GRIFFIN et al v. MEDTRONIC INC. et al

Filing 35

ORDER - The co-administrators of Arleen Griffin's estate (the "Estate") allege that Ms. Griffin's death on March 13, 2013 was caused by a malfunctioning insulin pump. Four years later, the Estate brought suit against the compani es that manufactured the insulin pump, Medtronic, Inc. and Medtronic Minimed, Inc., (collectively, "Defendants"). [Filing No. 1 .] On December 8, 2017, Defendants filed a Motion to Dismiss, [Filing No. 19 ], along with a Declaration f rom counsel and four exhibits, [Filing No. 21 ]. A month later, the Estate filed a Motion to Strike Defendants' Declaration and exhibits, or otherwise treat Defendants' Motion to Dismiss as a Motion for Summary Judgment. [Filing No. [26 ].] The Estate's Motion to Strike is now fully briefed and is ripe for the Court's consideration. For the foregoing reasons, the Estate's Motion to Strike, 26 , is GRANTED and Defendants' Declaration and supporting exhibits, [ Filing No. 21 ], are stricken. However, nothing in this Order shall preclude the Court from taking judicial notice of any documents in the future, consistent with the law of this Circuit. The Estate is GRANTED fourteen (14) days from the date of this Order in which to respond to Defendants' Motion to Dismiss. In the alternative, the Estate is reminded that, pursuant to Federal Rule of Civil Procedure 15(a)(1)(B), a plaintiff may amend its complaint once as a matter of course in response to a motion to dismiss. Should the Estate opt to amend its Complaint, it is GRANTED fourteen (14) days from the date of this Order in which to do so. (SEE ORDER). Signed by Judge Jane Magnus-Stinson on 2/8/2018. (APD)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
WILLIAM L. GRIFFIN, SR,
REGINALD JACKSON, JR,

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Plaintiffs,
v.
MEDTRONIC INC.,
MEDTRONIC MINIMED, INC.,
Defendants.

No. 1:17-cv-03292-JMS-MJD

ORDER
The co-administrators of Arleen Griffin’s estate (the “Estate”) allege that Ms. Griffin’s
death on March 13, 2013 was caused by a malfunctioning insulin pump. Four years later, the
Estate brought suit against the companies that manufactured the insulin pump, Medtronic, Inc. and
Medtronic Minimed, Inc., (collectively, “Defendants”). [Filing No. 1.] On December 8, 2017,
Defendants filed a Motion to Dismiss, [Filing No. 19], along with a Declaration from counsel and
four exhibits, [Filing No. 21]. A month later, the Estate filed a Motion to Strike Defendants’
Declaration and exhibits, or otherwise treat Defendants’ Motion to Dismiss as a Motion for
Summary Judgment. [Filing No. 26.] The Estate’s Motion to Strike is now fully briefed and is
ripe for the Court’s consideration.
I.
BACKGROUND
In this suit, the Estate alleges that on March 13, 2013, a Medtronic Insulin Pump failed to
consistently deliver insulin to Arleen Griffin, resulting in her death. [Filing No. 1 at 3.] On
September 15, 2017, the Estate filed suit against Defendants, claiming eleven causes of action

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arising out of Ms. Griffin’s death, including: (1) strict liability, (2) negligence, (3) failure to warn,
(4) design defect, (5) manufacturing defect, (6) breach of express warranty, (7) breach of implied
warranty of fitness for a particular purpose, (8) breach of implied warranty of merchantability, (9)
punitive damages, (10) unjust enrichment, and (11) loss of consortium. [Filing No. 1 at 4-16.]
On December 8, 2017, Defendants filed a Motion to Dismiss the Estate’s Complaint,
alleging that it pleads claims that “are not recognized under Indiana law, are inadequately pleaded,
and are expressly and/or impliedly preempted in their entirety by the Medical Device Amendments
(“MDA”) to the federal Food, Drug, and Cosmetic Act. . . .” [Filing No. 19 at 1.]
Contemporaneously with filing their Motion to Dismiss, Defendants filed four exhibits in
support thereof, along with a declaration. [Filing No. 21.] Three of Defendants’ supporting
documents involve premarket approval (“PMA”) from the U.S. Food and Drug Administration
(“FDA”):
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the FDA PMA database listing for the Medtronic MiniMed Continuous Glucose
Monitoring System, [Filing No. 21-1];

2.

a June 15, 1999 FDA Approval Letter for the Medtronic MiniMed Continuous
Glucose Monitoring System’s PMA, [Filing No. 21-2]; and

3.

the FDA PMA database listing for the Paradigm Real-Time Insulin Infusino (sic)
Pumps, [Filing No. 21-3],

(collectively, the “PMA Documents”).
Defendants cite the PMA Documents in the memorandum in support of their Motion to
Dismiss for the proposition that “the FDA originally granted premarket approval to the MiniMed
Continuous Glucose Monitoring System on June 15, 1999, under PMA No. 980022, and has since
approved numerous supplements.” [Filing No. 20 at 4-5.] The PMA Documents specifically relate

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to Defendants’ argument that the Estate’s claims are preempted by federal law. [Filing No. 20 at
23.]
In addition to the PMA Documents, Defendants also filed a summary of probate documents
related to the Estate, [Filing No. 21-3], which Defendants cite in support of their contention that
“court records reveal that Plaintiffs opened Ms. Griffin’s estate for the ‘sole purpose of collecting
damages for wrongful death,’ with no mention of any loss of consortium claim.” [Filing No. 20
at 38.]
In lieu of responding to Defendants’ Motion to Dismiss, the Estate filed a Motion to Strike
Defendants’ Declaration and exhibits, or otherwise treat Defendants’ Motion to Dismiss as a
Motion for Summary Judgment. [Filing No. 26.]
II.
DISCUSSION
In their Motion to Strike, the Estate argues that the Declaration and exhibits that Defendants
filed in support of their Motion to Dismiss are matters outside the pleadings, and that “pursuant to
Rule 12(d), the Court should either strike the Declaration and exhibits or treat the Defendants’
Motion as one for summary judgment under Rule 56.” [Filing No. 26 at 2.]
In response, Defendants argue that the Court should not strike the PMA Documents and
may take judicial notice of the same because “they are government records maintained on the
FDA’s public database, and are therefore not subject to reasonable dispute.” [Filing No. 27 at 2.]
In addition, Defendants argue that the Court should not convert the Motion to Dismiss to a motion
for summary judgment because “[s]uch a result would be unfair and unsupported in the law.”
[Filing No. 27 at 2.] With respect to the summary of probate documents, Defendants argue that
the Court may take judicial notice of such documents and that “simply providing the Court with
publicly-available court records that the Court is otherwise permitted to take judicial notice of on
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a Rule 12(b)(6) motion should not result in the conversion of a Rule 12(b)(6) motion to a Rule 56
motion for summary judgment.” [Filing No. 27 at 4.]
In its reply brief, the Estate argues that “judicial notice can be taken as to the existence” of
the PMA Documents, “but not as to the contents of the documents—even if the documents are
available as public records on the FDA’s website.” [Filing No. 32 at 3 (emphasis in original).]
Federal Rule of Civil Procedure 12(f) provides that the court “may strike from a pleading
an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” The
court may either strike on its own or on a motion by a party and has “considerable discretion” in
striking any redundant, immaterial, impertinent, or scandalous matter. Delta Consulting Grp., Inc.
v. R. Randle Const., Inc., 554 F.3d 1133, 1141 (7th Cir. 2009).
The Court finds significant the fact that the PMA Documents are, by Defendants’ own
admission, related only to Defendants’ preemption argument. [Filing No. 27 at 4.] The substance
of that argument is that the Estate’s Complaint fails to allege that the design of the product at issue
differed from federal requirements. [Filing No. 20 at 16; Filing No. 20 at 17.] However, in a
decision issued two days before Defendants filed their Motion to Dismiss, this Court held that
“[t]his argument asks more of [the plaintiff] than what is required at the pleading stage.” Bailey v.
Medtronic, Inc., 2017 WL 6035329, at *7 (S.D. Ind. Dec. 6, 2017) (quoting Fisk v. Medtronic,
Inc., 2017 WL 4247983, at *5 (N.D. Ind. Sept. 25, 2017)). This Court’s prior adoption of the
holding in Fisk renders the PMA Documents immaterial at this stage in the litigation. Specifically,
in Bailey, this Court quoted at length from Fisk’s finding that:
In order to ultimately prevail on this claim, [the plaintiff] will have to prove that
Medtronic violated a federal requirement in manufacturing the device and that she
suffered an injury as a result of a defect caused by that violation. But preemption is
an affirmative defense, and complaints need not address or plead around affirmative
defenses . . . If a complaint need not plead such a violation in the first place, it
follows that a complaint need not trace the injury to such a violation in particular.
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Bailey, 2017 WL 6035329, at *7 (quoting Fisk, 2017 WL 4247983, at *5 (citations omitted)). The
same logic applies to the Court’s consideration of the pending Motion to Strike: if a complaint
need not plead around preemption, then the Court need not consider PMA Documents relating
only to a preemption argument in connection with a Motion to Dismiss. Such documents are,
therefore, immaterial to the Court’s consideration of the Motion to Dismiss and will be stricken.
The Court notes, however, that the Estate appears to concede that the Court may take
judicial notice of the existence of the PMA Documents, just not the contents. [Filing No. 32 at
3.] Accordingly, if in considering Defendants’ Motion to Dismiss or any subsequent motion, the
Court finds it appropriate to take judicial notice of the existence of the PMA Documents, it will
do so at that time.
The same applies to the summary of probate documents related to the Estate. See United
States v. Wood, 925 F.2d 1580, 1582 (7th Cir. 1991) (“[t]he district court may also take judicial
notice of matters of public record”). If necessary, the Court may take judicial notice of the
summary of probate documents related to the Estate at an appropriate time.
III.
CONCLUSION
For the foregoing reasons, the Estate’s Motion to Strike, [26], is GRANTED and
Defendants’ Declaration and supporting exhibits, [Filing No. 21], are stricken. However, nothing
in this Order shall preclude the Court from taking judicial notice of any documents in the future,
consistent with the law of this Circuit.
The Estate is GRANTED fourteen (14) days from the date of this Order in which to
respond to Defendants’ Motion to Dismiss. In the alternative, the Estate is reminded that, pursuant
to Federal Rule of Civil Procedure 15(a)(1)(B), a plaintiff may amend its complaint once as a
matter of course in response to a motion to dismiss. Mitchell v. Muncie Cmty. Sch., 2016 WL
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3031084, at *8 n.3 (S.D. Ind. May 27, 2016). The 2009 notes to Rule 15 emphasize that this “will
force the pleader to consider carefully and promptly the wisdom of amending to meet the
arguments in the motion. A responsive amendment may avoid the need to decide the motion or
reduce the number of issues to be decided, and will expedite determination of issues that otherwise
might be raised seriatim.” Accordingly, should the Estate opt to amend its Complaint, it is
GRANTED fourteen (14) days from the date of this Order in which to do so. In doing so, the
Estate may find it provident to tailor its claims to those recognized by the Indiana Product Liability
Act, consistent with this Court’s holding in Bailey, 2017 WL 6035329.
Regardless of whether the Estate responds to the Motion to Dismiss or amends its
Complaint in response thereto, the Court believes its analysis in Bailey, 2017 WL 6035329 will
inform its resolution of this matter. The parties are therefore advised that any subsequent briefs
should specifically address the pleadings in this case in light of such analysis.

Date: 2/8/2018

Distribution via EFC only to all counsel of record.

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