Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_06-cv-00745/USCOURTS-azd-2_06-cv-00745-1/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1441 Petition for Removal- Product Liability

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1 Reply (doc. 59) at 17.

WO

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

Edward Harrison and )

Carol Harrison, husband and )

wife, )

)

Plaintiffs, ) No. CIV 06-0745 PHX RCB

)

vs. ) O R D E R

)

Howmedica Osteonics Corp., )

et al. )

)

Defendant. ) )

Currently there are four motions pending before the court in

this product liability action. The first, jointly filed, is a

motion by defendant Howmedica Osteonics Corporation (“Howmedica”), 

to “exclude” the testimony of the metallurgist retained by 

plaintiffs, Robert Anderson, Ph.D., and to strike “his reports in

their entirety[,]”1 as well as a motion for summary judgment (doc.

48). Second, because plaintiffs did not timely respond, Howmedica

is moving “for summary adjudication” of that joint motion (doc.

52). Third, Howmedica is moving “to strike plaintiffs’

controverting statement of facts” filed “in response to [its]

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2 Howmedica is moving to strike “Plaintiff’s Controverting

Statement of Facts in Response to Defendant’s Motion for Summary Judgment” (“PSOF”)

(doc. 54) because plaintiffs did not comply with LRCiv 56.1 in that they did not

“specifically controvert[] by a correspondingly numbered paragraph” any of the

“facts” in Defendant Howmedica’s Statement of Facts (“DSOF”). Based upon that

noncompliance, Howmedica asserts that its Statement of Facts is deemed admitted.

Initially plaintiffs did not comply with LRCiv 56.1(b). In response to this

motion to strike, however, plaintiffs did file a “Supplemental Controverting

Statement of Facts” (doc. 66) complying with that Local Rule. It would have been

preferable for plaintiffs to have fully complied with LRCiv 56.1(b) from the

outset. Given the extensive briefing which these motions have engendered, the lack

of prejudice to Howmedica, and because plaintiffs admitted many of the facts in

DSOF, the court denies this motion to strike (doc. 63). 

3 All references to the LGN herein shall be read as including the screws

which were used to set and place the LGN.

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motion to exclude” (doc. 60). Fourth, Howmedica similarly moves

“to strike plaintiffs’ controverting statement of facts” filed in

response to its summary judgment motion (doc. 63). 

Background2

Unless otherwise indicated, “for purposes of this motion”

plaintiffs do not dispute the following facts. See, e.g.,

Plaintiffs’ Supplemental Controverting Statement of Facts (“PSSOF”)

(doc. 68) at 1, ¶¶ 23-27.

While vacationing in Montana, on August 4, 2003, plaintiff

Edward Harrison sustained several injuries, including a fracture to

his right femur, in an all-terrain vehicle accident. Amended Co.

(doc. 14) at 3, ¶ 14. The next day, on August 5, 2003, to repair

Mr. Harrison’s fractured femur, Dr. Christopher Price implanted a

IntraMedullary Long Gamma Nail (“LGN”3

) manufactured and

distributed by defendant Howmedica. Id. at 3, ¶ 18. The LGN

“Operating Guide” describes the LGN as “a load-sharing device

designed to offer a faster, more successful, return to normal

lifestyles than alternative load-bearing devices such as plating or

complete reconstruction such as hip replacements.” DSOF (doc. 44)

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at 6, ¶ 32; see also PSSOF (doc. 68) at 1. According to that

Guide, the LGN is “superior to existing alternatives, because,

among other things, implantation is less invasive, it speeds

healing by allowing early weight-bearing and it is consistent with

activity levels that help a patient avoid complications brought on

by prolonged immobility such as muscle atrophy.” Id. (citation

omitted); see also PSSOF at 1. 

Plaintiffs admit that “[a]mong the risks understood by Dr.

Price and communicated to Mr. Harrison,” were the following, which

are “specifically identified in the LGN’s package insert[.]” Id. at

6, ¶ 34; see also PSSOF at 1. First, “No fracture fixation device

that is subject to material fatigue can be expected to withstand

activity in the same way as would a normal healthy bone.” Id. at

6-7, ¶ 34 (quoting exh. J thereto (LGN Package Insert); see also

PSSOF (doc. 68) at 1. The Insert continues: “The fracture fixation

system, therefore, will not be as strong, reliable or durable as a

normal human bone.” Id. Under the section entitled “Intended

Use[,]” the Insert explains that “[t]he [LGN] is intended for the

temporary stabilization of bone segments or fragments until bone

consolidation has been achieved.” Id. Also under the “Intended

Use” section, the Insert is explicit: “The patient should be warned

that the [LGN] cannot and does not replicate a normal healthy bone,

that the [LGN] can break or become damaged as a result of strenuous

activity or trauma, and that the [LGN] has a finite expected

service life[.]” Id.

“Delayed union or non-union of the fracture site[]” is one of

the listed “Adverse Effects” in the Package Insert. Id. Another

specifically identified “Adverse Effect[]” is that “[i]f healing is

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delayed or does not occur, the [LGN] may eventually break due to

metal fatigue.” Id. As the Insert explains it, “Locas on the

[LGN] produced by load bearing and the patient’s activity level

will dictate the longevity of the [LGN].” Id. Again, these were

“[a]mong the risks understood by Dr. Price and communicated to Mr.

Harrison[.]” Id. at 6, ¶ 34; see also PSSOF (doc. 68) at 1. 

As part of his discharge instructions, on August 12, 2003, Dr.

Price “limited Mr. Harrison to weight-bearing with a front-wheeled

walker, in part to ‘decrease the stress of the bone implant

system.’” Id. at 4, ¶ 23 (citing exh. D thereto (Price Dep’n) at

22:22-23); see also PSSOF at 1. Plaintiffs agree with Dr. Price’s

assessment that Mr. Harrison “was very inquisitive and . . . had a

good understanding of what the discharge plan was when he left.” 

Id. at 7, ¶ 35 (citation omitted); see also PSSOF (doc. 68) at 1. 

Upon returning to Arizona, Mr. Harrison “reported for a

follow-up review of his implant surgery on August 26, 2003, to Dr.

David Camarata of Arizona Bone and Joint Specialists.” Id. at 5,

¶ 25 (citation omitted); see also PSSOF (doc. 68) at 1. At that

time, and again on September 25, 2003 and on October 25, 2003, “Dr.

Camarata examined updated x-ray[s]” of Mr. Harrison’s right femur. 

Id. at 5, ¶ 26; see also PSSOF (doc. 68) at 1. “On each of these

visits, Dr. Camarata’s notes indicate he was satisfied with the

evidence of healing and alignment of the [LGN].” Id. (citation

omitted); see also PSSOF at 1. During the course of those visits,

“Dr. Camarata directed Mr. Harrison to continue with physical

therapy and with weight-bearing as tolerated – graduating

eventually from a walker to a cane.” Id. at 5, ¶ 27 (citation

omitted); see also PSSOF (doc. 68) at 1.

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In contrast to the facts outlined above, plaintiffs disagree

with Howmedica’s characterization of Mr. Harrison’s activity level

during physical therapy as “high[.]” PSSOF (doc. 68) at 1, ¶ 28. 

They disagree even though one of the excerpts from Dr. Camarata’s

deposition to which plaintiffs cite supports Howmedica’s view. Dr.

Camarata testified, “[T]he reality is he was doing too much.” Mot.

to Amend and Notice of Erratum (doc. 58), exh. A thereto (Price

Dep’n) at 38:3. Plaintiffs cite to another part of Dr. Camarata’s

deposition where he testified, after reviewing the notes from Mr.

Harrison’s physical therapy, that “for the most part, [it was] very

standard recovery in therapy, would have been exactly what [he]

expected.” Id. at 116:11-13. 

Following the weekend of November 15 and 16, 2003, “during

which Mr. Harrison participated in several activities including

golf, horseback riding and extensive walking, [he] saw Dr. Camarata

on November 18, 2003.” DSOF (doc. 44) at 5, ¶ 29; see also PSSOF

at 1. “Dr. Camarata’s notes from that visit indicate that Mr.

Harrison’s fracture had in fact not unionized and the [LGN] had

broken.” Id. (citation omitted); see also PSSOF at 1. “Attempts

at conservative treatment with a bone stimulator were abandoned due

to Mr. Harrison’s pain and a new device was implanted . . . on

November 25, 2003.” Id. at 6, ¶ 31 (citation omitted); see also

PSSOF at 1. As a result of the failed LGN, Mr. Harrison claims

that he has sustained “pain and permanent injury resulting in a

limp[.]” Amended Co. (doc. 14) at 6, ¶ 43. 

Discussion

I. Subject Matter Jurisdiction

The parties did not challenge this court’s subject matter

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jurisdiction, which purports to be based upon diversity of

citizenship pursuant to 28 U.S.C. § 1332. See Notice of Removal

(doc. 1). Nonetheless, because federal courts have limited

jurisdiction, this court has “an independent obligation to

determine whether subject-matter jurisdiction exists, even in the

absence of a challenge from any party.” Arbaugh v. Y & H Corp.,

126 S.Ct. 1235, 1244 (2006) (citation omitted). This obligation is

particularly compelling where, as here, subject matter jurisdiction

is not evident on the face of the removal petition or, for that

matter, on the face of the complaint. As this court explained in

ordering additional briefing on the jurisdiction issue, the notice

of removal was facially defective in that there were no allegations

of plaintiffs’ citizenship – only their residency. See Doc. 69 at

2. 

On several occasions this court has set forth “the simple

allegations needed to establish a natural person's state of

citizenship[] under § 1332(a)(1)[.]” Lacombe v. Bullhead City

Hospital Corp., 2007 WL 2702005, at *3 (D.Ariz. 2007) (internal

quotation marks and citations omitted). In particular:

To be a citizen of a state, a natural person 

must first be a citizen of the United States. . . . 

The natural person's state citizenship is then 

determined by her state of domicile, not her 

state of residence. A person's domicile is her 

permanent home, where she resides with the intention 

to remain or to which she intends to return. . . . A person residing in a given state is not necessarily

domiciled there, and thus is not necessarily a 

citizen of that state.

Id. (internal quotation marks and citations omitted) (emphasis

added). 

Howmedica has now amended its Notice of Removal to include

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citizenship allegations in accordance with the foregoing

definition. Based, inter alia, upon the deposition testimony of

plaintiff Edward Harrison, which establishes that plaintiffs live

part of the year in Phoenix, Arizona and part of the year in

Flagstaff, Arizona, Howmedica asserts that plaintiffs are domiciled

in Arizona and thus, in turn, Arizona citizens. Although not

mentioned in the Amended Notice of Removal, Howmedica also notes

that Mr. Harrison returned to Arizona and continued medical

treatment and therapy here, after his injury in Montana. This,

Howmedica contends, is further indicia that his domicile is

Arizona. 

A Notice of Removal “can be amended after the 30 day period

allowed to file [such a] notice ‘to add allegations . . . to

clarify defective allegations of jurisdiction previously made.’”

Sullivan v. BNSF Railway Company, 447 F.Supp.2d 1092, 1099 (D.Ariz.

2006) (quoting Barrow Dev. Co. v. Fulton Ins. Co., 418 F.2d 316,

317 (9th Cir. 1969)). As noted, Howmedica has timely amended its

Notice of Removal to cure the formal errors of pleading citizenship

with respect to plaintiffs. See Jenkins v. Commonwealth Land

Title Ins. Co., 95 F.3d 791, 794 (9th Cir. 1996) (“Whatever formal

defect existed by virtue of Commonwealth statement in its notice of

removal that [plaintiff] is a “resident of Hawai’i rather than a

citizen was . . . cured by the amendment [of the notice of

removal][.]”) 

Based upon the Amended Notice of Removal, it is now clear that

there is complete diversity of citizenship between plaintiffs,

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4 The claims against the other named defendant entities were dismissed

with prejudice. See Doc. 13 at 1-2.

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Arizona citizens, and defendant Howmedica,4 which is a citizen of

New Jersey, its place of incorporation and its principal place of

business. See 28 U.S.C. § 1332(c)(1) (A corporation is deemed to

be a citizen of both the State in which it is incorporated “and of

the State where it has its principal place of business[.]”) That

does not end the court’s inquiry into subject matter jurisdiction,

however. 

One other aspect of diversity jurisdiction is problematic here 

-- the presence of the fictitious defendants Black Corporations I -

X, and White Partnerships I-X. See Amended Co. (doc. 14) at 1-2, ¶

5. “This Circuit has long rejected naming ‘Doe’ defendants in

diversity actions, such as this, on the grounds that complete

diversity cannot exist if the identity and citizenship of some

defendants (i.e. the “Does’) are unknown.” Lacombe, 2007 WL

2702005, at *4 (internal quotation marks and citations omitted);

see also Richmond v. Smith, 127 F.R.D. 178, 179 (D.Nev. 1989)

(same) (citing cases). “By the same token though, the Ninth

Circuit has [long] held that where identity is unknown prior to the

filing of a complaint, the plaintiff should be given an opportunity

through discovery to identify the unknown defendant, unless it is

clear that discovery would not uncover the identities, or that the

complaint would be dismissed on other grounds.” Woodbeck v. U.S.,

2008 WL 312104, at *3 (D.Ariz. 2008) (internal quotation marks and

citation omitted). 

In the present case, the parties undertook extensive discovery

over the course of nearly six months. Despite having had ample

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opportunity to ascertain the identity of these fictitious entities,

and move to amend their complaint accordingly, plaintiffs did not

do that. Therefore, the court will sua sponte dismiss the claims

against the Black Corporations I-X and White Partnerships I-X. It

is “appropriate” to sua sponte dismiss claims against unknown

defendants is “[w]hen a plaintiff fails to use the discovery

process to identify an ‘unknown’ defendant[.]” Corrigan v. Unknown

King County Deputy #1, 2006 WL 3249135, at *2 (W.D.Wash. 2006)

(citation omitted). Dismissal under those circumstances is proper

because, “[a]s one court has observed ‘a district court otherwise

prepared to act on dispositive motions is not obligated to ‘wait

indefinitely for [the plaintiff] to take steps to identify and

serve . . . unknown defendants.’” Id. (quoting Figuerora v. Rivera,

147 F.3d 77, 82 (1st Cir. 1998)). 

Given Howmedica’s Amended Notice of Removal and the court’s

sua sponte dismissal of the fictitious defendants, there is now a

complete and affirmative showing that diversity jurisdiction exists

here. Having satisfied itself that it has subject matter

jurisdiction, the court will address to the merits of Howmedica’s

motions. 

Because discovery is complete, plaintiffs have had ample

opportunity to ascertain the identity of these fictitious entities,

and move to amend their complaint accordingly. Plaintiffs have not

done that, however. 

II. Summary Adjudication

Defendant is seeking summary adjudication because plaintiffs

did not timely respond to their initial motions to strike and for

summary judgment. Although defendant agreed to an extension of

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5 Courts within this district, including this one, have interpreted that

rule to mean that if a response is not timely filed pursuant to LRCiv 7.2, that

non-compliance may be deemed a consent to the granting of the motion. See, e.g.

Inter-Tel (Delaware), Inc. v. Fulton Communications, 2007 WL 1725349, at *1

(D.Ariz. 2007) (Broomfield, J.); and Higby v. Newby, 2006 WL 359862, at *4 (D.Ariz.

2006) (McNamee, C.J.). 

6 Document 64 is duplicative of document 57.

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time, until June 8, 2007, by which plaintiffs were to file their

response to those defense motions, Mot. for Summary Adjudication

(doc. 52), exh. B thereto at 1, plaintiffs did not file their

responses until June 13, 2007. Among other things, defendant

contends that this late filing could have been avoided had

plaintiffs requested an expedited transcript of defense expert Dr.

Gary Marrone. Id. at 2. Defendant also takes issue with

plaintiffs’ supposed “eleventh hour” request for an additional

extension of time until June 12, 2007. See id. at 3. For these

reasons, among others, in accordance with LRCiv 7.2(i)5 defendant

asserts that the court should deem plaintiffs’ untimely responses

as consent to the granting of motions to strike and for summary

judgment. 

Plaintiffs strenuously oppose this motion, asserting that

defendant has “sought to impose an unrealistic time limit” on their

response to defendant’s motions. Resp. (doc. 57 and 646) at 1.

This motion need not detain the court for long. As more fully

explained in Proctor v. Safeway Food & Drug, Inc., 2007 WL 2892944,

at *5 (D.Ariz. 2007), although the court realizes that LRCiv 7.2

“permits summarily granting motions for non-compliance” with that

Rule, it declines to do so here. Although there may be

circumstances where noncompliance with that Local Rule provides a

sufficient basis for granting a motion, this is not such a case. 

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Relatively speaking, the delay here was insignificant. Not only

that, resolving these motions on the merits is in keeping with the

“public policy favoring disposition of cases on their merits[.]”

See In re Phenylpropanolamine (PPA) Products, 460 F.3d 1217, 1129

(9th Cir. 2006) (citation omitted). Furthermore, that policy seems

especially strong here where it is readily apparent that the

parties have expended a fair amount of resources in terms of

discovery in terms of taking depositions and compiling expert

reports, not to mention the fairly extensive briefing on these

motions. Thus, the court denies defendant’s motion for summary

adjudication and instead opts to resolve these motions on the

merits. 

III. Motion to Exclude

As will be more fully discussed below, Howmedica contends that

the court should preclude Dr. Anderson from testifying that the LGN

is defective. Clearly if Howmedica prevails on that motion, it

will significantly impact Howmedica’s summary judgment motion in

terms of the admissible proof before the court. Thus, the court

will address Howmedica’s motion to exclude first. 

A. Statement of Controverting Facts

Before examining the merits of Howmedica’s motion to exclude,

there is one preliminary issue -- whether to strike plaintiffs’

statement of controverting facts submitted in response to that

motion to exclude. This motion to strike was precipitated at least

in part by the manner in which Howmedica presented its motions to

exclude and for summary judgment. 

In support of both its motion to exclude and its summary

judgment motion, Howmedica filed a “Statement of Facts” containing

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7 For ease of reference, the court took the liberty of numbering the

pages in this exhibit.

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55 paragraphs and 16 exhibits, totaling approximately 150 pages. 

Howmedica expressly states that it is submitting that Statement

pursuant to LRCiv 56.1(a), which governs summary judgment motions

only. In any event, plaintiffs responded by filing, inter alia, a

separate document entitled “Plaintiffs’ Controverting Statement of

Facts in Response to Defendant’s Motion to Exclude Expert

Opinion[,]” which includes 12 exhibits, totaling approximately 98

pages. See Doc. 56. Howmedica, in turn, filed a “motion to

strike” that statement of controverting facts. See Doc. 60 at 1.

These “statements of fact,” controverting or otherwise, are

not the proper means by which to present evidence in connection

with a motion to exclude. LRCiv 56.1(a) is explicit; such

statements are to be submitted in connection with “motions for

summary judgment[.]” LRCiv. 56.1. It necessarily follows then,

that a motion to strike, such as Howmedica’s, is not the proper

vehicle by which to challenge plaintiffs’ opposition to the

exclusion motion. Accordingly, the court denies Howmedica’s motion

to strike plaintiffs’ statement of controverting facts submitted in

response to Howmedica’s motion to exclude. Instead, the court will

consider the record before it on this motion to exclude within the

context of the governing legal standards outlined below.

B. Robert N. Anderson, Ph.D.

Basically, Robert N. Anderson, Ph.D., plaintiffs’

metallurgist, opines that the LGN has a design defect because it is

“susceptible to fatigue failure.” PSOF (doc. 56), exh. C thereto

at 1.7 Dr. Anderson further opines that one of three different

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surface treatments could have been employed on the LGN, which would

have “reduce[d] [its] susceptibility to fatigue failure.” Id.

Howmedica is moving to exclude Dr. Anderson’s opinions on two

separate bases. First, it contends that he is not qualified. 

Second, even if he is qualified, Howmedica maintains that Dr.

Anderson’s “opinions should be excluded for lack of sufficient

support.” Mot. (doc. 48) at 6. 

Howmedica’s first challenge to Dr. Anderson’s qualifications

is his purported lack of “real world experience[.]” See id. at 6

(citation omitted). Second, Howmedica challenges Dr. Anderson’s

qualifications because supposedly “since at least . . . 2000, this

is the only case in which [he] has tried to offer opinions about a

medical device that he claims is defectively designed or

manufactured.” Id. (citation omitted). With no explanation,

Howmedica further declares that because those are matters “outside

[his] area of expertise[,]” Dr. Anderson is not qualified to opine

as to whether the LGN “is defective, including whether [it]

performed as intended[.]” Id.

Plaintiffs vigorously dispute Howmedica’s assertion that Dr.

Anderson is not qualified, challenging both the factual predicate

and the legal basis for that assertion. Reciting Dr. Anderson’s

educational background, plaintiffs’ initial response is: “There is

no question [that] [he] is qualified to offer opinions in this

case.” Resp. (doc. 55) at 3. Without citing to any case law,

plaintiffs dispute Howmedica’s suggestion that “real world

experience” is essential to a finding that Dr. Anderson is

qualified within the meaning of Rule 702. Also without any legal

support, plaintiffs similarly contest Howmedica’s suggestion that

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prior litigation experience is a necessary precursor to finding an

expert witness qualified.

Howmedica did not directly respond to either of these

arguments. Rather it responded more generally, stating that

because Dr. Anderson is not a “biomechanics expert[,] . . . [h]e

cannot opine about the fatigue fracture and how the biomechanics of

the hip can lead to fatigue of the implant.” Reply (doc. 59) at 2. 

Howmedica then reiterated its belief that “Dr. Anderson is “going

beyond his expertise in metallurgy . . . [in] trying to offer

opinions about the design of the [LGN][,]” although again it does

not explain why. Id.

As to the asserted factual discrepancies, the court has

carefully reviewed the cited excerpts from Dr. Anderson’s

deposition and finds that the parties took some liberties in

construing his testimony. The court will overlook these differing

characterizations at this juncture because these claimed facts are

not dispositive of the qualification issue. Instead, the court

will focus primarily on the legal support or, more accurately, the

lack thereof for Howmedica’s claim that Dr. Anderson is not

qualified.

1. Qualifications

In the seminal case of Daubert v. Merrell Dow Pharmaceuticals,

Inc. 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the

Supreme Court cast trial judges in the role of “gatekeeper[s] in

determining whether to admit or exclude expert evidence[]” in

accordance with Rule 702. See Dukes v. Wal-Mart, Inc., 509 F.3d

1168, 1179 (9th Cir. 2007) (internal quotation marks omitted). The

Daubert Court “held that Federal Rule of Evidence 702 commands the

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primary focus for courts evaluating the admissibility of expert

testimony.” Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007). 

That Rule provides in part that “[i]f scientific, technical, or

other specialized knowledge will assist the trier of fact to

understand the evidence or to determine a fact issue,” an expert

“may testify thereto.” Fed. R. Evid. 702. Before a witness may

come “before the jury cloaked with the mantle of an expert[]” under

Rule 702, the Ninth Circuit has cautioned that “care must be taken

to assure that a proffered witness truly qualifies as an expert,

and that such testimony meets the requirements of [that] Rule[.]” 

Jinro America Inc. v. Secure Investments, Inc., 266 F.3d 993, 1004

(9th Cir. 2001). Thus, as an threshold matter, in accordance with

Rule 702 the court must determine whether the proffered witness is

“qualified as an expert by knowledge, skill, experience, training,

or education[.]” Fed. R. Evid. 702; see also Daubert v. Merrell Dow

Pharm., Inc., 43 F.3d 1311, 1315 (9th Cir. 1995) (“Daubert

II”)(whether proffered expert testimony is admissible “only arises

if it is first established that the individual[] whose testimony is

being proffered [is] [an] expert[] in a particular . . . field[]”).

“To satisfy this standard, it is essential that ‘the proposed

witness’s qualifying training or experience, and resultant

specialized knowledge, are sufficiently related to the issues and

evidence before the trier of fact [such] that the witness’s

proposed testimony will be of assistance to the trier of fact.’” In

re Apollo Group Inc. Securities Litigation, 2007 WL 3342704, at *2

(D.Ariz. 2007) (quoting 3 Jack B. Weinstein & Margaret A. Berger,

Weinstein’s Federal Evidence, ¶ 702[04][1][b], at 702-45 (other

citation omitted)). “Rule 702 contemplates a broad conception of

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expert qualifications[,]” as is evidenced by the advisory committee

notes thereto “emphasiz[ing] that Rule 702 is broadly phrased and

intended to embrace more than a narrow definition of qualified

expert.” Hangarter v. Provident Life & Accident Ins. Co., 373 F.3d

998, 1015 (9th Cir. 2004) (internal quotation marks and citations

omitted) (emphasis added by Hangarter Court). Accordingly, “[t]he

threshold for qualification is low, a minimal foundation of

knowledge, skill, and experience suffices.” Heston v. City of

Salinas, 2007 WL 4754777, at *2 (N.D.Cal. 2007) (citing, inter

alia, Hangarter, 373 F.3d at 1015-16). The burden is on the

proponent of the expert to establish, by “a preponderance of the

evidence . . . that the expert is qualified to render the

opinion[.]” Id. (citing Daubert,509 U.S. at 588-90). Whether a

proffered expert witness has sufficient qualifications is subject

to review under the relatively lenient abuse of discretion

standard. See Cooper, 510 F.3d at 876 (citation omitted). The

parties’ respective arguments as to whether Dr. Anderson qualifies

as an expert under Rule 702 must be analyzed against this legal

backdrop. 

Howmedica baldly asserts that Dr. Anderson has no “real world

experience designing, manufacturing or testing medical devices,

particularly implantable medical devices[]” such as the LGN. Mot.

(doc. 48) at 5-6. Therefore, he cannot qualify as an expert under

Rule 702. This argument is without merit. 

Assuming arguendo that Dr. Anderson lacks “real world

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8 According to Howmedica, Dr. Anderson has “no real world experience

designing . . . medical devices[.]” Mot. (doc. 48) at 6 (citation omitted). That

is a bit of an overstatement (and representative of the liberties both Howmedica

and plaintiffs took with the record), however, given his deposition testimony.

When specifically asked about “design solution[s]” which he devised, Dr. Anderson

testified that he advised “them” (presumably a manufacturer) to “change the

composition of the laser lens[]” on a device which cleans plaque from arteries so

that that laser would not “de-focus” during the process. PSOF (doc. 56), exh. A

(Deposition of Robert N. Anderson (March 12, 2007)) thereto at 34:9-10. Conceding

that “[his] design was very limited[,]” nonetheless, it seems to fall into the

category of the type of “real world experience” which Howmedica believes Dr.

Anderson lacks. See id. at 34:3. 

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experience” (however defined8), that is an insufficient basis for

concluding that he is not qualified under Rule 702. As set forth

earlier, that Rule expressly recognizes five separate grounds for

qualifying an expert: “knowledge, skill, experience, training, or

education.” Fed. R. Evid. 702 (emphasis added). This “disjunctive

conjunction,” which presumably “the drafters of the rule chose

deliberately suggests that an expert may be qualified on any of the

five bases listed.” Lavespere v. Niagara Mach. & Tool Works, Inc.,

910 F.3d 167, 176 (5th Cir. 1990) (footnote omitted), abrogated on

other grounds, Little v. Liquid Air Corp., 37 F.3d 1069 (5th Cir.

1996); Kopf v. Skyrm, 993 F.2d 374, 377 (4th Cir. 1993) (same). 

Thus, “[u]nder Rule 702, a witness may be qualified as an expert by

virtue of any one such factor, or upon a combination of any of the

factors listed in the rule.” Pacific Gas and Electric Co. v.

Howard P. Foley Co., Inc., 1993 WL 299219, at *5 (N.D.Cal. 1993)

(citing, inter alia, Exum v. General Electric Co., 819 F.3d 1158,

1163 (D.C.Cir. 1987)). Thus, although Dr. Anderson may not have

any “real world experience,” that does not mean that he cannot

qualify as an expert pursuant to Rule 702 because, as set forth

below, undisputably he can qualify on other grounds set forth in

that Rule. 

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According to his curriculum vitae, in addition to his several

chemistry related degrees, Dr. Anderson has a Ph.D. in metallurgy

from Stanford University. DSOF (doc. 44), exh. A thereto at 1. He

is also a registered, licensed metallurgical engineer in the State

of California. Id. Formerly Dr. Anderson was the Chairperson of

the Department of Materials Engineering at San Jose State

University, and a full professor there. Id. Additionally, Dr.

Anderson has several professional affiliations which seem

particularly significant in terms of this lawsuit. He is a member

of the American Academy of Forensic Sciences and past chairperson

of the Engineering Sciences Section; he is also a Fellow and Past

President of the National Academy of Forensic Engineers. Id. In

light of the foregoing, the court finds that Dr. Anderson has

sufficient knowledge, training and education to qualify him as an

expert in metallurgy under Rule 702, notwithstanding his supposed

lack of “real world experience.” 

Similarly unavailing is Howmedica’s contention that Dr.

Anderson does not qualify as an expert because of his purported

lack of recent experience in cases involving medical devices which

allegedly were defectively designed or manufactured. The court is

not aware of any requirement, and Howmedica cites to none,

correlating a witness’s expert status with the number of times that

witness has previously testified or otherwise participated in any

aspect of the legal process. The court declines to impose such a

requirement. Dr. Anderson’s alleged lack of participation in

similar litigation in recent years carries no weight with the court

in determining whether he qualifies as an expert pursuant to Rule

702. 

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Equally unpersuasive is Howmedica’s undeveloped argument that

Dr. Anderson is not qualified to opine that the LGN is defective

because it is beyond his area of expertise. In making this

argument, Howmedica misconstrues the nature of Dr. Anderson’s

testimony. Howmedica states that he will be opining as to “how the

biomechanics of the hip can lead to fatigue of the [LGN].” Reply

(doc. 59) at 2 (emphasis added). Even a cursory review of his

first report shows, however, that Dr. Anderson does not intend to

testify as to biomechanics. In that report, Dr. Anderson opines

that the LGN is defective because it “is manufactured from an ultra

high strength stainless steel alloy[,]” which “tend[s] to behave in

a brittle manner and [is] susceptible to fatigue failure.” PSOF

(doc. 56), exh. C thereto at 1. Employing one of three different

types of surface treatments to the surface of the LGN would, in Dr.

Anderson’s opinion, have made the LGN less susceptible to fatigue

failure. This testimony falls squarely within the province of Dr.

Anderson’s expertise in metallurgy. 

Dr. Anderson’s education, training, and experience, as

detailed in his curriculum vitae, meet the liberal standards for

qualification as an expert witness in metallurgy under Fed. R.

Evid. 702. Not only that, even Howmedica admits that as a

“qualified . . . metallurgist,” Dr. Anderson “can testify regarding

the fatigue fracture as it relates to metal[.]” Reply (doc. 59) at

3. Given the nature of Dr. Anderson’s proffered testimony, as just

summarized, Howmedica’s contention that he must qualify as an

expert in biomechanics is without merit. To the extent Howmedica’s

argument can be construed as asserting that Dr. Anderson lacks a

particularized expertise, i.e., biomechanics, that goes to the

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9 That Rule expressly provides, inter alia, that “[p]reliminary questions

concerning the qualification of a person to be a witness, . . . shall be determined

by the court[.]” Fed. R. Evid. 104(a).

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weight of his testimony, and not to whether he qualifies as an

expert in the first instance. See United States v. Garcia, 7 F.3d

885, 890 (9th Cir. 1993) (citation and footnote omitted). For the

reasons outlined above, the court denies Howmedica’s motion to

exclude the testimony of Dr. Anderson because he does not qualify

as an expert under Rule 702. 

2. Proffered Testimony

Once a court makes the “preliminary” determination under Fed.

R. Evid. 104(a)9 that a witness qualifies as an expert, the focus

shifts to that witness’s proffered testimony. As interpreted by

the Daubert Court, there is a two-part inquiry under Rule 702 for

determining the admissibility of proffered expert opinion testimony

such as Dr. Anderson’s. Expert testimony must be “not only

relevant, but reliable.” Daubert, 509 U.S. at 589, 113 S.Ct. 2786. 

“The test for reliability . . . ‘is not the correctness of the

expert’s conclusions, but the soundness of his methodology.’”

Stilwell, 482 F.3d at 1192 (quoting Daubert II, 43 F.3d at 1318). 

To determine whether Dr. Anderson’s testimony satisfies “the twin

concerns of reliability and helpfulness[]” which Rule 702 embodies

and whether it otherwise comports with Daubert and its progeny, a

fairly detailed review of his testimony is necessary. See id. at

1192 (internal quotation marks and citations omitted). 

Dr. Anderson prepared two reports in connection with this

litigation. In his first report, consisting of one page, Dr.

Anderson observes preliminarily that the LGN “is manufactured from

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10 Prior to the commencement of this action, Mr. Harrison’s daughter sent

the LGN to RJ LeeGroup, self-described “Materials Characterization Specialists[,]”

(doc. 56), exh. E thereto (LeeGroup Report) at 1, “for materials failure

analysis[.]” DSOF (doc. 44) at 8, ¶ 37; see also PSSOF at 2. “That analysis, . .

. , was directed at determining the failure mode of the [LGN] and if material

defects could be detected that would have limited the service life of [its]

components.” Id. (internal quotation marks and citation omitted); see also PSSOF

at 2. 

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an ultra high strength stainless steel alloy[.]” PSOF (doc. 56),

exh. C thereto at 1. Dr. Anderson declares that such “metals tend

to behave in a brittle manner and are susceptible to fatigue

failure.” Id. Dr. Anderson also recites his “understanding that

the [LGN] that was surgically implanted in Mr. Harrison was in

place for only approximately 14 weeks before the failure was

detected.” Id. 

Noting that the RJ LeeGroup report10 “indicate[d] that the

[LGN] failures started as a fatigue failure that progressed until

the remaining fracture surface failed in overload[,]” Dr. Anderson

confirms that this “failure also was observed in [his] inspection.” 

Id. The foregoing “indicates” to Dr. Anderson “that the [LGN] [is]

improperly designed.” Id. Dr. Anderson identified two ways in

which he believes the LGN is improperly designed: (1)“[t]he

situation stresses are too high for [its] dimensions[;]” and (2)

the surface of the LGN was not “finished to reduce susceptibility

to fatigue failure.” Id. Dr. Anderson did not elaborate with

respect to “situation stresses.” 

In contrast, Dr. Anderson did explain why he believes the lack

of surface finishes constitute a design defect. He stated that

“examination” shows that the LGN “ha[d] been polished, but [it]

ha[d] not been finished to reduce susceptibility to fatigue

fracture.” Id. Further, Dr. Anderson opines that “[t]his is

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normally done by putting compressive forces into the surfaces[,]”

but he does not explain in his report how this would be

accomplished. See id. Nor does Dr. Anderson explain how such

forces would have changed the result, if at all, in terms of the

LGN which was implanted in Mr. Harrison’s femur. Dr. Anderson does

not, for example, opine that if the LGN had been subjected to these

“compressive forces,” it would not have failed at 14 weeks, but

instead would have remained intact for some other finite period of

time beyond 14 weeks. In any event, knowing that at approximately

14 weeks it was detected that Mr. Harrison’s LGN failed, and based

on the “analysis” outlined above, Dr. Anderson “believes that the

[LGN] w[as] defective and not suitable for its intended purpose.” 

Id. 

Observing that there is agreement that the LGN “fail[ed] . . .

due to fatigue,” in his second report Dr. Anderson attempts to

refute certain aspects of the report prepared by Howmedica’s

retained metallurgists from Packer Engineering (“PE”). Id. at 2.

Questioning Howmedica’s view that the LGN failed because Mr.

Harrison was “very active[]” and that the LGN “is only designed for

temporary structural stability until the fracture heals[,]” Dr.

Anderson asserts that “failure in 3.5 months is unacceptably

temporary in a 145 pound man with limited mobility.” Id. at 3, ¶

5. From Dr. Anderson’s perspective, Howmedica “should have been

designed and manufactured a more substantial device that would

survive for more than 3.5 months.” Id. In this regard, Dr.

Anderson again faults the LGN’s lack of a surface finish “to

increase its resistance to fatigue failure.” Id. at 3, ¶ 7. 

Responding to the PE observations that “there is no industry

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standard requiring such additional surface treatment[,]” and that

“the [LGN] will still eventually fracture[,]” Dr. Anderson states,

somewhat ambivalently, that regardless of the foregoing, “it would

seem that a satisfactory design would ensure that the [LGN] lasted

longer than 3.5 months.” Id. (internal quotation marks omitted).

Interestingly, during his deposition Dr. Anderson declined to

give a specific time frame for the LGN “to have lasted” so that he

would not deem it “defective[.]” DSOF (doc. 44), exh. B thereto

(Deposition of Robert N. Anderson (March 12, 2007)) at 79. When

pressed as to how long the LGN should last so it would not, in Dr.

Anderson’s opinion, be defective, he replied, “it’s a sliding

scale[,]” but “[f]ourteen weeks seemed a little short.” Id. at

79:15 and 79:18-19. Further, Dr. Anderson admitted that he does

not “know what the actual number is[;]” nor has he “tried to look

at what number will be susceptible.” Id. at 79:19-21. When asked

his reason for stating that 14 weeks “seem[s] short[,]” his

response was circular: “Based upon the fact that it’s a short

time.” Id. at 79:22; and 79:25.

Disputing the “comment” by Howmedica’s metallurgist that

“[t]he fact that the [LGN] fractured is not a scientific basis for

determining the design was improper[,]” Dr. Anderson succinctly

concluded his second report in this way. The fact that the LGN

fractured, “add[ed] [to the fact] that it failed in three and a

half months in a 145 pound man with limited mobility,” means that

“you can state firmly that the design was improper.” Id. (internal

quotation marks omitted). 

During his deposition, Dr. Anderson testified that “there are

a number of . . . , inexpensive, well established techniques that

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could change the surface [of the LGN] to give [it] resistance to

fatigue.” PSOF (doc. 56), exh. A thereto (Dep’n of Robert N.

Anderson (March 12, 2007)) at 68:17-19. First, Dr. Anderson opines

that the LGN could have been subjected to ion implementation, a

technique not mentioned in either of his reports. See DSOF (doc.

44), exh. B thereto at 87:24-88:6. Another possible surface

treatment technique, also not mentioned in either of his reports,

would have been the use of “a plating or a coating[,]” such as

“cold plating[,]” or “titanium or a cobalt plating.” Id. at 92:15

- 93:7. Dr. Anderson’s third suggested technique (mentioned in

passing in his first report), is the use of “compressive

processes[,]” sometimes referred to as “peening[.]” Id. 96:18-

97:10. The use of any of these three techniques or processes, from

Dr. Anderson’s point of view, would result in the LGN being, as he

described it, “non-defective[]” in that it would have “[h]igh

resistance to fatigue failure[.]” Id. at 87:5-6. But again, Dr.

Anderson did not quantify that resistance in any way. 

In short, if allowed to testify, Dr. Anderson will opine that

the LGN is defective because “[one] could increase [its] . . .

fatigue resistance easily, . . . by [using one of these three types

of] surface changes, and none of that [was] done.” PSOF (doc. 56),

exh. A (Anderson Dep’n) thereto at 68:3-4. Continuing, Dr.

Anderson testified: “I think it’s defective that they can spend 25

years with a product and not spend a little bit of research and

effort to try and increase the resistance to fatigue.” Id. at

68:21-24. 

Shortly thereafter, when explicitly asked “what is your defect

criteria that you are employing[,]” Dr. Anderson reiterated,

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“Susceptible to fatigue, which could have been ameliorated.” DSOF

(doc. 44), exh. B thereto at 70:9-12. Following up, Dr. Anderson

was asked: “I take it then that, and you almost come right out and

say that earlier in your report, the fact that the [LGN] broke is

essentially what you rely on to conclude that it therefore must

have been defective, true?” Id. at 70:13-17. Dr. Anderson agreed

that “in part” he relied upon “the fact that the [LGN] broke . . .

to conclude that it . . . must have been defective[.]” Id. at

70:14-18. Dr. Anderson added that the manufacturer’s “recognition

of a defect[]” in that “the manufacturer itself says this part’s

going to fail[,]” and then “not trying to ameliorate it makes the

product defective.” Id. at 70:23-25. 

a. Reliability

Putting aside for the moment the issue of whether Dr. 

Anderson’s testimony as just recounted, is relevant, still, it is

not admissible under Daubert and its progeny unless is “satisf[ies]

a second hurdle, reliability.” See Cooper, 510 F.3d at 942. 

Assuring that an “‘expert’s opinion [has] a reliable basis in the

knowledge and experience of his discipline[,]’” is critical because

“[a]n expert witness - unlike other witnesses - ‘is permitted wide

latitude to offer opinions, including those that are not based on

first hand knowledge or observation[.]’” Jinro America, 266 F.3d at

1004 (quoting Daubert I, 509 U.S. at 592, 113 S.Ct. 2787) (other

citation omitted). This “preliminary” reliability determination

requires a trial court to “act as a gatekeeper to exclude junk

science that does not meet Rule 702's reliability standards[.]”

Cooper, 510 F.3d at 942 (internal quotation marks and citation

omitted). 

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11 Although Daubert I “focused on scientific testimony[,]” subsequently,

in Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 119 S.Ct. 1167, 143 L.Ed.2d

238 (1999), the Supreme Court “made clear that Daubert[I]’s principles apply to

“technical and other specialized knowledge’ as well.” Jinro American, 266 F.3d at

1004 (quoting Kumho, 526 U.S. at 141, 147-49). 

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“Rule 702 demands that expert testimony relate to scientific,

technical or other specialized knowledge, which does not include

unsubstantiated speculation and subjective beliefs.” Id. (internal

quotation marks and citation omitted). As the Daubert Court

explained:

[I]n order to qualify as scientific knowledge, 

an inference or assertion must be derived by 

the scientific method. Proposed testimony must 

be supported by appropriate validation - i.e., 

good grounds, based on what is known. In short, 

the requirement that an expert’s testimony pertain to

scientific knowledge establishes a standard 

of evidentiary reliability. 

Daubert, 509 U.S. at 590, 113 S.Ct. 2786 (internal quotation marks

omitted). Thus, “something doesn’t become ‘scientific knowledge’

just because it’s uttered by a scientist; nor can an expert’s selfserving assertion that his conclusions were ‘derived by the

scientific method’ be deemed conclusive[.]” Daubert II, 43 F.3d at

1315-1316. After Daubert, the court’s “task” is to “analyze not

what the experts say, but what basis they have for saying it.” Id.

at 1316. When the court does that here, as discussed below, it is

left with the firm conviction that Dr. Anderson’s opinion testimony

does not carry sufficient indicia of reliability to satisfy Rule

702 as explicated in Daubert and its progeny.

In assessing the reliability of scientific or other

specialized evidence such as engineering or metallurgy,11 the

Daubert Court enumerated four “non-exclusive” factors: “(1) whether

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a scientific theory or technique can be (and has been) tested; (2)

whether the theory or technique has been subjected to peer review

and publication; (3) the known or potential rate of error and the

existence and maintenance of standards controlling the technique’s

operation; and (4) whether the technique is generally accepted.” 

Id. at 942-943 (citing, inter alia, Daubert, 509 U.S. at 593-94,

113 S.Ct. 2786). Emphasizing that this “list of factors [i]s meant

to be helpful, not definitive[,]” the Supreme Court has

acknowledged that “those factors do not all necessarily apply even

in every instance in which the reliability of scientific testimony

is challenged.” Kumho Tire, 526 U.S. at 151, 119 S.Ct. 1167. 

Regardless of which factors a court focuses upon, however, at the

end of the day “[t]he goal is to make certain that an expert . . .

employs in the courtroom the same level of intellectual rigor that

characterizes the practice of an expert in the relevant field.” 

Cooper, 510 F.3d at 943 (internal quotation marks and citations

omitted). 

. . .

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12 When an expert has not done any “original research[]” and instead

relies upon “derivative analytical work,” the Ninth Circuit has observed that “it

makes little sense to ask whether the technique employed can be (and has been)

tested, . . . or what its known or potential rate of error might be[.]” Daubert II,

43 F.3d 1317 n.4. Here, evidently Dr. Anderson has not conducted any original

research in that his analysis appears to be based upon a review of two other

reports prepared in connection with this lawsuit; a “product experience” report;

and his visual examine of the LGN. See PSOF (doc. 56), exh. C thereto at 1; see

also id., exh. A thereto (Anderson Dep’n) at 23:23-29:22. Therefore, at first

glance the testing and rate of error factors do not seem to apply here. 

By the same token though, Dr. Anderson’s work is not derivative, at least as

the Ninth Circuit defines it. “Derivative analytical work,” according to the Ninth

Circuit, is conducted by “examin[ing] the available literature and studies within

[an expert’s] . . . field and draw[ing] different conclusions than the scientists

who performed the original work.” Daubert II, 43 F.3d at 1317 n.4 (emphasis

added). Dr. Anderson has “reviewed” five “peer-reviewed publications[,]” PSOF

(doc. 56), exh. D thereto (Affidavit of Robert N. Anderson (June 7, 2007)) at ¶ 1;

but there is no indication that he has drawn “different conclusions than the

scientists who performed the original work.” See Daubert II, 43 F.3d at 1317 n.4.

Thus, although Dr. Anderson’s work is not original research, because it is not

derivative, as the Ninth Circuit has used that term, recognizing the flexible

nature of the Daubert inquiry, the court will consider the testing and rate of

error factors in assessing the reliability of his testimony. 

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i. Testing12

Howmedica objects to Dr. Anderson’s testimony because he

did not test the LGN itself. Nor did Dr. Anderson test any of his

proposed design alternatives, i.e. the surface treatment

techniques. The crux of Dr. Anderson’s testimony is that the LGN

has a design defect in that it would have had higher resistance to

fatigue failure had it been subjected to one of three surface

treatments which he suggested. In light of that emphasis, the

court will focus on the lack of testing with respect to the

proposed design alternatives. 

Dr. Anderson unequivocally agreed during his deposition that

he is “going to . . . call [the LGN] defective because of the lack

of a surface treatment[.]” DSOF (doc. 44), exh. B thereto (Anderson

Dep’n) at 89:23- 90:1. One of Dr. Anderson’s proposed surface

treatment techniques is, as mentioned earlier, ion implementation. 

When asked whether he “ha[d] any testing of this [LGN] or a similar

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13 Howmedica urges the court not to consider what it characterizes as

this “improper affidavit[.]” See Reply (doc. 59) at 1. The court should not

consider this affidavit because from Howmedica’s point of view Dr. Anderson is

impermissibly “contradicting his prior [deposition] testimony[.]” Id. at 6

(citation omitted). Howmedica implies that Dr. Anderson’s affidavit is a sham and

as such, the court must disregard it. 

As the court reads Dr. Anderson’s affidavit, however, he is “elaborating

upon, explaining or clarifying prior testimony elicited by opposing counsel on

deposition[.]” See Scamihorn v. General Truck Drivers, 282 F.3d 1078, 1085 n.7 (9th

Cir. 2002) (citation omitted). At most, this affidavit is akin to those containing

“minor inconsistencies that result from an honest discrepancy, a mistake, or newly

discovered evidence,” which the Ninth Circuit has held do not “afford [a] basis for

exclu[sion][.]” See id. Consequently, despite Howmedica’s protestations, the court

does not view Dr. Anderson’s affidavit as a sham, and thus will not disregard it

on that basis. As will be seen, however, the court does not give that affidavit

much credence due to the largely unsubstantiated nature of the averments therein.

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device . . . made up of this steel alloy, but bombarded with ions

that [he] believe[s] tells [him] would have made [the LGN]

stronger[,]” Dr. Anderson responded, “No.” Id., exh. B thereto at

91:4-8. Similarly, Dr. Anderson was asked about testing with

respect to his suggestion of coating the LGN:

Have you done any testing of this [LGN] as 

designed and as dimensioned and with the 

materials used, but coated with either some 

sort of chrome or titanium or cobalt, to determine 

how much longer, if at all, this [LGN], not some 

other metal, but this implantable medical device

would have lasted?

95:19-24. Dr. Anderson candidly responded: “No, I think that’s the

job of the manufacturer that wants to make a safe product.” Id.,

exh. B thereto at 95:25-96:1. 

The burden is on plaintiffs, as the proponent of this

testimony, to demonstrate that Dr. Anderson’s “opinion or theory is

reliable, which takes into consideration any testing that has been

done of the theory.” See Martinez v. Terex Corporation, 241 F.R.D.

631, 638 (D.Ariz. 2007). Plaintiffs attempt to satisfy the testing

aspect of reliability by relying upon the affidavit of Dr.

Anderson, post-dating his deposition by roughly three months.13 In

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that affidavit, Dr. Anderson avers generally:

The metallic surface strengthening techniques/

processes which I opine would have increased 

 [LGN] surface strength so as to slow or 

prevent fatigue cracking and failure are tested 

and peer-reviewed and accepted in the metallurgical

community.

PSOF (doc. 56), exh. D thereto at ¶ 1. That bald assertion,

without more, such as the nature of the testing, by whom and the

circumstances under which it was done, where and when the testing

was performed, and perhaps most significantly, the results yielded

by the testing of those “metallic surface strengthening

techniques/process[,]” especially as they relate to the LGN, is not

a sufficient indicia of reliability under Rule 702, as elaborated

upon by the Daubert Court. Thus, because plaintiffs have “provided

no indication that the opinion or theor[ies] offered by” Dr.

Anderson regarding the alleged improper design of the LGN and

possible alternative designs “ha[ve] been tested[,]” apart from the

nonspecific averment quoted above, plainly “the testing factor of

the Daubert analysis cuts against a finding of reliability.” See

Martinez, 241 F.R.D. at 638.

ii. Peer Review and Publication

Turning to peer review and publication, this factor also

augurs against a finding of reliability. As with testing, the only

mention of peer review and publication in the record is Dr.

Anderson’s averment, with no elaboration, that the surface

treatments which he is advocating have been “peer-reviewed.” See

PSOF (doc. 56), exh. D thereto at ¶ 1. It is not entirely clear

from his affidavit, but apparently Dr. Anderson is relying upon the

five publications listed therein to show that his opinion that the

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LGN’s surface strength and hence its resistance to fatigue could

have been increased by certain surface changes has been peer

reviewed and the subject of publications. 

Merely reciting a list of publications does not establish the

level of peer review or publication which Daubert and its progeny

contemplate. Among other things, it cannot be discerned from that

list whether any of the cited publications bear directly on the

issues before this court. For example, Dr. Anderson relies upon a

publication pertaining to “fatigue behavior . . . for dental

implants[.]” See id. On the face of it, it is difficult if not

impossible to see how that publication could show that the surface

changes which Dr. Anderson propounds for the LGN, which plainly is

not a dental implant, have been subjected to peer review or

publication. 

Likewise, in his affidavit Dr. Anderson names a publication

relating to “abrasive waterjet preening[.]” Id. Yet, plaintiffs

have not pointed to anywhere else in this record, such as Dr.

Anderson’s deposition, showing that he opined that the design of

the LGN is defective because it was not subjected to that

particular surface treatment technique. Thus, even if that

publication establishes that “abrasive waterjet preening” has been

subjected to peer review and publication, the court fails to see

how that shows the reliability of Dr. Anderson’s proffered

opinions, which do not include that particular technique. 

Accordingly, Dr. Anderson cannot rely upon this particular

publication to show that the three surface treatments of which he

is a proponent have been subjected to the rigors of peer review or

publication. 

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What is more, there is no indication that either of Dr.

Anderson’s two reports, which were prepared in connection with this

litigation, were peer reviewed. In Martinez, the court held that

an expert’s reports which were only peer reviewed “in-house,

through a co-worker at [the expert’s] engineering firm[,]” did not

“rise to the level of publication or peer review contemplated in

Daubert to test the soundness of methodology used in the analysis.” 

Martinez, 241 F.R.D. at 638 (citing Daubert II, 43 F.3d at 1318)

(noting “[t]hat the research is accepted for publication in a

reputable scientific journal after being subjected to the usual

rigors of peer review is a significant indication that it is taken

seriously by other scientists, i.e., that it meets at least the

minimal criteria of good science.”)). Dr. Anderson’s reports were

not subjected to the minimal level of “peer review” described in

Martinez, let alone the “usual rigors of peer review” employed in

scientific and academic communities. See Daubert II, 43 F.3d at

1318. 

Further, relying largely upon Dr. Anderson’s affidavit,

plaintiffs seem to be implying that the “basis supporting [his]

opinion can be found based upon the materials he reviewed and his

educational and professional experience.” See Martinez, 241 F.R.D.

at 639. The court agrees with the conclusion in Martinez, however,

that “[w]hile such factors are relevant, they certainly do not

override the important factor of peer review and publication

identified in the Daubert inquiry.” See id. This is especially so

here where Dr. Anderson has done nothing more than cite to five

publications - two of which on the face of it do not appear to be

germane. Consequently, also as in Martinez, “the lack of peer

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review or publication regarding Plaintiff[s’] [alleged] design

defect and alternative design theories cuts against the reliability

of [Dr. Anderson’s] opinions regarding such in this case.” See id.

iii. Rate of Error

Plaintiffs indicate that Dr. Anderson “attests[,]” among other

things “that the scientific theory behind his compressive force

opinions has . . . an error rate[.]” Resp. (Doc. 55) at 5 (citing

PSOF (doc. 56) at ¶ 7). The cited reference does not mention error

rates at all, though. Thus, by omission, plaintiffs concede that

there is no known potential rate of error in terms of Dr.

Anderson’s alternative design theories. While not dispositive,

this factor too weighs against a finding of reliability as to Dr.

Anderson’s opinion that the LGN is defective due to an improper

design, and the purported existence of feasible design

alternatives. 

iv. General Acceptance

The only reference to general acceptance of Dr. Anderson’s

opinions is, once again, a cursory statement in his affidavit that

his opinions “are accepted in the metallurgical community.” See

PSOF (doc. 56), exh. D thereto at ¶ 1. The court has no reason to

doubt Dr. Anderson’s veracity. Surely Daubert demands more,

however, than an expert’s conclusory assertion that a given theory

has been generally accepted within the relevant scientific

community. Otherwise, the general acceptance criteria would be

rendered meaningless because it could be met by “the expert’s bald

assurance of validity[,]” which in a slightly different context the

Ninth Circuit has found does not comport with Daubert. See Daubert

II, 43 F.3d at 1316. 

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v. Litigation Generated Opinions

In further recognition of the flexible nature of the Daubert

inquiry, the Ninth Circuit has “provided additional guidance[]” for

evaluating the reliability of an expert’s opinion. Lust, 89 F.3d

at 597. One “very significant” additional factor “is whether the

experts are proposing to testify about matters growing naturally

and directly out of research they have conducted independent of the

litigation, or whether they have developed their opinions expressly

for purposes of testifying.” Daubert II, 43 F.3d at 1317. Dr.

Anderson’s research was not done “independent of th[is]

litigation.” See id. Instead, as should be abundantly clear by

now, his opinions were “developed . . . expressly for purposes of

testifying” in this action. See id. Therefore, it is incumbent

upon plaintiffs, as the proponents of Dr. Anderson’s testimony, to

come forth with “proof that the research and analysis supporting

the proffered conclusions have been subjected to normal scientific

scrutiny through peer review and publication.” See id. at 1318. 

As discussed above, plaintiffs have made no such showing here.

To be sure, it “is not dispositive[]” that an “expert failed

to subject his method to peer-review and to develop his opinion

outside the litigation.” Lust, 89 F.3d at 597. “[B]ut if these

guarantees of reliability are not satisfied,” id., the expert must

“explain precisely how [he] went about reaching [his] conclusions

and point to some objective source - a learned treatise, the policy

statement of a professional association, a published article in a

reputable scientific journal or the like – to show that [he has]

followed the scientific method, as it is practiced by (at least) a

recognized minority of scientists in [his] field.’” Daubert II, 43

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F.3d at 1318-19 (citing United States v. Rincon, 28 F.3d 921, 924

(9th Cir. 1994) (research must be described “in sufficient detail

that the district court [can] determine if the research is

scientifically valid”)) (footnote omitted). Dr. Anderson’s

testimony does not meet this standard. 

Dr. Anderson did not explain precisely how he derived his

conclusion that the LGN is defective. He does not identify, let

alone explain, the principles or the methods he used to arrive at

this conclusion. Citing to five publications and baldly averring

that they are “supportive of []his science and [his] opinion[]” is

not the sort of “precise” explanation Daubert and the case law

construing it mandates. In fact Dr. Anderson’s averment that his

opinions were “tested and peer-reviewed and accepted in the

metallurgical community[,]” is the type of “self-serving” assertion

which the Daubert II Court indicated cannot “be deemed conclusive.” 

See Daubert II, 43 F.3d at 1315-1316. Plaintiffs, as the party

proffering Dr. Anderson’s testimony, have not come close to

“explain[ing] [Dr. Anderson’s] methodology and demonstrat[ing] in

some objectively verifiable way that [he] has both chosen a

reliable scientific method and followed it faithfully.” See

Daubert II, 43 F.3d at 1319 n.11. As in Daubert II, plaintiffs

“neither explain the methodology [Dr. Anderson] followed to reach

[his] conclusions nor point to any external source to validate that

methodology.” Dr. Anderson’s conclusory averment quoted above does

not allow the court, as it must, “to determine whether the expert

has utilized the correct principles and methods, or whether they

have been reliably applied in the particular case[]” as Rule 702

requires. See In re Canvas Specialty, Inc., 261 B.R. 12, 21

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(Bankr. D.C.Ca. 2001). 

 Dr. Anderson provides no insight, for example, into the

methodology he used to determine that his three suggested surface

treatment techniques, in fact, would have resulted in increased

resistance to fatigue in the LGN. In contrast to the experts’

declarations in Metabolife International, Inc. v. Wornick, 264 F.3d

832 (9th Cir. 2001), which the Ninth Circuit found “facially

complied with Daubert II’s verification requirement for evidence

prepared in anticipation of litigation[,]” Dr. Anderson has not

“explain[ed] [his] methodology” at all. See id. at 845 (citation

omitted). Equally significant is the fact that Dr. Anderson did

not show “how the data found in [the cited] peer-reviewed”

documents “was used.” See id. (citation omitted). Moreover, Dr.

Anderson has not tied his opinion to the facts of this particular

case, making it extremely difficult for the court to properly

exercise its “gatekeeping inquiry” as Daubert mandates. See

Cooper, 510 F.3d at 942 (internal quotation marks and citations

omitted)(“[T]he gatekeeping inquiry must be tied to the facts of a

particular case.”) “[N]othing in either Daubert or the Federal

Rules of Evidence requires a district court to admit opinion

evidence that is connected to existing data only by the ipse dixit

of the expert.” General Elec. Co. v. Joiner, 522 U.S. 136, 146,

118 S.Ct. 512, 519 (1997). Yet, by offering Dr. Anderson’s largely

unsubstantiated testimony, essentially, this is what plaintiffs are

asking this court to do. 

vi. Other Criteria

Partly because Dr. Anderson’s opinion testimony does not fit

neatly into the Daubert and Rule 702 framework, and cognizant of

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14 See Desrosiers v. Flight Intern. of Florida Inc., 156 F.3d 952, 961 (9th

Cir. 1998) (citing cases) (The Ninth Circuit “repeatedly has stated that a district

court’s inquiry under both Rule 702 and Daubert is a flexible one.”) 

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the flexible nature of that inquiry,14 the court will briefly

examine some additional factors which it deems pertinent in

assessing the reliability of his testimony. The court stresses

that individually none of these factors is determinative. Taken

together, and especially because Dr. Anderson’s testimony does not

satisfy even one of the four Daubert criteria, these additional

factors further undermine the reliability of his testimony however. 

Dr. Anderson admitted that he did not “look[]” at “the process

through which [the LGN] went in order to initiate and ultimately

obtain FDA [Food and Drug Administration] approval[.]” DSOF (doc.

44), exh. B thereto (Anderson Dep’n) at 111:5-8. In fact, Dr.

Anderson did not review any FDA filings in connection with this

action. Id. at 31:8-10. He does not “believe” that he has “seen

the product data insert sheet that accompanied the [LGN] implanted

in Mr. Harrison[.]” Id. at 32:21-24. Nor did he ask for it. Id.

at 32:25-33:1. Likewise, Dr. Anderson did not “undertake[] any

investigation of the clinical history or performance of [the LGN]

of the type implanted in Mr. Harrison[.]” Id. at 30:23-31:2. Thus,

having carefully scrutinized Dr. Anderson’s reports, his affidavit,

and the cited excerpts from his deposition, the court is forced to

conclude that much of his proffered testimony falls into the

category of “unsubstantiated speculation and subjective beliefs.” 

See Cooper, 510 F.3d at 942 (internal quotation marks and citation

omitted). Dr. Anderson’s comment that the LGN is defective because

the manufacturer “spen[t] 25 years with [it] and [did] not spend a

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little bit of research and effort to try and increase the

resistance to fatigue[,]” is illustrative. See PSOF (doc. 56),

exh. A thereto (Anderson Dep’n) at 68:21-24. At the end of the

day, as in Daubert II, this court has not been presented with much

more than Dr. Anderson’s qualifications, his conclusions and his

“assurances of reliability[]” set forth in his affidavit. See

Daubert II, 43 F.3d at 1319. Plainly Rule 702 and Daubert require

more.

For all of these reasons, on this record the court finds,

succinctly put, that “there is simply too great an analytical gap

between the data and the opinion[s] proffered[]” by Dr. Anderson. 

See Joiner, 522 U.S. at 146, 118 S.Ct. at 519 (citation omitted). 

Thus, because as discussed above plaintiffs have not satisfied any

of the Daubert factors, or otherwise shown sufficient indicia of

reliability with respect to Dr. Anderson’s proffered testimony, the

court, in its gatekeeping capacity, finds that his testimony does

not comport with Rule 702 or Daubert in terms of reliability. 

b. Relevancy

Although the court could exclude Dr. Anderson’s testimony

based on its lack of reliability alone, it will briefly consider

the relevancy prong of Daubert as well. Under Daubert, “relevance

means that the evidence will assist the trier of fact to understand

or determine a fact in issue.” Cooper, 510 F.3d at 942 (citing

Daubert, 509 U.S. at 591-92, 113 S.Ct. 2786). “Encompassed in the

determination of whether expert testimony is relevant is whether it

is helpful to the jury, which is the central concern of Rule 702.” 

Id. (internal quotation marks and citation omitted). Addressing

the passing reference to “‘fit’” in Daubert, which “‘goes primarily

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to relevance,’” the Ninth Circuit in Daubert II espoused the view

that “obviously” the Supreme Court “did not intend this prong of

Rule 702 “to be merely a reiteration of the general relevancy

requirement of 402.” Daubert II, 43 F.3d at 1321 n. 17 (quoting

Daubert, 509 U.S. at ___, 113 S.Ct. at 2795). This seemingly

broader, heightened relevance standard is necessary, from the Ninth

Circuit’s perspective, given the Supreme Court’s recognition “that

scientific expert testimony carries special dangers to the factfinding process because it ‘can be both powerful and quite

misleading because of the difficulty in evaluating it.’” Id.

(quoting Daubert, 509 U.S. at ___, 113 S.Ct. at 2798) (other

quotation marks and citations omitted). Thus, the Ninth Circuit

has instructed that “[f]ederal judges must . . . exclude proffered

scientific evidence under Rules 702 and 403 unless they are

convinced that it speaks clearly and directly to an issue in

dispute in the case, and that it will not mislead the jury.” Id.

(emphasis added). 

Under that standard, the court must exclude Dr. Anderson’s

testimony which it has found to be inherently unreliable. Allowing

a jury to consider such unreliable evidence obviously would be

misleading, in direct contravention of Daubert. Therefore, the

court finds that not only is Dr. Anderson’s testimony not reliable,

it is also not relevant within the meaning of Rule 702. 

3. Fed. R. Evid. 403

Finally, the court would be remiss if it did not recognize the

existence of one additional “important constraint” on Dr.

Anderson’s proffered testimony, which is Fed. R. Evid. 403. Jinro

America, 266 F.3d at 1005. Even “[o]therwise admissible expert

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testimony may be excluded under [that Rule] if its probative value

is substantially outweighed by the danger of unfair prejudice,

confusion of the issues, or undue delay.” Id. at 1006. Such is

the case here. Given the court’s finding that Dr. Anderson’s

testimony is both unreliable, and hence not relevant, the court

necessarily concludes that the prejudicial effect of such testimony

outweighs its probative value. Accordingly, for all of the reasons

previously discussed, the court grants Howmedica’s motion to

exclude the testimony of Dr. Robert N. Anderson. 

IV. Summary Judgment

A. Governing Legal Standards

Pursuant to Fed.R.Civ.P. 56(c), a party is entitled to summary

judgment “if the pleadings, depositions, answers to

interrogatories, and admissions on file, together with the

affidavits, if any, show that there is no genuine issue as to any

material fact and that the moving party is entitled to a judgment

as a matter of law.” It is beyond dispute that “[t]he moving

party bears the initial burden to demonstrate the absence of any

genuine issue of material fact.” Horphag Research Ltd. v. Garcia, 

475 F.3d 1029, 1035 (9th Cir. 2007) (citation omitted). 

“Once the moving party meets its initial burden, ..., the

burden shifts to the nonmoving party to set forth, by affidavit or

as otherwise provided in Rule 56, specific facts showing that there

is a genuine issue for trial.” Nidds v. Schindler Elevator Corp.,

113 F.3d 912, 916 (9th Cir. 1996) (internal quotation marks and

citations omitted). When assessing the record to determine whether

there is a “genuine issue for trial,” the court must “view the

evidence in the light most favorable to the nonmoving party,

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drawing all reasonable inferences in his favor.” Horphag, 475 F.3d

at 1035 (citation omitted). Likewise, the court may not make

credibility determinations; nor may it weigh conflicting evidence.

See Anderson, 477 U.S. at 255. Thus, as framed by the Supreme

Court, the ultimate question on a summary judgment motion is

whether the evidence “presents a sufficient disagreement to require

submission to a jury or whether it is so one-sided that one party

must prevail as a matter of law.” Id. at 251-52.

B. Theories of Liability

Plaintiffs’ complaint is not the model of case theory

definition. Under the heading “Amended Complaint” they list

“Products Liability, Strict Liability, Res Ipsa Loquitur, [and]

Negligence[.]” Amended Co. (Doc. 14) at 1. In the body of that

complaint plaintiff did not differentiate among any of those

claimed theories, however. Instead, quoting practically verbatim

from ARS § 12-681(5)’s definition of a “product liability

action[,]” plaintiffs sweepingly allege that the LGN is defective

in manufacturing, design, and due to a failure to warn. See id. at

5, ¶ 31. Next, plaintiffs broadly allege that “[t]he manufacture,

design and warnings placed on [the LGN] were negligently

performed.” Id. As part of their negligence claim, plaintiffs

further allege that the LGN “was insufficient for the purpose for

which it was sold or otherwise designed.” Id. at 5, ¶ 33. 

This court, sitting in diversity jurisdiction, must apply

state law to plaintiffs’ negligence and strict product liability

claims. See Stilwell, 482 F.3d at 1193-94 (citations omitted). 

“Arizona permits tort claims against medical device

manufacturers[,]” such as Howmedica. See id. at 1194 citation

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omitted). Arizona has adopted the Restatement (Second) of Torts

strict liability and negligence standards. Id. (citations

omitted).

“To establish a prima facie case for strict products liability

in Arizona, a plaintiff must show that the product was in a

defective condition (when it left the defendant’s hands), that the

defect made the product unreasonably dangerous, and that the defect

was a proximate cause of plaintiff’s injuries.” Southwest Pet

Products, Inc. v. Koch Industries, Inc., 273 F.Supp.2d 1041, 1051

(D.Ariz. 2003) (citation omitted). “Failure to prove any of these

elements is fatal.” Gebhardt v. Mentor Corp., 191 F.R.D. 180, 184

(D.Ariz. 1999) (citation omitted), aff’d on other grounds without

pub’d opinion, 15 Fed.Appx. 540 (9th Cir. 2001). 

“There are three categories of defects in strict products

liability actions: manufacturing defects; design defects; and

informational defects in regard to instructions and warnings.” 

Southwest Pet Products, 273 F.Supp.2d at 1051 citation omitted). 

As should be evident by now the only category of defect which is

seriously contested on this motion is that of design defect. 

Nonetheless, in part because Howmedica separately moved on each of

these defect theories (and to be thorough), the court will briefly

address the manufacturing and informational defects before turning

to the design defect issue. 

1. Manufacturing Defects

“A defectively manufactured product is one that is flawed as a

result of something that went wrong during the manufacturing

process.” Id. at 1051 n. 15 (internal quotation marks and citation

omitted). Plaintiffs expressly “concede[] that [Dr. Anderson] is

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not going to offer any opinions . . . that the metal alloy

specified and used in the product was not appropriate.” DSOF (doc.

44) at 13, ¶ 54 (citation omitted); see also PSSOF at 5, ¶ 54. Not

only that, plaintiffs also expressly admit, as the LeeGroup report

found, “that the [LGN] failed due to fatigue and was free from

manufacturing defects[.]” Id. at 8, ¶ 38 (citation omitted); see

also PSSOF (doc. 68 - dup. Of 66) at 2. Consequently, the court

grants Howmedica’s motion insofar as it is seeking summary judgment

as to plaintiffs’ claims, whether sounding in strict product

liability or negligence, premised upon a manufacturing defect. 

2. Informational Defects

In a similar vein, plaintiffs expressly admit that Dr.

Anderson “is not going to offer any opinions regarding . . .

defective or inadequate warnings[.]” DSOF (doc. 44) at 13, ¶ 54

(citation omitted); see also PSSOF at 5, ¶ 54. In the absence of

such proof, the court also grants summary judgment in favor of

Howmedica to the extent plaintiffs are seeking to recover in strict

product liability or negligence based upon alleged defects in

instructions and warnings. 

3. Design Defects

Dr. Anderson is plaintiffs’ only expert witness on the issue

of design defect. Because the court is excluding his testimony and

reports, the issue thus becomes whether there remains sufficient

evidence to allow plaintiffs to withstand summary judgment on their

design defect claims, whether couched in terms of strict liability

or negligence. 

In Arizona, a plaintiff cannot prevail in a strict products

liability action based on “proof of the defect alone[.]” Southwest

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15 Unless otherwise indicated, hereinafter all references to the

“Restatement” shall be read as referring to this version.

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Pet Products, 273 F.Supp.2d at 1051 (citation omitted). Instead,

“a strict [product] liability claim arises when a product is in a

defective condition unreasonably dangerous, . . . and the product

fail[s] to perform as safely as an ordinary consumer would expect

when used in an intended or reasonable manner (the consumer

expectation test), or the benefits of the challenged design . . .

outweigh the risk of danger inherent in the design[.]” Stilwell,

482 F.3d at 1194 (internal quotation marks and citations omitted)

(emphasis added). Relying upon Gebhardt, Howmedica urges this

court to find, in effect, that as a matter of law the LGN was not

in a “defective condition unreasonably dangerous.” 

The Gebhardt court granted summary judgment in favor of a

medical device manufacturer because the plaintiff “failed to

demonstrate that a reasonable health-care provider would not

prescribe the [device] for any class of patients and thus that

th[at] [device] was defectively designed.” 191 F.R.D. at 185

(footnote omitted). In so holding, the court “look[ed] to the

Restatement (Third) of Torts”15 which states in pertinent part:

 A prescription drug or medical device is not 

reasonably safe due to defective design if the

foreseeable risks of harm posed by the drug or 

medical device are sufficiently great in relation 

to its foreseeable therapeutic benefits that 

reasonable health-care providers, knowing of such

foreseeable risks and therapeutic benefits, would 

not prescribe the drug or medical device for any 

class of patients.

Id. (quoting Restatement, § 6(c)). Applying that standard,

the Gebhardt court reasoned that summary judgment in the

manufacturer’s favor on “Plaintiff’s design defect claim[]” was

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“proper” because one of plaintiffs’ experts “testified that he

might have used the [device] if confronted with Plaintiff’s medical

condition in the operating room.” Id. (citation omitted). 

Given the testimony of two of Mr. Harrison’s treating

physicians, Howmedica argues that like the medical device

manufacturer in Gebhardt it, too, is entitled to summary judgment

on plaintiffs’ design defect claims. In particular, Dr. Price, the

physician who first implanted the LGN, was asked “as between the

[LGN] and whatever else was available at the time, how did [he]

come to select the [LGN]?” Mot. to Strike, etc. (doc. 63) at 6, ¶

5 (citing deposition of Dr. Price (Jan. 5, 2007) at 16:14-17). He

responded: “Experience, ease of availability and an excellent track

record.” Id. (citing Price Dep’n at 16:18-19). Inquiring as to

what he meant by “excellent track record[,]” Dr. Price agreed that

he was “speaking personally and with regards to the experience of

[his] partners and others that [he] know[s] of firsthand from [his]

practice . . . in Missoula[,]” Montana. Id. (citing Price Dep’n at

17:9-14). 

To clarify his statement that he “had used this device

exclusively since 2001[,]” Dr. Price was further asked, “When you

use the term ‘this device’ are you referring specifically to the

Howmedica product?” Id. (citing Price Dep’n at 16:20-23). Dr.

Price answered affirmatively, explaining that when he said

“exclusively, there may be a DHS there now and again for particular

purposes, but for a primary intertrochanteric hip fracture that was

[his] device of choice[,]” and it “still” is. Id. (citing Price

dep’n at 16:25-17:5). Thus, since August of 2003, when he used the

LGN on Mr. Harrison, to the time of his deposition in January,

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16 Despite otherwise fairly extensive briefing, this is the penultimate

argument, summarily presented, in Howmedica’s Reply.

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2007, Dr. Price estimates that he has used the LGN “[p]robably

40[]" times. Id. (citing Price dep’n at 17:6-8). 

To bolster its argument based upon section 6(c), Howmedica

also relies upon the testimony of Dr. Camarata, one of Mr.

Harrison’s treating physicians in Arizona. Howmedica points out

that Dr. Camarata “testified that he ha[d] no criticisms of Dr.

Price’s decision to use the LGN, but would choose a different

device because of personal preference[.]” Reply (doc. 62) at 6

(citation omitted). Based upon the preceding testimony, Howmedica

asserts that it is entitled to summary judgment on plaintiffs’

design defect claim because “[p]laintiffs cannot establish that a

reasonable health-care provider would not utilize [the LGN] in

treating patients[.]” Id. 

Given the potentially significant impact of Gebhardt, combined

with the fact that Howmedica presented this argument almost as an

afterthought,16 the court ordered plaintiffs to file a sur-reply

“addressing the applicability, if any, of the Restatement (Third)

of Torts, Section 6(c) to the present case.” Doc. 69 at 4. 

Plaintiffs’ sur-reply is not directly responsive to that specific

issue. Instead, without discussing section 6(c) or Gebhardt,

plaintiffs broadly counter that the governing legal standard is

“‘whether a reasonable manufacturer, with knowledge of such

dangers, nevertheless would have put the product on the market.’”

Sur-Reply (doc. 72) at 2 (quoting Dart v. Wiebe Manufacturing,

Inc., 147 Ariz. 242, 249, 709 P.2d 876, 883 (1985)). Plaintiffs

further note that application of that standard requires an analysis

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17 Accord Madsen v. American Home Products Corp., 477 F.Supp.2d 1025, 1037

(E.D. Mo. 2007) (applying § 6(c) and finding that plaintiff “failed to establish

a genuine issue of mater fact on her design defect claims” as to certain diet drugs

where she did “not present[] any evidence that reasonable health-care provides,

knowing the risks and benefits, would not have prescribed [those drugs] to any

class of patients[]”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7

(E.D.Pa. 1998) (quoting Restatement § 6(c)) (granting summary judgment in favor of

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of seven risk/benefit factors. See id. at 2-3 (citation omitted). 

Enumerating those factors, but without indicating where in the

record there is any supporting evidence, plaintiffs baldly assert

that they have “demonstrated a viable claim that should be

presented to a jury.” Id. at 3. 

The court is fully cognizant that Arizona has not “formally

adopted” the Restatement (Third). See Gebhardt, 191 F.R.D. at 185. 

By the same token, though, “Arizona has demonstrated a willingness

to look to” that particular version of the Restatement “as the

current statement of the law[.]” Id. (citing Jimenez v. Sears,

Roebuck & Co., 183 Ariz. 399, 904 P.2d 861, 867 (1995)). That

willingness continues to this day. See, e.g., 1800 Ocotillo, LLC 

v. WLB Group, Inc., ___ P.3d ___, 2008 WL 240949, at *8 (Ariz. App.

Div. 1 Jan. 29, 2008) (citing to the Restatement with respect to

apportionment of liability to support the holding that “a

contractual provision limiting the amount of damages for a party’s

negligence is a form of assumption of risk[]”). Thus (and given

the absence of any compelling reason not to do so by plaintiffs),

as did the Gebhardt court, this court will apply section 6(c) of

the Restatement. When it does that, the result is the same as in

Gebhardt. Plaintiffs have not “demonstrated that a reasonable

health-care provider would not prescribe the [LGN] for any class of

patients and thus that the [LGN] was defectively designed.” See

Gebhardt, 191 F.R.D. at 185 (footnote omitted) (emphasis added.17

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bone screw manufacturer on strict liability design defect claim where plaintiffs

did not “come forward with any evidence which would support a claim that ‘the

foreseeable risks of harm posed by the . . . medical device [we]re sufficiently

great in relation to its foreseeable therapeutic benefits that reasonable healthcare providers, knowing of such foreseeable risks and therapeutic benefits, would

not prescribe the . . . medical device for any class of patients[]’”).

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Indeed, as detailed above, the record proof is to the contrary. 

Health-care providers, such as Dr. Price, would and continue to use

the LGN for patients who have sustained fractures such as that

sustained by Mr. Harrison. 

Having scrutinized the record, the court is aware that

Howmedica rather selectively quoted from Dr. Camarata on this

point. Almost immediately after testifying, as Howmedica notes,

that he would not use the LGN because of “personal preference[,]”

Dr. Camarata testified: “The reason a lot of us never used [the

LGN] was that it had a history of, not fracture where his nail did,

but fracture at the tip of that nail.” Mot. to Strike, etc. (doc.

63), exh. B thereto (Camarata Dep’n at 46:20-23). As Dr. Camarata

colloquially put it, “That was the big knock on that nail.” Id.,

exh. B thereto at 46:23. 

Even taking into account Dr. Camarata’s full testimony on this

point, given the seemingly demanding standard of section 6(c), the

court remains convinced that plaintiffs have not met their burden

of proof thereunder. “The comments to § 6 elaborat[ing] on the

requirements for establishing a defective design of a . . . medical

device” thereunder further support this view. Madsen, 477

F.Supp.2d at 1037. More specifically, those comments state, among

other things, that a “medical device that has usefulness to any

class of patients is not defective in design even if it is harmful

to other patients.” Id. (quoting Restatement, § 6, comment b)

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(emphasis added). In light of the foregoing, although there is

proof in this record that some health care providers did not use

the LGN because of its “history of . . . fractur[ing] at the

tip[,]” there is also contrary proof. See Mot. to Strike, etc.

(doc. 63), exh. B thereto (Camarata Dep’n at 46:20-23). 

Consequently, plaintiffs have not met their burden under section

6(c). 

As in Gebhardt, there is an alternative basis for finding the

LGN does not have a design defect within the meaning of the

Restatement, and hence that summary judgment in Howmedica’s favor

is proper. Section two of the Restatement “defines a defectivelydesigned product as one where the foreseeable risks of harm posed

by the product could have been reduced or avoided by the adoption

of a reasonable alternative design.” Gebhardt, 191 F.R.D. at 185

n.2 (internal quotation marks omitted). Based upon the admission

by plaintiffs’ experts in Gebhardt “that there was no way that the

[medical device] could have been redesigned to avoid the

erosion[,]” the court held that the device at issue was not

defectively designed as section two defines it. Id. (citations

omitted). 

The same is true here. Howmedica’s metallurgist decisively 

opined, “Creation of a fixation device that will never fracture is

not feasible, and this fact is well known in the industry.” DSOF

(doc. 44) at 12, ¶ 50; and exh. M thereto (PE Report) at 4, ¶ 8. 

Plaintiffs do not expressly refute dispute this. Instead, they

resort to Dr. Anderson’s general opinion “that the [LGN] is

defectively designed[.]” PSSOF (doc. 68) at 4, ¶ 50 (citation

omitted). As previously discussed, however, the court is not

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considering Dr. Anderson’s testimony. Therefore, the record as

presently constituted supports a finding, as in Gebhardt, that the

LGN is not a defectively designed product under section 2 of the

Restatement. 

Even disregarding Gebhardt and its application of the

Restatement (Third), nonetheless, the court finds that summary

judgment is proper on plaintiffs’ design defect claims. The Ninth

Circuit’s decision in Stilwell provides a basis, apart from

sections two and 6(c) of the Restatement (Third), for granting that

relief. In Stilwell, a case remarkably similar to the present one,

plaintiff brought a product liability action against the

manufacturer of metal reconstruction nails which were used “to

stabilize a compound . . . fracture of her right femur.” Stilwell,

482 F.3d at 1188 (footnote omitted). The “two nails failed during

the healing process, causing [plaintiff] pain, suffering, and

disability.” Id. “[R]eject[ing] her claims for lack of proof of

causation[,]” the district court granted summary judgment in favor

of the manufacturer. Id. The Ninth Circuit held that the district

court “wrongly excluded the testimony” of plaintiff’s expert

metallurgist. Id. at 1189. Nonetheless, the Ninth Circuit

affirmed “because evidence . . . , including [the expert’s]

deposition testimony and reports, d[id] not demonstrate that any

alleged defects were a cause of the delayed healing of

[plaintiff’s] fractured leg.” Id.

Regardless of whether they are framed in terms of strict

liability or negligence, the Ninth Circuit stated that plaintiff’s

claims “must rely on the allegation that [the] product is

defective.” Id. at 1194 (citations omitted). To determine whether

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a given product is defective requires “some understanding of the

product’s purpose.” Id. (citation omitted). The Stilwell Court

found that plaintiff “failed to provide” that evidence to the

district court though. Id. The Court explained that plaintiff did

“not point[] to any evidence, beyond her doctors’ impressions

regarding the failure rate of the . . . nail, to explain to a jury

the intended duration of its use, which she conceded was not

indefinite.” Id. The Ninth Circuit further noted the “contrary”

proof before the district court. See id. One of plaintiff’s

doctors had “expressed concern that [her] cigarette use would

impede her healing and [another] [had] stated that he would not be

surprised if an intermedullary rod, like [plaintiff’s], failed

after one year, which is longer than the time expected for the

healing process.” Id.

On appeal plaintiff also “did not rely on any record

evidence to support [her] contention[]” that “at a minimum, the

second . . . nail should have performed longer than it did[.]” Id.

at 1195. Instead, she “repeatedly reminded [the Circuit Court]

that her treating physicians testified that a . . . nail failure is

rare[.]” Id. The Stilwell Court held that plaintiff’s “vague

arguments regarding the expected life of the . . . nail . . . d[id]

not refute [the manufacturer’s] evidence that the . . . nails

performed as intended in th[at] case.” Id. Therefore, the Court

concluded that the evidence did “not establish that the . . . nails

in question caused any actionable harm to [plaintiff].” Id.

There is a similar lack of record evidence before this court. 

Plaintiffs have “not pointed to any evidence, . . . , to explain to

a jury the intended duration of [the LGN’s] use[.]” See id. at

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1194. Much like Stilwell, plaintiffs are relying upon “doctors’

impressions regarding the failure rate” of the LGN. See id. In

particular, one of Mr. Harrison’s physicians, Dr. Camarata,

testified that “it’s extremely unusual for this nail to break,

anytime. It’s even more unusual for the nail to break at three

months.” Mot. to Amend and Notice of Erratum (doc. 58), exh. D

thereto (Camarata Dep’n) at 108:13-15. Plaintiffs add that

Howmedica’s orthopaedic expert agreed that in his “experience[,]”

he had “never seen [a LGN] fail or break in this short of period of

time as did [Mr. Harrison’s][.]” Id., exh. B thereto (Marrone

Dep’n) at 42:11-14. “[R]arity does not indicate infallibility[,]”

however, as the Ninth Circuit so aptly stated when confronted with

similar evidence in Stilwell. See Stilwell, 482 F.3d at 1195. 

In their Response, plaintiffs further contend that “there is

evidence Howmedica intended the [LGN] to last longer than the 14

weeks it did[,]” and thus there is a “jury issue” because the LGN

“failed so soon[.]” See Resp. (doc. 53) at 2. Yet, plaintiffs do

not cite to anywhere in this extensive record to support that

contention. See Resp. (doc. 53) at 2. Plaintiffs’ SOF does

include cites, but careful examination of the cited references

reveals that they pertain only to the undisputed fact that “Mr.

Harrison’s fracture was healing at the time the [LGN] broke.” See

Mot to Strike (doc. 63) at 4, ¶ 3; see also PSOF (doc. 54) at 2-3,

¶ 3 (and cited references). Those references do not show that

Howmedica intended the product to last for any particular period of

time.

On the other hand, Dr. Price, also one of Mr. Harrison’s

treating physicians, unequivocally testified that in his “opinion 

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. . . the [LGN] did what it was supposed to do.” DSOF (doc. 44) at

11, ¶ 47; and exh. D thereto (Price Dep’n) at 10:9-10. In a

similar vein, Dr. Camarata agreed that he does “[n]ot always[] 

. . . equate a breaking device with a defective device[.]” Reply

(doc. 62) at 3 (quoting Mot. to Strike (doc. 63), exh. B thereto

(Camarata Dep’n) at 76:14-16). Further, when asked whether

“implantable medical devices can fail for reasons having nothing at

all to do with whether there’s a defect in the product[,]” Dr.

Camarata responded, “True.” Id. (quoting Mot. to Strike (doc. 63),

exh. B thereto (Camarata Dep’n) at 76:17-20). 

As just explained, in response to the foregoing, plaintiffs

have not come forth with any “concrete evidence” showing that there

is a genuine issue for trial with respect to the intended duration

of the LGN’s use – evidence which the Stilwell Court deemed

critical to surviving the manufacturer’s summary judgment motion

there. At most plaintiff have “vague arguments regarding the

expected life of the” LGN. See Stilwell, 489 F.3d at 1194. This

“vague argument” is based upon Howmedica’s initial disclosure

indicating that the LGN “is designed for temporary stabilization

of bone segments until bone consolidation has been achieved[.]”

PSOF (doc. 54), exh. B thereto. From that, plaintiffs contend that

“a jury can readily infer that Howmedica intended the [LGN] to last

until the reasonably expected time for bony consolidation, which

the doctor’s [sic] and material scientists in this case agree

typically takes longer than 14 weeks, including in Mr. Harrison’s

case.” Resp. (doc. 53) at 3. Plaintiffs are disregarding the

fact, however, that only reasonable inferences may be drawn in

opposing summary judgment. See Ackerman v. Western Elec. Co. Inc.,

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860 F.2d 1514, 1520 (9th Cir. 1988) (internal quotation marks and

citation omitted) (emphasis added by Ackerman Court) (“A party

opposing summary judgment is entitled to the benefit of only

reasonable inferences that may be drawn from the evidence put

forth.”) 

“Inferences, . . . , cannot be drawn out of ‘thin air’;

instead, the proponent must adduce evidence of a factual predicate

from which to draw inferences.” Highlen v. Johanns, 2007 WL

220777, at *4 (S.D.Cal. 2007) (quoting American Int’l Group, Inc.

v. American Int’l Bank, 926 F.2d 829, 836 (9th Cir. 1991)). That

factual predicate is missing here. Plaintiffs have not pointed to

record evidence that “bony consolidation . . . typically takes

longer than 14 weeks[.]” See Resp. (doc. 53) at 3. Moreover, it is

undisputed that Mr. Harrison’s fracture was healing, but the bones

had not yet unionized when the LGN broke. See, e.g., Mot. to

Strike, etc. (doc. 36) at 4, ¶ 3; and Mot. to Amend and Notice of

Erratum (doc. 58), exh. D thereto (Camarata Dep’n) at 30:22-31:1

(agreeing that Mr. Harrison did not “have full bone union” when Dr.

Camarata saw him “on the last office visit” before the LGN broke). 

To withstand summary judgment, plaintiffs must rely on something

more than “‘mere speculation, conjecture, or fantasy[.]’” See Bates

v. Clark County, 2006 WL 3308214, at * 2 (D.Nev. Nov. 13, 2006)

(quoting O.S.C. Corp. v. Apple Computer, Inc., 792 F.2d 1464, 1467

(9th Cir. 1986)). Yet in the end, that is all that plaintiffs are

left with in the present case.

Plaintiffs attempt to distinguish Stilwell because of the

different time frames involved. In Stilwell one nail failed at

three years and another at twenty months, whereas the LGN here

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failed at 14 weeks. Plaintiffs further note that in Stilwell

plaintiff’s doctor testified “that he would not be surprised if [a

nail], . . ., failed after one year, which is longer than the time

expected for the healing process.” Stilwell, 484 F.3d at 1194. 

These factual distinctions do not undermine Stilwell’s

applicability here, however. The court does not find these factual

differences determinative given that the crux of the Court’s

holding in Stilwell was the absence of any evidence regarding the

nails’ intended duration. Here, plaintiffs have similarly failed

to direct the court to such evidence. As in Stilwell, the court

believes that it is being “ask[ed] . . . to blindly accept the 

. . . [LGN’s] failure before [Mr. Harrison’s] fracture healed as

prima facie evidence that the[] [LGN] w[as] defective.” See id. at

1193. The court declines to do that. 

It is beyond dispute that “a mere ‘scintilla’ of evidence” is

not sufficient “to defeat a properly supported motion for summary

judgment[.]” Fazio v. City & County of San Francisco, 125 F.3d

1328, 1331 (9th Cir. 1997) (quoting Anderson, 477 U.S. at 249,

252). “[I]nstead, the nonmoving party must introduce some

significant probative evidence tending to support the complaint.” 

Id. Plaintiffs have not done that. Accordingly, the court grants

summary judgment in Howmedica’s favor as to plaintiffs’ design

defect claims, whether based upon negligence or strict liability. 

Conclusion

In sum, the court hereby:

(1) DENIES “Defendant Howmedica Osteonics Corp.’s Motion for

Summary Adjudication of its to [sic] Motion for Summary Judgment

and Motion to Exclude Expert Robert N. Anderson” (doc. 52);

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(2) DENIES “Defendant Howmedica Osteonics Corp.’s Motion to

Strike Plaintiffs’ Controverting Statement of Facts in Response to

Defendant’s Motion to Exclude Expert Opinion” (doc. 60);

(3) DENIES “Defendant Howmedica Osteonics Corp.’s Motion to

Strike Plaintiffs’ Controverting Statement of Facts in Response to

Defendant’s Motion for Summary Judgment” (doc. 63); and

 (4) GRANTS “Defendant Howmedica Osteonics Corp.’s Motion to

Exclude Plaintiffs’ Expert Robert N. Anderson and Motion for

Summary Judgment” (doc. 48). The clerk is directed to enter

judgment for Defendant Howmedica Osteonics Corp. And terminate this

action.

DATED this 27th day of March, 2008.

Copies to counsel of record

Case 2:06-cv-00745-RCB Document 73 Filed 03/31/08 Page 56 of 56