Kubicki ex rel. Kubicki v. Medtronic, Inc.
This text of 293 F. Supp. 3d 129 (Kubicki ex rel. Kubicki v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
KETANJI BROWN JACKSON, United States District Judge
TABLE OF CONTENTS
I. INTRODUCTION...139
II. FACTS RELATED TO CAROLINE AND HER INJURIES...141
A. The Hypoglycemic Event...141
B. The Medtronic Paradigm Insulin Pump Model MMT-522 And The Medtronic MiniMed Paradigm Quick-set Infusion Set, Model MMT-396...143
1. The Design And Operation Of These Medical Devices...143
2. The Approval, Manufacturing, And Marketing Of These Medical Devices...145
C. Infusion Set Recalls In 2009 And 2013...146
1. 2009 Return And Replace Recall Of The "Lot 8" Batch...146
2. 2013 Paradigm Infusion Set Recall...146
3. 2013 FDA Warning Letter...148
III. PROCEDURAL HISTORY...149
A. The Initial Pump-Related Legal Action The Plaintiffs Brought Against Medtronic Alone...149
B. Plaintiffs' Amended Complaint, Which Adds Unomedical And Claims That Relate Specifically To The Infusion Set...150
C. Medtronic's And Unomedical's Motions For Summary Judgment...151 *138IV. LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT...152
V. RULING ON CAUSATION...152
A. The Record Evidence Thus Far Submitted Is Not Sufficient To Warrant Granting Summary Judgment To Defendants On Causation Grounds...153
B. The Parties Will Be Permitted To Revisit The Causation Question After Expert Discovery Is Completed...156
VI. RULING ON TIMELINESS...157
A. The Law Pertaining To Timeliness: Statutes Of Limitations, The Discovery Rule, And The Relation Back Doctrine...157
1. The Discovery Rule...158
2. The Relation Back Doctrine...158
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...159
1. Caroline's Insulin-Delivery Device Is A Multifaceted Medical Product, And The Manufacturers Of The Various Components Are Clearly Identified...160
2. Plaintiffs Rely On Dissimilar Cases To Support Their Contention That Their Infusion Set Claims Accrued In 2013...162
3. The Relation Back Doctrine Does Not Save The Infusion Set-Related Claims Against Unomedical...164
C. Plaintiffs' Infusion Set Claims Against Medtronic Relate Back To Their Preexisting MMT-522 Pump Claims Against That Defendant, And Thus Are Deemed Timely...166
VII. RULING ON PREEMPTION...167
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...168
1. The MDA's Device-Classification Scheme...168
2. Express Preemption Of State Law Claims Under the MDA...170
3. Implied Preemption Of State Law Claims Under the MDA...172
B. With One Exception, The MDA Expressly Preempts All Of The Kubickis' MMT-522 Pump Claims...173
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...174
2. Plaintiffs Have Not Established That Their Pump-Related State Law Claims Are Genuinely Equivalent To Specific Federal Law Requirements...176
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...178
b. Plaintiffs have not identified a genuinely equivalent parallel state law claim pertaining to Medtronic's failure to report events to the FDA...182
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...185 *139VIII. RULING ON THE LEARNED INTERMEDIARY DOCTRINE, THE KUBICKIS' INFUSION SET WARRANTY CLAIM, AND PUNITIVE DAMAGES...188
A. Medtronic Is Not Entitled To Summary Judgment With Respect To The Failure To Warn Claims On The Basis Of The Learned Intermediary Doctrine...188
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...190
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...192
IX. CONCLUSION...193
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.
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KETANJI BROWN JACKSON, United States District Judge
TABLE OF CONTENTS
I. INTRODUCTION...139
II. FACTS RELATED TO CAROLINE AND HER INJURIES...141
A. The Hypoglycemic Event...141
B. The Medtronic Paradigm Insulin Pump Model MMT-522 And The Medtronic MiniMed Paradigm Quick-set Infusion Set, Model MMT-396...143
1. The Design And Operation Of These Medical Devices...143
2. The Approval, Manufacturing, And Marketing Of These Medical Devices...145
C. Infusion Set Recalls In 2009 And 2013...146
1. 2009 Return And Replace Recall Of The "Lot 8" Batch...146
2. 2013 Paradigm Infusion Set Recall...146
3. 2013 FDA Warning Letter...148
III. PROCEDURAL HISTORY...149
A. The Initial Pump-Related Legal Action The Plaintiffs Brought Against Medtronic Alone...149
B. Plaintiffs' Amended Complaint, Which Adds Unomedical And Claims That Relate Specifically To The Infusion Set...150
C. Medtronic's And Unomedical's Motions For Summary Judgment...151 *138IV. LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT...152
V. RULING ON CAUSATION...152
A. The Record Evidence Thus Far Submitted Is Not Sufficient To Warrant Granting Summary Judgment To Defendants On Causation Grounds...153
B. The Parties Will Be Permitted To Revisit The Causation Question After Expert Discovery Is Completed...156
VI. RULING ON TIMELINESS...157
A. The Law Pertaining To Timeliness: Statutes Of Limitations, The Discovery Rule, And The Relation Back Doctrine...157
1. The Discovery Rule...158
2. The Relation Back Doctrine...158
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...159
1. Caroline's Insulin-Delivery Device Is A Multifaceted Medical Product, And The Manufacturers Of The Various Components Are Clearly Identified...160
2. Plaintiffs Rely On Dissimilar Cases To Support Their Contention That Their Infusion Set Claims Accrued In 2013...162
3. The Relation Back Doctrine Does Not Save The Infusion Set-Related Claims Against Unomedical...164
C. Plaintiffs' Infusion Set Claims Against Medtronic Relate Back To Their Preexisting MMT-522 Pump Claims Against That Defendant, And Thus Are Deemed Timely...166
VII. RULING ON PREEMPTION...167
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...168
1. The MDA's Device-Classification Scheme...168
2. Express Preemption Of State Law Claims Under the MDA...170
3. Implied Preemption Of State Law Claims Under the MDA...172
B. With One Exception, The MDA Expressly Preempts All Of The Kubickis' MMT-522 Pump Claims...173
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...174
2. Plaintiffs Have Not Established That Their Pump-Related State Law Claims Are Genuinely Equivalent To Specific Federal Law Requirements...176
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...178
b. Plaintiffs have not identified a genuinely equivalent parallel state law claim pertaining to Medtronic's failure to report events to the FDA...182
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...185 *139VIII. RULING ON THE LEARNED INTERMEDIARY DOCTRINE, THE KUBICKIS' INFUSION SET WARRANTY CLAIM, AND PUNITIVE DAMAGES...188
A. Medtronic Is Not Entitled To Summary Judgment With Respect To The Failure To Warn Claims On The Basis Of The Learned Intermediary Doctrine...188
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...190
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...192
IX. CONCLUSION...193
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)
*140allege 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 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 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,
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 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
Posthumus immediately notified a resident advisor, Siobhan Chapman, who in turn notified another resident advisor, Rebecca Barloon. (See Dep. of Rebecca Barloon ("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
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 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.)
*143In 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-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 *144follow 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 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.)
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).
*145(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.)
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 Data6 ; 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 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 *146p-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 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. ,
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
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.
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
The pictures from the safety notification, which were issued to remind users about the correct way to refill the reservoir, are reproduced below.
(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 *148the 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 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
Notably, in the text of its 2013 letter to Medtronic, the FDA expressly admonished Medtronic for its reporting failures. (See
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
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-based claims, as well as their implied warranty claims. See Kubicki v. Medtronic , No. 12cv0734,
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 *150alleged 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 ,
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
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 in21 C.F.R. § 820.30 et seq. related to design controls[ ]" (id. ¶ 89);
*151• "[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 in21 C.F.R. § 801 , et seq. and21 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 in21 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 [which] parallels the requirements set forth in21 C.F.R. § 820 , et seq " (id. ¶ 92).
(See also
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
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 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
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, *152each 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
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 ,
The moving party has the burden of demonstrating the absence of a genuine dispute as to any material fact. See Celotex Corp. v. Catrett ,
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'
*153claims. (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.).
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
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, *154Medtronic 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 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).)
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 *155the 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 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. ,
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 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 *156gave 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 ,
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 ,
As detailed below, the Court is permitting certain claims against Medtronic to proceed (see infra Part VII.B, VII.C) ), *157and 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
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 ,
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. ,
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 plaintiff gains inquiry notice that wrongdoing may be involved." Bussineau ,
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 ,
2. The Relation Back Doctrine
Federal Rule of Civil Procedure 15(c)"governs when an amended pleading 'relates *159back' 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 Crociere S. p. A. ,
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 ,
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 *160June 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.
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 ,
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 ,
*161Thus, 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 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 "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. ,
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 *162question, 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
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 ,
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 ,
A more analogous case is Colarossi v. Schmid Laboratories, Inc. ,
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 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-delivery 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-delivery 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 *1642009 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 [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 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 ,
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 ,
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 about closely-related corporate entities. Cf. Krupski ,
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 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 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 *167the 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 ,
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 of the U.S. Constitution. See Gade v. Nat'l Solid Wastes Mgmt. Ass'n ,
Medtronic argues that Section 360k(a) of the Medical Device Amendments to the *168Food, 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-delivery 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 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. ,
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,"
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
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 ,
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 ,
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 ,
[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 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 ,
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.
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 ,
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. ,
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 ,
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,
In Buckman Company v. Plaintiffs' Legal Committee ,
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 only to the extent that such common law tort claims are truly parallel to the requirements of federal law. See Cupek ,
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 *174express 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 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 ,
*175Both 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 ,
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[,]"
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 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 ,
In arguing that the MMT-522 Pump was not PMA approved and is therefore *176ineligible 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 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 ,
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 attempts to accomplish this difficult task were "admittedly skimpy[,]" Kubicki ,
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, *177Plaintiffs 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. ,
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,
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);
•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);
*179•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
•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
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 servicing of all finished devices intended for human use.' " In re Medtronic ,
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 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 ,
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,
The Sixth Circuit's decision in Howard v. Sulzer Orthopedics, Inc. ,
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 *181warranty. In their amended complaint, for example, Plaintiffs cite to
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
*182Consequently, 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.
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
(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.
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 ,
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 genuine ly *184-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 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 v. Pacesetter, Inc. ,
The court in In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation ,
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 *185on 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.
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
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 (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 ,
In its prior opinion denying Medtronic's motion to dismiss, the Court addressed the *186issue 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 ,
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 ,
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 *187claims" that would have been expressly preempted if it had instead opted for the more arduous PMA process, see Lohr ,
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. ,
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.
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 ,
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 ,
Second, and possibly even more significant, while Medtronic is correct to observe that the professional's actual reliance on the allegedly inadequate information that a manufacturer provides is key to assessing causation, see Patteson ,
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 *190inadequate instructions 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 ,
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.
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 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-delivery 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 *191below, 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.
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. ,
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 ,
In this regard, In re General Motors Corp. Anti-Lock Brake Products Liability Litigation ,
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 ,
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. ,
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-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 *194joint proposed schedule for expert discovery.
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