Kennedy v. Medtronic, Inc.

851 N.E.2d 778, 366 Ill. App. 3d 298, 303 Ill. Dec. 591, 2006 Ill. App. LEXIS 489
CourtAppellate Court of Illinois
DecidedJune 6, 2006
Docket1-04-1621
StatusPublished
Cited by14 cases

This text of 851 N.E.2d 778 (Kennedy v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering Appellate Court of Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Kennedy v. Medtronic, Inc., 851 N.E.2d 778, 366 Ill. App. 3d 298, 303 Ill. Dec. 591, 2006 Ill. App. LEXIS 489 (Ill. Ct. App. 2006).

Opinion

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 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 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. 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 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:

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Madsen v. C. R. Bard, Inc.
N.D. Illinois, 2022
Cleeton v. SIU Healthcare, Inc.
2021 IL App (4th) 200490 (Appellate Court of Illinois, 2021)
Plass v. Dekalb Eye Consultants, LLC
2020 IL App (2d) 190403-U (Appellate Court of Illinois, 2020)
Urbaniak v. American Drug Stores, LLC.
2019 IL App (1st) 180248 (Appellate Court of Illinois, 2019)
Lempa v. Sandoz Inc.
N.D. Illinois, 2019
Huskey v. Ethicon, Inc.
29 F. Supp. 3d 736 (S.D. West Virginia, 2014)
Smith v. St. Jude Medical
California Court of Appeal, 2013
Smith v. St. Jude Medical CA1/5
217 Cal. App. 4th 313 (California Court of Appeal, 2013)
Stephens v. Hook-SupeRx
359 F. App'x 648 (Seventh Circuit, 2009)
Quaid v. Baxter Healthcare Corp.
910 N.E.2d 1236 (Appellate Court of Illinois, 2009)

Cite This Page — Counsel Stack

Bluebook (online)
851 N.E.2d 778, 366 Ill. App. 3d 298, 303 Ill. Dec. 591, 2006 Ill. App. LEXIS 489, Counsel Stack Legal Research, https://law.counselstack.com/opinion/kennedy-v-medtronic-inc-illappct-2006.