Hawn et al v. Medtronic MiniMed, Inc. et al

Filing 88

OPINTION AND ORDER: The Court hereby ORDERS as follows: 1. the Hawns motion to amend their complaint 79 is GRANTED; 2. the Clerk of Court SHALL FILE the tendered amended complaint into the record; 3. the motions to dismiss 71 , 74 are DENIED as moot. Signed by Judge Karen K. Caldwell on 3/27/2017.(KM)cc: COR

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CENTRAL DIVISION
AT LEXINGTON
DONALD HAWN and PAM HAWN,

CIVIL ACTION NO. 5:16-93-KKC

Plaintiffs,
V.

OPINION AND ORDER

MEDTRONIC MINIMED, INC.,
MEDTRONIC, INC.,
UNOMEDICAL A/S, and
DOES 1-100
Defendant.

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This 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 moot.
In 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.
The 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.
The Hawns assert four causes of action against the defendants: strict liability, breach of
express warranty, breach of implied warranty, and negligence.
This 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.
Medtronic 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.

Because 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.

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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).
A 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 factors).
The 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.
At this 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
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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.
Accordingly, the Court hereby ORDERS as follows:
1) the Hawns motion to amend their complaint (DE 79) is GRANTED;
2) the Clerk of the Court SHALL FILE the tendered amended complaint into the record;
and
3) the motions to dismiss (DE 71, 74) and motion for a hearing (DE 71) are DENIED as
moot.

Dated March 27, 2017.

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