Kuhn v. Sandoz Pharaceuticals Corp

Decision Date15 December 2000
Docket NumberNo. 83,226,83,226
Citation270 Kan. 443,14 P.3d 1170
Parties(Kan. 2000) GAIL KUHN, as Special Administrator of the Estate of JENNIFER JEAN KUHN BISHOP, deceased; JERRY BISHOP, Individually as Heir-at-Law of JENNIFER JEAN KUHN BISHOP, deceased; and JERRY BISHOP, as Parent, Natural Guardian and Next Friend of RYAN THOMAS KUHN BISHOP, a Minor, Heir-at-Law of JENNIFER JEAN KUHN BISHOP, deceased, Appellants, v. SANDOZ PHARMACEUTICALS CORPORATION, a Delaware Corporation; SANDOZ LTD., a Foreign Corporation; and SANDOZ PHARMA LTD., a Foreign Corporation, Appellees. Opinion filed
CourtKansas Supreme Court

Appeal from Sedgwick district court, D. KEITH ANDERSON, judge.

SYLLABUS BY THE COURT

1. Summary judgment is appropriate if there are no genuine issues of material fact and the movant is entitled to judgment as a matter of law. K.S.A. 60-256(c). Summary judgment decisions are reviewed de novo. An appellate court resolves all facts and inferences which may reasonably be drawn from the evidence in favor of the party against whom the ruling is sought.

2. The admissibility of expert testimony is subject to K.S.A. 60-456(b). The Frye test, Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), however, acts as a qualification to the 60-456(b) statutory standard. Frye is applied in circumstances where a new or experimental scientific technique is employed by an expert witness.

3. Frye requires that before expert scientific opinion may be received into evidence, the basis of the opinion must be shown to be generally accepted as reliable within the expert's particular scientific field. If a new scientific technique's validity has not been generally accepted or is only regarded as an experimental technique, then expert testimony based upon the technique should not be admitted.

4. Although abuse of judicial discretion describes a highly deferential standard, it can refer to questions of law warranting independent appellate review. Questions of law are presented when an appellate court seeks to review the factors and considerations forming a district court's discretionary decision. In this case, we have a first impression issue on the admission of medical causation proof that warrants our unlimited review. The appropriate label for the standard of review in this case is "de novo."

5. The term "pure opinion" is used to characterize an expert opinion developed from inductive reasoning based on the experts' own experience, observation, or research. The Frye test does not apply to pure opinion testimony. The Frye test does apply when an expert witness reaches a conclusion by deduction from applying a new or novel scientific principle, formula, or procedure developed by others.

6. The validity of pure opinion is tested by cross-examination of the witness. The validity of an opinion subject to Frye is tested by inquiring into general acceptance as reliable within the expert's particular scientific field.

7. Although compliance with Frye is necessary when a witness reaches a conclusion by applying a scientific theory or process based on the work or discovery of others, experts may testify concerning their own experimentation and observation and opinions based on their own work without first showing general acceptance.

8. The Frye test is concerned with the methodologies underlying expert testimony rather than the conclusions of that testimony.

9. Under K.S.A. 60-456(b) there is no requirement that before an expert witness may give an opinion the expert must demonstrate that many, most, or all other experts would agree with the opinion.

10. A Kansas jury has a constitutional mandate to decide between conflicting facts, including conflicting opinions of causation. A district judge under K.S.A. 60-456(b) controls the admissibility of expert opinion evidence that would unduly prejudice or mislead a jury or confuse the question for resolution. Cross-examination, the submission of contrary evidence, and the use of appropriate jury instructions form a preferred method of resolving factual disputes.

11. In a summary judgment case in which the district court used the Frye test to strike plaintiffs' experts' causation opinions advanced to explain a mother's death 3 days after the delivery of her baby, the record is examined and it is held: (1) The Frye test is not applicable to plaintiffs' experts' causation opinions, and (2) the district court erred in: (a) granting summary judgment to defendant pharmaceutical corporation and dismissing plaintiffs' claims with prejudice, as genuine issues of material fact remain, (b) requiring proof of both general and specific causation, and (c) excluding plaintiffs' experts' studies, literature, and other evidence on which the experts relied without making findings identifying the excluded items and expressing the reasons for exclusion.

Reversed and remanded with directions.

Channel P. Townsley, of Hutton & Hutton, of Wichita, argued the cause, and Andrew W. Hutton, of the same firm, was with him on the briefs for appellants.

Joe G. Hollingsworth, of Spriggs & Hollingsworth, of Washington, D.C., argued the cause, and Katharine R. Latimer, of the same firm, Wyatt M. Wright, of Foulston & Siefkin L.L.P., of Wichita, and Grant J. Esposito, of Mayer, Brown & Platt, of New York, New York, were with him on the brief for appellees.

The opinion of the court was delivered by SIX, J.:

This case reviews the district court's use of the Frye test, Frye v. U.S., 293 F. 1013 (D.C. Cir. 1923), to strike plaintiffs' expert causation opinions advanced to explain a mother's death 3 days after the delivery of her baby. Summary judgment was entered for defendant Sandoz Pharmaceuticals Corporation (Sandoz). The plaintiffs, Gail Kuhn, the mother of Jennifer Kuhn Bishop, deceased, and as Special Administrator of her Estate; Jerry Bishop, the deceased's husband; and Ryan Thomas Kuhn Bishop, the deceased's minor son, appeal.

The plaintiffs' underlying product liability/negligence suit asserts wrongful death and survivor claims. The plaintiffs contend that the drug Parlodel, manufactured by Sandoz, caused or contributed to Jennifer's death. The district court reasoned that all of plaintiffs' experts' causation opinions and all studies, literature, and other evidence on which plaintiffs' experts relied was unreliable as a matter of law.

Our jurisdiction is under K.S.A. 20-3018(c), a transfer on our order from the Court of Appeals.

We review whether the district court committed error by: (1) granting summary judgment in favor of Sandoz based on the failure of medical causation proof and (2) reasoning that the opinions on causation expressed by plaintiffs' experts failed the Frye test.

Genuine issues of material fact remain. We reverse and remand. The Frye test is not applicable to the expert causation opinions at issue here.

FACTS

Jennifer Bishop gave birth to a baby boy at 7:47 a.m. on July 25, 1993, in the Hays, Kansas, hospital. Because Jennifer had decided not to breast-feed her baby, she received a 2.5 mg. tablet of Parlodel at 5:30 p.m. during dinner on that day to prevent postpartum lactation (the production of breast milk.) She vomited at 6:15 p.m., was overcome by nausea at 6:30 p.m., experienced chills and elevated blood pressure at 6:40 p.m., and vomited again at 7 p.m. By 7:30 p.m., Jennifer's temperature increased to 102.3 degrees Fahrenheit. She vomited again at 7:40 p.m. and continued to complain of a headache and chilling. At 9 p.m., she was drowsy and could not open her left hand on request. At 9:30 p.m., she screamed and became stiff and less responsive. Jennifer remained rigid over the next 30 minutes, relaxing only when she was given Benadryl at 10:13 p.m. At 10:45 p.m., she was transferred to the intensive care unit, suffered a respiratory arrest, and lapsed into a coma. She was pronounced dead at 3:30 p.m. on July 28, 1993.

The autopsy reported that the probable cause of the death was "related to postpartum eclampsia" or "possible bacteremia." Definitions are appropriate here to assist the reader: "postpartum" ("[a]fter childbirth"), "eclampsia" (the "[o]ccurrence of one or more convulsions, not attributable to other cerebral conditions such as epilepsy or cerebral hemorrhage, in a patient with preeclampsia"), and "bacteremia" (a condition characterized by "viable bacteria in the circulating blood"). Stedman's Medical Dictionary (26th ed. 1995), pp. 1413, 540, 181.

The autopsy description of Jennifer's central nervous system stated that sections of the cerebrum and cerebellum showed "hyperemia and some diffuse edema and possible petechial hemorrhage" and that sections of the brain stem "demonstrate[d]

softening and mild edema with hyperemia." The following definitions apply: "hyperemia" ("[t]he presence of an increased amount of blood in a part or organ"), "edema" ("[a]n accumulation of an excessive amount of watery fluid in cells, tissues, or serious cavities"), and "petechial" (a condition characterized by "[m]inute hemorrhagic spots, of pinpoint to pinhead size, in the skin"). Stedman's at 824, 544, 1337.

Jennifer's discharge summary listed the final diagnosis regarding her death as "Bacteria with Strep Group D," a condition that brought about "cerebral edema and probable herniation of the brain stem secondary to postpartum toxemia." ("Toxemia" refers to the "[c]linical manifestations observed during certain infectious diseases, assumed to be caused by toxins and other noxious substances elaborated by the infectious agent. . . . A lay term referring to the hypertensive disorders of pregnancy." Stedman's at 1826.) The plaintiffs sued Sandoz , the manufacturer of Parlodel, on July 16, 1996.

DISCUSSION
The FDA Report

Plaintiffs' claim was presented in the context of a decade-long disagreement between Sandoz and the Food and Drug Administration (FDA) concerning the use of Parlodel for the prevention of physiologic lactation. (Parlodel's generic name is bromocriptine.) The FDA...

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