Spence et al v. Dexcom, Inc. et al

Filing 55

MEMORANDUM OPINION OF THE COURT. Signed by District Judge Eli J. Richardson on 1/23/19. (DOCKET TEXT SUMMARY ONLY-ATTORNEYS MUST OPEN THE PDF AND READ THE ORDER.)(gb)

IN THE UNITED STATES DISTRICT COURT FOR THE
MIDDLE DISTRICT OF TENNESSEE
NASHVILLE DIVISION

MARK FRANCIS MACDUFF SPENCE,
SR., et al.,
Plaintiffs,
v.
DEXCOM, INC., et al.,

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NO. 3:18-cv-0369
JUDGE RICHARDSON

Defendants.
MEMORANDUM OPINION
Pending before the Court are Defendant Dexcom’s Motion to Sever (Doc. No. 6);
Plaintiff’s Motion to Remand (Doc. No. 25); Defendants Heritage Medical Associates, Wierum,
and Marksbury’s1 Renewed Motion to Dismiss (Doc. No. 34); and Defendant Dexcom’s Motion
to Dismiss (Doc. No. 36).
BACKGROUND
This action was filed in the Davidson County Circuit Court, seeking damages for the death
of Plaintiffs’ son, Mark Spence (“Spence”), who died on March 9, 2017, allegedly because of a
defective G5 Mobile Continuous Glucose Monitoring System (“the G5”) designed, developed,
marketed and sold by Defendant Dexcom and prescribed for Spence by Defendant Marksbury, a
nurse practitioner employed by Heritage Medical Associates (“Heritage”). Defendant Wierum, a
physician employed by Heritage, supervised Spence’s treatment with the G5. Doc. No. 1-5.2

1

Defendant Tiffanie Marksbury was known as Tiffanie Wright at the time of the filing of this case
but has since married and now goes by Tiffanie Marksbury. Doc. No. 34, n.1.
Defendants Heritage, Marksbury and Wierum will be referred to, collectively, as the “Heritage
Defendants.”
2

1

Plaintiffs contend that the G5 inaccurately measured blood glucose levels and failed to sound when
Spence’s glucose levels were dangerously high or low. Consequently, Plaintiffs claim, the
defective G5 failed to provide an adequate warning to Spence that he was experiencing a severe
hypoglycemic event, and he died in his sleep. Doc. No. 30.
Dexcom removed the action to this Court, contending that the Court has original subject
matter jurisdiction, pursuant to 28 U.S.C. § 1331, because the case involves the federal Food and
Drug Administration (“FDA”) and, therefore, arises under the laws of the United States. Dexcom
also asserted that Plaintiffs are attempting to enforce provisions of the federal Food, Drug, and
Cosmetic Act (“FDCA”) and FDA regulations. Dexcom further argued that the Court has diversity
jurisdiction, pursuant to 28 U.S.C. § 1332, because there is complete diversity among all properly
joined and served parties and the amount in controversy exceeds $75,000.
Soon after removal, Dexcom filed a Motion to Sever the claims against the Heritage
Defendants as fraudulently misjoined3 with the claims against Dexcom and, alternatively, because
the Heritage Defendants are not necessary parties. Doc. No. 6. Plaintiffs have responded in
opposition to the Motion to Sever (Doc. No. 27), and Dexcom has filed a Reply (Doc. No. 31).
Plaintiffs filed a Motion to Remand the case to state court (Doc. No. 25), to which Dexcom
has filed an opposition (Doc. No. 32), and Plaintiffs have filed a Reply. Doc. No. 44.
The Heritage Defendants filed a Renewed Motion to Dismiss Certain Claims (Doc. No.
34), to which Plaintiffs have filed a Response. Doc. No. 39. Dexcom has filed a Motion to Dismiss
the First Amended Complaint (Doc. No. 36), to which Plaintiffs have responded (Doc. No. 40),
and Dexcom has replied. Doc. No. 45.

3

Dexcom made clear that its assertion of fraudulent misjoinder was in addition to its assertion of
fraudulent joinder. Doc. No. 6 at n. 1 and Doc. No. 7 at n. 1.
2

Plaintiff’s First Amended Complaint4 alleges causes of action for product
liability/negligent manufacture against Dexcom (Count I); product liability/negligent failure to
warn against Dexcom (Count II); product liability/strict liability against Dexcom (Count III);
negligence against Heritage Associates (Count IV); negligence against Wierum (Count V); and
negligence against Wright/Marksbury (Count VI). Doc. No. 30. Plaintiffs contend that this action
must be remanded to state court because there is no diversity of citizenship and no federal question
jurisdiction.
REMOVAL AND REMAND
Dexcom removed this action from state court, pursuant to 28 U.S.C. §§ 1441 and 1446 and
in reliance upon 28 U.S.C. §§ 1331, 1332 and 1337, alleging federal question jurisdiction and
diversity jurisdiction.5 The party removing the action to federal court bears the burden of showing
that the district court has original jurisdiction over the action. Watson v. Cartee, 817 F.3d 299, 303
(6th Cir. 2016). Removal petitions are strictly construed, with all doubts resolved against removal.
Gooden v. Unum Life Ins. Co. of America, 181 F. Supp. 3d 465, 470 (E.D. Tenn. 2016). If at any
time before final judgment it appears that the district court lacks subject-matter jurisdiction, the
case shall be remanded. 28 U.S.C. § 1447(c).
DIVERSITY JURISDICTION
Dexcom contends that the Court has diversity jurisdiction, pursuant to 28 U.S.C. § 1332,
because there is complete diversity among all properly joined parties. Because Plaintiffs and the

Although Plaintiff’s First Amended Complaint was filed after the Motion to Sever and the
Motion to Remand, no party has contended, and the Court does not find, that these motions are
somehow less applicable to the First Amended Complaint than to the original Complaint.
4

5

The Heritage Defendants consented to removal in accordance with 28 U.S.C. § 1446(b)(2)(A).
Doc. No. 1-4.
3

Heritage Defendants are citizens of the same state, the Court cannot exercise diversity jurisdiction
so long as the Heritage Defendants are parties. According to Dexcom, the Heritage Defendants
were improperly joined, so their Tennessee citizenship should be disregarded for purposes of
assessing diversity of citizenship. Diversity jurisdiction must exist at the time of removal. Roberts
v. Mars Petcare US, Inc., 874 F.3d 953, 958 (6th Cir. 2017). The party seeking to bring the case
into federal court carries the burden of establishing diversity jurisdiction. Schmidt v. PennyMac
Loan Servs., LLC, 106 F. Supp. 3d 859, 873 (E.D. Mich. 2015).
SEVERANCE
Dexcom asks the Court to sever the claims of the Heritage Defendants, an action that would
“create” diversity jurisdiction by removing all defendants of the same (Tennessee) citizenship as
the Plaintiffs. The Federal Rules of Civil Procedure provide that a court may, at any time in the
proceeding, on motion or on its own, add or drop a party or sever any claim against a party. Fed.
R. Civ. P. 21. Severance is a procedural device to be employed only in exceptional circumstances.
Agnesini v. Doctor’s Assocs., Inc., 275 F.R.D. 456, 458 (S.D. N.Y. 2011).
In considering a motion to sever under Rule 21, courts consider principles of fundamental
fairness and judicial efficiency as well as prejudice to any party or resulting undue delay. Reynolds
v. Merck Sharp & Dohme Corp., Case No. 3:15 cv 397, 2016 WL 3090951, at *2 (N.D. Ohio June
2, 2016). The moving party is tasked with establishing that severance is required to avoid prejudice
or confusion and to promote the ends of justice. Id. (citing Agnesini, 275 F.R.D. at 458). Courts
have also considered whether settlement of the claims or judicial economy would be facilitated;
whether prejudice would be avoided if severance were granted; and whether different witnesses
and documentary proof are required for the claims sought to be severed and the claims that would
remain. Reuter v. Medtronic, Inc., 996 F. Supp. 2d 671, 682 (S.D. Ohio 2014); Allstate Ins. Co. v.

4

Electrolux Home Products, Inc., No. 1:16cv1946, 2016 WL 6995271, at *3 (N.D. Ohio Nov. 30,
2016). Applying this standard, the court “has virtually unfettered discretion” in determining
whether severance is appropriate. Brown v. Kentucky Utils. Co., NO. 3:15-CV-352-GNS, 2015
WL 6476096, at *1 (W.D. Ky. Oct. 26, 2015). Claims may be severed if the court determines, in
its discretion, that the interest of justice would be served by doing so. Does 1-144 v. Chiquita
Brands Int’l, Inc., 285 F. Supp. 3d 228, 239 (D. D.C. 2018).
FRAUDULENT JOINDER
Dexcom has asserted fraudulent joinder in three different procedural contexts. First,
Dexcom asserted it in its Notice of Removal as grounds for the Court’s recognition of diversity
jurisdiction. (Doc. No. 1 at 10-13). Second, Dexcom has moved to sever the Heritage Defendants
on the grounds that they were fraudulently joined. (Doc. No. 7 at 2-4). Third, Dexcom has asserted
fraudulent joinder in its opposition to Plaintiffs’ motion to remand.6 (Doc. No. 32 at 14-17). In any
of these three contexts, the claim of fraudulent joinder, if valid, would defeat Plaintiff’s motion to
remand.

6

Thus, Dexcom has asserted fraudulent joinder in conjunction with removing in the first place, in
conjunction with a motion to sever the non-diverse parties that would defeat diversity jurisdiction,
and in response to a motion for remand. It appears that each of the three approaches is proper as a
procedural matter. The Sixth Circuit has at least tacitly accepted the first of these strategies. See,
e.g., Pollington v. G4S Secure Sols. (USA) Inc., 712 F. App'x 566 (6th Cir. 2018). The second
strategy is permissible. “Under the doctrine of ‘fraudulent joinder,’ federal courts may sever the
non-diverse defendant from the case if the claim against him is so frivolous that its only
conceivable purpose is to destroy diversity and prevent removal.” Murriel-Don Coal Co. v. Aspen
Ins. UK Ltd., 790 F. Supp. 2d 590, 592 (E.D. Ky. 2011). It appears that third strategy also is
permissible As the Sixth Circuit has explained in a case involving a case of fraudulent joinder but
no motion to sever, “When a non-diverse party has been joined as a defendant, then in the absence
of a substantial federal question the removing defendant may avoid remand only by demonstrating
that the non-diverse party was fraudulently joined. Fraudulent joinder is “a judicially created
doctrine that provides an exception to the requirement of complete diversity.” Casias v. Wal-Mart
Stores, Inc., 695 F.3d 428, 432 (6th Cir. 2012) (citations and quotation marks omitted).

5

To prove fraudulent joinder, a defendant must present sufficient evidence that the plaintiff
cannot establish a cause of action against the non-diverse defendants under state law. Roberts, 874
F.3d at 958. In other words, the possibility of fraudulent joinder requires proof that the plaintiff
has no colorable claim against the non-diverse defendant under state law. Id. The district court
must resolve all disputed questions of fact and ambiguities in the controlling state law in favor of
the non-removing party. Id. All doubts as to the propriety of removal are resolved in favor of
remand. Id. In considering fraudulent joinder allegations, a court applies a test similar to, but more
lenient (towards the plaintiff) than, the analysis applicable to a Rule 12(b)(6) motion to dismiss.
Casias v. Wal-Mart Stores, Inc., 695 F.3d 428, 433 (6th Cir. 2012). The removing party bears the
burden of demonstrating fraudulent joinder. Id.
Dexcom has failed to meet its burden. It does not show that Plaintiffs could not establish a
cause of action against the Heritage Defendants. The claims against the Heritage Defendants are
claims for negligence. To establish a negligence claim under Tennessee law requires Plaintiffs to
show: (1) a duty of care owed by the Defendants to the Plaintiff; (2) conduct falling below the
applicable standard of care amounting to a breach of that duty; (3) an injury or loss; (4) causation
in fact; and (5) proximate, or legal cause. Kellner v. Budget Car and Truck Rental, 359 F.3d 399,
403 (6th Cir. 2004).
The element of duty7 in a negligence action is the legal obligation to conform to a
reasonable person standard of care to protect against unreasonable risks of harm. Eden W. ex rel.
Evans v. Tarr, 517 S.W.3d 691, 695 (Tenn. Ct. App. 2015). Although whether a defendant owed

7

Dexcom argues that there is no duty in Tennessee for healthcare providers to advise patients of
adverse events reported to the FDA. Doc. No. 1 at 12. However, Plaintiffs’ claims against the
Heritage Defendants go far beyond mere failure to advise Plaintiff of adverse events reported to
the FDA.
6

a plaintiff a duty of care is a question of law for the Court, all persons have a duty to use reasonable
care to refrain from conduct that will foreseeably cause injury to others. Tanner v. Ogden, No. 313-0042, 2014 WL 1413495, at *1 (M.D. Tenn. Apr. 11, 2014). Whether a defendant breached the
duty of care and whether cause in fact and proximate cause exist are generally questions of fact
for the finder of fact. Eden W., 517 S.W.3d at 695-96.
Dexcom misleadingly argues that the only claims against the Heritage Defendants are
failure to advise Spence of an FDA warning letter and a G5 device recall and failure to train Spence
on use of the G5. Doc. No. 32 at 15. The First Amended Complaint, however, alleges the following
against the Heritage Defendants: (1) negligent failure to exercise the degree of care, skill, and
diligence required in recommending that Spence use the G5; (2) negligent failure to conduct
appropriate due diligence regarding the G5 before prescribing it for their patients; (3) negligently
allowing employees to prescribe the G5 without conducting due diligence; (4) negligent failure to
provide warning of the defective nature of the G5; (5) negligent failure to ensure that employees
stayed informed about the dangers of the G5; (6) negligently and recklessly prescribing the G5 for
Spence; (6) negligent failure to ensure that Spence received appropriate training on the G5; and
(7) negligent failure properly to monitor Spence’s use of the G5.
Resolving all ambiguities and doubts in favor of Plaintiffs, as the Court is required to do,
these allegations sufficiently allege plausible negligence claims against the Heritage Defendants.
Dexcom has not shown that Plaintiff has no colorable claim against the non-diverse Heritage
Defendants under state law and, therefore, has not shown that they were fraudulently joined.
Accordingly, the claim of fraudulent joinder fails and thus neither defeats Plaintiff’s motion to
remand directly, nor provides a basis to defeat the motion indirectly by severing the Heritage
Defendants and thereby destroying diversity jurisdiction. As held by the Sixth Circuit, when a non-

7

diverse party has been joined as a defendant, then in the absence of a substantial federal question,
the removing defendant may avoid remand only by demonstrating that the non-diverse party was
fraudulently joined. Casias, 695 F.3d at 432.
FRAUDULENT MISJOINDER
Dexcom also asserts that the Heritage Defendants were fraudulently misjoined in this
action. As noted above, the doctrine of fraudulent joinder addresses whether a claim is viable
against the defendant who allegedly was fraudulently joined. By contrast, the doctrine of
fraudulent misjoinder addresses whether the claims against the defendant who allegedly was
fraudulent misjoined—whether or not viable claims standing on their own—were improperly
joined in the removed action with the claims against the other defendant(s) in order to destroy
diversity. Asher v. Minnesota Mining and Mfg. Co., No. Civ.A. 04CV522KKC, 2005 WL
1593941, at *4 (E.D. Ky. June 30, 2005). Fraudulent misjoinder is concerned with the situation
where “potentially viable but unrelated claims against resident and non-resident defendants [were]
joined in one action to destroy diversity and thereby prevent removal by the non-resident
defendants.” Lyons v. Lutheran Hosp. of Ind., No. 104CV0728DFHVSS, 2004 WL 2272203, at
*4 (S.D. Ind. Sept. 15, 2004).
Whereas the fraudulent joinder doctrine has been widely accepted, most courts have
declined to adopt the fraudulent misjoinder doctrine. Staubus v. Purdue Pharma., L.P. No. 2:17CV-122-TAV-CLC, 2017 WL 4767688, at *4 (E.D. Tenn. Oct. 20, 2017) (collecting cases). Only
one decision within the Sixth Circuit, Asher,8 has recognized the fraudulent misjoinder doctrine,
and that decision has been questioned in more recent opinions. Id.

8

Even Asher, however, noted that the Sixth Circuit has not adopted or addressed the fraudulent
misjoinder doctrine. 2005 WL 1593941, at *4.
8

The Eleventh Circuit, which established the fraudulent misjoinder doctrine in 1996 in
Tapscott v. MS Dealer Serv. Corp., 77 F.3d 1353 (11th Cir. 1996), abrogated on other grounds by
Cohen v. Office Depot, Inc., 204 F.3d 1069 (11th Cir. 2000). In Tapscott,9 the court held that
diversity jurisdiction was proper where diversity was destroyed only through the misjoinder of
parties under Fed. R. Civ. P. 20. Id. at 1360; see also Central Bank v. Jerrolds, No. 14-1163, 2015
WL 1486368, at *3 (W.D. Tenn. March 31, 2015). The doctrine of fraudulent misjoinder emerged
in cases in which a plaintiff joined unrelated claims against a non-diverse defendant for the purpose
of destroying diversity. In re Darvocet, Darvon and Propoxyphene Products Liab. Litig., 889 F.
Supp. 2d 931, 943 (E.D. Ky 2012).
As noted by the court in Staubus, several factors weigh against adopting the fraudulent
misjoinder doctrine. Even courts that have recognized the doctrine struggle to apply it. Staubus,
2017 WL 4767688, at *4; Central Bank, 2015 WL 1486368, at *3-4. As noted by the Central Bank
court, a fraudulent misjoinder analysis requires the Court “to wade into a thorny thicket of unsettled
law . . . and the last thing the federal courts need is more procedural complexity.” Central Bank,
2015 WL 1486368, at *3.
The Court declines to adopt the fraudulent misjoinder doctrine in this case. The Sixth
Circuit, as noted earlier, has stated that a removing defendant may avoid remand (unless there is a
federal question) only by demonstrating that the non-diverse defendant was fraudulently joined,
with no mention of fraudulent misjoinder. Casias, 695 F.3d at 432. In addition to the fact that the
Sixth Circuit has not adopted this doctrine, the doctrine is ambiguous, and its standards are

At times in its opinion, the court in Tapscott used the term “fraudulent joinder” to refer to the
concept that since has become known as the doctrine of “fraudulent misjoinder” distinct from the
doctrine of fraudulent joinder.
9

9

unclear.10 Because the Court must resolve any ambiguities in favor of remand and the fraudulent
misjoinder doctrine disfavors remand, the Court declines to adopt the doctrine in the present action.
In any event, however, Dexcom has failed to demonstrate anything improper, let alone
“fraudulent,” about the joinder of the Heritage Defendants.11 As explained below, the claims
against the Heritage Defendants are not unrelated to the claims against Dexcom and were in fact
properly joined. There is no evidence that Plaintiffs joined unrelated claims against the Heritage
Defendants for the purpose of destroying diversity jurisdiction.
NECESSARY PARTIES
Dexcom alternatively urges the Court, if it determines the Heritage Defendants were
properly joined, to sever the Heritage Defendants from this action on the grounds that they are not
“necessary” parties under Fed. R. Civ. P. 19.12 To determine whether a defendant is necessary, a
court must consider: (1) whether complete relief can be given to existing parties in the defendant’s
absence; (2) whether disposition in the defendant’s absence may impair the defendant’s ability to

For example, whether misjoinder must be “egregious” or just something more than “mere
misjoinder” is one of many unsettled questions about the fraudulent misjoinder doctrine. Staubus,
2017 WL 4767688, at *5.
10

11

As suggested in the footnote immediately above, one of the problems with the fraudulent joinder
doctrine is that there is no consensus as to whether it requires: (1) an objective inquiry into was
joinder was improper; (2) an objective inquiry into whether joinder was egregiously improper or
baseless; or (3) an objective inquiry into whether the joinder of claims against a non-diverse
defendant was “fraudulent” in the sense that it was in bad faith, as for example if it was motivated
by a desire to defeat diversity, See Rutherford v. Merck & Co., 428 F. Supp. 2d 842, 854 (S.D. Ill.
2006)
12

Rule 21 permits a district court to retain diversity jurisdiction over a case by dropping a nondiverse party if that party’s presence in the action is not required under Fed. R. Civ. P. 19; that is,
the party to be dropped must not be a necessary party (even if it is a proper party in that its joinder
was proper under the rules of civil procedure). Priester v. Bent Creek Golf Club, LLC, No. 3:17CV-284, 2018 WL 2305703, at *2 (E.D. Tenn. May 21, 2018) (citing Safeco Ins. Co. of America
v. City of White House, TN, 36 F.3d 540, 545 (6th Cir. 1994)).
10

protect its interest in the controversy; or (3) whether the defendant’s absence would expose
existing parties to substantial risk of double or inconsistent obligations. Id.; Fed. R. Civ. P.
19(a)(1).
Severing the Heritage Defendants under these circumstances runs the risk of not affording
Plaintiffs the opportunity for complete relief, impairing the Heritage Defendants’ ability to protect
their interest in the controversy, and exposing the parties to inconsistent judgments. In the event
of severance, one jury could find that the Heritage Defendants were not negligent because the G5
device was not defective or unreasonably dangerous while, conversely, another jury could find
that Dexcom was negligent and is strictly liable because the same G5 device was defective and
unreasonably dangerous. One jury could find that the G5 device was the proximate cause of
Spence’s death, and the other jury could find that the G5 device was not the proximate cause of
Spence’s death. Given the assertions of comparative fault, a jury in the Heritage Defendants’ case
could find that Dexcom, not the Heritage Defendants, is primarily liable for Spence’s death, while
a jury in Dexcom’s case could find that the Heritage Defendants, not Dexcom, are primarily liable
for that death. Such a result would deprive Plaintiffs of relief, even though each party was found
by a jury to be primarily liable. Furthermore, the two separate juries could render inconsistent
decisions on damages.
The Court also notes that the evidence necessary to establish Plaintiffs’ claims against the
Heritage Defendants significantly overlaps the evidence necessary to establish their claims against
Dexcom. The same or similar expert testimony would be required as to both medical negligence
and product liability to establish that the G5 was unreasonably dangerous and to establish
Plaintiffs’ damages. The factual proof as to what happened to Spence—his condition, his
treatment, his death, and Plaintiffs’ damages—would also be required in both instances.

11

For these reasons, the Court finds that the Heritage Defendants are “necessary” parties to
this action under Fed. R. Civ. P. 19.
PERMISSIVE JOINDER
Alternatively, the Court finds that, even if the Heritage Defendants are not necessary
parties, they were permissibly joined in this action pursuant to Fed. R. Civ. P. 20, and, in the
Court’s discretion, should not be severed.13 Persons may be joined in one action as defendants if
(1) any right to relief is asserted against them jointly, severally, or (in the alternative) with respect
to or arising out of the same transaction, occurrence, or series of transactions or occurrences and
(2) any question of law or fact common to all defendants will arise in the action. Fed. R. Civ. P.
20(a)(2).14 Because it does not lend itself to bright-line rules, resolution of this issue generally
requires a case-by-case analysis. Bridgeport Music, Inc. v. 11C Music, 202 F.R.D. 229, 232 (M.D.
Tenn. 2001); Costello v. Home Depot U.S.A., Inc., 888 F. Supp. 2d 258, 263 (D. Conn. 2012). “All
logically related claims by or against different parties [properly can] be tried in a single
proceeding.” Id. Under Sixth Circuit precedent, the words “transaction or occurrence” are to be
given “broad and liberal interpretation in order to avoid a multiplicity of suits.” Allstate, 2016 WL
6995271, at *2.
The claims against both Dexcom and the Heritage Defendants arise from the death of Mark
Spence and the assertion that his death was caused by a dangerous and defective G5 Mobile
Continuous Glucose Monitoring System. Plaintiffs allege that Dexcom manufactured the defective

13

These Defendants were not permissibly joined simply because they were not fraudulently joined.
In other words, even if they were not fraudulently joined, the Court must still satisfy itself that
they were properly joined.
14

Rule 20(a) is designed to promote judicial economy and trial convenience. Bridgeport, 202
F.R.D. at231.
12

monitor and that the Heritage Defendants prescribed and treated Spence with that defective
monitor. Plaintiffs contend that Dexcom was negligent and is strictly liable for defective
manufacture and failure to warn. Plaintiff allege that the Heritage Defendants were negligent in
selecting and recommending the use of the G5 without determining whether it was a safe and
effective device, in failing to warn Spence of the risks of the G5, and in failing to train him
regarding use of the G5. Plaintiffs aver that Spence’s death was the direct and proximate result of
the tortious conductof each and every one of the Defendants. Plaintiffs’ right to relief is asserted
against all Defendants arising from related activities.
For permissive joinder to be proper, Rule 20 does not require that all questions of law and
fact raised by the dispute be common, but neither does it establish any qualitative or quantitative
test of commonality. Lee v. Dell Products, L.P., No. 3:06cv0001, 2006 WL 2981301, at *10 (M.D.
Tenn. Oct. 16, 2006). The common-question rule requires not that common questions of law or
fact predominate, but instead only that the claims involve the same or closely related factual and
legal issues. Allstate, 2016 WL 6995271, at *3.
The common issues here are whether the G5 device was defective or unreasonably
dangerous, whether the G5 device was the cause of Spence’s death, and, if so, what amount of
damages Plaintiffs are entitled to recover. If the negligence claims against the Heritage Defendants
were severed, a jury in that case would have to determine whether the Heritage Defendants
breached the standard of care in selecting, prescribing, and treating Spence with the G5 device and
whether that breach was the cause of Spence’s death. Whether it was prudent to prescribe the G5
device will largely depend upon whether that device was defective and/or unreasonably dangerous.
Similarly, in determining whether Dexcom is liable under the product liability causes of action
asserted against it, a jury would also have to determine whether the device was defective or

13

unreasonably dangerous and whether the device was the cause of Spence’s death. 15 In both cases,
if liability is found, a jury would have to determine the amount of damages to which Plaintiffs are
entitled.
For all these reasons, the Court, in its discretion, declines to sever the Heritage Defendants
from this action. Dexcom’s Motion to Sever will be denied.
FEDERAL QUESTION
Dexcom asserts another basis for this Court’s jurisdiction: federal question. The district
courts have original jurisdiction of all civil actions arising under the Constitution, laws, or treaties
of the United States. 28 U.S.C. § 1331. Dexcom claims that Plaintiffs’ right to relief depends upon
federal law questions and that Plaintiffs are attempting to enforce provisions of the Federal Food,
Drug, and Cosmetic Act (“FDCA”) and Federal Food and Drug Administration (“FDA”)
regulations.
The threshold inquiry in determining whether a claim arises under federal law must be
determined by reference to the “well-pleaded complaint.” Arrington v. Medtronic, Inc., 130 F.
Supp. 3d 1150, 1158 (W.D. Tenn. 2014). It is well-settled that neither an actual nor an anticipated
federal defense nor the mere presence of a federal issue will establish the necessary jurisdictional
elements to remove a state cause of action. Id.; Merrell Dow Pharmaceuticals, Inc. v. Thompson,16

15

A manufacturer or seller of a product shall not be liable for any injury caused by the product
unless the product is determined to be in a defective condition or unreasonably dangerous at the
time it left the control of the manufacturer or seller. Tenn. Code Ann. § 29-28-105(a). Besides
showing a defective or unreasonably dangerous condition, a product liability plaintiff must always
prove that the unreasonably dangerous or defective condition was the proximate cause of his
injury. Jackson v. Ford Motor Co., 842 F.3d 902, 907 (6th Cir. 2016).
16

The Court is aware that Merrell Dow did not make a federal cause of action a necessary condition
for federal-question jurisdiction; it simply treated the absence of such a cause of action as a factor
relevant to, but not dispositive of, the “sensitive judgments about congressional intent” required
by 28 U.S.C. § 1331. Grable & Sons Metal Products, Inc. v. Darue Engineering & Mfg., 545 U.S.
308, 309 (2005).
14

478 U.S. 804, 808 (1986) (defense that raises federal question is inadequate to confer federal
jurisdiction).
State laws that implicate a substantial question of federal law can open the door to federal
court. Estate of Cornell v. Bayview Loan Serv., LLC, 908 F.3d 1008, 1015 (6th Cir. 2018). The
question is whether the state-law claim necessarily raises a stated federal issue that is “actually
disputed and substantial” and which a federal forum may entertain without disturbing any
congressionally-approved balance of federal and state judicial responsibilities. Id. This pathway is
a “slim category” that is to be read narrowly. Id.
The First Amended Complaint alleges state-law causes of action for negligence and
violation of the Tennessee Product Liability Act of 1978. Tenn. Code Ann. § 29-28-101, et seq. It
does not assert a federal cause of action. Doc. No. 30. The First Amended Complaint does
reference the FDCA and FDA regulations. Id. Plaintiffs reference such federal law to: (1) show
notice to Dexcom of multiple complaints concerning the G5; (2) show that the FDA warned
Dexcom about its failure to comply with the Medical Device Amendments (“MDA”); (3) state that
Dexcom is required to report complaints to the FDA; (4) allege that Dexcom was not in compliance
with Pre-Market Approval (“PMA”) requirements under the MDA; and (5) argue that Dexcom
violated FDA regulations by failing to report certain complaints to the agency.17
Notice to Dexcom about complaints, and a warning to Dexcom about failure to comply
with the MDA, suggest that Dexcom knew or should have known about a problem—a suggestion
that would help establish an element of both strict liability and negligence. Plaintiffs have not, and

17

Dexcom itself claims that the required reports to the FDA are essentially irrelevant. Doc. No. 1
at 12.
15

cannot, state a cause of action for Dexcom’s alleged failure to report something to the FDA.18
Plaintiffs allege that Dexcom had a common law duty to report certain things to the public. The
allegations that Dexcom failed to comply with PMA or FDA requirements do not, and do not
purport to, state causes of action; rather, they are one way to help show a breach of the standard of
care for negligence. Plaintiffs’ claims are premised on the dangerous nature of the G5, not on any
failure to report or comply with FDA regulations. In other words, the alleged failure to comply
with federal regulations is not a separate claim; rather, it is a means of helping to establish the
breach of the standard of care required for their state-law claim.
Plaintiffs are also not challenging the federal oversight or original approval of the G5. As
shown above, Plaintiffs’ action against Dexcom is for creating, manufacturing, marketing,
distributing, and failing to warn about an allegedly defective and unreasonably dangerous device
in violation of the Tennessee Product Liability Act, not for violating federal law. Federal
regulations and requirements are part of the context for determining whether Dexcom breached
the standard of care. Their alleged violation, however, is not the gravamen of any of Plaintiffs’
causes of action, even if it may be part of the proof.
Moreover, the federal issues here are not “substantial.” In Gunn v. Minton, 568 U.S. 251
(2013), the Supreme Court clarified the substantiality inquiry to require that the disputed federal
issue be significant to the federal system as a whole and not just to the particular lawsuit or parties
at issue. Id. at 260; Schilmiller v. Medtronic, Inc., 44 F. Supp. 3d 721, 730 (W.D. Ky. 2014). In
the earlier case of Grable & Sons Metal Products, Inc. v. Darue Engineering & Mfg, 545 U.S. 308
(2005), a taxation case, the Court focused on the broader significance of the interests of the federal

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Federal law requires that any action to enforce or to restrain violations of the FDCA must be
brought by and in the name of the United States. 21 U.S.C. § 337(a). Thus, there is no private right
of action.
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government in recovering delinquent taxes through the seizure and sale of property. Schilmiller at
730. On the other hand, in Gunn, the Court held that resolution of a patent issue in the context of
a legal malpractice action under state law, although vitally important to the parties, did not include
a federal issue that was significant to the federal system as a whole and thus did not support federalquestion jurisdiction. Id.
Plaintiff’s claims against Dexcom are state-law claims. Whether Dexcom complied with
federal law is not the “necessary” or “central” issue Dexcom characterizes it to be. Again, the
common questions of law and fact are whether the G5 was defective and unreasonably dangerous
and whether the G5 was the proximate cause of Spence’s death. Dexcom’s potential defense of
compliance with federal law is not sufficient to create federal question jurisdiction. Merrell Dow,
478 U.S. at 808; Arrington, 130 F. Supp. 3d at 1158. And the Court finds that, as in Gunn and
Schilmiller, the federal issues in dispute in this case fail to meet the substantiality requirement.
They are important to these particular litigants, but they are not significant to the federal system
as a whole.
Similarly, Dexcom’s argument that the MDA pre-empts Plaintiffs’ claims against it does
not create federal question jurisdiction. The “well-pleaded complaint rule” provides that federal
jurisdiction exists only when a federal question is presented on the face of a plaintiff’s properly
pleaded complaint. Schilmiller, 44 F. Supp. 3d at 728. Thus, a case may not be removed to federal
court on the basis of a federal defense, even if the defense is anticipated in the plaintiff’s complaint.
Id.; Merrell Dow, 478 U.S. at 808 (defense that raises federal question is inadequate to confer
federal jurisdiction). Dexcom’s defense that the MDA pre-empts Plaintiffs’ claims, even if it is a

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valid defense, which the Court does not find, is not a basis, under these circumstances, for federal
jurisdiction.19
The Court finds that it has no federal question jurisdiction in this matter.
CONCLUSION
For all these reasons, Dexcom’s Motion to Sever will be denied, Plaintiffs’ Motion to
Remand will be granted, and this case will be remanded to state court for further proceedings.
Defendants’ Motions to Dismiss will be denied without prejudice. An appropriate Order will enter.
IT IS SO ORDERED.
___________________________________
ELI RICHARDSON
UNITED STATES DISTRICT JUDGE

The Court is aware that the Sixth Circuit recognizes “complete preemption” as an exception to
the well-pleaded complaint rule. Schilmiller, 44 F. Supp. 3d at 728. In this case, however, even if
there were some limited preemption, federal law does not “completely” preempt Plaintiff’s product
liability and negligence claims.
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