HIGGINBOTTOM v. DEXCOM INC (2024)

ORDER

The matters before the Court are the (1) Motion to Remand to Superior Court of San Diego, California (“Motion to Remand”) filed by Plaintiff Joseph Higginbottom (ECF No. 10); (2) Motion to Dismiss filed by Defendant Tandem Diabetes Care, Inc. (“Tandem”) (ECF No. 15); and (3) Motion to Dismiss filed by Defendant Dexcom, Inc. (“Dexcom”) (ECF No. 16).

I. PROCEDURAL BACKGROUND

On January 26, 2024, Plaintiff initiated this action, individually and on behalf of the Estate of Anthony Higginbottom, by filing a Complaint in the Superior Court of California, County of San Diego, Case No. 37-2024-00003700-CU-PL-CTL. (See ECF Nos. 1-2, 1-3.)

On January 30, 2024, Defendant Tandem removed the action to this Court on the basis that there is complete diversity between Plaintiff and Tandem, the amount in controversy exceeds $75,000, and Tandem satisfied the procedural requirements for removal. (ECF No. 1, NOR.)

On February 29, 2024, Plaintiff filed the Motion to Remand, which requests that the Court remand the action to state court on the basis that it lacks subject matter jurisdiction, the removal was procedurally improper, and the Colorado River abstention doctrine applies. (ECF No. 10.)

On March 4, 2024, Plaintiff filed the First Amended Complaint (“FAC”), the operative pleading.¹ (ECF No. 11.)

On March 18, 2024, Tandem filed a Motion to Dismiss (ECF No. 15) and Dexcom filed a Motion to Dismiss (ECF No. 16).

On April 2, 2024, Tandem filed a Response in opposition to the Motion to Remand. (ECF No. 22.)

On April 9, 2024, Plaintiff filed a Reply in support of the Motion to Remand. (ECF No. 26.)

On April 12, 2024, Plaintiff filed Responses in opposition to the Motions to Dismiss. (ECF Nos. 27, 28.)

On April 22, 2024, Dexcom filed a Reply in support of its Motion to Dismiss (ECF No. 30) and Tandem filed a Reply in support of its Motion to Dismiss (ECF No. 31).

On May 23, 2024, Plaintiff filed a Notice of Supplemental Authority. (ECF No. 32.)

On May 31, 2024, Tandem filed a Response to Plaintiff's Notice of Supplemental Authority. (ECF No. 33.)

On July 19, 2024, Dexcom filed a Notice of Supplemental Authority. (ECF No. 34.)

II. ALLEGATIONS IN THE FIRST AMENDED COMPLAINT 2

A. Dexcom's G6 System

Dexcom manufactures, tests, labels, promotes, sells, and/or distributes the Dexcom G6 Integrated Continuous Glucose Monitoring System (“G6 System”). “The G6 System is a prescribed medical device intended for use by diabetic patients to replace fingerstick blood glucose testing and scanning and to detect and alert dangerous glucose levels likely to trigger life-threatening medical events as a part of short-term and long-term diabetes treatment plan.” (ECF No. 11, FAC ¶ 18.) The G6 System “is the first real-time, integrated Continuous Glucose Monitoring system (hereinafter ‘iCGM’)” that does not require “fingersticks or calibrations.” Id. ¶ 29. The G6 System, as shown in the User Guide, has three components: (1) “a wearable patch sensor which continuously measures blood glucose values (hereinafter ‘BGV’) from interstitial fluids below the skin”; (2) “a transmitter that attaches to the sensor and collects the BGV data and then pushes the information via a Bluetooth® connection to”; (3) “a display device: either its proprietary receiver or a smartphone using its proprietary application” (“G6 App”). Id. ¶¶ 21, 31. The G6 App “allows patients to use their smartphones and smartwatches ․ as the display device to receive real-time BGV readings, notifications, and sound alarms resulting from potential hyperglycemic and hypoglycemic events.” Id. ¶ 32. The G6 System is designed to “ ‘sound the alarm’ when a near-dangerous glucose level is detected to provide the diabetic patient with advance warning to avoid a potential hyperglycemic or hypoglycemic event.” Id. ¶ 23. “The G6 Systems have a propensity to obtain inaccurate glucose readings, fail to transmit glucose readings, and/or notify and alert its users of potential hyperglycemic and hypoglycemic events.” Id. ¶ 24. A defect or maloperation of any of the three components would cause a user not to receive “accurate and timely BGV alerts and warnings,” causing injury or death. Id. ¶¶ 33–36.

The G6 System “is cleared for sale by the Federal Food and Drug Administration (hereinafter ‘FDA’) as a Class II device.” Id. ¶ 27.

B. Tandem's t:slim pump

Tandem manufactures, tests, labels, promotes, sells, and/or distributes the Tandem t:slim X2 Insulin Pump (“t:slim pump”). “The t:slim pump is a prescribed medical device originally intended for use by diabetic patients as an automated insulin delivery system (hereinafter ‘AID’) to provide subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.” Id. ¶ 19. The t:slim pump may be used “solely for continuous insulin delivery and originally worked in tandem with Dexcom's G5 continuous glucose monitoring system.” Id. Later, the t:slim added “interoperable technology for delivering insulin under the skin for children and adults with diabetes.” Id. ¶ 20. This new t:slim type, referred to as an alternate controller enabled infusion pump (“ACE insulin pump”), “was the first interoperable pump” such that “it could be used with different components that make up diabetes therapy systems; such as, AID systems and Dexcom's G6 System, allowing patients to tailor their diabetes management to their individual device preferences.” Id.

On June 21, 2018, “Tandem's original t:slim pump AID system obtained premarket market approval (hereinafter ‘PMA’) as a Class III medical device for the pump's ‘Basal-IQ’ technology.” Id. ¶ 37. “This pump was compatible with Dexcom's G5 Mobile CGM or any compatible iCGM.” Id. On February 19, 2019, Tandem had “reclassified the t:slim pump with interoperable technology as a Class II medical device under the De Novo classification clearance; applying special controls for the t:slim pump's integration with the G6 System.” Id. ¶ 38. On June 4, 2020, Tandem's “t:slim pump with interoperable technology obtained a substantial equivalence determination under the FDA's 510(k) submission process for this Class II medical device's update to its software, allowing the patient to create a ‘User Settable Max Basal Limit.’ ” Id. ¶ 39.

C. Integration of the G6 System and t:slim pump

The t:slim pump can integrate with Dexcom's G6 System sensor and transmitter. “The t:slim pump provides regular insulin dosing and can also allow patients to administer corrective dosing based on the detection of episodes of hyperglycemia and hypoglycemia from the G6 System BGV data displayed on the t:slim device.” Id. ¶ 22. When integrated with the t:slim pump, the G6 System “increases the risk of insulin stacking,” which is the taking of multiple insulin doses at close intervals causing a rapid blood sugar level drop. Id. ¶ 24. Using patient settings and glucose trends, “[t]he t:slim pump AID and ACE systems supply infusions of insulin.” Id. ¶ 25. “When inaccurate hyperglycemic results are transmitted to the t:slim pump display device, a patient may overdose themselves with insulin by administering a corrective bolus and cause him or her to quickly fall into hypoglycemia.” Id.

D. Decedent's Use of the Devices

Decedent was prescribed Dexcom's G6 System and Tandem's t:slimp pump by his medical provider as part of his treatment plan. “Plaintiff's spouse purchased the G6 System from Dexcom and the t:slim pump from Tandem on behalf of [D]ecedent, a minor.” Id. ¶ 42. “During the relevant time, [D]ecedent used the G6 System as the primary device for glucose testing and for diabetes treatment decisions,” monitoring his BGV trends in real-time to prevent hyperglycemic and hypoglycemic episodes and managing Decedent's diabetes. Id. ¶¶ 43, 45. “During the relevant time, [D]ecedent used the t:slim pump to administer bolus of insulin as needed or at preset intervals in accordance with the user instructions and training provided by Tandem.” Id. ¶ 44.

On August 4, 2020, “[D]ecedent changed out his sensor with his new one that evening, undertook the necessary programming, and went to bed. After the two-hour start up process, the G6 System read his BGV as extremely high.” Id. ¶ 49. On August 5, 2020, at 2:00 a.m., Decedent's BGV read 258 and at 7:00 a.m. his BGV read 214. At around 7:28 a.m., “[D]ecedent administered a corrective insulin bolus from his t:slim pump as his BGV were still reading high at 218.” Id. ¶ 50. “From that time until 8:43 AM, the t:slim pump continued to supply basal loads of insulin infusions in addition to his basal profile settings, thereby stacking his insulin and rapidly dropping him into hypoglycemia.” Id. At 8:43 a.m. when the t:slim pump administered a second bolus, Decedent was driving a vehicle outside of Cheyene, Wyoming. “The stacked insulin ․ administered by the t:slim pump contrary to the basal profile settings and in addition to the corrective dose [D]ecedent administered based on an inaccurate BGV calculated and displayed by the G6 system” caused Decedent to “drop[ ] into hypoglycemia, pass[ ] out behind the wheel, and crash[ ] into a Laramie County weed and pest truck servicing the shoulder of the road.” Id. ¶ 52. Decedent “died from the injuries suffered in the collision.” Id. ¶ 53. The G6 App did not alert Decedent to the dangerous glucose levels or stop “receiving glucose information from the G6 System prior to stacked insulin bolus rapidly decreasing his BGV.” Id. ¶ 54. The G6 System failed to make accurate real-time readings of his BGV prior to administering the corrective bolus. The G6 System and the t:slim pump “malfunctioned by allowing” an additional insulin infusion at 8:43 a.m. when Decedent's BGV levels were no longer reading as high. Id. ¶ 57. The G6 System and t:slim pump failed to notify or “sound the alarm of the dangerous glucose level,” depriving “[D]ecedent and/or Plaintiff the ‘golden window’ of time to intervene and prevent the ․ collision.” Id. ¶ 59.

Plaintiff relied on Defendants’ representations that their devices were accurate and efficient for treating his son's diabetes. Defendants knew or should have known that their devices were dangerous; designed to present unreasonable risks of inaccurate calculations, BGV readings, and notifications; had a high likelihood and potential for harm; were not accompanied by adequate instructions, guidelines, and safety precautions; were advertised to conceal or fail to warn of known dangers; and were represented to be safe for intended use. Defendants had a duty to warn Plaintiff, Decedent's physician, and/or the medical community about the potential malfunction of Defendants’ products. The G6 System and t:slim pump are inherently dangerous and defective, unfit and unsafe for their intended and foreseeable uses, and do not meet or perform to the patients’ and their providers’ expectations. The G6 System and t:slim pump had design, manufacturing, and warning defects. Defendants acted willfully, wantonly, with evil motive, and recklessly in designing, manufacturing, and marketing the devices.

Plaintiff suffered pecuniary loss from the loss of love, comfort, society, attention, services, and support of Decedent.

Plaintiff brings the following five claims against Defendants: (1) negligence, (2) strict products liability – design defect, (3) strict products liability – manufacturing defect; (4) strict products liability – failure to warn; and (5) wrongful death. Plaintiff seeks damages, loss of income, costs of suit, costs under California Civil Code §§ 998 & 1032, interest, attorneys’ fees, and other relief as the Court deems just and proper.

III. MOTION TO REMAND

A. Contentions

Plaintiff contends that Tandem improperly removed this action because Tandem is a forum defendant that was served before removal, even if Tandem had been served pre-removal such removal is improper, the Notice of Removal does not contain other filings from the state court docket, and Tandem did not obtain consent from Dexcom prior to removal. Alternatively, Plaintiff requests the Court invoke Colorado River abstention and remand this action.

Tandem contends that the forum defendant rule does not apply as it had not been served at the time of removal, a majority of courts have interpreted the forum defendant rule to only apply when the defendant had been joined and served prior to removal, consent from Dexcom was not required as it had not been properly served at the time of removal, Tandem properly filed its notice of removal in state court, and Tandem complied with the statute's requirements for filings from the state court docket. Tandem contends that the exceptional circumstances under the Colorado River doctrine are not present in this case.

B. Legal Standard

“Under 28 U.S.C. § 1441, a defendant may remove an action filed in state court to federal court if the federal court would have original subject matter jurisdiction over the action.” Moore-Thomas v. Alaska Airlines, Inc., 553 F.3d 1241, 1243 (9th Cir. 2009). District courts have original jurisdiction over “all actions where the matter in controversy exceeds the sum or value of $75,000, exclusive of interest and costs,” and the dispute is between “citizens of different States.” 28 U.S.C. § 1332(a).

“A motion to remand is the proper procedure for challenging removal.” Moore-Thomas, 553 F.3d at 1244. “[R]emand may be ordered either for lack of subject matter jurisdiction or for ‘any defect’ in the removal procedure.” Aguon-Schulte v. Guam Election Comm'n, 469 F.3d 1236, 1240 (9th Cir. 2006) (quoting 28 U.S.C. § 1447(c)). “The strong presumption against removal jurisdiction means that the defendant always has the burden of establishing that removal is proper.” Gaus v. Miles, Inc., 980 F.2d 564, 566 (9th Cir. 1992) (quotation omitted).

C. Discussion

1. Forum Defendant Rule

28 U.S.C. § 1441(b)(2) states that “[a] civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” 28 U.S.C. § 1441(b)(2). This provision, referred to by courts as the “forum defendant rule,” “confines removal on the basis of diversity jurisdiction to instances where no defendant is a citizen of the forum state.” Lively v. Wild Oats Mkts., Inc., 456 F.3d 933, 939 (9th Cir. 2006). The Court of Appeals for the Ninth Circuit has instructed that courts should “construe the removal statute against removal jurisdiction.” Gaus, 980 F.2d at 566.

As alleged in the Complaint, Plaintiff is a citizen of Wyoming and Tandem and Dexcom are citizens of California. (See NOR at 3; ECF No. 1-2 ¶¶ 2–7; ECF No. 10-1 at 6–7.) Plaintiff and Tandem do not dispute, and the Court agrees, that complete diversity exists and the amount in controversy requirement has been satisfied. (See NOR at 3; ECF No. 10-1 at 6.) Diversity jurisdiction exists over this matter. The parties, however, dispute whether Tandem properly removed this action as a forum defendant.

a. Whether the Notice of Removal was Filed Pre-Service

As an initial matter, Plaintiff and Tandem dispute whether the Notice of Removal was filed before or after Defendants were served in this case. Both parties agree that Defendants were served on January 30, 2024, at 1:37 p.m. (See ECF No. 10-1 at 9; ECF No. 22 at 8.) Plaintiff contends that the Clerk of Court for the Southern District of California docketed the Notice of Removal on January 30, 2024, at 3:50 p.m. Plaintiff contends the Clerk of Court's docketing of the Notice of Removal was the case initiating action and service was “perfected” prior to the removal of the case. (ECF No. 10-1 at 9.) Tandem contends that it filed the Notice of Removal and received a Notice of Electronic Filing of such on January 30, 2024, at 12:38 p.m. (ECF No. 22 at 14.) Tandem contends that the Court must look to the Clerk of Court Notice of Electronic Filing to determine when the case was initiated, which was prior to the 1:37 p.m. service. Tandem contends that Defendants had not been served prior to the filing of the Notice of Removal.

The Ninth Circuit has held, for determining the running of the statute of limitations, “[p]apers and pleadings including the original complaint are considered filed when they are placed in the possession of the clerk of the court.” Cintron v. Union Pac. R.R. Co., 813 F.2d 917, 920 (9th Cir. 1987) (citation and quotation omitted). This is known as the “constructive filing doctrine.” The Ninth Circuit has expanded the constructive filing doctrine to determining the timeliness of filing of appeal notices, United States v. Preston, 352 F.2d 352, 353 n.1 (9th Cir. 1965), and to objections to magistrate judge's findings, conclusions, and recommendations, Smith v. Frank, 923 F.2d 139, 141–42 (9th Cir. 1991).

The timing issue in this case is when the Notice of Removal was considered filed with this Court. While Plaintiff contends that the constructive filing doctrine has only been applied in statute of limitations contexts, the Court finds no reason to deviate from the constructive filing doctrine and finds the above-cited Ninth Circuit authority instructive in this context. Plaintiff does not cite to any legal authority to require the Court to hold otherwise, and the Court's Local Rules support the Court's conclusion to apply the doctrine here. See S.D. Cal. CivLR 5.4(c) (“Service of Pleadings and Documents Filed Electronically. The [Notice of Electronic Filing] that is automatically generated by the Court's Electronic Filing System constitutes service of the filed document on Filing Users. Parties who are not Filing Users must be served with a copy of any pleading or other document filed electronically in accordance with the Federal Rules of Civil Procedure and these Local Rules.”). The Court finds that the Notice of Removal was considered filed with the Court at 12:38 p.m., as reflected in the Notice of Electronic Filing. (See ECF No. 22 at 14.) Accordingly, the Notice of Removal was filed prior to the time when Defendants were served. The Court now turns to whether the pre-service removal was proper.

b. Snap Removal 3

Plaintiff contends that a forum defendant cannot remove an action under the statute for the following reasons: barring “removal by forum defendants reflects the absence of the reason for diversity of citizenship removals in the first place”; the “absurdity doctrine” militates against following the literal language of the statute; § 1441(b)(2) is ambiguous; and permitting snap removal “could not have been intended by Congress.” (ECF No. 10-1 at 7; ECF No. 26 at 4.) Tandem contends that the forum defendant rule did not bar removal because the plain language of § 1441(b)(2) is unambiguous in that a defendant that has not been properly joined and served may remove an action, and a majority of courts have interpreted the forum defendant rule to only apply when a forum defendant is properly joined and served.

District courts have reached different conclusions on the permissibility of snap removal, and the Ninth Circuit has yet to decide whether snap removal is permitted. Casola v. Dexcom, Inc., 98 F.4th 947, 965 (9th Cir. 2024) (stating that “the final chapter on snap removals in the Ninth Circuit remains to be written”); see, e.g., Loewen v. McDonnell, No. 19-cv-00467-YGR, 2019 WL 2364413, at *7 (N.D. Cal. June 5, 2019) (stating that the Northern District has consistently held that a forum defendant may remove an action prior to receiving proper service and collecting Northern District cases); U.S. Bank Nat'l Ass'n v. Pac. Life Ins. Co., No. 8:23-cv-01020-FWS-JDE, 2023 WL 8890832, at *4 (C.D. Cal. Dec. 21, 2023) (“Under Defendant's proposed interpretation, its expediency in removing the case means that it avoids application of the forum-defendant rule ․ The court observes that the weight of the case law in this District militates against Defendant's proposed interpretation of the forum defendant rule, in part because it promotes gamesmanship.” (collecting Central District cases)); Hong Kong Cont'l Trade Co. v. Ltd. v. Nat. Balance Pet Foods, Inc., No. LA CV22-00571-JAK (AFMx), 2023 WL 2664246, at *4 (C.D. Cal. Mar. 28, 2023) (“This Court has previously concluded that the plain text of Section 1441(b)(2) permits snap removal․ Permitting snap removal is neither absurd nor in conflict with the intent of Congress.”); Vallejo v. Amgen, Inc., No. CV 13-03666 BRO (MANx), 2013 WL 12147584, at *2 (C.D. Cal. Aug. 30, 2013) (collecting cases and stating that “[t]hose that granted remand either (1) read § 1441(b)(2)’s plain language as requiring at least one defendant to have been served before removal was permitted, ․ or (2) concluded that permitting removal before plaintiff had a meaningful opportunity to serve defendants ran afoul of the absurdity doctrine” and “[t]hose courts that denied remand applied § 1441(b)(2) literally and required a forum defendant to be properly joined and served before the statute's removal restrictions would apply” (citations omitted)).

In the absence of binding authority, the Court looks to “the language of the statute itself.” Republic of Sudan v. Harrison, 587 U.S. 1, 8, 139 S.Ct. 1048, 203 L.Ed.2d 433 (2019). 28 U.S.C. § 1441 provides that “[a] civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” 28 U.S.C. § 1441(b)(2). The plain language of the statute is unambiguous: removal is prohibited where a forum defendant has been “properly joined and served.” Id.

“It is well established that ‘when the statute's language is plain, the sole function of the courts–at least where the disposition required by the text is not absurd–is to enforce it according to its terms.’ ” Lamie v. U.S. Tr., 540 U.S. 526, 534, 124 S.Ct. 1023, 157 L.Ed.2d 1024 (2004). Plaintiff contends that strict interpretation of the statute would not align with the reason for diversity of citizenship removals, is not what Congress would have intended, and leads to an absurd result. The Court recognizes that snap removal by a forum defendant in some situations could be the result of gamesmanship, but “while it might seem anomalous to permit a defendant sued in its home state to remove a diversity action, the language of the statute cannot simply be brushed aside.” Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 706 (2d Cir. 2019). Congress may have written the statute to balance competing interests in limiting gamesmanship and providing a bright-line rule on service. See id. Plaintiff has not cited to any authority indicating that strict interpretation would contradict Congress’ intent behind the statute. Moreover, many courts have found that strict interpretation does not lead to an absurd result on similar grounds as those stated herein. See, e.g., Hong Kong Cont'l, 2023 WL 2664246, at *4; Loewen, 2019 WL 2364413, at *7–8. The Court does not find that strict interpretation of the statute would lead to an absurd result.

The Court's finding is bolstered by the holdings of four other circuit courts that have interpreted § 1441(b)(2) to allow removal by a forum defendant when the defendant has not been properly joined and served. See Tex. Brine Co. v. Am. Arbitration Ass'n, Inc., 955 F.3d 482, 487 (5th Cir. 2020) (“[W]e do not have any doubt about the propriety of removal because, as discussed, the text is unambiguous ․ A non-forum defendant may remove an otherwise removable case even when a named defendant who has yet to be properly joined and served is a citizen of the forum state.” (citations and quotations omitted)); Gibbons, 919 F.3d at 707 (“[A] home-state defendant may in limited circumstances remove actions filed in state court on the basis of diversity of citizenship – is authorized by the text of Section 1441(b)(2) and is neither absurd nor fundamentally unfair.”); Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147, 152, 154 (3d Cir. 2018) (“Starting with the text, we conclude that the language of the forum defendant rule in section 1441(b)(2) is unambiguous. Its plain meaning precludes removal on the basis of in-state citizenship only when the defendant has been properly joined and served․ Furthermore, we do not perceive that the result in this case rises to the level of the absurd or bizarre.”); McCall v. Scott, 239 F.3d 808, 813 n.2 (6th Cir. 2001) (“Where there is complete diversity of citizenship, ․ the inclusion of an unserved resident defendant in the action does not defeat removal under 28 U.S.C. § 1441(b).”). Accordingly, the Court finds that the Notice of Removal was not procedurally defective on forum defendant grounds.

2. Obtaining Consent from Dexcom

Plaintiff contends that the case should be remanded because Tandem did not obtain consent from Dexcom prior to removal as is required under § 1446(b)(2)(A). Tandem contends that because Dexcom had not been served at the time of removal, consent was not required.

28 U.S.C. § 1446 provides that “[w]hen a civil action is removed solely under section 1441(a), all defendants who have been properly joined and served must join in or consent to the removal of the action.” 28 U.S.C. § 1446(b)(2)(A). The Ninth Circuit has explained that only defendants who have been properly joined and served must consent to removal. Destfino v. Reiswig, 630 F.3d 952, 957 (9th Cir. 2011); see also Baiul v. NBC Sports, a division of NBCUniversal Media, LLC, 732 Fed. App'x 529, 531 (9th Cir. 2018) (collecting Ninth Circuit cases finding that the unanimity rule under § 1446(b)(2)(A) applies to only defendants who have been properly joined and served).

Because Dexcom had not been properly served at the time of removal, consent from it was not necessary. The Motion to Remand is denied on this ground.

3. Filings from State Court Docket

Plaintiff contends that Tandem did not follow the statutory removal requirement because the Notice of Removal “only contains a copy of the unstamped state court complaint and does not include the other filings within the state court docket.” (ECF No. 10-1 at 7–8.) Tandem contends that it was only required to file the Notice of Removal because there was no process, pleadings, or orders that had been served on either Defendant in the state court action.

28 U.S.C. § 1446 provides that a defendant removing an action from state court to a district court must file “a notice of removal” and “a copy of all process, pleadings, and orders served upon such defendant or defendants in such action.” 28 U.S.C. § 1446(a).

Plaintiff has not indicated what other process, pleadings, and orders he had served on either Defendant in the state court action that Tandem did not attach to the Notice of Removal. And based upon the Court's finding above, Tandem had not been served with the Complaint at the time of removal, so even a copy of the Complaint was not required. In any event, the failure to attach “a copy of all process, pleadings, and orders served upon such defendant or defendants in such action,” id., to a notice of removal is a curable defect and not a sufficient basis for remand. Kuxhausen v. BMW Fin. Servs. NA LLC, 707 F.3d 1136, 1142 (9th Cir. 2013) (“We agree with a leading treatise and with our sister circuits that this de minimis procedural defect[, failing to attach the original complaint,] was curable even after expiration of the thirty-day removal period.” (citations and quotations omitted)). Accordingly, the Court finds that attachment of required documents to the Notice of Removal is not a ground for remand in this case.

4. Colorado River Abstention

Plaintiff contends in the alternative that the Court should invoke the Colorado River abstention and decline jurisdiction because 24 other related Dexcom cases began in state court, federal court is an inconvenient forum to hear a single case when 24 others are pending in state court and substantial progress has been made in the state court cases, Tandem is forum shopping, and federal preemption is not a compelling reason to override other extraordinary factors favoring abstention. Tandem contends that the Colorado River doctrine does not apply in this case because there is no concurrent state litigation of the matter as the entire case was removed and the state court litigation is not sufficiently parallel to this case. Tandem contends that it is not involved in the state court litigation and the state court litigation has no bearing on its defense of the safety and efficacy of its product. In response, Plaintiff contends that there is a risk of duplicative discovery and contradictory rulings because the state court recently issued an order identifying 42 other cases that are “related” to this action and 39 of the 43 cases are awaiting rulings on motions to compel arbitration.

In Colorado River, the Supreme Court “recognized there may be circumstances in which traditional abstention principles do not apply, yet considerations of ‘wise judicial administration, giving regard to conservation of judicial resources and comprehensive disposition of litigation,’ nonetheless justify a decision to stay or dismiss federal proceedings pending resolution of concurrent state court proceedings.” Smith v. Centr. Ariz. Water Conservation Dist., 418 F.3d 1028, 1032–33 (9th Cir. 2005) (quoting Colorado River Water Conservation Dist. v. United States, 424 U.S. 800, 817, 96 S.Ct. 1236, 47 L.Ed.2d 483 (1976)). However, such circumstances are “exceedingly rare.” Id.; Am. Int'l Underwriters (Philippines), Inc. v. Cont'l Ins. Co., 843 F.2d 1253, 1256 (9th Cir. 1988) (“[A]bstention from the exercise of federal jurisdiction is considered an extraordinary and narrow exception to the duty of a District Court to adjudicate a controversy properly before it.” (quotation and citation omitted)). The Ninth Circuit has elaborated that “the Colorado River doctrine is a narrow exception to the virtually unflagging obligation of the federal courts to exercise the jurisdiction given to them.” Smith, 418 F.3d at 1033 (quotation and citation omitted). The Supreme Court has “limited Colorado River, emphasizing that courts may refrain from deciding an action for damages only in ‘exceptional’ cases, and only ‘the clearest of justifications’ support dismissal.” R.R. Street & Co. v. Transport Ins. Co., 656 F.3d 966, 978 (9th Cir. 2011) (quoting Colorado River, 424 U.S. at 818–19, 96 S.Ct. 1236).

The Ninth Circuit requires the court to “carefully consider both the obligation to exercise jurisdiction and the combination of factors counseling against that exercise” in determining whether to stay ⁴ or dismiss the case. The most commonly considered factors in the Ninth Circuit include:

(1) which court first assumed jurisdiction over any property at stake; (2) the inconvenience of the federal forum; (3) the desire to avoid piecemeal litigation; (4) the order in which the forums obtained jurisdiction; (5) whether federal law or state law provides the rule of decision on the merits; (6) whether the state court proceedings can adequately protect the rights of the federal litigants; (7) the desire to avoid forum shopping; and (8) whether the state court proceedings will resolve all issues before the federal court.

Id. at 978–79.

Here, Plaintiff is asking the Court to abstain on the grounds that “42” other state court cases exist that are “related” to this case as they are all brought against Dexcom concerning a “single integrated diabetes monitoring system.” (ECF No. 10-1 at 11; ECF No. 26 at 5.) In the Notice of Related Cases filed in state court,⁵ the filing states that “[t]here are 44 pending cases originally filed in the Superior Court of California, individual plaintiffs relating to their alleged use of a Dexcom G6 Continuous Glucose Monitoring System,” 43 of those cases name Dexcom as the sole defendant, and the present case before this Court is the only case that also names Tandem as a defendant. (ECF No. 10-2 at 153–54.)

The first and second abstention factors “are irrelevant in this case because the dispute does not involve a specific piece of property, and both the federal and state forums are located in [San Diego].” R.R. Street, 656 F.3d at 978.

As to the third factor, “[p]iecemeal litigation occurs when different tribunals consider the same issue, thereby duplicating efforts and possibly reaching different results.” Am. Int'l Underwriters (Philippines), 843 F.2d at 1258. “The mere possibility of piecemeal litigation does not constitute an exceptional circumstance.” R.R. Street, 656 F.3d at 979. The case must instead “raise a special concern about piecemeal litigation, which can be remedied by staying or dismissing the federal proceeding.” Id. (quotation and citation omitted). Any case involving the Colorado River doctrine could predictably involve possible “conflicting results, piecemeal litigation, and some duplication of judicial efforts,” which are the “unavoidable price of preserving access to ․ federal relief.” Neuchatel Swiss Gen. Ins. Co. v. Lufthansa Airlines, 925 F.2d 1193, 1195 (9th Cir. 1991) (alteration in original) (quotation omitted). “Instead, there must be exceptional circumstances present that demonstrate that piecemeal litigation would be particularly problematic.” Seneca Ins. Co. v. Strange Land, Inc., 862 F.3d 835, 842–43 (9th Cir. 2017). Here, Plaintiff generally contends that there are numerous related cases brought against Dexcom in state court that concern an integrated diabetes monitoring system and those cases have made substantial progress. However, this would be true in any situation with duplicative cases, and Plaintiff has not presented any “exceptional circumstances” that would render the present situation “particularly problematic.” Seneca Ins. Co., 862 F.3d at 843. Plaintiff has not shown there is anything about this case that “evinces a special or important rationale or legislative preference for resolving these issues in a single proceeding.” Id. In fact, this case involves issues against a defendant, Tandem, that has not been raised in state court in any related action. The third factor weighs in favor of the Court exercising jurisdiction over this matter.

Plaintiff does not discuss the fourth factor concerning the order in which the forums obtained jurisdiction. In any event, the majority of the cases pending in state court were filed prior to Plaintiff filing this Complaint in January 2024. (See ECF No. 10-2 at 154–55.) With respect to the progress of the state court cases, Plaintiff generally states that “substantial progress has been made in earlier filed state court cases.” (ECF No. 10-1 at 11.) Tandem contends that “the state litigation may not exist much longer” because “[t]here is an enforceable clause at issue; and the state court has already granted motions to compel arbitration for four of the cases.” (ECF No. 22 at 21 n.1.) In addition to the fact that several cases have already been sent to arbitration, it is unclear based on the parties’ briefing how far along the state court cases are in their proceedings, but neither party has indicated that the underlying legal claims have been determined in the state court cases. The Court finds that this favor weighs slightly in favor of exercising jurisdiction over this case.

As to the fifth factor, this case involves application of California law.⁶ While “the presence of federal-law issues must always be a major consideration weighing against surrender [of jurisdiction],” the “presence of state-law issues may weigh in favor of that surrender” only “in some rare circumstances.” Moses H. Cone Mem'l Hosp. v. Mercury Constr. Corp., 460 U.S. 1, 26, 103 S.Ct. 927, 74 L.Ed.2d 765 (1983). This case involves state tort law issues, “routine issues of state law ․ which the district court is fully capable of deciding.” Travelers Indem. Co. v. Madonna, 914 F.2d 1364, 1370 (9th Cir. 1990). Thus, this factor does not weigh against the Court's exercise of jurisdiction. See R.R. Street Co., 656 F.3d at 980–81.

The sixth factor concerns adequacy of state court. “A district court may not stay or dismiss the federal proceeding if the state proceeding cannot adequately protect the rights of the federal litigants. For example, if there is a possibility that the parties will not be able to raise their claims in the state proceeding, a stay or dismissal is inappropriate.” Id. at 981. Plaintiff contends that state court could adequately protect the rights of the litigants, and Tandem does not contend otherwise. There is no doubt that the state court “has the authority to address the rights and remedies in this case.” Id. “Like source of law, however, this factor is more important when it weighs in favor of federal jurisdiction.” Id. (quotation and citation omitted).

The Ninth Circuit has generally “affirmed a Colorado River stay or dismissal when it was readily apparent that the federal plaintiff was engaged in forum shopping.” Id. (collecting cases). Here, Tandem does not contend that Plaintiff has engaged in forum shopping. On the other hand, Plaintiff generally contends that Tandem is forum shopping. Plaintiff filed this case in state court first, then Tandem removed it to federal court by virtue of a “snap” removal four days after the Complaint was filed. To the extent that Tandem's behavior constitutes “forum shopping,” the Court finds that this factor weighs slightly in favor of remand.

The final factor “is whether the state court proceeding sufficiently parallels the federal proceeding.” Id. at 982. “[E]xact parallelism,” is not required; the two actions must be “substantially similar.” Id. (citation omitted). “[T]he existence of a substantial doubt as to whether the state proceedings will resolve the federal action precludes” a Colorado River stay or dismissal. Smith, 418 F.3d at 1033. Here, Plaintiff contends that there are “42 other cases that are ‘related’ to this case” and “[t]his parallel litigation overwhelming[ly] tips in favor of federal Colorado River abstention.” (ECF No. 26 at 5.) Tandem contends that there is no sufficiently parallel action because this case involves a plaintiff, another defendant, and another product not involved in the state court actions such that the state litigation “would have no bearing on the defense of safety and efficacy of its product.” (ECF No. 22 at 22.) The Court finds that resolution of the underlying issues in the cases in state court will not resolve all the claims before this Court. Not only is Plaintiff not a party to any of the state court cases such that the underlying facts may differ, but Tandem is not a defendant in any of the state court cases. In other words, there may be no underlying claim in any of the state court actions that could determine Tandem's liability. The fact that there may be overlapping issues with the state court actions related to Dexcom does not require the Court to invoke abstention under Colorado River. A district court may dismiss or stay a case under Colorado River “only if it has full confidence that the parallel state proceeding will be an adequate vehicle for the complete and prompt resolution of the issues between the parties.” Gulfstream Aerospace Corp. v. Mayacamas Corp., 485 U.S. 271, 277, 108 S.Ct. 1133, 99 L.Ed.2d 296 (1988) (quotation omitted). The Court finds that there is “substantial doubt” that the resolution of the other state court cases would resolve the claims brought by Plaintiff in this action. Smith, 418 F.3d at 1033. The eighth factor weighs in favor of the Court exercising jurisdiction.

The Court finds that, on balance, the factors do not weigh in favor of remanding the action to state court under the Colorado River doctrine. Plaintiff's Motion to Remand is denied.

IV. MOTIONS TO DISMISS

Tandem moves to dismiss the FAC on the grounds that federal law expressly preempts Plaintiff's claims, the FAC fails to adequately plead facts to state claims for relief, and Plaintiff's wrongful death claim is derivative of the products liability claims and must be dismissed.

Dexcom moves to dismiss the FAC on the grounds that federal law expressly preempts Plaintiff's claims, federal law impliedly preempts Plaintiff's claims, California law bars Plaintiff's design defect claims, the FAC includes conclusory allegations in alleging facts supporting the claims, and the punitive damages demand is tied to non-viable claims and the surrounding facts are not adequately plead. Dexcom also moves to dismiss the FAC for failure to join all necessary parties, or, in the alternative, Dexcom requests the Court compel Plaintiff to join Decedent's mother as a plaintiff.

A. Legal Standard

Rule 12(b)(6) of the Federal Rules of Civil Procedure permits dismissal for “failure to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). In order to state a claim for relief, a pleading “must contain ․ a short and plain statement of the claim showing that the pleader is entitled to relief.” Id. 8(a)(2). Dismissal under Rule 12(b)(6) “is proper only where there is no cognizable legal theory or an absence of sufficient facts alleged to support a cognizable legal theory.” Shroyer v. New Cingular Wireless Servs., Inc., 622 F.3d 1035, 1041 (9th Cir. 2010) (citation omitted).

“To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citation omitted). However, “a plaintiff's obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (alteration in original) (quoting Fed. R. Civ. P. 8(a)). A court is not “required to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.” Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). “In sum, for a complaint to survive a motion to dismiss, the non-conclusory factual content, and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir. 2009) (citation omitted).

B. Tandem's Motion to Dismiss

1. Federal Express Preemption

Tandem contends that Plaintiff's state law claims fail in light of the Medical Devices Amendment (“MDA”) express preemption provision. Tandem contends that the two prongs of the test established in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), are met because the t:slim X2 insulin pump with Basil-IQ technology is a Class III medical device approved through the PMA process that is subject to federal requirements and Plaintiff's claims seek to impose requirements that are different to federal requirements such that they are not permissive parallel claims.

Plaintiff contends that whether the t:slim pump in this case underwent PMA is not an issue resolvable at this stage in the proceedings. Plaintiff contends that even if the t:slim pump underwent PMA, the state claims in the FAC fall within the narrow exception in Riegel for state law claims that are not preempted if they are parallel with federal law.

Congress enacted the MDA to the Food, Drug, and Cosmetic Act (“FDCA”) “to extend the coverage ․ to medical devices.” Stengel v. Medtronic Inc., 704 F.3d 1224, 1226 (9th Cir. 2013) (en banc); see Riegel, 552 U.S. at 315–16, 128 S.Ct. 999. Under the MDA, medical devices are divided “into three classes according to user risk,” with Class I devices posing the least risk and Class III posing the most risk. Stengel, 704 F.3d at 1226. Class I devices are subject to “general controls,” “such as labeling requirements.” 21 U.S.C. § 360c(a)(1)(A); Riegel, 552 U.S. at 316, 128 S.Ct. 999. Class II devices are subject to “general controls” in addition to “special controls,” such as “performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines ․, [and] recommendations.” 21 U.S.C. § 360c(a)(1)(B); Riegel, 552 U.S. at 316, 128 S.Ct. 999. “If a device cannot be determined to provide a reasonable assurance of safety and effectiveness under Class I or II controls and is either marketed as a life-supporting device or may cause an unreasonable risk of illness or injury, it is a Class III device.” Stengel, 704 F.3d at 1226; see 21 U.S.C. § 360c(a)(1)(C). Class III devices are subject to the FDA's pre-market approval (“PMA”) process. 21 U.S.C. § 360c(a)(1)(C); Riegel, 552 U.S. at 316, 128 S.Ct. 999.

The FDA's PMA “is a rigorous process.” Riegel, 552 U.S. at 317, 128 S.Ct. 999. “The FDA performs a risk-benefit assessment of the device and determines the adequacy of the manufacturer's proposed label.” Stengel, 704 F.3d at 1226. Then, the FDA “denies, approves, or approves with conditions on distribution, marketing, or sale.” Id. After approval, “the manufacturer is required to report any information that reasonably suggests that the device (1) ‘[m]ay have caused or contributed to a death or serious injury’ or (2) ‘[h]as malfunctioned’ and that any recurring malfunction ‘would be likely to cause or contribute to a death or serious injury.’ ” Id. at 1226–27 (quoting 21 C.F.R. § 803.50(a)).

The MDA “imposed a regime of detailed federal oversight.” Riegel, 552 U.S. at 316, 128 S.Ct. 999. The MDA includes an express preemption provision that states:

Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a).⁷ The FDA interprets this preemption in 21 C.F.R. § 808.1(d), which states that:

State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the Federal Food, Drug, and Cosmetic Act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.

21 C.F.R. § 808.1(d). Section 808.1 provides that “State or local requirements of general applicability” are not preempted “where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.” Id. § 808.1(d)(1).

In Riegel, the Supreme Court provided a two-prong framework to determine whether a state law claim is preempted under § 360k. First, the court must determine “whether the Federal Government has established requirements applicable to [the device at issue].” Riegel, 552 U.S. at 321, 128 S.Ct. 999. If it has, then the court “must determine whether the [state law] claims are based upon [the state's] 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. at 321–22, 128 S.Ct. 999 (quotations omitted). The state “requirements” referenced in the MDA include not just statutory and regulation duties, but also those imposed by common-law tort doctrines. See id. at 324–25, 128 S.Ct. 999. Under the second prong, State law claims that are not expressly preempted are claims “for violating a state-law duty that parallels a federal-law duty under the MDA.” Stengel, 704 F.3d at 1228.

Claims concerning medical devices may also be impliedly preempted by the MDA when they solely seek to enforce violations of MDA requirements and are not based on traditional state tort law. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352–53, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). The Ninth Circuit has confirmed that there is “ ‘narrow gap’ through which a state-law claim must fit to escape preemption by the FDCA: ‘The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).’ ” Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013) (emphasis in original) (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Lib. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)).

a. First Prong of Riegel Test

The Court must first consider “whether the Federal Government has established requirements applicable to” the t:slim pump at issue in this case. Riegel, 552 U.S. at 321, 128 S.Ct. 999.

Tandem contends that the insulin pump at issue is the t:slim X2 insulin pump with Basal-IQ technology that is a Class III, PMA-approved device. Tandem contends that Plaintiff alleges this fact at the start of the FAC but then “provides an inaccurate (and nonsensical) overview of the pump and explains that the device changed names, properties, and classifications ․ twice.” (ECF No. 15 at 17.) Tandem contends that the t:slim X2 insulin pump with Basal-IQ technology that is a Class III device as shown by the website cited in the FAC. Tandem requests the Court take judicial notice of the fact that Decedent used the t:slim X2 insulin pump with Basal-IQ technology device based on Tandem's “Customer Relationship Management System” record, which is attached to the Motion, for Decedent. Id. Tandem contends that because the t:slim X2 insulin pump with Basal-IQ technology that is a Class III device used by Decedent, it is subject to federal requirements and the first Riegel prong is satisfied.

Plaintiff contends that Tandem relies on extrinsic evidence, thereby converting the motion to dismiss into a motion for summary judgment. Plaintiff objects to Tandem's internal Customer Relationship Management System record because it is a “biased record of a party opponent unable to be considered under judicial notice.” (ECF No. 27 at 15.) Plaintiff does not dispute that “the first t:slimp pump went through PMA” and contends that the device and software subsequently changed its regulatory status. Id. at 14.

As an initial matter, the Court declines to take judicial notice of Tandem's Customer Relationship Management System record and the facts contained therein. Fed. R. Evid. 201(b) (providing that judicial notice is permitted for an adjudicative fact if it is not “subject to reasonable dispute”—i.e. if it is “generally known,” or “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned”); United States v. Ritchie, 342 F.3d 903, 908 (9th Cir. 2003) (“Courts may only take judicial notice of adjudicative facts that are ‘not subject to reasonable dispute.’ ” (quoting Fed. R. Evid. 201(b))).

In the FAC, Plaintiff alleges that Tandem's original t:slim pump obtained PMA as “a Class III medical device for the pump's ‘Basil-IQ’ technology.” (FAC ¶ 37.) Plaintiff alleges that in 2019, “Tandem reclassified the t:slim pump with interoperable technology as a Class II medical device under the De Novo classification clearance” and “applying controls for the t:slim pump's integration with the G6 System.” Id. ¶ 38. Plaintiff alleges that in 2020, “the t:slim pump with interoperable technology obtained a substantial equivalence determination under the FDA's 510(k) submission process for this Class II medical device's update to its software.” Id. ¶ 39. Plaintiff alleges that during the relevant time, Decedent used Tandem's t:slim pump. Viewing these allegations and the reasonable inferences therefrom in the light most favorable to Plaintiff, the t:slim pump Decedent was using at the time he died was a Class II device. In its Motion, Defendant contends that “Plaintiff provides an inaccurate (and nonsensical) overview of the pump” and asserts that the allegations are “simply not true.” (ECF No. 15 at 17.) At this stage in the proceedings, the Court must assume the truthfulness of the allegations in the FAC. Tandem fails to move to dismiss on the grounds, much less argue, that a Class II device is one in which “the Federal Government ․ established [applicable] requirements.” Riegel, 552 U.S. at 321–22, 128 S.Ct. 999; see, e.g., Sanchez v. Stryker Corp., No. CV10-08832 ODW (JCGx), 2011 WL 13217944, at *4 (C.D. Cal. Apr. 26, 2011) (“[B]ecause the Device at issue is a Class II device subjected only to the limited substantial equivalency review of the 510(k) notification process, the Court finds that Plaintiff's claims premised upon FDA violations are not preempted and, therefore, survive dismissal.”); Fender v. Medtronic, Inc., 887 F. Supp. 1326, 1330 (E.D. Cal. 1995) (“First, tort claims relating to the manufacture, design, or labeling of Class III devices that have gone through the PMA process are preempted․ The PMA process is itself a specific requirement applicable to a particular device under the FDA's preemption regulation. On the other hand, tort claims relating to a Class II device, which is not subject to the PMA process, will not be preempted unless there are specific regulations for the device that relate to safety or effectiveness.”); see also In re Bard IVC Filters Prod. Liab. Litig., 969 F.3d 1067, 1074 (9th Cir. 2020) (discussing whether a device's reclassification from Class III to II included “ ‘specific’ requirements ‘applicable to a particular device’ under 21 C.F.R. § 808.1(d)” such that the plaintiff's claims were preempted). Based upon the allegations in the FAC, the Court cannot find that the device at issue is a Class III device having received PMA such that the first Riegel prong is satisfied, and Tandem does not argue that the device was a Class II device with federal requirements satisfying the first Riegel prong. The Court need not reach the second prong given the Court's finding as to the first prong. Plaintiff's claims against Tandem as alleged in the FAC are not expressly preempted.

The Court denies Tandem's Motion to Dismiss on the grounds that Plaintiff's claims are expressly preempted.

2. Sufficiently of Allegations

Tandem moves to dismiss Plaintiff's claims on the grounds that Plaintiff fails to plead sufficient facts to state plausible design defect, manufacturing defect, and failure to warn claims because Plaintiff does not identify a defect or causation.

Plaintiff contends, without providing additional analysis, that “Tandem argues the FAC fails to plausibly allege facts regarding defect and causation for Plaintiff's negligence, strict liability design defect, and failure to warn claims․ Not so.” (ECF No. 27 at 21.) Plaintiff concedes that “the FAC fails to allege facts regarding how the t:slim pump used by [D]ecedent deviated from intended manufacturing defects.” (ECF No. 27 at 21.) Plaintiff accordingly “seeks leave to amend the FAC to assert additional factual bases to plausibly plead its manufacturing defect claims.” Id.

As an initial matter, given Plaintiff's concession about the sufficiency of the allegations for his manufacturing defect claims, the Court grants Tandem's Motion to Dismiss Plaintiff's manufacturing defect claims.

a. Design Defect Claims

Plaintiff brings design defect claims based upon a theory of negligence (claim 1) and strict liability (claim 2).

Under California law, “under either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury.” Merrill v. Navegar, Inc., 26 Cal.4th 465, 479, 110 Cal.Rptr.2d 370, 28 P.3d 116 (2001). “Under a negligence theory, a plaintiff must also prove an additional element, namely, that the defect in the product was due to negligence of the defendant.” Id. (quotations and citations omitted). In a strict liability action based on design defect, a product must be defective in one of two ways. First, a product's design is defective under the “consumer expectation test” “if the product has failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner.” Barker v. Lull Eng'g Co., 20 Cal.3d 413, 418, 143 Cal.Rptr. 225, 573 P.2d 443 (1978). Second, under the “risk benefit test,” the design of a product is defective if the design embodies “excessive preventable danger,” i.e., “the benefits of the challenged design do not outweigh the risk of danger inherent in such design.” Id. For a negligent design defect claim, “the test of negligent design involves a balancing of the likelihood of harm to be expected from a [product] with a given design and the gravity of harm if it happens against the burden of the precaution which would be effective to avoid the harm.” Merrill, 26 Cal.4th at 479, 110 Cal.Rptr.2d 370, 28 P.3d 116 (quotations and citations omitted). A manufacturer or other seller may be held liable for negligence in marketing a product as a result of the product's design. Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1305, 144 Cal.Rptr.3d 326 (2012). Even if a seller may have done all it “could reasonably have done to warn about a risk or hazard related to the way a product was designed, it could be that a reasonable person would conclude that the magnitude of the reasonably foreseeable harm as designed outweighed the utility of the product as so designed.” Id. (quoting Merrill, 26 Cal.4th at 479–80, 110 Cal.Rptr.2d 370, 28 P.3d 116).

Here, Plaintiff generally alleges that Tandem knew the G6 System was designed to transmit inaccurate BGV readings to the t:slim pump creating an unreasonable risk of dangerous insulin stacking. (See, e.g., FAC ¶¶ 88, 92, 93, 103, 106.) However, these allegations relate to the alleged negligence of Dexcom's G6 System, but are conclusory as to Tandem and do not sufficiently allege a defect with Tandem's insulin pump. Cf. Oregon v. Bos. Sci. Corp., No. 1:21-cv-0192-DAD-BAK, 2022 WL 1607960, at *7 (E.D. Cal. May 20, 2022) (listing the allegations in the complaint sufficiently “identif[ing] several aspects of the [device at issue] that are purportedly defectively designed” and “that the potential risk of harm posed by those alleged defects outweighed any benefits offered by the product”). In reviewing the allegations in the FAC, Plaintiff fails to allege nonconclusory allegations identifying what aspect of the insulin pump's design made it defective or how any such defect resulted from Tandem's negligence.

Tandem additionally contends that Plaintiff's design defect claim based upon a theory of strict liability must be dismissed because California law ⁸ does not recognize strict liability design defect claims for prescription medical devices. The Court agrees. California law precludes strict liability claims based on a design defect with respect to manufacturers of prescription medical devices. See Garrett v. Howmedica Osteonics Corp., 214 Cal. App. 4th 173, 182, 153 Cal.Rptr.3d 693 (2013) (recognizing “an exemption from design defect strict liability products liability for all implanted medical devices”); see also Fussy v. RTI Surgical, 1:21-cv-01397-DAD-BAK, 2022 WL 1122615, at *3 (E.D. Cal. Apr. 14, 2022) (dismissing strict liability design defect claim for a prescribed medical device). Here, Plaintiff alleges in the FAC that “[t]he t:slim pump is a prescribed medical device.” (FAC ¶ 19.) Plaintiff's strict liability claim for a design defect claim must be dismissed for this additional reason.

The Court grants Tandem's Motion to Dismiss as to Plaintiff's design defect claims.

b. Failure to Warn Claims

Plaintiff brings failure to warn claims based upon a theory of negligence (claim 1) and strict liability (claim 4). Tandem contends that Plaintiff fails to identify any risk or injury Tandem knew or should have known about and fails to allege causation.

Under California law, strict liability applies to manufacturers of all products “for failure to warn of known or reasonably scientifically knowable risks that we previously applied specifically to manufacturers of prescription drugs.” Carlin v. Superior Court, 13 Cal.4th 1104, 1109, 56 Cal.Rptr.2d 162, 920 P.2d 1347 (1996). A strict liability cause of action “require[s] a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.” Id. at 1112, 56 Cal.Rptr.2d 162, 920 P.2d 1347. “Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about.” Anderson v. Owens-Corning Fiberglas, Corp., 53 Cal.3d 987, 1002, 281 Cal.Rptr. 528, 810 P.2d 549 (1991). “Whether asserting a negligent or a strict liability failure-to-warn claim, the plaintiff must also establish that the manufacturer's failure to warn was a substantial factor in causing [the plaintiff's] injury.” Himes v. Somatics, LLC, 322 Cal.Rptr.3d 1, 549 P.3d 916, 923 (2024) (quotation omitted) (alteration in original). The Supreme Court of California considered a certified question from the Ninth Circuit on how the plaintiff must “prove that the failure to warn caused his or her injury.” Id., 322 Cal.Rptr.3d 1, 549 P.3d at 921. The court answered that

A plaintiff is not required to show that a stronger warning would have altered the physician's decision to prescribe the product to establish causation. Instead, a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient's position would have thereafter declined the treatment. The causation analysis, however, must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of a more adequate warning.

Id.; see also id. at 928, 549 P.3d at 921 (“In sum, under the learned intermediary doctrine, the physician's judgment and advice remains central to the causation analysis, but the ultimate decision of whether to go forward with the treatment resides with the patient.”).

California applies the “learned intermediary” doctrine, which provides that “the duty to warn runs to the physician, not to the patient.” Carlin, 13 Cal.4th at 1116, 56 Cal.Rptr.2d 162, 920 P.2d 1347 (emphasis in original); Brown v. Superior Court, 44 Cal.3d 1049, 1062 n.9, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) (“It is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to the physician.”); Bigler-Engler v. Breg, Inc., 7 Cal. App. 5th 276, 320, 213 Cal.Rptr.3d 82 (2017) (applying the learned intermediary doctrine to implanted medical devices); Himes, 322 Cal.Rptr.3d 1, 549 P.3d at 921 (“For manufacturers of prescription drugs and many medical devices, however, the duty to warn runs to the physician, not to the patient.” (quotation omitted)); Saavedra v. Eli Lily & Co., No. 2:12-cv-9366-SVW-MAN, 2013 WL 6345442, at *3 (C.D. Cal. Feb. 26, 2013) (applying the learned intermediary doctrine to both strict liability and negligent theory failure to warn claims).

Here, Plaintiff alleges that “Tandem had a duty to warn Plaintiff, [D]ecedent's physician, and/or the medical community of the potential for t:slim to malfunction or otherwise not operate as Tandem represented and failed to do so.” (FAC ¶ 84.) Plaintiff alleges that “Tandem knew, or reasonably should have known, the t:slim pump posed a significant risk of insulin stacking if the G6 System transmitted an inaccurate BGV, which would likely cause a hypoglycemic event resulting in significant injuries or death.” Id. ¶ 144. Plaintiff alleges that “Tandem had a duty to warn of the risk of harm associated with the t:slim pump administering insulin based upon inaccurate BGV transmitted to the device by the G6 System and to provide adequate warnings concerning the risk of insulin stacking to patients using the t:slim pump.” Id. ¶ 146. While these allegations are sufficient to allege a risk—insulin stacking—that Tandem failed to warn about, Plaintiff fails to allege that this is a risk that “a reasonably prudent manufacturer would have known and warned about.” Carlin, 13 Cal. 4th at 1112, 56 Cal.Rptr.2d 162, 920 P.2d 1347.

As to causation, Plaintiff fails to allege facts that the prescribing physician “would still recommend [the insulin pump]” if warnings had been given.⁹ Himes, 322 Cal.Rptr.3d 1, 549 P.3d at 921; see Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“[A] product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician.”).; Tapia v. Davol, Inc., 116 F. Supp. 3d 1149. 1158, 1158 (S.D. Cal. 2015) (“[W]hile Plaintiff alleges the specific defect in Defendants’ product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.”). Based upon the fact that Plaintiff fails to sufficiently allege a risk and causation for a failure to warn claim under either a theory of negligence or strict liability, the Court grants Tandem's Motion to Dismiss these claims.

3. Wrongful Death Claim

Tandem moves to dismiss Plaintiff's wrongful death claim on the ground that it is derivative of Plaintiff's product liability claims.

The elements of a claim for wrongful death include “(1) a ‘wrongful act or neglect’ on the part of one or more persons that (2) ‘cause[s]’ (3) the ‘death of [another] person’ on legal theories of negligence and strict liability.” Norgart v. Upjohn Co., 21 Cal. 4th 383, 390, 87 Cal.Rptr.2d 453, 981 P.2d 79 (1999) (quoting Cal. Civ. Proc. Code § 377.600); Quiroz v. Seventh Ave. Ctr., 140 Cal. App. 4th 1256, 1263, 45 Cal.Rptr.3d 222 (2006) (“The elements of the cause of action for wrongful death are the tort (negligence or other wrongful act), the resulting death, and the damages, consisting of the pecuniary loss suffered by the heirs.” (quotation and citation omitted)).

In this case, Plaintiff does not elaborate in the FAC under what theory the wrongful death claim is brought. Regardless, Plaintiff fails to adequately allege actionable wrongdoing on the part of Tandem under either a negligence or strict liability theory as provided above. See Patton v. Forest Lab., Inc., No. EDCV 17-922-MWF (DTBx), 2018 WL 5269239, at *10 (C.D. Cal. Sept. 19, 2018) (concluding that “[s]ince the SAC fails to allege any actionable wrongdoing on the part of Defendants, ․ Plaintiffs’ wrongful death claim must be dismissed”). Tandem's Motion to Dismiss the wrongful death claim is granted.

C. Dexcom's Motion to Dismiss

1. Federal Express Preemption

Dexcom contends that Plaintiff's claims are expressly preempted under the MDA. Dexcom contends that the Riegel prongs are met because the G6 System design, manufacturing, and labeling are subject to specific requirements imposed by the FDA “to provide a reasonable assurance of safety and effectiveness” and Plaintiff's claims seek to impose different or additional requirements beyond those imposed by the FDA. (ECF No. 16-1 at 16–17.)

Plaintiff contends that the G6 System received approval through FDA's De Novo classification process that is designed for novel devices without a predicate device but are considered to have low to moderate risk. Plaintiff contends that the De Novo classification representing “a general recognition of the device's safety and effectiveness under specified controls, rather than detailed, device-specific requirements.” (ECF No. 28 at 11.) Plaintiff contends that without specific requirements, state law claims concerning manufacturing defects, design defects, and failure to warn are not imposing requirements different from or in addition to federal requirements. Plaintiff thus contends that the Court need not consider the second Riegel prong because the FAC's allegations are not expressly preempted at the pleading stage.

In Reply, Dexcom contends that the FDA imposed device-specific requirements that are applicable to the G6 System, which satisfies the first Riegel prong, and Plaintiff does not respond to Dexcom's arguments regarding the second prong, which waives his opposition.

a. First Prong of Riegel Test

The parties do not dispute that the FDA classified the G6 System as a Class II device that was cleared for sale through the De Novo process and subject to special controls.¹⁰ (See FAC ¶ 27; ECF No. 16-1 at 12; ECF No. 28 at 8.) The parties dispute whether the special controls are specific requirements for the G6 System such that the first Riegel prong is satisfied.

In analyzing the first Riegel prong with respect to specific requirements, “the scope of preemption is limited to instances where there are specific FDA requirements applicable to a particular device.” Papike v. Tambrands, Inc., 107 F.3d 737, 742 (9th Cir. 1997) (quotation omitted).

After Dexcom submitted a De Novo classification ¹¹ request for the G6 System, the FDA classified the device as Class II “with the establishment of special controls” determined by the FDA in addition to general controls that “provide reasonable assurance of the safety and effectiveness of the device for its intended use.” 87 Fed. Reg. 9237, 9237–98 (Feb. 18, 2022). In the FDA's “final order,” it “codif[ied] the classification of the device by adding 21 CFR 862.1355” and “named the generic type of device ‘integrated continuous glucose monitoring system (iCGM).’ ” 87 Fed. Reg. at 9238. The codified classification and special controls, as stated in the final order, states that the identified device is “[a]n integrated continuous glucose monitoring system” classified as Class II with listed “special controls for this device.” 21 C.F.R. § 862.1355(a), (b).

Dexcom contends that the codified “special controls” are FDA “device-specific requirements provid[ing] reasonable assurances of the safety and effectiveness of the G6 and mitigated the risks to health associated with the use of the G6.” (ECF No. 16-1 at 14.) Plaintiff contends that the “specific controls for CGM devices do[ ] not contain specific, device-level requirements.” (ECF No. 28 at 8.)

The FDA regulations provide that “state requirements are pre-empted ‘only’ when the FDA has established ‘specific counterpart regulations or ․ other specific requirements applicable to a particular device.’ ” Medtronic, Inc. v. Lohr, 518 U.S. 470, 498, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (quoting 21 C.F.R. § 808.1(d)). In Lohr, the Supreme Court addressed with the issue of whether FDA regulations were specific requirements applicable to the particular device at issue. The Court explained that “federal requirements must be ‘applicable to the device’ in question, and, according to the regulations, pre-empt state law only if they are ‘specific counterpart regulations’ or ‘specific’ to a ‘particular device.’ ” Id. at 500, 116 S.Ct. 2240. The Court stated that “[t]he statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.” Id. The Court found that the regulations at issue contained generality “unlike a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question” and that “the federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation that the statute or regulations were designed to protect from potentially contradictory state requirements.” Id. at 501, 116 S.Ct. 2240.

The Ninth Circuit recently addressed whether FDA “specific controls” for a Class II device were specific requirements in In re Bard IVC Filters Prod. Liab. Litig., 969 F.3d 1067 (9th Cir. 2020). The regulations at issue before the Ninth Circuit addressed risks to “adverse tissue reaction” and “health related infection,” which are “common to devices that contact the body” or “common to use of many devices.” Id. at 1074 (quotations omitted). The court elaborated that the regulations did not “contain[ ] anything specific to intravascular filters, let alone to the particular intravascular filter at issue here.” Id. The court found that “[l]ike the general requirements in Lohr, the documents ‘reflect important but generic concerns about device regulation generally, not the sort of concerns a specific device or field of device regulation that the statute or regulations were designed to protect from potentially contradictory state requirements.’ ” Id. (quoting Lohr, 518 U.S. at 501, 116 S.Ct. 2240).

Here, the FDA codified the list of “special controls” for an “integrated continuous glucose monitoring system (iCGM).” 21 C.F.R. § 862.1355(b). The “special controls,” which include “[d]esign verification and validation” complying with the listed conditions and labeling requirements, were intended to provide “a reasonable assurance of safety and effectiveness.” 87 Fed. Reg. 9237, 9237 (Feb. 18, 2022); 21 C.F.R. § 862.1355(b). These “specific controls” are not only specific requirements to a specific type of device—an iCGM—but the FDA established these special controls in classifying “the device,” which was the G6 System. 87 Fed. Reg. at 9237. On February 18, 2022, the FDA issued a final order classifying iCGM devices Class II (special controls) in response to Dexcom's request for De Novo classification of its G6 System. Id. The FDA stated “[a]fter review of the information submitted in the request, we determined that the device can be classified into [C]lass II with the establishment of special controls” and the special controls with general controls “will provide reasonable assurance of the safety and the effectiveness of the device.” Id. at 9237–38. The FDA stated in the final order, “the FDA is codifying the classification of the device by adding 21 CFR 862.1355,” and the FDA has “named the generic type of device ‘integrated continuous glucose monitoring system (iCGM),’ and it is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time.” Id. at 9238. The Court finds that the “special controls” codified in 21 C.F.R. § 862.1355(b) are “specific requirements applicable to a particular device.” 21 C.F.R. § 808.1(d). The Court's finding is consistent with Supreme Court and Ninth Circuit authority involving device-specific requirements. See Lohr, 518 U.S. at 501–502, 116 S.Ct. 2240 (finding that the federal requirements were not device specific); Papike, 107 F.3d at 742 (finding that the “tampon labeling regulation is device- and disease-specific and preemption is warranted” and was “consistent with [Lohr], which did not involve device-specific federal requirements”).

Plaintiff contends that Dexcom fails to point to binding authority that supports its position that devices having undergone De Novo classification are expressly preempted. Conversely, Plaintiff has not pointed to, and the Court is not aware of, any binding authority that claims relating to a device that underwent De Novo classification cannot be expressly preempted when the FDA promulgated specific regulations regarding the device. See Papike, 107 F.3d at 739 (holding that claims relating to a Class II device that had FDA regulations concerning labeling were expressly preempted).

Plaintiff contends that this Court should decline to find preemption at this stage of the proceedings like the court in Tuttle v. Dexcom, Inc., No. 1:20-CV-4744-LMM, 2021 WL 8998920 (N.D. Ga. May 20, 2021). The court in Tuttle considered the parties’ disagreement over whether Dexcom's “G6 System and its De Novo classification avenue to approval” means that the device is subject to federal requirements. Id. at *6. The court found that it could not “hold at this stage in the proceedings that the G6 System is subject to FDA ‘requirements’ ” as “Dexcom's case for preemption turns on the nature of the De Novo classification process” and “the regulations for continuous glucose monitoring systems that are to be published through that process, have not yet been codified.” Id. While Tuttle also involved Dexcom's G6 System and, importantly, the FDA had not yet classified the G6 System codified with special controls at the time that the Tuttle order was issued. The facts before this Court are different, and the Court finds differently than Tuttle for the reasons set forth above.

Plaintiff additionally relies on Desch v. Merz N. Am., Inc., No. 22-CV-02688, 2023 WL 2734671 (E.D.N.Y. Mar. 31, 2023), to support its contention that there is no binding authority regarding preemption of lower risk devices having undergone De Novo classification. The facts at bar are different than those in Desch, which did not involve the G6 System. See Desch, 2023 WL 2734671, at *4 (holding that the plaintiff's “claims are not expressly preempted because the FDA's special controls document on which [d]efendants rely does not impose any specific requirements on the [device]”).

Accordingly, the Court finds that the FDA has promulgated specific federal requirements for the G6 System such that first prong of Riegel has been met.

b. Second Riegel Prong

The second Riegel prong requires the Court to determine whether Plaintiff's state law claims are based on “any requirement” of California ¹² law with respect to the G6 System that is “different from, or in addition to” federal requirements and “relate to safety and effectiveness.” Riegel, 552 U.S. at 321–22, 128 S.Ct. 999.

Dexcom contends that the second prong is satisfied because Plaintiff's claims seek to impose different or additional requirements beyond the FDA imposed requirements.

Plaintiff fails to respond to Dexcom's arguments regarding the second Riegel prong. The Court finds that Plaintiff waived its argument on the issue. See Pac. Dawn LLC v. Pritzker, 831 F.3d 1166, 1178 n.7 (9th Cir. 2016) (holding an argument was waived because a party failed to raise the argument in its opposition brief). In any event, the FDA imposes five device-specific labeling requirements. See 21 C.F.R. § 862.1355(b)(7). The FAC alleges that Dexcom is liable for failing to include warnings different from or in addition to those listed in 21 C.F.R. § 862.1355(b)(7). (See FAC ¶¶ 143, 145, 147.) Based upon the allegations of the FAC, Riegel’s second prong has been met. The Court concludes that Plaintiff's claims against Dexcom are expressly preempted.¹³ Dexcom's Motion to Dismiss Plaintiff's claims on express preemption grounds is granted.

V. CONCLUSION

IT IS HEREBY ORDERED that the Motion to Remand (ECF No. 10) is denied.

IT IS FURTHER ORDERED that Tandem's Motion to Dismiss (ECF No. 15) is granted as follows. Plaintiff's claims against Tandem in the FAC are dismissed without prejudice and with leave to amend on the grounds that Plaintiff fails to plausibly state claims for relief.

IT IS FURTHER ORDERED that Dexcom's Motion to Dismiss (ECF No. 16) is granted as follows. Plaintiff's claims against Dexcom in the FAC are dismissed without prejudice and with leave to amend under the preemption doctrine. The remainder of Dexcom's Motion to Dismiss is denied.¹⁴

IT IS FURTHER ORDERED that Plaintiff may file an amended complaint, entitled “Second Amended Complaint,” within twenty-one (21) days of the entry of this Order. If Plaintiff does not file an amended complaint, the Court will direct the Clerk of Court to close this case.

FOOTNOTES

1.   For the purposes of the ruling on the Motion to Remand, the Court only considers the original Complaint. Generally, “whether remand is proper must be ascertained on the basis of the pleadings at the time of removal.” Broadway Grill, Inc. v. Visa Inc., 856 F.3d 1274, 1277 (9th Cir. 2017).

4.   The Ninth Circuit “generally require[s] a stay rather than dismissal.” R.R. Street, 656 F.3d at 978 n.8. Here, however, Plaintiff only requests the Court remand the action rather than stay it.

5.   The Court takes judicial notice of the Notice of Related Cases filing in state court as a matter of public record. Fed. R. Evid. 201(c)(1); see Burbank-Glendale-Pasadena Airport Auth. v. City of Burbank, 136 F.3d 1360, 1364 (9th Cir. 1998) (taking judicial notice of pleadings filed in a related state court action); Meredith v. Oregon, 321 F.3d 807, 817 n.10 (9th Cir. 2003) (taking judicial notice of state court filing).

6.   The Court discusses applicability of California law at this stage in the proceedings later in this Order.

7.   The subsection (b) exception “permits the FDA to exempt some state and local requirements from pre-emption.” Riegel, 552 U.S. at 316, 128 S.Ct. 999. The parties do not contend that any subsection (b) exception applies to this case.

8.   Both parties agree that California law applies for the purpose of deciding Tandem's Motion to Dismiss. (See, e.g., FAC ¶ 87; ECF No. 15 at 9 n.1, 25; ECF No. 27 at 21.) Plaintiff applies California law and does not mention the potential applicability of Wyoming law. For the purposes of this Order, Plaintiff has waived any argument on whether Wyoming law applies. The Court assumes without deciding that California law applies in ruling on Tandem's pending Motion to Dismiss.

9.   In his Response in opposition, Plaintiff does not point to any allegations in the FAC to permit the Court to make any other finding.

10.   The Court denies Dexcom's request for judicial notice of the FDA Decision Summary for the Dexcom G6 (ECF No. 16-1 at 2) because the Court need not consider this document in ruling on the pending Motion to Dismiss. See Asvesta v. Petroutsas, 580 F.3d 1000, 1010 n.12 (9th Cir. 2009) (denying request for judicial notice where judicial notice would be “unnecessary”).

11.   De Novo classification is an alternative way for devices to receive Class I or II classification where “there is no legally marketed device on which to base a review of substantial equivalence and which meet the definition of class I or II as described in section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3.” 21 C.F.R. § 860.200(a).

12.   Plaintiff and Dexcom agree that California law applies. (See, e.g., FAC ¶ 96; ECF No. 16-1 at 21.)

13.   The Court need not consider the remainder of Dexcom's arguments raised in the Motion to Dismiss.

14.   The Court declines to address the issue of adding Jodi Higginbottom (ECF No. 16-1 at 25–26) because the Court dismisses the FAC as currently pleaded.

HAYES, Judge: