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Gregory K. Tucker and Rebecca Tucker v. Wright Medical Technology

February 27, 2013

GREGORY K. TUCKER AND REBECCA TUCKER, PLAINTIFFS,
v.
WRIGHT MEDICAL TECHNOLOGY, INC., TRUMAN, K. BOSIC, M.D.,
WRIGHT MEDICAL GROUP, INC., AND 0 DOES 1 THROUGH 100, INCLUSIVE, DEFENDANTS.



The opinion of the court was delivered by: United States District Court Judge Yvonne Gonzalez Rogers

[PROPOSED] ORDER GRANTING IN PART AND DENYING IN PART MOTIONS TO EXCLUDE CERTAIN OPINIONS, TESTIMONY, AND EVIDENCE OF L. HENDRICKSON, M. AND EVIDENCE PRESENTED IN SUPPORT OF PLAINTIFFS' 2 OPPOSITION TO MOTION FOR SUMMARY JUDGMENT

Date: January 15, 2013 Time: 2:00 p.m.

Action Filed: May 6, 2011

Testimony of Kevin Bosic, M.D., and Evidentiary Objections contained in its Reply to Motion for 4 Summary Judgment. Having considered Defendant Wright Medical Technology, Inc.'s Motions, which 5 came before the Court on January 15, 2013, the papers filed in support thereof, the papers filed in 6 response thereto, and all other arguments presented, and GOOD CAUSE SHOWING THEREFORE, IT 7

IS HEREBY ORDERED that the following evidence, opinions, and testimony are excluded: 8 9

Defendant Wright Medical Technology submitted its Motions to Exclude Testimony of Lester Hendrickson, Motion to Exclude Certain Testimony of Mari Truman, P.E., Motion to Exclude 3 Bozic's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection: Exclude all of Dr. Bozic's Opinions regarding  FRE 702(c) - Not the Sustained: complications experienced by patients with total product of reliable ______ hip replacements resulting from their abuse of principles and methods alcohol.  FRE 702(d) -- Unreliable Overruled:  FRCP 26(a)(2) -- facts and XX Bozic Rebuttal, p. 1, ¶¶ 2, 3, 4 data needed to support expert opinion must be disclosed

Exclude all of Dr. Bozic's Opinions regarding the  FRE 702(a) - Expert not Sustained: impact of plaintiff Gregory Tucker's alcohol abuse qualified ______ on the failure of his hip prosthesis.  FRE 702(c) - Not the Overruled: Bozic Rebuttal, p. 1, ¶¶ 2, 3, 4 product of reliable principles and methods XX  FRE 702(d) -- Unreliable Exclude all case reports and all of Bozic's  FRE 702(c) - Not the Sustained: Opinions based on those reports. product of reliable ______ Bozic Report, p. 1 ¶ 3, p. 2 ¶ 1 principles and methods  FRE 702(d) -- Unreliable Overruled:

Declaration of Kevin Bozic Evidentiary Objections Ruling on the

Objection:

2 As treating physician for the plaintiff, I have  FRE 403 (re-presentation Sustained: 24

formed opinions regarding the fracture of the hip of cumulative evidence, ______ implant at issue in this matter. My report letter waste of time) dated September 6, 2012, and my rebuttal report  FRE 403 (prejudicial); Overruled: letter dated September 24, 2012 are incorporated Laser Design, Intern. LLC XX by reference and attached hereto as Exhibit "B." v. BJ Crystan, Inc., Case Nos. C 03-1179 JSW, C This declaration will expand on and explain my 03-3905 JSW, 2007 WL excluded as prejudicial). 4 It is within the expertise of an orthopaedic  FRE 403 (prejudicial); Sustained: 7 surgeon to diagnose the basic fact of failure of an Laser Design, 2007 WL ______ orthopaedic implant, and the probable cause of 735763 at *4 that failure based upon patient history, and Overruled:

knowledge and experience in the field of XX orthopaedic surgery in general and specifically hip replacement surgery, In this case, as treating physician I have firsthand knowledge regarding Mr. Tucker's hip replacement at issue.

5 In 2006, Mr. Tucker was 42 years old with a  FRE 403 (re-presentation Sustained: 13 history of alcohol-induced osteonecrosis of cumulative evidence, ______ involving both hips. He had previously waste of time) underwent a hemi-resurfacing arthroplasty on the Overruled: left hip in November 2003 with an excellent XX result.

6 The Profemur modular hip system was selected  FRE 403 (prejudicial); Sustained: 17 to allow use of a hard-on-hard (ceramic-ceramic) Laser Design, 2007 WL _______ bearing, which was felt to be beneficial in a 735763 at *4 young, active patient who is at risk for wear and Overruled: osteolysis with a metal-on-polyethylene bearing. XX

7 The risks and benefits of the hard-on-hard  FRE 403 (re-presentation Sustained: bearing, specifically the ceramic-ceramic of cumulative evidence, _______ characteristic was discussed with Mr. Tucker. As waste of time) part of this discussion and as noted in my  FRE 403 (prejudicial); Overruled: operation report dated March 30, 2006, we also Laser Design, 2007 WL XX discussed the potential risk of "fracture", This 735763 at *4 discussion of fracture related to the ceramic- ceramic component of the hip implant. This discussion of fracture did not relate to the long neck of the modular hip system. 8 After the completion of Mr. Tucker's right hip  FRE 403 (re-presentation Sustained: 27 total hip replacement surgery in 2006, I observed of cumulative evidence, _______ excellent results in Mr. Tucker's right hip. There waste of time)

Declaration of Kevin Bozic Evidentiary Objections Ruling on the Objection: opinions as an expert witness and treating 735763 at *4 (N.D. Cal. physician. Mar. 7, 2007) (expert testimony offered after close of expert discovery, in opposition to motion for summary judgment,

Declaration of Kevin Bozic Evidentiary Objections Ruling on the

Objection:

were no issues noted regarding his right hip Overruled:

biomechanics being compromised or having an XX alternation in his gait. The results for the right hip were excellent, until May 7, 2010, when the hip implant fractured.

9 As an orthopedic surgeon and Mr. Tucker's  FRE 403 (prejudicial); Sustained: treating physician, I reasonably expected the hip Laser Design, 2007 WL _______ implant in Mr. Tucker to be designed in such a 735763 at *4 way and to such specifications that the modular Overruled: neck would not fracture during Mr. Tucker's XX routine activities.

10 In my treatment of Mr. Tucker, none of the  FRE 403 (prejudicial); Sustained: activities or personal history of Mr. Tucker, who Laser Design, 2007 WL _______ worked as a professional engineer, operated a 735763 at *4 ranch on his property, and engaged in the use of Overruled: alcohol, would have lead me to believe the XX modular neck would fracture.

In my treatment of Mr. Tucker and through my  FRE 403 (prejudicial); Sustained: years of experience as an orthopaedic surgeon, I Laser Design, 2007 WL _______ reasonably expected the hip system and neck to 735763 at *4 be able to withstand the same forces in use as are Overruled: encountered in the activities of daily living. An XX artificial hip system that is not able to withstand this level of activity is unreasonably dangerous to the patient, and needlessly places the patient's health and safety at risk. 12 As an experienced well qualified orthopaedic  FRE 403 (prejudicial); Sustained:

surgeon, I am aware of the medical literature Laser Design, 2007 WL regarding modularity of total hip replacements 735763 at *4 systems and the effect of patient weight and Overruled: obesity on hip implants, and I reasonably expect XX designers and manufacturers, such as Wright Medical, to be aware of the same available medical literature and to account for such in the design and manufacturing of their hip replacement products.

13 In selecting Wright Medical's product, Wright  FRE 403 (prejudicial); Sustained: and its agents never disclosed that it had Laser Design, 2007 WL _______ encountered fractures of the modular neck prior 735763 at *4

Declaration of Kevin Bozic Evidentiary Objections Ruling on the Objection: to Mr. Tucker's 2006 surgery and never informed Overruled: me that obesity was a significant concern XX regarding fractures of the Profemur long neck.

14 In the article "Corrosion-Induced Fracture of a  5 FRE 403 (prejudicial); Sustained: Double-Modular Hip Prosthesis, published by Laser Design, 2007 WL _______ my research group, we discuss the risks and 735763 at *4 benefits of Wright Medical's modular Profemur Overruled: product. While it is recognized that modularity XX allows the surgeon to more closely restore patient anatomy, such as limb length, lateral offset, and femoral anteversion, and to better balance the soft tissue to achieve optimal biomechanics, it must also be weighed against the increases in the number of mechanical junctions, which introduce potential failures through fretting (micromotion), corrosion, and ultimately fracture. The articles discusses that the long neck is 25% longer than the standard neck, which produces roughly 25% higher bending stresses, The long neck may contribute to a greater risk of fracture, Ultimately the article concludes, that there is a risk of implant fracture at the stem-neck junction when a long neck is implanted in heavy patients.

15 As treating physician for Mr. Tucker had Wright  FRE 403 (prejudicial); Sustained: 18 Medical or its agents informed me of the Laser Design, 2007 WL _______ previous fractures or the increased fracture risk 735763 at *4 associated with the Profemur long neck in Overruled: heavier patients, I would have selected a XX different hip system for Mr. Tucker. 16 Additionally, as a treating physician, I have  FRE 403 (prejudicial); Sustained: stopped using the Profemur Modular Hip System Laser Design, 2007 WL _______ in its entirety. I stopped after the second fracture 735763 at *4 of a Profemur long neck in my patients, which Overruled: was Mr. Tucker in 2010. XX

Hendrickson's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection:

Opinion That "Failure" After Four Years is  FRE 702(b) - Not based on Sustained:

Evidence That the Implant was Defective and sufficient facts or data

Unreasonably Dangerous at the Time of Implantation. (ipse dixit)

Hendrickson's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the

Objection:

Report, at p. 7 ¶ 8. product of reliable Overruled: principles and methods XX  FRE 702(d) - Does not apply the principles and methods to the facts of the case

Opinions Related to The Manufacture of the  FRE 702(b) - Not based on Sustained:

Implant. sufficient facts or data XX

Report, at p. 5, p. 7 ¶¶ 7, 9; Rebuttal, at pp. 1-2. (ipse dixit)  FRE 702(c) - Not the product of reliable Overruled: principles and methods  FRE 702(d) - Does not apply the principles and methods to the facts of the case

Opinions Relating to Implantation As Evidence of  FRE 702(b) - Not based on Sustained: Intended Use. sufficient facts or data ______ Rebuttal at p. 4. (ipse dixit)  FRE 702(c) - Not the Overruled: product of reliable XX 15 principles and methods 16  FRE 702(d) - Does not apply the principles and 17 methods to the facts of the case

Opinions Relating to Modular Design As The  FRE 702(b) - Not based on Sustained: 18 19 Cause Of The Implant "Failure" sufficient facts or data ______ Rebuttal, at pp. 2, 4, 7. (ipse dixit) 20  FRE 702(c) - Not the Overruled: product of reliable XX 21 principles and methods

22  FRE 702(d) - Does not apply the principles and 23 methods to the facts of the case 24 Opinions Regarding Abuse Or Misuse Of Implant  FRE 702(b) - Not based on Sustained: 25 After Implantation And Mr. Tucker's Contribution sufficient facts or data ______ To "Failure" (ipse dixit) 26 Report, at p. 7 ¶¶12-13; Rebuttal, at p. 4.  FRE 702(c) - Not the Overruled: XX 27 product of reliable principles and methods

Hendrickson's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection:  FRE 702(d) - Does not 3 apply the principles and methods to the facts of the case.  4 5 FRE 702(a) - not qualified to provide opinions on this 6 issue. 7  Sustained:

Opinions Regarding Stresses and Mr. Tucker's FRE 702(b) - Not based on Fall. sufficient facts or data ______ 8 Report, p. 6. (ipse dixit)  FRE 702(c) - Not the Overruled: 9 product of reliable XX principles and methods 10  FRE 702(d) - Does not 11 apply the principles and methods to the facts of the 12 case 13 Opinions Regarding Permanency and Life  FRE 702(b) - Not based on Sustained:

Expectancy of Implants. sufficient facts or data ______ 14 Report, at p. 7 ¶¶ 1-2; Rebuttal, at p.8. (ipse dixit)  FRE 702(c) - Not the Overruled: 15 product of reliable XX 16 principles and methods  FRE 702(d) - Does not 17 apply the principles and methods to the facts of the 18 case 19 Opinions Regarding Knowledge of Wright Medical  FRE 702(b) - Not based on Sustained: and Designers/Manufacturers. sufficient facts or data ______

Report, at p. 7 ¶10. (ipse dixit)

 FRE 702(c) - Not the Overruled: product of reliable XX 22 principles and methods  FRE 702(d) - Does not apply the principles and methods to the facts of the 23 24 case 25 Opinions Related to Comparisons to Non-Medical  FRE 702(b) - Not based on Sustained: Device Consumer Products. XX 26 sufficient facts or data Rebuttal, at p.3. (ipse dixit) 27  FRE 702(c) - Not the Overruled: product of reliable ______

Hendrickson's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection: principles and methods 3  FRE 702(d) - Does not apply the principles and methods to the facts of the case 4 5 Opinions related to warnings to Mr. Tucker.  FRE 702(a) - Not helpful to Sustained: 6 Rebuttal, at p. 8. trier of fact - Legal XX (sustained 7 Conclusion. to extent that opinion  FRE 702(a) - not qualified references to provide opinions on this direct warnings to 8 9 issue. Mr. Tucker, 10 rather than warnings to 11 doctor 12 Overruled:

Opinions Alleging That Wright Medical Introduced  FRE 702(a) - Not helpful to Sustained: Into The Stream of Commerce a Device That Was trier of fact - Legal XX 15 Defective and Unreasonably ...


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