Johnson v. Medtronic, Inc.

• Decision Date: 01 May 2012
• Docket Number: Nos. WD 73382,WD 73429.,s. WD 73382
• Citation: 365 S.W.3d 226
• Parties: Jeffrey Allen JOHNSON and Tammy Elaine Johnson, Appellants–Respondents, v. MEDTRONIC, INC., Respondent–Appellant.
• Court: Missouri Court of Appeals

365 S.W.3d 226

Jeffrey Allen JOHNSON and Tammy Elaine Johnson, Appellants–Respondents,

v.MEDTRONIC, INC., Respondent–Appellant.

Nos. WD 73382, WD 73429.

Missouri Court of Appeals, Western District.

March 6, 2012.

Motion for Rehearing and/or Transfer to

Supreme Court Denied May 1, 2012.

Richard McLeod, Kansas City, MO, for Appellant–Respondents.

Patrick Lysaught, Kansas City, MO, for Respondent–Appellants.

Before ALOK AHUJA, P.J., THOMAS H. NEWTON, and JAMES EDWARD WELSH, JJ.

JAMES EDWARD WELSH, Judge.

Jeffrey Allen and Tammy Elaine Johnson appeal the circuit court's grant of summary judgment in favor of Medtronic, Inc.,¹ in regard to the Johnsons' product liability claims for failure to warn and product defect. The Johnsons claimed that a defibrillator used on Jeffrey Johnson was unreasonably dangerous and in a defective condition because it automatically reverted to an asynchronous mode after each synchronized shock, permitted a user to give an asynchronous shock where a synchronized shock was medically indicated, and lacked any audible warning or other notice while using the defibrillator to alert the operator of the change from synchronized to asynchronous mode. They also claimed that Medtronic did not give adequate warning of this dangerous condition. The circuit court found that, as a matter of law, the instructions accompanying the defibrillator were adequate, that Medtronic's affirmative defense of the learned-intermediary doctrine applied to the failure to warn claim, and that the physician's use of the defibrillator in violation of the appropriate standard of care could not constitute a reasonably anticipated use by Medtronic. The Johnsons appeal, asserting that the circuit court erred in granting summary judgment because (1) genuine issues of material fact precluded summary judgment on their failure to warn claim, (2) the circuit court misapplied the law on the learned intermediary doctrine in regard to the failure to warn claim, and (3) genuine issues of material fact precluded summary judgment on their product defect claim. Medtronic also filed a cross-appeal asserting that the circuit court erred in failing to expand its basis for granting summary judgment because it failed to include that the Johnsons were unable to make a submissible case because (1) their only two liability experts should be excluded, (2) their usability study should be excluded, and (3) they could not establish causation. We affirm in part and reverse in part.

The evidence established that Jeffrey Johnson suffered from recurring atrial fibrillation, which is a heart rhythm disorder. On November 9, 2005, Jeffrey Johnson's wife, Tammy Johnson, took Jeffery Johnson to the emergency room at North Kansas City Hospital after Johnson experienced another episode of atrial fibrillation. At the emergency room, the nursing staff confirmed that Jeffrey Johnson was in atrial fibrillation. The staff contacted Northland Cardiology, which was the cardiology group of choice of Jeffrey Johnson for his condition. Dr. Steven Starr, the cardiologist that Jeffrey Johnson normally saw, was not available, but Dr. David M. Hahn was available.

Thereafter, Dr. Hahn arrived at the emergency room, confirmed that Jeffrey Johnson was in atrial fibrillation, and prepared to electrically cardiovert Jeffrey Johnson's heart to restore his heart beat to a normal rhythm. Electrical cardioversion involves the application of an electric shock to a patient's heart through the use of a defibrillator. Jeffrey Johnson had previously advised Dr. Starr and others at Northland Cardiology that he was supposed to undergo only biphasic cardioversion, which required the use of a biphasic defibrillator. At the emergency room, Jeffrey Johnson specifically confirmed with Dr. Hahn that a biphasic defibrillator would be used, and Dr. Hahn agreed that he knew that he should use a biphasic defibrillator and that he would do so. The specific device selected by Dr. Hahn for this procedure was the LifePak 9P defibrillator, which was manufactured by Medtronic. The LifePak 9P was a monophasic defibrillator.

The LifePak 9P defibrillator transmits shocks in either synchronous or asynchronous mode. The most basic function of the device is the delivery of a nonsynchronized shock in an emergency situation when a patient is suffering from cardiac arrest or ventricular fibrillation. The LifePak 9P is also used for non-emergency situations, such as electric cardioversion of atrial fibrillation. To cardiovert a patient suffering from atrial fibrillation, the standard medical protocol requires that the synchronous mode be selected on the defibrillator. If instead the asynchronous mode is selected while attempting cardioversion of atrial fibrillation, ventricular fibrillation can occur, which is much more serious and potentially more dangerous than atrial fibrillation. The default setting for the LifePak 9P is the asynchronous mode. Thus, for a synchronized shock to be given, the synchronous mode must be manually selected by the operator of the device for each synchronized shock. After each synchronized shock, the LifePak 9P automatically resets itself to the asynchronous mode, presumably to be ready for use in an emergency situation.

Further, the LifePak 9P had three levels of use instructions regarding synchronization of the LifePak 9P. First, an instruction manual was provided to users of the LifePak 9P defibrillator at North Kansas City Hospital and instructed the users how to operate the device and how to place the device in the synchronous mode. The instruction manual stated, “If synchronized cardioversion needs to be reattempted, press sync again, device automatically returns to the asynchronous mode after each synchronized discharge.” Thus, the instructions in the instruction manual told the user that the defibrillator would reset to the asynchronous mode after each synchronized shock and that the device had to be reset to synchronous mode before attempting any subsequent synchronized shocks. Second, a label was displayed and affixed to the top of the machine itself, giving instructions for use regarding synchronization. The instructions specifically stated, “Push SYNC for each synchronized attempt.” ² Third, the LifePak 9P's display monitor allowed a user to determine whether or not the machine was in synchronous mode. An illuminated amber light on the SYNC button indicated when the machine was synchronized with the patient's heart rhythm. A green light reading “SYNC” displayed on the monitor whenever the LifePak 9P defibrillator was in the synchronous mode. Additionally, markers or carats appeared at the top on the “QRS complex” when the device was in synchronous mode. These indicators disappeared when the device was in asynchronous mode (although the monitor did not affirmatively state that the device was prepared to deliver a nonsynchronized shock).

Prior to delivering the first shock from the LifePak 9P, Dr. Hahn selected the synchronous mode. Dr. Hahn then administered a synchronized shock to Jeffrey Johnson. This treatment was unsuccessful, however, and Jeffrey Johnson remained in a state of atrial fibrillation. At this point, Dr. Hahn again used the LifePak 9P in a second attempt to electrically cardiovert Jeffrey Johnson's heart beat. Dr. Hahn, however, did not select the synchronous mode on the LifePak 9P, and he made no effort to confirm that the LifePak 9P defibrillator was still in the synchronous mode before delivering the second shock (other than his erroneous assumption that the defibrillator was still in synchronous mode). Thus, because the LifePak 9P automatically resets itself to the asynchronous mode, a nonsynchronized shock was given to Jeffrey Johnson instead of a synchronized one. As a result, Johnson went into ventricular fibrillation, a serious, life-threatening condition. Dr. Hahn then applied 12 or more additional shocks to Jeffrey Johnson over the course of approximately 40 minutes in an effort to electrically cardiovert Johnson's heart.³ Johnson remained in ventricular fibrillation after each of these subsequent shocks.

Finally, Dr. Hahn switched from the monophasic LifePak 9P defibrillator to a biphasic LifePak 12 defibrillator. Dr. Hahn applied one shock from the biphasic LifePak 12 defibrillator and successfully cardioverted Jeffrey Johnson's heart on the first shock.

Dr. Hahn admitted that he was aware that a patient with atrial fibrillation, who was stable and not under hemodynamic duress, should be given a synchronized shock and not a nonsynchronized shock. Further, he admitted that he had knowledge that some defibrillators possibly automatically reset to the asynchronous mode after being operated in the synchronous mode. Dr. Hahn said that he intended the second shock on Jeffrey Johnson be delivered as a synchronized shock and erroneously assumed that the defibrillator was still in synchronous mode, but that he did nothing further to confirm that the shock would be delivered in the synchronous mode. Dr. Hahn acknowledged that he had the physical capability of confirming whether the LifePak 9P was in the synchronous mode but that he did not confirm it “in the usual manners.” Dr. Hahn said that, for all the shocks given after the initial shock, he did not know whether he was delivering a synchronized or nonsynchronized shock to Jeffrey Johnson. He admitted that “it was not a step in my mind to determine whether it was synchronized or nonsynchronized.”

Dr. Hahn also admitted that he had never read the instruction manual on how to synchronize the LifePak 9P defibrillator and that he had never read the instructions affixed on the device itself. He admitted that, had he read those instructions, he would have understood them and that he could have followed them. Finally, Dr. Hahn acknowledged that, had he read these materials, he “presumably” would have followed the instructions and pushed the “SYNC” button before each synchronized attempt....