Kubicki v. Medtronic, Inc.

• Court: District Court, District of Columbia
• Decided: February 5, 2018
• Docket: Civil Action No. 2012-0734
• Status: Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

) JOHN KUBICKI & KAREN KUBICKI, ) on behalf of CAROLINE KUBICKI, ) ) Plaintiffs, ) Civil No. 12-cv-734 (KBJ) ) v. ) ) MEDTRONIC, INC., et al., ) ) Defendants. ) )

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

ii 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

iii 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 [insulin-

delivery 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

4 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

6 (“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 MMT-

522 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.)

10 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.)

11 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

12 No. 35-5, ¶ 8.) The pump component of this approved device is the Paradigm MMT-

522. 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. 138-

63, at 2), and Unomedical’s name also appears on the instruction sheet for the MMT-

396 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 p-

cap, 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’ causation- related 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 MMT-

522 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 insulin-

delivery 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 products-

liability 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 MMT-

522 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 co-

defendant 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 insulin-

delivery 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 product-

liability 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 set-

related 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.” Rendall-

Speranza, 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 pump-

related 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 MMT-

522 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 FDA-

approved 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 device-

related 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 Wolicki-

Gables 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.”).

81 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

82 “[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.

83 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).

86 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’ pump-

related 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.

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

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

93 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

94 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 learned-

intermediary 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

95 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.

96 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).)

97 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

98 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 fact-

based 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

99 “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 anti-

lock 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

100 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

101 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-

102 396 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