that ostensibly involves only state law
claims) may run afoul of this delegation.
In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the
Supreme Court held that if establishing the defendant’s liability for the plaintiff’s state
64

law claim requires demonstrating that the FDCA has been violated, then prosecution of
the state law action intrudes upon the FDA’s exclusive province to enforce the FDCA,
rendering the suit impliedly preempted. Id. at 349–53. The Supreme Court was also
clear in Buckman that implied preemption is by no means absolute; that is, a plaintiff
may rely on a violation of an FDCA requirement as a predicate for a state tort claim
where the plaintiff brings a claim for a “traditional state tort law which [] predated the
federal enactments in question[.]” Id. at 353. By contrast, if the state law claim would
not exist in the absence of the FDCA, “then the plaintiff is effectively suing for a
violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiff’s
claim is thus impliedly preempted under Buckman.” Riley v. Cordis Corp., 625 F.
Supp. 2d 769, 777 (D. Minn. 2009) (citation omitted).
All this means that the doctrines of express and implied preemption, though
related, are analytically distinct. The MDA’s express preemption provision prohibits a
plaintiff from imposing additional requirements on a PMA-approved device, but allows
enforcement of genuinely parallel state law requirements with respect to that device.
Implied preemption in the medical-device context prohibits a plaintiff from enforcing
FDCA requirements in the absence of a preexisting state law claim that addresses those
same duties, irrespective of whether the device was approved through the PMA process
(as was the case with Medtronic’s MMT-522 Pump) or the § 510(k) substantial
equivalence process (as was the case with the MMT-396 Infusion Set). With respect to
PMA-approved medical devices, then, the interrelation between express preemption and
implied preemption produces a “narrow gap” in which plaintiffs can proceed to
vindicate established state law duties that exist entirely independent of federal law, but

65

only to the extent that such common law tort claims are truly parallel to the
requirements of federal law. See Cupek, 405 F.3d at 423. But where applicable, either
doctrine suffices to prevent a plaintiff from advancing state common law claims
regarding alleged injuries from the use of FDA-approved medical devices.
B.

With One Exception, The MDA Expressly Preempts All Of The
Kubickis’ MMT-522 Pump Claims

As a threshold matter, the instant parties dispute whether the insulin pump that
was prescribed to Caroline Kubicki at the time of her injury—Medtronic’s MMT-522
Pump—is a PMA-approved medical device such that express preemption applies at all.
(See Medtronic’s Mem. at 15–16; Pls.’ Opp’n at 40–42.) They also disagree regarding
(a) whether Plaintiffs have identified specific federal requirements that can form the
basis for a parallel state claim under Riegel (see Medtronic’s Mem. at 47–52; Pls.’
Opp’n at 44–51); (b) whether Plaintiffs have, in fact, asserted state law claims that are
genuinely parallel to any such federal requirement (see Pls.’ Opp’n at 50–51;
Medtronic’s Reply at 19); and (c) whether the alleged violation of state and federal law
caused Caroline’s injury (see Medtronic’s Mem. at 49–52, 52 n.12; Pls.’ Opp’n at 53–
55; Medtronic’s Reply at 19–20). For the reasons explained below, this Court
concludes that Medtronic is entitled to summary judgment based on express preemption
for all of the tort claims that pertain to the MMT-522 Pump, with the exception of
Plaintiffs’ pump-related manufacturing defect claim, which cannot be adequately
assessed prior to expert discovery. 20 The Court’s conclusions regarding express

20

With respect to this carve-out, the Court rejects Medtronic’s argument that it is entitled to summary
judgment “because there is absolutely no evidence of any manufacturing defect with the MMT-522
Pump . . . Caroline was allegedly using at the time of the incident.” (Medtronic’s Mem. at 33; see also
id. at 33–34 (arguing that manufacturing records show that Caroline’s pump using at the time

66

preemption are based on its finding that (1) the FDA approved the MMT-522 Pump
through the PMA process, and thus the MDA’s express preemption provision is
applicable to that device, and (2) with respect to the non-manufacturing pump-related
claims, Plaintiffs have either failed to identify a specific FDA requirement upon which
their allegedly parallel state law claims can be based, or failed to establish that any
genuinely equivalent parallel state law claim exists.
1.

State Law Claims Pertaining To The MMT-522 Pump Are
Subject To The MDA’s Express Preemption Provision
Because That Device Was Approved Pursuant To The FDA’s
Premarket Approval Process

In support of its argument that the Kubickis’ pump-related claims are expressly
preempted under the MDA, Medtronic points to evidence that it says “conclusively
demonstrates [that] the MMT-522 Pump has Premarket Approval.” (Medtronic’s Mem.
at 44 (citing a declaration that it says establishes that “the FDA approved the MMT-522
Pump as a PMA supplement—PMA No. P980022/S013”).) Plaintiffs appear to accept
the representation that the insulin-delivery system of which the MMT-522 Pump is a
part received the FDA’s stamp of premarket approval, but they argue that the FDA’s
approval was not all-encompassing for the purpose of the MDA’s express preemption
clause, because “the FDA did not approve the use of the MMT-522 Insulin Pump in
isolation, but instead approved the Real Time System [consisting of the pump and a

conformed with all applicable specifications and were free from manufacturing defects).) While
Plaintiffs concede that they “do not have evidence at this point that there were any deviations from any
. . . manufacturing specifications that the FDA approved[,]” (Mot. Hr’g Tr. at 28:21–24), their experts
have yet to conduct any destructive testing of the pump, (see id. at 29:2–30:6). Thus, this Court finds
that it would be premature to dismiss the claims that are based on the assertion that Medtronic deviated
from the manufacturing specifications for the MMT-522 pump, and that such a deviation caused
Caroline’s injury, prior to expert discovery. (See id. at 28:11–30:6.) See also Riegel, 552 U.S. at 321–
22. If the proposed destructive testing of the pump is conducted during the expert discovery process,
and if it does not reveal any evidence of a manufacturing defect, Medtronic may renew its preemption
contention with respect to the manufacturing defect claim.

67

blood glucose sensor] ‘as a whole’ and on the basis that it would purportedly be
marketed, sold, and ultimately used as a system[.]” (Pls.’ Opp’n at 41 (emphasis
added).) As a result, Plaintiffs say, Medtronic cannot rely on the express preemption
doctrine with respect to the MMT-522 Pump standing alone.
At least two federal district courts have rejected this same argument in the
context of litigation pertaining to this same pump model. See Duggan, 840 F. Supp. 2d
at 471-73; Bentzley v. Medtronic, 827 F. Supp. 2d 443, 450–51 (E.D. Pa. 2011). The
plaintiffs in both Duggan and Bentzley argued—as Plaintiffs do here—that although
Medtronic’s Paradigm Real Time System (which consists of both the MMT-522 Pump
and a continuous glucose monitor) was approved through the PMA process, the MMT522 Pump should be considered to be substantially equivalent to Medtronic’s earlier
model MMT-515 pump, which had only “entered the market through the § 510k process
and not the premarket approval process.” Duggan, 840 F. Supp. 2d at 471 (“The
Duggans argue that while certain aspects of the Paradigm Real Time System may have
received premarket approval, the [MMT-522] pump itself did not; instead, they contend,
only the capacity of the pump and the sensor to communicate with each other was
granted premarket approval.”); see Bentzley, 827 F. Supp. 2d at 451 (“Plaintiff attempts
to raise an issue of material fact by arguing that the MMT–522 pump is separate and
apart from the insulin infusion system and did not gain approval through the PMA
process.” (internal quotation marks and citation omitted)). Both courts rejected this
contention, noting that it is well-established that “once premarket approval is granted,
all claims relating to all components of the device are preempted.” Duggan, 840 F.
Supp. 2d at 471 (citations omitted); Bentzley, 827 F. Supp. 2d at 452 (“Plaintiff’s

68

contention that, in considering a preemption issue, the Court must break a medical
device into its component parts, is without legal support. In fact, courts that have dealt
with this issue have done just the opposite.” (citations omitted)); see also, e.g., Aaron.
v. Medtronic, Inc., 209 F. Supp. 3d 994, 1003 (S.D. Ohio 2016) (“Premarket approval
extends to all components of an approved device, even when a physician uses the
components separately.”); Hawkins v. Medtronic, No. 13cv0499, 2014 WL 346622, at
*5 (E.D. Cal. Jan. 30, 2014) (“The requirements set forth in the premarket approval for
the entire device are just as applicable to the components that together form the FDAapproved device as the device itself.”). This Court agrees with the persuasive views
expressed in these prior cases for several reasons.
To begin with, it is clear that breaking down a PMA-approved medical device
into its components for the purpose of evaluating the reach of the MDA’s express
preemption clause, as Plaintiffs suggest, runs afoul of the statutory definition of
“device” under the MDA. That is, per the statute, a medical “device” includes “any
component, part, or accessory[,]” 21 U.S.C. § 321(h), and in the context of the
Paradigm Infusion System, there is no question that the MMT-522 Pump is precisely
such a component part. Thus, the MMT-522 Pump falls within the scope of the devicerelated PMA approval that Medtronic received.
Nor can this Court accept the Kubickis’ related argument that the FDA has
conceded that only the Paradigm Infusion System as a whole—and not the MMT-522
Pump standing alone—was approved through the PMA process. (See Pls.’ Opp’n at 41
(citing FDA Response to Citizen Petition, Sept. 23, 2011, Ex. C to Decl. of Michael
Brown, ECF No. 133-5, at 56–58)). In this regard, Plaintiffs point to a Citizen Petition

69

that was submitted to the FDA in 2010, requesting that the FDA modify the PMA letter
the agency had issued for the Paradigm Infusion System to include the following
language: “This approval is limited solely to the ability of the pump to accept data
from the sensor and the ability for the sensor to communicate directly to the pump, and
this approval does not extend to the pump itself.” (Id. at 57 (internal quotation marks
omitted).) The FDA rejected this request, stating that it had “approved the PMA
supplement for the Paradigm System, including both the 522 pump and the Guardian RT
sensor, on April 7, 2006[,]” and that the amendment request was being denied
“[b]ecause the approval letter, as issued, applies to the Paradigm System as a whole[.]”
(Id. at 58.) Like the Duggan and Bentzley courts (which considered and rejected the
same Citizen Petition argument Plaintiffs make here, see Duggan, 840 F. Supp. 2d at
472; Bentzley, 827 F. Supp. 2d at 451), this Court sees no ambiguity in the agency’s
statements regarding the scope of the PMA approval: the letter states unequivocally
that “both the 522 pump and the Guardian RT sensor” had received premarket approval.
(FDA Response to Citizen Petition at 58 (emphasis added).) And the fact that the
agency expressly declined to amend its materials to exclude the pump from its PMA
approval further underscores that it was not the agency’s intention for any such
exclusion to be made. See Duggan, 840 F. Supp. 2d at 472 (“To the extent there was
any ambiguity about the scope of the approval letter, this rejection of the Citizen
Petition is the cherry on the icing.”).
In arguing that the MMT-522 Pump was not PMA approved and is therefore
ineligible for express-preemption treatment, the Kubickis actually make no mention of
Duggan or Bentzley (see Pls.’ Opp’n at 40–42), and this Court sees no obvious reason to

70

reach a different conclusion than its sister courts did when those courts carefully
considered whether Medtronic’s MMT-522 Pump should have received premarket
approval for the purpose of the expression-preemption analysis. Therefore, this Court
likewise holds that the FDA granted the MMT-522 pump premarket approval, and that
the first prong of the Riegel test for express preemption (i.e., whether the medical
device at issue is subject to federal requirements) is satisfied. See Duggan, 840 F.
Supp. 2d at 469 (explaining that “[t]he FDA’s premarket approval (‘PMA’) process
imposes federal requirements on a medical device under the MDA”). 21
2.

Plaintiffs Have Not Established That Their Pump-Related
State Law Claims Are Genuinely Equivalent To Specific
Federal Law Requirements

Turning to the next step in the Riegel analysis, as explained above, plaintiffs who
seek to counter a defendant’s authorized invocation of the MDA’s express preemption
provision with respect to a medical device that received premarket approval must
identify specific federal requirements with respect to which genuinely parallel state law
claims exist, and must plausibly allege that the defendants’ violation of state (and
federal) law in the claimed manner caused the plaintiffs’ injury. The Kubickis’ early

21

The recent authority that Plaintiffs have brought to this Court’s attention, see Brackin v. Medtronic,
No. 12-cv-00734-KGB (W.D. Tenn. September 14, 2017), does not alter this Court’s conclusion. (See
Ex. 1 to Pls.’ Notice of Supp. Auth., ECF No. 156-1.) Brackin involved a motion to dismiss, and that
court merely concluded that it could not “conclusively determine whether [the pump at issue has]
received premarket approval” at that early stage of the litigation. Brackin, slip op. at 10; see also id. at
6 (considering the express preemption defense but “emphasiz[ing] that this issue arises at the motion to
dismiss stage”). The Brackin court also noted that the pump at issue therein was the MMT-523 Pump,
and that defendants’ assertion that the MMT-522 Pump was a predecessor to the MMT-523 Pump was
“insufficient to establish that the 523 pump was subject to premarket approval within the meaning of
Riegel.” Brackin, slip. op. at 9. By contrast, this case concerns the MMT-522 Pump, and the record
here contains unrefuted evidence that the MMT-522 Pump received premarket approval as a component
of the Real Time System. (See FDA Response to Citizen’s Petition.) Moreover, Brackin’s reasoning is
not binding on this Court, and to the extent that the Brackin court’s holding could be read to allow a
court to break a PMA-approved system into component parts for purposes of the express preemption
analysis, this Court finds that the decision runs counter to the prevailing weight of authority cited
above and is unpersuasive.

71

attempts to accomplish this difficult task were “admittedly skimpy[,]” Kubicki, 2013
WL 1739580, at *8, but the Court deemed them passable for the purpose of Medtronic’s
motion to dismiss, id. Notably, however, in its opinion regarding the motion to dismiss,
the Court expressly announced its expectation that “as this action proceeds, Plaintiffs
will refine their claims to more specifically articulate the parallel relationship between
the alleged common law duties and the federal requirements.” Id. at *9. And it further
warned that “[s]hould Plaintiffs fail to do so, Defendants may renew their express
preemption objections at a later, appropriate time.” Id.
This means that the express preemption arguments that Medtronic makes in the
instant motion for summary judgment are both anticipated and well-founded. 22 Yet,
Plaintiffs are correct to note that the mere fact that the FDA has granted premarket
approval to a device does not render all state law claims relating to the product
preempted carte blanche. (See Pls.’ Opp’n at 38 (“A PMA-approved medical device
manufacturer ‘is protected by law from civil liability so long as they comply with
federal law[.]’” (quoting Bausch v. Stryker Corp., 630 F.3d 546, 550 (7th Cir. 2010)
(emphasis in original))).) See also Bryant v. Medtronic, Inc., 623 F.3d 1200, 1205 (8th
Cir. 2010) (explaining that a state law claim that “parallel[s]” federal requirements and
is “premised on a violation of FDA regulations” can survive express preemption).

22

Plaintiffs make the odd suggestion that the Court’s ruling on Medtronic’s motion to dismiss disposed
of the preemption question in their favor such that Medtronic cannot raise a preemption argument now.
(See Pls.’ Opp’n at 38–39 (“Medtronic. . . has re-couched its failed motion to dismiss as a motion for
summary judgment, asserting the precise arguments this Court has already rejected.”)). Given the
language of the Court’s ruling on the motion to dismiss, however, any such contention is misguided;
indeed, the Court’s opinion sought to stave off this very argument by expressly stating that the
preemption findings therein “should in no way be viewed as discounting Defendants’ argument that in
order to avoid preemption, a plaintiff must specifically identify a federal requirement applicable to the
device which the defendant allegedly violated and a valid, pre-existing state law duty that is genuinely
parallel to that federal requirement, and [must] also explain how the alleged federal violation caused
the alleged injury.” Kubicki, 2013 WL 1739580, at *8 (emphasis omitted).

72

Therefore, for present purposes, the key question is which violations of state law are the
Kubickis claiming in regard to the MMT-522 Pump in the context of this action, and are
those state law claims truly parallel to identified federal law requirements applicable to
that device?
The Kubickis have brought five categories of state law claims in the instant
action, including negligence, breach of warranty, and failure to warn (see supra Part
III.B), and importantly, they maintain that these state law claims do not impose any
requirements that are “different from, or in addition to” the FDA’s requirements, 21
U.S.C. § 360(k)(a)(1), because these claims are predicated on the MMT-522 Pump
having been “manufactured, designed, and labeled in violation of federal law[.]” (Pls.’
Opp’n at 44(emphasis added).) 23 The federal requirements that Plaintiffs say Medtronic
has violated with respect to the design, manufacturing, and labeling of the MMT-522
Pump are certain of the FDA’s “current good manufacturing practice” (CGMP)
requirements—i.e., the generic FDA regulations that “govern the methods used in, and
the facilities and controls used for, the design, manufacture, packaging, labeling,
storage, installation, and servicing of all finished devices intended for human use[,]” 21
C.F.R. § 820.1(a)(1)—and also the FDA regulations that require medical device
manufacturers to monitor and report adverse events involving their products (see 21
C.F.R. § 803, and to adhere to certain standards with respect to the product’s labeling
and use instructions, see 21 C.F.R. §§ 801.5, 801.15. Furthermore, as proof that the

23

Plaintiffs have forcefully disclaimed any contention that their complaint alleges “that the Insulin
Pump should have been designed, labeled, or manufactured differently from its FDA-approved
standards.” (Pls.’ Opp’n at 44.) See Kubicki, 2013 WL 1739580, at *7 (“Plaintiffs[] expressly and
unambiguously confirm[] that each claim is premised exclusively upon post-approval violations of
federal law—a representation on which this Court today relies, and to which Plaintiff shall, in the
future course of this litigation, be bound.”) This is to be expected, as any such claims would clearly be
preempted. See Riegel, 552 U.S. at 321–22.

73

MMT-522 Pump violates these particular federal standards, Plaintiffs cite the 2013
Warning Letter that memorialized the FDA’s determination that Medtronic’s
manufacture and distribution of the MMT-522 Pump had transgressed certain CGMPs
(see supra Part II.C.3), and they also point to the fact that Medtronic indisputably failed
to report to the FDA certain post-approval adverse incidents regarding the pump. (See
Pls.’s Opp’n at 44–51.)
Plaintiffs are correct that the FDA once determined that Medtronic violated
various CGMPs with respect to its production and marketing of the MMT-522 Pump,
and it is undisputed that Medtronic failed to notify the FDA of certain adverse events
that were allegedly pump-related (including Caroline’s injury) in a timely manner. (See
2013 Warning Letter at 25–26). But for the reasons that follow, this Court finds that
the CGMPs that Plaintiffs cite are generally insufficient to be the basis for an allegedly
parallel state law claim regarding the MMT-522 Pump, and that there is no truly
parallel state common law claim that pertains to the one sufficiently-specific federal
law requirement that Plaintiffs rely upon (the requirement that manufacturers report
adverse incidents).
a.

The CGMPs and general labeling and instruction
regulations that Plaintiffs cite are insufficient to support a
parallel state law claim asserting a design, manufacturing,
or labeling defect, or a breach of warranty

The Kubickis say that their negligent design, manufacturing, labeling, and breach
of warranty common law claims parallel the following CGMPs and other regulations
that pertain to product labeling and use instructions:
•

21 C.F.R. § 820.25 (requiring manufacturers to hire “sufficient”
personnel and ensure that they have the “necessary” education,
training and experience);

74

•

21 CFR § 820.30 (requiring manufacturers, in general, to
establish maintain “procedures to control the design of the
device” in order to ensure that specified design requirements are
met);

•

21 CFR § 820.50 (requiring manufacturers, in general, to
establish procedures to ensure products and services conform to
specified requirements);

•

21 CFR § 820.70 (requiring manufacturers, in general, to
“establish and maintain process control procedures that describe
any process controls necessary to ensure conformance to
specifications”);

•

21 CFR § 820.72 (requiring manufacturers to ensure that all
inspection, measuring, and test equipment is “suitable”);

•

21 CFR § 820.75 (requiring manufacturers to establish,
maintain, and update process parameters and conduct
revalidations when processes or designs change, and to ensure
that “qualified individuals” perform the validated processes);

•

21 CFR § 820.80 (requiring manufacturers, in general, to
“establish and maintain procedures for acceptance activities”);

•

21 C.F.R. § 820.90 (requiring manufacturers, in general, to
“establish and maintain procedures to control product that does
not conform to specified requirements”);

•

21 C.F.R. § 820.100 (requiring manufacturers, in general, to
“establish and maintain procedures for implementing corrective
and preventive action”);

•

21 C.F.R. § 820.198 (requiring manufacturers to “establish and
maintain procedures for receiving, reviewing, and evaluating
complaints by a formally designated unit[,]” including ensuring
“timely” and “uniform” review of complaints);

•

21 CFR § 820.250 (requiring manufacturers, “[w]here
appropriate,” to “establish and maintain procedures for
identifying valid statistical techniques required for establishing,
controlling, and verifying the acceptability of process capability
and product characteristics”);

•

21 C.F.R. § 801.5 (requiring device manufacturers to provide
“adequate directions for use”); and

75

•

21 C.F.R. § 801.15 (requiring medical device labeling to be
“prominen[t] and “conspicuous[]”).

(See 2d Am. Compl. ¶¶ 43–53.)
Medtronic insists that because these CGMPs and regulations pertaining to
product labels and use instructions “are not device-specific regulations[,]” they cannot
qualify as “device specific federal requirements” that can be the basis for any
purportedly parallel state law claim “within the meaning of [the MDA’s express
preemption clause].” (Medtronic’s Mem. at 48; see also id. at 49.) Thus, Medtronic
appears to have invoked one side of an existing circuit split over whether the CGMPs
“can[] support any viable parallel claim surviving express preemption[.]” (Id. at 48.)
The Eighth and Eleventh Circuits have held that a plaintiff cannot rely on the CGMPs to
escape the MDA’s express preemption mandate, because the CGMPs are too general to
create specific federal requirements that can be enforced under state law. See WolickiGables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301-02 (11th Cir. 2011); In re Medtronic,
Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1206–07 (8th Cir. 2010).
By contrast, the Fifth, Sixth, and Seventh Circuits have found that certain CGMPs are
sufficiently specific to create federal requirements that a plaintiff can enforce through a
parallel state law tort action. See, e.g., Bass v. Stryker Corp., 669 F.3d 501, 511–13
(5th Cir. 2012); Howard v. Sulzer Orthopedics, Inc., 382 F. App’x 436, 440 (6th Cir.
2010); Bausch v. Stryker Corp., 630 F.3d 546, 554–56 & 554 n.1 (7th Cir. 2010).
Notably, the courts that refuse to find that the FDA’s CGMPs can give rise to
parallel state law claims for express preemption purposes note that the CGMPs are
general prescriptions that “govern ‘the methods used in, and the facilities and controls
used for, the design, manufacture, packaging, labeling, storage installation and

76

servicing of all finished devices intended for human use.’” In re Medtronic, 592 F.
Supp. 2d at 1157 (emphasis added) (quoting 21 C.F. R. § 820.1(a)(1)). Accordingly,
these courts reason, the CGMPs “are simply too generic, standing alone, to serve as the
basis for [a] manufacturing-defect claim[]” because “the CGMPs[] provide specific
methods to be used for only a small number of medical devices” and “[i]n most cases, it
is left to the manufacturer to determine the best methods to obtain quality objectives.”
Id. (emphasis, internal quotation marks, and citation omitted); see also id. at 1162
(finding that design-defect claims which are derivative of a CGMP-based manufacturing
claim are preempted); Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, 588 (E.D.N.Y.
2009) (holding that claims based on an alleged violation of the CGMPs are preempted
because the CGMPs are “intentionally vague and open-ended”); cf. Horn v. Boston Sci.
Neuromodulation Corp., No. CV409-074, 2011 WL 3893812, at *9 (S.D. Ga. Aug. 26,
2011) (concluding that a claim based on the alleged breach of FDA regulations was
preempted where the regulations at issue “fail to provide any tangible or concrete
standard” because “to allow a violation of such a flexible standard to result in liability
would, in itself, be imposing a standard ‘different from, or in addition to’ those imposed
by the MDA” (quoting 21 U.S.C. § 360k(a)(1))). In the absence of any guidance from
the D.C. Circuit on this issue, this Court finds such reasoning compelling, and thus it,
too, concludes that the CGMPs that Plaintiffs have cited are insufficient to qualify as a
federal requirement upon which the Kubickis’ purportedly parallel state law claims can
be based.
As previously explained, in order to have a viable—i.e., not expressly
preempted—state law claim for an injury allegedly caused by a medical device that

77

received premarket approval, the plaintiff must identify specific, concrete federal
requirements that are applicable to the device in question and that the manufacturer has
allegedly violated in a manner that also gives rise to liability under state law. See
Caplinger, 921 F. Supp. 2d at 1214. There is no question that if a state law claim is to
be identified as truly “parallel” (i.e., not demanding anything more of the manufacturer
than the federal law requires), the federal-requirement baseline must be specifically
established; yet, by their nature, the CGMPs merely prescribe overarching guidelines
for manufacturers to follow when developing their own procedures, rather than
specifically enforceable duties. Indeed, the FDA itself has noted the flexibility that the
CGMPs afford to manufacturers:
Because this regulation must apply to so many different types
of devices, the regulation does not prescribe in detail how a
manufacturer must produce a specific device. Rather, the
regulation provides the framework that all manufacturers must
follow by requiring that manufacturers develop and follow
procedures and fill in the details that are appropriate to a
given device according to the current state-of-the-art
manufacturing for that specific device.
Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality
System Regulation, 61 Fed. Reg. 52,602, 52,603 (Oct. 7, 1996) (emphasis added). This
Court is persuaded that federal regulations that admittedly “do[] not prescribe in detail
how a manufacturer must produce a specific device[,]” id., are incapable of serving as
the benchmark for a reasoned determination of whether state law claims that impose
liability for a manufacturer’s failure to produce the device in a certain way establish
duties that are truly parallel to the federal law.
The Sixth Circuit’s decision in Howard v. Sulzer Orthopedics, Inc., 382 F. App’x
436, 440 (6th Cir. 2010), which Plaintiffs cite (see Pls.’ Opp’n at 45), is not to the

78

contrary. The plaintiff in Howard brought a claim for negligence per se, seeking relief
for injuries that he suffered when his implanted artificial knee failed due to oily residue
left behind on the implant as the result of the manufacturing processes. The Howard
court concluded that these claims were not expressly preempted because the plaintiff
had “identif[ied] a specific GMP that he thought had been violated” and “the particular
GMP that he cites is not so vague as to be incapable of enforcement.” 382 F. App’x at
440 (emphasis added). The court in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.
2010), another case on which Plaintiffs rely (see Pls.’ Opp’n at 44), likewise recognized
that the court must evaluate whether particular CGMPs prescribe duties specifically
enough to permit evaluation of the parallel character of a state law claim. Cf. Bausch,
630 F.3d at 556 (“First, the meaning of the FDA’s requirements will present questions
of law for the court to decide, not questions of fact for a jury to decide. Second, those
questions of law will be questions of federal law, subject to the usual processes for
reconciling conflicting views.”).
Here, this Court finds that, for the most part, the CGMPs that Plaintiffs cite are
simply too vague and generic to form the foundation for a reasoned assessment of a
parallel state claim for a design, manufacturing, or labeling defect, or for breach of
warranty. In their amended complaint, for example, Plaintiffs cite to 21 C.F.R.
§ 820.25(a), which requires every manufacturer to “have sufficient personnel with the
necessary education, background, training, and experience to assure that all activities
required by this part are correctly performed.” 21 C.F.R. § 820.25(a). (See also 2d
Am. Compl. ¶ 48.) The federal regulations do not specify any ratio of employees to
products, nor does it say whether “necessary education” means a GED, high school

79

diploma, bachelor’s degree, or otherwise. How, then, can a court reasonably determine
that common law negligence liability based on an allegedly insufficient number of
qualified employees extends no farther than the federal regulation that it purportedly
parallels? Similarly, elsewhere in their amended complaint, Plaintiffs cite to the CGMP
regulation that requires manufacturers to “establish and maintain procedures to ensure
that the design requirements relating to a device are appropriate and address the
intended use of the device, including the needs of the user and patient.” 21 C.F.R.
§ 820.30(c). (See also 2d Am. Compl. ¶ 62.) Here, again, this regulation provides no
guidance on what is specifically required to achieve compliance, and thus cannot serve
as a genuine comparator for any considered evaluation of the scope of similar state law
duties.
With respect to product labeling and use instructions, the non-CGMP regulations
that Plaintiffs cite similarly only require that information on a label be “conspicuous[]”
and “prominen[t],” see 21 C.F. R. § 801.15, and that the manufacturer provide
“adequate directions . . . under which the layman can use a device safely and for the
purposes for which it is intended[,]” 21 C.F.R. § 801.5. Again, the lack of specificity
with respect to the demands of federal law means that there is no meaningful baseline
against which to compare the requirements of the state common law, and thus no
reasonable way to determine whether Plaintiffs’ state common law claims are truly
parallel. And none of the other CGMPs and regulations that Plaintiffs reference—save
the adverse event reporting requirements, discussed below—are any more specific. 24

24

See, e.g., 21 C.F.R. § 820.30(c) (“Each manufacturer shall establish and maintain procedures to
ensure that the design requirements relating to a device are appropriate and address the intended use of
the device, including the needs of the user and patient.”); id § 820.30(e) (“Each manufacturer shall

80

Consequently, the FDA’s 2013 Warning Letter that put Medtronic on notice of
its violation of certain generalized CGMP provisions is really of no moment,. To be
sure, the FDA did find that Medtronic had violated certain CGMPs in the exercise of its
expertise and discretion, but none of the delineated violations specifically pertained to
the blocking of the vents on the p-cap (see infra Part III.C.3; 2013 Warning Letter at 2–
25), and the FDA did not flesh out any of the general CGMPs in a manner that is
sufficient to establish that the exact requirements of federal law such that Plaintiffs can
credibly claim that truly parallel state law requirements exist. The 2013 Warning Letter
also says nothing about the non-CGMP labeling and use instruction regulations on
which Plaintiffs rely, and to this Court’s knowledge, the FDA has no otherwise
illuminated the specific contours of those general federal standards.

establish and maintain procedures to ensure that formal documented reviews of the design results are
planned and conducted at appropriate stages of the device’s design development. The procedures shall
ensure that participants at each design review include representatives of all functions concerned with
the design stage being reviewed and an individual(s) who does not have direct responsibility for the
design stage being reviewed, as well as any specialists needed.”); id. § 820.30(f) (“Each manufacturer
shall establish and maintain procedures for verifying the device design. Design verification shall
confirm that the design output meets the design input requirements. The results of the design
verification, including identification of the design, method(s), the date, and the individual(s)
performing the verification, shall be documented in the DHF.”); id. § 820.70(g) (“Each manufacturer
shall ensure that all equipment used in the manufacturing process meets specified requirements and is
appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment,
cleaning, and use.”); id. § 820.72(a) (“Each manufacturer shall ensure that all inspection, measuring,
and test equipment . . . is suitable for its intended purposes and is capable of producing valid results.
Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely
calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling,
preservation, and storage of equipment, so that its accuracy and fitness for use are maintained.”); id.
§ 820.90(a) (“Each manufacturer shall establish and maintain procedures to control product that does
not conform to specified requirements. The procedures shall address the identification, documentation,
evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance
shall include a determination of the need for an investigation and notification of the persons or
organizations responsible for the nonconformance. The evaluation and any investigation shall be
documented.”); id. § 820.100(a) (“Each manufacturer shall establish and maintain procedures for
implementing corrective and preventive action.”); id. § 820.198(a) (“Each manufacturer shall maintain
complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing,
and evaluating complaints by a formally designated unit.”); id. § 820.198(b) (“Each manufacturer shall
review and evaluate all complaints to determine whether an investigation is necessary. When no
investigation is made, the manufacturer shall maintain a record that includes the reason no investigation
was made and the name of the individual responsible for the decision not to investigate.”).

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b.

Plaintiffs have not identified a genuinely equivalent parallel
state law claim pertaining to Medtronic’s failure to report
events to the FDA

With respect to Plaintiffs’ reliance on 21 C.F.R. § 803 to support the state
common law claims that arise from Medtronic’s alleged failure to track incidents and
make required reports to the FDA (see, e.g., 2d Am. Compl. ¶ 49), a slightly different
preemption analysis is required. This particular regulation stands in stark contrast to
the general CGMPs and the product labeling and use instruction regulations described
above, because the reporting mandates laid out in this regulation are fairly specific
about what types of events must be reported to the agency and when. For example,
section 803.50(a) requires device manufacturers to make certain reports within 30 days
of the manufacturer’s receipt of certain information, as follows:
(a) If you are a manufacturer, you must report to us the
information required by § 803.52 in accordance with the
requirements of § 803.12(a), no later than 30 calendar days
after the day that you receive or otherwise become aware of
information, from any source, that reasonably suggests that a
device that you market:
(1) May have caused or contributed to a death or
serious injury or
(2) Has malfunctioned and this device or a similar
device that you market would be likely to cause or
contribute to a death or serious injury, if the
malfunction were to recur.
Id. Another provision of this federal regulation requires Medtronic to report certain
information within five days of becoming aware of an “event [that] necessitates
remedial action to prevent an unreasonable risk of substantial harm to the public
health[,]” id. § 803.53(a), and the precise information that such reports must contain is
also specified in the regulation, see id. § 803.52(a)–(c) (requiring the reporting of

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“[p]atient information[,]” including name, age, gender, and weight; the “[a]dverse event
or product problem[,]” including the nature of the event, the date of the event, the date
of the report, and any test results; and “[d]evice information[,]” including brand,
manufacture location, model number, and date the device was implanted). Thus, unlike
the general, flexible guidelines that the various CGMPs to which Plaintiffs point
establish, see supra Part VII.B.2, these particular reporting requirements are plainly
“not so vague as to be incapable of enforcement.” Howard, 382 F. App’x at 440.
Where Plaintiffs’ preemption arguments fall short is with respect to Plaintiffs’
obligation to assert state common law claims that are “genuinely equivalent” to these
FDA regulations, Wolicki–Gables, 634 F.3d at 1300, such that the lawsuit does not
impose any requirements that are “different from, or in addition to, the federal ones,”
Riegel, 552 U.S. at 321–22 (internal quotation marks and citation omitted). The
Kubickis’ counsel all but admitted during this Court’s motions hearing that no
equivalent adverse event reporting claims exist under state law. (See Mot. Hr’g Tr. at
17:9–14 (“So if you’re asking whether or not the District of Columbia has an identical
requirement, either codified in a state statute or that exists in common law, regarding
the tracking of complaints to take an example, the answer is no.”).) And that admission
is, in effect, a concession that the Kubickis’ state law failure to warn claims that are
based on Medtronic’s alleged failure to report adverse events to the FDA are expressly
preempted. See Riley, 625 F. Supp. 2d at 777. 25

25
The cases on which Plaintiffs rely in this context—Hughes v. Boston Scientific Corp., 631 F.3d 762
(5th Cir. 2011), and Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013)—are inapposite. In
Hughes, the plaintiffs were able to point to a specific Mississippi statute that contained reporting
requirements, see 631 F.3d at 769, and in Stengel, the court found that a failure to warn claim survived
a motion to dismiss where the state law “contemplates a warning to a third party such as the FDA[,]”
704 F.3d at 1233.

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In their papers, Plaintiffs struggle mightily to avoid the implications of the
undisputed fact that there is no D.C. common law claim that imposes liability for a
manufacturer’s failure to report to the FDA adverse incidents concerning an approved
medical device. For example, they point to the established D.C. common law claim for
failure to warn consumers of foreseeable harm associated with use of the product (see,
e.g., 2d Am. Compl. Counts XVI–XVIII), and construct the following argument:
because Medtronic failed to track adverse events adequately and to notify the FDA in a
timely manner of adverse events involving the over-delivery of insulin to patients,
Medtronic deprived the FDA of important information regarding the pump that the
agency could have then used to require Medtronic to change its label in order to provide
the adequate warnings to Caroline and her physicians regarding risks associated with
the pump that D.C. law requires. (See, e.g., 2d Am. Compl. ¶ 49 (“Medtronic’s failure
to track and report adverse events kept important safety information from the FDA and,
therefore, device users such as Caroline Kubicki.”).) Thus, Plaintiffs insist that
Medtronic’s violation of the federal reporting requirements effectively amounted to a
failure to warn consumers for the purpose of D.C.’s common law tort. (See, e.g., id.
¶ 212.)
This creative effort to craft a D.C. common law claim that is substantially
equivalent to the federal law’s adverse-event reporting requirements fails for at least
two reasons. First of all, it ignores the overarching mandate that the state claim and the
federal claim must be genuinely—as opposed to effectively—equivalent. That is, if
Plaintiffs’ core contention is that the state common law was violated because Medtronic
failed to warn consumers of device-related risks upon learning new adverse

84

information, then the federal requirement that such a claim actually parallels is a duty
to warn consumers of device-related risks in light of new adverse events (i.e., the duty
to update product labels post-approval), not the C.F.R.’s requirement that manufacturers
report such events to the FDA. Put another way, the common law failure to warn claim
is not, in fact, the functional equivalent of a manufacturer’s failure to report adverse
incidents to the FDA in violation of federal law, and Plaintiffs have not identified a
federal regulation that imposes upon manufacturers the specific obligation to warn
consumers of adverse post-approval events.
Second, Plaintiffs’ parallel state law claim argument ultimately relies on sheer
speculation: Plaintiffs contend that, if Medtronic had complied with the federal
requirement to report adverse events to the FDA, and if the FDA had directed Medtronic
to update the label of the MMT-522 Pump based on these reported events, then
Medtronic would have had the duty to provide adequate warnings to consumers, as D.C.
common law requires. But it is by no means certain that the FDA would have directed
Medtronic to give consumers different or additional information about the MMT-522
Pump if the agency had been made aware of other incidents that predated Caroline’s
hypoglycemic injury. And unless such label changes would necessarily have occurred
as a result of Medtronic’s failure to notify the FDA, Plaintiffs’ contention that
Medtronic’s failure to notify the agency is the functional equivalent of failing to warn
consumers in violation of state law cannot be sustained. Cf. Webster, 259 F. Supp. 2d
at 36 (“Nor can plaintiffs create an issue of fact regarding their defective warning claim
by speculating that if the FDA had known of the delayed perforation and tamponade
incidents during the clinical trials and if defendant had investigated all the adverse

85

incidents, the FDA would have either recalled the lead or placed it on alert, and
therefore, Dr. Lewis would not have implanted it in plaintiff’s heart.” (emphasis
omitted)). Thus, this Court does not accept Plaintiffs’ argument that Medtronic’s
established reporting failures are truly parallel to the complaint’s claims that Medtronic
is liable for failing to provide adequate warnings to Caroline and her physicians
regarding risks associated with the pump under District of Columbia law.
The court in In re Medtronic, Inc. Sprint Fidelis Leads Products Liability
Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009), reached a similar conclusion about
the plaintiffs’ purportedly parallel state law claims in the context of a multi-district
litigation relating to another Medtronic product, when it characterized the state law
claims as actually and plainly imposing additional requirements on Medtronic under
these circumstances. It reasoned that a defective-labeling state law claim that is tied to
the manufacturer’s alleged failure to disclose new information it discovered after the
FDA’s premarket approval of its medical device falls squarely within the preemptive
scope of Riegel:
Plaintiffs cannot escape that under their theory of liability,
Medtronic would have been required to provide warnings
above and beyond those on the [] product label—a label that
was specifically approved by the FDA as part of the PMA
process. Mandating that a manufacturer provide warnings
beyond those on the device label would impose requirements
different from, or in addition to those approved by the FDA,
and are thus preempted.
Simply put, Section 360k(a)
preempts claims that are, as here, premised on a post-sale duty
to warn, where the plaintiff alleges the defendant was required
to provide additional warnings in light of later-received
reports of injury to others caused by the same medical device.
Id. at 1159 (internal quotation marks and citations omitted).

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The instant case involves this same dynamic, because the Kubickis’ pump-related
failure to warn claim are fundamentally based on the contention that Medtronic
breached a duty to provide additional warnings, and to recall the pump for label
changes, in light of the deficiencies in the device that the post-approval events revealed.
But the MDA’s express preemption clause prohibits the Court (or a jury) from making
any such liability determination. See id.; see also Cupek, 405 F.3d at 424 (“Any claim,
under state law . . . that Defendant failed to warn patients beyond warnings required by
the FDA, or that Defendant failed to recall a product without first going through the
PMA supplement process[,] would constitute state requirements ‘different from’ or ‘in
addition to’ the requirements of the federal PMA application and supplement process.”
(quoting 21 U.S.C. § 360k(a))); Horn v. Thoratec Corp., 376 F.3d 163, 176–77 (3d Cir.
2004) (holding that failure to warn claims are preempted if they would require the
manufacturer “to provide different warnings and instructions from those approved by
the FDA[,]” since the manufacturer was “prohibited . . . by the FDA’s PMA approval
order from making any such changes” (citations omitted)).
All things considered, then, this Court is confident that the one claimed violation
of federal law that is sufficiently specific to support a parallel state law claim
concerning the MMT-522 Pump—i.e., Medtronic’s established failure to report
subsequent adverse events to the FDA in a timely manner, as the adverse reporting
regulations require (see 2013 Warning Letter at 25–26)—does not actually equate with
the D.C. common law failure to warn claims that the Kubickis allege (see 2d Am.
Compl. ¶¶ 495, & Counts I–III (failure to warn as element of negligence); XVI–XVIII

87

(failure to warn under Restatement of Torts)), and as a result, the MDA’s express
preemption provision bar these state law claims.
C.

The Implied Preemption Doctrine Does Not Bar Plaintiffs’
Claims Against Medtronic For The Allegedly Negligent Design,
Manufacture, And Labeling Of The MMT-396 Infusion Set,
And The Claims Based On Medtronic’s Alleged Failure To
Warn Consumers About That Product Also Survive

At this point, it is crucial to recall that the FDA authorized Medtronic to market
the allegedly defective components of the insulin-delivery system that Caroline was
using at the time of her injury through two different processes: the MMT-522 Pump
was subjected to the PMA process, while the agency cleared the MMT-396 Infusion Set
through the § 510(k) “substantial equivalence” route. (See Medtronic’s Stmt. of Facts
¶¶ 7–9.) Thus, the doctrine of express preemption is inapplicable to claims pertaining
to the MMT-396 Infusion Set, see Lohr, 518 U.S. at 492–94, and the Kubickis can
proceed with their infusion set-related state law tort claims so long as those claims do
not implicate the FDA’s exclusive authority to enforce the FDCA and its implementing
regulations. See 21 U.S.C. § 337(a); see also Buckman, 531 U.S. at 349 n.4 (“The
FDCA leaves no doubt that it is the Federal Government rather than private litigants
who are authorized to file suit for noncompliance with the medical device provisions.”).
In its prior opinion denying Medtronic’s motion to dismiss, the Court addressed
the issue of whether Plaintiffs’ claims relating to the MMT-522 Pump (the only claims
asserted in the complaint at that time) were impliedly preempted, and determined that
they were not. See Kubicki, 2013 WL 1739580, at *11 (“Because Plaintiffs are
asserting breach of recognized state law duties which are parallel to federal regulations
(as opposed to an independent implied right action under the MDA to directly enforce
those regulation), their claims are not impliedly preempted under Buckman.” (citations
88

and emphasis omitted)). This Court need not revisit the pump-related implied
preemption evaluation now, because it has already decided that the Kubickis’ pumprelated claims are expressly preempted in any event. (See supra Part VI.B.) 26 Thus, the
only preemption question that remains at this time is whether implied preemption bars
the Kubickis’ state law claims against Medtronic concerning the MMT-396 Infusion
Set.
It is well established that state law tort claims with respect to a § 510(k) device
can persist unabated if they “rely[] on traditional state tort law [that] had predated the
federal enactments” that purportedly preempt them, Buckman, 531 U.S. at 353; and
alternatively, state law claims are deemed impliedly preempted if “the existence of the
federal enactments is a critical element in their case[,]” id. The seminal Supreme Court
case on implied preemption—Buckman Company v. Plaintiffs’ Legal Committee, 531
U.S. 341 (2001)—involved an allegation that a medical device manufacturer had made
fraudulent representations to the FDA regarding the intended use of a medical device,
which had led the FDA to grant § 510(k) approval to the device that injured the
plaintiff. See id. at 343. The Supreme Court ruled that such a “fraud-on-the-FDA”
claim could not be established apart from the federal approval process, and would
“inevitably conflict with the FDA’s responsibility to police fraud consistently with the
Administration’s judgment and objectives.” Id. at 350. Therefore, the Court held that
the fraud claim was impliedly preempted. See id. at 348; see also id. at 347–48 (noting

26

As suggested above, when it comes to PMA-approved devices, the overly of express and implied
preemption analyses results in a particularly complex, nuanced inquiry. See In re Medtronic, Inc., 623
F.3d at 1204 (citing Riley, 625 F. Supp. 2d at 777) (explaining that “[t]he plaintiff must be suing for
conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the
plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly
preempted under Buckman).”).

89

that “petitioner’s dealings with the FDA were prompted by the MDA, and the very
subject matter of petitioner’s statements were dictated by that statute’s provisions”).
Accordingly, courts have held that “a private litigant cannot bring a state-law claim
against a defendant when the state-law claim is in substance (even if not in form) a
claim for violating the FDCA—that is, when the state claim would not exist if the
FDCA did not exist.” Riley, 625 F. Supp. 2d at 777 (citing Buckman, 531 U.S. at 352–
53); see also Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692, 705 (S.D. Tex. 2014)
(“Because these claims would apply to a seller of a product not subject to any federal
regulations who engaged in similar alleged misconduct, they are not impliedly
preempted.”).
Applying these standards, and keeping in mind the Supreme Court’s admonition
in Lohr that, a medical device manufacturer that elects to proceed through § 510(k)
faces the possibility of having “to defend itself against state-law claims” that would
have been expressly preempted if it had instead opted for the more arduous PMA
process, see Lohr, 518 U.S. at 494, this Court concludes that the Kubickis’ claims
against Medtronic that allege the negligent design, manufacture, and labeling of the
MMT-396 Infusion Set exist independently of the FDCA, and in fact, are precisely the
type of claims that the Lohr Court anticipated would be allowed to proceed. See, e.g.,
Schouest, 13 F. Supp. 3d at 704 (finding that state law fraud, negligence, and breach of
warranty claims relating to medical device were not impliedly preempted where they
“would exist in a world without the FDCA”); In re Medtronic, Inc. Implantable
Defibrillators Litig., 465 F. Supp. 2d 886, 899–900 (D. Minn. 2006) (holding that
negligence and strict liability claims were not impliedly preempted because plaintiffs

90

relied on traditional state causes of action and did not seek to recover for fraud on the
FDA).
In addition, although Plaintiffs have conceded that no common law claim for
failure to report adverse events to the FDA exists under District of Columbia law, to the
extent that the Kubickis’ failure to warn claim alleges that Medtronic breached “a duty
of reasonable care” owed to Caroline Kubicki, her parents, and her physicians “to
adequately warn of the foreseeable harm associated with the use” of the MMT-396
Infusion Sets (2d Am. Compl. ¶ 205)—including “a duty to provide specific directions
for the safe use” of the product (id. ¶ 206 (emphasis in original)) and “sufficient
warnings and instructions for use” (id. ¶ 210)—this claim, too, survives Defendant’s
implied preemption argument. 27 Under D.C. law, there has long been a recognized tort
claim that can be brought against manufacturers that fail to warn consumers of known
product defects. See, e.g., Payne v. Soft Sheen Prods., 486 A.2d 712, 721–22 (D.C.

27

Once again, the distinction between the alleged negligent failure to report adverse events to the
FDA, on the one hand, and the failure to warn the public about foreseeable risks associated with a
device, on the other, matters. The courts of appeals have split over whether a state law failure to report
claim (when one is recognized) is impliedly preempted: the Sixth and Eighth Circuits have refused to
allow state law tort claims based on alleged violations of FDA reporting requirements to proceed,
finding that such claims encroach on the FDA’s exclusive province to enforce the FDCA, see, e.g.,
Marsh v. Genentech, Inc., 693 F.3d 546, 553 (6th Cir. 2012) (holding that “failure to submit reports to
the FDA that the FDA requires is arguably a species of fraud on the agency under the state Act” that
directly implicates that Supreme Court’s holding in Buckman); In re Medtronic, Inc., 623 F.3d at 1204,
while the Fifth, Seventh, and Ninth Circuits have held that state law failure to report claims based on
allegations that a manufacturer failed to report adverse events to the FDA are not impliedly preempted
under Buckman, because such claims are based on an alleged “breach of a ‘recognized state-law duty’
rather than ‘an implied right of action under federal law[,]’” Hughes, 631 F.3d at 775 (quoting Bausch,
630 F.3d at 557–58); see also, e.g., Stengel, 704 F.3d at 1233 (“The Stengels’ proposed new claim
under Arizona law, insofar as the state-law duty parallels a federal-law duty under the MDA, is not
preempted.”). The D.C. Circuit has not waded into this dispute, and this Court finds no reason to do so
here, given Plaintiffs’ admission that there is no common law claim for failing to report adverse events
to the FDA in this jurisdiction. The resulting inevitable conclusion is that the only potentially viable
failure to warn claim in Plaintiffs’ complaint is the contention that Medtronic breached its duty to warn
consumers directly. (See, e.g., 2d Am. Compl. ¶ 212 (alleging that Medtronic “breached its duty to
warn Caroline Kubicki, her parents, her physicians and the FDA of the foreseeable harm associated
with the use” of its product).)

91

1985); Russell v. G. A. F. Corp., 422 A.2d 989, 991 (D.C. 1980). Therefore, this Court
is persuaded that the Kubickis’ failure to warn consumers claim (i.e., their contention
that Medtronic negligently failed to warn consumers about the dangers of the MMT-396
Infusion Set and to provide sufficient instructions for its safe use) exists independently
of federal law in a manner that withstands Defendants’ implied preemption argument.
In sum, with respect to Medtronic’s preemption contentions, this Court concludes
that (1) Medtronic is entitled to summary judgment, on the basis of express preemption,
with respect to the all of the claims that pertain to the MMT-522 Pump (with the
exception of Plaintiffs’ manufacturing defect claim), and (2) the Kubickis cannot
maintain a (non-existent) state law claim for Medtronic’s alleged failure to report to the
FDA adverse events involving the MMT-396 Infusion Set, and thus Medtronic is
entitled to summary judgment on any such claim on the basis of implied preemption,
but (3) the doctrine of implied preemption presents no bar to the Kubickis’ claims
relating to design, manufacture, and labeling of the MMT-396 Infusion Set, or to their
claims that Medtronic violated established state common law by failing to warn
consumers about risks associated with the MMT-396 Infusion Set.
VIII. RULING ON THE LEARNED INTERMEDIARY DOCTRINE, THE
KUBICKIS’ INFUSION SET WARRANTY CLAIM, AND PUNITIVE
DAMAGES
Finally, this Court turns to a series of alternative and miscellaneous arguments
that Medtronic makes in support of its contention that it is entitled to an award of
summary judgment in this case.

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A.

Medtronic Is Not Entitled To Summary Judgment With Respect
To The Failure To Warn Claims On The Basis Of The Learned
Intermediary Doctrine

To further assail the Kubickis’ unpreempted infusion set-related failure to warn
consumers claims, Medtronic points to “the learned intermediary doctrine” (Medtronic
Mem. at 63–66), which “holds that, because prescription [devices] are available to the
public only through a physician and are to be administered only under a physician’s
supervision, the [device] manufacturer’s duty is to adequately inform the physician,
who is expected to function as a ‘learned intermediary’ between the company and the
patient in protecting the patient and providing direct information about the [device] to
the patient.’” MacPherson, 775 F. Supp. at 422-23; see also Patteson v. AstraZeneca,
LP, 876 F. Supp. 2d 27, 34 (D.D.C. 2012) (“As long as the [prescription] manufacturer
properly warns a prescribing physician of the dangerous propensities of its product, the
manufacturer is excused from warning each patient who receives the [product].”). In
this regard, Medtronic argues that, because “Medtronic’s duty to warn of any dangers
associated with these products ran [only] to the licensed medical professional who
prescribed them[,]” and because Dr. Dandona (Caroline’s physician) testified that “he
did not read or rely upon the warnings and would not have altered his decision to
prescribe the MMT-522 Pump and MMT-396 Infusion Set” to Caroline even if the
warnings had been sufficient (Medtronic’s Mem. at 64), the Kubickis cannot establish
that Medtronic’s alleged failure to warn caused Caroline’s injury. In other words,
through the learned intermediary doctrine, Medtronic maintains that the allegedly
inadequate warnings—which Dr. Dandona admittedly did not see or read—could not
have caused Caroline’s injury, and thus the company cannot be held liable for its
alleged failure to warn. (See id. (arguing that when the physician would have
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prescribed the medical device regardless of what he “may have read or not read,” or
“when the prescribing physician did not read, or rely upon, the warnings that were
actually provided, there can . . . be no liability”).)
This Court rejects Medtronic’s conclusion that there is no genuine issue of
material fact related to its potential liability for the allegedly faulty labels and
instructions that purportedly failed to warn Caroline, her parents, and Dr. Dandona of
the risks pertaining to improper use of the MMT-396 Infusion Set for at least two
reasons. First of all, the case law makes clear that, for the learned intermediate doctrine
to absolve a manufacturer, the warning that is given to the professional must be
adequate. See McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006 (“[E]ven in the
context of a learned intermediary, if the warning to the intermediary is inadequate or
misleading, the manufacturer remains liable for injuries sustained by the ultimate user.”
(internal quotation marks omitted)); see also Patteson, 876 F. Supp. 2d at 34 (holding
that if the manufacturer “properly warns a prescribing physician of the dangerous
propensities of its product, the manufacturer is excused from warning each patient”
(emphasis added)). The adequacy of the label and insert that Medtronic provided with
the MMT-396 Infusion Set is indisputably still at issue in this case, which plainly
precludes summary judgment in Medtronic’s favor on learned intermediary grounds.
See Payne, 486 A.2d at 723 (“[I]n cases in which there is a potential for serious injury,
the adequacy of even a relatively clear warning should not be determined as a matter of
law but is a question of fact for the jury[.]”).
Second, and possibly even more significant, while Medtronic is correct to
observe that the professional’s actual reliance on the allegedly inadequate information

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that a manufacturer provides is key to assessing causation, see Patteson, 876 F. Supp.
2d at 34 (“An inadequate warning alone, however, is not enough; the learnedintermediary doctrine also requires that the inadequate warning be a ‘producing cause’
of the plaintiff’s injury.”), Medtronic has not successfully established that there is no
genuine issue of fact regarding causation in the instant case. This is primarily because,
although Dr. Dandona did testify that he did not review or rely upon the instructions for
the infusion set (see Dep. of Paresh Dandona (“Dandona Dep.”). Ex. 5 to Pls.’ Opp’n,
ECF No. 138-7, at 7:16–20), his sworn testimony reveals that Dr. Dandona was not the
medical professional who was responsible for reviewing Medtronic’s materials and
explaining to patients how to use the device. In response to a direct deposition question
about whether or not he had “ever reviewed [] the instructions for use for . . . the
infusion set?” Dr. Dandona stated:
No. I’m – I’m not into the technology of each individual
pump. It’s too much. And that function is given to the CDEs,
who are the pump trainers, and they have all the details of that.
So I sort of decide on the policy of installing a pump, the
kind of infusion rates that should be appropriate for a patient,
but the rest of the functions are carried out by the educators.
(Id. at 7:19–8:2.) Thus, the record makes crystal clear that Dr. Dandona viewed his role
as determining the overall “policy of installing a pump” and setting “the kind of
infusion rates that should be appropriate for a patient,” and that he delegated the
technical responsibility of providing patients with instructions for using the prescribed
insulin-delivery device properly to agents he calls “pump trainers.” Yet, to this Court’s
knowledge, the pump trainers have not testified in the context of this matter, so nothing
in the record establishes that the pump trainers who instructed Caroline on how to use
the infusion set eschewed reading or relying upon the allegedly inadequate instructions

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and warnings that Medtronic included in the infusion set packaging. Furthermore,
under District of Columbia law, there is a presumption that the functional user of a
device (here, the trainers) would have read the manufacturers’ instructions and would
have known how to use the device based on those instructions, in the absence of any
evidence about what the trainers actually knew and said. See Payne, 486 A.2d at 725
(explaining that the law presumes that “the user would have read an adequate warning,
and that in the absence of evidence rebutting the presumption, a jury may find that the
defendant’s product was the producing cause of the plaintiff’s injury”).
Consequently, on the record the parties have provided, a reasonable jury might
well conclude that Medtronic’s infusion set instructions (imparted to Caroline by the
pump trainers) were inadequate and ultimately caused Caroline’s injury, despite Dr.
Dandona’s testimony regarding his own personal lack of review and reliance on any
such instructions when he prescribed the device to Caroline. Put another way, contrary
to Medtronic’s contentions, it was Caroline’s pump trainer, not Dr. Dandona, who was
the pertinent ‘learned intermediary’ for the purpose of Plaintiffs’ failure to warn claim,
and thus, Dr. Dandona’s testimony about his own personal lack of reliance on
Medtronic’s materials (without regard to what the agents who served as the relevant
instructing professionals for present purposes relied upon) is manifestly insufficient to
break the chain of causation between the allegedly inadequate instructions and
Caroline’s injury as a matter of law.

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B.

Medtronic Is Entitled To Summary Judgment On Plaintiffs’
Breach Of Express Warranty Claim Because The Statements
On Which Plaintiffs Rely Do Not Create An Actionable
Warranty

Medtronic also insists that summary judgment is warranted with respect to the
the MMT-396 Infusion Set breach of warranty claims that Plaintiffs have brought. (See
Medtronic’s Mem. at 67–68; Medtronic’s Reply at 30–31.) 28 As clarified in Plaintiffs’
opposition brief, the Kubickis allege that Medtronic warrantied that the MMT-396
Infusion Set was safe and functional through advertising and promotional statements
about that product, and Medtronic also represented that design modifications to the
venting system made the insulin-deilvery system safer, but that turned out not to be so.
(See Pls.’ Opp’n at 81–82 (pointing to statements that Medtronic made in advertising
materials, including that Medtronic infusion sets “ensure success”; that the vents in the
p-cap would reduce “clogging and malfunction”; and that Medtronic infusion sets “are
made with patented tubing, which is clog and kink resistant, assuring that the insulin is
being safely delivered” (quoting Medtronic Infusion Set Brochure, Ex. 65 to Pls.’
Opp’n, ECF No. 138-68, at 3).) 29 As explained below, this Court finds that Medtronic
is entitled to summary judgment on these express warranty claims, because the
statements to which Plaintiffs point do not amount to an enforceable warranty.

28

This Court has already held that any warranty claims relating to the MMT-522 Pump are expressly
preempted. See supra Part VII.B.
29

Notably, the Kubickis’ express warranty contentions, which reference Medtronic’s advertising and
promotional materials, differ from the complaint’s related claim that Medtronic included an express
warranty in the product packaging for the MMT-396 Infusion Set. (See 2d Am. Compl. ¶ 160.)
Plaintiffs appear to have abandoned their product-packaging express warranty claim, as they have not
countered Medtronic’s representation that the infusion set lots at issue in this case “were not
accompanied by any warranty.” (Medtronic’s Stmt. of Facts ¶ 27; see also Pls.’ Opp’n at 81–82
(arguing that, with respect to the infusion set, a warranty existed as a result of statements made in
advertisements).)

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In order to succeed on a breach of warranty claim under District of Columbia
law, a plaintiff must prove “that the defendant breached an express promise made about
the product sold.” Witherspoon v. Philip Morris Inc., 964 F. Supp. 455, 464 (D.D.C.
1997). The D.C. Code explains that an enforceable express warranty arises when the
seller makes to the buyer “(a) [a]ny affirmation of fact or promise . . . which relates to
the goods and becomes part of the basis of the bargain” or “(b) [a]ny description of the
goods which is made part of the basis of the bargain[.]” D.C. Code § 28:2-313(1). In
either case, such an expression “creates an express warranty that the goods shall
conform to the [description], affirmation or promise.” Id. An express warranty can
exist even if the seller does not use the words “warrant” or “guarantee,” but it is well
established that “an affirmation merely of the value of the goods or a statement
purporting to be merely the seller’s opinion or commendation of the goods does not
create a warranty.” D.C. Code. § 28:2-313(2). Furthermore, when the plaintiff alleges
only that a manufacturer’s “advertisements and promotionals statements contained
broad claims amounting to a warranty[,]” the alleged breach of warranty claim cannot
survive. Witherspoon, 964 F. Supp. at 465 (emphasis added; internal quotation marks
and citation omitted); see also, e.g., Forouzesh v. Starbucks Co., No. CV 16-3830, 2016
WL 4443203, at * 4 (C.D. Cal. Aug. 19, 2016) (dismissing breach of warranty claim
predicated on the defendant’s representations that its beverages were sold “in cups of
various sizes[,]” because a reasonable consumer would not have interpreted the
defendant’s representation to be an affirmation of fact or description regarding the
“specific amount of liquid” in the cups); Hubbard v. Gen. Motors Corp., No.
95Civ.4362, 1996 WL 274018, at *7 (S.D.N.Y. May 22, 1996) (holding that statements

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made in advertisements that vehicles are “the most dependable, long-lasting trucks on
the planet” constituted “puffery” rather than an actionable warranty regarding vehicle’s
braking system, particularly where the statements made “no reference whatsoever to the
type or quality of the vehicles’ braking system”).
Here, it is clear to this Court that any warranty claim that is based on the
statements in Medtronic’s advertising materials to which Plaintiffs point to fails as a
matter of law, due to the nature of the statements at issue. For example, Plaintiffs
contend that Medtronic warrantied the MMT-396 Infusion Set’s p-cap vent design by
asserting that the vents in the p-cap would reduce “clogging and malfunction” and that
Medtronic infusion sets “are made with patented tubing, which is clog and kink
resistant, assuring that the insulin is being safely delivered” (see Pls.’ Opp’n at 81–82
(quoting Medtronic Infusion Set Brochure in the advertising materials)), but such a
generalized endorsement of the product’s purportedly superior structure is not a factbased promise that the product will perform in a certain way. See Witherspoon, 964 F.
Supp. at 464; Hoffman v. A.B. Chance Co., 339 F. Supp. 1385, 1387 (M.D. Pa. 1972)
(holding that advertisements representing that a brake lock device “offered
unprecedented safety” did not create an actionable warranty). Indeed, to qualify as an
express promise of the type that is enforceable as a warranty, the manufacturer must do
more than make generalized statements commending the product; instead, it must
articulate verifiable facts about product performance, such that lack of conformity with
those representations can plausibly be established. See, e.g., City of Wyoming v.
Procter & Gamble Co., No. 15-2101, 2016 WL 5496321, at *9–10 (D. Minn. Sept. 28,
2016) (holding that packaging and advertising statements describing wet wipes as

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“flushable” were “affirmations of fact” sufficient to create an express warranty). By
contrast, Medtronic’s statements about the MMT-396 Infusion Set appear to this
Court’s eye to be more in the nature of advertising “puffery,” see Pearson v. Chung,
961 A.2d 1067, 1076 (D.C. 2008), rather than specific affirmations of fact upon which a
reasonable consumer could reasonably rely and ultimately seek to enforce.
In this regard, In re General Motors Corp. Anti–Lock Brake Products Liability
Litigation, 966 F. Supp. 1525 (E.D. Mo. 1997), is instructive. In that case, plaintiffs
sought to assert a breach of warranty claim against General Motors, arguing that
General Motors’s advertising statements that a vehicles’ crash avoidance system was
“99 percent more effective” than a crash protection system, and that “[a] driver is 100
times more likely to benefit from a vehicle’s crash-avoidance capabilities (such as antilock brakes) than from its crash-survival capabilities (such as air bags)[,]” created a
warranty that the vehicles’ systems were free of safety defects, and that General Motors
had breached this warranty because the systems were defective and not, in fact, safe.
Id. at 1531. The court dismissed this warranty claim, finding that “comparative claims
[such as these], often involving large numbers, are puffing because a consumer cannot
reasonably believe that there is a test behind the claims.” Id.; cf. In re XM Satellite
Radio Holdings Sec. Litig., 479 F. Supp. 2d 165, 180 (D.D.C. 2007) (dismissing
securities fraud claim that was predicated on adverting statements because “generalized
positive statements about ‘cost effective,’ ‘smart,’ ‘sound’ and ‘efficient’ growth are
vague and incapable of objective verification, they are not the type of statement upon
which a reasonable investor would rely” and instead constitute mere “puffery”); Hoyte
v. Yum! Brands, Inc., 489 F. Supp. 2d 24, 30 (D.D.C. 2007) (granting motion to

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dismiss negligent misrepresentation claim based on “KFC’s claims that its restaurants
serve the ‘best food’” because such a statement “is a non-measurable, ‘bald statement of
superiority’ that is non-actionable puffery”).
The bottom line is this: in this Court’s considered judgment, much of the
advertising language that Plaintiffs say gives rise to their breach of warranty claims
actually dooms these allegations, because instead of essentially guaranteeing that the
MMT-396 Infusion Set will operate a certain specified way, Medtronic’s statements
appear to be merely the type of general commendation that courts have long held does
not create an enforceable warranty. See Witherspoon, 964 F. Supp. at 464.
C.

While Medtronic Is Entitled To Summary Judgment On
Plaintiffs’ Stand-Alone Punitive Damages Claim, It Is
Premature To Foreclose Punitive Damages As A Remedy

Finally, Medtronic argues that summary judgment should be entered in its favor
with respect to Plaintiffs’ punitive damages claims. (See Medtronic Mem. at 68–70.)
Plaintiffs’ complaint alleges that all of Medtronic’s failures and deficiencies with
respect to the medical devices at issue in this case were malicious, willful, and wanton,
and that the company has acted without regard for the safety of others—facts that,
Plaintiffs say, entitle them to an award of punitive damages. (See 2d Am. Compl.
¶¶ 254–259.) See also Rogers v. Ingersoll-Rand Co., 971 F. Supp. 4, 12 (D.D.C. 1997)
(“Punitive damages are properly awarded where the act of the defendant is accompanied
by fraud, ill will, recklessness, wantonness, oppressiveness, willful disregard of the
plaintiff’s rights, or other circumstances tending to aggravate the injury.”). To the
extent that Plaintiffs seek punitive damages as a separate cause of action, Medtronic’s
motion is well-founded, and this Court can easily dispose of such claims, as it is clear
beyond cavil that the District of Columbia only recognizes punitive damages as a
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remedy and not an independent cause of action. See, e.g., Mitchell v. E. Sav. Bank,
FSB, 890 F. Supp. 2d 104, 110 (D.D.C. 2012); Gharib v. Wolf, 518 F. Supp. 2d 50, 56
(D.D.C. 2007) (citing Int’l Kitchen Exhaust Cleaning Ass’n v. Power Washers of N.
Am., 81 F. Supp. 2d 70, 74 (D.D.C. 2000)). Therefore, and on this basis alone,
Medtronic is entitled to summary judgment on Counts XXI, XXII, and XXIII of
Plaintiffs’ Second Amended Complaint.
However, notably, nothing in this Court’s decision should be construed as
precluding Plaintiffs from seeking punitive damages as a remedy at the appropriate
time. That is, insofar as Medtronic argues that no such remedy is available on the
current record (see Medtronic’s Mem. at 69–70), the parties are reminded that the
record is subject to further development in this case, because they have yet to engage in
expert discovery. (See supra Part V.) This Court will not accept Medtronic’s
suggestion that it evaluate—and foreclose completely—any punitive damages remedy
now; instead, the Court will await future discussion of the appropriateness of Plaintiffs’
request for punitive damages in the context of the parties’ preparations for trial. Cf.
D.C. Std. Civ. Jury Instr. Nos. 13-12, 16-2, 16-3.
IX.

CONCLUSION
The facts of this matter are relatively straightforward—a tragic, devastating

injury purportedly caused by Defendants’ allegedly tortious conduct with respect to a
widely marketed insulin-delivery device—but the intersection of law and life can be
quite complicated. Even prior to engaging in expert discovery, Medtronic and
Unomedical have vigorously maintained that the Kubickis cannot persist with the
various state law claims they have filed pertaining to the MMT-522 Pump and MMT-

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396 Infusion Set for several nuanced reasons, and having carefully reviewed the parties’
summary judgment filings and the exhibits thereto, as well as their statements of fact,
this Court agrees with Defendants with respect to certain claims, and disagrees with
respect to others. For the reasons explained at length above, the Court finds that
Unomedical is entitled to summary judgment with respect to all of the claims Plaintiffs
have brought against it on timeliness grounds, and Medtronic is entitled to summary
judgment with respect to certain claims, as follows: (1) all of Plaintiffs’ claims that
pertain to the MMT-522 Pump, except Plaintiffs’ manufacturing defect claim, (2)
Plaintiffs’ claims that Medtronic failed to report to the FDA adverse events regarding
the MMT-396 Infusion Set in violation of state law, (3) Plaintiffs’ breach of warranty
claims, and (4) Plaintiffs’ stand-alone claim for punitive damages. However, the Court
concludes that genuine issues of material fact remain with respect to Plaintiffs’
negligent design, manufacture, labeling, and failure to warn consumers claims relating
to the MMT-396 Infusion Set, and that there are also triable issues of fact with respect
to causation—at least for now. Thus, as set forth in the accompanying order,
Unomedical’s Motion for Summary Judgment is GRANTED, Medtronic’s
Motion for Summary Judgment is GRANTED in part and DENIED in part, and the
parties are ordered to submit a joint proposed schedule for expert discovery.

DATE: February 5, 2018

Ketanji Brown Jackson
KETANJI BROWN JACKSON
United States District Judge

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