Reese v. Stroh, 33128-1-I

• Decision Date: 13 June 1994
• Docket Number: No. 33128-1-I,33128-1-I
• Citation: 74 Wn.App. 550,874 P.2d 200
• Court: Washington Court of Appeals
• Parties: William Foster REESE, and Frances Reese, husband and wife, individually and the marital community composed thereof, Appellants, v. James E. STROH, Jr., M.D., and Mary Jo Stroh, husband and wife, individually and the marital community composed thereof, Respondents.

Page 550

74 Wn.App. 550

874 P.2d 200

William Foster REESE, and Frances Reese, husband and wife individually and the marital community composed thereof, Appellants, v. James E. STROH, Jr., M.D., and Mary Jo Stroh, husband and wife, individually and the marital community composed thereof, Respondents.

No. 33128-1-I.

Court of Appeals of Washington Division 1.

June 13, 1994.

Review Granted Sept. 8, 1994.

Dwayne Richards, Douglass North, Seattle, for appellants.

Malcolm Edwards, Seattle, Bryan Harnetiaux, Spokane Linda Clapham, Seattle, amicus curiae.

Mary Spillane, Kathryn Battuello, Seattle, for respondents.

AGID, Judge.

William Foster Reese and Frances Reese (the Reeses) brought this medical malpractice action against Dr. James E. Stroh, Jr., alleging that he negligently failed to treat Mr. Reese's emphysema condition with a protein replacement therapy called Prolastin. The Reeses contend that the trial court erred in excluding their expert medical witness testimony on the basis that it lacked sufficient foundation to go to the jury. We reverse.

I. FACTS

William Reese (Reese) was born in 1938. In 1984, Reese began seeing Dr. Stephen Aprill for treatment of asthma. One year later, Dr. Aprill referred Reese to Dr. Stroh ¹ because he was concerned that "something else" was going on with Reese's condition. Dr. Stroh diagnosed Reese with asthma, chronic obstructive pulmonary disease and alpha-1 antitrypsin (AAT) deficiency. AAT is a blood-borne protein which prevents the enzyme, neutrophil elastase, from destroying the alveoli in the lungs. National Institutes of Health, Intravenous Replacement Therapy for Patients With Severe Alpha-1 Antitrypsin Deficiency, 248 JAMA 1693 (1982). A person with severe AAT has very little antitrypsin in his or her blood, i.e., 25 to 40 milligrams per hundred. When Dr. Stroh tested Reese's serum level in May 1985, it was 35.5. Experts believe that, in patients with AAT deficiency, the unchecked action of neutrophil elastase or "proteases" on lung tissue causes development of emphysema. Mark D. Wewers et al., Replacement Therapy for Alpha-1 Antitrypsin Deficiency Associated with Emphysema, 316 New Eng.J.Med. 1055, 1060 (1987).

When Dr. Stroh diagnosed Reese with AAT deficiency in 1985, AAT therapy, marketed under the name Prolastin, was not available. Dr. Stroh prescribed bronchodilator medications steroids, and antibiotics, and urged Reese to stop smoking and avoid allergens and environmental irritants. Dr. Stroh told Reese that he should "not worry" about his emphysema and that it was "not serious". Dr. Stroh estimated that Reese would lose approximately one percent of his lung capacity per year more than the average person.

In November 1989, Reese learned that his brother had been diagnosed with AAT deficiency and was going to begin Prolastin therapy. According to the plaintiffs' expert witness, Dr. Robert Fallat, Prolastin was first released on the market in 1987. It is a preparation of the natural protein AAT drawn from pooled human serum. An injection of Prolastin into the blood of patients with AAT deficiency raises their blood protein levels from 25-35 milligrams to 150 milligrams and maintains the serum level above the critical 80 milligram level for about 1 week. This is the level thought to prevent patients from developing lung disease as a result of AAT deficiency. After learning about Prolastin from his brother, Reese went to see his brother's doctor, Dr. Michael D. Eulburg. Dr. Eulburg began Reese on Prolastin therapy in March 1990, as soon as arrangements could be made to pay for the drug.

In October 1990, the Reeses filed this action against Dr. Stroh, alleging that his failure to prescribe Prolastin resulted in a worsening of Reese's lung function. At trial, the defense moved to exclude Dr. Fallat's testimony on the ground that it lacked adequate foundation. The plaintiffs presented Dr. Fallat's testimony as an offer of proof. Dr. Fallat is a pulmonary physician and chief of the pulmonary division at California Pacific Medical Center in San Francisco. He is board qualified in internal and pulmonary medicine. He has been doing research on AAT deficiency since 1966. Dr. Fallat testified that in 1987, the Food and Drug Administration (FDA) met with a large working group of physicians from the National Institutes of Health (NIH) to discuss the possibility of treating AAT deficiency with Prolastin. Based on studies concluding that the administration of Prolastin would correct AAT deficiency in the blood stream, and "that there was a very strong association between [AAT] deficiency of this protein and the rapid development of emphysema in some people with this deficiency," the FDA approved the drug without statistical proof that the drug was effective in halting the progression of lung disease. ² The FDA determined that proving the efficacy of Prolastin in treating emphysema would require a population study involving 600 people. The study would take 3-5 years to complete and would be very expensive. Because the study was "impossible" to do and "wouldn't be done," the FDA decided to release the drug for AAT deficient patients "because it was very probable that the material was safe and effective". Dr. Fallat added that "it was very important to get this treatment out because there were people suffering". Dr. Fallat also testified that, as of May 1992, over 2,000 were being treated with Prolastin and there had been no documented cases of hepatitis or AIDS contamination. He also stated that "preliminary results would suggest that [the drug] is stabilizing the patients."

Dr. Fallat acknowledged that only population studies could prove with statistical significance that a particular drug is effective in treating patients with a particular disease, and that no such study had been done on Prolastin. However, he distinguished between drawing the conclusion that a drug has been proven effective for a certain population and the conclusion that a drug has a good probability of improving a specific patient's condition. Dr. Fallat testified that Reese is a severely AAT-deficient patient, labeled a "ZZ" phenotype. For patients with severe AAT deficiency like Reese, there was a strong consensus among the NIH working group members that AAT would be of particular benefit, i.e., for those severely deficient patients who had already developed "significant disease".

In addition to the FDA approval of Prolastin and the preliminary salutary results from its use, Dr. Fallat testified to his own clinical experience in treating AAT-deficient patients with Prolastin. He stated that of the 35-40 such patients on his registry, half are being treated with the drug. Dr. Fallat testified that, for those patients

[Prolastin therapy] certainly has been safe and seemingly effective. It seems to be particularly useful in patients who have an inflammatory or asthmatic component which again is in Mr. Reese's case a particularly good example of the kind where you would expect to see a favorable response with the use of Prolastin.

On the basis of the information and studies supporting the FDA's approval of Prolastin, Dr. Fallat's clinical experience, and the specific information known to him about Reese's medical condition, Dr. Fallat concluded that, based upon reasonable medical probability, Prolastin therapy would be effective for Reese. Dr. Fallat further concluded that, had Dr. Stroh prescribed Prolastin for Reese as soon as it became available, the treatment would have "reduced the rate of decline by 50 percent".

After hearing the offer of proof, the trial court ruled that Dr. Fallat's testimony lacked the necessary scientific foundation and was therefore inadmissible. In light of the court's ruling, the plaintiffs decided not to call their other expert witnesses, whose testimony would have been to the same effect. Dr. Stroh then moved for a directed verdict, which the trial court granted. This appeal followed.

II. DISCUSSION

A. Applicability of the Frye Standard in Civil Cases

The issue here is whether there was an adequate foundation for Dr. Fallat's expert opinion that Prolastin more probably than not would have improved Mr. Reese's condition. Before we can decide this issue, however, we must determine the proper standard or test for evaluating the admissibility of expert medical testimony. For the reasons discussed below, we hold that the Frye rule ³ does not apply to expert testimony in civil cases. Even if it did, Dr. Fallat's testimony was admissible because the methods he used to reach his conclusion were generally accepted in the medical community.

Initially, we note that Washington courts, with one exception, have neither discussed nor applied Frye in the context of a civil case, ⁴ and the Supreme Court has never adopted Frye as the standard to be followed in civil cases. Rather, the Supreme Court has intimated that a Frye analysis is appropriate only in criminal and quasi-criminal cases. See State v. Canaday, 90 Wash.2d 808, 813, 585 P.2d 1185 (1978) (expressly adopting the Fryre analysis for determining the admissibility of testimony based on scientific experimental procedures in criminal trials). ⁵ In In Re Johnston, 109 Wash.2d 493, 498, 745 P.2d 864 (1987), the court noted that "[Frye's] rationale has been applied in the context of criminal trials, but not in the context of prison disciplinary proceedings." ⁶ See also Paul C. Giannelli, The Admissibility of Novel Scientific Evidence: Frye v. United States, a Half-Century Later, 80 Colum.L.Rev. 1197, 1240 n. 321 (1980) ("The overwhelming majority of cases involving the admissibility of novel scientific techniques have been criminal prosecutions.").

In rejecting the Frye test, we adopt the approach taken by the United States Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., --- U.S. ----, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). There, the Court abandoned use of the Frye standard in favor of a more...