Harrison v. Howmedica Osteonics Corp.

Full title: Edward Harrison and Carol Harrison, husband and wife, Plaintiffs, v…

Court: United States District Court, D. Arizona

Date published: Mar 27, 2008

No. CIV 06-0745 PHX RCB (D. Ariz. Mar. 27, 2008)

Opinion

No. CIV 06-0745 PHX RCB.

March 27, 2008

ORDER

ROBERT BROOMFIELD, Senior District Judge

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] 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).

1 Reply (doc. 59) at 17.

Background ²

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).

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) 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.

3 All references to the LGN herein shall be read as including the screws which were used to set and place the LGN.

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 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.

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 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 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 (9^th 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 (9^th 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, 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.

4 The claims against the other named defendant entities were dismissed with prejudice. See Doc. 13 at 1-2.

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 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 (1^st 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 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.

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.).

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.

6 Document 64 is duplicative of document 57.

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. 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 (9^th 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 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 surface treatments could have been employed on the LGN, which would have "reduce[d] [its] susceptibility to fatigue failure."Id.

7 For ease of reference, the court took the liberty of numbering the pages in this exhibit.

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 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 (9^th Cir. 2007) (internal quotation marks omitted). The Daubert Court "held that Federal Rule of Evidence 702 commands the primary focus for courts evaluating the admissibility of expert testimony." Cooper v. Brown, 510 F.3d 870, 942 (9^th 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 (9^th 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 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 (9^th 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 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 (5^th Cir. 1990) (footnote omitted), abrogated on other grounds, Little v. Liquid Air Corp., 37 F.3d 1069 (5^th Cir. 1996); Kopf v. Skyrm, 993 F.2d 374, 377 (4^th 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.

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.

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.

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 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 (9^th 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).

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).

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 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 Lee Group 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."

10 Prior to the commencement of this action, Mr. Harrison's daughter sent the LGN to RJ Lee Group, self-described "Materials Characterization Specialists[,]" (doc. 56), exh. E thereto (Lee Group 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.

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 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 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 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, "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).

"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 self-serving 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 inDaubert 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 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).

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).

. . .

i. Testing ¹²

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.

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 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 that affidavit, Dr. Anderson avers generally:

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 (9^th 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.

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 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.

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 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 withDaubert. See Daubert II, 43 F.3d at 1316. 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 F.3d at 1318-19 (citing United States v. Rincon, 28 F.3d 921, 924 (9^th 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 (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 (9^th 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 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.

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

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 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'" inDaubert, which "`goes primarily 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 fact-finding 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 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 (9^th 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, 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 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 (9^th 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 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 Lee Group 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 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:

15 Unless otherwise indicated, hereinafter all references to the "Restatement" shall be read as referring to this version.

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, theGebhardt court reasoned that summary judgment in the manufacturer's favor on "Plaintiff's design defect claim" was "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, 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 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.

16 Despite otherwise fairly extensive briefing, this is the penultimate argument, summarily presented, in Howmedica's Reply.

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. (citingJimenez 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 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.

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 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'").

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) (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 defectively-designed 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 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 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 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 . . . 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., 860 F.2d 1514, 1520 (9^th 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 (9<sup>th</sup> 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 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 inStilwell, 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);

(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.