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Exclusion Of Medical Expert Testimony




KENNEDY,                                              No. 97-16945
                                                     D.C. No.
v.                                                    CV-89-02331-CAL

COLLAGEN CORPORATION,                                 OPINION

Appeal from the United States District Court
for the Northern District of California
Charles A. Legge, District Judge, Presiding

Submitted November 12, 1998*
Pasadena, California

Filed December 7, 1998

Before: Warren J. Ferguson, Stephen Reinhardt, and
David R. Thompson, Circuit Judges.

Opinion by Judge Ferguson



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


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



FERGUSON, Circuit Judge:

Charlotte and Robert Kennedy brought an action in the dis-
trict court in 1988 against the Collagen Corporation and its
employees for alleged injuries sustained by Mrs. Kennedy fol-
lowing injections with Collagen's medical product, Zyderm.
Zyderm is a substance made from the skin, tendons, and con-
nective tissue of bovine animals. A doctor injects Zyderm into
facial wrinkles for a smoother appearance. Mrs. Kennedy
claims that she developed atypical systemic lupus erythemato-
sus (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 lia-
bility, breach of express and implied warranty, battery, and

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. Colla-
gen 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 tem-
poral 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 consider-
ation 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 judg-
ment and remanded.

In the meantime, the Supreme Court decided Daubert v.
Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579 (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 inadmis-
sible under Daubert. The district court reviewed Dr. Spin-
dler'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 con-
text of a summary judgment motion. See General Electric Co
v. Joiner, _______ U.S. _______, 118 S.Ct. 512, 519 (1997). We con-
clude 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
1 Plaintiffs argue that because Dr. Spindler is a medical expert, rather
than a scientific expert, Daubert's requirement of scientific validity is not
applicable here. This court, after Daubert, has held that a medical doctor's
testimony regarding the cause of an injury may be based on experience
and review of medical records only. See Sementilli v. Trinidad Corp., No.
96-16034, slip op. 12865, 12879 (9th Cir. filed Sept. 16, 1998) (as
amended Nov. 12, 1998) (per curiam). However, in this case, involving

the injection of a substance by a medical doctor for medical reasons, we
will follow the uniform practice among courts in judging the admission of
clinical medical testimony by the Daubert standard. See, e.g., Moore v.
Ashland Chemical, Inc., 151 F.3d 269 (5th Cir. 1998) (en banc).


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.


I. Daubert

[1] 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. 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. The Court
stated that many factors will bear on this inquiry. For exam-
ple, a judge may consider whether the theory has been sub-
jected 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. The Court emphasized that the focus
of the inquiry envisioned by Rule 702 must be on the princi-
ples and methodology underlying an expert's testimony, not

on the conclusions. Id. at 506. The Court later refined this lan-
guage, explaining that a district judge may reject expert testi-
mony where the "analytical gap" between the data and the
expert's conclusion is too great. Joiner, 118 S.Ct. at 519.

[2] 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`scientifi-


cally valid principles.' " Daubert v. Merrill Dow Pharmaceu-
ticals, Inc., 43 F.3d 1311, 1318 (9th Cir. 1995).

II. Scientific Knowledge

[3] 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 con-
ducted 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 med-
ical laboratory tests; and (7) Mrs. Kennedy's medical reports.2
The district court, in rejecting Dr. Spindler's testimony, deter-
mined that the testimony was not based on scientific reason-
ing, 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 persua-
sive weight to be accorded such testimony by a jury.

[4] 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
2 We note, as a preliminary matter, that the parties do not dispute that
Dr. Spindler, who is a rheumatologist, is an expert in lupus, autoimmune
diseases, and immunological conditions.


autoantibodies. Dr. Spindler co-authored a peer-reviewed
publication describing a scientific relationship between
Zyderm collagen injections and the development of autoim-
mune reactions and autoantibodies. These reactions accom-
pany autoimmune diseases known as dermatomyositis and
polymyositis-like syndrome. A scientist for defendant Colla-
gen, Dr. Frank DeLustro, validated Dr. Spindler's methodol-
ogy. 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. Ken-
nedy'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 pro-
duced 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,
3 Physicians identify "atypical SLE" when a patient does not meet all of
the criteria required for an official diagnosis of SLE.


in which lupus-type symptoms develop after exposure to cer-
tain medications.

It is understandable why litigants and judges could be skep-
tical about Dr. Spindler's conclusion. Collagen has been clas-
sified by the Food and Drug Administration as a medical
device, rather than a drug. The typical medical devices are
inert objects such as pacemakers, heart valves and replace-
ment inserts. The substances comprising such devices are not
absorbed or metabolized by a person's body. To claim that
such inert objects may cause lupus surely would be "junk
science." Even the Kennedys recognize that if parts of colla-
gen are not metabolized, then collagen likely is not the cause
of Mrs. Kennedy's injuries. Their complaint alleges that colla-
gen is a drug, chemical, or compound.

The evidence before us reasonably demonstrates that colla-
gen is not like metal or plastics or other objects usually
labeled medical devices. After examining defendant's litera-
ture and laboratory tests, Dr. Spindler contends that collagen
should be classified as a drug because it is absorbed by the
body. The body breaks down the collagen fibers into amino
acids, which are then metabolized into the body. The Texas
Department of Health agrees that Zyderm could have been
classified as a drug since it achieves its intended purpose
through a chemical reaction. Furthermore, the defendant ran
laboratory tests that showed such a reaction, as have other
researchers, who have concluded that, after multiple injec-
tions, collagen can induce autoantibodies. Thus, the analogy
between "drug-induced lupus" and collagen-induced lupus is
a close one. It is from this foundation that Dr. Spindler seeks
to testify.

The district court, in rejecting Dr. Spindler's testimony,
emphasized that no epidemiological or animal studies link
Zyderm to SLE or atypical SLE. Other circuits, however,
have found that it is scientifically permissible to reach a con-
clusion on causation without these types of studies. See, e.g.,


Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1384 (4th Cir.
1995) (finding, under Daubert, that expert testimony need not
be based on epidemiological data or identical case studies to
prove causation). Here, Dr. Spindler explained that epidemio-
logical studies linking an increased incidence of SLE to
patients injected with collagen would be almost impossible to
perform because patients who have collagen injections nor-
mally do not seek treatment from rheumatologists for their
reactions. Patients who have collagen injections usually con-
sult the injecting doctor when any subsequent problems arise.
Because the injecting doctor typically is a plastic surgeon or
dermatologist, he is not trained to recognize autoimmune or
immune disorders. Thus, the causal connection goes unrecog-

[5] Other circuits have allowed clinical medical experts to
testify to an opinion on causation as long as it is based on
methods reasonably relied on by experts in their field. See,
e.g., Zuchowicz v. United States, 140 F.3d 381, 387 (2d Cir.
1998) (accepting the district court's conclusion that plaintiff's
experts based their opinions on such methods). Here, based on
his knowledge of the connection between collagen and vari-
ous autoimmune disorders, combined with his observation of
Mrs. Kennedy's injuries and her medical history and labora-
tory tests, Dr. Spindler concluded that Zyderm, a collagen
product, had caused Mrs. Kennedy's particular auto-immune
disorder, atypical SLE. The fact that a cause-effect relation-
ship between Zyderm and lupus in particular has not been
conclusively established does not render Dr. Spindler's testi-
mony inadmissible. See Ambrosini v. Labarraque, 101 F.3d
129, 139 (D.C. Cir. 1996), cert. dismissed, Upjohn Co. v.
Ambrosini, _______ U.S. _______, 117 S.Ct. 1572 (1997)(reversing

district court's finding that expert testimony was inadmissible
because none of the studies relied upon specifically concluded
that Depo-Provera caused the type of birth defects suffered by
the plaintiff). Dr. Spindler set forth the steps he took in arriv-
ing at his conclusion in his deposition. Dr. Spindler's analogi-
cal reasoning was based on objective, verifiable evidence and


scientific methodology of the kind traditionally used by rheu-
matologists. This is precisely what Daubert requires. See, e.g.,
Hopkins v. Dow Corning Corp., 33 F.3d 1116, 1125 (9th Cir.
1994) (finding admissible expert testimony of a rheumatolog-
ist based on medical records, his clinical experience, prelimi-
nary results of an epidemiological study and medical
literature). We note also that defendant Collagen has not
introduced any evidence that Dr. Spindler's reasoning is not
scientifically valid. See Ambrosini, 101 F.3d at 139 (noting
that lack of contradictory evidence supported admissibility of
expert's opinion regarding causation).

[6] Although the district court properly may exclude expert
testimony if the court concludes too great an analytical gap
exists between the existing data and the expert's conclusion,
here the gap was of the district court's making. The court did
not consider all of the data relied upon by Dr. Spindler,
namely, studies by the defendant and others finding that
Zyderm can induce autoimmune reactions. Consequently, the
court abused its discretion in concluding that Dr. Spindler's
testimony failed to meet Daubert's scientific knowledge

III. Assisting the Trier of Fact

[7] The second requirement of Rule 702 under Daubert is
that the expert testimony must assist the trier of fact. The cru-
cial issue in this case is causation. As we noted in our unpub-
lished opinion in this case, California law provides the
substantive standard governing proof of causation in personal
injury cases. Kennedy, 1992 WL 217803, at *1. The Kenne-
dys must prove causation "within a reasonable medical proba-
bility based upon competent expert testimony." Jones v.
Ortho Pharmaceutical Corp., 163 Cal. App.3d 396, 402

[8] The Daubert opinions emphasize that causation need
not be established to a high degree of certainty for expert tes-


timony to be admissible under Rule 702. The Supreme Court
stressed that, "[i]t would be unreasonable to conclude that the
subject of scientific testimony must be `known' to a certainty;
arguably, there are no certainties in science." Daubert, 509
U.S. at 590. On remand, we stated: "Not knowing the mecha-
nism whereby a particular agent causes a particular effect is
not always fatal to a plaintiff's claim. Causation can be
proved even when we don't know precisely how the damage
occurred, if there is sufficiently compelling proof that the
agent must have caused the damage somehow. " Daubert, 43
F.3d at 1314.

[9] Dr. Spindler's proffered testimony clearly meets the
requirement, as Dr. Spindler was prepared to testify that based
on "reasonable medical probability" Zyderm caused Mrs.
Kennedy's immunological injuries.

IV. Conclusion

Judges in jury trials should not exclude expert testimony
simply because they disagree with the conclusions of the
expert. The Daubert duty is to judge the reasoning used in
forming an expert conclusion. The test is whether or not the
reasoning is scientific and will assist the jury. If it satisfies
these two requirements, then it is a matter for the finder of
fact to decide what weight to accord the expert's testimony.
In arriving at a conclusion, the factfinder may be confronted
with opposing experts, additional tests, experiments, and pub-
lications, all of which may increase or lessen the value of the
expert's testimony. But their presence should not preclude the
admission of the expert's testimony -- they go to the weight,
not the admissibility. As one court has summarized:

      Disputes as to the strength of [an expert's] creden-
      tials, faults in his use of [a particular] methodology,
      or lack of textual authority for his opinion, go to the
      weight, not the admissibility, of his testimony.


McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1044 (2d Cir.

[10] We conclude that the district court failed to consider
all of the reasoning or methodology relied on by Dr. Spindler
in linking Zyderm to Mrs. Kennedy's illness and, thus, erred
in finding that Dr. Spindler's testimony was not supported by
scientific evidence. Because Dr. Spindler's testimony is sup-
ported by scientific evidence and will assist the trier of fact,
we hold that, his testimony is admissible under Rule 702.
Thus, reviewing the defendant's summary judgment motion
de novo, we reverse the district court's grant of summary
judgment in favor of defendant. The district court at trial must
admit the testimony and evidence of Dr. Spindler.


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