Court Opinion

ID: 2726253
Source: CourtListenerOpinion
Date Created: 2014-09-08 21:00:15.564862+00
Date Added: 2024-06-11T12:39:47.177407
License: Public Domain

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:

                                             2
                 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

                                              3
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.

                                              4
      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

                                            5
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.

                                             6
       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:

                                             7
              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

                                             8
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.

                                               9
       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

                                            10
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.
                                                    12
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

                                            13
               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
                                                  14
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.
                                                   15
             (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.

                                           16
      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

                                            17
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.

                                          18