Kennedy v. Medtronic, Inc.

SECOND
DIVISION
June 6, 2006

No. 1-04-1621

SHARON KENNEDY, as Administrator of the Estate of ) Appeal from the
Ralph G. Studzinski, ) Circuit Court of
) Cook County.
Plaintiff-Appellant, )
)
v. )
) Honorable
MEDTRONIC, INC., ) David G. Lichtenstein,
) Judge Presiding.
Defendant-Appellee. )

JUSTICE SOUTH delivered the opinion of the court:

Plaintiff, Sharon Kennedy, as administrator of the estate of her father, Ralph G.

Studzinski, brought this negligence action seeking damages for the alleged injury and wrongful

death of her father following the implantation of a cardiac pacemaker and lead manufactured by

defendant, Medtronic, Inc. The trial court granted Medtronic's motion for summary judgment.

The following facts are taken from the pleadings, depositions, affidavits, and exhibits

contained in the record on appeal: On July 16, 1999, Dr. Joshua Salvador, a medical doctor

licensed to practice medicine in Illinois, surgically implanted a Medtronic pacemaker and lead

into the aorta and left ventricle of decedent's heart. Mr. Studzinski was 75 years old at the time

of the procedure. Various witnesses provided deposition testimony, including Dr. Salvador, who

testified that Mr. Studzinski had been his patient for over 15 years and had various health

problems. Mr. Studzinski was afraid of hospitals and refused to have the implantation procedure
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performed unless it was done on an outpatient basis. Dr. Salvador had inserted hundreds of

pacemakers during the course of his career but had retired from hospital surgery and given up his

surgical privileges at Thorek Hospital in 1995. The procedure performed on Mr. Studzinski

occurred in an outpatient setting at Dr. Salvador's clinic, the Heart, Lung, and Vascular Institute

(HLVI), which had just opened. It was the first such procedure Dr. Salvador had performed at

HLVI, and he released Mr. Studzinski on the same day.

Dr. Salvador testified that Mr. Studzinski was provided local anesthesia with intravenous

sedation, and his blood pressure, heart, and respiratory rates were monitored. Dr. Isham Afifi, a

dentist who worked with Dr. Salvador at HLVI, monitored Mr. Studzinski during the surgery. A

record of the monitoring of the patient=s vital signs was not maintained. A clinical specialist

provided by Medtronic was handed the wires from the pacemaker and checked them. Two

registered nurses were also present, one of whom was the doctor=s wife and one who was

provided by a local agency.

Following the surgery, Mr. Studzinski continued to experience various health problems.

In December 1999, he was taken to Oak Park Hospital after he was found in bed unresponsive.

Dr. Balasubramaniam Iyer testified he discovered the electrode to the pacemaker had been

placed in the left ventricle of the heart and determined it would need to be relocated to the right

ventricle. On December 26, 1999, Dr. Iyer removed the device and implanted a new pacemaker

and lead into the right ventricle. On April 24, 2000, Mr. Studzinski died of acute renal failure

and congestive heart failure. Dr. Salvador subsequently admitted he deviated from the standard

of care by inserting the pacemaker lead into the left ventricle and not identifying that the

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pacemaker lead was left there.

Medtronic is a medical device manufacturer that makes a variety of implantable cardiac

devices, including cardiac pacemakers and leads. These products are prescription medical

devices which Medtronic sells only to licensed physicians. The safety of the device implanted

into the decedent was not an issue, and there was no evidence of a defect. Heather Friedman,

who had worked as a clinical specialist for Medtronic for approximately eight years, was present

during the surgery. She provided technical support to ensure the lead parameters were correctly

calibrated and the lead was functioning properly.

Friedman testified she is a registered nurse and while working for Medtronic she has

provided technical support for one to three pacemaker insertion procedures per day, five days a

week. Friedman was trained as a clinical specialist by Medtronic and was certified by the

National Association of Pacing Electrophysiology (NASPE). Friedman=s primary responsibility

was to make sure that when the doctor puts the lead into the ventricle, she paces the heart and

determines whether it is capturing or sensing appropriately. Friedman did not assist the doctor in

inserting the pacemaker and lead and could not make a judgment as to whether the lead was

placed in the appropriate ventricle. During Mr. Studzinski's surgery, in addition to herself and

Dr. Salvador, she recalled a man, referred to as a doctor, stood at the head of the table and took

the patient's blood pressure, and he had difficulty inserting the patient=s IV. There was also a

woman present who was responsible for "the sterile field."

Friedman further testified there was a continuous cardiac monitor on the patient and a

portable X-ray machine which was used during the surgery which enabled her to see the lead.

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She did not have the medical expertise, however, to tell whether the lead was in one place or

another. Friedman recalled the patient screamed somewhat loudly that he was in pain several

times during the beginning of the procedure. At the completion of the surgery, she interrogated

the device and made sure the lead was capturing appropriately and that there was an adequate

amount of energy to pace it. Friedman testified that a pacemaker should be placed in the right

ventricle and was not made aware that it had been placed in Mr. Studzinski's left ventricle until

the date of her deposition. The procedure involving Mr. Studzinski was the first time ever she

had participated in a setting outside of a hospital. The only experiences she had in 1998 and

1999 involving same-day surgeries were battery or generator replacements.

Plaintiff testified that she accompanied her father to Dr. Salvador=s office on the day of

the surgery. The surgical room was located downstairs from the office, and although she was

unhappy with her father's decision to have the procedure performed there, it was what he wanted.

Prior to the procedure, Friedman, the representative from the pacemaker manufacturer, told her,

" 'Don't worry about anything. Dr. Salvador has put in thousands of these. He's very qualified

and everything is going to be fine. ' " Plaintiff took her father home that same evening, although

he was very groggy when he left the clinic.

Dr. Kathleen Ward testified that she has participated in many invasive surgical

procedures, including pacemaker implants, and is familiar with the role of the technical

representative. Dr. Ward opined that Friedman should have refused to participate in the insertion

of the decedent=s pacemaker. Her opinion was based on the fact that the procedure was not done

in a hospital but in an office structure, and that she should have noticed there were no recovery

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room facilities and personnel to supervise the patient after the surgery. Dr. Ward testified the

procedure could not have gone forward or been completed without Friedman.

Dr. Harvey Alpern, a cardiologist with a background in pacemaker implant procedures,

testified in his deposition that a reasonable standard of care would require the doctor to monitor

and record the various vital signs during the pacemaker implant surgery. The implantation of a

single lead pacemaker, such as the one in this case, also requires monitoring for at least part of a

day in order to make sure that any changes in the body do not dislodge the newly placed device.

Dr. Alpern opined that "an inpatient admission to a monitored bed, whether it be in the hospital

or as part of the hospital complex, is necessary." When asked what criticisms he had of

Friedman, he replied:

"[S]he went to a facility that was not a full-fledged medical

center or associated with any major hospital and it was an

outpatient facility and since she testified that she had never seen

this before, my criticism is that she should have called - either left

or called her superiors to find out what to do."

Dr. Alpern testified that one of the choices available to Friedman was to leave and not provide

the equipment until she received approval from one of her superiors.

On April 18, 2002, the trial court granted plaintiff leave to file her second amended

complaint in which she added Medtronic as a party. In her wrongful death and survival cause of

action against them, plaintiff alleged that her father suffered severe complications due to the

improperly inserted pacemaker lead which resulted in his death. Plaintiff also alleged, in

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relevant part, that Medtronic was negligent in selling the pacemaker to Dr. Salvador and through

its participation and assistance in the pacemaker implant procedure.

On March 9, 2004, the trial court granted Medtronic's motion for summary judgment. On

May 12, 2004, plaintiff's complaint against defendants Dr. Salvador, Holistic and Anti-Aging

Institute, and HLVI was dismissed with prejudice following resolution, compromise, and/or

settlement. On June 2, 2004, the trial court granted plaintiff's motion for Rule 304(a) (155 Ill. 2d

R. 304(a)) findings in her cause against Medtronic, the sole remaining defendant, and this

appealed followed. Amicus curiae briefs have been filed by St. Jude Medical, Inc., and Product

Liability Advisory Council, Inc., in support of Medtronic.

Plaintiff contends the trial court erred by granting Medtronic=s motion for summary

judgment because it owed the decedent a duty of care and because genuine issues of material fact

exist with respect to breach and proximate causation. Specifically, plaintiff contends Medtronic

owed decedent, under the unique circumstances of this case, the following three duties: (1) to

refrain from providing a pacemaker to Dr. Salvador and from participating in the insertion of the

pacemaker when she knew he intended to proceed in an inadequate facility without qualified

personnel present and without monitoring any of the patient's vital signs; (2) to warn of the

dangers inherent in proceeding with the surgery under the conditions present; and (3) to assist

with the insertion in a reasonable manner once it voluntarily undertook to participate. Medtronic

responds there is no legal basis to support any of plaintiff 's claims of duty and, in particular, that

it had no duty to prevent physician malpractice or to guarantee against it. Medtronic also asserts

that under the learned intermediary doctrine it was exempt from having to warn decedent or his

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family of any dangers in proceeding with the surgery.

We apply a de novo standard of review in appeals from summary judgment rulings.

Williams v. Covenant Medical Center, 316 Ill. App. 3d 682, 688 (2000). Summary judgment is

appropriate when the pleadings, depositions, and admissions, together with any affidavits, show

that there is no genuine issue of material fact. 735 ILCS 5/2-1005(c) (West 2002); Gilbert v.

Sycamore Municipal Hospital, 156 Ill. 2d 511, 517-18 (1993). Accordingly, the party moving

for summary judgment must show, as a matter of law, that it is entitled to judgment. Wright v.

St. John's Hospital of the Sisters of the Third Order of St. Francis , 229 Ill. App. 3d 680, 682

(1992).

When ruling on a motion for summary judgment, the evidence must be viewed in the

light most favorable to the nonmovant. Williams, 316 Ill. App. 3d at 687-88. Where a

reasonable person could draw divergent inferences from the undisputed facts, summary

judgment should be denied. Outboard Marine Corp. v. Liberty Mutual Insurance Co, 154 Ill. 2d

90, 102 (1992); Loyola Academy v. S & S Roof Maintenance, Inc., 146 Ill. 2d 263, 272 (1992).

The purpose of summary judgment is not to try a question of fact but to determine whether one

exists. Golla v. General Motors Corp., 167 Ill. 2d 353, 358 (1995). "Summary judgment is a

drastic measure and should only be granted if the movant's right to judgment is clear and free

from doubt." Outboard Marine Corp., 154 Ill. 2d at 102. In deciding a motion for summary

judgment, however, inferences may be drawn from the undisputed facts. Loyola Academy, 146

Ill. 2d at 272. "If what is contained in the papers on file would constitute all of the evidence

before a court and would be insufficient to go to a jury but would require a court to direct a

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verdict, summary judgment should be entered." Pyne v. Witmer, 129 Ill. 2d 351, 358 (1989).

The essential elements of a cause of action based on common law negligence are the

existence of a duty owed by the defendant to the plaintiff, a breach of that duty, and an injury

proximately caused by that breach. Kirk v. Michael Reese Hospital & Medical Center, 117 Ill.

2d 507, 525 (1987). The issue before us concerns the existence of a duty, i.e., whether

defendant and plaintiff stood in such a relationship to one another that the law imposed upon

defendant an obligation of reasonable conduct for the benefit of plaintiff that would support this

cause of action. Ward v. K mart Corporation, 136 Ill. 2d 132, 140 (1990). "Four factors are

relevant to deciding whether a duty of care exists: (1) the reasonable foreseeability of injury; (2)

the likelihood of injury; (3) the burden of guarding against injury; and (4) the consequences of

placing that burden on the defendant." Brewster v. Rush-Presbyterian-St. Luke's Medical

Center, 361 Ill. App. 3d 32, 35-36 (2005), citing City of Chicago v. Beretta U.S.A. Corp., 213 Ill.

2d 351, 391 (2004). A duty to warn exists where there is unequal knowledge, actual or

constructive of a dangerous condition, and the defendant, possessed of such information, knows

or should know that harm might or could occur if no warning is given. Happel v. Wal-Mart

Stores, Inc., 199 Ill. 2d 179, 186 (2002).

A >Whether a duty of care exists is a question of law to be determined by the court.=

[Citation.]@ Beretta, 213 Ill. 2d at 391. However, the question of whether the defendant

breached its duty and whether the breach was the proximate cause of the decedent=s injuries are

factual matters for the jury to decide. Bajwa v. Metropolitan Life Insurance Co., 208 Ill. 2d 414,

422 (2004).

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In Kirk, cited by Medtronic, the learned intermediary doctrine was adopted by our

supreme court. Under that doctrine, Amanufacturers of prescription drugs have a duty to warn

prescribing physicians of the drugs= known dangerous propensities, and the physicians, in turn,

using their medical judgment, have a duty to convey the warnings to their patients.@ Kirk, 117

Ill. 2d at 517. The doctrine=s rationale is that a doctor is considered in the best position to

prescribe drugs and monitor their use because he is knowledgeable of the propensities of the

drugs he is prescribing and the susceptibilities of his patient. Kirk, 117 Ill. 2d at 518.

Consequently, in selling prescription drugs, the manufacturer is only required to warn the

prescribing doctor, who then acts as a Alearned intermediary@ between the manufacturer and the

consumer. Kirk, 117 Ill. 2d at 518. The learned intermediary doctrine was considered by this

court in relation to a medical device manufacturer in Hansen v. Baxter Heathcare Corp., 309

Ill. App. 3d 869 (1999). There, in the context of the doctrine, we found that a medical device

manufacturer has no duty to warn physicians of the device=s dangers which the medical community generally

appreciates. Hansen, 309 Ill. App. 3d at 881.

In Fakhouri v. Taylor, 248 Ill. App. 3d 328 (1993), also cited by Medtronic, the plaintiff,

as administrator of the decedent=s estate, filed a wrongful death claim against the defendant

pharmacists who filled the prescriptions on which the decedent allegedly overdosed. The

plaintiff claimed the pharmacists had a duty to warn either the decedent or his doctor that the

prescribed dosage of medication was for an excessive and unsafe quantity. We found that

pharmacists, like drug manufacturers, do not have a duty to warn customers of a drug=s potential

adverse effects where the pharmacists did nothing more than fill the prescriptions as ordered by

the doctor. We noted, to hold otherwise would be to place the pharmacist in the middle of the

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doctor-patient relationship. Fakhouri, 248 Ill. App. 3d at 332-33.

In Happel, relied upon by plaintiff, a regular customer of the defendant=s pharmacy was

injured when she was prescribed a medication that was related to the one she was allergic to.

Happel, 199 Ill. 2d at 181. The pharmacy regularly asked customers about their known drug

allergies and the plaintiff's allergy information was in the pharmacy's computer and available to

it when it filled her prescription. Happel, 199 Ill. 2d at 181-83. The pharmacy's computer

system was designed to notify the pharmacist of a contraindication and the pharmacist would

have to override the system by entering a special code before dispensing the medication.

Happel, 199 Ill. 2d at 182-83. The defendant's pharmacy's failure to adhere to its own policy

caused the plaintiff=s injury. Happel, 199 Ill. 2d at 183-84.

The supreme court concluded that the scope of protection provided to pharmacists by the

learned intermediary doctrine is limited, particularly in situations where a pharmacy has

knowledge that a prescribed medication is contraindicated for a specific customer. Happel, 199

Ill. 2d at 195. The learned intermediary doctrine, therefore, did not relieve defendant=s pharmacy

of a duty to warn either the customer or her doctor that the prescribed drug was contraindicated

because the pharmacy knew of the customer=s allergies and knew that she was placed at risk of

serious injury or death by taking the medicine. Happel, 199 Ill. 2d at 197. The supreme court

found that imposing the duty to warn would not require the pharmacist to learn the customer's

condition and monitor her drug use because it already had all the knowledge it needed. Happel,

199 Ill. 2d at 187. Also, imposing a duty on the defendant's pharmacy to warn would not intrude

into the doctor-patient relationship, forcing it to practice medicine without a license, because the

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plaintiff was not asking the pharmacist to exercise any medical judgment or interject himself into

the customer's relationship with her doctor. Happel, 199 Ill. 2d at 187-88. Finally, by asking

customers about their drug allergies, the pharmacy was found to engender reliance in the

customer that it would take steps to ensure the customer did not receive a drug which she was

allergic to. Happel, 199 Ill. 2d at 188.

While we find the cases relied upon by the parties to be instructive, the situation here

differs, and no Illinois case has addressed plaintiff=s specific claim. She advances a theory that

Medtronic owed her father a duty to refrain from providing a pacemaker to Dr. Salvador, and

participating in the insertion of the device, once Medtronic=s clinical specialist discovered the

procedure was being performed in a setting that was not part of a hospital with adequate qualified

personnel, and which lacked proper monitoring devices to check the patient=s vital signs. Plaintiff

also claims Medtronic owed her father a duty to warn of the dangers inherent in proceeding with

the surgery under the conditions present at Dr. Salvador=s clinic.

We reject plaintiff's claim and find the four factors in determining whether a duty exists

do not weigh in her favor. Dr. Salvador admitted that he deviated from the standard of care by

inserting the pacemaker lead, which was free from defects, into the left ventricle of Mr.

Studzinski's heart. Friedman was not responsible for the insertion of the pacemaker and lead and

testified that she could not make a judgment as to where a lead was placed. Plaintiff alleged in

her second amended complaint that her father suffered severe complications due to Dr. Salvador's

error which resulted in his death. These alleged injuries, however, unlike those experienced by

the plaintiff in Happel, were not reasonably foreseeable to Medtronic or likely based upon the

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surgery being performed at a clinic such as Dr. Salvador's. The implant surgery could have been

performed by Dr. Salvador at a full-fledged hospital, and the same error could have occurred.

Moreover, in Happel, in stark contrast to this case, the defendant had all of the knowledge it

needed that plaintiff was allergic to the medication which had been prescribed and would be

placed at risk of serious injury if she took the prescription.

We also find the burden and consequences of imposing the duty proposed by plaintiff to

be substantial. It would be a significant burden to require Medtronic to monitor the conditions

under which a doctor performs surgery. In Happel, the defendant was not required to learn the

customer's condition or monitor her drug use because it already had that necessary information.

Moreover, a central aspect of the learned intermediary doctrine, as first adopted by our supreme

court in Kirk, is that a licensed physician, such as Dr. Salvador, has the knowledge of his patient's

medical history and background, and, therefore, he is in a better position, utilizing his medical

judgment, to determine a patient's needs and what medical care should be provided. It would be

unreasonable, and potentially harmful, to require a clinical specialist such as Friedman to delay or

prevent a medical procedure simply because she believes the setting is not appropriate or the

doctor is unqualified. To hold otherwise would place a medical device manufacturer, such as

Medtronic, in the middle of the doctor-patient relationship. In Happel, unlike the case at hand,

imposing the duty on the defendant's pharmacy to warn did not intrude upon the doctor-patient

relationship because the pharmacy was not asked to exercise any modicum of medical judgment

or interject itself into the customer's relationship with her doctor. Finally, as pointed out by

amicus, the consequences of requiring such screening by Medtronic would run the risk of

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imposing additional liability on the manufacturer in the event it determined a physician was not in

a position to properly implant a device, refused to provide one, and the patient suffered adverse

medical consequences because he did not have access to a needed device.

Plaintiff relies, in the alternative, upon section 324A of the Restatement (Second) of Torts

in support of her claim that Medtronic owed a duty to assist in a reasonable manner with the

surgery once it voluntarily undertook to participate. Plaintiff maintains that Medtronic also

voluntarily assumed a duty because Friedman, prior to the surgery, reassured plaintiff about Dr.

Salvador=s qualification in performing the implant procedure.

ALike other issues of duty, whether a defendant has voluntarily undertaken a duty to a

plaintiff is a question of law for the court that is properly addressed in a motion for summary

judgment.@ Lange v. Fisher Real Estate Development Corp., 358 Ill. App. 3d 962, 973 (2005).

AUnder the voluntary undertaking theory of liability, the duty of care to be imposed on a

defendant is limited to the extent of the undertaking.@ Lange, 358 Ill. App. 3d at 973. Section

324(A) of the Restatement (Second) of Torts has been adopted by courts in Illinois to analyze

voluntary undertaking claims. See, e.g., Bailey v. Edward Hines Lumber Co., 308 Ill. App. 3d 58,

65 (1999). Section 324(A) provides:

AOne 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

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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.@ Restatement (Second) of

Torts '324A (1965).

In the instant case, Medtronic's clinical specialist attended the surgery to provide technical

support and ensure that the lead parameters were correctly calibrated and the lead was functioning

properly. This limited role did not entail her voluntarily assuming a duty, under section 324A of

the Restatement (Second) of Torts, for the placement of the lead into the correct ventricle of the

patient's heart. Likewise, plaintiff has failed to demonstrate that Medtronic voluntarily assumed a

duty based simply upon a brief conversation between Friedman and plaintiff during which she

allegedly reassured plaintiff prior to her father's surgery. According to plaintiff's deposition

testimony, Friedman told her not to worry, that Dr. Salvador had put in thousands of pacemakers,

and everything would be fine. Plaintiff never alleged that Friedman made any representations

about the conditions under which the surgery was being performed at the clinic. We find there is

no basis for us to conclude that decedent would not have proceeded with the surgery without

Friedman=s alleged reassurance. On the contrary, plaintiff, herself, testified that her father

insisted upon having the procedure performed at the clinic, despite her reservations, and that it

was his decision. This was consistent with Dr. Salvador's testimony that Mr. Studzinski, who had

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been his patient for over a decade, was afraid of hospitals and would not agree to have the surgery

unless it was done on an outpatient basis. For the foregoing reasons, we reject plaintiff's claim

that Medtronic voluntarily assumed a duty.

Inasmuch as Medtronic did not owe a legal duty to the decedent that would support

plaintiff=s negligence cause of action, we find the trial court properly granted the motion for

summary judgment.

Accordingly, the judgment of the circuit court of Cook County is affirmed.

Affirmed.

WOLFSON and HALL, JJ., concur.

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