Opinion

Reese v. Stroh

  • 128 Wash. 2d 300
  • 907 P.2d 282
Court
Washington Supreme Court
Filed
Dec 14, 1995
Status
Published
Author
Johnson
On the bench
Johnson
Cited by
81 cases
Authority
More cited than 5.0%

holding that lack of statistical support for medical opinion on causation does not make the opinion inadmissible; there were no statistically significant studies proving the efficacy of Prolastin therapy when used to treat emphysema yet medical doctor was allowed to testify that failure to use Prolastin to treat plaintiff's emphysema was cause of plaintiff's worsening condition

How later courts described this case

  • holding that lack of statistical support for medical opinion on causation does not make the opinion inadmissible; there were no statistically significant studies proving the efficacy of Prolastin therapy when used to treat emphysema yet medical doctor was allowed to testify that failure to use Prolastin to treat plaintiff's emphysema was cause of plaintiff's worsening condition
  • stating that, in civil cases, the burden of proof is a preponderance of the evidence
  • Frye inapplicable to medical expert testimony that use of Prolastin would be effective in treating AAT (a blood-borne protein) deficient patients where FDA (Food and Drug Administration) approved use of Prolastin in treating AAT-deficient patients and defendant did not argue that theory or methodology involved in Prolastin therapy lacks acceptance in the scientific community
  • Frye inapplicable to medical expert testimony that use of Prolastin would be effective in treating AAT (a blood-borne protein

Written by the judges who cited it.

The opinion

Johnson, J.

(concurring) — The majority reaches the correct result in this case but its approach is of no precedential value and offers no help to parties and courts faced with similar problems. The majority fails to analyze and apply ER 702 in any meaningful manner. I write separately to provide a constructive framework for applying ER 702 in cases involving the admissibility of expert testimony based on scientific evidence, and I would adopt the analytical framework used by the United States Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 , 113 S. Ct. 2786 , 125 L. Ed. 2d 469 (1993), and relied upon by the Court of Appeals. Reese v. Stroh, 74 Wn. App. 550 , 874 P.2d 200 (1994). In order to reach ER 702, I must first express my disagreement with *311 the majority’s interpretation of our state’s Frye 3 jurisprudence.

Washington and the Frye Standard

In a recent criminal case considering the admissibility of DNA evidence, this court explained the relationship between the Frye general acceptance standard and ER 702. State v. Cauthron, 120 Wn.2d 879, 887 , 846 P.2d 502 (1993). We held that when novel scientific evidence is at issue, courts apply Frye’s general acceptance standard as an initial inquiry in determining admissibility. Cauthron, 120 Wn.2d at 887 . Once the proposed scientific evidence is deemed to be generally accepted, then the court addresses the requirements of ER 702. Cauthron, 120 Wn.2d at 887 .

In criminal cases, we follow this rule in addressing the admissibility of expert scientific evidence, but never has it been, nor now should it be, adopted as the rule in civil cases. Before the adoption of the Rules of Evidence, no Washington appellate decision had applied Frye in a civil case. Since the adoption of the Rules of Evidence in 1979, only four reported civil cases have used a Frye-type analysis in applying ER 702 and ER 703 to scientific or medical evidence. In re Young, 122 Wn.2d 1 , 857 P.2d 989 (1993) (Frye applied separately from ER 702 in a civil commitment proceeding); In re Petersen, 120 Wn.2d 833 , 846 P.2d 1330 (1993) (citing a criminal case, without discussion or comment, for the proposition that in an attorney disciplinary proceeding ER 702 requires expert opinion to be based on an explanatory theory generally accepted in the scientific community); Intalco Aluminum Corp. v. Department of Labor & Indus., 66 Wn. App. 644 , 833 P.2d 390 (1992) (holding the general acceptance in the scientific community requirement applies to the methods used by expert medical witnesses, not to their conclusions), review denied, 120 Wn.2d 1031 (1993); Burkett v. Northern, 43 Wn. App. 143 , 715 P.2d 1159 (holding ER 702 allows a trial court to *312 use the Frye general acceptance standard to assess the reliability of a theory or methodology propounded in an expert opinion and offered in a novel field), review denied, 106 Wn.2d 1008 (1986). These cases do not individually, nor as a group, support the majority’s holding that the Frye rule applies in civil cases addressing the admissibility of novel scientific evidence.

Additional reasons exist that require a distinction in approaches between civil and criminal cases. See Reese, 74 Wn. App. at 557 . The primary reason for this distinction arises out of differences in the burden of proof—beyond a reasonable doubt in criminal cases, and a preponderance of the evidence in civil cases. Additionally, in the criminal context where the power of the State stands in marked disproportion to the resources of most defendants, the State should be forced to clear the initial obstacle of general acceptance as described in Frye. Reese, 74 Wn. App. at 558-59 . This higher burden of admissibility is required to protect the liberty interests of defendants. Higher burdens are not required, however, in the civil context because the parties are generally more evenly situated and better prepared to address the evidence of the opposing party. Reese, 74 Wn. App. at 559 . Because both parties have the resources to present expert testimony on scientific evidence, ER 702 (as discussed infra) performs the necessary function of insuring evidentiary reliability and relevance. The Daubert analysis of ER 702 provides a more appropriate analytical framework under which to argue and have rulings on the admissibility of scientific evidence.

This case provides a third reason for not applying Frye as a preliminary hurdle in civil cases: the difficulty in determining what is or is not novel scientific evidence. The majority, in its effort to assess the novelty of Prolastin augmentation therapy to treat AAT deficiency, demonstrates this difficulty. In support of its determination that Prolastin augmentation therapy is not novel, the majority states, "Prolastin therapy has proven valuable in treating other serum protein deficiencies such as hemo *313 philia.” Majority at 303. This incorrectly confuses the theory behind Prolastin augmentation therapy with the therapy itself. Augmentation therapy is the process of supplementing a substance found in the blood that is not present or present in an inadequate amount. The lack of certain serum proteins in the blood has been identified as the cause of some medical conditions. For example, patients with hemophilia A suffer from an inadequate supply of the blood serum protein Factor VIII. See Leon W. Hoyer, Hemophilia A, 330 N. Eng. J. Med. 38 (Jan. 6, 1994). The treatment of hemophilia A involves augmenting the blood with concentrated Factor VIII taken from human donors.

AAT deficiency is also a condition caused by the inadequate amount of a blood serum protein. While both hemophilia and AAT deficiency are caused by abnormal levels of a blood serum protein, the resulting conditions are completely unrelated: hemophilia is a bleeding disorder, while AAT deficiency affects the lungs and is one cause of emphysema. Prolastin is the trade name for purified human AAT drawn from human blood serum. Br. of Appellants at App. 2. Prolastin itself is used to treat only AAT deficiency; Prolastin is not used to treat hemophilia. The theory underlying augmentation therapy is not novel; however, the specific medical use of Prolastin augmentation therapy very well could be considered novel. Prolastin augmentation therapy is being used to treat a different type of condition caused by different blood protein interactions than those in patients with hemophilia. Factor VIII augmentation for hemophiliacs has been used as a treatment since the 1970s and the complex interactions of the proteins that result in the blood’s ability to clot have been well documented. See Hoyer, at 38. The relationship between AAT deficiency and emphysema, however, was not well understood in 1989, two years after the FDA approved Prolastin for treating AAT deficiency in 1987. See American Thoracic Soc’y, Guidelines for the Approach to the Patient With Severe Hereditary Alpha-l-Antitrypsin Deficiency, 140 Am. Rev. Respir. Disease 1494, 1494 (1989).

*314 Identifying these differences between Prolastin augmentation therapy and augmentation therapy for conditions such as hemophilia illuminates the difficulties the trial court faced in determining the novelty of Prolastin augmentation therapy. The majority solves this by concluding, "[a]n expert opinion regarding application of an accepted theory or methodology to a particular medical condition does not implicate Frye.” Majority at 307. Rather than clarifying the applicability of Frye, this ruling only raises additional questions. What is the methodology properly being considered—augmentation therapy or Prolastin augmentation therapy? What is the particular medical condition—abnormal blood serum protein levels or AAT deficiency? In this case, it is easy to see how the trial court could reach the conclusion that AAT augmentation therapy is novel.

I would not extend the rule articulated in Cauthron to civil cases involving the admissibility of novel scientific evidence. Additionally and independently, a constructive application of ER 702 performs the necessary reliability and relevance assessment required in all cases involving scientific evidence.

Reliability and Relevance of Scientific Evidence

The issue we need to resolve is whether the trial court applied the correct standard in excluding expert testimony on the effectiveness of Prolastin augmentation therapy for AAT deficiency. Both the majority and the Court of Appeals agree the trial court erred by excluding the testimony under the Frye general acceptance standard because the evidence at issue was not novel. Majority at 307. Next, the majority finds that the admissibility of Dr. Fallat’s testimony is governed by ER 702, but rejects the Court of Appeals reliance on Daubert in establishing a framework for applying ER 702. Majority at 306-08. In applying ER 702, the majority concludes Dr. Fallat’s testimony as to the effectiveness of Prolastin augmentation therapy should have been admitted because he was a qualified expert, and *315 his testimony would assist the jury in determining a fact at issue. 4 Majority at 308-09. This ends the majority’s inquiry. The majority does not tell us how to determine the reliability of the evidence on which Dr. Fallat’s testimony is based, even though it recognizes that such a reliability assessment is required by ER 702. Majority at 307-08.

Under ER 104 and ER 702, the trial court acts as gatekeeper, assessing the reliability and relevance of all scientific evidence. Reese, 74 Wn. App. at 559 ; Daubert, 113 S. Ct. at 2795 . A reliability assessment is also implicit in any determination of relevance under ER 402. When considering the admissibility of expert scientific testimony, ER 104(a) and ER 702 require a judge to determine (1) whether the expert is qualified to provide scientific testimony, (2) whether the proposed testimony constitutes scientific knowledge, and (3) whether the proposed testimony will assist the trier of fact in resolving an issue of fact. See Daubert, 113 S. Ct. at 2796 .

The majority completely fails to address this second step in its approach to applying ER 702. Majority at 308-09. However, it is this second step’s determination of "scientific knowledge” that ensures the reliability and relevance of the expert testimony. The determination of "scientific knowledge” requires a two-prong inquiry: (1) whether it is more likely than not the expert’s methodology and principles are reliable, and (2) whether those principles and methodology can properly be applied to the facts at issue. See Daubert, 113 S. Ct. at 2795-97 . The Supreme Court listed four, nonexclusive factors for a trial court to examine in this two-prong reliability evaluation: testing; peer review and publication; known or potential error rate; and general acceptance. Daubert, 113 S. Ct. at 2796-97 . This inquiry into "scientific knowledge” is *316 required regardless of whether the offered scientific evidence is novel or not. Daubert, 113 S. Ct. at 2796 n.11.

In ignoring the two-prong inquiry into "scientific knowledge” required by ER 702 and noted above, the majority fails to offer a method to determine the underlying reliability of Dr. Fallat’s testimony and whether the Prolastin studies upon which Dr. Fallat relied are in fact reliable. The better approach, and the one taken in Daubert and by the Court of Appeals, is to focus on the reliability of the evidence in all civil cases where the admissibility of scientific evidence is at issue. Under this approach, the general acceptance standard of Frye is not abandoned—its purpose and placement is merely changed. In criminal cases, it remains an initial, required, and dispositive inquiry. In civil cases, it becomes one of the nonexclusive factors a court may consider under ER 702 to determine whether proposed expert testimony is based on scientific knowledge, i.e., reliability and relevance.

The majority explicitly tells us that it is declining the opportunity to adopt the reliability test from Daubert , but, at the same time, offers trial courts no alternatives for performing this necessary task. Because the Court of Appeals clearly sets forth standards for trial courts to determine the reliability of scientific evidence under ER 702,1 would affirm its reasoning and analysis.

Smith, J., and Utter, J. Pro Tern., concur with Johnson, J.

Frye v. United States, 293 F. 1013 , 34 A.L.R. 145 (D.C. Cir. 1923).

The majority also addresses the trial court’s concern with the lack of statistical support of the proffered testimony in this case. Majority at 309.1 agree with the majority that ER 703 does not require an expert to base an opinion on statistical studies. However, the existence of statistical data can properly be considered in determining the reliability of proposed scientific testimony under ER 702. Reese, 74 Wn. App. at 560-61 .

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

A word about cookies

We need a few to keep you signed in and the library working. The rest help us see which pages people use and where they get stuck. They stay off unless you say yes.