Tucker et al v. Wright Medical Technology, Inc. et al

Filing 147

ORDER by Judge Yvonne Gonzalez Rogers granting in part and denying in part 76 Motion for Summary Judgment (lrc, COURT STAFF) (Filed on 3/19/2013) Modified on 3/19/2013 (fs, COURT STAFF).

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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GREGORY K. TUCKER and REBECCA
TUCKER,

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Plaintiffs,

Case No.: 11-cv-03086-YGR
ORDER GRANTING IN PART AND DENYING IN
PART DEFENDANT’S MOTION FOR SUMMARY
JUDGMENT

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Northern District of California

United States District Court

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vs.
WRIGHT MEDICAL TECHNOLOGY, INC.,
et al.,
Defendants.

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Pending before the Court is Defendant Wright Medical Technology, Inc.’s Motion for

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Summary Judgment on All Causes of Action. Plaintiffs Gregory Tucker and Rebecca Tucker filed

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this products liability action against Defendants Wright Medical Technology, Inc., Wright Medical

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Group, Inc., and Does 1–100 in state court on May 6, 2011. Arising from an alleged failure of a

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Profemur hip implant manufactured by Defendant, Plaintiffs allege claims for: (1) strict liability based

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on theories of design defect, manufacturing defect, and failure to warn; (2) negligence based on

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design defect; (3) negligence based on failure to warn; and (4) loss of consortium by Rebecca Tucker.

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(See Dkt. No. 1.)

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Defendant Wright Medical Technology filed a Motion for Summary Judgment on All Causes

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of Action on December 5, 2012. (“Motion” or “Mot.” [Dkt. No. 76].) Plaintiffs filed their Opposition

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to Defendant’s Motion for Summary Judgment on All Causes of Action on December 18, 2012.

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(“Opposition” or “Opp.” [Dkt. No. 86].) Defendant filed its reply and objections to evidence on

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January 3, 2013. (“Reply” [Dkt. No. 98].) On January 15, 2013, the Court held oral argument on the

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Motion. (Dkt. No. 108.)

Having carefully considered the papers submitted and the pleadings in this action, the

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arguments of counsel, and for the reasons set forth below, the Court hereby:
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100;

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

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GRANTS Defendant’s Motion for Summary Judgment as to the claim for strict liability
based on manufacturing defect;

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

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GRANTS Defendant’s Motion for Summary Judgment as to strict liability based on
failure to warn;

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Northern District of California

DENIES Defendant’s Motion for Summary Judgment as to the claim for negligence
based on design defect;

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United States District Court

GRANTS Defendant’s Motion for Summary Judgment as to the claim for strict liability
based on design defect;

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

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GRANTS Defendant’s Motion for Summary Judgment as to the claim for negligence
based on failure to warn; and

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

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DENIES Defendant’s Motion for Summary Judgment as to Mrs. Tucker’s claim for loss
of consortium.

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DISMISSES WITH PREJUDICE Defendants Wright Medical Group, Inc. and Does 1–

I.

FACTUAL AND PROCEDURAL BACKGROUND

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Plaintiff Gregory Tucker was diagnosed with osteonecrosis in both hips in 2003. (RSS No.

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3.)1 Mr. Tucker’s medical history includes obesity, alcohol abuse, degenerative disc disease, right

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knee meniscus tear, falls, and alcohol-induced osteonecrosis. (RSS No. 18.)
On March 20, 2006, Mr. Tucker underwent a right hip replacement surgery performed by a

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treating physician, Dr. Kevin Bozic. (RSS No. 54.) Dr. Bozic prescribed the Profemur® hip system

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and implanted it in Mr. Tucker. (RSS No. 6.) Among other reasons, Dr. Bozic chose this prosthesis

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“to allow use of a hard-on-hard (ceramic-ceramic) bearing.” (Id.) The implant consisted of a cup, a

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head, a neck and a stem (PHA0-1224 long neck combined with a Plasma Z-Stem). (RSS No. 54.) At

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“RSS” refers to Plaintiffs’ Response and Supporting Separate Statement of Undisputed Material Facts and
Supporting Evidence in Support of Its Opposition to Defendant’s Motion for Summary Judgment of All
Counts. (Dkt. No. 89.) Unless otherwise noted, the references to the material fact numbers include the
evidence supporting the same.

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the time of this surgery, Mr. Tucker was 6’3” tall and weighed 257 pounds. (RSS Nos. 50 & 54.)2

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On May 7, 2010, Mr. Tucker’s right hip implant fractured. (RSS No. 1.) Metal fatigue is a

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well-known phenomenon and modular orthopedic implants are known to be susceptible to fretting and

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fretting-induced fatigue. (RSS No. 8.)3 Although the parties seem to disagree on what initiated the

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failure of the implant, the parties agree that fretting, corrosion, and metal fatigue each played a role in

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the fracture of the neck of the implant. (RSS No. 60.) Prior to the implant breakage on May 7, 2010,

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Dr. Bozic observed positive results with Mr. Tucker’s right hip and no complications. (Declaration of

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Kevin Bozic, M.D. in Support of Plaintiffs’ Opposition to Defendant’s Motion for Summary

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Judgment (“Bozic Decl.” [Dkt. No. 90]) ¶ 8.)
Plaintiffs initiated this action in state court on May 6, 2011, alleging claims for strict liability

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Northern District of California

based on theories of design defect, manufacturing defect, and failure to warn; negligence based on

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United States District Court

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design defect; negligence based on failure to warn; and loss of consortium by Mrs. Tucker.

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Defendant filed three motions to exclude opinion testimony of Plaintiffs’ experts in conjunction with

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the summary judgment motion and at trial. (Dkt. Nos. 62, 63 & 67.) Specifically, Defendant sought

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to exclude: (1) the expert opinion of Dr. Lester Hendrickson in its entirety, or in the alternative,

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certain opinions of Dr. Hendrickson (Dkt. No. 63); (2) certain opinion testimony of Dr. Bozic (Dkt.

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No. 62); and (3) certain opinion testimony of Mari Truman, P.E. (Dkt. No. 67). Plaintiffs opposed

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each of the motions to exclude (Dkt. Nos. 77, 80 & 83) and Defendant, in turn, filed replies and

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evidentiary objections. (Dkt. Nos. 95, 96 & 97.) The Court issued its rulings on the motions to

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exclude and expert-related evidentiary issues on February 27, 2013. (Dkt. No. 115.)

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Mr. Tucker also had procedures performed on his left hip. Mr. Tucker underwent a left hip hemiresurfacing
on November 24, 2003 and a total left hip replacement surgery on April 26, 2007. (RSS No. 4.)

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Fretting is a process that results from very slight oscillatory motion between surfaces pressed together in
physical contact. (Declaration of Lester Hendrickson, PhD, in Support of Plaintiffs’ Opposition to Defendant’s
Motion for Summary Judgment on All Causes of Action (Dkt. No. 88 [“Hendrickson Decl.”]) ¶¶ 8–9; see also
Expert Report of Brad James, Ph.D., P.E., FASM [Dkt. No. 73-4] at 5 (“Fretting occurs at the contact area
between two metal surfaces that are under load and subject to cyclic relative micro-motion. The contact force
and relative motion causes adhesion between the mating surfaces. Adhered particles are removed from the
surfaces, resulting in metal loss and the presence of potentially abrasive material between the surfaces.”)
(footnote omitted), attached as Ex. D to Declaration of Michael O. Fawaz in Support of Defendant Wright
Medical Technology, Inc.’s Motion for Summary Judgment on All Causes of Action [Dkt. No. 73].)
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II.

LEGAL STANDARD
Summary judgment is appropriate when no genuine dispute as to any material fact exists and

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the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). A party seeking

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summary judgment bears the initial burden of informing the court of the basis for its motion, and of

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identifying those portions of the pleadings, depositions, discovery responses, and affidavits that

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demonstrate the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317,

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323 (1986). Material facts are those that might affect the outcome of the case. Anderson v. Liberty

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Lobby, Inc., 477 U.S. 242, 248 (1986). The “mere existence of some alleged factual dispute between

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the parties will not defeat an otherwise properly supported motion for summary judgment; the

fact is “genuine” if there is sufficient evidence for a reasonable jury to return a verdict for the non-

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Northern District of California

requirement is that there be no genuine issue of material fact.” Id. at 247–48 (dispute as to a material

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moving party).

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Where the moving party will have the burden of proof at trial, it must affirmatively

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demonstrate that no reasonable trier of fact could find other than for the moving party. Soremekun v.

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Thrifty Payless, Inc., 509 F.3d 978, 984 (9th Cir. 2007). On an issue where the non-moving party will

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bear the burden of proof at trial, the moving party can prevail merely by pointing out to the district

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court that the non-moving party lacks evidence to support its case. Id. If the moving party meets its

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initial burden, the opposing party must then set out “specific facts” showing a genuine issue for trial

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in order to defeat the motion. Id. (quoting Anderson, 477 U.S. at 250). The opposing party’s

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evidence must be more than “merely colorable” but must be “significantly probative.” Id. at 249–50.

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Further, that party may not rest upon mere allegations or denials of the adverse party’s evidence, but

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instead must produce admissible evidence that shows a genuine issue of material fact exists for trial.

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Nissan Fire & Marine Ins. Co. v. Fritz Cos., Inc., 210 F.3d 1099, 1102–03 (9th Cir. 2000); Nelson v.

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Pima Cmty. College Dist., 83 F.3d 1075, 1081–1082 (9th Cir. 1996) (“mere allegation and speculation

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do not create a factual dispute”); Arpin v. Santa Clara Valley Transp. Agency, 261 F.3d 912, 922 (9th

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Cir. 2001) (“conclusory allegations unsupported by factual data are insufficient to defeat [defendants’]

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summary judgment motion”).

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When deciding a summary judgment motion, a court must view the evidence in the light most

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favorable to the non-moving party and draw all justifiable inferences in its favor. Anderson, 477 U.S.

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at 255; Hunt v. City of Los Angeles, 638 F.3d 703, 709 (9th Cir. 2011). However, in determining

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whether to grant or deny summary judgment, it is not a court’s task “to scour the record in search of a

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genuine issue of triable fact.” Keenan v. Allan, 91 F.3d 1275, 1279 (9th Cir. 1996) (internal

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quotations omitted). Rather, a court is entitled to “rely on the nonmoving party to identify with

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reasonable particularity the evidence that precludes summary judgment.” See id.; Carmen v. San

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Francisco Unified Sch. Dist., 237 F.3d 1026, 1031 (9th Cir. 2001) (“The district court need not

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examine the entire file for evidence establishing a genuine issue of fact, where the evidence is not set

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forth in the opposing papers with adequate references so that it could conveniently be found.”)

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III.

DISCUSSION

Northern District of California

United States District Court

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A.

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Moving party Wright Medical Technology, Inc. seeks dismissal of Wright Medical Group,

Dismissal of Defendant Wright Medical Group and Does 1–100

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Inc. and Does 1–100 with prejudice, arguing that Wright Medical Group has not been served and

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Plaintiffs have offered no explanation why they have not named any Doe defendants. Plaintiffs stated

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at oral argument that they have no objection to dismissing these defendants. Accordingly, the Court

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hereby DISMISSES WITH PREJUDICE Wright Medical Group, Inc. and Does 1–100.

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B.

Motions to Exclude Expert Testimony and Objections to Evidence

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As discussed above, Defendant filed three motions to exclude opinion testimony of three of

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Plaintiffs’ experts concurrently with its summary judgment motion. (See Dkt. Nos. 62, 63 & 67.) The

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Court has issued its order granting in part and denying in part Defendant’s motions to exclude (Dkt.

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No. 115), including rulings on evidentiary objections to expert declarations submitted with Plaintiffs’

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Opposition to Defendant’s Motion (see Dkt. Nos. 87, 88 & 90; Reply at 1–4).4 Additional evidentiary

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issues with respect to the Motion for Summary Judgment are addressed below.

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The proposed form of order regarding Defendant’s motions to exclude and evidentiary objections to expert
declarations was provided to the Court by Defendant. (See Dkt. Nos. 105 & 107.) To the extent that Defendant
failed to include any objection to a particular expert opinion or declaration statement in its proposed order,
those objections are deemed waived.
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Plaintiffs object to the Declaration of Debby Daurer in Support of Defendant’s Motion

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(“Daurer Decl.”). (See Dkt. No. 72.) They argue that Defendant failed to identify Ms. Daurer both in

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its initial disclosures and in response to a deposition notice of the person most knowledgeable about

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modular necks. Having not identified her, Plaintiffs contend that “Wright is now attempting to use

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Ms. Daurer to provide testimony regarding the history of the Profemur system, including the FDA

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clearance, changes to the devices design [sic], the total amount of systems sold, the fracture rate of the

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necks, availability of the hip system, the CAPA testing, and Safety Alert letters that went out.” (Opp.

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at 5.)

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Declaration of Debby Daurer

Defendant responds that the Daurer Declaration should not be excluded because she has long

Northern District of California

been known to Plaintiffs, and her declaration only identifies background information, information

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disclosed through other sources, or authenticates facts already in the record that Plaintiffs are not

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otherwise disputing. (Reply at 5.) Specifically, Mr. Tucker testified in his deposition regarding

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communications with Ms. Daurer, she was identified by Defendant’s 30(b)(6) witness at deposition,

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and Plaintiffs cite to an email by Ms. Daurer in support of their Opposition. (Id.) In addition,

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Defendant asserts Ms. Daurer authenticates information that is uncontested, known through other

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sources, and/or has otherwise been produced during discovery. Plaintiffs do not object to the

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authenticity of any documents she attaches. (Id. at 6.)

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The Court agrees with Defendant. Plaintiffs do not object to the substance of the Daurer

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Declaration or the exhibits attached thereto. Her identity comes as no surprise to Plaintiffs, and

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Plaintiffs could have elected—but chose not—to depose Mr. Daurer. Moreover, Plaintiffs do not

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claim that the 30(b)(6) witness whose deposition was taken was inadequate or unprepared. For these

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reasons, the Court DENIES Plaintiffs’ request to exclude the Daurer Declaration.

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2.

Declaration of Thomas M. Gray in Support of Plaintiffs’ Opposition

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Defendant objects to portions of the Declaration of Thomas M. Gray in Support of

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Plaintiffs’ Opposition (“Gray Decl.” [Dkt. No. 91]) as new and cumulative, prejudicial, and/or a waste

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of time. (See Reply at 4–5; Gray Decl. ¶¶ 2–24, 25–29 & 31.) Defendant fails to make even a

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colorable effort at explaining the basis for any of its objections, particularly the nature of the alleged

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prejudicial effect or how the evidence “waste[s]” this Court’s time. Defendant’s objections are

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OVERRULED.

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Defendant previously objected to Ex. S attached to the Gray Declaration. (Reply at 5.)

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Defendant has now withdrawn this evidentiary objection. (Dkt. No. 112 at 4.) Accordingly, the Court

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need not rule on this objection.

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C.

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Plaintiffs allege claims for strict liability and negligence based on design defect. The Court

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Design Defect

will address each claim of design defect in turn.
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Design Defect: Strict Liability
a.
Summary of California Law Regarding Strict Liability for Medical
Implants

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“A manufacturer is strictly liable for injuries caused by a product that is (1)

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defectively manufactured, (2) defectively designed, or (3) distributed without adequate instructions or

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warnings of its potential for harm.” Hufft v. Horowitz, 4 Cal. App. 4th 8, 13 (Cal. Ct. App. 1992)

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(citing Barker v. Lull Eng’g Co., 20 Cal. 3d 413, 428 (1978)). Generally, design defects exist where a

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product is built in accordance with its intended specifications, but the design itself is inherently

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defective. Barker, 20 Cal. 3d at 429. “[A] product is defective in design either (1) if the product has

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failed to perform as safely as an ordinary consumer would expect when used in an intended or

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reasonably foreseeable manner, or (2) if, in light of [] relevant factors . . . , the benefits of the

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challenged design do not outweigh the risk of danger inherent in such design.” Barker, 20 Cal. 3d at

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418.
California courts have found an “exception” to the above general rule of strict liability when it

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comes to prescription drugs. Artiglio v. Superior Court, 22 Cal. App. 4th 1388, 1392 (Cal. Ct. App.

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1994). In Brown v. Superior Court, the California Supreme Court concluded that “a drug

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manufucturer’s liability for a defectively designed drug should not be measured by the standards of

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strict liability” but, rather, the “appropriate test for determining responsibility is the test stated in

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comment k [to section 402A of the Restatement Second of Torts (“Comment k”)].”5 44 Cal. 3d 1049,

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Comment k provides: “Unavoidably unsafe products. There are some products which, in the present state of
human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are
especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper
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1061 (1988) (basing its conclusion, in part, on “the public interest in the development, availability,

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and reasonable price of drugs”). Brown established that “a manufacturer is not strictly liable for

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injuries caused by a prescription drug so long as the drug was properly prepared and accompanied by

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warnings of its dangerous propensities that were either known or reasonably scientifically knowable at

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the time of distribution.” 44 Cal. 3d at 1069.6 Despite the exception for prescription drugs set forth in

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Brown, drug manufacturers remain subject to liability for manufacturing defects, negligence, and for

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failure to warn of known or reasonably knowable side effects. Id. at 1069 n.12.
While the holding in Brown was limited to prescription drugs, the Court of Appeal in Hufft v.

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caused by an implanted prescription medical product which has been (1) properly made and (2)

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distributed with information regarding risks and dangers of which the manufacturer knew or should

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Northern District of California

Horowitz “follow[ed] Brown’s lead [to] hold that a manufacturer is not strictly liable for injuries

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have known at the time.” 4 Cal. App. 4th at 11 (emphasis supplied). The extension to medical

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implants was further addressed by the Court of Appeal in Artiglio v. Superior Court:

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We therefore follow the lead of the Hufft and Plenger courts, and conclude that the
entire category of medical implants available only by resort to the services of a
physician are immune from design defect strict liability. There is no contention
anywhere in the record of these coordinated cases that any of the breast implants, the
subject of the various claims, were obtained other than by the services of a
physician. Therefore, the determination that strict liability based on design defect is
unavailable for all such claims is one to be made as a matter of law, and without the
benefit of any factfinding, except for the sole factual determination, made without
dispute in these cases, that the breast implants are all physician-directed and
physician-applied. Summary adjudication was therefore appropriate.

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directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other
drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or
under the prescription of a physician. . . . The seller of such products, again with the qualification that they are
properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held
to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply
the public with an apparently useful and desirable product, attended with a known but apparently reasonable
risk.”
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Brown explicitly disapproved of prior precedent that held Comment k should not be applied to a drug unless
the trial court first determined that the drug was “unavoidably dangerous.” 44 Cal.3d at 1068–69. The court
held that Comment k “was intended to and should apply to all prescription drugs.” Id. at 1069 n.11 (“[T]he
benefit of the negligence standard stated in the comment would be greatly diminished if all drugs were required
to run the gauntlet of a risk[-]benefit analysis in order to qualify for application of the standard.”).
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b.

Summary of Argument and Analysis

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Defendant argues that Brown, Hufft, and the unavoidably unsafe defense set

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forth in Comment k act as a complete bar to Plaintiffs’ strict liability design defect claim. (Mot. at 8–

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9.) Defendant notes that numerous district courts in California have prohibited such strict liability

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claims. See, e.g., Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 2149095 (N.D. Cal. May 31,

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2011); Currier v. Stryker Corp., No. 2:11-cv-1203 JAM-EFB, 2011 WL 4898501 (E.D. Cal. Oct. 13,

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2011). Here, the parties agree that the device at issue was available only through a prescribing

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physician, and that Mr. Tucker’s physician, Dr. Bozic, prescribed and installed the device. (RSS Nos.

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5–6.) As such, Defendant contends the claim cannot withstand summary judgment.
While recognizing that Hufft extended the holding in Brown to implanted prescription medical

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Northern District of California

devices, Plaintiffs principally respond that in order to be exempt from strict liability, Defendant must

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still show that the device was properly made and distributed with information regarding known risks

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and dangers. (Opp. at 15.) They argue the evidence shows that the product’s design outweighed the

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benefits, that safer alternatives existed, that known neck breakages prior to 2006 were not disclosed in

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warnings, and that a manufacturing defect could “[]not be ruled out.” (Id.) Plaintiffs fail to address

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Defendant’s cited authority directly. In doing so, Plaintiffs assert the Motion must be denied.
Plaintiffs’ failure to address Defendant’s authority is telling.7 In Rhynes and Currier, two

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district courts granted motions to strike plaintiffs’ strict liability design defect claims because

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“controlling California law unequivocally prohibits strict liability claims for design defect against

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manufacturers of prescription implantable medical devices.” Rhynes, 2011 WL 2149095, at *6 (citing

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Brown, Hufft, and Artiglio); Currier, 2011 WL 4898501, at *2 (stating the same). While these were

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not summary judgment motions, it was undisputed in Rhynes (as here) that “Rhyne’s hip implant

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prosthesis was obtained through a physician and qualifies as a prescribed device.” 2011 WL

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Plaintiffs cite to Rosburg v. Minnesota Mining & Mfg. Co., 181 Cal. App. 3d 726 (Cal. Ct. App. 1986) for the
proposition that “[a] design defect in strict liability still requires the benefits of the challenged design to
outweigh the risk of danger inherent in the design.” (Opp. at 14.) Rosburg, however, preceded Brown, Hufft,
and Artiglio and the district court cases referenced herein. Moreover, Rosburg did not mandate that a riskbenefit analysis be undertaken in a strict liability case. Rather, the Court of Appeal inquired into whether there
was substantial evidence to support the trial court’s decision that benefits of the product outweighed the risk of
injury. Rosburg, 181 Cal. App. 3d at 734. There, the court held that there was substantial evidence to support
the trial court’s finding regarding the risk-benefit analysis. Id.
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2149095, at *6. Moreover, the Rhynes court confronted the precise argument Plaintiffs make here—

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namely, that Hufft limited liability to cases where the product has been properly made and distributed

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with adequate warnings and defendant Stryker was not immune from strict liability since the

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complaint contained allegations of manufacturing defect and improper warnings. Id. at *7.

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Importantly, the district court held:

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Plaintiffs misconstrue the quoted language from Hufft to suggest that a manufacturer
is only immune from strict liability for defective design if there are no allegations of
manufacturing defects or inadequate warning labels. Properly read, and as the rest of
Hufft makes clear, this statement means that a manufacturer of prescription medical
devices can be held strictly liable only for manufacturing defects or inadequate
warnings-it may not be held strictly liable for design defects. . . . California law
categorically protects manufacturers of prescription medical devices from strict
liability for design defects.

Northern District of California

Rhynes, 2011 WL 2149095, at *7 (striking strict liability design defect allegations without leave to

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amend); Currier, 2011 WL 4898501, at *3 (dismissing with prejudice plaintiff’s claim based “on the

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design defect theory [because] such a claim is prohibited under California law”).

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Plaintiffs’ attempt to salvage the strict liability claim by bootstrapping it to their negligent

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design claim—i.e., the risk-benefits analysis—is unavailing. (See Opp. at 14.) Plaintiffs ignore that

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the California Supreme Court has rejected conditioning strict liability on a risk-benefit analysis.

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Brown, 44 Cal. 3d at 1069 n.11 (“[T]he benefit of the negligence standard stated in [Comment k]

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would be greatly diminished if all drugs were required to run the gauntlet of a risk[-]benefit analysis

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in order to qualify for application of the standard.”). In addition, the district court in Adams v. I-Flow

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Corp. stated that under Brown, “the California Supreme Court held that both of the tests for

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establishing design defect in California-i.e., the consumer expectations test and the risk-benefit test-

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are inappropriate in the context of prescription pharmaceutical products.” No. CV09-09550 R(SSx),

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2010 WL 1339948, at *6 (C.D. Cal. Mar. 30, 2010) (emphasis supplied). There, the court held that

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the design defect claim based on strict liability was “unequivocally barred by California law” and thus

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“stricken without leave to amend.” Id.

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“[T]he determination that strict liability based on design defect is unavailable for all such

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claims is one to be made as a matter of law, and without the benefit of any factfinding, except for the

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sole factual determination, made without dispute in these cases, that the . . . implants are all physician-

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directed and physician-applied.” Artiglio, 22 Cal. App. 4th at 1397 (emphasis supplied; affirming

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summary adjudication). Accordingly, because the implant at issue was prescribed and installed by Dr.

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Bozic, the Court finds that Plaintiffs’ strict liability claim based on design defect is precluded as a

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matter of California law. Defendant’s Motion for Summary Judgment on this claim is GRANTED.

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2.

Design Defect: Negligence

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a.

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A plaintiff alleging a design defect claim under a negligence theory must prove

Summary of Law

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“that the defect in the product was due to negligence of the defendant.” Chavez v. Glock, Inc., 207

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Cal. App. 4th 1283, 1305 (Cal. Ct. App. 2012) (quoting Merrill v. Navegar, Inc., 26 Cal. 4th 465, 479

damages. Howard v. Omni Hotels Mgmt. Corp., 203 Cal. App. 4th 403, 428 (Cal. Ct. App. 2012); see

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(2001)). As with a general negligence claim, the plaintiff must show breach of duty, causation, and

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also Jud. Council of Cal. Civ. Jury Instructions (“CACI”) No. 1220 (entitled “Negligence—Essential

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Factual Elements”). As to the standard of care for negligence, a “[designer/manufacturer/etc.] is

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negligent if [it] fails to use the amount of care in [designing/manufacturing/etc.] the product that a

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reasonably careful [designer/manufacturer/etc.] would use in similar circumstances to avoid exposing

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others to a foreseeable risk of harm. [¶] In determining whether [defendant] used reasonable care,

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[the jury] should balance what [defendant] knew or should have known about the likelihood and

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severity of potential harm from the product against the burden of taking safety measures to reduce or

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avoid the harm.” Howard, 203 Cal. App. 4th at 428 (seventh alteration supplied; all other alterations

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in original) (quoting CACI 1221 [entitled “Negligence—Basic Standard of Care”]).

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Generally, “the test of negligent design involves a balancing of the likelihood of harm to be

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expected from a [product] with a given design and the gravity of harm if it happens against the burden

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of the precaution which would be effective to avoid the harm.” Merrill, 26 Cal. 4th at 479 (internal

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citations and quotations omitted); Chavez, 207 Cal. App. 4th at 1305 (quoting Merrill). Even if a

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manufacturer has done all it reasonably could have done to warn about a risk or hazard related to a

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product’s design, a reasonable person could conclude that the magnitude of the reasonably foreseeable

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harm as designed outweighed the utility of the product as designed. Chavez, 207 Cal. App. 4th at

28

1305. “Thus, ‘most of the evidentiary matters’ relevant to applying the risk[-]benefit test in strict

11

1

liability cases ‘are similar to the issues typically presented in a negligent design case.’” Id. (quoting

2

Merrill, 26 Cal. 4th at 479–80). Here, both parties have addressed Plaintiffs’ negligent design claim

3

under the framework of a risk-benefit analysis. (Mot. at 9; Opp. at 6.)

4

“In evaluating the adequacy of a product’s design under the risk-benefit test, ‘a jury may

5

consider, among other relevant factors, the gravity of the danger posed by the challenged design, the

6

likelihood that such danger would occur, the mechanical feasibility of a safer alternative design, the

7

financial cost of an improved design, and the adverse consequences to the product and to the

8

consumer that would result from an alternative design.’” Chavez, 207 Cal. App. 4th at 1308–09

9

(quoting Barker, 20 Cal. 3d at 431–32); see also CACI 1204 (entitled “Strict Liability—Design

10

Defect—Risk-Benefit Test—Essential Factual Elements—Shifting Burden of Proof”).

Northern District of California

b.

12
United States District Court

11

Summary of Argument

Defendant submits that Plaintiffs cannot make a prima facie showing of

13

causation because their experts have not and cannot prove that the Profemur® design was inherently

14

defective. (Mot. at 10.) Relying exclusively on another case against Wright entities in the Central

15

District of Illinois, Defendant argues that summary judgment is appropriate when a plaintiff “does not

16

submit evidence necessary to undergo the risk-benefit analysis.” (Id. (citing Cappellano v. Wright

17

Medical Group, Inc., 838 F. Supp. 2d 816 (C.D. Ill. 2012).)

18

In that case, determined under Illinois law, the district court found that plaintiff provided

19

sufficient evidence that an alternate (monolithic) design was available at the time the Profemur®

20

prosthesis was manufactured, and that there were advantages to a modular design over the monolithic.

21

Id. at 829. However, plaintiff’s evidence failed to provide “information from which th[e] court could

22

compare the risks of the modular design of the Profemur® prosthesis with the risks of the proposed

23

alternate monolithic design.” Id.; see id. at 832 (granting summary judgment because plaintiff failed

24

to offer evidence from which the court could conduct a “threshold risk-utility analysis”). Specifically,

25

the court held that “[b]ased on Jablonski [v. Ford Motor Co., 353 Ill. Dec. 327, 955 N.E.2d 1138,

26

1158 (2011)], Defendants [were] correct that Plaintiff [was] required to show that the monolithic

27

design did not have dangers of equal or greater magnitude.” Id. at 829. The Cappellano court also

28

held that even though plaintiff produced evidence that chromium cobalt may be stronger, he failed to

12

1

provide a basis for whether the risks of a titanium alloy neck outweighed the benefits, and he failed to

2

provide a cost comparison between the two alternate designs. Id. at 829–30.
Defendant next contends that any showing Plaintiffs have made regarding defect is

3
4

“inconsequential” because Defendant has met its burden showing that “on balance, the benefits of the

5

[chosen] Profemur® design outweigh[ed] its risks and that the Profemur® met the state of the art

6

standard at the time of its design.” (Mot. at 10.) Specifically, Defendant argues that its experts opine

7

that modular systems, such as the Profemur, have distinct advantages in fitting patient anatomy that

8

better enable surgeons to optimize a patient’s biomechanics. (Id. at 11 (citing RSS Nos. 9, 10 & 17).)

9

The medical community “generally believes” these benefits outweigh disadvantages because modular

material selection, Defendant argues that titanium alloy has “superior biocompatibility and superior

12
Northern District of California

hip prostheses continue to be extensively used. (Mot. at 11 (citing RSS Nos. 11 & 12).) As to

11

United States District Court

10

corrosion resistance” compared to cobalt chromium alloys, which is the primary alternative material

13

suggested by Plaintiffs. (Mot. at 11 (citing RSS No. 13).) Recognizing that cobalt chromium

14

generally has superior wear resistance and fatigue strength than titanium, Defendant argues that such

15

implants may be too stiff and may result in stress shielding of nearby bone, bone resorption, and

16

possible implant loosening. (Mot. at 11 (citing RSS No. 13).) In sum, Defendant argues that

17

Plaintiffs only identify “potential risks with different design elements, such as the material selection

18

and modular form” but ignore the benefits of the Profemur design. (Mot. at 13.)8
Plaintiffs respond that Defendant itself glosses over the risks of its chosen design and that the

19
20

risks outweighed the benefits here based on increased risks in higher demand patients, Defendant’s

21

knowledge, and the availability of safer alternatives. (Opp. at 6.) More specifically, Plaintiffs argue

22

that they have provided expert opinion showing: (i) Defendant’s knowledge of the susceptibility of

23
8

24
25
26
27
28

Defendant also makes a number of arguments regarding the reasonableness of its conduct and causation.
First, at the time of the implant, Defendant contends that it knew of only two failures out of more than 58,000
installations. (Mot. at 12 (citing RSS No. 35).) Second, the Profemur had been fully tested to industry
standards and met FDA requirements, which Plaintiffs’ expert Truman admitted in another Profemur litigation.
(Mot. at 13 (citing RSS Nos. 24–26, 28–29 & 61–62).) Defendant argues that because the design was
“consistent with the then-state-of-the-art, . . . [it has] a defense that can defeat [the] negligent design claim[]
under California law.” (Mot. at 13 (citing Rosburg, 181 Cal. App. 3d at 735).) Finally, Defendant argues that
factors or conditions in Mr. Tucker’s medical history, including his obesity, alcohol abuse, and alcohol-induced
osteonecrosis, served as contraindications and risk factors, which ultimately “affect[ed] his biomechanics by
acutely and chronically overloading his right hip joint.” (Mot. at 11–12 (citing RSS Nos. 18–20 & 27).)
13

1

the modular design to fretting and fracture because titanium alloy was not strong enough to withstand

2

foreseeable forces on the device for heavier patients; (ii) Defendant’s awareness from testing that the

3

device could not sustain forces of those in higher weight groups, who were the target group of users;

4

(iii) Defendant failed to consider safer alternatives of either switching to a stronger material (cobalt

5

chromium) or using surface treatments; and (iv) potential costs of these alternatives. (Opp. at 6–7; see

6

id. at 14 (“the risks in using the titanium alloy for long necks outweighed the benefits touted by

7

Wright, especially in light of the viable safer alternatives that were not cost prohibitive”).)

8

c.

Analysis

9

The Court first notes that the Cappellano decision is not persuasive authority as

Defendant, this Court would have to find that a juror could not reasonably find that the risks of the

12
Northern District of California

Plaintiffs’ negligent design defect claim is based on California law.9 To grant summary judgment to

11

United States District Court

10

Profemur outweighed its benefits. Similarly, the Court would have to hold that no juror could find

13

that Defendant failed to use the amount of care in designing the product that a reasonable designer

14

would have used in similar circumstances to avoid exposing others to a foreseeable risk of harm. See

15

Howard, 203 Cal. App. 4th at 428; CACI 1221.
Plaintiffs have presented sufficient evidence from which a jury could balance what defendant

16
17

“knew or should have known about the likelihood and severity of potential harm . . . against the

18

burden of taking safety measures to reduce or avoid the harm” (Howard, 203 Cal. App. 4th at 428;

19

CACI 1221), such that it could find that Defendant’s conduct fell below the standard of reasonable

20

care. In analyzing the risks and benefits, a jury may consider, among other relevant factors, the

21

gravity of the danger posed by the challenged design, the likelihood that such danger would occur, the

22

mechanical feasibility of a safer alternative design, the financial cost of an improved design, and the

23

adverse consequences to the product and to the consumer that would result from an alternative design.

24

Chavez, 207 Cal. App. 4th at 1308–09 (quoting Barker, 20 Cal. 3d at 431–32); see also CACI 1204.10

25
26
27
28

9

Neither Jablonski nor Cappellano has been adopted by a state or district court outside of Illinois or the
Seventh Circuit.
10

The parties agree that implant design is a balancing act that takes into consideration many factors. (RSS No.
12.)
14

Plaintiffs’ evidence relates to various factors that, when taken in the light most favorable to

1
2

Plaintiffs, directly implicate the balancing that must be done to determine the reasonableness of

3

Defendant’s conduct. For example, Plaintiffs’ expert Dr. Lester Hendrickson concludes that the

4

Profemur’s modular design introduced a risk of failure to the device by fretting, corrosion, and

5

fatigue. (Hendrickson Decl. ¶ 14; id. ¶ 10 (fatigue, fracture, and fretting were direct result of design).)

6

According to Dr. Hendrickson, fretting is well-known in the industry. (Id. ¶ 34.) Plaintiffs’ expert

7

Mari Truman states that the Profemur and its long neck were defectively designed, in part, because

8

Defendant failed to use cobalt chromium, which was a stronger material and a reasonable, available

9

alternative that could have been used at a minimal cost. (Declaration of Mari Truman, P.E. in Support

87]) ¶¶ 62–65 & 70–71.) Truman also states that surface treatments (such as “shock peening, roller

12
Northern District of California

of Plaintiffs’ Opposition to Defendant’s Motion for Summary Judgment (“Truman Decl.” [Dkt. No.

11

United States District Court

10

burnishing, and surface hardening/coatings”) could have been utilized by Defendant to enhance the

13

fatigue strength of the Profemur. (Id. ¶ 61.) These treatments were common, available, and not cost

14

prohibitive had Defendant chosen to use them. (Id. ¶¶ 61 & 69–70.) Truman further states that in

15

light of Defendant’s marketing of the product to heavier and/or more active individuals (such as Mr.

16

Tucker), its testing—while perhaps meeting industry standards11—was insufficient in light of the

17

implants’ foreseeable use. (Id. ¶¶ 56, 68–69.)
Plaintiffs also argue that Defendant knew of twelve neck breakages prior to the time of Mr.

18
19

Tucker’s implant surgery. (RSS No. 53.) To summarize Truman’s conclusions: “[h]ad Wright used

20

[cobalt chromium] in the long neck from the beginning, applied available surface treatments to the

21

titanium neck, properly tested the implant for heavier-active individuals in the U.S., or provided

22

adequate warnings and contraindications[,] the fracture rate of the Profemur Long Necks would have

23

been much lower. . . . [I]t is [her] opinion that the risks of Wright Medical’s titanium alloy long neck

24

11

25
26
27
28

“Deviation from an industry norm is not necessarily the test for a defective product.” Howard, 203 Cal. App.
4th at 426. “[E]xpert evidence about compliance with industry standards can be considered on the issue of
defective design, in light of all other relevant circumstances, even if such compliance is not a complete defense.
An action on a design defect theory can be prosecuted and defended through expert testimony that is addressed
to the elements of such a claim, including risk-benefit considerations.” Id. Expert evidence regarding a
manufacturer’s compliance with regulations and trade custom are evidence for a jury to consider with other
facts and circumstances. Id. at 421 (noting that where a manufacturer has reason to know of greater dangers
despite its compliance with regulations, that manufacturer may not be insulated from negligence liability).

15

1

outweigh[ed] the general benefits described by Wright’s experts in active-heavy individuals, such as

2

Mr. Tucker.” (Id. ¶¶ 70–71.)

3

Defendant’s response to Plaintiffs’ evidence and experts is largely to explain why the evidence

4

does not show that the risks were so great as to outweigh the benefits, how its conduct was reasonable

5

in light of what it knew, and/or to argue that Plaintiffs’ evidence is incorrect or misleading. (See

6

Reply at 8–12.)12 This all goes to weight of the evidence that must be considered in a balancing of

7

factors. Taking the evidence in the light most favorable to Plaintiffs, there are triable issues of fact as

8

to relevant factors, including but not limited to, the risks and benefits of the Profemur, Defendant’s

9

knowledge of the risks, the likelihood and foreseeability of harm, the magnitude of foreseeable harms,

10

available safety measures, and—as with any negligence claim—whether Defendant’s conduct was

11

reasonable. California law requires such balancing to be done by the jury, not the Court.
For these reasons, Defendant’s Motion for Summary Judgment on the negligent design claim

Northern District of California

United States District Court

12
13

is DENIED.

14

D.

15

To establish a claim for manufacturing defect under a strict liability theory, a plaintiff has the

Manufacturing Defect: Strict Liability

16

burden of establishing that: (1) he has been injured by the product; (2) the injury occurred because the

17

product was defective; and (3) the defect existed when the product left the hands of the defendant.

18

Fender v. Medtronic, Inc., 887 F. Supp. 1326, 1333 (E.D. Cal. 1995); see CACI 1201 (entitled “Strict

19

Liability—Manufacturing Defect—Essential Factual Elements”). A manufacturing defect exists if the

20

product “differs from the manufacturer’s intended result or from other ostensibly identical units of the

21

same product line.” Barker, 20 Cal. 3d at 429. In other words, such a claim posits “that a suitable

22

design is in place, but that the manufacturing process has in some way deviated from that design.” In

23

re Coordinated Latex Glove Litig., 99 Cal. App. 4th 594, 613 (Cal. Ct. App. 2002); Gonzalez v.

24

Autoliv ASP, Inc., 154 Cal. App. 4th 780, 792 (Cal. Ct. App. 2007) (“A manufacturing defect occurs

25

when an item is manufactured in a substandard condition.”).

26
27
28

12

Defendant disputes that it had notice of twelve neck breakages prior to 2006, but admits that as of the date of
Mr. Tucker’s implant surgery, it was aware of two fractures of a Profemur product, which were both in Europe.
(RSS Nos. 7 & 53.)
16

1

Defendant argues that summary judgment must be granted on the manufacturing defect claim

2

because the sole expert opining on the existence of a manufacturing defect (Dr. Hendrickson) simply

3

states that “[b]ased on the physical evidence available from [his] analysis, the fatigue fracture was

4

initiated by fretting, which was a direct result of the design of the device, with errors in manufacturing

5

most likely contributing factors.” (Hendrickson Decl. ¶ 10; RSS No. 31.) Defendant argues that Dr.

6

Hendrickson has failed to elaborate or even specify what the manufacturing error was that contributed

7

to the device’s failure. (Mot. at 14.) At the same time, he contradicts his other statements that “the

8

subject hip device failed because, and only because, it is modular in design.” (RSS No. 32.) Absent

9

Dr. Hendrickson’s conclusion, Defendant contends there is no evidence in the record supporting a

10
11

manufacturing defect claim.
Plaintiffs respond that this claim presents a “classic” dispute of material fact because the

Northern District of California

United States District Court

12

parties’ experts (both metallurgists) disagree on the existence of a manufacturing defect. (Opp. at 15–

13

15.) Plaintiffs argue that Dr. Hendrickson’s opinion regarding the manufacturing defect is based on

14

his “thorough examination” of the device. (Opp. at 16.) Dr. Hendrickson also states that a

15

“[m]anufacturing defect[] cannot be ruled out merely by relying on device history records as a

16

manufacturing defect is device specific and requires examination of the specific device at issue.”

17

(Hendrickson Decl. ¶ 11; see RSS Nos. 29 & 33.) In addition, he concludes that “a manufacturing

18

defect cannot be ruled out” because Defendant’s experts “admit” that the damage caused during the

19

device’s extraction makes it impossible to determine the “presence or absence of any surface of

20

dimensional defect.” (Hendrickson Decl. ¶ 12.) Finally, Dr. Hendrickson notes that Defendant’s

21

expert Dr. James “did not perform the type of tests necessary to determine whether or not a

22

manufacturing defect of a metallurgical nature existed, therefore he has no basis for excluding that

23

type of manufacturing defect as a contributing factor.” (Id.)

24

The Court finds that Plaintiffs fail to meet their burden of identifying “specific facts” showing

25

a genuine issue for trial to defeat Defendant’s Motion on this claim. Soremekun, 509 F.3d at 984

26

(quoting Anderson, 477 U.S. at 250); Arpin, 261 F.3d at 922 (“conclusory allegations unsupported by

27

factual data are insufficient to defeat [defendants’] summary judgment motion”). The Court has

28

sustained Defendant’s objections to Dr. Hendrickson’s opinions related to the manufacture of the

17

1

implant. Such opinions have not been supported with any facts showing the existence of such defect.

2

Even considering statements the statements in the Hendrickson Declaration at paragraphs 10–12 in the

3

light most favorable to Plaintiffs, they still have provided no facts showing that the defect existed

4

when the product left the hands of Defendant. To state here that a manufacturing defect “cannot be

5

ruled out” is simply speculation based on an absence of facts. The same is true of the argument that a

6

manufacturing defect “most likely contribut[ed]” to a design defect. Notably, no evidence in the

7

record, other than Dr. Hendrickson’s own statements, has been identified in Plaintiffs’ responsive

8

separate statement. Moreover, to the extent that Dr. Hendrickson asserts that Defendant’s experts

9

have not conducted sufficient testing to rule out a manufacturing defect, he misunderstands the burden

10
11

on this Motion.
Having failed to identify (or even explain) how the device at issue deviated from Defendant’s

Northern District of California

United States District Court

12

intended design or from other implants of the same product line, Plaintiffs have failed to raise a triable

13

issue of fact on their manufacturing defect claim. For these reasons, Defendant’s Motion for

14

Summary Judgment on the strict liability manufacturing defect claim is GRANTED.

15

E.

16

Plaintiffs assert two claims for failure to warn: one under a strict liability theory and the

17
18
19
20
21
22
23
24
25
26

Failure to Warn

second under a negligence theory. Defendants seek summary judgment on both claims.
The California Supreme Court has provided the following explanation of the differences
between a strict liability and negligent failure to warn claim:
[F]ailure to warn in strict liability differs markedly from failure to warn in the
negligence context. Negligence law in a failure-to-warn case requires a plaintiff to
prove that a manufacturer or distributor did not warn of a particular risk for reasons
which fell below the acceptable standard of care, i.e., what a reasonably prudent
manufacturer would have known and warned about. Strict liability is not concerned
with the standard of due care or the reasonableness of a manufacturer’s conduct. . . .
[I]n strict liability, as opposed to negligence, the reasonableness of the defendant’s
failure to warn is immaterial.
Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987, 1002–03 (1991) (footnote omitted).
A manufacturer of a prescription drug is obligated warn physicians, not patients, of potential

27

side effects associated with its pharmaceutical products. Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th

28

Cir. 2004) (“Motus II”). Known as the “learned intermediary” doctrine, the duty to warn the

18

1

physician—rather than the patient—also applies to prescription implants. Valentine v. Baxter

2

Healthcare Corp., 68 Cal. App. 4th 1467, 1483 (Cal. Ct. App. 1999) (“In the case of prescription

3

drugs and implants, the physician stands in the shoes of the ‘ordinary user’ because it is through the

4

physician that a patient learns of the properties and proper use of the drug or implant.”) A

5

manufacturer discharges its duty to warn if it provides an adequate warning to the physician,

6

regardless of whether the warning reaches the patient. Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 991

7

(C.D. Cal. 2001) (“Motus I”), aff’d, 358 F.3d 659 (9th Cir. 2004). A plaintiff must prove that “no

8

warning was provided or that the warning was inadequate” and “also that the inadequacy or absence

9

of a warning caused the plaintiff’s injury.” Id. “[A] product defect claim based on insufficient

10

warnings cannot survive summary judgment if stronger warnings would not have altered the conduct

11

of the prescribing physician.” Motus II, 358 F.3d at 661.

Northern District of California

United States District Court

12

1.

Summary of Law

13

a.

Failure to Warn: Strict Liability

14

In California, a defendant manufacturer can be held strictly liable for failure to

15

warn if the plaintiff proves the following: “(1) the defendant manufactured, distributed, or sold the

16

product; (2) the product had potential risks that were known or knowable at the time of manufacture

17

or distribution, or sale; (3) that the potential risks presented a substantial danger to users of the

18

product; (4) that ordinary consumers would not have recognized the potential risks; (5) that the

19

defendant failed to adequately warn of the potential risks; (6) that the plaintiff was harmed while

20

using the product in a reasonably foreseeable way; (7) and that the lack of sufficient warnings was a

21

substantial factor in causing the plaintiff’s harm.” Rosa v. City of Seaside, 675 F. Supp. 2d 1006,

22

1011 (N.D. Cal. 2009), aff’d sub nom., Rosa v. Taser Int’l, Inc., 684 F.3d 941 (9th Cir. 2012), (citing

23

CACI 1205 [entitled “Strict Liability—Failure to Warn—Essential Factual Elements”]). With respect

24

to a known or knowable risk, the plaintiff must prove that “the defendant did not adequately warn of a

25

particular risk that was known or knowable in light of the generally recognized and prevailing best

26
27
28

19

1

scientific and medical knowledge available at the time of manufacture and distribution.” Rosa, 675 F.

2

Supp. 2d at 1012 (citing Anderson, 53 Cal. 3d at 1002).13
Generally, the purpose of requiring adequate warnings is to inform consumers about a

3
4

product’s hazards of which they are unaware, so that they may either refrain from using the product

5

altogether or avoid the danger by careful use. Taylor v. Elliott Turbomachinery Co., Inc., 171 Cal.

6

App. 4th 564, 577 (Cal. Ct. App. 2009); Anderson, 53 Cal. 3d at 1003. The duty to warn continues

7

for as long as the manufacturer is manufacturing and distributing the product. Valentine, 68 Cal. App.

8

4th at 1482. On the other hand, “[t]here is no duty to warn of known risks or obvious dangers.”

9

Chavez, 207 Cal. App. 4th at 1304; Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996) (“a

community”). “In most cases, . . . the adequacy of a warning is a question of fact for the jury.”

12
Northern District of California

pharmaceutical manufacturer may not be required to provide warning of a risk known to the medical

11

United States District Court

10

Jackson v. Deft, Inc., 223 Cal. App. 3d 1305, 1320 (Cal. Ct. App. 1990).

13

b.

Failure to Warn: Negligence

14

To prevail on a claim for negligent failure to warn, a plaintiff must prove that:

15

“(1) the defendant manufactured, distributed, or sold the product; (2) the defendant knew or

16

reasonably should have known that the product was dangerous or was likely to be dangerous when

17

used in a reasonably foreseeable manner; (3) the defendant knew or reasonably should have known

18

that users would not realize the danger; (4) the defendant failed to adequately warn of the danger or

19

instruct on the safe use of the product; (5) a reasonable manufacturer, distributor, or seller under the

20

same or similar circumstances would have warned of the danger or instructed on the safe use of the

21

product; (6) the plaintiff was harmed; and (7) the defendant’s failure to warn or instruct was a

22

substantial factor in causing the plaintiff’s harm.” Rosa, 675 F. Supp. 2d at 1011–12 (citing CACI

23

1222 [entitled “Negligence—Manufacturer or Supplier—Duty to Warn—Essential Factual

24

Elements]).
As discussed above, this claim “requires a plaintiff to prove that a manufacturer or distributor

25
26
27
28

did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what
In a strict liability warning claim, “a defendant . . . may present evidence of the state of the art, i.e., evidence
that the particular risk was neither known nor knowable by the application of scientific knowledge available at
the time of manufacture and/or distribution.” Anderson, 53 Cal. 3d at 1004.
13

20

1

a reasonably prudent manufacturer would have known and warned about.” Anderson, 53 Cal. 3d at

2

1002; Chavez, 207 Cal. App. 4th at 1305. A “reasonable manufacturer would not be charged with

3

knowing more than what would come to light from the prevailing scientific and medical knowledge.”

4

Valentine, 68 Cal. App. 4th at 1483–84. It might, for example, prevail against a negligence claim

5

where it decided a risk of harm was not so great as to require a warning based on its own testing that

6

showed a result contrary to that of others in the scientific community. Anderson, 53 Cal. 3d at 1003.

7

As with a strict liability warning claim, adequacy of a warning in a negligence claim is usually a

8

question of fact. Res-Care Inc. v. Roto-Rooter Servcs. Co., 753 F. Supp. 2d 970, 991 (N.D. Cal.

9

2010).

10

2.

Summary of Argument

11

Defendant argues that both failure to warn claims must be dismissed because Dr. Bozic

Northern District of California

United States District Court

12

received adequate warning of the potential risks associated with the Profemur, including warnings

13

relating to an increased likelihood of failure in patients with obesity, those with active lifestyles, or

14

those who cannot follow instructions. (Mot. at 16 (citing RSS Nos. 38–40).) Defendant contends that

15

the warnings repeatedly cautioned the physician of risk factors that could lead to device failure by

16

fracture, that Dr. Bozic—as a skilled orthopedic surgeon—understood these warnings, and that in

17

signing an Authorization for Surgery and Informed Consent, Mr. Tucker acknowledged that he

18

understood that the implant may fail and/or need to be repaired or replaced. (RSS Nos. 36–37 & 40–

19

41.) In addition, Defendant argues that its warnings were reasonable in light of the fractures known to

20

it at the time of Mr. Tucker’s implant, and that it promptly issued a Safety Alert to physicians

21

identifying this risk once it become aware of it. (RSS Nos. 46–47 & 53; Mot. at 19.)

22

Defendant also emphasizes that the record is devoid of any evidence that Dr. Bozic ever read

23

or relied upon Defendant’s warnings in deciding to implant the Profemur into Mr. Tucker. (RSS No.

24

52.) Without this, Defendant contends that Plaintiffs cannot establish the essential element of

25

proximate cause: “[t]here is no evidence that different or additional warnings regarding the potential

26

risks of the Profemur® hip products would have changed Dr. Bozic’s decision to use the device.”

27

(Mot. at 19; see Reply at 14.)

28

21

Plaintiffs principally respond that Defendant provided an insufficient warning regarding the

1
2

risk of fracture of the long neck in heavier demand patients. (Opp. at 17.) Plaintiffs argue that

3

Defendant knew of actual fractures, yet failed to provide specific warnings, and that even as a skilled

4

orthopedic surgeon, Dr. Bozic was not adequately informed of the risk of fractures or the increased

5

likelihood of the same based on weight or activity levels. (Id. at 17–21; see RSS Nos. 36–42; Bozic

6

Decl. ¶ 13.) To the extent that Dr. Bozic did warn Mr. Tucker of a risk of fracture, he explains that

7

this was limited to the risk of fracture of the ceramic component of the device—not fractures in the

8

long neck. (RSS No. 44.) Plaintiffs also assert that the warnings were “undermined” by Defendant’s

9

marketing of the Profemur, and that the Safety Alert sent in 2008 was too little, too late (Opp. at 19;

10

RSS Nos. 46–47.)

Northern District of California

Dr. Bozic’s declaration in response to the summary judgment motion provides first that “had

12
United States District Court

11

Wright Medical . . . informed [him] of the previous fractures or the increased fracture risk associated

13

with the Profemur long neck in heavier patients, [he] would have selected a different hip system for

14

Mr. Tucker.” (Bozic Decl. ¶ 15.) Second, Dr. Bozic has in fact “stopped using the Profemur Modular

15

Hip System in its entirety . . . after the second fracture of [the] long neck in [his] patients, which was

16

Mr. Tucker in 2010.” (Id. ¶ 16.) However, Dr. Bozic never states that he read the warning prior to

17

the surgery. (See RSS No. 52; Bozic Decl. ¶ 13.)14

18

3.

Analysis

19

The critical issue on Plaintiffs’ warning claims is the issue of causation. For both

20

claims, a plaintiff is required to prove that the defendant’s failure to warn or instruct was a substantial

21

factor in causing the plaintiff’s harm. Rosa, 675 F. Supp. 2d at 1011–12; CACI 1205 & 1222. “A

22

plaintiff asserting causes of action based on a failure to warn must prove not only that no warning was

23

provided or the warning was inadequate, but also that the inadequacy or absence of the warning

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caused the plaintiff’s injury.” Motus I, 196 F. Supp. 2d at 991 (emphasis supplied).
In Motus I, the district court considered whether a plaintiff could invoke a rebuttable

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presumption in California to prove that a failure to warn or inadequate warning was a “substantial
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At oral argument, when pointedly asked by the Court whether there was evidence that Dr. Bozic read the
warnings, Plaintiffs’ counsel stated that he “underst[ood] he read through all the materials,” but he did not
identify specific evidence in the record supporting this.
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factor” in causing harm. 196 F. Supp. 2d at 991. Under such presumption, once plaintiff established

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that a manufacturer provided inadequate warnings, the burden shifted to defendant to show that an

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adequate warning would not have affected the doctor’s conduct in prescribing the drug. Id. The

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district court concluded that the rebuttable presumption did not apply, and thus defendant Pfizer “may

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prevail in its motion for summary judgment if [plaintiff] has failed to adduce evidence that [the

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prescribing physician] would have acted differently had Pfizer provided an adequate warning about

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the risk of suicide associated with the ingestion of [the drug].” Id. at 995.

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The district court noted that plaintiff may have been able to create a genuine issue of fact if the
properly-warned physician could have detected adverse reactions to the drug and reduced the injury,

affected the physician’s (or any reasonable physician’s) decision to prescribe the drug to plaintiff. Id.

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or with evidence that the risk of suicide associated with the drug was so high that it would have

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at 995. The court also held that:

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Plaintiff has presented no evidence that Dr. Trostler relied on statements from Pfizer
in making his decision to prescribe Zoloft to Mr. Motus. Dr. Trostler’s recollection of
how he learned about Zoloft is vague. But he did state unequivocally that in making
that decision, he did not rely either on any statements Pfizer representatives made to
him nor any written materials they may have provided to him. Indeed, Dr. Trostler
stated that he did not read the package insert or PDR entry for Zoloft until after Mr.
Motus committed suicide. It follows that the inclusion of adequate warnings in that
information would not have affected his decision.
Id. at 996 (emphasis supplied).
The Ninth Circuit in Motus II affirmed the district court’s grant of summary judgment because

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the prescribing physician testified that “he did not read the warning label that accompanied Zoloft or

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rely on information provided by Pfizer’s detail men [sic] before prescribing the drug to Mr. Motus.”

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358 F.3d at 661. Because he failed to read the published warnings before prescribing the drug, the

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adequacy of the warnings was irrelevant to the case’s disposition. Id. (claim based on insufficient

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warnings “cannot survive summary judgment if stronger warnings would not have altered the conduct

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of the prescribing physician”).

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As in the Motus opinions, despite the fact that it is Plaintiffs’ affirmative burden to identify

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that the inadequate warnings substantially caused the injury, there is no evidence that Dr. Bozic read

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the warnings provided by Defendant. At best, the Bozic Declaration at paragraph 15 poses a

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hypothetical that (i) a stronger warning would have affected his selection of the Profemur and (ii) that

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he would have necessarily read the stronger warning. But this hypothetical invokes the rebuttable

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presumption that was rejected in Motus I. Even after Defendant’s Motion was filed, Plaintiffs fail to

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sufficiently dispute this issue, nor do they provide any law to support their position. As noted above,

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inadequacy of the warning and causation are separate elements of Plaintiffs’ affirmative burden.

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Where the physician did not read the warnings, adequacy is irrelevant and “it follows that the

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inclusion of adequate warnings in that information would not have affected his decision.” Motus II,

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358 F.3d at 661; Motus I, 196 F. Supp. 2d at 996.

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For these reasons, the Court GRANTS Defendant’s Motion for Summary Judgment on the strict
liability and negligent failure to warn claims.

Northern District of California

F.

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Loss of Consortium

On July, 24, 2012, the Court entered an order based on a stipulation that “Mrs. Rebecca

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Tucker is not making a claim for ‘mental pain and suffering’ in the above-captioned action and is not

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pursuing damages for ‘mental pain and suffering.’” (Dkt. No. 44.) The parties also stipulated to

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strike a portion of the complaint, such that paragraph 38 reads as follows: “As a proximate result of

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said negligent conduct of the defendants, and each of them, plaintiff REBECCA TUCKER has been

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injured by the loss of her husband’s companionship and services, including, the loss of love,

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companionship, comfort, care, assistance, protection, affection, society, and moral support.” (Id.)

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Defendant contends that Mrs. Tucker’s consortium claim fails for three reasons. First, it is

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derivative of the other claims, and because those claims fail, this one must as well. (Mot. at 20.)

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Second, Defendant argues that she has no claim because she stipulated that her claim is not based on

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mental pain and suffering, which is what consortium claims are intended to compensate. (Mot. at 21

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(consortium refers to non-economic aspects of marriage relations).) Third, Defendant argues that

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even if there were no stipulation, she cannot prove her damages without an expert and no retained

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expert has addressed her damages. (Id.) As the record stands, there is no evidence in the record to

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otherwise calculate the amount of damages. (Id.)

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Plaintiffs respond that Mrs. Tucker stipulated that she is not seeking “separate damages for
mental pain and suffering.” (Opp. at 23.) Despite the stipulation, she has suffered damage to her

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marital interests with regard to: (i) intimacy and sexual relations; (ii) Mr. Tucker taking out his anger,

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fear, and/or frustration on her and/or threatening her; and (iii) Mrs. Tucker consequently “feeling

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bereft of Mr. Tucker’s affection and tenderness that she had previously known.” (Id.) Plaintiffs also

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assert that no expert is needed to show damages, and that a jury can determine the amount of

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compensation for her lost marital interests. Plaintiffs do not dispute that Mrs. Tucker’s claim is

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derivative of the products liability claims. (Id. at 22.)
The Court agrees with Plaintiffs. In the stipulation, the parties struck a portion of the

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complaint but left intact Mrs. Tucker’s allegations regarding the “loss of her husband’s

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companionship and services, including, the loss of love, companionship, comfort, care, assistance,

the Court can draw is that these allegations and Mrs. Tucker’s claim for damages related thereto

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Northern District of California

protection, affection, society, and moral support.” (See Dkt. No. 44.) The only reasonable conclusion

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remained in the litigation. As such, the Court rejects Defendant’s argument that the stipulation itself

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forecloses this claim.
In addition, Plaintiffs’ negligent design claim will proceed to trial. As such, summary

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judgment on this derivative claim is inappropriate. Dominguez v. Excel Mfg. Co. Inc., C-09-03611

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EDL, 2010 WL 4698739, at *16 (N.D. Cal. Nov. 8, 2010) (where negligence claim in products

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liability case survives summary judgment, so does the loss of consortium claim). The Court further

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agrees with Plaintiffs that expert testimony is not necessary to determine Mrs. Tucker’s damages.
For these reasons, Defendant’s Motion for Summary Judgment on Mrs. Tucker’s loss of

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consortium claim is DENIED.

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IV.

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CONCLUSION
For the reasons stated above, Defendant’s Motion for Summary Judgment is GRANTED IN

PART AND DENIED IN PART. Specifically, the Court:


100;

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

GRANTS Defendant’s Motion for Summary Judgment as to the first claim for strict
liability based on design defect, manufacturing defect, and failure to warn;

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DISMISSES WITH PREJUDICE Defendants Wright Medical Group, Inc. and Does 1–



DENIES Defendant’s Motion for Summary Judgment as to the second claim for

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negligence based on a design defect;

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

based on failure to warn; and

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GRANTS Defendant’s Motion for Summary Judgment as to third claim for negligence



DENIES Defendant’s Motion for Summary Judgment as to the fourth claim for loss of
consortium.

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This Order terminates Dkt. No. 76.

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IT IS SO ORDERED.

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Dated: March 19, 2013

_______________________________________
YVONNE GONZALEZ ROGERS
UNITED STATES DISTRICT COURT JUDGE

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Northern District of California

United States District Court

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