Primiano v. Cook

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

MARYLOU PRIMIANO; CHARLES 

PRIMIANO,

Plaintiffs-Appellants,

No. 06-15563

v.

D.C. No.

YAN COOK; STRYKER CORPORATION;

ROBERT J. TAIT M.D.,

 CV-03-00373-

JCM/PAL

Defendant,

OPINION

HOWMEDICA OSTEONICS

CORPORATION,

Defendant-Appellee.



Appeal from the United States District Court

for the District of Nevada

James C. Mahan, District Judge, Presiding

Argued and Submitted February 13, 2008

Submission Withdrawn and Supplemental Briefing

Requested March 3, 2008

Resubmitted July 15, 2009

San Francisco, California

Filed March 10, 2010

Before: Dorothy W. Nelson, Andrew J. Kleinfeld, and

Michael Daly Hawkins, Circuit Judges.

Opinion by Judge Kleinfeld

3801

3804 PRIMIANO v. HOWMEDICA OSTEONICS

COUNSEL

Peter C. Wetherall, Las Vegas, Nevada, for plaintiffs-

appellants Marylou and Charles Primiano.

Frederick D. Baker (argued), Wayne A. Wolff, San Francisco,

California; Ralph A. Campillo, Los Angeles, California, for

defendant-appellee Howmedica Osteonics Corporation.

OPINION

KLEINFELD, Circuit Judge:

We address admissibility under Daubert1 of medical testi-

mony.

1

Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

PRIMIANO v. HOWMEDICA OSTEONICS 3805

I. Facts

Marylou Primiano has suffered a miserable ordeal since she

had elbow surgery. The question raised by her litigation2 is

whether her ordeal resulted from a defective product, the arti-

ficial elbow Howmedica Osteonics Corporation manufac-

tured. The district court granted summary judgment against

her and dismissed her case, but that result could not have

occurred had her medical expert’s testimony been considered.

His testimony would have established a genuine issue of

material fact, because he thought the plastic bearing between

the metal parts of the artificial elbow wore out so quickly that

it must have been defective. The district court ruled that his

testimony was inadmissible, leaving Primiano with inade-

quate evidence to establish a genuine issue of fact. The ques-

tion before us is whether excluding Primiano’s expert’s

testimony was an abuse of discretion.

Ms. Primiano, an active 36-year-old woman, fell in her

kitchen and broke her elbow. The injury, serious for anyone,

was especially serious for her, because she has had rheuma-

toid arthritis for years. Unlike osteoarthritis, a degenerative

process of wear and tear on the joints, rheumatoid arthritis is

a chronic inflammatory disease of the connective tissue in the

joints.3 Her physician, Robert J. Tait, M.D., performed sur-

gery April 18, 2000, two days after her fall. He replaced her

elbow joint with a device made by the defendant, How-

medica, consisting of titanium pieces to replace the bone and

polyethylene components to prevent the metal from rubbing

against metal.

2

The complaint also names Mr. Primiano as a plaintiff, for his deriva-

tive claim for loss of consortium etc., and names Stryker Corporation as

owner of Howmedica Osteonics Corporation, Robert J. Tait M.D., the sur-

geon who operated on Ms. Primiano, and Yan Cook, a Howmedica sales

representative. Only the Primianos’ appeal challenging the summary judg-

ment and exclusion of evidence in favor of Howmedica is before us.

3

Blakiston’s Gould Medical Dictionary 1353 (3d ed. 1972).

3806 PRIMIANO v. HOWMEDICA OSTEONICS

Two thirds of the way through surgery, Dr. Tait discovered

that Howmedica had made a mistake in the packing and ship-

ping, so even though he was replacing Ms. Primiano’s right

elbow, the humeral component (the humerus is the arm bone

running from the elbow to the shoulder) sent to him was

labeled for the left arm. He consulted Howmedica’s represen-

tative (“Did I kill him? No, I didn’t.”) with Ms. Primiano’s

arm open on the table and was told that the components are

symmetrical, identical in every respect except that the locking

pin goes in the opposite side of the left humeral component,

so the component he had could be used. The hole had to be

drilled in Ms. Primiano’s bone from the inside instead of the

outside, but the artificial joint would be equally functional.

Dr. Tait completed the operation, and it appeared to be a suc-

cess.

But by July, Ms. Primiano’s elbow squeaked, and by

December, Dr. Tait could hear the metal-on-metal contact,

which he confirmed in an x-ray. In February, Dr. Tait per-

formed a second surgery addressing the evident failure of the

implant and risk of metallosis (a destructive immune response

of the body to flecks of metal shaved off by metal-on-metal

contact), replacing the humeral component with a longer one.

He used Howmedica’s left arm humeral component again,

though the long instead of the standard, to avoid having to

redrill the remaining bone. He observed massive metallosis

and “severe polyethylene wear” on the bearing surrounding

the pin. Again, the surgery appeared to go fine. But the next

month, Ms. Primiano was having trouble controlling her arm

and the joint had a “cracking” sound. She obtained a second

opinion from an orthopedic surgeon who concluded that the

components appeared “to be adequately fixed and in good

position.” But in June her problems with the joint had not

gone away, so she consulted a third orthopedic surgeon, who

recommended a third surgery. In July this surgeon replaced

her Howmedica device with one from its competitor, Zimmer.

That surgeon performed a fourth surgery the next April to cor-

PRIMIANO v. HOWMEDICA OSTEONICS 3807

rect loosening. A pin backed out of position, so she needed

yet another surgery, her fifth, in September.

Primiano sued Howmedica, Dr. Tait, and others in state

court for negligence, strict liability, breach of warranty, and

loss of consortium.4 Howmedica removed the case to federal

court based on diversity. All that is before us now is the prod-

ucts liability case.

In the summary judgment papers, Howmedica’s experts, an

orthopedic surgeon and a chemist, provided opinions that the

polyethylene was as it should be, and the rapid failure of the

prosthesis and excessive wear on the polyethylene compo-

nents resulted from “malalignment of the prosthesis” along

with increased risk of complication because of Ms. Primi-

ano’s rheumatoid arhtritis and her age. The product literature

distributed to physicians said that the prosthesis would not

restore function to the level expected with normal healthy

bone, and was vulnerable to excessive loading from activity.

Evidently, younger patients such as Ms. Primiano may do

worse because they are more active. The manufacturer’s liter-

ature says “[w]hile the expected life of the total elbow

replacement components is difficult to estimate, it is finite.”

Primiano’s expert witness, Arnold-Peter Weiss, M.D.,

declared that the polyethylene bushing had worn through in

less than eight months, “not a usual or expected circum-

stance.” Though finite, the typical lifespan of elbow prosthe-

ses “far exceeds” how long this one lasted. Dr. Weiss testified

in his deposition that although wear starts immediately, elbow

prostheses last as long as ten or fifteen years, even twenty,

and the earliest he had seen them wear out was around five

to eight years, varying with the patient’s activity level.

Though misalignment could cause excessive wear, he had

looked at the x-rays and found no significant misalignment.

4

Primiano’s complaint says that she is not suing Dr. Tait for malprac-

tice, just as an agent of Howmedica in selling the prosthesis.

3808 PRIMIANO v. HOWMEDICA OSTEONICS

Nor would ordinary daily activity produce such extraordinar-

ily rapid wear. Nor could he find technically inappropriate use

of the prosthesis by Dr. Tait. His opinion was that the extraor-

dinarily rapid wear was caused by abrasive wear and genera-

tion of debris from movement of the titanium against the

polyethylene. And he concluded that the prosthesis failed to

perform in a manner reasonably to be expected by a surgeon

using it, because it failed too early.

The district court granted defendants’ motion to exclude

Dr. Weiss’s testimony as not meeting the Daubert standard

and granted summary judgment. The court concluded that Dr.

Weiss’s testimony would not be helpful to the jury. The judge

reasoned: “Well, I mean it’s like res ipsa loquitur, the elbow

failed. Now, why did it fail? Maybe it was malpractice,

maybe it was Dr. Tait.” The evidence of rapid wear “doesn’t

make it defective.” “I think [Dr. Tait’s] opinion is weakened

by the fact that he didn’t see the plaintiff. He didn’t examine

her. He didn’t talk to her.” “[T]here’s no peer review . . . no

publication . . . there’s got to be an objective source that he

relies on.” The court rejected plaintiff’s argument, that testi-

mony that the premature failure was not attributable to over-

use, medical malpractice, “her physiology,” or other factors

external to the device, would assist the jury.

II. Analysis

We review summary judgment de novo.5 The substantive

question the jury would have to answer, in this diversity case

arising out of state tort law, is established by Nevada law. The

question whether evidence is admissible, though, is governed

by federal law. The Federal Rules of Evidence “govern pro-

ceedings in the courts of the United States.”6 That is generally

true in diversity cases because the Federal Rules of Evidence

5

Carmen v. San Francisco Unified Sch. Dist., 237 F.3d 1026, 1029 (9th

Cir. 2001).

6

Fed. R. Evid. 101.

PRIMIANO v. HOWMEDICA OSTEONICS 3809

are statutes enacted by Congress.7 Though there are excep-

tions, such as state substantive law in the guise of an evidenti-

ary rule,8 no exception applies here.

[1] Ms. Primiano’s burden was to establish a defect in the

manufacture of the artificial elbow. In Nevada, “those prod-

ucts are defective which are dangerous because they fail to

perform in the manner reasonably to be expected in light of

their nature and intended function.”9 A plaintiff need not “pro-

duce direct evidence of a specific product defect [or] negate

any alternative causes of the accident.”10 An “unexpected,

dangerous malfunction” suffices.11

[2] Federal Rule of Evidence 702 controlled admissibility

of Dr. Weiss’s opinion. That rule establishes several require-

ments for admissibility: (1) the evidence has to “assist the

trier of fact” either “to understand the evidence” or “to deter-

mine a fact in issue”; (2) the witness has to be sufficiently

qualified to render the opinion:

If scientific, technical, or other specialized knowl-

edge will assist the trier of fact to understand the evi-

dence or to determine a fact in issue, a witness

qualified as an expert by knowledge, skill, experi-

ence, training, or education, may testify thereto in

the form of an opinion or otherwise, if (1) the testi-

mony is based upon sufficient facts or data, (2) the

testimony is the product of reliable principles and

7

Sims v. Great Am. Life Ins. Co., 469 F.3d 870, 878-79 (10th Cir. 2006).

8

See Feldman v. Allstate Ins. Co., 322 F.3d 660, 666 (9th Cir. 2003);

Wray v. Gregory, 61 F.3d 1414, 1417 (9th Cir. 1995) (per curiam).

9

Allison v. Merck & Co., 878 P.2d 948, 952 (Nev. 1994) (internal quota-

tion marks omitted); Ginnis v. Mapes Hotel Corp., 470 P.2d 135, 138

(Nev. 1970) (internal quotation marks omitted).

10

Stackiewicz v. Nissan Motor Corp., USA, 686 P.2d 925, 927 (Nev.

1984).

11

Id. at 928.

3810 PRIMIANO v. HOWMEDICA OSTEONICS

methods, and (3) the witness has applied the princi-

ples and methods reliably to the facts of the case.12

Though Daubert is sometimes loosely spoken of as though it

established the court’s “gatekeeping” function, that is not

quite right. Trial courts have always had a gatekeeping func-

tion for opinion evidence. Daubert held that Federal Rule of

Evidence 702 replaces the old Frye13 gatekeeping test, “gen-

eral acceptance in the particular field,” with a different test

which is, in some respects, more open to opinion evidence.14

[3] The requirement that the opinion testimony “assist the

trier of fact” “goes primarily to relevance.”15 For scientific

opinion, the court must assess the reasoning or methodology,

using as appropriate such criteria as testability, publication in

peer reviewed literature, and general acceptance, but the

inquiry is a flexible one.16 Shaky but admissible evidence is

to be attacked by cross examination, contrary evidence, and

attention to the burden of proof, not exclusion.17 In sum, the

trial court must assure that the expert testimony “both rests on

a reliable foundation and is relevant to the task at hand.”18

Kumho Tire Co. v Carmichael holds that the Daubert frame-

work applies not only to scientific testimony but to all expert

testimony.19 It emphasizes, though, that the “test of reliability

is ‘flexible’ and Daubert’s list of specific factors neither nec-

12

Fed. R. Evid. 702.

13

Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).

14

Daubert, 509 U.S. at 588 (“Nothing in the text of [Rule 702] estab-

lishes ‘general acceptance’ as an absolute prerequisite to admissibility.”);

id. at 589 (“That austere standard, absent from, and incompatible with, the

Federal Rules of Evidence, should not be applied in federal trials.”).

15

Id. at 591.

16

Id. at 592-4.

17

Id. at 596.

18

Id. at 597.

19

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999); see also

White v. Ford Motor Co., 312 F.3d 998, 1007 (9th Cir. 2002).

PRIMIANO v. HOWMEDICA OSTEONICS 3811

essarily nor exclusively applies to all experts or in every case.”20

The “list of factors was meant to be helpful, not definitive,”21

and the trial court has discretion to decide how to test an

expert’s reliability as well as whether the testimony is reliable,22

based on “the particular circumstances of the particular case.”23

[4] We further interpreted Daubert on remand.24 In that

case, the evidence proffered was scientific epidemiological

evidence, of insufficient reliability for admissibility. We took

pains to point out that the problem was methodology, not the

conclusion to which the evidence would lead. “[T]he test

under Daubert is not the correctness of the expert’s conclu-

sions but the soundness of his methodology.”25 Under

Daubert, the district judge is “a gatekeeper, not a fact finder.”26

When an expert meets the threshold established by Rule 702

as explained in Daubert, the expert may testify and the jury

decides how much weight to give that testimony.

Testimony by physicians may or may not be scientific evi-

dence like the epidemiologic testimony at issue in Daubert.

The classic medical school texts,27 Cecil28 and Harrison,29

explain that medicine is scientific, but not entirely a science.

20

Kumho Tire, 526 U.S. at 141.

21

Id. at 151.

22

Id. at 152.

23

Id. at 150.

24

Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1313

(9th Cir. 1995).

25

Id. at 1318.

26

United States v. Sandoval-Mendoza, 472 F.3d 645, 654 (9th Cir.

2006).

27

Jock Murray, Neurology Texts for Internists, 123 Annals of Internal

Med. 477, 477-79 (1995).

28

Cecil Textbook of Medicine 1 (James B. Wyngaarden & Lloyd H.

Smith Jr. eds., 17th ed. 1985).

29

Harrison’s Principles of Internal Medicine 3 (Dennis L. Kasper et al.

eds., 16th ed. 2005).

3812 PRIMIANO v. HOWMEDICA OSTEONICS

“[M]edicine is not a science but a learned profession, deeply

rooted in a number of sciences and charged with the obliga-

tion to apply them for man’s benefit.”30 “Evidence-based

medicine” is “the conscientious, explicit and judicious use of

current best evidence in making decisions about the care of

individual patients.”31 “Despite the importance of evidence-

based medicine, much of medical decision-making relies on

judgment—a process that is difficult to quantify or even to

assess qualitatively. Especially when a relevant experience

base is unavailable, physicians must use their knowledge and

experience as a basis for weighing known factors along with

the inevitable uncertainties” to “mak[e] a sound judgment.”32

When considering the applicability of Daubert criteria to

the particular case before the court, the inquiry must be flexi-

ble. Peer reviewed scientific literature may be unavailable

because the issue may be too particular, new, or of insuffi-

ciently broad interest, to be in the literature.33 Lack of cer-

tainty is not, for a qualified expert, the same thing as

guesswork.34 “Expert opinion testimony is relevant if the

knowledge underlying it has a valid connection to the perti-

nent inquiry. And it is reliable if the knowledge underlying it

has a reliable basis in the knowledge and experience of the

relevant discipline.”35 “[T]he factors identified in Daubert

may or may not be pertinent in assessing reliability, depend-

ing on the nature of the issue, the expert’s particular expertise,

and the subject of his testimony.”36 Reliable expert testimony

30

Cecil Textbook of Medicine, supra, at 1.

31

Harrison’s Principles of Internal Medicine, supra, at 3.

32

Id.

33

Clausen v. M/V New Carissa, 339 F.3d 1049, 1056, 1060 (9th Cir.

2003).

34

Id. at 1059.

35

Sandoval-Mendoza, 472 F.3d at 654 (internal quotation marks and

citation omitted).

36

White v. Ford Motor Co., 312 F.3d 998, 1007 (9th Cir. 2002) (internal

quotation marks omitted).

PRIMIANO v. HOWMEDICA OSTEONICS 3813

need only be relevant, and need not establish every element

that the plaintiff must prove, in order to be admissible.37

[5] We have some guidance in the cases for applying Dau-

bert to physicians’ testimony. “A trial court should admit

medical expert testimony if physicians would accept it as use-

ful and reliable,” but it need not be conclusive because “medi-

cal knowledge is often uncertain.”38 “The human body is

complex, etiology is often uncertain, and ethical concerns

often prevent double-blind studies calculated to establish sta-

tistical proof.”39 Where the foundation is sufficient, the liti-

gant is “entitled to have the jury decide upon [the experts’]

credibility, rather than the judge.”40 We held in United States

v. Smith that even a physician’s assistant was qualified based

on experience to offer his opinion.41

[6] Other circuits have taken similar approaches focusing

especially on experience. The Sixth Circuit held that a district

court abused its discretion by excluding a physician’s testi-

mony based on extensive, relevant experience even though he

had not cited medical literature supporting his view.42 Like-

wise the Third Circuit pointed out that a doctor’s experience

might be good reason to admit his testimony.43 Thus under our

precedents and those of other circuits, the district court in this

case was pushing against the current, but that alone does not

imply an abuse of discretion.

37

See Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187, 1192 (9th Cir.

2007).

38

Sandoval-Mendoza, 472 F.3d at 655.

39

Id.

40

Id. at 656.

41

520 F.3d 1097, 1105 (9th Cir. 2008).

42

Dickenson v. Cardiac & Thoracic Surgery of E. Tenn., 388 F.3d 976,

982 (6th Cir. 2004).

43

Schneider ex rel. Estate of Schneider v. Fried, 320 F.3d 396, 406-07

(3d Cir. 2003).

3814 PRIMIANO v. HOWMEDICA OSTEONICS

[7] A close look at the foundation for Dr. Weiss’s opinion,

the nature of medical opinion, and the question posed by

Nevada law does. Dr. Weiss is a board certified orthopedic

surgeon and a professor at Brown University School of Medi-

cine in the Division of Hand, Upper Extremity and

Microvascular Surgery, department of Orthopedics. He has

published over a hundred articles in peer-reviewed medical

journals including several specifically on the elbow and at

least one somewhat related to this case, “Capitellocondylar

Total Elbow Replacement: A Long-Term Follow-up Study.”44

He has years of experience implanting various elbow pros-

thetics and has performed five to ten revisions of total elbow

replacements that had been performed by other physicians. He

has examined the various types of prosthetics available, and

has maintained familiarity with the peer-reviewed literature.

He testified that the very short lifespan of Ms. Primiano’s arti-

fical elbow is “outside of my review of the known literature.”

He conceded on cross examination that there was “no pub-

lished peer-reviewed article that [I’m] aware of that states a

strict minimum lifespan of a polyethylene component in a

total elbow system,” but explained that “I wouldn’t expect

any literature, because you don’t see it. It’s hard to write a

paper about something that doesn’t occur. I mean, this is

really bizarre.”

[8] A court would have to find that Dr. Weiss is “qualified

as an expert by knowledge, skill, experience, training, or educa-

tion”45 to render an opinion on elbow replacements. The dis-

trict court appears to have rejected the opinion based in part

on two elements of Rule 702, whether his opinion would

assist the trier of fact, and whether it was based upon suffi-

cient facts or data.

44

Andrew J. Weiland, Arnold-Peter C.Weiss, Robert P. Wills & J. Rus-

sell Moore, Capitellocondylar Total Elbow Replacement: A Long-Term

Follow-up Study, 71 J. of Bone & Joint Surgery, 217, 217-22 (1989).

45

Fed. R. Evid. 702.

PRIMIANO v. HOWMEDICA OSTEONICS 3815

[9] The district court thought Dr. Weiss’s opinion would

not assist the jury because Dr. Weiss could not say why the

plastic part of the artificial elbow failed so quickly. The “will

assist” requirement, under Daubert, “goes primarily to rele-

vance.”46 What is relevant depends on what must be proved,

and that is controlled by Nevada law. Nevada law establishes

that “those products are defective which are dangerous

because they fail to perform in the manner reasonably to be

expected in light of their nature and intended function.”47 In

Nevada, a plaintiff need not “produce direct evidence of a

specific product defect [or] negate any alternative causes of

the accident.”48 An “unexpected, dangerous malfunction” suf-

fices.49 Since Dr. Weiss, with a sufficient basis in education

and experience, testified that the artificial joint “fail[ed] to

perform in the manner reasonably to be expected in light of

[its] nature and intended function,” that was enough to assist

the trier of fact. He did not have to know why it failed.

[10] The district court’s other concerns, that Dr. Weiss

never saw or talked to Ms. Primiano, and there was no publi-

cation supporting his opinion that the device failed extraordi-

narily early, both might be useful to the jury as impeachment,

but neither furnished an adequate basis for excluding his opin-

ion. What he most needed to see was what was inside her arm,

not outside it, and he did. He saw the x-rays. He also saw the

polyethylene from the implant installed in Primiano’s first

surgery. As for lack of a publication backing his opinion up,

Daubert offers several reasons why an opinion unsupported

by peer-reviewed publication may be admissible,50 and Dr.

46

Daubert, 509 U.S. at 591.

47

Allison v. Merck & Co., 878 P.2d 948, 952 (Nev. 1994) (internal quo-

tation marks omitted); Ginnis v. Mapes Hotel Corp., 470 P.2d 135, 138

(Nev. 1970) (internal quotation marks omitted).

48

Stackiewicz v. Nissan Motor Corp., USA, 686 P.2d 925, 927 (Nev.

1984).

49

Id. at 928.

50

Daubert, 509 U.S. at 593.

3816 PRIMIANO v. HOWMEDICA OSTEONICS

Weiss furnished another one, that the phenomenon is so

extraordinary that the specialists who publish articles do not

see it in their practices.

[11] Dr. Weiss’s background and experience, and his

explanation of his opinion, leave room for only one conclu-

sion regarding its admissibility. It had to be admitted. Once

admitted, the opinion precluded summary judgment, because

if the jury accepted it, then the Howmedica prosthesis “fail-

[ed] to perform in the manner reasonably to be expected.”51

His methodology, essentially comparison of what happened

with Ms. Primiano’s artificial elbow with what surgeons who

use artificial elbows ordinarily see, against a background of

peer-reviewed literature, is the ordinary methodology of evi-

dence based medicine: “not a science but a learned profession

deeply rooted in a number of sciences,”52 “the conscientious,

explicit and judicious use of current best evidence in making

decisions about the care of individual patients”53 and “rel[y-

ing] on judgment—a process that is difficult to quantify or

even to assess qualitatively. Especially when a relevant expe-

rience base is unavailable, physicians must use their knowl-

edge and experience as a basis for weighing known factors

along with the inevitable uncertainties” to “mak[e] a sound judg-

ment.”54

[12] The jury may reject Dr. Weiss’s opinion. It may con-

clude that Ms. Primiano’s level of activity, or error by Dr.

Tait in performing the surgery, caused the failure. Or it may

conclude that the negligence that matters was in the packing

and shipping department of Howmedica, when they sent the

wrong pieces to the hospital. But those possibilities bear on

51

Allison, 878 P.2d at 952.

52

Cecil Textbook of Medicine 1 (James B. Wyngaarden & Lloyd H.

Smith Jr. eds., 17th ed. 1985).

53

Harrison’s Principles of Internal Medicine 3 (Dennis L. Kasper et al.

eds., 16th ed. 2005).

54

Id.

PRIMIANO v. HOWMEDICA OSTEONICS 3817

the merits of Ms. Primiano’s claim, not the admissibility of

Dr. Weiss’s opinion. Given that the judge is “a gatekeeper,

not a fact finder,”55 the gate could not be closed to this rele-

vant opinion offered with sufficient foundation by one quali-

fied to give it.

REVERSED.

55

Sandoval-Mendoza, 472 F.3d at 654.