Full opinion text
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 IV. 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 VIII. 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) allege that the defendants failed to warn users and the FDA "of the foreseeable harm associated with the use" of the insulin-delivery devices (id. ¶ 205; see id. ¶¶ 204-253 (Counts XVI-XX) ), and that the Kubickis are entitled to "punitive damages" because each defendant company "acted maliciously, willfully, wantonly, and recklessly without regard to the safety of others" (id. ¶ 262; see id. ¶¶ 254-263 (Counts XXI-XXV) ). To date, the parties have completed fact discovery-but not expert discovery-in this matter, and Plaintiffs have pared down the charges against Unomedical, such that the only claims remaining against the Unomedical defendants are the failure to warn claims that appear in the complaint both as separate 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.) 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. 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, 2013 WL 1739580 (D.D.C. Mar. 21, 2013). As explained fully below, this Court now concludes that Medtronic's Motion for Summary Judgment must be GRANTED IN PART AND DENIED IN PART , and that Unomedical's Motion for Summary Judgment must be GRANTED in full. In sum, this Court has determined that neither defendant is entitled to summary judgment on causation grounds at this point in the litigation (prior to expert discovery), but that summary judgment can and will be entered in Unomedical's favor on the basis of the statute of limitations. The Court will also grant summary judgment to Medtronic with respect to certain claims in the complaint-i.e. , all claims that pertain to the MMT-522 Pump (with the exception of Plaintiffs' manufacturing defect claim) and the failure to report claims that relate to the MMT-396 Infusion Set-because federal law either expressly or impliedly preempts such claims. In addition, the Court will grant Medtronic's motion for summary judgment on Plaintiffs' breach of warranty claim because the statements on which Plaintiffs predicate their claim do not create an actionable warranty. The Court will also grant Medtronic's motion for summary judgment with respect to Plaintiffs' stand-alone claim for punitive damages, because D.C. law does not recognize such a claim, but the Court finds that any ruling on the availability of punitive damages as a remedy is premature prior to the completion of expert discovery. This Court sees no other basis for granting summary judgment in Medtronic's favor with respect to the remaining infusion set claims (negligent design, manufacture, and labeling, and failure to warn) at this time. However, Medtronic can seek summary judgment on causation grounds upon the parties' completion of expert discovery. A separate Order consistent with this Memorandum Opinion will follow. II. FACTS RELATED TO CAROLINE AND HER INJURIES A. The Hypoglycemic Event Caroline was diagnosed with Type I diabetes at the age of six, and was first prescribed an insulin pump in March of 2001, at age 12, after she had experienced difficulty controlling her blood glucose levels with self-administered insulin shots. (See Medtronic's Stmt. of Undisputed Material Facts ("Medtronic's Stmt. of Facts"), ECF No. 133-2, ¶¶ 13-14, 17; see also Pls.' Stmt. of Genuine Issues of Material Fact ("Pls.' Stmt. of Facts"), ECF No. 138-70, ¶¶ 8-9) (noting that Caroline had experienced three hypoglycemic events prior to receiving a prescription for the insulin pump in 2001).) 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 id. ) The various data points that Caroline's parents were able to retrieve from Caroline's pump and glucometer indicate that Caroline's blood sugar level was 77 mg/dL at approximately 7:02 p.m., and that Caroline gave herself six units of insulin at approximately 8:30 p.m. (See Dep. of Karen Kubicki ("K. Kubicki Dep."), Ex. F to Brown Decl., ECF No. 133-5 at 94-106, at 129:20-130:8; J. Kubicki Dep. at 212:3-24; see also Handwritten Glucometer Readings, Ex. 21 to K. Kubicki Dep., ECF 133-5, at 117.) Posthumus left the dorm for a couple of hours beginning at around 11:00 p.m., and Caroline was sleeping both when Posthumus left and when she returned around 12:30 a.m. (See Posthumus Dep. at 60:3-61:20.) At 8:00 a.m. the following morning, Posthumus discovered Caroline in distress in her bed; Caroline was foaming at the mouth and was otherwise unresponsive. (See Medtronic's Stmt. of Facts ¶ 28.) Posthumus immediately notified a resident advisor, Siobhan Chapman, who in turn notified another resident advisor, Rebecca Barloon. (See Dep. of Rebecca Barloon ("Barloon Dep."), Ex. 1 to Pls.' Opp'n, ECF No. 138-3, at 42:21-23.) Posthumus also called 911 and reported that Caroline was unconscious and vomiting. (See GW Police Dep't Incident Report, Ex. 11 to Pls.' Opp'n, ECF No. 138-13, at 2.) Emergency personnel responded, and when they checked Caroline's blood sugar, it registered at 20 mg/dL-an extraordinarily low level. (See DCFEMS Incident Report, Ex. 13 to Pls.' Opp'n, ECF No. 138-15, at 3.) The paramedics gave Caroline an emergency injection of glucose, and then transported her to GW Hospital, where doctors administered further glucose; however, none of these efforts changed Caroline's condition. (See id. ; GW Hosp. Recs., Ex. 2 to Pls.' Opp'n, ECF No. 138-4, at 6.) At GW Hospital, a CT head scan revealed that Caroline was suffering from "diffuse cerebral edema." (GW Hosp. Recs. at 2.) Caroline now resides in a nursing facility in a persistent vegetative state, with no realistic possibility of recovery. (See Mot. Hr'g Tr. at 9:23-10:8.) The readings that Plaintiffs were able to recover from Caroline's glucometer showed that Caroline's insulin levels had fluctuated in the days leading up to her injury-from a low of 43 mg/dL to a high of 568 mg/dL. (See Handwritten Glucometer Readings.) The full set of data could not be recovered from the MMT-522 Pump's memory because Mr. Kubicki removed the battery from the pump after a Medtronic customer service representative told him that doing so would not impact the data saved on the device. (See Tr. of Tele. Call, Ex. 17 to Pls.' Opp'n, ECF No. 138-19, at 9.) The parties conducted joint non-destructive testing of Caroline's pump, which did not reveal any defects. (See Pls.' Opp'n at 67-68.) The MMT-396 Infusion Set that Caroline was using was discarded at an unknown time shortly after Caroline's injury, and therefore the parties were not able to conduct any testing on that device. (See K. Kubicki Dep. at 322:14-325:16.) In the days after the hypoglycemic event, the Kubickis began gathering information in an attempt to determine what had caused Caroline's blood sugar to drop so low. Their efforts included speaking to Caroline's treating physicians at GW Hospital, one of whom suggested to the Kubickis that they preserve and test the MMT-522 Pump because it appeared that Caroline had suffered an insulin overdose. (See J. Kubicki Dep. at 23:25-25:13.) The Kubickis collected and retained Caroline's medical supplies, including the packaging materials for the discarded infusion set, and they consulted with an attorney approximately five weeks after the incident. (See id. at 22:22-23:18.) B. The Medtronic Paradigm Insulin Pump Model MMT-522 And The Medtronic MiniMed Paradigm Quick-set Infusion Set, Model MMT-396 1. The Design And Operation Of These Medical Devices The MMT-522 Pump is an FDA-regulated, insulin-pumping medical device that a patient wears outside her body. The device both monitors the patient's blood glucose levels and delivers insulin at rates that the patient programs. (See Decl. of Donna Twisdom ("Twisdom Decl."), ECF No. 35-4, ¶ 3.) The MMT-522 Pump and the MMT-396 Infusion Set work together as a system, and appear as follows when attached to a patient: Generally speaking, the insulin pump works by delivering background insulin throughout the day according to the "basal rate" that the user sets, and the user can also give herself a dose of insulin (called a "bolus") on demand when she eats. (See Mot. Hr'g Tr. at 59:21-60:21.) A cylindrical reservoir housed in the pump contains the insulin itself, and the insulin is delivered to the body through the infusion set. The infusion set, which is a separate medical device, consists of a thin plastic tube that has a tubing connector-called a "p-cap"-at one end; the p-cap connects the tube to the insulin reservoir. (See Decl. of Rabi Gharabli ("Gharabli Decl."), ECF 132-1, ¶ 10.) On the other end of the tube, there is a small needle that the user inserts into her body. (See id. ) Notably, when the pump's insulin reservoir needs to be refilled, the user must follow a number of steps carefully to accomplish this goal successfully. Specifically, the user must disconnect the infusion set from her body; remove the empty reservoir 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). (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 Data ; 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. 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. The FDA cleared the MMT-396 Infusion Set, including the vented p-cap connector that is at the center of this case, on June 7, 2001, through the 510(k) clearance process. (See Decl. of Mark O'Donnell ("O'Donnell Decl."), ECF No. 133-3, ¶ 8.) Medtronic designed and manufactured the p-cap connector, while Unomedical, which owns the 510(k) for the MMT-396 Infusion Set, designed and manufactured all the other components of the MMT-396 Infusion Set. (See id. ¶¶ 8-9.) Printed on the exterior of the MMT-396 Infusion Set packaging is the notation, "Assembled for Unomedical AS in Mexico," (Packaging Photos, Ex. 61 to Pls.' Opp'n, ECF No. 138-63, at 2), and Unomedical's name also appears on the instruction sheet for the MMT-396 Infusion Set (Infusion Set Instructions, Ex. F to Gharabli Decl., ECF No. 134-3, at 22), as well as on the individual MMT-396 Infusion Sets themselves (Mot. Hr'g Tr. 73:19-74:6). Unomedical's role with respect to the p-cap was limited to the assembling of its MMT-396 Infusion Set tubing with the p-cap that Medtronic provided. (See Unomedical's Stmt. of Facts ¶ 29.) Unomedical then provided the assembled MMT-396 Infusion Set to Medtronic, which Medtronic in turn sold to users in connection with its line of Paradigm insulin pumps, including the MMT-522 Pump. (See id. ¶ 30; O'Donnell Decl. ¶ 9.) The MMT-522 Pump and MMT-396 Infusion Set are prescription-only devices (see Medtronic's Stmt. of Fact, ECF No. 131-2, ¶¶ 7, 9), which means that the devices are "available to the public only through a physician and are to be [used] only under a physician's supervision[.]" MacPherson v. Searle & Co. , 775 F.Supp. 417, 422 (D.D.C. 1991). C. Infusion Set Recalls In 2009 And 2013 1. 2009 Return And Replace Recall Of The "Lot 8" Batch On June 29, 2009, approximately 22 months after Caroline's injury, Medtronic issued a recall for the "Lot 8" batch of its Paradigm infusion sets because of a possible manufacturing defect. Specifically, Medtronic determined that a silicone lubricant used during manufacturing could clog the vents in the p-cap of the infusion sets in the impacted lot, and thus could cause the pump to deliver too much or too little insulin. (See Lot 8 Recall Notice, Ex. 26 to Pls.' Opp'n, ECF No. 138-28.) Patients with impacted infusion sets were instructed not to use them and to return the sets to Medtronic for replacements. (See id. ) The MMT-396 Infusion Set that Caroline had at the time of her injury did not come from Lot 8 and therefore would not have been part of this recall. (See Medtronic's Resp. to Pls.' Fourth Set of Reqs. for Produc., Ex. 28 to Pls.' Opp'n, ECF No. 138-30 at 4.) In connection with the Lot 8 recall, Medtronic issued a "Questions & Answers" sheet in which it stated that all other Medtronic infusion sets were safe to use. (See Questions & Answers Regarding the "Lot 8" Quick-set Induction Set Recall, Ex. 27 to Pls.' Opp'n, ECF No. 138-29, at 2-3.) Medtronic made no mention of Unomedical-which had manufactured the parts of the infusion set other than the p-cap and had assembled the infusion sets, as explained above-in the documents associated with this recall. 2. 2013 Paradigm Infusion Set Recall Four years after the Lot 8 recall, on June 7, 2013, Medtronic issued a broad "Class I recall" of its Paradigm infusion sets, including the MMT-396 Infusion Set that Caroline had owned at the time of her injury. (See Infusion Sets Recall Notice ("2013 Recall Notice"), Ex. 18 to Pls.' Opp'n, ECF No. 138-20, at 2.) Unlike the Lot 8 recall, this recall did not involve replacement of the recalled device; rather, Medtronic provided more information to users, explaining in the recall announcement that there was a risk of under- or over-delivery of insulin if the top of the insulin reservoir or the inside of the p-cap becomes wet while the user is refilling the reservoir with insulin. (See id. ) The impetus for this recall was Medtronic's discovery (first through viewing videos uploaded on YouTube) that some users were holding the insulin reservoir horizontally when refilling it, which can result in fluid touching the inside of the p-cap and blocking the vents. (See E-Mail from S. Schriever (June 11, 2013), Ex. 57 to Pls.' Opp'n, ECF No. 138-59, at 2.) In the notification sent to pump users in connection with the recall, Medtronic specifically instructed users to ensure that the insulin vial is upright when removing it from the reservoir in order to prevent liquid transfer to the p-cap, and it also declared that users should ensure that the reservoir tip and p-cap are dry before connecting them. (See Letter from Shirajul Karim (June 10, 2013) ("Dear User Letter"), Ex. 29 to Pls.' Opp'n, ECF No. 138-31, at 2-3.) The recall notice identified Unomedical A/S as one of the manufacturers of the recalled infusion sets. (See 2013 Recall Notice at 2.) The pictures from the safety notification, which were issued to remind users about the correct way to refill the reservoir, are reproduced below. (Dear User Letter at 2-3.) In the context of the instant litigation, Medtronic characterizes the issue that led to the 2013 infusion set recall as a "temporary blocked vent," and it asserts that "[t]he precise sequence of events required for the temporary blocked vent to occur (spilled fluid on the interior of the p-cap connector, saturation of all four vents, and excess pressure building) make it a rare occurrence." (Medtronic's Mem. at 29.) Medtronic further maintains that it is even more unlikely that a temporary blocked vent will injure an infusion set user, because the user should have detached the pump and infusion set from herself while the reservoir was being refilled. (See id. at 29-30.) Medtronic claims that it has received fewer than 100 complaints per year from users regarding temporary blocked vents (out of approximately 425,000 pump users), and that it "implemented [the 2013 recall as a] voluntary field corrective action" after "becoming 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.) The FDA cited various deficiencies, including Medtronic's "[f]ailure to establish and maintain procedures for implementing corrective and preventative action, as required by 21 C.F.R. 820.100(a) [,]" (id. at 3); "failure to identify actions needed to correct and prevent recurrence of the Paradigm Insulin Infusion Pumps (MMT-5XX, 7XX) device failure" (id. ); and "failure to review and evaluate all complaints to determine whether an investigation is necessary and to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate when no investigation is made" (id. at 5). The FDA also announced the agency's conclusion that, due to the 13 different CGMP violations the that agency had found, Paradigm insulin pumps dating back to 2002 qualify as "adulterated" under 21 U.S.C. § 351(h), and also "misbranded under section 502(t)(2) of the Act." (Id. at 2, 15.) None of the 13 CGMP violations that are discussed in the warning letter pertain to the temporary-block-vent condition of the MMT-396 Infusion Set that the Kubickis allege in their complaint. Notably, in the text of its 2013 letter to Medtronic, the FDA expressly admonished Medtronic for its reporting failures. (See id. at 25-26 (asserting that Medtronic's "Paradigm Insulin Infusion Pumps are misbranded ... in that your firm failed or refused to furnish material or information respecting the device that is required by or under the [MDA]" regarding incidents where users reportedly received an overdose of insulin from the pump).) The FDA further faulted Medtronic for not "establish[ing] internal systems that provide for timely and effective indication, communication, and evaluation of events that may be subject to [medical device reporting] requirements[,]" and for not "establish[ing] internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part." (Id. at 26.) III. PROCEDURAL HISTORY A. The Initial Pump-Related Legal Action The Plaintiffs Brought Against Medtronic Alone On September 2, 2010, the Kubickis filed a lawsuit against Medtronic on Caroline's behalf in the Superior Court of the District of Columbia. (See Brown Decl. ¶ 3.) That complaint was dismissed without prejudice after the parties entered into a tolling agreement, and when the agreement expired, the Kubickis initiated the instant lawsuit by refiling their complaint against Medtronic in Superior Court. (See id. ) Their initial complaint asserted claims for negligence, strict liability, misrepresentation, fraud, breach of express and implied warranties, violation of the District of Columbia Deceptive Trade Practices Act, and failure to warn under Restatement of Torts § 388, based on Caroline's use of the "Medtronic MiniMed Paradigm® Insulin Pump Model MMT-522." (See Compl., Ex. A to Notice of Removal, ECF No. 1, ¶ 4.) This initial complaint did not contain any specific allegations pertaining to the MMT-396 Infusion Set. (See generally id. ) Medtronic removed the complaint to federal court on May 8, 2012. (See Notice of Removal, ECF No. 1-2.) 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, 2013 WL 1739580, at *1 (D.D.C. Mar. 21, 2013). However, the Court rejected Medtronic's contention that the remaining claims in the complaint should be dismissed on either express or implied preemption grounds. Id. at *9-11. With respect to express preemption, the Court found that the Kubickis had "assert[ed] violations of the requirements set forth by the FDA as the cause of the alleged defects and ensuing violation of District of Columbia law[,]" such that the state law claims survived a challenge under Rule 12(b)(6). Id. at *8. However, in so holding, the Court kept the door open for Medtronic to renew its express preemption challenge following discovery, noting that "[w]hile the Court finds Plaintiffs' pleading sufficient to pass muster at this motion to dismiss stage, the Court does expect that as this action proceeds, Plaintiffs will refine their claims to more specifically articulate the parallel relationship between the alleged common law duties and the federal requirements." Id. at *9. As for implied preemption, the Court rejected Medtronic's preemption argument on the grounds that Plaintiffs were not seeking to assert claims based on violation of FDA regulations (which the Supreme Court has found improper), but instead were pleading claims under " 'traditional state tort law.' " Id. at *11 (quoting Buckman Company v. Plaintiffs' Legal Committee , 531 U.S. 341, 352, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) ). 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.) Medtronic and Unomedical then filed pre-discovery dispositive motions related to the amended complaint, which this Court denied on January 14, 2015; the Court instructed the parties instead to proceed to engage in fact discovery, and it provided both defendants with the opportunity to file either an answer or an omnibus motion addressing all issues regarding the legal sufficiency of the complaint in response to a second amended complaint that the plaintiffs proposed to file after discovery. (See Order Revising Schedule for Pretrial Proceedings, ECF No. 111.) On July 31, 2015, after the scheduled period of fact discovery ended, the Kubickis filed a second amended complaint, which is the operative complaint for the purpose of the instant motions. (See 2d Am. Compl.). As noted above, this complaint asserts causes of action for negligence (Counts I-V), strict liability (Counts VI-X), breach of express warranties (Counts XI-XV), failure to warn (Counts XVI-XX), and punitive damages (Counts XXI-XXV). (See generally id. ) There are multiple counts pertaining to each theory of liability because each theory is asserted separately against each of the five entities named as defendants in the complaint (Medtronic, Inc., Medtronic Diabetes, Medtronic MiniMed Inc., Unomedical Devices SA de CV, and Unomedical Devices A/S, respectively). (See generally id. ) The claims against Medtronic pertain to both the MMT-522 Pump and the MMT-396 Infusion Set (see id. Counts I-III, VI-VIII, XI-XIII, XVI-XVIII, XXI-XXVIII, while the claims against Unomedical pertain only to the MMT-396 Infusion Set (see id. Counts IV-V, IX-X, XIV-XV, XIX-XX, XXIV-XXV). Notably, the Kubickis' negligence claims against Medtronic allege that Medtronic violated various duties in connection with the company's design and marketing of the MMT-522 Pump and MMT-396 Infusion Set, including: • "[the D]uty to act with reasonable care in designing the MiniMed Insulin Pump and Paradigm Infusion Sets [which] parallels the federal requirements set forth in 21 C.F.R. § 820.30 et seq. related to design controls[ ]" (id. ¶ 89); • "[the D]uty to act with reasonable care in providing adequate instructions for use, labeling and warnings for the MiniMed Insulin Pump and Paradigm Infusion Sets [which] parallels the federal requirements set forth in 21 C.F.R. § 801, et seq. and 21 U.S.C. § 352 [ ]" (id. ¶ 90); • "[the D]uty to act with reasonable care in documenting, logging, investigating, and reporting to the FDA and the public any complaints it received from users concerning instances of unintended overdelivery of insulin in the MiniMed Insulin Pump and Paradigm Infusion Sets [which] parallels the requirements set forth in 21 C.F.R. § 820, et seq. and 21 C.F.R. 803, et seq [ ]" (id. ¶ 91); and • "[the D]uty to act with reasonable care in manufacturing the MiniMed Insulin Pump and Paradigm Infusion Sets [which] parallels the requirements set forth in 21 C.F.R. § 820, et seq " (id. ¶ 92). (See also id. at ¶¶ 95-98, 101-04.) The Kubickis assert these same alleged negligent breaches of duty with respect to Unomedical regarding the MMT-396 Infusion Set. (See id. ¶¶ 107-10, 113-16.) As for their strict liability claims against Medtronic, which are asserted under the Restatement of Torts § 402A, the Kubickis allege that Medtronic sold "MiniMed Insulin Pumps and Paradigm Infusion Sets to Ms. Kubicki in a defective condition that was unreasonably dangerous to consumers such as Ms. Kubicki[ ]" due to the inadequate labeling, inadequate instructions for priming and filling, inadequate warnings concerning the devices' potential to cause an unintended overdelivery of insulin, improper design in violation of FDA design control regulations, improper manufacture in violation of FDA CGMPs, and failure to provide notice of complaints and adverse events. (Id. ¶¶ 121, 128, 135.) The Kubickis make identical allegations against Unomedical with respect to the MMT-396 Infusion Set. (See id. ¶¶ 142-49.) The Kubickis' breach of warranty claims assert that Medtronic breached an express warranty allegedly set forth in the product packaging that the MMT-522 Pump would be free from "defects in materials and workmanship for a period of four years from the date of purchase[,]" (id. ¶ 158), as well as the express guarantee that the MMT-396 Infusion Set would be free from "defects in materials and workmanship for a period of up to three days from the date the packaging of the individual infusion set was opened" (id. ¶ 160). Plaintiffs further allege that Medtronic had "warranted in advertising and promotional materials" that the MMT-522 Pump and MMT-396 Infusion Set were "safe for use because the company had modified the design from previous models to move the pressure-venting component from the insulin pump to the infusion set ... [and] that this [design modification] would make the updated models of the devices safer than the previous versions and other models on the market by preventing vent blockage[,]" and that Medtronic had breached this warranty. (Id. ¶ 162; see also id. at ¶¶ 164-85.) Plaintiffs likewise assert that Unomedical breached the three-day warranty that it offered on the MMT-396 Infusion Set, in addition to the promotional warranty that the design changes made the device safer. (See id. ¶¶ 191-93, 200-02.) C. Medtronic's And Unomedical's Motions For Summary Judgment Medtronic and Unomedical have each moved for summary judgment with respect to Plaintiffs' Second Amended Complaint. (See Medtronic's MSJ; Unomedical's MSJ.) Medtronic makes three overarching arguments, each of which would dispose of this case in its entirety: (1) there is no evidence of causation (Medtronic's Mem. at 21-31), (2) Plaintiffs' claims are expressly and impliedly preempted (see id. at 31-45), and (3) the statute of limitations bars Plaintiffs' claims (see id. at 45-53). Medtronic further argues that Medtronic is entitled to summary judgment on the punitive damages claim because the record contains no evidence of intentional wrongdoing. (See id. at 58-60.) Unomedical asserts that it is entitled to summary judgment on the basis of the statute of limitations and implied preemption (Unomedical's Mem. at 25-26; 44-47), and it also seeks summary judgment on Plaintiffs' punitive damages claims, arguing that its alleged misconduct is not sufficiently outrageous or egregious to state a claim for punitive damages (see id. at 49-50). This Court held a hearing on these motions on November 3, 2016, during which Plaintiffs represented to the Court that they were abandoning all of the claims against Unomedical except for the failure to warn claims that are brought under both the negligence and strict liability theories. (See Mot. Hr'g Tran. at 5:5-6:1.) IV. LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT The standard that applies to motions for summary judgment brought under Federal Rule of Civil Procedure 56 is clear beyond cavil. A court must grant summary judgment to the movant if the moving party "shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). "A fact is material if it 'might affect the outcome of the suit under the governing law,' and a dispute about a material fact is genuine 'if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.' " Steele v. Schafer , 535 F.3d 689, 692 (D.C. Cir. 2008) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). The moving party has the burden of demonstrating the absence of a genuine dispute as to any material fact. See Celotex Corp. v. Catrett , 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Once the moving party has met this burden, the non-moving party must "designate 'specific facts showing that there is a genuine issue for trial.' " Id. at 324, 106 S.Ct. 2548 (quoting Fed. R. Civ. P. 56(e) ). Although the Court must view the evidence in the light most favorable to the non-moving party and draw all reasonable inference in that party's favor, see, e.g. , Grosdidier v. Broad. Bd. of Governors, Chairman , 709 F.3d 19, 23 (D.C. Cir. 2013) (citation omitted), the non-moving party must show more than "[t]he mere existence of a scintilla of evidence in support of" his or her position, Anderson , 477 U.S. at 252, 106 S.Ct. 2505. That is, in order to advance to trial, "there must be evidence on which the jury could reasonably find" for the non-moving party. Id. Thus, the non-moving party "may not rest upon mere allegation or denials of his pleading but must present affirmative evidence showing a genuine issue for trial." Laningham v. U.S. Navy , 813 F.2d 1236, 1241 (D.C. Cir. 1987) (internal quotation marks and citation omitted). V. RULING ON CAUSATION As explained, Medtronic's summary judgment brief opens with an argument that it maintains disposes of this entire case: that the record contains insufficient evidence to support a jury finding that either the MMT-522 Pump or the MMT-396 Infusion Set actually caused Caroline's injuries, and thus there is no genuine dispute of fact regarding the causation element, which pertains to all of Plaintiffs' claims. (See Medtronic's Mem. at 31-32.) 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. A. The Record Evidence Thus Far Submitted Is Not Sufficient To Warrant Granting Summary Judgment To Defendants On Causation Grounds As Medtronic itself acknowledges, "[b]ecause [Caroline] was alone for a significant portion" of the evening of September 8, 2007, "we are left with an incomplete picture of exactly what happened to [her]." (Medtronic's Mem. at 21-22.) Nevertheless, Medtronic maintains that it is entitled to summary judgment at this juncture, because, in its view, what we do know from the facts that the parties have gathered thus far indicates that Caroline was not actually using her insulin pump and the associated infusion set at the time of her hypoglycemic event. (Id. at 35.) The centerpiece of Medtronic's causation claim is the deposition testimony of Caroline's roommate (Magdelena Posthumus) that the MMT-522 Pump was "not attached to [Caroline]" when Posthumus discovered Caroline in distress on the morning of September 9, 2007, but instead was laying on Caroline's desk. (See Medtronic's Mem. at 22 ("According to Ms. Posthumus, when she discovered Ms. Kubicki at 8:00 a.m., the MMT-522 Pump was not attached to Ms. Kubicki." (citing Posthumus Dep. at 20:5-12, 20:20-23, 67:24-68:22, 70:5-13) ) (emphasis omitted); see also Medtronic's Stmt. of Facts ¶ 29.) In addition, Medtronic points to Posthumus's statement to the 911 dispatcher, made shortly after she discovered her roommate, that Caroline, " 'ha[d] something that's supposed to attach to her body but it's not attached[,]' " and that Posthumus did not know whether Caroline " 'took it out herself[.]' " (Medtronic's Mem. at 22 (quoting 911 Call Transcript, Ex. W to Brown Decl., ECF No. 133-5, at 221) (first alteration in original).) Medtronic further maintains that the police officers who responded to the scene reported that Posthumus had told them that Caroline " 'carried around a device that 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 the time she suffered her acute hypoglycemic injury." (Id. at 61 (citing GWU Hosp. Records, ECF No. 138-4, at 4).) Plaintiffs also point to other statements in Caroline's medical records that suggest that it was Posthumus who removed the pump from Caroline's body (id. at 61 (citing GWU Hosp. Records at 4) ), or that Caroline had removed the pump herself on the morning of September 9 (id. at 61 (citing GWU Hops. Records at 6) ). Plaintiffs also note that a resident advisor had recalled seeing an small plastic box on Caroline's body while Caroline was unconscious in her bed (id. at 61-62 (citing Barloon Dep. at 59, 96:18-25, 89:25-93:23, 97:8-15) ), and that a paramedic has removed a "sticker" attached to Caroline's abdomen, which they surmise was the "the adhesive attached to her infusion set" (id. at 62 (citing Humphrey Dep. at 46:21-47:10, 59:8-15) ). Additionally, when deposed, both of the Kubickis testified that it simply was not Caroline's practice to take her pump off at night. (See id. (citing J. Kubicki Dep. at 418:2-4; K. Kubicki Dep. at 395:15-21).) In response, Medtronic insists that the Kubickis "mischaracteriz[e]" the evidence (Reply in Support of Medtronic's Mot. ("Medtronic's Reply"), ECF No. 145, at 11), and it provides detailed, alternative characterizations of the deposition testimony and medical records at issue (id. at 10-14). Moreover, Medtronic reiterates that "[t]he only testimony concerning what Ms. Kubicki was doing on the evening in question came from Posthumus, who testified Ms. Kubicki was asleep when Posthumus left for the evening and remained in that state from the time Posthumus returned to her dorm and read a book for an hour to when she awoke and discovered Ms. Kubicki in distress the following morning." (Medtronic's Reply at 15 (citing Medtronic Mem at 22).) This Court has no doubt that the instant record is not sufficient to establish indisputably that Caroline was not connected to her insulin pump on the night in question, because there is evidence the points in both directions, and because the issue primarily turns on Ms. Postumus's recollection of events, as Medtronic appears to have acknowledged. It is well established that "[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge at summary judgment." Barnett v. PA Consulting Grp., Inc. , 715 F.3d 354, 358 (D.C. Cir. 2013) (citation omitted). And, indeed, this Court's role in deciding a motion for summary judgment is not to "determine the truth of the matter, but instead [to] decide only whether there is a genuine issue for trial." Id. As this Court views the current record, there is evidence from which a reasonable jury could conclude either that the insulin pump was involved in Caroline's injury because it was attached to her on the night in question (see, e.g. , GWU Hosp. Records at 4, 6; Barloon Dep. at 59, 96:18-25, 89:25-93:23, 97:8-15) or that the insulin pump had nothing to do with Caroline's injury because it was laying on her desk unused at the time that Postumous discovered Caroline (see, e.g. , Posthumus Dep. at 20:5-12, 20:20-23, 67:24-68:22, 70:5-13; 911 Call Transcript). Drilling down even farther, it appears that, even if the jury were to conclude that the pump was on Caroline's desk, the causation question would not be entirely resolved, because the current record does not explain when or how Caroline's insulin pump ended up there. Based on the existing record evidence, then, a jury could only reasonably infer that the pump was placed on the desk sometime between 8:30 p.m. on the evening of September 8th-when Caroline gave herself six units of insulin (see K. Kubicki Dep. at 129:20-130:8)-and the morning of September 9th-when emergency personnel took Caroline to the hospital. Within this key block of time is a substantial period for which no competent individual can provide eyewitnesses testimony, because Posthumus was out with friends from 10:30 p.m. the evening of September 8th until 12:30 a.m. the following morning, and was asleep thereafter. Thus, Posthumus's testimony does not go far enough in answering the question of whether the pump did or did not contribute to Caroline's injury, even if it is deemed credible, which means that expert opinion regarding whether the factual circumstances reflected in the record indicate that Caroline was actually using the allegedly defective pump within the pertinent timeframe on the night of September 8th and the morning of September 9th is likely to be necessary. Consequently, the current testimony and documentary evidence are simply not sufficient to establish that there is no issue of fact for trial with respect to the material issue of whether Caroline was using her insulin pump at the time of her injury. If nothing else, it is patently obvious that the parties' volley of competing evidentiary interpretations and witness-credibility assessments raise more causation questions than the record presently answers, and these lingering questions are plainly ones that a jury-and not this Court-must resolve. See In re Fort Totten Metrorail Cases Arising Out of Events of June 22, 2009 , 895 F.Supp.2d 48, 70 (D.D.C. 2012) (noting that "proximate causation is ordinarily a question of fact for the jury.... [and] that it is only the exceptional case in which questions of proximate cause pass from the realm of fact to one of law" (internal quotation marks and citations omitted) ); see also Boodoo v. Cary , 21 F.3d 1157, 1161 (D.C. Cir. 1994) ("The court may not substitute its judgment for that of the jury: it neither assesses witness credibility nor weighs evidence." (citation omitted) ); Ferebee v. Chevron Chem. Co. , 736 F.2d 1529, 1536 (D.C. Cir. 1984) (finding that, where there was conflicting evidence regarding causation, court properly submitted the question to jury). B. The Parties Will Be Permitted To Revisit The Causation Question After Expert Discovery Is Completed To be clear: this Court's ruling on causation is a relatively narrow one, in that it pertains only to the pending motions for summary judgment. (See supra n.16.) The Court anticipates that the parties will undertake expert discovery in this matter (see Order Revising Schedule for Pretrial Proceedings, ECF No. 11, at 1-3 (setting schedule for fact discovery and initial motions, and providing that "[i]f any claims remain after this Court rules on the dispositive motions, the Court will schedule an additional period of expert discovery in preparation for trial") ), and in complex medical product liability cases such as this one, expert testimony regarding causation is ordinarily indispensable under District of Columbia law. See, e.g. , Otis Elevator Co. v. Tuerr , 616 A.2d 1254, 1260 (D.C. 1992) (noting the necessity of expert testimony "when recovery is sought for permanent injuries or where there are complicated medical questions related to causation of such injuries") (citations omitted); see also Baltimore v. B.F. Goodrich Co. , 545 A.2d 1228, 1231 (D.C. 1988) (explaining that expert testimony is necessary to establish causation in cases involving "medically complicated" claims with "multiple and/or preexisting causes") (citations omitted). As detailed below, the Court is permitting certain claims against Medtronic to proceed (see infra Part VII.B, VII.C) ), and therefore, the Court will issue a separate order that requires the parties to submit a joint proposed schedule for a period of expert discovery to commence forthwith. Once this expert discovery period has concluded, the Court will permit Medtronic to renew and supplement its request for summary judgment on the issue of causation. VI. RULING ON TIMELINESS Turning to another major argument that Medtronic and Unomedical raise in the context of their motions for summary judgment-timeliness-the Court notes that the parties do not dispute that Plaintiffs' product-liability claims for negligence, strict liability, and failure to warn are subject to the three-year statute of limitations laid out in D.C. Code § 12-301. (See Medtronic's Mem. at 55; Unomedical's Mem. at 25; Pls.' Opp'n at 63.) See also D.C. Code § 12-301(8) (actions "for which a limitation is not otherwise specially prescribed" must be brought within three years "from the time the right to maintain the action accrues"). And the parties also appear to agree that the Kubickis' claims as they relate to the MMT-522 Pump are timely. (See Medtronic's Mem. at 55.) The statute of limitations dispute is over whether the tort claims that pertain to the MMT-396 Infusion Set-which were first introduced into this litigation on November 19, 2013, six years after Caroline's injury-are time-barred. (See id. at 55-62; Unomedical's Mem. at 25-34; Pls.' Opp'n. at 63-76; Pls.' Mot. for Leave to File the First Am. Compl., ECF No. 38.) For the reasons explained below, this Court finds that the infusion set-related tort claims that the Kubickis have brought agai