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McDonough v. Allina Health System

August 17, 2004


Anoka County District Court. File No. C5-02-7577.

Considered and decided by Peterson, Presiding Judge; Anderson, Judge; and Parker, Judge.*fn1


1. The district court did not err in excluding expert testimony as not generally accepted in the applicable medical or scientific community when appellants did not demonstrate that physicians, neurologists, or scientists generally accept the theory that high infusion rates of immunoglobulin cause strokes.

2. The district court did not abuse its discretion in excluding the expert testimony as unreliable when the experts did not eliminate other potential causes of the stroke or otherwise demonstrate the reliability of their opinions that a high infusion rate of immunoglobulin caused a stroke.

The opinion of the court was delivered by: G. Barry Anderson, Judge



In this medical-malpractice action, the district court held a Frye-Mack hearing and excluded appellants' experts' opinions because their opinions lacked a reliable and generally accepted scientific basis. Because appellants did not have expert testimony to support the medical-negligence claim, the district court granted summary judgment. Appellants argue that the district court erred. We affirm.


In April 2000, Dr. Susan Evans diagnosed appellant Kari McDonough with multiple sclerosis. Dr. Evans is a neurologist and is McDonough's treating physician. On October 16, 2001, Dr. Evans sent an order to Allina Infusion Therapy Services to administer an intravenous infusion of 200 mg/kg per day of immunoglobulin ("IVIg") to McDonough for two days. Dr. Evans's order did not specify the infusion rate at which the IVIg was to be infused.

Pharmacist Ceci Do, an employee of respondent Allina Health Systems, prepared a plan for the administration of the IVIg. Based on McDonough's weight of approximately 200 pounds, Do calculated a plan for the administration of Baxter Gammagard 5% IVIg, which resulted in the infusion of a total of 400 ml over two and a half hours, starting at an infusion rate of 25 ml/hr and increasing at 15 minute intervals to 50 ml/hr, 75 ml/hr, 100 ml/hr, 150 ml/hr, 200 ml/hr, and then 250 ml/hr until the infusion was completed.

On October 17, 2001, Allina Home infusion nurse Patricia Beaver administered 400 ml of IVIg over approximately three and a half hours to McDonough. McDonough developed chills while the infusion rate was running at 150 ml/hr. Beaver stopped the infusion and called Do. Do advised Beaver to reduce the infusion rate to 125 ml/hr and see if the chills were still present at the lower rate. The infusion rate was slowed to 75 ml/hr and thereafter increased to 100 ml/hr until the end of the infusion. McDonough's chills disappeared after the reduction of the infusion rate. At the end of the infusion, McDonough experienced a fever. Beaver instructed McDonough to obtain over-the-counter Tylenol and Benadryl and to take them 30 minutes before the infusion scheduled for the next day.

On October 18, 2001, Beaver administered the second day of infusion to McDonough. McDonough took Tylenol and Benadryl before the infusion and did not experience chills or fever during the infusion. Do's plan for October 18 was for an infusion of 400 ml over four hours and 37 minutes. Do prepared the bag of IVIg to be infused on October 18 and placed a label on the bag stating, "DO NOT EXCEED MAX RATE OF 100 ML/HR DUE TO PATIENT'S INTOLERANCE TO HIGHER RATE." Do testified that this schedule was meant as a suggested infusion rate for Beaver and that, in her opinion, it would have been appropriate for Beaver to use any infusion rate up to the maximum recommended by the manufacturer of 400 ml/hr as long as the patient was comfortable. Baxter's recommended rate of infusion as set out in the package information sheet is as follows:

It is recommended that initially a 5% solution be infused at a rate of 0.5 mL/kg/Hr. If infusion at this rate and concentration causes the patient no distress, the administration rate may be gradually increased to a maximum rate of 4 mL/kg/Hr. Patients who tolerate the 5% concentration at 4 mL/kg/Hr can be infused with the 10% concentration at 0.5 mL/kg/Hr. If no adverse effects occur, the rate can be increased gradually up to a maximum of 8 mL/kg/Hr.

The parties dispute how long the October 18 infusion actually lasted. Appellants contend that the infusion lasted approximately one hour and 45 minutes, with half infused during the last 15 minutes at a rate equal to or greater than 800 ml/hr. Beaver contends the infusion lasted two and a half hours. McDonough testified that she felt fine following the infusion and did not experience any adverse effects that day.

On October 19, 2001, McDonough awoke with a severe headache in the right temple area and was nauseated. An MRI showed that McDonough had suffered a stroke, causing an acute non-hemorrhagic infarction of ...

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