KETANJI BROWN JACKSON, United States District Judge.
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
C. Infusion Set Recalls In 2009 And 2013...146
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
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
A. The Law Pertaining To Timeliness: Statutes Of Limitations, The Discovery Rule, And The Relation Back Doctrine...157
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
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
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
B. With One Exception, The MDA Expressly Preempts All Of The Kubickis' MMT-522 Pump Claims...173
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
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
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)
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.)
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
A separate Order consistent with this Memorandum Opinion will follow.
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).)
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
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.)
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-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
(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:
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.)
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
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.
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
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).
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.
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
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
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.)
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).)
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.)
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
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)).
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.)
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:
(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.)
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,
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.)
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).
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'
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.
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 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
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
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).
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)),
Turning to another major argument that Medtronic and Unomedical raise in the context of their motions for summary judgment — timeliness — the Court notes that the parties do not dispute that Plaintiffs' product-liability claims for negligence, strict liability, and failure to warn are subject to the three-year statute of limitations laid out in D.C. Code § 12-301. (See Medtronic's Mem. at 55; Unomedical's Mem. at 25; Pls.' Opp'n at 63.) See also D.C. Code § 12-301(8) (actions "for which a limitation is not otherwise specially prescribed" must be brought within three years "from the time the right to maintain the action accrues"). And the parties also appear to agree that the Kubickis' claims as they relate to the MMT-522 Pump are timely. (See Medtronic's Mem. at 55.) The statute of limitations dispute is over whether the tort claims that pertain to the MMT-396 Infusion Set — which were first introduced into this litigation on November 19, 2013, six years after Caroline's injury — are time-barred. (See id. at 55-62; Unomedical's Mem. at 25-34; Pls.' Opp'n. at 63-76; Pls.' Mot. for Leave to File the First Am. Compl., ECF No. 38.) For the reasons explained below, this Court finds that the infusion set-related tort claims that the Kubickis have brought against Unomedical are not timely, because such claims could have (and should have) been discovered shortly after Caroline's injury in 2007, and Unomedical had no notice of the infusion set claims against it until the Kubickis filed an amended complaint, six years after the injury occurred. However, the infusion set-related tort claims against Medtronic are not time-barred, because these otherwise untimely claims concerning the MMT-396 Infusion Set relate back to the timely claims that the Kubickis had filed against Medtronic concerning the MMT-522 Pump.
A statute of limitations is the legislatively prescribed time period (usually a period of years) within which an authorized legal claim must be filed. See Statute of Limitations, Black's Law Dictionary (10th ed. 2014) (defining statute of limitations); see also Rudder v. Williams, 47 F.Supp.3d 47, 52 (D.D.C. 2014) ("`Statutes of limitations ... represent a pervasive legislative judgment that it is unjust to fail to put the adversary on notice to defend within a specified period of time and that the right to be free of stale claims in time comes to prevail over the right to prosecute them.'" (quoting United States v. Kubrick, 444 U.S. 111, 117, 100 S.Ct. 352, 62 L.Ed.2d 259 (1979) (alteration in original))). Claims that are brought beyond the statutory time period are ordinarily barred. See Untalasco v. Lockheed Martin Corp., 249 F.Supp.3d 318, 323 (D.D.C. 2017) ("[T]he general rule that one can glean from [precedent] is that courts should apply the [District of Columbia] statute of limitations strictly, even though barring actions often seems arbitrary and inequitable." (internal quotation marks, citation, and emphasis omitted)). However, when a plaintiff files a timely legal action regarding an injury, and then later seeks to assert a potentially out-of-time claim in the context of an amended complaint, two independent and alternative concepts can apply to permit such an amendment: "the
The discovery rule alters the typical understanding of when the statute of limitations starts to run, (i.e., when it "accrues.") It is well established that, "[w]here the fact of an injury can be readily determined, a claim accrues for purposes of the statute of limitations at the time the injury actually occurs." Colbert v. Georgetown Univ., 641 A.2d 469, 472 (D.C. 1994) (citations omitted). But, if the injury is not apparent, and/or if the causal link between tortious conduct and injury is not immediately clear, District of Columbia courts apply the "discovery rule[,]" which holds that the statute of limitations begins to run not on the date that the injury happened, but "`when the plaintiff has knowledge of (or by the exercise of reasonable diligence should have knowledge of) (1) the existence of the injury, (2) its cause in fact, and (3) some evidence of wrongdoing.'" Lee v. Wolfson, 265 F.Supp.2d 14, 17 (D.D.C. 2003) (quoting Bussineau, 518 A.2d at 425); see also Colbert, 641 A.2d at 473 (holding that plaintiff's claim for medical malpractice did not accrue until she "discovered or reasonably should have discovered all of the essential elements of her possible cause of actions") (quotation marks and citation omitted).
The District of Columbia Court of Appeals has made clear that, per the discovery rule, "the statute of limitation[s] for negligence begins to run at such time a prospective plaintiff gains inquiry notice that wrongdoing may be involved." Bussineau, 518 A.2d at 427-28. This means that what a plaintiff knows, or should have known, about the defendant's potential fault is key. Id. Nevertheless, the statute of limitations will be deemed to run even if the plaintiff does not fully comprehend the extent to which a potential defendant may have caused the injury. See Baker v. A.H. Robins Co., 613 F.Supp. 994, 996 (D.D.C. 1985). Furthermore, a plaintiff who has suffered an injury must act reasonably and diligently to investigate the possibility of a claim, and a litigant is deemed to have inquiry notice of a claim that he should have discovered by exercising this reasonable diligence. See id. at 996; see also Reeves v. Eli Lilly & Co., 368 F.Supp.2d 11, 21 (D.D.C. 2005) (emphasizing that the reasonableness of an investigation is evaluated under an objective standard). Put another way:
Diamond v. Davis, 680 A.2d 364, 381 (D.C. 1996). In the context of the discovery rule, it is the defendant's burden to show that the plaintiff has not acted with reasonable diligence. See Smith v. Brown & Williamson Tobacco Corp., 108 F.Supp.2d 12, 17 (D.D.C. 2000).
Federal Rule of Civil Procedure 15(c) "governs when an amended pleading `relates
Significantly for present purposes, the relation-back doctrine and the discovery rule both generally pertain to knowledge of the claim; however, these doctrines address different parties. The discovery rule focuses on the knowledge of the plaintiff, while the relation back doctrine focuses on whether a defendant has had fair notice of the plaintiff's claim. Compare Lee, 265 F.Supp.2d at 17 (holding that the statute of limitations begins to run under the discovery rule when a plaintiff knows, or should know, of an injury, its causation, and some wrongdoing on the part of the defendant) with Meijer, Inc., 533 F.3d at 866 ("The underlying question is whether the original complaint adequately notified the defendants of the basis for liability the plaintiffs would later advance in the amended complaint."); Hartley v. Wilfert, 931 F.Supp.2d 230, 233 (D.D.C. 2013) (explaining that, for purposes of the relation back doctrine, "notice to the defendant is relevant to the inquiry"); see also, e.g., Dover v. Medstar Wash. Hosp. Ctr., 989 F.Supp.2d 57, 59, 61-62 (D.D.C. 2013) (holding that claims for violations of D.C.'s overtime statute did not relate back to timely claims for intentional interference with prospective advantage and economic expectancy, intentional misrepresentation, and defamation because of defendants' lack of notice of the alleged wage payment violations). Ultimately, "[s]o long as the original and amended [complaints] state claims that are tied to a common core of operative facts, relation back will be in order." Mayle v. Felix, 545 U.S. 644, 664, 125 S.Ct. 2562, 162 L.Ed.2d 582 (2005).
Plaintiffs first named Unomedical as a defendant, and made associated claims arising from Unomedical's manufacture of the MMT-396 Infusion Set, on January 10, 2014 — more than six years after Caroline's hypoglycemic event. (See Am. Compl.) In response to the timeliness objection that both Medtronic and Unomedical raise in their summary judgment motions, Plaintiffs insist that their newly-asserted infusion set claims are not time-barred, because Plaintiffs "could not have conceivably connected Caroline Kubicki's severe hypoglycemic injury" to a defect or malfunction in the MMT-396 Infusion Set prior to June 2013 Paradigm Infusion Set recall. (Pls.' Opp'n at 65; see also id. at 66 ("[T]he public was not made aware of the role of the Infusion Set in the over-delivery of insulin until June 7, 2013, when the Class I recall concerning the temporary vent block condition was issued." (citation omitted)).) This Court rejects the Kubickis' contention that their product-liability claims arising from the MMT-396 Infusion Set accrued only as of
First of all, as explained in Part II.B, supra, a mechanical insulin-delivery pump is a complex medical device that has many intricate parts, even to the lay observer. In the wake of Caroline's injury, basic due diligence in evaluating the suspected source of the alleged insulin overdose would have led a reasonable plaintiff to discover relatively quickly that Caroline's insulin-delivery device has various components; moreover, a reasonable plaintiff certainly would have surmised that any one of the device's various components could have been responsible for Caroline's injury. Indeed, the record establishes that the Kubickis understood at the time of Caroline's injury that the MMT-522 Pump and the MMT-396 Infusion Set worked together to provide insulin to Caroline (see J. Kubicki Dep. at 85:3-9; K. Kubicki Dep. at 324:3-16), which makes it all the more unreasonable for Plaintiffs to have filed an initial complaint that only contained claims related to an alleged defect in one component of Caroline's insulin-delivery device (the MMT-522 Pump).
The fact that Karen Kubicki may have subjectively believed that the potentially defective insulin-delivery product was a unitary object (see K. Kubicki Dep. at 324:3-16 (asserting that she considered the pump and infusion set as "one [and] the same")) is of no moment. As explained, the applicable standard of knowledge for the purposes of the discovery rule is an objective one, see Baker, 613 F.Supp. at 996, and given the totality of the facts and circumstances here, (including those that would have been uncovered by a diligent investigation), it is clear to this Court that an objectively reasonable plaintiff would have readily discovered that the pump and the infusion set were distinct components of the Caroline's insulin-delivery device, especially after one of Caroline's physicians specifically expressed to the Kubickis a concern about the fact that Caroline's MMT-396 Infusion Set had been discarded after the injury. (See K. Kubicki Dep. at 322:6-7 (acknowledging that the doctor had told them "you would want everything that [Caroline] was using" in trying to figure out what happened); see also id. at 322:14-23, 324:3-16.) And even without such pointed statements from persons with knowledge of the device in question, a reasonable plaintiff would have at least consulted the packaging materials that accompanied the seemingly defective medical device, and thereby would have discovered that the infusion set tubing that delivers insulin to the body was packaged separately from the potentially defective mechanical pump — another indisputable marker of a separate piece of medical equipment.
Plaintiffs' contention that, as laypeople, they could not possibly have known that a defect in the p-cap valve of the MMT-396 Infusion Set caused Caroline's injury before the recall in June of 2013 (see Pls.' Opp'n at 66) misses the mark entirely, insofar as it suggests that the statute of limitations does not accrue on a products-liability claim until the plaintiff has sufficient information to make specific allegations with respect to causation. Quite to the contrary, it is well established that, while a plaintiff must have "knowledge of wrongdoing to commence the statute of limitation[s,]" Bussineau, 518 A.2d at 432 n.11, he need not "have certain knowledge of causation[,]" Dawson v. Eli Lilly and Co., 543 F.Supp. 1330, 1334 (D.D.C. 1982).
In this case, there is an additional wrinkle: the Kubickis' unreasonable failure to assert timely product-liability tort claims relating to a key component of Caroline's insulin-delivery device also means they failed to identify Unomedical, and to include that company as a defendant in this action in a timely fashion. Again, while Karen Kubicki may not have actually known that there was another company involved in the manufacture of the medical device that she suspected caused Caroline's injury (see Pls.' Opp'n at 68 (referencing Karen Kubicki's statement that she "did not know who made the Infusion Set and only thought that Medtronic was involved")), and in this Court's view, an objectively reasonable plaintiff would easily have discovered at the time of Caroline's injury that a potential tort claim arising from the MMT-396 Infusion Set existed and was assertable against that product's manufacturer. What is more, the product packaging and instructions related to the MMT-396 Infusion Set clearly state that the MMT-396 Infusion Set was "Assembled in Mexico for Unomedical A/S" (Packaging Photos; Infusion Set Instructions), and Unomedical's name also appears on the MMT-396 Infusion Set itself (Mot. Hr'g Tr. 73:19-74:6.), which makes the Kubickis' failure to conduct even the most minimal investigation all the more obvious here.
In any event, there is no question that the Kubickis had an obligation to conduct an investigation into all of the potential sources of the product that they suspected was the cause of Caroline's injury. They were certainly aware that someone had manufactured all of the components of the device in question; thus, they were on "inquiry" notice that medical-device manufacturers had a role in making Caroline's infusion set, and should have looked into whether any companies other than Medtronic were involved. See Berkow v. Lucy Webb Hayes Nat'l Training Sch. for Deaconesses & Missionaries Conducting Sibley Mem'l Hosp., 841 A.2d 776, 781 (D.C. 2004) (noting that "a plaintiff's knowledge of one defendant's misconduct will `create inquiry notice of claims against a potential co-defendant ... if (1) a reasonable plaintiff would have conducted an investigation as to the co-defendant, and (2) such an investigation would have revealed some evidence of wrongdoing[,]'" and holding that plaintiff's knowledge of one doctor's misdiagnosis of him placed him on inquiry notice of claims against other doctors who allegedly contributed to the misdiagnosis (quoting Cevenini v. Archbishop of Wash., 707 A.2d 768, 773 (D.C. 1998) (alteration in original))).
This all means that nothing about the circumstances here persuades this Court that it was reasonable for the Kubickis to forego an investigation of all of the potential producers of the various parts of Caroline's insulin-delivery device when they undertook to bring a timely products-liability lawsuit in 2010. It is undisputed that the MMT-396 Infusion Set works together with the MMT-522 Pump, and even setting aside the obvious indications on the packaging materials and the device itself that a company other than Medtronic was involved with the manufacture of that component, a reasonable plaintiff would have investigated the origins of the device in
The functional connection between the MMT-522 Pump and the MMT-396 Infusion Set, and the fact that the Kubickis suspected a defect in Caroline's insulin-delivery system immediately but chose to file a timely action against only one of the companies involved in the manufacture of the components of that system, differentiates this case from Lee v. Wolfson, 265 F.Supp.2d 14 (D.D.C. 2003), on which Plaintiffs rely. The plaintiff in Lee sued for damages as a result of injuries that she suffered when an unattended vehicle in a parking garage struck her. Notably, after testing showed no issues with the parking break mechanism, Lee's complaint alleged that the cause of her injury was human error in either failing to set the parking brake or inadvertently releasing it, id. at 16, and consistent with this theory, Lee initially named the owner of the rolling car and the parking garage as defendants, id. The National Highway Traffic Safety Administration subsequently issued a recall to correct a defect in the parking brake design, which prompted Lee to seek to amend her complaint to add the car's manufacturer, id. at 16-17, and the Court authorized the amendment as timely. In finding that Lee's claims against the manufacturer did not accrue until the recall notice issued, the Lee court held that "plaintiff here cannot automatically be expected to know that wrongful conduct on the part of [the manufacturer] might have caused the release of the [rolling car's] parking brake at the time of her injury, particularly when no defect in the parking brake was revealed during the investigation of the accident by the police or plaintiff's expert." Id. at 18.
Here, by contrast, the Kubickis' initial claim of wrongdoing concerned an alleged product-related defect pertaining to the insulin-infusion system that Caroline used (otherwise they could not have in good faith sued Medtronic). And having suspected a problem with that system, it was incumbent upon the Kubickis to conduct a reasonable inquiry into all of the possible components of that system in a timely fashion. See Diamond, 680 A.2d at 381; see also Colbert, 641 A.2d at 472-73 (holding that "[w]here the fact of an injury can be readily determined, a claim accrues for purposes of the statute of limitations at the time the injury actually occurs[,]" but "[w]here the relationship between the fact of injury and the alleged tortious conduct may be obscure," the claim accrues when the plaintiff "knew or should have known that she had suffered injury as a result of the defendants' negligence"). In other words, the instant case is substantially different from Lee, because while the plaintiff in Lee lacked fair notice of any wrongdoing with respect to the parking brake system of the car that had injured her and was instead proceeding on a human-error tort theory, the Kubickis suspected a product defect from the outset, and therefore, had the obligation to examine timely all of the
A more analogous case is Colarossi v. Schmid Laboratories, Inc., 830 F.Supp. 230 (D.N.J. 1993), in which the court found that a claim against a manufacturer of intrauterine devices ("IUDs") was untimely under District of Columbia law. The plaintiff in Colarossi learned from her doctor in 1978 that her IUD might have caused an infection that led to permanent injuries. Id. at 237. The court found that her claim accrued at that point in time, noting that "[f]aced with permanent injury and [a] statement by her doctor that her IUD may have been the cause, wrongdoing by someone was more than a hypothetical possibility and the wrongdoing element was met." Id. (alterations, internal quotation marks, and citation omitted); see also id. at 236 ("The wrongdoing element does not, however, require that the plaintiff know the identity of the party responsible for the injury."). In the alternative, the court found that the claim accrued no later than 1986, which was when the plaintiff learned of, and participated in, litigation related to Dalkon Shield IUDs. Id. at 237. Notably, the Colarossi plaintiff made a critical mistake in connection with that litigation: she failed to review her own medical records to determine the specific manufacturer of the IUD that she had used, and as a result, she only sued the manufacturer of Dalkon Shield IUDs, not the manufacturer of the brand of IUD that was identified in her medical records. Id. When the plaintiff later learned of her error and tried to sue the correct manufacturer, the court pegged 1986 as the latest possible accrual date because, at that point, "not only was [the plaintiff] aware of the possibility of wrongdoing, she took affirmative action to obtain legal redress." Id.; see also id. (faulting plaintiff for failing to exercise due diligence because she failed to examine her medical records before initiating suit).
So it is here. The Kubickis knew of potential wrongdoing on the part of the manufacturers of Caroline's insulin-delivery system in 2007, when Caroline suffered her injury and when her treating physician advised them that Caroline's insulin-delivery system (consisting of the MMT-522 pump and MMT-396 Infusion Set) could be the cause. (See J. Kubicki Dep. at 23:25-25:13.) And even if it was reasonable for the Kubickis to fail to make a connection between the insulin-delivery system and potential wrongdoing in 2007, they undeniably had made that connection by the time they filed a lawsuit against Medtronic in 2010, which means that, at the very latest, their product-liability claims accrued in 2010 (see Brown Decl. ¶ 3), four years before they undertook to litigate tort claims specifically pertaining to the MMT-396 Infusion Set.
The 2009 Lot 8 recall — through which Medtronic recalled certain MMT-396 Infusion Sets from a particular manufacturing lot but provided public assurances that all other lots were safe and effective (see 2009 Recall Notice, Ex. 18 to Pls.' Opp'n, ECF No. 138-28, at 1) — has no bearing on the aforementioned analysis of the accrual of the Kubickis' claims. Plaintiffs assert that Medtronic's safety assurances with respect to non-Lot 8 infusion sets "led Plaintiffs to not consider the MMT-396 Infusion Set as a potential cause in fact." (Pls.' Opp'n at 70.) But, if anything, the 2009 recall notice would have spurred a reasonable plaintiff to inquire further regarding this component of the Caroline's insulin-delivery system, because in the context of the Lot 8 recall, Medtronic expressly identified a particular fault mechanism in the MMT-396 Infusion Set that could result in the over-delivery of insulin, i.e., the blocking of air vents in the tubing connector. (See Questions & Answers Regarding the "Lot 8" Quick-set Infusion Set Recall, Ex. 27 to Pls.' Opp'n, ECF No. 138-29, at 3; see also
Thus, armed with the general knowledge that blockage of the infusion set air vents could lead to an over-delivery of insulin, and believing that Caroline was injured as the result of an over-delivery of insulin, an objectively reasonable plaintiff would by no means have felt "reassured" by Medtronic's assertions; instead, she would have even more vigorously investigated, and pursued, tort claims against any entity that had played a role in the manufacture of Caroline's MMT-396 Infusion Set, including Unomedical.
Plaintiffs have invoked the "relation back" doctrine to maintain that, even if this Court concludes that the amended complaint's claims related to the MMT-396 Infusion Set are untimely because those claims could have been discovered long before Plaintiffs filed the amended complaint, the infusion set claims should nevertheless be deemed timely. (See Pls.' Opp'n at 74.) To support this argument, Plaintiffs cite to Federal Rule of Civil Procedure 15(c)(1)(B), which provides that an amended pleading relates back to the date of the original pleading when "the amendment asserts a claim or defense that arose out of the conduct, transaction, or occurrence set out — or attempted to be set out — in the original pleading[.]" Fed. R. Civ. P. 15(c)(1)(B). In this regard, Plaintiffs argue that "the Second Amended Complaint does not introduce any new legal theories into this litigation, but instead only amplifies the original factual allegations to include the Infusion Set" (Pls.' Opp'n at 75 (emphasis added) (internal citations and quotation marks omitted)). Be that as it may, this Court concludes that the infusion set-related claims against Unomedical cannot be considered to relate back to the original complaint for statute of limitations purposes, for the following reasons.
It is clear beyond cavil that relation back under Rule 15(c)(1)(B) is permissible only if the defendant had "sufficient notice of the facts and claims giving rise to the proposed amendment" prior to the expiration of the statute of limitations. United States v. Hicks, 283 F.3d 380, 388 (D.C. Cir. 2002). Thus, the general rule is that "new parties, either plaintiffs or defendants, cannot be added to an action by amendment after the applicable limitations period has expired[,]" 6A Charles A. Wright, et al., Federal Practice & Procedure § 1498 (3d ed. 2017), because a new defendant typically would not be aware of the claims, having not been named in the original suit. Rule 15(c)(1)(C) alters this general rule, but it allows the addition of a
Thus, "relation back under Rule 15(c)(1)(C) depends on what the party to be added knew or should have known, not on the amending party's knowledge or its timeliness in seeking to amend the pleading." Krupski, 560 U.S. at 541, 130 S.Ct. 2485 (emphasis added); see also Philogene v. Dist. of Columbia, 864 F.Supp.2d 127, 133 (D.D.C. 2012) ("This Circuit has explained that the purpose of [Rule 15(c)(1)(C)] is to `avoid the harsh consequences of a mistake that is neither prejudicial nor a surprise to the misnamed party.'" (quoting Rendall-Speranza v. Nassim, 107 F.3d 913, 918 (D.C. Cir. 1997))); see, e.g., Placide Ayissi-Etoh v. Mae, 49 F.Supp.3d 9, 13-14 (D.D.C. 2014) (holding that amendment adding individual capacity claims to employment discrimination suit did not relate back under Rule 15(c)(1)(C) to original complaint alleging corporate capacity claims where record "strongly support[ed] an inference that the individual [d]efendants did not have notice" of potential for individual capacity claims, such that the amendment "would be highly prejudicial"). Consequently, "[a] potential defendant who has not been named in a lawsuit by the time the statute of limitations has run is entitled to repose — unless it is or should be apparent to that person that he is the beneficiary of a mere slip of the pen, as it were." Rendall-Speranza, 107 F.3d at 918.
The Kubickis here have presented no evidence that contradicts Unomedical's contention that it was not aware of this litigation until 2014. (See Decl. of Rabi Gharabit, Ex. D to Unomedical's Reply, ECF No. 142-5, ¶ 4.) Nor is this a circumstance where the omission of Unomedical was due to clerical error or confusion about closely-related corporate entities. Cf. Krupski, 560 U.S. at 554-55, 130 S.Ct. 2485 (concluding that the district court erred in denying relation back where the corporate defendant that plaintiff sought to add under Rule 15(c)(1)(C) was related to named defendant, had "constructive notice" of the original complaint within the Rule 4(m) period, and should have known that it would have been named in the original complaint but for plaintiff's mistake about which corporate entity was the proper defendant); Miller v. Holzmann, Civil Action No. 95-1231, 2007 WL 778599, at *2-3 (D.D.C. Mar. 6, 2007) (holding that an amended complaint adding a new defendant related back to prior complaint where all defendants were closely-related members of the same corporate family and represented by the same counsel and the newly-named defendant should have known that it was the intended defendant all along). Indeed, the Kubickis did not make any specific product-defect allegations regarding the MMT-396 Infusion Set — the only portion of the insulin-delivery system to which Unomedical had any connection — until 2014, and Unomedical therefore would have no reason to suspect before that time that it could be subject to liability for Caroline's injuries. This lack of notice undoubtedly forecloses the Kubicki's reliance on the relation back doctrine to render timely their tort claims against
As a party to the original action, Medtronic stands in markedly different shoes than Unomedical does, as far as the Kubicki's infusion set claims are concerned. As explained above, Federal Rule of Civil Procedure 15(c)(1)(B) specifically contemplates the circumstances under which an amendment to a pleading "relates back to the date of the original pleading" for the purpose of the statute of limitations, and unlike the infusion set claims against Unomedical (which had nothing to relate back to because Unomedical was not named in the original complaint), the relation-back question with respect to the MMT-396 Infusion Set claims that Plaintiffs have belatedly brought against Medtronic is whether these claims "arose out of the conduct, transaction, or occurrence" laid out in Plaintiffs' initial pleading, Fed. R. Civ. P. 15(c)(1)(B), such that Medtronic had "been put on notice regarding the claim ... raised by the amended pleading[,]" 6A Charles A. Wright, et al., Federal Practice & Procedure § 1497 (3d ed. 2017).
Not surprisingly, Medtronic says `no': it argues that the initial complaint provided no notice of the potential infusion set claims, and that "[t]he addition of an entirely new device as a potential cause of Ms. Kubicki's injuries is a `substantial' alteration to this case and provides Plaintiffs with an entirely new legal theory for why Ms. Kubicki was injured." (Medtronic's Mem. at 62.) Elsewhere in its brief, however, Medtronic acknowledges that "the MMT-522-Pump and MMT-396 Infusion Set worked together to deliver insulin[,]" such that one component of the system would be useless for insulin-delivery without the other. (Id. at 61.) In addition, Medtronic does not dispute the fact that both medical devices are sold under Medtronic's name, and are components of the same system that Medtronic markets for use to deliver insulin to consumers. (See Product Photos, Ex. 61 to Pls.' Opp'n, ECF 138-63, at 2; Infusion Set User Guide, Ex F. to Decl. of Michael Wallace, ECF No. 133-4, at 12 ("The Quick-set is indicated for the subcutaneous infusion of medicine, including insulin, from a Paradigm infusion pump and reservoir."); Pump User Guide, Ex. 24 to Pl.'s Opp'n, ECF No. 138-26, at 4 (instructing user to "insert the infusion set into your body as described in the next section.").)
Thus, Medtronic's insistence that it had no notice of any potential claims arising from the design or operation of Caroline's infusion set is unpersuasive. The initial complaint clearly alleges that Caroline was injured when she received an overdose of insulin as a result of being connected to the MMT-522 Pump. (See Compl. ¶¶ 14 ("A number of technical problems have been reported with the use of insulin pumps including, but not limited to, the pumps' delivery of too much insulin resulting in hypoglycemia."); 16 ("On or about September 9, 2007, Caroline Kubicki ... was found to be unresponsive and unarousable by her roommate as a result of her malfunctioning MiniMed Insulin Pump."); 72 ("If Caroline had known the true facts concerning the risks of the use of the MiniMed Insulin Pump, in particular, the risk of significant hypoglycemic event with anoxic brain injury, she would not have used the product.").) Consequently, Medtronic knew from the outset that the company was facing timely allegations of product-related deficiencies that had allegedly caused a serious injury, and the subsequent addition of even more specific allegations regarding another component of
In short, as explained above, the relation back doctrine deems timely an otherwise untimely amendment to a complaint when the defendant had adequate notice of the claims that are subsequently added, and this Court is confident that such is the case with respect to the Kubicki's infusion set claims against Medtronic. Given the allegations of the original complaint and the interrelation between the pump and the infusion set in delivering insulin to users, Medtronic knew or should have known from Plaintiffs' initial allegations that infusion set claims existed and may yet be asserted, and Medtronic can hardly be heard to complain that it was not sufficiently alerted to a potential problem with MMT-396 Infusion Set and the p-cap valve in particular, when these components play a crucial role in ensuring that the pump delivers insulin at the correct rate and when the Kubickis' core allegation was over-delivery of insulin to a pump-user. Therefore, although the claims in Plaintiffs' complaint concerning the MMT-396 Infusion Set were not asserted timely in the first instance, this Court concludes that these otherwise time-barred claims relate back to the timely claims regarding the MMT-522 Pump that Plaintiffs brought against Medtronic in the initial complaint, and as a result, these claims against Medtronic are deemed timely for statute of limitations purposes.
The thorniest legal issue that Medtronic raises as grounds for dismissal of the Kubickis' claims is preemption — a doctrine that has its roots in the Supremacy Clause of the U.S. Constitution. See Gade v. Nat'l Solid Wastes Mgmt. Ass'n, 505 U.S. 88, 108, 112 S.Ct. 2374, 120 L.Ed.2d 73 (1992) ("[U]nder the Supremacy Clause, from which our pre-emption doctrine is derived, any state law, however clearly within a State's acknowledged power, which interferes with or is contrary to federal law, must yield." (internal quotation marks and citation omitted)). As relevant here, Congress has vested the Food and Drug Administration ("FDA") with the authority to regulate medical devices; consequently, state law legal claims that pertain to such devices implicate questions of both express preemption and implied preemption. As a general matter, express preemption occurs when a federal statute explicitly sets forth the particular circumstances in which state law claims cannot be maintained. See Waterview Mgmt. Co. v. FDIC, 105 F.3d 696, 700 (D.C. Cir. 1997). By contrast, as relevant here, "[i]mplied preemption occurs ... where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress left no room for supplementary state regulation[,]" Armstrong v. Accrediting Council for Continuing Edu. & Training, 168 F.3d 1362, 1369 (D.C. Cir. 1999) (internal quotation marks and citation omitted), which renders state law claims that seek merely to enforce federal duties effectively barred. See Buckman, 531 U.S. at 352, 121 S.Ct. 1012.
Medtronic argues that Section 360k(a) of the Medical Device Amendments to the
The parties' arguments are largely based on established law concerning the express and implied preemption of state law claims involving medical devices — law that is "charitably speaking, utterly conflicted[,]" In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F.Supp.2d 1147, 1150 (D. Minn. 2009) — and as explained below, the parties' various contentions yield mixed results. In sum, this Court concludes that all of the claims pertaining to the MMT-522 Pump are expressly preempted, with the exception of one narrow aspect of the claim alleging a pump-related manufacturing defect, and that none of the claims pertaining to the MMT-396 Infusion Set are impliedly preempted, except for one claim that pertains to Medtronic's allegedly tortious failure to report adverse events to the FDA. What remains, then, is a single manufacturing defect claim concerning the MMT-522 Pump, as well as almost all of the claims against Medtronic that pertain to the MMT-396 Infusion Set; these will be the claims at issue during the forthcoming period of expert discovery.
In 1976, Congress responded to "a bevy of state laws regulating medical devices largely enacted due to the failure of the Dalkon Shield contraceptive in the 1970s," id. at 1150, by enacting the Medical Device Amendment ("MDA") to the Federal Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. §§ 301-399h. In essence, the MDA expanded the regulatory scope of the FDCA to include medical devices. See In re Medtronic, 592 F.Supp.2d at 1150-51 (citing 21 U.S.C. § 360k). As amended, the FDCA "classifies medical devices in three categories based on the risk that they pose to the public[,]" Medtronic, Inc. v. Lohr, 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), with Class III being reserved for those devices that pose the most significant risk of illness or injury to users.
Notably, once the FDA has granted premarket approval to a device, the manufacturer generally may not make changes to the design, labeling, manufacturing process, or any other aspect of the device without further FDA approval. See id. at 319, 128 S.Ct. 999; see also id. at 323, 128 S.Ct. 999 ("[T]he FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness."). "If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application." Id. (citing § 360e(d)(6), 21 C.F.R. § 814.39(c)). Furthermore, a PMA device manufacturer also has certain post-approval reporting duties, including the obligation to report to the FDA all known incidents in which the device "(1) [m]ay have caused or contributed to death or serious injury, or (2) [may have] malfunctioned and ... would be likely to cause or contribute to death or serious injury, if the malfunction were to recur[.]" 21 CFR § 803.50(a). Such reporting must take place within 30 days of when the manufacturer "receive[s] or otherwise become[s] aware of [the] information." Id.
In recognition of the fact that the lengthy PMA process can substantially delay the introduction of improvements to existing medical devices, "the [MDA] ... permits devices that are `substantially equivalent' to pre-existing devices to avoid the PMA process." Lohr, 518 U.S. at 478, 116 S.Ct. 2240 (quoting 21 U.S.C. § 360e(b)(1)(B)). To be substantially equivalent to a pre-existing Class I, II, or III medical device, "the new device must have the same intended use as the predicate device, and either (i) have the same technological characteristics as the predicate device or (ii) be shown to be as safe and effective as the predicate devices." Ivy Sports, 767 F.3d at 83 (quoting 21 U.S.C. § 360c(i)(1)(A) (internal quotation marks omitted). The FDA has a process for conducting a substantial equivalence review — known as the "§ 510(k) process" — which is triggered when a manufacturer who intends to introduce a new medical device into the market submits to the FDA a "premarket notification" that "states the new device's intended use, identifies the predicate devices to which the new device is substantially equivalent, and offers a
It is important to recognize that "[t]he § 510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is completed in an average of only 20 hours." Lohr, 518 U.S. at 478-79, 116 S.Ct. 2240 (citation omitted). This is in large part because, while the PMA process focuses on the safety and efficacy of a device, the § 510(k) process focuses only on whether the new device is equivalent to an existing device. Id. at 493, 116 S.Ct. 2240. Thus, "`[t]he attraction of substantial equivalence to manufacturers is clear. [Section] 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed very quickly.'" Id. at 479, 116 S.Ct. 2240 (quoting Robert Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L.J. 511, 516 (1988)) (second alteration in original). Consequently, the abbreviated § 510(k) process has become the route by which the vast majority of new medical devices — including Class III devices, which by definition pose the highest level of risk to the patient — enter the marketplace. See id.; see also Riegel, 552 U.S. at 317, 128 S.Ct. 999 ("In 2005, for example, the FDA authorized the marketing of 3,148 devices under § 510(k) and granted premarket approval to just 32 devices.").
Manufacturers who opt to engage in the expensive and time-consuming PMA process with respect to new medical devices get the benefit of express statutory protection from certain state law claims relating to the device. See 21 U.S.C. § 360k(a); Lohr, 518 U.S. at 492-94, 116 S.Ct. 2240. In this regard, section 360k(a) of Title 21 of the U.S. Code states (in relevant part) that
21 U.S.C. § 360k(a). The reach of this express exemption clause has been extensively litigated over the past three decades, and as a result, the Supreme Court has established a two-part test that courts must use when evaluating whether state law claims fall within the scope of 21 U.S.C. § 360k(a). See Riegel, 552 U.S. at 321-22, 128 S.Ct. 999. Pursuant to the prescribed analysis, courts must consider, first, "whether the Federal Government has established requirements applicable to" the device, and second, "whether the [plaintiff's] common-law claims are based upon [state] requirements with respect to the device that are `different from, or in addition to,' the federal ones, and that relate to safety and effectiveness." Id. (quoting 21 U.S.C. § 360k(a)).
It is by now well established that the FDA's affirmative grant of premarket approval to a medical device through the PMA review process satisfies the first prong of this two-part inquiry. Id. at 322-23, 128 S.Ct. 999 (noting that premarket approval "imposes requirements under the MDA" because "the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application" (internal quotation marks omitted)). By contrast, if a device has been approved
With respect to the second prong of the express preemption inquiry, the Supreme Court has held that state common law claims for negligence, strict liability, and breach of warranty, among other things, qualify as "requirements ... with respect to devices" for the purpose of the MDA's express preemption clause. Riegel, 552 U.S. at 324, 327, 128 S.Ct. 999. Thus, current express preemption disputes in the medical-device context often involve the issue of whether the asserted state common law claims effectively impose obligations on manufacturers that are "different from, or in addition to" the federal requirements. Id. at 321, 128 S.Ct. 999 (quoting § 360k(a)(1)); see, e.g., Cupek v. Medtronic, Inc., 405 F.3d 421, 424-25 (6th Cir. 2005); In re Medtronic, Inc., 592 F.Supp.2d at 1156-65; see also Duggan, 840 F.Supp.2d at 469 (commenting that "[m]any state common law claims impose duties with respect to devices that are "different from, or in addition to" federal requirements, satisfying the preemption test's second prong" (citations omitted)).
It is important to underscore the fact that, as the MDA has been interpreted, the express preemption clause does not afford the manufacturer of a PMA-approved medical device absolute immunity from all device-related lawsuits arising under state law, but only those that are based on requirements that differ from, or augment, the federal requirements. See Hughes v. Boston Sci. Corp., 631 F.3d 762, 767 (5th Cir. 2011) ("[A] manufacturer is not protected from state tort liability when the claim is based on the manufacturer's violation of applicable federal requirements."). This means that "[Section] 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case `parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330, 128 S.Ct. 999 (citations omitted). However, "[p]laintiffs cannot simply incant the magic words `[the manufacturer] violated FDA regulations' in order to avoid preemption." In re Medtronic, 592 F.Supp.2d at 1158. Rather, for such a "parallel" claim to survive, a plaintiff must (1) point to specific federal requirements that the manufacturer
Thus, while it is the device manufacturer's burden to invoke the MDA's express preemption clause based on the FDA's premarket approval of the device at issue, see Bruesewitz v. Wyeth LLC, 562 U.S. 223, 251 n.2, 131 S.Ct. 1068, 179 L.Ed.2d 1 (2011) (noting that federal preemption is an affirmative defense which a defendant must invoke and establish in the first instance), once the defendant does so, the burden shifts to the plaintiff to establish that the state law claims it seeks to maintain are truly parallel to the federal requirements at issue, and that the alleged breach of these parallel duties caused the plaintiff's injury, cf. Carter v. Novartis Consumer Health, Inc., 582 F.Supp.2d 1271, 1287-88 (C.D. Cal. 2008) (applying burden shifting framework to an FDCA express preemption clause relating to prescription drugs). And it is in the context of demonstrating that the state law claims are not expressly preempted because the state law duty is "genuinely equivalent" to the applicable federal law requirements for a device, Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (internal quotation marks and citation omitted), that the plaintiff must specify the particular federal requirement at issue, identify the truly parallel state law claim, and establish the requisite causation. See McAfee v. Medtronic, Inc., No. 12-cv-417, 2016 WL 2588807, at *1 (N.D. Ind. May 5, 2016); see also Wolicki-Gables, 634 F.3d at 1300 (explaining that "[s]tate and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law" (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)).
Unlike express preemption, the doctrine of implied preemption does not rest on the provisions of a statute; instead, it necessarily follows from the legislature's intent to confer all regulatory authority to a federal body. For example, the FDCA vests the FDA with exclusive authority to investigate potential violations of medical device requirements, regardless of whether the FDA has approved the device through the rigorous PMA process or the less onerous § 510(k) substantial equivalence process. See, e.g., Martin v. Medtronic, Inc., No. 15-cv-0994, 2017 WL 825410, at *9 (E.D. Ca. Feb. 24, 2017) (finding that doctrine of implied preemption barred warranty claim relating to PMA-approved device); Jones v. Medtronic, Inc., 89 F.Supp.3d 1035, 1046 (D. Ariz. 2015) (noting that implied preemption is available where device is approved through the 510(k) process)). Thus, a plaintiff's attempt to enforce federal requirements in the context of private litigation (even a suit that ostensibly involves only state law claims) may run afoul of this delegation.
In Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the Supreme Court held that if establishing the defendant's liability for the plaintiff's state law claim requires demonstrating that the FDCA has been violated, then prosecution of the state law action intrudes upon the FDA's exclusive province to enforce the FDCA, rendering the suit impliedly preempted. Id. at 349-53, 121 S.Ct. 1012. The Supreme Court was also clear in Buckman that implied preemption is by no means absolute; that is, a plaintiff may rely on a violation of an FDCA requirement as a predicate for a state tort claim
All this means that the doctrines of express and implied preemption, though related, are analytically distinct. The MDA's express preemption provision prohibits a plaintiff from imposing additional requirements on a PMA-approved device, but allows enforcement of genuinely parallel state law requirements with respect to that device. Implied preemption in the medical-device context prohibits a plaintiff from enforcing FDCA requirements in the absence of a preexisting state law claim that addresses those same duties, irrespective of whether the device was approved through the PMA process (as was the case with Medtronic's MMT-522 Pump) or the § 510(k) substantial equivalence process (as was the case with the MMT-396 Infusion Set). With respect to PMA-approved medical devices, then, the interrelation between express preemption and implied preemption produces a "narrow gap" in which plaintiffs can proceed to vindicate established state law duties that exist entirely independent of federal law, but only to the extent that such common law tort claims are truly parallel to the requirements of federal law. See Cupek, 405 F.3d at 423. But where applicable, either doctrine suffices to prevent a plaintiff from advancing state common law claims regarding alleged injuries from the use of FDA-approved medical devices.
As a threshold matter, the instant parties dispute whether the insulin pump that was prescribed to Caroline Kubicki at the time of her injury — Medtronic's MMT-522 Pump — is a PMA-approved medical device such that express preemption applies at all. (See Medtronic's Mem. at 15-16; Pls.' Opp'n at 40-42.) They also disagree regarding (a) whether Plaintiffs have identified specific federal requirements that can form the basis for a parallel state claim under Riegel (see Medtronic's Mem. at 47-52; Pls.' Opp'n at 44-51); (b) whether Plaintiffs have, in fact, asserted state law claims that are genuinely parallel to any such federal requirement (see Pls.' Opp'n at 50-51; Medtronic's Reply at 19); and (c) whether the alleged violation of state and federal law caused Caroline's injury (see Medtronic's Mem. at 49-52, 52 n.12; Pls.' Opp'n at 53-55; Medtronic's Reply at 19-20). For the reasons explained below, this Court concludes that Medtronic is entitled to summary judgment based on express preemption for all of the tort claims that pertain to the MMT-522 Pump, with the exception of Plaintiffs' pump-related manufacturing defect claim, which cannot be adequately assessed prior to expert discovery.
In support of its argument that the Kubickis' pump-related claims are expressly preempted under the MDA, Medtronic points to evidence that it says "conclusively demonstrates [that] the MMT-522 Pump has Premarket Approval." (Medtronic's Mem. at 44 (citing a declaration that it says establishes that "the FDA approved the MMT-522 Pump as a PMA supplement — PMA No. P980022/S013").) Plaintiffs appear to accept the representation that the insulin-delivery system of which the MMT-522 Pump is a part received the FDA's stamp of premarket approval, but they argue that the FDA's approval was not all-encompassing for the purpose of the MDA's express preemption clause, because "the FDA did not approve the use of the MMT-522 Insulin Pump in isolation, but instead approved the Real Time System [consisting of the pump and a blood glucose sensor] `as a whole' and on the basis that it would purportedly be marketed, sold, and ultimately used as a system[.]" (Pls.' Opp'n at 41 (emphasis added).) As a result, Plaintiffs say, Medtronic cannot rely on the express preemption doctrine with respect to the MMT-522 Pump standing alone.
At least two federal district courts have rejected this same argument in the context of litigation pertaining to this same pump model. See Duggan, 840 F.Supp.2d at 471-73; Bentzley v. Medtronic, 827 F.Supp.2d 443, 450-51 (E.D. Pa. 2011). The plaintiffs in both Duggan and Bentzley argued — as Plaintiffs do here — that although Medtronic's Paradigm Real Time System (which consists of both the MMT-522 Pump and a continuous glucose monitor) was approved through the PMA process, the MMT-522 Pump should be considered to be substantially equivalent to Medtronic's earlier model MMT-515 pump, which had only "entered the market through the § 510k process and not the premarket approval process." Duggan, 840 F.Supp.2d at 471 ("The Duggans argue that while certain aspects of the Paradigm Real Time System may have received premarket approval, the [MMT-522] pump itself did not; instead, they contend, only the capacity of the pump and the sensor to communicate with each other was granted premarket approval."); see Bentzley, 827 F.Supp.2d at 451 ("Plaintiff attempts to raise an issue of material fact by arguing that the MMT-522 pump is separate and apart from the insulin infusion system and did not gain approval through the PMA process." (internal quotation marks and citation omitted)).
To begin with, it is clear that breaking down a PMA-approved medical device into its components for the purpose of evaluating the reach of the MDA's express preemption clause, as Plaintiffs suggest, runs afoul of the statutory definition of "device" under the MDA. That is, per the statute, a medical "device" includes "any component, part, or accessory[,]" 21 U.S.C. § 321(h), and in the context of the Paradigm Infusion System, there is no question that the MMT-522 Pump is precisely such a component part. Thus, the MMT-522 Pump falls within the scope of the device-related PMA approval that Medtronic received.
Nor can this Court accept the Kubickis' related argument that the FDA has conceded that only the Paradigm Infusion System as a whole — and not the MMT-522 Pump standing alone — was approved through the PMA process. (See Pls.' Opp'n at 41 (citing FDA Response to Citizen Petition, Sept. 23, 2011, Ex. C to Decl. of Michael Brown, ECF No. 133-5, at 56-58)). In this regard, Plaintiffs point to a Citizen Petition that was submitted to the FDA in 2010, requesting that the FDA modify the PMA letter the agency had issued for the Paradigm Infusion System to include the following language: "This approval is limited solely to the ability of the pump to accept data from the sensor and the ability for the sensor to communicate directly to the pump, and this approval does not extend to the pump itself." (Id. at 57 (internal quotation marks omitted).) The FDA rejected this request, stating that it had "approved the PMA supplement for the Paradigm System, including both the 522 pump and the Guardian RT sensor, on April 7, 2006[,]" and that the amendment request was being denied "[b]ecause the approval letter, as issued, applies to the Paradigm System as a whole[.]" (Id. at 58.) Like the Duggan and Bentzley courts (which considered and rejected the same Citizen Petition argument Plaintiffs make here, see Duggan, 840 F.Supp.2d at 472; Bentzley, 827 F.Supp.2d at 451), this Court sees no ambiguity in the agency's statements regarding the scope of the PMA approval: the letter states unequivocally that "both the 522 pump and the Guardian RT sensor" had received premarket approval. (FDA Response to Citizen Petition at 58 (emphasis added).) And the fact that the agency expressly declined to amend its materials to exclude the pump from its PMA approval further underscores that it was not the agency's intention for any such exclusion to be made. See Duggan, 840 F.Supp.2d at 472 ("To the extent there was any ambiguity about the scope of the approval letter, this rejection of the Citizen Petition is the cherry on the icing.").
In arguing that the MMT-522 Pump was not PMA approved and is therefore
Turning to the next step in the Riegel analysis, as explained above, plaintiffs who seek to counter a defendant's authorized invocation of the MDA's express preemption provision with respect to a medical device that received premarket approval must identify specific federal requirements with respect to which genuinely parallel state law claims exist, and must plausibly allege that the defendants' violation of state (and federal) law in the claimed manner caused the plaintiffs' injury. The Kubickis' early attempts to accomplish this difficult task were "admittedly skimpy[,]" Kubicki, 2013 WL 1739580, at *8, but the Court deemed them passable for the purpose of Medtronic's motion to dismiss, id. Notably, however, in its opinion regarding the motion to dismiss, the Court expressly announced its expectation that "as this action proceeds, Plaintiffs will refine their claims to more specifically articulate the parallel relationship between the alleged common law duties and the federal requirements." Id. at *9. And it further warned that "[s]hould Plaintiffs fail to do so, Defendants may renew their express preemption objections at a later, appropriate time." Id.
This means that the express preemption arguments that Medtronic makes in the instant motion for summary judgment are both anticipated and well-founded.
The Kubickis have brought five categories of state law claims in the instant action, including negligence, breach of warranty, and failure to warn (see supra Part III.B), and importantly, they maintain that these state law claims do not impose any requirements that are "different from, or in addition to" the FDA's requirements, 21 U.S.C. § 360(k)(a)(1), because these claims are predicated on the MMT-522 Pump having been "manufactured, designed, and labeled in violation of federal law[.]" (Pls.' Opp'n at 44(emphasis added).)
Plaintiffs are correct that the FDA once determined that Medtronic violated various CGMPs with respect to its production and marketing of the MMT-522 Pump, and it is undisputed that Medtronic failed to notify the FDA of certain adverse events that were allegedly pump-related (including Caroline's injury) in a timely manner. (See 2013 Warning Letter at 25-26). But for the reasons that follow, this Court finds that the CGMPs that Plaintiffs cite are generally insufficient to be the basis for an allegedly parallel state law claim regarding the MMT-522 Pump, and that there is no truly parallel state common law claim that pertains to the one sufficiently-specific federal law requirement that Plaintiffs rely upon (the requirement that manufacturers report adverse incidents).
The Kubickis say that their negligent design, manufacturing, labeling, and breach of warranty common law claims parallel the following CGMPs and other regulations that pertain to product labeling and use instructions:
(See 2d Am. Compl. ¶¶ 43-53.)
Medtronic insists that because these CGMPs and regulations pertaining to product labels and use instructions "are not device-specific regulations[,]" they cannot qualify as "device specific federal requirements" that can be the basis for any purportedly parallel state law claim "within the meaning of [the MDA's express preemption clause]." (Medtronic's Mem. at 48; see also id. at 49.) Thus, Medtronic appears to have invoked one side of an existing circuit split over whether the CGMPs "can[] support any viable parallel claim surviving express preemption[.]" (Id. at 48.) The Eighth and Eleventh Circuits have held that a plaintiff cannot rely on the CGMPs to escape the MDA's express preemption mandate, because the CGMPs are too general to create specific federal requirements that can be enforced under state law. See Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1301-02 (11th Cir. 2011); In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1206-07 (8th Cir. 2010). By contrast, the Fifth, Sixth, and Seventh Circuits have found that certain CGMPs are sufficiently specific to create federal requirements that a plaintiff can enforce through a parallel state law tort action. See, e.g., Bass v. Stryker Corp., 669 F.3d 501, 511-13 (5th Cir. 2012); Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436, 440 (6th Cir. 2010); Bausch v. Stryker Corp., 630 F.3d 546, 554-56 & 554 n.1 (7th Cir. 2010).
Notably, the courts that refuse to find that the FDA's CGMPs can give rise to parallel state law claims for express preemption purposes note that the CGMPs are general prescriptions that "govern `the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage installation and servicing of all finished devices intended for human use.'" In re Medtronic, 592 F.Supp.2d at 1157 (emphasis added) (quoting 21 C.F. R. § 820.1(a)(1)). Accordingly, these courts reason, the CGMPs "are simply too generic, standing alone, to serve as the basis for [a] manufacturing-defect claim[]" because "the CGMPs[] provide specific methods to be used for only a small number of medical devices" and "[i]n most cases, it is left to the manufacturer to determine the best methods to obtain quality objectives." Id. (emphasis, internal quotation marks, and citation omitted); see also id. at 1162 (finding that design-defect claims which are derivative of a CGMP-based manufacturing claim are preempted); Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, 588 (E.D.N.Y. 2009) (holding that claims based on an alleged violation of the CGMPs are preempted because the CGMPs are "intentionally vague and open-ended"); cf. Horn v. Boston Sci. Neuromodulation Corp., No. CV409-074, 2011 WL 3893812, at *9 (S.D. Ga. Aug. 26, 2011) (concluding that a claim based on the alleged breach of FDA regulations was preempted where the regulations at issue "fail to provide any tangible or concrete standard" because "to allow a violation of such a flexible standard to result in liability would, in itself, be imposing a standard `different from, or in addition to' those imposed by the MDA" (quoting 21 U.S.C. § 360k(a)(1))). In the absence of any
As previously explained, in order to have a viable — i.e., not expressly preempted — state law claim for an injury allegedly caused by a medical device that received premarket approval, the plaintiff must identify specific, concrete federal requirements that are applicable to the device in question and that the manufacturer has allegedly violated in a manner that also gives rise to liability under state law. See Caplinger, 921 F.Supp.2d at 1214. There is no question that if a state law claim is to be identified as truly "parallel" (i.e., not demanding anything more of the manufacturer than the federal law requires), the federal-requirement baseline must be specifically established; yet, by their nature, the CGMPs merely prescribe overarching guidelines for manufacturers to follow when developing their own procedures, rather than specifically enforceable duties. Indeed, the FDA itself has noted the flexibility that the CGMPs afford to manufacturers:
Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, 61 Fed. Reg. 52,602, 52,603 (Oct. 7, 1996) (emphasis added). This Court is persuaded that federal regulations that admittedly "do[] not prescribe in detail how a manufacturer must produce a specific device[,]" id., are incapable of serving as the benchmark for a reasoned determination of whether state law claims that impose liability for a manufacturer's failure to produce the device in a certain way establish duties that are truly parallel to the federal law.
The Sixth Circuit's decision in Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436, 440 (6th Cir. 2010), which Plaintiffs cite (see Pls.' Opp'n at 45), is not to the contrary. The plaintiff in Howard brought a claim for negligence per se, seeking relief for injuries that he suffered when his implanted artificial knee failed due to oily residue left behind on the implant as the result of the manufacturing processes. The Howard court concluded that these claims were not expressly preempted because the plaintiff had "identif[ied] a specific GMP that he thought had been violated" and "the particular GMP that he cites is not so vague as to be incapable of enforcement." 382 Fed.Appx. at 440 (emphasis added). The court in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), another case on which Plaintiffs rely (see Pls.' Opp'n at 44), likewise recognized that the court must evaluate whether particular CGMPs prescribe duties specifically enough to permit evaluation of the parallel character of a state law claim. Cf. Bausch, 630 F.3d at 556 ("First, the meaning of the FDA's requirements will present questions of law for the court to decide, not questions of fact for a jury to decide. Second, those questions of law will be questions of federal law, subject to the usual processes for reconciling conflicting views.").
Here, this Court finds that, for the most part, the CGMPs that Plaintiffs cite are simply too vague and generic to form the foundation for a reasoned assessment of a parallel state claim for a design, manufacturing, or labeling defect, or for breach of
With respect to product labeling and use instructions, the non-CGMP regulations that Plaintiffs cite similarly only require that information on a label be "conspicuous[]" and "prominen[t]," see 21 C.F. R. § 801.15, and that the manufacturer provide "adequate directions ... under which the layman can use a device safely and for the purposes for which it is intended[,]" 21 C.F.R. § 801.5. Again, the lack of specificity with respect to the demands of federal law means that there is no meaningful baseline against which to compare the requirements of the state common law, and thus no reasonable way to determine whether Plaintiffs' state common law claims are truly parallel. And none of the other CGMPs and regulations that Plaintiffs reference — save the adverse event reporting requirements, discussed below — are any more specific.
With respect to Plaintiffs' reliance on 21 C.F.R. § 803 to support the state common law claims that arise from Medtronic's alleged failure to track incidents and make required reports to the FDA (see, e.g., 2d Am. Compl. ¶ 49), a slightly different preemption analysis is required. This particular regulation stands in stark contrast to the general CGMPs and the product labeling and use instruction regulations described above, because the reporting mandates laid out in this regulation are fairly specific about what types of events must be reported to the agency and when. For example, section 803.50(a) requires device manufacturers to make certain reports within 30 days of the manufacturer's receipt of certain information, as follows:
Id. Another provision of this federal regulation requires Medtronic to report certain information within five days of becoming aware of an "event [that] necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health[,]" id. § 803.53(a), and the precise information that such reports must contain is also specified in the regulation, see id. § 803.52(a)-(c) (requiring the reporting of
Where Plaintiffs' preemption arguments fall short is with respect to Plaintiffs' obligation to assert state common law claims that are "genuinely equivalent" to these FDA regulations, Wolicki-Gables, 634 F.3d at 1300, such that the lawsuit does not impose any requirements that are "different from, or in addition to, the federal ones," Riegel, 552 U.S. at 321-22, 128 S.Ct. 999 (internal quotation marks and citation omitted). The Kubickis' counsel all but admitted during this Court's motions hearing that no equivalent adverse event reporting claims exist under state law. (See Mot. Hr'g Tr. at 17:9-14 ("So if you're asking whether or not the District of Columbia has an identical requirement, either codified in a state statute or that exists in common law, regarding the tracking of complaints to take an example, the answer is no.").) And that admission is, in effect, a concession that the Kubickis' state law failure to warn claims that are based on Medtronic's alleged failure to report adverse events to the FDA are expressly preempted. See Riley, 625 F.Supp.2d at 777.
In their papers, Plaintiffs struggle mightily to avoid the implications of the undisputed fact that there is no D.C. common law claim that imposes liability for a manufacturer's failure to report to the FDA adverse incidents concerning an approved medical device. For example, they point to the established D.C. common law claim for failure to warn consumers of foreseeable harm associated with use of the product (see, e.g., 2d Am. Compl. Counts XVI-XVIII), and construct the following argument: because Medtronic failed to track adverse events adequately and to notify the FDA in a timely manner of adverse events involving the over-delivery of insulin to patients, Medtronic deprived the FDA of important information regarding the pump that the agency could have then used to require Medtronic to change its label in order to provide the adequate warnings to Caroline and her physicians regarding risks associated with the pump that D.C. law requires. (See, e.g., 2d Am. Compl. ¶ 49 ("Medtronic's failure to track and report adverse events kept important safety information from the FDA and, therefore, device users such as Caroline Kubicki.").) Thus, Plaintiffs insist that Medtronic's violation of the federal reporting requirements effectively amounted to a failure to warn consumers for the purpose of D.C.'s common law tort. (See, e.g., id. ¶ 212.)
This creative effort to craft a D.C. common law claim that is substantially equivalent to the federal law's adverse-event reporting requirements fails for at least two reasons. First of all, it ignores the overarching mandate that the state claim and the federal claim must be genuinely
Second, Plaintiffs' parallel state law claim argument ultimately relies on sheer speculation: Plaintiffs contend that, if Medtronic had complied with the federal requirement to report adverse events to the FDA, and if the FDA had directed Medtronic to update the label of the MMT-522 Pump based on these reported events, then Medtronic would have had the duty to provide adequate warnings to consumers, as D.C. common law requires. But it is by no means certain that the FDA would have directed Medtronic to give consumers different or additional information about the MMT-522 Pump if the agency had been made aware of other incidents that predated Caroline's hypoglycemic injury. And unless such label changes would necessarily have occurred as a result of Medtronic's failure to notify the FDA, Plaintiffs' contention that Medtronic's failure to notify the agency is the functional equivalent of failing to warn consumers in violation of state law cannot be sustained. Cf. Webster v. Pacesetter, Inc., 259 F.Supp.2d 27, 36 (D.D.C. 2003) ("Nor can plaintiffs create an issue of fact regarding their defective warning claim by speculating that if the FDA had known of the delayed perforation and tamponade incidents during the clinical trials and if defendant had investigated all the adverse incidents, the FDA would have either recalled the lead or placed it on alert, and therefore, Dr. Lewis would not have implanted it in plaintiff's heart." (emphasis omitted)). Thus, this Court does not accept Plaintiffs' argument that Medtronic's established reporting failures are truly parallel to the complaint's claims that Medtronic is liable for failing to provide adequate warnings to Caroline and her physicians regarding risks associated with the pump under District of Columbia law.
The court in In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147 (D. Minn. 2009), reached a similar conclusion about the plaintiffs' purportedly parallel state law claims in the context of a multi-district litigation relating to another Medtronic product, when it characterized the state law claims as actually and plainly imposing additional requirements on Medtronic under these circumstances. It reasoned that a defective-labeling state law claim that is tied to the manufacturer's alleged failure to disclose new information it discovered after the FDA's premarket approval of its medical device falls squarely within the preemptive scope of Riegel:
Id. at 1159 (internal quotation marks and citations omitted).
The instant case involves this same dynamic, because the Kubickis' pump-related failure to warn claim are fundamentally based on the contention that Medtronic breached a duty to provide additional warnings, and to recall the pump for label changes, in light of the deficiencies in the device that the post-approval events revealed. But the MDA's express preemption clause prohibits the Court (or a jury) from making any such liability determination. See id.; see also Cupek, 405 F.3d at 424 ("Any claim, under state law ... that Defendant failed to warn patients beyond warnings required by the FDA, or that Defendant failed to recall a product without first going through the PMA supplement process[,] would constitute state requirements `different from' or `in addition to' the requirements of the federal PMA application and supplement process." (quoting 21 U.S.C. § 360k(a))); Horn v. Thoratec Corp., 376 F.3d 163, 176-77 (3d Cir. 2004) (holding that failure to warn claims are preempted if they would require the manufacturer "to provide different warnings and instructions from those approved by the FDA[,]" since the manufacturer was "prohibited ... by the FDA's PMA approval order from making any such changes" (citations omitted)).
All things considered, then, this Court is confident that the one claimed violation of federal law that is sufficiently specific to support a parallel state law claim concerning the MMT-522 Pump — i.e., Medtronic's established failure to report subsequent adverse events to the FDA in a timely manner, as the adverse reporting regulations require (see 2013 Warning Letter at 25-26) — does not actually equate with the D.C. common law failure to warn claims that the Kubickis allege (see 2d Am. Compl. ¶¶ 495, & Counts I-III (failure to warn as element of negligence); XVI-XVIII (failure to warn under Restatement of Torts)), and as a result, the MDA's express preemption provision bar these state law claims.
At this point, it is crucial to recall that the FDA authorized Medtronic to market the allegedly defective components of the insulin-delivery system that Caroline was using at the time of her injury through two different processes: the MMT-522 Pump was subjected to the PMA process, while the agency cleared the MMT-396 Infusion Set through the § 510(k) "substantial equivalence" route. (See Medtronic's Stmt. of Facts ¶¶ 7-9.) Thus, the doctrine of express preemption is inapplicable to claims pertaining to the MMT-396 Infusion Set, see Lohr, 518 U.S. at 492-94, 116 S.Ct. 2240, and the Kubickis can proceed with their infusion set-related state law tort claims so long as those claims do not implicate the FDA's exclusive authority to enforce the FDCA and its implementing regulations. See 21 U.S.C. § 337(a); see also Buckman, 531 U.S. at 349 n.4, 121 S.Ct. 1012 ("The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.").
In its prior opinion denying Medtronic's motion to dismiss, the Court addressed the
It is well established that state law tort claims with respect to a § 510(k) device can persist unabated if they "rely[] on traditional state tort law [that] had predated the federal enactments" that purportedly preempt them, Buckman, 531 U.S. at 353, 121 S.Ct. 1012; and alternatively, state law claims are deemed impliedly preempted if "the existence of the federal enactments is a critical element in their case[,]" id. The seminal Supreme Court case on implied preemption — Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) — involved an allegation that a medical device manufacturer had made fraudulent representations to the FDA regarding the intended use of a medical device, which had led the FDA to grant § 510(k) approval to the device that injured the plaintiff. See id. at 343, 121 S.Ct. 1012. The Supreme Court ruled that such a "fraud-on-the-FDA" claim could not be established apart from the federal approval process, and would "inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives." Id. at 350, 121 S.Ct. 1012. Therefore, the Court held that the fraud claim was impliedly preempted. See id. at 348, 121 S.Ct. 1012; see also id. at 347-48, 121 S.Ct. 1012 (noting that "petitioner's dealings with the FDA were prompted by the MDA, and the very subject matter of petitioner's statements were dictated by that statute's provisions"). Accordingly, courts have held that "a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA — that is, when the state claim would not exist if the FDCA did not exist." Riley, 625 F.Supp.2d at 777 (citing Buckman, 531 U.S. at 352-53, 121 S.Ct. 1012); see also Schouest v. Medtronic, Inc., 13 F.Supp.3d 692, 705 (S.D. Tex. 2014) ("Because these claims would apply to a seller of a product not subject to any federal regulations who engaged in similar alleged misconduct, they are not impliedly preempted.").
Applying these standards, and keeping in mind the Supreme Court's admonition in Lohr that, a medical device manufacturer that elects to proceed through § 510(k) faces the possibility of having "to defend itself against state-law
In addition, although Plaintiffs have conceded that no common law claim for failure to report adverse events to the FDA exists under District of Columbia law, to the extent that the Kubickis' failure to warn claim alleges that Medtronic breached "a duty of reasonable care" owed to Caroline Kubicki, her parents, and her physicians "to adequately warn of the foreseeable harm associated with the use" of the MMT-396 Infusion Sets (2d Am. Compl. ¶ 205) — including "a duty to provide specific directions for the safe use" of the product (id. ¶ 206 (emphasis in original)) and "sufficient warnings and instructions for use" (id. ¶ 210) — this claim, too, survives Defendant's implied preemption argument.
In sum, with respect to Medtronic's preemption contentions, this Court concludes that (1) Medtronic is entitled to summary judgment, on the basis of express preemption, with respect to the all of the claims that pertain to the MMT-522 Pump (with the exception of Plaintiffs' manufacturing defect claim), and (2) the Kubickis cannot maintain a (non-existent) state law claim for Medtronic's alleged failure to report to the FDA adverse events involving the MMT-396 Infusion Set, and thus Medtronic is entitled to summary judgment on any such claim on the basis of implied preemption, but (3) the doctrine of implied preemption presents no bar to the Kubickis' claims relating to design, manufacture, and labeling of the MMT-396 Infusion Set, or to their claims that Medtronic violated established state common law by failing to warn consumers about risks associated with the MMT-396 Infusion Set.
Finally, this Court turns to a series of alternative and miscellaneous arguments that Medtronic makes in support of its contention that it is entitled to an award of summary judgment in this case.
To further assail the Kubickis' unpreempted infusion set-related failure to warn consumers claims, Medtronic points to "the learned intermediary doctrine" (Medtronic Mem. at 63-66), which "holds that, because prescription [devices] are available to the public only through a physician and are to be administered only under a physician's supervision, the [device] manufacturer's duty is to adequately inform the physician, who is expected to function as a `learned intermediary' between the company and the patient in protecting the patient and providing direct information about the [device] to the patient.'" MacPherson, 775 F.Supp. at 422-23; see also Patteson v. AstraZeneca, LP, 876 F.Supp.2d 27, 34 (D.D.C. 2012) ("As long as the [prescription] manufacturer properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient who receives the [product]."). In this regard, Medtronic argues that, because "Medtronic's duty to warn of any dangers associated with these products ran [only] to the licensed medical professional who prescribed them[,]" and because Dr. Dandona (Caroline's physician) testified that "he did not read or rely upon the warnings and would not have altered his decision to prescribe the MMT-522 Pump and MMT-396 Infusion Set" to Caroline even if the warnings had been sufficient (Medtronic's Mem. at 64), the Kubickis cannot establish that Medtronic's alleged failure to warn caused Caroline's injury. In other words, through the learned intermediary doctrine, Medtronic maintains that the allegedly inadequate warnings — which Dr. Dandona admittedly did not see or read — could not have caused Caroline's injury, and thus the company cannot be held liable for its alleged failure to warn. (See id. (arguing that when the physician would have prescribed the medical device regardless of what he "may have read or not read," or "when the prescribing physician did not read, or rely upon, the warnings
This Court rejects Medtronic's conclusion that there is no genuine issue of material fact related to its potential liability for the allegedly faulty labels and instructions that purportedly failed to warn Caroline, her parents, and Dr. Dandona of the risks pertaining to improper use of the MMT-396 Infusion Set for at least two reasons. First of all, the case law makes clear that, for the learned intermediate doctrine to absolve a manufacturer, the warning that is given to the professional must be adequate. See McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006) ("[E]ven in the context of a learned intermediary, if the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user." (internal quotation marks omitted)); see also Patteson, 876 F.Supp.2d at 34 (holding that if the manufacturer "properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient" (emphasis added)). The adequacy of the label and insert that Medtronic provided with the MMT-396 Infusion Set is indisputably still at issue in this case, which plainly precludes summary judgment in Medtronic's favor on learned intermediary grounds. See Payne, 486 A.2d at 723 ("[I]n cases in which there is a potential for serious injury, the adequacy of even a relatively clear warning should not be determined as a matter of law but is a question of fact for the jury[.]").
Second, and possibly even more significant, while Medtronic is correct to observe that the professional's actual reliance on the allegedly inadequate information that a manufacturer provides is key to assessing causation, see Patteson, 876 F.Supp.2d at 34 ("An inadequate warning alone, however, is not enough; the learned-intermediary doctrine also requires that the inadequate warning be a `producing cause' of the plaintiff's injury."), Medtronic has not successfully established that there is no genuine issue of fact regarding causation in the instant case. This is primarily because, although Dr. Dandona did testify that he did not review or rely upon the instructions for the infusion set (see Dep. of Paresh Dandona ("Dandona Dep."). Ex. 5 to Pls.' Opp'n, ECF No. 138-7, at 7:16-20), his sworn testimony reveals that Dr. Dandona was not the medical professional who was responsible for reviewing Medtronic's materials and explaining to patients how to use the device. In response to a direct deposition question about whether or not he had "ever reviewed [] the instructions for use for ... the infusion set?" Dr. Dandona stated:
(Id. at 7:19-8:2.) Thus, the record makes crystal clear that Dr. Dandona viewed his role as determining the overall "policy of installing a pump" and setting "the kind of infusion rates that should be appropriate for a patient," and that he delegated the technical responsibility of providing patients with instructions for using the prescribed insulin-delivery device properly to agents he calls "pump trainers." Yet, to this Court's knowledge, the pump trainers have not testified in the context of this matter, so nothing in the record establishes that the pump trainers who instructed Caroline on how to use the infusion set eschewed reading or relying upon the allegedly
Consequently, on the record the parties have provided, a reasonable jury might well conclude that Medtronic's infusion set instructions (imparted to Caroline by the pump trainers) were inadequate and ultimately caused Caroline's injury, despite Dr. Dandona's testimony regarding his own personal lack of review and reliance on any such instructions when he prescribed the device to Caroline. Put another way, contrary to Medtronic's contentions, it was Caroline's pump trainer, not Dr. Dandona, who was the pertinent `learned intermediary' for the purpose of Plaintiffs' failure to warn claim, and thus, Dr. Dandona's testimony about his own personal lack of reliance on Medtronic's materials (without regard to what the agents who served as the relevant instructing professionals for present purposes relied upon) is manifestly insufficient to break the chain of causation between the allegedly inadequate instructions and Caroline's injury as a matter of law.
Medtronic also insists that summary judgment is warranted with respect to the the MMT-396 Infusion Set breach of warranty claims that Plaintiffs have brought. (See Medtronic's Mem. at 67-68; Medtronic's Reply at 30-31.)
In order to succeed on a breach of warranty claim under District of Columbia law, a plaintiff must prove "that the defendant breached an express promise made about the product sold." Witherspoon v. Philip Morris Inc., 964 F.Supp. 455, 464 (D.D.C. 1997). The D.C. Code explains that an enforceable express warranty arises when the seller makes to the buyer "(a) [a]ny affirmation of fact or promise ... which relates to the goods and becomes part of the basis of the bargain" or "(b) [a]ny description of the goods which is made part of the basis of the bargain[.]" D.C. Code § 28:2-313(1). In either case, such an expression "creates an express warranty that the goods shall conform to the [description], affirmation or promise." Id. An express warranty can exist even if the seller does not use the words "warrant" or "guarantee," but it is well established that "an affirmation merely of the value of the goods or a statement purporting to be merely the seller's opinion or commendation of the goods does not create a warranty." D.C. Code. § 28:2-313(2). Furthermore, when the plaintiff alleges only that a manufacturer's "advertisements and promotionals statements contained broad claims amounting to a warranty[,]" the alleged breach of warranty claim cannot survive. Witherspoon, 964 F.Supp. at 465 (emphasis added; internal quotation marks and citation omitted); see also, e.g., Forouzesh v. Starbucks Corp., No. CV 16-3830, 2016 WL 4443203, at *4 (C.D. Cal. Aug. 19, 2016) (dismissing breach of warranty claim predicated on the defendant's representations that its beverages were sold "in cups of various sizes[,]" because a reasonable consumer would not have interpreted the defendant's representation to be an affirmation of fact or description regarding the "specific amount of liquid" in the cups); Hubbard v. Gen. Motors Corp., No. 95Civ.4362, 1996 WL 274018, at *7 (S.D.N.Y. May 22, 1996) (holding that statements made in advertisements that vehicles are "the most dependable, long-lasting trucks on the planet" constituted "puffery" rather than an actionable warranty regarding vehicle's braking system, particularly where the statements made "no reference whatsoever to the type or quality of the vehicles' braking system").
Here, it is clear to this Court that any warranty claim that is based on the statements in Medtronic's advertising materials to which Plaintiffs point to fails as a matter of law, due to the nature of the statements at issue. For example, Plaintiffs contend that Medtronic warrantied the MMT-396 Infusion Set's p-cap vent design by asserting that the vents in the p-cap would reduce "clogging and malfunction" and that Medtronic infusion sets "are made with patented tubing, which is clog and kink resistant, assuring that the insulin is being safely delivered" (see Pls.' Opp'n at 81-82 (quoting Medtronic Infusion Set Brochure in the advertising materials)), but such a generalized endorsement of the product's purportedly superior structure is not a fact-based promise that the product will perform in a certain way. See Witherspoon, 964 F.Supp. at 464; Hoffman v. A.B. Chance Co., 339 F.Supp. 1385, 1387 (M.D. Pa. 1972) (holding that advertisements representing that a brake lock device "offered unprecedented safety" did not create an actionable warranty). Indeed, to qualify as an express promise of the type that is enforceable as a warranty, the manufacturer must do more than make generalized statements commending the product; instead, it must articulate verifiable facts about product performance, such that lack of conformity with those representations
In this regard, In re General Motors Corp. Anti-Lock Brake Products Liability Litigation, 966 F.Supp. 1525 (E.D. Mo. 1997), is instructive. In that case, plaintiffs sought to assert a breach of warranty claim against General Motors, arguing that General Motors's advertising statements that a vehicles' crash avoidance system was "99 percent more effective" than a crash protection system, and that "[a] driver is 100 times more likely to benefit from a vehicle's crash-avoidance capabilities (such as anti-lock brakes) than from its crash-survival capabilities (such as air bags)[,]" created a warranty that the vehicles' systems were free of safety defects, and that General Motors had breached this warranty because the systems were defective and not, in fact, safe. Id. at 1531. The court dismissed this warranty claim, finding that "comparative claims [such as these], often involving large numbers, are puffing because a consumer cannot reasonably believe that there is a test behind the claims." Id.; cf. In re XM Satellite Radio Holdings Sec. Litig., 479 F.Supp.2d 165, 180 (D.D.C. 2007) (dismissing securities fraud claim that was predicated on adverting statements because "generalized positive statements about `cost effective,' `smart,' `sound' and `efficient' growth are vague and incapable of objective verification, they are not the type of statement upon which a reasonable investor would rely" and instead constitute mere "puffery"); Hoyte v. Yum! Brands, Inc., 489 F.Supp.2d 24, 30 (D.D.C. 2007) (granting motion to dismiss negligent misrepresentation claim based on "KFC's claims that its restaurants serve the `best food'" because such a statement "is a non-measurable, `bald statement of superiority' that is non-actionable puffery").
The bottom line is this: in this Court's considered judgment, much of the advertising language that Plaintiffs say gives rise to their breach of warranty claims actually dooms these allegations, because instead of essentially guaranteeing that the MMT-396 Infusion Set will operate a certain specified way, Medtronic's statements appear to be merely the type of general commendation that courts have long held does not create an enforceable warranty. See Witherspoon, 964 F.Supp. at 464.
Finally, Medtronic argues that summary judgment should be entered in its favor with respect to Plaintiffs' punitive damages claims. (See Medtronic Mem. at 68-70.) Plaintiffs' complaint alleges that all of Medtronic's failures and deficiencies with respect to the medical devices at issue in this case were malicious, willful, and wanton, and that the company has acted without regard for the safety of others — facts that, Plaintiffs say, entitle them to an award of punitive damages. (See 2d Am. Compl. ¶¶ 254-259.) See also Rogers v. Ingersoll-Rand Co., 971 F.Supp. 4, 12 (D.D.C. 1997) ("Punitive damages are
However, notably, nothing in this Court's decision should be construed as precluding Plaintiffs from seeking punitive damages as a remedy at the appropriate time. That is, insofar as Medtronic argues that no such remedy is available on the current record (see Medtronic's Mem. at 69-70), the parties are reminded that the record is subject to further development in this case, because they have yet to engage in expert discovery. (See supra Part V.) This Court will not accept Medtronic's suggestion that it evaluate — and foreclose completely — any punitive damages remedy now; instead, the Court will await future discussion of the appropriateness of Plaintiffs' request for punitive damages in the context of the parties' preparations for trial. Cf. D.C. Std. Civ. Jury Instr. Nos. 13-12, 16-2, 16-3.
The facts of this matter are relatively straightforward — a tragic, devastating injury purportedly caused by Defendants' allegedly tortious conduct with respect to a widely marketed insulin-delivery device — but the intersection of law and life can be quite complicated. Even prior to engaging in expert discovery, Medtronic and Unomedical have vigorously maintained that the Kubickis cannot persist with the various state law claims they have filed pertaining to the MMT-522 Pump and MMT-396 Infusion Set for several nuanced reasons, and having carefully reviewed the parties' summary judgment filings and the exhibits thereto, as well as their statements of fact, this Court agrees with Defendants with respect to certain claims, and disagrees with respect to others. For the reasons explained at length above, the Court finds that Unomedical is entitled to summary judgment with respect to all of the claims Plaintiffs have brought against it on timeliness grounds, and Medtronic is entitled to summary judgment with respect to certain claims, as follows: (1) all of Plaintiffs' claims that pertain to the MMT-522 Pump, except Plaintiffs' manufacturing defect claim, (2) Plaintiffs' claims that Medtronic failed to report to the FDA adverse events regarding the MMT-396 Infusion Set in violation of state law, (3) Plaintiffs' breach of warranty claims, and (4) Plaintiffs' stand-alone claim for punitive damages. However, the Court concludes that genuine issues of material fact remain with respect to Plaintiffs' negligent design, manufacture, labeling, and failure to warn consumers claims relating to the MMT-396 Infusion Set, and that there are also triable issues of fact with respect to causation — at least for now. Thus, as set forth in the accompanying order, Unomedical's Motion for Summary Judgment is
