Kennedy v. Collagen Corp.

• Decision Date: 12 November 1998
• Docket Number: No. 97-16945,97-16945
• Parties: Prod.Liab.Rep. (CCH) P 15,397, 98 Daily Journal D.A.R. 12,407 Charlotte KENNEDY and Robert Kennedy, Plaintiffs-Appellants, v. COLLAGEN CORPORATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 1226

161 F.3d 1226

Prod.Liab.Rep. (CCH) P 15,397, 98 Daily Journal

D.A.R. 12,407

Charlotte KENNEDY and Robert Kennedy, Plaintiffs-Appellants, v. COLLAGEN CORPORATION, Defendant-Appellee.

No. 97-16945.

United States Court of Appeals Ninth Circuit.

Submitted Nov. 12, 1998. ^*

Decided Dec. 7, 1998.

Michael M. Essmyer, Essmyer & Hanby, Houston, TX, for plaintiffs-appellants.

Frederick D. Baker, Sedgwick, Detert, Moran & Arnold, San Francisco, CA, for defendant-appellee.

Appeal from the United States District Court for the Northern District of California; Charles A. Legge, District Judge, Presiding. D.C. No. CV-89-02331-CAL.

Before: FERGUSON, REINHARDT, and THOMPSON, Circuit Judges.

FERGUSON, Circuit Judge:

Charlotte and Robert Kennedy brought an action in the district court in 1988 against the Collagen Corporation and its employees for alleged injuries sustained by Mrs. Kennedy following injections with Collagen's medical product, Zyderm. Zyderm is a substance made from the skin, tendons, and connective tissue of bovine animals. A doctor injects Zyderm into facial wrinkles for a smoother appearance. Mrs. Kennedy claims that she developed atypical systemic lupus erythematosus (SLE), a debilitating and incurable autoimmune disease, as a result of the Zyderm injections. Plaintiffs' litigation pleads common law causes of action for negligence, strict liability, breach of express and implied warranty, battery, and conspiracy.

This is the third time this case has been before us after a grant of summary judgment for the defendant. Most recently, we reversed the district court's determination that federal law preempted the state common law causes of action. Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir.1995). In 1992, we also reversed the district court's grant of summary judgment for the defendant and remanded the case. Kennedy v. Collagen Corp., 974 F.2d 1342 (table), 1992 WL 217803 (9th Cir.1992). The district court had concluded that the affidavit of Dr. Joseph Spindler, who is plaintiffs' expert witness, was insufficient to create a genuine issue of material fact as to whether Zyderm caused Mrs. Kennedy's injuries. The district court determined that the Spindler affidavit raised only a temporal relationship between the injections of Zyderm and Mrs. Kennedy's injuries, that is, that the injuries occurred soon after the injections. This court initially affirmed the grant of summary judgment by the district court. After due consideration of a petition for rehearing, however, we determined that Dr. Spindler based his opinion on other factors in addition to the temporal relationship, and, accordingly, we granted the petition for rehearing, reversed the grant of summary judgment and remanded.

In the meantime, the Supreme Court decided Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), which held that the Frye standard of "general acceptance within the scientific community," under which we had reviewed Dr. Spindler's affidavit, was superseded by Federal Rule of Evidence 702. In April of 1997, Collagen Corporation filed their third motion for summary judgment, alleging that the Kennedy's expert testimony as to causation was inadmissible under Daubert. The district court reviewed Dr. Spindler's affidavit under Daubert, found it inadmissible, and once again granted summary judgment to the defendant. This issue is now before us on appeal.

We review the district court's decision to exclude expert scientific testimony for abuse of discretion, even in the context of a summary judgment motion. See General Electric Co. v. Joiner, 522 U.S. 136, 118 S.Ct. 512, 519, 139 L.Ed.2d 508 (1997). We conclude that the district court improperly applied the Daubert test, because it failed to consider relevant scientific evidence relied on by the plaintiffs' expert witness, Dr. Spindler, to support his conclusion. ¹ Thus, the court abused its discretion in excluding his testimony. We hold that, because plaintiffs adduced enough admissible evidence to create a genuine issue of material fact as to whether Zyderm caused Mrs. Kennedy's atypical SLE, the district court erred in granting summary judgment to defendant.

Discussion

I. Daubert

Daubert established that, faced with a proffer of expert scientific testimony, the trial judge, in making the initial determination whether to admit the evidence, must determine whether the expert's testimony reflects (1) "scientific knowledge," and (2) will assist the trier of fact to understand or determine a material fact at issue. 509 U.S. at 592, 113 S.Ct. 2786. This requires "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." Id. at 592-93, 113 S.Ct. 2786. The Court stated that many factors will bear on this inquiry. For example, a judge may consider whether the theory has been subjected to peer review and publication, although in some instances well-grounded but innovative theories will not have been published, and, thus, should not be excluded on this basis alone. Id. at 593, 113 S.Ct. 2786. The Court emphasized that the focus of the inquiry envisioned by Rule 702 must be on the principles and methodology underlying an expert's testimony, not on the conclusions. Id. at 506, 113 S.Ct. 2786. The Court later refined this language, explaining that a district judge may reject expert testimony where the "analytical gap" between the data and the expert's conclusion is too great. Joiner, 522 U.S. 136, 118 S.Ct. at 519.

When the Supreme Court remanded Daubert to this court, we added that, where the proffered testimony is not based on independent research, in order to be admissible as "scientific knowledge," it must be supported by "objective, verifiable evidence that the testimony is based on 'scientifically valid principles.' " Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1318 (9th Cir.1995).

II. Scientific Knowledge

Dr. Spindler relied upon a wide variety of objective, verifiable evidence in forming his opinion that Zyderm causes autoimmune disorders such as atypical SLE: (1) peer-reviewed articles; (2) clinical trials and product studies conducted by the defendant; (3) the Texas Department of Health's investigation; (4) his examination of Mrs. Kennedy; (5) Mrs. Kennedy's medical history; (6) Mrs. Kennedy's medical laboratory tests; and (7) Mrs. Kennedy's medical reports. ² The district court, in rejecting Dr. Spindler's testimony, determined that the testimony was not based on scientific reasoning, because it focused on the lack of specific studies proving Zyderm causes lupus, and the absence of consensus in the medical community on this point. In doing so, however, the district court ignored the scientific studies relied upon by Dr. Spindler that reinforce the validity of the methodology Dr. Spindler relied upon in reaching his conclusion. Ultimately, the trial court failed to distinguish between the threshold question of admissibility of expert testimony and the persuasive weight to be accorded such testimony by a jury.

Dr. Spindler used the traditional scientific methodology of a clinical medical expert in providing his opinion that Zyderm causes autoimmune disorders, such as atypical SLE. In particular, he relied on the finding, established in both peer-reviewed publications and clinical studies, that Zyderm induces the body to produce the same autoimmune antibodies that are the hallmark of autoimmune diseases like SLE. An independent study by researchers in San Diego concluded that bovine collagen--Zyderm's active ingredient--can induce autoantibodies. Dr. Spindler co-authored a peer-reviewed publication describing a scientific relationship between Zyderm collagen injections and the development of autoimmune reactions and autoantibodies. These reactions accompany autoimmune diseases known as dermatomyositis and polymyositis-like syndrome. A scientist for defendant Collagen, Dr. Frank DeLustro, validated Dr. Spindler's methodology. Furthermore, Collagen Corporation's own clinical trials reveal that numerous patients develop autoantibody reactions following bovine collagen injections. Finally, the Texas Department of Health investigated collagen injections in about 40 reported cases of autoimmune reactions from the product, and found varying temporal relationships between collagen injections and the onset of autoimmune diseases.

In addition to these scientific and clinical studies of the connection between collagen and autoimmune disorders, Dr. Kennedy's opinion relied on a physical examination of Mrs. Kennedy and a review of her extensive medical history and records, including laboratory tests. Mrs. Kennedy's history and medical records reveal that, prior to the injections of defendant's collagen product, she was free of lupus or any other autoimmune disease. After the third injection of Zyderm, Mrs. Kennedy suffered a severe adverse reaction and was diagnosed as having an atypical form of SLE. ³ Mrs. Kennedy's body produced autoantibodies following her injections with Zyderm, such as those produced by patients suffering from lupus. Physicians recognize lupus as an incurable autoimmune disease set off when something goes wrong with the body's immune system and antibodies that normally fight germs begin to attack healthy tissue. Mrs. Kennedy also produced elevated levels of antihistone antibodies, which are commonly found in patients with a condition known as "drug-induced lupus," a disease accepted in the medical community, in which lupus-type symptoms develop after exposure to certain medications.

It is understandable why litigants and judges could be skeptical about Dr. Spindler's conclusion. Collagen has been classified by the Food and Drug Administration as a medical device, rather than a drug. The typical medical devices are inert objects such as pacemakers,...