United States District Court, E.D. Kentucky, Central Division, Lexington
OPINION AND ORDER
K. CALDWELL, CHIEF JUDGE
matter is before the Court on the motions to dismiss filed by
the named defendants in this action (DE 71, 74) and the
plaintiffs' motion to amend their complaint (DE 79),
which they filed in response to the motions to dismiss. For
the following reasons, the Court will grant the motion to
amend the complaint and will deny the motions to dismiss as
their complaint, plaintiffs Donald and Pam Hawn allege that
the defendants design, manufacture and sell the MiniMed
Paradigm Quick-Set Infusion Sets. The Minimed infusion set is
intended to help diabetics regulate their blood sugar by
providing a constant source of insulin and an alternative to
multiple daily injections of insulin. The Hawns allege that
the infusion set is used in conjunction with an insulin pump.
Diabetics set the pump to deliver a steady trickle of insulin
throughout the day and may program the pump to release higher
doses at meals or when their blood sugar is high.
Hawns allege that the infusion sets were defective in their
design, manufacture, and marketing and that they were prone
to deliver incorrect and life-threatening doses of insulin.
They allege that Donald was correctly using the infusion set
at various times in 2013 but that it failed to deliver the
correct dose of insulin. The Hawns allege that the device
caused Donald to suffer a seizure, a dislocated shoulder and
broken bones, back pain, diabetic ketoacidosis, and vomiting.
They allege that, ultimately, the infusion set caused Donald
to lose his job as a nurse.
Hawns assert four causes of action against the defendants:
strict liability, breach of express warranty, breach of
implied warranty, and negligence.
case was originally filed in the Southern District of Texas.
The Texas court entered an order dismissing defendant
Unomedical Devices S.A. de C.V. (DE 32, Opinion.) The three
remaining named defendants - Medtronic MiniMed, Inc. and
Medtronic, Inc. (together, “Medtronic”) and
Unomedical A/S (“Unomedical”) - then jointly
moved to transfer the case to this Court. The Hawns, who
reside in Kentucky, did not oppose the motion. By order dated
March 29, 2016, the Texas court transferred this action here.
then moved to dismiss the action for failure to state a
claim. Unomedical also moved to dismiss the complaint,
largely adopting Medtronic's arguments but asserting an
additional defense to the breach of warranty claim. The Hawns
responded to the motion to dismiss but have also filed a
motion to amend their complaint. The proposed amended
complaint would add substantial allegations to the complaint.
the window for amending their complaint as a matter of course
has closed, see Fed. R. Civ. P. 15(a)(1)(A)-(B), the
Hawns may only amend with written consent from the defendants
or the Court's permission. Fed.R.Civ.P. 15(a)(2). The
defendants oppose the motion. Accordingly, this Court must
determine whether to permit amendment. Rule 15(a)(2) provides
that leave to amend a pleading shall be freely given when
justice so requires. Fed. R.Civ. P. 15(a)(2). The granting or
denial of a motion to amend is within the sound discretion of
the Court. Marks v. Shell Oil Co., 830 F.2d 68, 69
(6th Cir. 1987).
district court should consider the following factors in
ruling on a party's motion to amend: (1) undue delay in
filing the motion; (2) lack of notice to adverse parties; (3)
whether the movant is acting in bad faith, or with a dilatory
motive; (4) failure to cure deficiencies by previous
amendments; (5) the possibility of undue prejudice to adverse
parties; and (6) whether the amendment is futile. Foman
v. Davis, 371 U.S. 178, 182 (1962); Robinson v.
Michigan Consol. Gas Co., 918 F.2d 579, 591 (6th Cir.
1990); see also Birchwood Conservancy v. Webb, 302
F.R.D. 422, 424 (E.D. Ky. 2014) (listing Foman
defendants do not address the first five of these factors.
Instead, they argue that the Court should prohibit the
proposed amendment because the amendment would be futile. An
amendment is “futile” if “the proposed
amendment would not permit the complaint to survive a motion
to dismiss.” Miller v. Calhoun Cnty., 408 F.3d
803, 817 (6th Cir. 2005). “If a proposed amendment is
not clearly futile, ” then the court should
allow the amendment. United States ex rel. Griffith v.
Conn, No. CV 11-157-ART, 2015 WL 8682294, at *3 (E.D.
Ky. Dec. 11, 2015) (quoting Wright & Miller, 6 Fed. Prac.
& Proc. Civ. § 1487 (3d ed.) (emphasis added).
“The proper vehicle to address an amendment that is
subject to dismissal-but not clearly so-is a
standalone motion to dismiss, rather than a motion for leave
to amend a complaint.” Id.
juncture, the Court cannot find that the proposed amendments
are so clearly futile that they must be prohibited. This is a
product liability case. The Hawns seek to add 25 paragraphs
to the current complaint, which consists of 109 paragraphs.
The defendants argue that the amendments are futile, not only
because these allegations are not sufficient to state a
claim, but also because the claims themselves are preempted,
time barred, and prohibited under comment k to Section 402A
of the Restatement of Torts. The Court finds that the best
and most appropriate course to resolve the viability of the
claims is to permit the Hawns to amend them, which would
still allow the defendants to present their arguments in
favor of dismissal through a motion to dismiss under Rule 12
of the Federal Rules of Civil Procedure specifically aimed at
the amended complaint.
the Court hereby ORDERS as follows:
Hawns motion to amend their complaint (DE 79) is GRANTED;
Clerk of the Court SHALL FILE the tendered amended ...