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Kubicki v. Medtronic, Inc.

United States District Court, District of Columbia

February 5, 2018

JOHN KUBICKI & KAREN KUBICKI, on behalf of CAROLINE KUBICKI, Plaintiffs,
v.
MEDTRONIC, INC., et al., Defendants.

          MEMORANDUM OPINION

          KETANJI BROWN JACKSON, UNITED STATES DISTRICT JUDGE

         TABLE OF CONTENTS

         I. INTRODUCTION ................................................................................................ 1

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

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

         B. The Medtronic Paradigm Insulin Pump Model MMT-522 And The Medtronic MiniMed Paradigm Quick-set Infusion Set, Model MMT-396 ..................................................................................... 8

         1. The Design And Operation Of These Medical Devices ....................... 8

         2. The Approval, Manufacturing, And Marketing Of These Medical Devices ............................................................................................... 12

         C. Infusion Set Recalls In 2009 And 2013 ................................................... 14

         1. 2009 Return And Replace Recall Of The “Lot 8” Batch ................... 14

         2. 2013 Paradigm Infusion Set Recall .................................................. 15

         3. 2013 FDA Warning Letter ............................................................... 17

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

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

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

         C. Medtronic's And Unomedical's Motions For Summary Judgment .............................................................. 24

         IV. LEGAL STANDARD FOR MOTIONS FOR SUMMARY JUDGMENT ........... 25

         V. RULING ON CAUSATION ............................................................................... 26

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

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

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

         A. The Law Pertaining To Timeliness: Statutes Of Limitations, The Discovery Rule, And The Relation Back Doctrine ........................... 35

         1. The Discovery Rule ......................................................................... 36

         2. The Relation Back Doctrine ............................................................. 37

         B. Plaintiffs Could Have Discovered Their Claims Against Unomedical Regarding The MMT-396 Infusion Set Near The Time Of Caroline's Injury; Therefore, The Infusion Set Claims That Plaintiffs Belatedly Asserted Against Unomedical Are Untimely ..................................................................... 39

         1. Caroline's Insulin-Delivery Device Is A Multifaceted Medical Product, And The Manufacturers Of The Various Components Are Clearly Identified ................................................................................ 40

         2. Plaintiffs Rely On Dissimilar Cases To Support Their Contention That Their Infusion Set Claims Accrued In 2013 ......................................... 44

         3. The Relation Back Doctrine Does Not Save The Infusion Set-Related Claims Against Unomedical ................................................................ 48

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

         VII. RULING ON PREEMPTION ......................................................................... 54

         A. The Law Pertaining To Classification Of Medical Devices And The Express And Implied Preemption Of State Law Claims Under The Medical Device Amendments To The Food, Drug And Cosmetics Act ............................................................. 57

         1. The MDA's Device-Classification Scheme ...................................... 57

         2. Express Preemption Of State Law Claims Under the MDA ............... 60

         3. Implied Preemption Of State Law Claims Under the MDA ............... 64

         B. With One Exception, The MDA Expressly Preempts All Of The Kubickis' MMT-522 Pump Claims .................... 66

         1. State Law Claims Pertaining To The MMT-522 Pump Are Subject To The MDA's Express Preemption Provision Because That Device Was Approved Pursuant To The FDA's Premarket Approval Process .......... 67

         2. Plaintiffs Have Not Established That Their Pump-Related State Law Claims Are Genuinely Equivalent To Specific Federal Law Requirements ...................................................................................... 71

         a. . The CGMPs and general labeling and instruction regulations that Plaintiffs cite are insufficient to support a parallel state law claim asserting a design, manufacturing, or labeling defect, or a breach of warranty ....................................... 74

         b. Plaintiffs have not identified a genuinely equivalent parallel state law claim pertaining to Medtronic's failure to report events to the FDA ....................................................................... 82

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

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

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

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

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

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

         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.)[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, 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).)[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 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.)[4] Caroline now resides in a nursing facility in a persistent vegetative state, with no realistic possibility of recovery. (See Mot. Hr'g Tr. at 9:23-10:8.)

         The readings that Plaintiffs were able to recover from Caroline's glucometer showed that Caroline's insulin levels had fluctuated in the days leading up to her injury-from a low of 43 mg/dL to a high of 568 mg/dL. (See Handwritten Glucometer Readings.) The full set of data could not be recovered from the MMT-522 Pump's memory because Mr. Kubicki removed the battery from the pump after a Medtronic customer service representative told him that doing so would not impact the data saved on the device. (See Tr. of Tele. Call, Ex. 17 to Pls.' Opp'n, ECF No. 138-19, at 9.) The parties conducted joint non-destructive testing of Caroline's pump, which did not reveal any defects. (See Pls.' Opp'n at 67-68.)[5] The MMT-396 Infusion Set that Caroline was using was discarded at an unknown time shortly after Caroline's injury, and therefore the parties were not able to conduct any testing on that device. (See K. Kubicki Dep. at 322:14-325:16.)

         In the days after the hypoglycemic event, the Kubickis began gathering information in an attempt to determine what had caused Caroline's blood sugar to drop so low. Their efforts included speaking to Caroline's treating physicians at GW Hospital, one of whom suggested to the Kubickis that they preserve and test the MMT-522 Pump because it appeared that Caroline had suffered an insulin overdose. (See J. Kubicki Dep. at 23:25-25:13.) The Kubickis collected and retained Caroline's medical supplies, including the packaging materials for the discarded infusion set, and they consulted with an attorney approximately five weeks after the incident. (See Id. at 22:22-23:18.)

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

         1. The Design And Operation Of These Medical Devices

         The MMT-522 Pump is an FDA-regulated, insulin-pumping medical device that a patient wears outside her body. The device both monitors the patient's blood glucose levels and delivers insulin at rates that the patient programs. (See Decl. of Donna Twisdom (“Twisdom Decl.”), ECF No. 35-4, ¶ 3.) The MMT-522 Pump and the MMT- 396 Infusion Set work together as a system, and appear as follows when attached to a patient:

         (IMAGE OMITTED)

         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:

         (IMAGE OMITTED)

(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[6]; see also infra Part VII.A.1 (discussing the FDA's “premarket approval” (“PMA”) process). This system did not include an insulin pump as a component.

         Medtronic first released its “Paradigm” insulin pump system into the market in 2001, and it received 510(k) approval for its Paradigm MMT-515 Insulin Pump in May of 2004. See 510(k) Premarket Notification.[7] Thereafter, in October of 2005, Medtronic sought “approval for modifications to the MMT 515/715 external insulin pump and to the Guardian RT sensor to enable the pump to accept data from the sensor, and to enable the sensor to communicate directly to the pump.” (Ex. A. to Decl. of Mark Faillance (“PMA Approval”), ECF No. 35-5, at 9.) The FDA approved this new, combined system, known as the Paradigm Real Time System, through a PMA Supplement on April 7, 2006. (See Decl. of Mark Faillance (“Faillance Decl.”), ECF No. 35-5, ¶ 8.) The pump component of this approved device is the Paradigm MMT-522.[8]

         The FDA cleared the MMT-396 Infusion Set, including the vented p-cap connector that is at the center of this case, on June 7, 2001, through the 510(k) clearance process. (See Decl. of Mark O'Donnell (“O'Donnell Decl.”), ECF No. 133-3, ¶ 8.) Medtronic designed and manufactured the p-cap connector, while Unomedical, which owns the 510(k) for the MMT-396 Infusion Set, designed and manufactured all the other components of the MMT-396 Infusion Set. (See Id. ¶¶ 8-9.) Printed on the exterior of the MMT-396 Infusion Set packaging is the notation, “Assembled for Unomedical AS in Mexico, ” (Packaging Photos, Ex. 61 to Pls.' Opp'n, ECF No. 138-63, at 2), and Unomedical's name also appears on the instruction sheet for the MMT-396 Infusion Set (Infusion Set Instructions, Ex. F to Gharabli Decl., ECF No. 134-3, at 22), as well as on the individual MMT-396 Infusion Sets themselves (Mot. Hr'g Tr. 73:19-74:6).

         Unomedical's role with respect to the p-cap was limited to the assembling of its MMT-396 Infusion Set tubing with the p-cap that Medtronic provided. (See Unomedical's Stmt. of Facts ¶ 29.) Unomedical then provided the assembled MMT-396 Infusion Set to Medtronic, which Medtronic in turn sold to users in connection with its line of Paradigm insulin pumps, including the MMT-522 Pump. (See Id. ¶ 30; O'Donnell Decl. ¶ 9.) The MMT-522 Pump and MMT-396 Infusion Set are 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.

         (IMAGE OMITTED)

(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.)[9] The FDA cited various deficiencies, including Medtronic's “[f]ailure to establish and maintain procedures for implementing corrective and preventative action, as required by 21 C.F.R. 820.100(a)[, ]” (id. at 3); “failure to identify actions needed to correct and prevent recurrence of the Paradigm Insulin Infusion Pumps (MMT-5XX, 7XX) device failure” (id.); and “failure to review and evaluate all complaints to determine whether an investigation is necessary and to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate when no investigation is made” (id. at 5). The FDA also announced the agency's conclusion that, due to the 13 different CGMP violations the that agency had found, Paradigm insulin pumps dating back to 2002 qualify as “adulterated” under 21 U.S.C. § 351(h), and also “misbranded under section 502(t)(2) of the Act.” (Id. at 2, 15.) None of the 13 CGMP violations that are discussed in the warning letter pertain to the temporary-block-vent condition of the MMT-396 Infusion Set that the Kubickis allege in their complaint.[10]

         Notably, in the text of its 2013 letter to Medtronic, the FDA expressly admonished Medtronic for its reporting failures. (See Id. at 25-26 (asserting that Medtronic's “Paradigm Insulin Infusion Pumps are misbranded . . . in that your firm failed or refused to furnish material or information respecting the device that is required by or under the [MDA]” regarding incidents where users reportedly received an overdose of insulin from the pump).)[11] The FDA further faulted Medtronic for not “establish[ing] internal systems that provide for timely and effective indication, communication, and evaluation of events that may be subject to [medical device reporting] requirements[, ]” and for not “establish[ing] internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part.” (Id. at 26.)

         III. PROCEDURAL HISTORY

         A. The Initial Pump-Related Legal Action The Plaintiffs Brought ...


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