This opinion will be unpublished and

may not be cited except as provided by

Minn. Stat. § 480A.08, subd. 3 (1996).

STATE OF MINNESOTA

IN COURT OF APPEALS

C0-96-613

Sally Wesely and Thomas Wesely,

as Trustees for the heirs and next-of-kin

of Philip Wesely, deceased,

Appellants,

vs.

Jeffrey Alexander, M.D., et al.,

Respondents.

Filed December 10, 1996

Affirmed

Peterson, Judge

Hennepin County District Court

File No. 938717

Dean A. LeDoux, Gray, Plant, Mooty, Mooty & Bennett, P.A., 3400 City Center, 33 South Sixth Street, Minneapolis, MN 55402 (for Appellant)

William M. Hart, Joseph W.E. Schmitt, Robert M. Frazee, Meagher & Geer, 4200 Multifoods Tower, 33 South Sixth Street, Minneapolis, MN 55402 (for Respondent)

Considered and decided by Peterson, Presiding Judge, Klaphake, Judge, Davies, Judge.

U N P U B L I S H E D O P I N I O N

PETERSON, Judge

On appeal from a judgment, appellants challenge the district court's grant of respondents' motion for JNOV. We affirm.

FACTS

Appellants Sally and Thomas Wesely, as trustees for the heirs of their deceased son, Phillip Wesely, brought a medical malpractice action against respondents Dr. Jeffrey Alexander, Dr. Stephen Bonfilio, and Park Nicollet Medical Center (Park Nicollet) for the wrongful death of their son.

In 1989, when Phillip was nine years old, he was diagnosed with attention deficit hyperactivity disorder (ADHD) by Dr. Bonfilio, a pediatric psychologist employed by Park Nicollet. Dr. Bonfilio referred Phillip to Dr. Alexander, who was also employed by Park Nicollet. Dr. Alexander gave Phillip a complete physical exam and also diagnosed him with ADHD.

In April 1991, Dr. Reno Backus, a specialist in pediatric neurology, gave Phillip a neurological exam and a magnetic resonance imaging (MRI) head scan. The results of these tests indicated that Phillip suffered from juvenile onset metachromatic leukodystrophy (MLD). MLD is a degenerative brain disease that without treatment will progress until death. It is one of a group of diseases known as lysosomal storage diseases.

Dr. Backus felt that a bone marrow transplant (BMT) should be considered as treatment for Phillip; he referred Phillip to Dr. Chester B. Whitley, a pediatrician and geneticist at the University of Minnesota.

BMT treatment is a procedure during which the recipient's natural bone marrow is eradicated by chemotherapy. Bone marrow is a key component of the body's immune system; it produces white blood cells, which fight off infection. BMT treatment leaves the body without its natural immune system and, as a result, the recipient becomes highly susceptible to infections and other body invasions.

After the recipient's natural bone marrow has been eradicated, the donor's bone marrow is transplanted into the bloodstream and travels through the bloodstream to its intended destination in the body. If the bone marrow "takes," it is said to be "engrafted." The new bone marrow is a "graft."

Graft-versus-host disease (GVHD) is a major complication of BMT treatment. GVHD is frequently fatal. GVHD occurs when the graft begins to produce white blood cells and those cells recognize the recipient as a foreign body. The donor marrow's white blood cells attack and try to kill the recipient, just as cells would attack a virus or other invader in the donor's body. GVHD is treated with drugs that suppress the immune system and thwart the graft's ability to produce white blood cells. However, because this treatment destroys the recipient's immunity against infection, the recipient becomes susceptible to life-threatening disease.

Finding a good genetic match between a BMT donor and recipient is critical to lessen the risk of GVHD. The more genetically similar the donor and the recipient, the less likely the graft-produced white blood cells will aggressively try to kill the recipient. A genetically matched sibling is the best donor. No related donor with an acceptable match for Phillip could be found.

In 1983, the University of Minnesota began using BMT to treat children with MLD. The University received a research grant from the National Institute of Health to study the effect of BMT for treating lysosomal storage diseases. Dr. William Krivit was the principal investigator for this grant, which covered the period from September 1, 1991 to September 1, 1996.

Appellants met with Dr. Krivit and Dr. Whitley to discuss a potential BMT using an unrelated donor. Appellants consented to Phillip's BMT using an unrelated donor and signed a consent form.

On December 4, 1991, Phillip received a BMT from an unrelated donor. Dr. Krivit was the primary physician responsible for Phillip's BMT treatment and attended to Phillip on a daily basis.

After the BMT, Phillip experienced fevers; he developed severe mucositis and began to reject oral medications; he developed Grade III skin GVHD and liver GVHD; and he had difficulties with high blood pressure. Despite these complications, Phillip's condition improved sufficiently to allow his discharge. He was, however, readmitted twice for line infection and recurrent GVHD. In June 1992, a test of Phillip's DNA indicated that the transplant was engrafted.

At the six-month post-BMT follow-up examination on June 15, 1992, Phillip's neurological status had significantly deteriorated from three months earlier. On June 19, 1992, Phillip was evaluated in the University's Pediatric Neurology Clinic for possible infectious process. He had a running fever and trouble breathing. He was readmitted to the University Health Center and then transferred into intensive care. A chest x-ray revealed Phillip had develpoed a fungal infection, aspergillosis. Phillip's respiratory condition deteriorated until he died on June 29, 1992. He was 12 years old. An autopsy indicated that "[t]he massive aspergillus infection of the brain was the immediate cause" of Phillip's death.

In their malpractice action, appellants claimed that Dr. Alexander's and Dr. Bonfilio's failures to diagnose Phillip's MLD when they first saw him delayed his treatment, and the delay caused his death. Appellants' only evidence on the issue of causation was the expert testimony of Dr. Krivit, who testified that the progression of Phillip's MLD contributed to his death by aspergillosis because "[t]he continued deterioration of his central nervous system provided that incapability of having normal responses from the brain stem allowing for increased infections in his body." Dr. Krivit's ultimate opinion was that if Phillip had received the BMT earlier he would be alive today.

Respondents did not request a Frye hearing to determine the admissibility of Dr. Krivit's causation testimony. Instead, one week before trial, respondents brought a motion in limine to exclude the testimony. The trial court denied this motion as untimely, but expressly reserved its ruling on the admissibility of Dr. Krivit's testimony on the merits.

The jury found that Dr. Alexander and Dr. Bonfilio were negligent in their care and treatment of Phillip and that their negligence was a direct cause of Phillip's death. Appellants were awarded $1,250,000 in pecuniary damages. On posttrial motions, the trial court ruled that Dr. Krivit's testimony should not have been admitted because it failed to meet admissibility requirements for expert testimony. Because appellants' proof of causation was based solely on Dr. Krivit's testimony, the trial court concluded that appellants failed to establish that respondents' negligence caused Phillip's death and granted respondents' motion for JNOV.

D E C I S I O N

The granting of a JNOV is a question of law that this court reviews de novo. Johnson v. Southern Minn. Mach. Sales, 442 N.W.2d 843, 846 (Minn. App. 1989), review denied (Minn. Sept. 21, 1989).

The standard to be applied in determining the propriety of granting a motion for JNOV is whether there is any competent evidence reasonably tending to support the verdict. A motion for JNOV admits every inference reasonably to be drawn from the evidence as well as the credibility of the testimony for the adverse party. Only where the facts are undisputed and reasonable minds can draw but one conclusion does the question become one of law for the court.

Imdieke v. Blenda-Life, Inc., 363 N.W.2d 121, 123-24 (Minn. App. 1985) (citations omitted), review denied (Minn. Apr. 26, 1985).

1. Allowance of Posttrial Affidavits

As an initial matter, appellants argue that the trial court erred in considering evidence regarding the ineffectiveness of BMT as treatment for MLD that was submitted with posttrial motions. This evidence included a letter from Dr. Mary M. Horowitz and an article by Dr. P.M. Hoogerbrugge. The letter contained data from case studies of BMT patients and the article questioned the use of BMT as an effective treatment for MLD. Appellants claim that considering this evidence was improper because the evidence was not offered or referred to at trial.

Preliminary questions concerning the qualification of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court * * *. In making its determination it is not bound by the rules of evidence except those with respect to privileges.

Minn. R. Evid. 104(a).

In its memorandum, the trial court described the procedures it used after denying respondents' motion in limine to exclude Krivit's testimony and explained its reasons for using the procedures.

In consideration of judicial economy, the Court permitted the trial to proceed, while expressly reserving its ruling on the admissibility of Dr. Krivit's testimony on the merits. In effect, at the same time that the jury heard the testimony in this case, the parties tried the Frye issue to the court. By proceeding in this fashion, the Court sought to avoid additional expense and inconvenience to the parties and their expert witnesses. In addition, a complete trial on the merits gave the parties an opportunity to present and develop testimony relating to extremely sophisticated issues of first impression. The experts' actual testimony at trial was both helpful and necessary in analyzing [appellants'] case in chief and [respondents'] instant Motions.

This explanation demonstrates that the posttrial submissions were used by the trial court to determine whether Krivit's causation testimony was admissible. They were not used as supplemental substantive evidence. Although the procedure used by the trial court was somewhat unorthodox, we are not persuaded that it was impermissible.

A trial judge is given wide latitude in determining whether there is sufficient foundation upon which an expert may state an opinion.

Benson v. Northern Gopher Enters., 455 N.W.2d 444, 446 (Minn. 1990). We see no reason why this wide latitude should not include the latitude to determine the procedure to be followed to establish foundation.

We disagree with appellants' contention that, under Di Re v. Central Livestock Order Buying Co., 253 Minn. 120, 91 N.W.2d 453 (1958), the trial court erred in basing its decision on the posttrial submissions. Unlike the present case, Di Re involved the use of evidence submitted after trial as support for factual determinations, not solely for use in determining whether there was sufficient foundation for expert opinion testimony. Id. at 127, 91 N.W.2d at 458.

2. Admissibility of Expert Witness's Testimony

The trial court ruled that Dr. Krivit's testimony should not have been admitted because it failed to meet admissibility requirements for expert testimony. The court concluded that experts in the field do not agree that a BMT using an unrelated donor is an effective treatment for juvenile-onset MLD. The trial court concluded that Dr. Krivit's testimony only could have confused the jury. We agree.

The decision to exclude expert medical evidence rests within the trial court's discretion and will not be disturbed unless it is based on an erroneous view of the law or is an abuse of discretion. Reinhardt v. Colton, 337 N.W.2d 88, 93 (Minn. 1983).

A. The Frye Test

The test applied in Minnesota to determine the admissibility of emerging scientific techniques was articulated in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). State v. Schwartz, 447 N.W.2d 422, 424 (Minn. 1989); see State v. Klawitter, 518 N.W.2d 577, 578 n.1 (Minn. 1994) (recognizing that the U.S. Supreme Court overruled Frye in Daubert v. Merrell-Dow Pharmaceutical, Inc., 509 U.S. 579, 113 S. Ct. 2786 (1993), but declining to express an "opinion on the continued vitality of the Frye rule in Minnesota"). In Frye, the court said:

Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.

Frye, 293 F. at 1014. The Minnesota Supreme Court further requires "that experts in the field generally agree that the evidence is reliable and trustworthy." Schwartz, 447 N.W.2d at 424.

Although Dr. Krivit's background and expertise demonstrate that he is an expert in the area of BMT treatment, his expertise, by itself, is not sufficient to establish a foundation for his causation testimony. It must also be established that his testimony was based on a well-recognized scientific principle. The trial court properly concluded that there was insufficient foundation for Dr. Krivit's testimony that, had Phillip received a BMT earlier, he would be alive today.

At the time of the trial, only 200 patients worldwide had received a BMT as treatment for 30 different types of storage diseases. Between 1981 and 1993, only 20 patients worldwide had received a BMT for treatment of MLD. Dr. Krivit had per- formed only three BMTs for MLD. The first two patients are alive, the third died. Phillip was the fourth patient with MLD to receive a BMT at the University of Minnesota. But Phillip was the first patient treated with a BMT using an unrelated donor.

Because the number of MLD patients treated with a BMT using an unrelated donor is extremely limited, it cannot be concluded that Dr. Krivit's testimony that Phillip would have lived if he had received the BMT earlier is based on a well-recognized principle. Dr. Krivit's testimony indicated that a BMT using an unrelated donor is a very risky procedure with a high probability of contracting GVHD. The fact that Phillip was the first MLD patient at the University of Minnesota to receive BMT treatment using an unrelated donor leads to the conclusion that the procedure is experimental. Furthermore, the consent form signed before Phillip's surgery indicated that Phillip was participating in a research program entitled, "Treatment of Lysosomal Inborn Errors of Metabolisim (metachromatic leukodystrophy) Histocompatible Bone Marrow Transplantation." The application for a grant to conduct the research stated that, "The hypothesis to be tested is whether or not BMT for patients with specific storage diseases results in significant improvement in neurologic and cognitive outcome." Thus, under the Frye test, Dr. Krivit's testimony is inadmissible.

B. Rule 702 and the Daubert Test

The trial court also considered the admissibility of Dr. Krivit's testimony under Minn. R. Evid. 702 and Daubert.

Minn. R. Evid. 702 states:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.

Under the test established by Daubert, the trial court must determine whether the expert is testifying to

(1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.

Daubert, 509 U.S. at 592-93, 113 S. Ct. at 2796 (footnote omitted).

Thus, under Minn. R. Evid. 702 and Daubert, before admitting expert testimony, the trial court must determine whether the proffered testimony is grounded in "scientific knowledge" having a standard "evidentiary reliability" or "trustworthiness." Id. at 590 & n.9, 113 S. Ct. at 2795 & n.9.

There are four factors to be considered when determining the reliability of expert testimony: (1) Is the expert's theory or technique falsifiable? (2) Has the theory or technique been published in peer-reviewed professional journals? (3) What is the known or potential rate of error of the scientific technique? (4) Has the theory or technique received general acceptance within the scientific community?

Id. at 593-94, 113 S. Ct. at 2796-97.

We apply the above factors as follows:

(1) Tested Theory

Dr. Krivit's theory can be tested.

(2) Published

Dr. Krivit has had his work published in numerous peer-reviewed articles. He has also published case studies on his patients. He testified that the scientific community is polarized on the effectiveness of BMT for MLD, but there have not been any published challenges or criticisms in the scientific community regarding the soundness of his scientific methodology.

(3) Potential Rate of Error

Over 200 persons in the world have received BMT treatment for 30 types of storage diseases. Between 1981 and 1993, only 20 patients worldwide received BMT treatment for MLD. There is an established morbidity rate for related donor BMTs. Dr Krivit testified that there is 10-20% mortality rate and a 20-40% morbidity rate of severe GVHD in HLA identical siblings. He did not indicate that there is an established morbidity rate for treatment using an unrelated donor.

(4) General Acceptance

Dr. Krivit testified that BMT treatment for genetic metabolic diseases has received general acceptance in the community of scientists and doctors who are familiar with the procedure. He identified physicians who are proponents of the procedure and stated that 32 institutions in the United States and Canada are working in this area. But he also conceded that some disagree with the use of the procedure. Also, as has already been discussed, there have been very few instances where BMT using an unrelated donor has been used as treatment for MLD.

In sum, we reach the same conclusion applying Daubert that we reached under Frye. Dr. Krivit's theory regarding the effect of delaying BMT treatment is not generally accepted in the scientific community. Without his testimony, appellants have no evidence that respondents caused Phillip's death. Thus, the trial court properly granted respondents' motion for JNOV.

Because we conclude that the trial court properly granted respondents' motion for JNOV, we will not address other issues raised by the parties.

Affirmed.