Medtronic, Inc. v. Lori A. Malander, Individually and as Personal Representative of the Estate of David M. Malander, Sr., and Kathleen Malander , 996 N.E.2d 412 ( 2013 )

Oct 11 2013, 5:43 am
FOR PUBLICATION
ATTORNEYS FOR APPELLANT: ATTORNEYS FOR APPELLEES:
KEVIN R. KNIGHT WILLIAM E. WININGHAM
Ice Miller, LLP D. BRUCE KEHOE
Indianapolis, Indiana Wilson Kehoe Winingham, LLC
Indianapolis, Indiana
LORI G. COHEN
R. CLIFTON MERRELL
Greenberg Traurig, LLP
Atlanta, Georgia
DANIEL I.A. SMULIAN
Greenberg Traurig, LLP
New York, New York
IN THE
COURT OF APPEALS OF INDIANA
MEDTRONIC, INC., )
)
Appellant-Defendant, )
)
vs. ) No. 49A02-1211-CT-925
)
LORI A. MALANDER, Individually and as )
Personal Representative of the Estate of DAVID )
M. MALANDER, SR., Deceased and )
KATHLEEN MALANDER, )
)
Appellees-Plaintiffs. )
APPEAL FROM THE MARION SUPERIOR COURT
The Honorable Theodore M. Sosin, Judge
Cause No. 49D02-0901-CT-537
October 11, 2013
OPINION - FOR PUBLICATION
BARNES, Judge
Case Summary
Medtronic, Inc., (“Medtronic”) appeals the trial court’s denial of its motion for
summary judgment in an action against it by Lori Malander, individually and as the
personal representative of the Estate of David Malander, deceased, and Kathleen
Malander (collectively, the “Malanders”). We affirm.
Issues
Medtronic raises two issues, which we restate as:
I. whether the trial court properly found that the Malanders’
claim was not preempted by federal law; and
II. whether the trial court properly denied summary judgment
regarding whether Medtronic voluntarily assumed a duty
to David.
Facts
We first note that many of the facts of this case are subject to a stipulated
protective order. As such, portions of the briefs and appendices are excluded from public
access. See Ind. Admin. R. 9(G)(4)(c). Indiana Administrative Rule 9(G)(4)(d)
provides:
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Orders, decisions, and opinions issued by the court on appeal
shall be publicly accessible, but each court on appeal should
endeavor to exclude the names of the parties and affected
persons, and any other matters excluded from public access,
except as essential to the resolution of litigation or
appropriate to further the establishment of precedent or the
development of the law.
We have attempted to exclude matters covered by the protective order from this opinion.
However, to the extent such matters are included in this opinion, we deem such
information to be essential to the resolution of the litigation or appropriate to further the
establishment of precedent or the development of the law. See, e.g., Recker v. Review
Bd. of Ind. Dep’t of Workforce Dev., 958 N.E.2d 1136, 1139 (Ind. 2011) (“As to the
facts of the case that derive from the records of the Department and are discussed in this
opinion, we deem such information to be public as essential to the resolution of the
litigation and appropriate to further the establishment of precedent and the development
of the law.”).
Due to heart problems, Dr. Lawrence Klein implanted a Medtronic defibrillator
and a Medtronic Transvene Model 6936 right ventricular lead (“Lead”) in David
Malander in 1997. The Lead was a Class III medical device subject to premarket Food
and Drug Administration (“FDA”) approval. Dr. Klein upgraded the defibrillator in
2004, but left the Lead in place.
During a follow-up appointment, Dr. Klein learned that the device had
experienced nine episodes of random short V-V intervals. A short V-V interval is “an
interval where the device is sensing electrical activity . . . in the heart or perhaps in the
lead, that has a very . . . short interval.” Appellant’s App. p. 402. The Malanders
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describe a short V-V interval as when the defibrillator “incorrectly senses electrical
activity in the heart, or in the lead, at a much faster rate than the heart is capable of.”
Appellees’ Br. p. 7. Medtronic describes a short V-V interval as “a false-positive; in
more technical terms, it is an abbreviated sensing interval in which the [defibrillator]
senses electrical activity that is not actually related to the heart’s rhythm.” Appellant’s
Br. p. 9. In 2006, Dr. Klein scheduled David for another surgery to upgrade the
defibrillator and possibly replace the Lead. Dr. Klein was aware that the Lead had a high
failure rate of 34.6% and was concerned about the short V-V intervals.
During the December 7, 2006 surgery, Joseph von Weigandt, a Medtronic Clinical
Specialist, was present and assisted Dr. Klein with testing the Lead. The testing did not
reveal any problems with the Lead. Dr. Klein also called Medtronic during the surgery
and talked to Peter Choukalas and Don Ruzin of Medtronic’s technical services
department. Dr. Klein requested all of the information they possessed on short V-V
intervals. Dr. Klein asked, “Did we test it properly, is this lead functioning normally . . .
is there any information about the short V-V intervals that I need to know about. Are
they okay, do they indicate a lead failure?” Id. at 681. Ruzin responded, “Don’t worry
about that; it doesn’t mean anything. . . . I don’t think that’s a problem . . . .” Id. at 685.
Dr. Klein chose not to replace the Lead.
David died on January 2, 2007, following an incident of ventricular tachycardia on
December 31, 2006. Testing revealed 361 short V-V intervals of his defibrillator
between December 14, 2006, and December 31, 2006.
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The Malanders filed a complaint against Medtronic and Dr. Klein. As to
Medtronic, the Malanders alleged in Count 7 that Medtronic was negligent by:
a. Failing in its design of the 6936 lead, failing to
properly warn and instruct as to the hazards of use of
that model lead, and failing to recall that lead, in that
the 6936 lead had an usually [sic] high incidence of
fracture and failure of the lead;
b. Failing to recall this lead, and further failing to give
adequate warnings to purchasers and users of the 6936
Transvene lead about the unreasonably dangerous and
defective condition of the lead and of the dangerous
propensity of the lead to fail without warning; and,
c. Failing to recommend that the 6936 lead be removed
or capped off during David Malander’s December 7,
2006 surgery.
Id. at 10. The Malanders claim that internal Medtronic memorandums distributed to their
technicians prior to David’s surgery indicated that short V-V intervals were indicative of
lead failure and that the technicians should have recommended replacement of the Lead.
In October 2011, Medtronic filed a motion for summary judgment. Medtronic
alleged that the Malanders’ claims were preempted by federal law pursuant to the
Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetics Act,
21 U.S.C. Section 360k(a), and Riegel v. Medtronic, 552 U.S. 312, 128 S. Ct. 999 (2008).
In the Malanders’ response to Medtronic’s motion for summary judgment, they
acknowledged that Count 7(a) and 7(b) of their complaint were preempted by federal law.
However, the Malanders argued that Count 7(c) was based on Medtronic’s negligence
during the December 2006 surgery and was not preempted. The Malanders argued that
Medtronic assumed a duty to David when its technicians advised Dr. Klein regarding the
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Lead but did not advise him to replace the Lead. Medtronic filed a response, and after a
hearing, the trial court denied Medtronic’s motion for summary judgment. The trial court
certified the order for interlocutory appeal, and we accepted jurisdiction over the appeal
pursuant to Indiana Appellate Rule 14(B).
Analysis
Medtronic argues that the trial court erred by denying its motion for summary
judgment. Summary judgment is appropriate when there is no genuine issue of material
fact and the moving party is entitled to judgment as a matter of law. Ind. Trial Rule 56.
We liberally construe all designated evidentiary material in a light most favorable to the
non-moving party to determine whether there is a genuine issue of material fact.
Bradshaw v. Chandler, 916 N.E.2d 163, 166 (Ind. 2009). The party that lost in the trial
court has the burden of persuading the appellate court that the trial court erred. Id. Our
review of a summary judgment motion is limited to those materials designated to the trial
court. Mangold v. Ind. Dep’t of Natural Res., 756 N.E.2d 970, 973 (Ind. 2001).
I. Preemption
Medtronic argues that the Malanders’ claim in paragraph 7(c) of the complaint is
preempted by federal law. The federal law at issue is part of the MDA, which “swept
back some state obligations and imposed a regime of detailed federal oversight” on
medical devices. Riegel, 552 U.S. at 316, 128 S. Ct. at 1003. The regulatory scheme
“established various levels of oversight for medical devices, depending on the risks they
present.” Id., 128 S. Ct. at 1003. At issue here are Class III devices, which receive the
most federal oversight. Id. at 317, 128 S. Ct. at 1003.
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Class III devices are subject to “a rigorous regime of premarket approval,” which
includes review of the device’s proposed labeling. Id., 128 S. Ct. at 1004. “The FDA
evaluates safety and effectiveness under the conditions of use set forth on the label, [21
U.S.C.] § 360c(a)(2)(B), and must determine that the proposed labeling is neither false
nor misleading, [21 U.S.C.] § 360e(d)(1)(A).” Id. at 318, 128 S. Ct. at 1004. “Once a
device has received premarket approval, the MDA forbids the manufacturer to make,
without FDA permission, changes in design specifications, manufacturing processes,
labeling, or any other attribute, that would affect safety or effectiveness.” Id. at 319, 128
S. Ct. at 1005 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). “If the applicant wishes to make
such a change, it must submit, and the FDA must approve, an application for
supplemental premarket approval, to be evaluated under largely the same criteria as an
initial application.” Id., 128 S. Ct. at 1005 (citing 21 U.S.C. § 360e(d)(6); 21 CFR §
814.39(c)).
After premarket approval, the devices are also subject to reporting requirements.
Id., 128 S. Ct. at 1005 (citing 21 U.S.C. § 360i). The reporting requirements include “the
obligation to inform the FDA of new clinical investigations or scientific studies
concerning the device which the applicant knows of or reasonably should know of, 21
CFR § 814.84(b)(2),” and the obligation “to report incidents in which the device may
have caused or contributed to death or serious injury, or malfunctioned in a manner that
would likely cause or contribute to death or serious injury if it recurred, [21 CFR] §
803.50(a).” Id., 128 S. Ct. at 1005.
Additionally, the MDA provides:
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Except as provided in subsection (b) of this section, 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.A. § 360k(a).
The Supreme Court analyzed this preemption clause in Riegel. There, the
plaintiffs brought an action against the manufacturer of a heart catheter after the catheter
ruptured in his coronary artery during heart surgery. The complaint alleged that the
catheter “was designed, labeled, and manufactured in a manner that violated New York
common law.” Riegel, 552 U.S. at 321, 128 S. Ct. at 1005. The Riegel court held that
the preemption clause establishes a two-pronged test for determining if state law claims
are preempted. First, we must determine whether the Federal Government has imposed
“requirements” on the device. Id., 128 S. Ct. at 1006. If so, we must then determine
whether the state law claims impose requirements “different from, or in addition to” the
federal ones and whether the requirements relate to “safety and effectiveness” or to “any
other matter included in a requirement applicable to the device.” Id. at 321-22, 128 S. Ct.
at 1006 (citing 21 U.S.C. § 360k(a)).
The Court answered the first prong in the affirmative. The Court found that
premarket approval imposes “requirements” in the case of Class III devices. Id. at 322,
128 S. Ct. at 1007. In considering the second prong, the Court concluded that common
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law causes of action for negligence and strict liability impose “requirements” and are
preempted by the MDA. Id. at 323-25, 128 S. Ct. at 1007-08. The Court explained:
State tort law that requires a manufacturer’s catheters to be
safer, but hence less effective, than the model the FDA has
approved disrupts the federal scheme no less than state
regulatory law to the same effect. Indeed, one would think
that tort law, applied by juries under a negligence or strict-
liability standard, is less deserving of preservation. A state
statute, or a regulation adopted by a state agency, could at
least be expected to apply cost-benefit analysis similar to that
applied by the experts at the FDA: How many more lives will
be saved by a device which, along with its greater
effectiveness, brings a greater risk of harm? A jury, on the
other hand, sees only the cost of a more dangerous design,
and is not concerned with its benefits; the patients who reaped
those benefits are not represented in court.
Id. at 325, 128 S. Ct. at 1008.
The Court noted that “[s]tate requirements are pre-empted under the MDA only to
the extent that they are ‘different from, or in addition to’ the requirements imposed by
federal law.” Id. at 330, 128 S. Ct. at 1011 (quoting 21 U.S.C. § 360k(a)(1)). The
preemption clause “does not prevent a State from providing a damages remedy for claims
premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’
rather than add to, federal requirements.” Id. (quoting Medtronic v. Lohr, 518 U.S. 470,
495, 116 S. Ct. 2240 (1996)). “Parallel” claims would not be preempted. Id. Ultimately,
the Court held that the plaintiffs’ claims were preempted because they asserted that the
device violated state tort law notwithstanding compliance with the relevant federal
requirements.
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Medtronic argues that the Malanders have not alleged a parallel claim and that it is
entitled to summary judgment as a matter of law. According to Medtronic, this action
involves a claim that their technicians should have provided additional warnings above
and beyond the warnings on the device’s label, and the MDA preempts such claims. The
Malanders counter that their claim is not preempted because it involves negligent oral
representations by Medtronic’s technicians, not the device’s labeling.
Indiana courts have only addressed the MDA’s preemption clause once. In
McGookin v. Guidant Corp., 942 N.E.2d 831 (Ind. Ct. App. 2011), a child died after
receiving a pacemaker. The parents brought an action against the manufacturer of the
pacemaker for wrongful death, product liability, breach of express and implied
warranties, actual fraud, constructive fraud, negligence, violation of the Indiana
Deceptive Consumer Sales Act, and intentional and negligence infliction of emotional
distress. The basis of their claim was that “the labeling for [their daughter’s] pacemaker
was inadequate because it failed to warn of a lack of testing of the Automatic Capture
feature with small children, unipolar epicardial leads, and abdominal implantation.”
McGookin, 942 N.E.2d at 833. “In other words, their complaint challenge[d] labeling
expressly approved by the FDA.” Id.Based on the MDA’s preemption clause and the United States Supreme Court’s
opinion in Riegel, we concluded that the plaintiffs’ claims were preempted. We noted
that the plaintiffs did not allege that the manufacturer violated federal requirements.
Rather, the plaintiffs contended that the manufacturer “should be liable for its failure to
add warnings that are permitted, but not required, by federal law.” Id. at 838. We
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concluded that this allegation was “an attempt to impose a standard of care in addition to
the FDA’s specific federal requirements” and that the claim was preempted. Id.The facts of this case, however, are distinguishable from Riegel and McGookin.
The Malanders’ claim here relates to oral representations made by a manufacturer’s
representatives during a surgical procedure regarding a specific device’s performance,
not general allegations regarding the labeling, design, or manufacture of the device. Few
courts have considered this issue.
Medtronic relies on Baker v. Medtronic, Inc., No. 2:99-CV-1355, 2002 WL
485013 (S.D. Ohio, Eastern Div. Mar. 28, 2002). In Baker, the battery on the plaintiff’s
anti-spasm medication pump failed. The physician had noted that the low battery alarm
was occurring, scheduled a surgery for three weeks later, and contacted Medtronic’s
representative, who informed the physician’s nurse that the pump would continue
working for approximately four weeks. Four days before the surgery, the battery failed.
The plaintiff brought an action against Medtronic and argued, in part, that the
technician’s representations were “off label representations” that were not regulated by
the FDA. Baker, 2002 WL 485013, *8. The court noted that the labeling information
contained detailed graphs regarding the pump’s battery life, and the information given to
the physician’s nurse was consistent with the information in the labeling. The court
concluded that the information was not an “off label” representation, and the claim was
preempted. Id.11
Medtronic also relies on Wolicki-Gables v. Arrow Intern., Inc., 641 F. Supp.2d
1270 (M.D. Fla. 2009).1 There, the plaintiff was implanted with a drug delivery pump
and catheter for the treatment of chronic pain. The device manufacturer’s independent
contractor sales representative, Nelson, was present during surgery to replace the
allegedly malfunctioning pump. More complications ensued, and the plaintiffs filed an
action against the device’s manufacturer, Nelson, and others. The plaintiffs alleged
Nelson, “as a sales representative, owed a duty to Plaintiffs to instruct and educate [the
plaintiff’s] operating surgeon to ensure that the pain pump was functioning properly, to
verify Plaintiff’s consent to Defendant Nelson’s presence in the operating room, and to
not dispose of any devices removed from Plaintiff.” Wolicki-Gables, 641 F. Supp.2d at
1291.
The district court granted summary judgment to Nelson. The court first noted that,
because it had granted the manufacturer’s motion for summary judgment based on
preemption, it also granted summary judgment to Nelson, who had joined in the
manufacturer’s motion. The court did not differentiate the claim against Nelson and the
claim against the manufacturer and gave no analysis of the preemption of the claim
against Nelson. The court then noted that, even if the plaintiffs’ negligence claim against
Nelson was not preempted, the claim still failed. In particular, the court noted that
1
Medtronic also relies on Franklin v. Medtronic, No. 09-CV-02301, 2010 WL 2543579 (D. Col. May 12,
2010). In Franklin, the plaintiff alleged, in part, that Medtronic should have recalled its defibrillators or
warned physicians and users of defects. The district court concluded that Medtronic was not required to
issue a recall or warning under the FDA regulations and that the plaintiff’s claim would establish
requirements different from or in addition to the federal requirements. Thus, the plaintiff’s claim was
preempted. Here, however, the plaintiffs’ claim relates to oral representations given to David’s physician
during his surgery, not the failure to issue a recall or the failure to give a warning.
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Nelson did not participate in the surgery, did not advise the doctor or interact with him,
and did not improperly dispose of the removed device. The Eleventh Circuit affirmed the
district court’s decision but likewise gave no analysis of the preemption of the claim
against Nelson. Wolicki-Gables v. Arrow Intern. Inc., 634 F.3d 1296 (11th Cir. 2011).
Given the lack of analysis in Wolicki-Gables, we find Adkins v. Cytyc Corp, No.
4:06CV00053, 2008 WL 2680474 (W.D. Va. July 3, 2008), more persuasive. There, the
plaintiff suffered thermal burns to her sigmoid colon and a perforated uterus during an
endometrial ablation procedure. The procedure was performed with a NovaSure device,
and the manufacturer’s representative was in the operating room “and advised and
directed [the doctor] on the proper way” to use the device. Adkins, 2008 WL 2680474,
*1. The plaintiff brought an action against the manufacturer “alleging breach of implied
warranty of merchantability, breach of express warranty, negligence through inadequate
design and negligent warnings or instruction of the surgeon by defendants’ corporate
representative.” Id.The manufacturer filed a motion to dismiss based on preemption. The district
court agreed that the plaintiff’s common law claims for negligence and breach of
warranty were preempted under the MDA. However, the court concluded that the
Plaintiff’s cause of action regarding the representative’s direct actions “during the
surgery in negligently instructing the operating physician” were not governed by Riegel’s
preemption holding. Id. at *2. The court noted:
The FDA does not regulate interactions between
corporate representatives and physicians on-site at a particular
surgery, and where it does not mandate special physician
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training for a drug, it does not specify how such an interaction
at surgery must be performed. These localized situations are
traditional matters for the common law, not the FDA’s
regulatory approval process. Such a claim does not challenge
the design, manufacture, and labeling of the NovaSure device
so as to implicate Riegel preemption, but rather challenges
negligence by a corporate agent acting as a de facto
physician’s assistant during a surgical procedure.
Id. at *3. The district court ultimately dismissed the claim because of the lack of specific
allegations in the complaint but allowed the plaintiff to amend the complaint.
Likewise, we conclude that the Malanders’ claim concerns the allegedly negligent
interaction between the physician and Medtronic’s technicians. Unlike Baker, the
Malanders’ claim does not involve the mere restatement of information given in the
labeling. As in Adkins, their claim does not concern the design, manufacture, or labeling
of the lead. Rather, the Malanders’ challenge involves negligence of Medtronic’s
technicians in giving David’s physician allegedly faulty advice regarding the
performance of one specific lead. As such, we conclude that the Malanders’ claim is not
preempted by the MDA, and the trial court properly denied Medtronic’s motion for
summary judgment on this issue.
II. Assumed Duty
On appeal, Medtronic also argues that it did not assume a duty to the Malanders.2
To prevail on a claim of negligence, the plaintiff must show: (1) a duty owed to the
2
We note that Medtronic did not request summary judgment on the assumption of a duty issue. Rather, in
responding to Medtronic’s preemption agreement, the Malanders discussed Medtronic’s assumption of a
duty to David, and Medtronic addressed the issue in its reply brief. On appeal, Medtronic argues that it
did not assume a duty to David. It is unclear why the Malanders argued the assumption of duty issue in
response to Medtronic’s motion for summary judgment on preemption. It is also unclear why Medtronic
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plaintiff by defendant; (2) breach of duty because of conduct falling below the applicable
standard of care; and (3) compensable injury proximately caused by defendant’s breach
of duty. Kroger Co. v. Plonski, 930 N.E.2d 1, 6 (Ind. 2010). The parties here argue only
regarding whether Medtronic had a voluntarily assumed duty.
“A duty of care may . . . arise where one party assumes such a duty, either
gratuitously or voluntarily.” Plan-Tec, Inc. v. Wiggins, 443 N.E.2d 1212, 1219 (Ind. Ct.
App. 1983). “The assumption of such a duty creates a special relationship between the
parties and a corresponding duty to act in the manner of a reasonably prudent person.”
Id. Failure to act in a reasonable manner will give rise to an action for negligence. Id.“The existence and extent of such a duty are ordinarily questions for the trier of fact.”
Merrill v. Knauf Fiber Glass GmbH, 771 N.E.2d 1258, 1270 (Ind. Ct. App. 2002), trans.
denied. However, the court will decide the issue as a matter of law when the record
contains insufficient evidence to establish such a duty. Id.Section 324A of the Restatement (Second) of Torts parallels Indiana’s doctrine of
assumed duty. Ward v. First Indiana Plaza Joint Venture, 725 N.E.2d 134, 136 (Ind. Ct.
App. 2000), trans. denied. Section 324A provides:
One who undertakes, gratuitously or for consideration, to
render services to another which he should recognize as
necessary for the protection of a third person or his things, is
subject to liability to the third person for physical harm
resulting from his failure to exercise reasonable care to
protect his undertaking, if
is now requesting summary judgment on the issue not raised in its summary judgment motion.
Regardless, as neither party raises the issue of waiver, we will address Medtronic’s assumption of a duty.
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(a) his failure to exercise reasonable care increases the
risk of such harm, or
(b) he has undertaken to perform a duty owed by the other
to the third person, or
(c) the harm is suffered because of reliance of the other or
the third person upon the undertaking.
Id.Medtronic argues that it did not assume a duty to make a medical recommendation
regarding the removal of the Lead, that it did not control the “instrumentality” or assume
a duty owed by Dr. Klein, that it did not have superior knowledge to Dr. Klein, and that
its internal documents did not give rise to a duty to make medical recommendations.
Appellant’s Br. p. 31. According to Medtronic, Dr. Klein was in charge of the surgical
procedure regardless of any advice given by the technicians, Dr. Klein had the same
information that the technicians had, and its technicians are prohibited from practicing
medicine.
The Malanders, however, argue not that Medtronic had a duty to make medical
recommendations, but rather that it assumed a duty to make “technical” recommendations
to Dr. Klein regarding the Lead. Appellee’s Br. p. 17. The Malanders do not allege that
Medtronic should have participated in the surgery, was responsible for deciding whether
to remove the Lead, or was involved with the physician/patient relationship. Rather, the
Malanders argue that, having voluntarily agreed to give technical support, the technical
support should have been made in a “reasonable and prudent manner.” Id. at 21.
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We agree with the Malanders. In fact, Medtronic concedes that, “[h]aving
volunteered to provide technical support, Medtronic at most assumed a duty to provide
that support in a reasonable and prudent manner.” Appellant’s Br. p. 32. Medtronic’s
failure to exercise reasonable care in giving technical support would clearly increase the
risk of harm to a patient. Medtronic voluntarily undertakes to perform the technical
support for physicians to assist the physician in using their devices. The Malanders
designated evidence that Medtronic’s technician was present in the operating room and
that Dr. Klein talked on the telephone to additional technicians regarding the short V-V
intervals experienced by David’s Lead. The Malanders also designated evidence that
Medtronic’s technicians failed to follow the recommendations of its own internal
memoranda regarding the short V-V intervals associated with this particular lead.
Appellant’s App. p. 508. Although Medtronic designated deposition testimony that the
small number of short V-V intervals associated with David’s lead would not have been
concerning, the designated evidence creates a genuine issue of material fact. Because
“[t]he existence and extent of such a duty are ordinarily questions for the trier of fact,”
Merrill, 771 N.E.2d at 1270, and genuine issues of material fact exist regarding whether
Medtronic assumed a duty here, summary judgment on this argument would have been
improper.
Conclusion
We conclude that the MDA does not preempt the Malanders’ claim against
Medtronic and that genuine issues of material fact exist regarding whether Medtronic
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assumed a duty to David. Consequently, the trial court properly denied Medtronic’s
motion for summary judgment. We affirm.
Affirmed.
CRONE, J., and PYLE, J., concur.
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