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

IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA -- OAKLAND DIVISION


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 Dangerous. Conclusion. Report, at p. 7 ¶ 11. Overruled:

Opinions Regarding Exhibit E and Exhibit E  FRE 702(a) - Not helpful to Sustained:

(schematic). Report, Exhibit E. trier of fact, may confuse trier of fact Overruled:

Opinions Related to Ethical Obligations of  FRE 702(a) - not qualified Sustained: 21 Designers/Manufacturers. to provide opinions on this XX 22 Rebuttal, at p. 3. issue. Overruled:

Hendrickson Declaration Evidentiary Objection(s) Ruling on the

Objection:

2 My Report dated September 17, 2012 ("Report") is  FRE 403 (presentation of Sustained: attached hereto as Exhibit "B." My Rebuttal cumulative evidence, ______

Report dated October 2, 2012 ("Rebuttal Report") waste of time)

Hendrickson Declaration Evidentiary Objection(s) Ruling on the

Objection:

is attached hereto as Exhibit "C." Overruled:

XX

5 My examination in this case consisted of the review  FRE 403 (re-presentation Sustained: of relevant documents, peer reviewed technical of cumulative evidence, ______

literature, and a physical examination of the failed hip implant. waste of time) Overruled:

6 My physical examination of the hip implant  FRE 403 (re-presentation Sustained: included a visual inspection, physical of cumulative evidence, ______ measurements, stereo optical microscopy, x-ray radiography, and energy dispersive x-ray waste of time) Overruled: spectroscopy. This was a nondestructive approach XX that is standard for the industry and is substantially similar to the methods used by defendant's expert Dr. James. 7 My Report dated September 17, 2012 ("report") is  FRE 403 (re-presentation Sustained: 12 attached hereto as Exhibit "B," clearly states that of cumulative evidence, _______ my conclusions are based on the non-destructive examination and analysis of components, the waste of time) Overruled: information contained within the documents reviewed, my educational background, and my experience of more than forty years analyzing failed consumer products, including artificial hips and other prosthetic implants. Many, if not all of my conclusions and opinions are supported by the peer reviewed literature "ASM Handbook, Volume 11, Failure Analysis and Prevention," referenced in my report, and "Engineering Design, A Materials and Processing Approach," referenced in my rebuttal report. 8 Based on my education and my experience of 40  Sustained:

FRE 403 (re-presentation years as a University Professor responsible for of cumulative evidence, _______ developing and teaching numerous times, a graduate level course on the subject Failure waste of time) Overruled: Analysis and Prevention, and based on my physical examination of the failed hip implant, as well as my experience in examining numerous other failed prosthetic implants, I was able to determine that the subject implant fractured due to metal fatigue initiated by a process known technically as fretting.

9 Fretting results from very slight oscillatory motion  FRE 403 (re-presentation Sustained: between two surfaces pressed together in physical _______ of cumulative evidence, contact. My examination of the design of the waste of time) modular neck and stem of the subject Wright Overruled:

Profemur prosthetic hip confirmed that inherent in XX

Hendrickson Declaration Evidentiary Objection(s) Ruling on the

Objection: its design, it contains two surfaces pressed together in physical contact, a condition necessary for the initiation of fretting. In other words, fretting is not possible, nor is the subsequent fatigue fracture of the subject prosthetic hip, without the modular nature of the device.

10 Based on the physical evidence available from my  FRE 403 (re-presentation Sustained: analysis, the fatigue fracture was initiated by of cumulative evidence, _______ fretting, which was a direct result of the design of the device, with errors in manufacturing most likely waste of time) Overruled: contributing factors. XX 11 Manufacturing defects cannot be ruled out merely  FRE 403 (prejudicial); Sustained: by relying on device history records as a Laser Design, 2007 WL _______ manufacturing defect is device specific and requires examination of the specific device at issue. 735763 at *4 While defense expert Dr. James claims in his rebuttal report that "the necks that fractured in Mr.

Overruled: XX

Tucker's implant passed all dimensional and surface inspection," he offers no evidence that the stem in which the neck is pressed was inspected in a similar manner, or that the stem dimensions were compatible with the neck. 12 In this case, as discussed in my rebuttal report, both  FRE 403 (re-presentation Sustained: Dr. James and Dr. Ochoa admit in their reports that of cumulative evidence, _______ given the damage suffered to the device because of the fracture and extraction of the device during the waste of time) Overruled: revision surgery the presence or absence of any XX surface of dimensional defect cannot be made. This means that a manufacturing defect cannot be ruled out. Furthermore, Dr. James did not perform the type of tests necessary to determine whether or not a manufacturing defect of a metallurgical nature existed, therefore he has no basis for excluding that type of manufacturing defect as a contributing factor to fracture of the subject hip prosthesis.

13 Wright knew or should have known of the  FRE 403 (re-presentation Sustained: propensity for failure of the device due to fretting of cumulative evidence, _______ wear and metal fatigue and should have designed the device to resist this failure phenomenon. As waste of time) Overruled: explained in the report, this conclusion is drawn XX from my over 40 years of experience. This was later admitted by defendant's expert Brad James in his deposition. (James Dep. 23:10-24-2.)

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: 14 Additionally, all modular hip implants contain one  FRE 403 (re-presentation Sustained: feature that non-modular implants do not, and that of cumulative evidence, _______ is a tapered, press-fit connection between the neck and stem. It is precisely this feature in the design waste of time) Overruled: that introduces the risk of failure by the mechanism XX of fretting, corrosion, and fatigue. 15 My conclusion that there is no evidence the subject  FRE 403 (re-presentation Sustained: 7 total hip replacement device was of cumulative evidence, _______ abused or misused after implantation is right hip of waste of time) Mr. Tucker is based on the review of the medical Overruled: records and other discovery materials. XX 16 In my report and rebuttal report I refer to the hip  FRE 403 (prejudicial); Sustained: 10 implant that fractured in Mr. Tucker as a permanent Laser Design, 2007 WL _______ implant. The reason I use the term "permanent" is that the device is intended to be a long term 735763 at *4 solution for the problem the device is correcting as XX opposed to temporary, which would imply that it was a short term solution. Also permanent refers to the fact that the medical device is surgically inserted and will not be removed or revised until it is medically necessary. There is no option for the patient to elect to remove the medical device themselves. This definition is in contrast to other temporary fixation prosthetic devices such as bone plates, which must retain their structural integrity only long enough to permit complete healing of the fractured bone, and then may be electively removed with no adverse effects to the patient. 17 Exhibit E to my report is a schematic illustrating  FRE 403 (prejudicial); Sustained: 19

the relative positions of the component parts of the Laser Design, 2007 WL ______ hip replacement. While the exhibit is not the 735763 at *4 implant that failed in this matter, it is substantially Overruled: similar and is useful in showing how the various XX parts of the hip implant relate to each other and provides visual context to the discussion of the different parts of the implant. 18 My report goes into great detail describing how  FRE 403 (presentation of Sustained: generally accepted testing procedures (the same cumulative evidence, ______ ones used by defense expert Dr. James) were used waste of time) to determine, using the scientific method, that the mechanism of fracture was metal fatigue. This is  FRE 403 (prejudicial); the same conclusion reached by Dr. James. Fatigue Laser Design, 2007 WL is considered as a "Failure Mechanism" universally 735763 at *4 in the scientific community. This is common knowledge. The technical definition of "Failure" as it applies to the field of metallurgy is well known to Overruled:

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: every competent metallurgist, and can be found in any number of peer reviewed publications, including the Metals Handbook, Volume 11, referenced in my report on page 5. That definition is: "Failure." "A general term used to imply that a part in service (1) has become completely inoperable, (2) is still operable but is incapable of performing its intended function, or(3) has deteriorated seriously, to the point that it has become unreliable or unsafe for continued use." This definition is an integral part of the knowledge gained from my education and training as a metallurgist, and when applied to the subject Wright Medical prosthetic hip, shows conclusively that the hip has "Failed", i.e. it has become completely inoperable.

Overruled:

19 From an engineering design perspective, as  FRE 403 (prejudicial); Sustained: discussed in the reference "Engineering Design, A Laser Design, 2007WL ______ Materials and Processing Approach" listed on page 3 of my rebuttal re 735763 at *4 port, those factors that promote fatigue failure are, or should be, well Overruled: XX understood by the designers of products such as prosthetic hips that are known by virtue of their very function to be subject to repeated or cyclic loads. There are engineering design philosophies familiar to those educated in the field of metallurgy that serve to provide ways of eliminating, or greatly reducing the probability of fracture by fatigue, and for predicting with reasonable accuracy the fatigue life of products that have a propensity to fracture by fatigue. My knowledge of these design philosophies, and my understanding of the mechanisms that are involved in the time dependent aspect of the fatigue fracture process, indicate that any product that fails by fatigue in four years when there is a reasonable expectation that the product will survive and function as intended for much longer times, has failed to perform as a reasonable consumer would anticipate, and consequently is defective. The consequences of failure are considerable discomfort and anguish, and financial hardship to the patient and therefore the defective product is unreasonably dangerous.

20 The fact that medical industry anticipates that  FRE 403 (prejudicial); Sustained: prosthetic hips should survive and function safely Laser Design, 2007 WL _______ for a period of time much longer than four years is reflected in the failure statistics quoted by Dr. 735763 at *4 Overruled: James in his rebuttal report in section 3.1, in which XX he states "That large studies have shown that just survival statistics, consequently they are defective. 21 My report goes into much more detail in describing  FRE 403 (presentation of Sustained: 10

the observed "parallel groves" than is cited in cumulative evidence, _______ Defendant's motion. For example, the grooves waste of time) were not readily visible to the unaided eye; these  Overruled: grooves were located on the neck at and adjacent to FRE 403 (prejudicial); the location of the fatigue fracture origin; there is a Laser Design, 2007 WL XX line of demarcation on the groove pattern between 735763 at *4 where the surface has worn, from an area where there is no apparent wear. All of these observations, when combined with the knowledge obtained from my educational training and experience explain how and why the fatigue fracture supports my conclusion. It is common knowledge within the metallurgy profession that any series of uniformly spaced, parallel lines on the free surface of any product subjected to dimensional control are generated by a cutting or grinding tool. The machine controlled mechanical finishing processes used in manufacturing produce periodic movements, thus the symmetry of the surface features. The location of the "parallel grooves" which is on the neck extending to the location of the fracture origin (a location which is not disputed by defendant's expert Dr. James) and the surface wear, which is a clearly visible feature which, as a metallurgist I was trained to interpret, invokes the mechanism of fretting, which was clearly defined in my report (page 5), and discussed in detail. The bases for my opinion to which the defendant objects, and the how and why it was reached, are included in my fundamental knowledge of the field of metallurgy, and are clearly spelled out in my report. Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection:

over one-percent of all hip implant revisions are necessary because of implant fracture." This means that 99% of those that require revision surgery do not fail by fracture. In his original report, on page 12 Dr. James includes a table of data on hip prosthesis fracture rates reported in the literature. In his deposition he removed the DePuy S-Rom implants from the list, but the others listed show that the failure rates are in the range of 0.27% to 11.0% , which means that most hip implants do not fail by fracture. It implies that those that do fail by fracture are different in some aspect which caused failure. They did not perform as expected, based on Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: 22 My stated opinion that "[t]he fact that it was  FRE 403 (prejudicial); Sustained: 3 implanted in Mr. Tucker, who weighed in the range Laser Design, 2007 WL _______ of 257 to 265 pounds, is in itself evidence that it 735763 at *4 was being used as intended," is taken out of context Overruled: by the defendant. It fails to include the fact that my XX report includes several bases that support this opinion, and when considered collectively clearly support the opinion expressed. It fails to include the statement that if Mr. Tucker's weight was excessive (by Wright Medical standards) for this particular modular hip implant, it should not have been implanted in Mr. Tucker. It was not Mr. Tucker's decision to use this particular implant.

Documents reviewed show no evidence that Wright Medical provided any information to the physician, and certainly not to Mr. Tucker, that this specific implant was improper for Mr. Tucker. Furthermore, the defendant fails to recognize that I reviewed documents describing Mr. Tucker's activity subsequent to the date of implant, and found no evidence that these were excessively vigorous. Collectively, these observations form the basis for the opinion that the subject implant was being used as intended and this is contained in my report.

23 The defendant claims that the underlying theme of  FRE 403 (re-presentation Sustained: the opinions in my report and rebuttal report is that of cumulative evidence, _______ "the failure of the hip implant occurred because, waste of time, evidence and only because of the modular design of the Overruled: implant." The Defendant claims that I did not mischaracterized) perform an analysis of the Profemur design or  FRE 403 (not helpful to XX explain how I reached this conclusion. This is a trier of fact) complete mischaracterization of the contents of my  702(a) (qualification to original report and of my rebuttal report. provide opinion testimony) 24 The statement is based first on the facts resulting  FRE 403 (prejudicial); Sustained: 21 from a scientific examination of the physical Laser Design, 2007 WL _______ evidence, which is described in detail in my 735763 at *4 original report, and which reached the same Overruled: conclusions as those reported by Dr. Brad James, XX defendant's expert metallurgist. The conclusions were, to quote Dr. James' original report "The subject device fractured by a combination of corrosion, fretting and fatigue." The only difference between Dr. James' conclusions and my conclusions is that Dr. James concluded that there was no evidence of a manufacturing defect. My conclusion was that errors in manufacturing were contributing factors. Dr. James admits nevertheless, (page 5 of his report) that given the "substantial

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: fretting of the neck and stern modular taper surfaces, no determination of the presence of absence of any surface or dimensional defect could be made." Therefore he cannot rule out any contribution of a surface or dimensional defect to the cause of fracture. Most importantly, however, is the common conclusion that there was "substantial fretting of the neck and stern modular taper surfaces". Once this fact is established, i.e. fretting has occurred on the surface where the fatigue crack originated (both Dr. James and I agree as to the location of the fatigue crack origin) as pointed out several times in my report, it follows that there was microscopic movement between the neck and stern. This is the only possible way that fretting can occur. As pointed out numerous times in my report, the only possible reason that any movement occurred is because the subject hip was of modular design, i.e. the neck and stein were two different pieces of metal. Absent this fact, fretting is impossible. It follows that if fretting is impossible, and if the fatigue fracture initiated because of fretting damage, then absent the fretting damage a fatigue crack would not have initiated, and absent the initiation of a fatigue crack, there would have been no fatigue fracture. The chain of events that caused fracture of the specific prosthetic hip that was implanted in Mr. Tucker, and which failed by fatigue fracture, started because of the modular design of the hip implant. My report clearly describes this process and the basis for the opinion to which the defendant objects.

25 Defendant objects to my stated opinions that: (1)  FRE 403 (re-presentation Sustained: There is no evidence the subject total hip of cumulative evidence, _______ replacement device was abused or misused after implantation in the right hip of Mr. Tucker, (2) waste of time)  FRE 403 (prejudicial); Overruled: There is no evidence that Mr. Tucker's actions Laser Design, XX during the time period he depended on the 2007 WL performance of the subject total hip replacement 735763 at *4 device to allow him to function normally did anything contribute to the ultimate failure of the device, (3) There is no evidence that Mr. Tucker's activity after the device was implanted was excessively vigorous. The reasons for reaching these opinions are spelled out in detail in both my original report and my rebuttal report. They are based on the results of the examination of the physical evidence which identified the cause of fracture, which both Dr. James and I agree was fretting corrosion and fatigue, and on information

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: gleaned from my review of the documents listed in my original report. These documents indicate that there is no evidence that Mr. Tucker's activity subsequent to implantation of the subject prosthetic hip was in violation of any admonitions he received from either his physician or Wright Medical. There is no evidence that Mr. Tucker received any notice in the form of pain or discomfort when performing his activities that he was acting inappropriately for an individual with a prosthetic hip. Absent any of these indicators of misuse, it follows logically that there is no evidence of misuse. After the subject device failed, and the failure mechanism was established, there is no feasible way of load testing the device to obtain any scientific data relating to possible misuse. The bases for the opinions are that misuse implies a violation of some written or verbal detailed instruction or prohibition, or the participation in an activity that is anticipated to produce some physical sensation of pain. Absent either of these events, there is no evidence of abuse or misuse. These bases are clearly represented in my reports. 26 The defendant does not object to my conclusion,  FRE 403 (prejudicial); Sustained: 15 that the remaining 5% fractured instantaneously Laser Design, 2007 WL _______ when a force acted that produced a local stress in excess of the strength 735763 at *4 of the alloy used to Overruled: manufacture the neck. Even though there is no XX objection to this part of the conclusion, it is important to note that the basis for this opinion is the fact that a scientific examination of the failed prosthetic hip produced the results that the fracture mechanism was metal fatigue. The final fracture by an overstress mechanism is a characteristic of metal fatigue, and is unique to that mechanism.

27 The defendant appears to object to my opinion as to  FRE 403 (prejudicial); Sustained: when or how this actually occurred, My statement Laser Design, 2007 WL _______ was based on the University of San Francisco Medical Center Discharg 735763 at *4 e Summary for patient Overruled: Gregory Tucker, admitted on 05/17/10 and XX discharged on 05/20/10, which lists Dr. Telmer J. Guillaume as the provider, and is dated 05/24/10, contains the following statement in part: "He underwent a right ceramic on ceramic total hip replacement with a modular femoral stem in March 2006. He did well until Friday, May 7, 2010, when he suffered a fall and was seen in the local emergency department. X-rays showed a broken femoral stem at the modular neck." Regardless of

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: when or how it occurred, this has no bearing on other opinions presented in either myoriginal report or my rebuttal report. 29 My experience in analyzing failed prosthetic  FRE 403 (prejudicial); Sustained: 5 devices in the past has resulted in understanding Laser Design, 2007 WL _______ that the industry classifies implants into two broad categories. One category is "permanent" implants, 735763 at *4 Overruled: and the second is "temporary" fixation devices. XX Permanent implants are devices that are intended to be permanent, with no intended date of removal absent a failure to perform the intended function. A "temporary" fixation device is one that is implanted for the purpose of assisting the body in a healing process, with the option of removing the implant after its intended function has been performed. My opinions are based on this knowledge and experience.

30 There are numerous technical publications that  FRE 403 (prejudicial); Sustained: support my contention that prosthetic hips are Laser Design, 2007 WL _______ intended to be permanent devices, however I saw no need to provide documentation of what is 735763 at *4 Overruled: considered to be an accepted distinction. For XX example, an article located on the website, www.fda.gov/MedicalDevices/..../Implants and Prosthetics/default.htm, states the following: "Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be removed when they are no longer needed." The same article lists examples of questions a patient should ask a doctor before agreeing to an implant procedure. One such question is "Will my implant be permanent or removable? If the device is permanent, find out how long it should last."

31 Defendant contends that my assertion that a  FRE 403 (prejudicial); Sustained: consumer has the right to expect the device to Laser Design, 2007 WL ______ perform for more than four years fails to take into account any bio-mechanical, physiological, 735763 at *4 Overruled: behavioral, surgical, or environmental factors that XX are known to affect the performance of total hip replacements. However, Wright Medical, as the designer and manufacturer of the hip implant is the party responsible for considering and accounting for the bio-mechanical, physiological, behavioral, surgical and environmental factors of their target market when designing prosthetic hips, and has the

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: ethical responsibility to minimize the effects of these factors on the durability of the device, rather than simply tell the consumer that we don't know how long this device will last and someday at some unspecified time, you may need revision surgery. A consumer has the right to know, and the manufacturer has the obligation to provide accurate information, concerning the anticipated lifetime of a product that, in the event of failure, can cause harm to the consumer. 33 As a result of my university education and training,  FRE 403 (prejudicial); Sustained: which began in the year 1959, and as a result of my Laser Design, 2007 WL ______ experience in analyzing numerous other prosthetic implants including prosthetic hips, I have acquired 735763 at *4 Overruled: knowledge concerning fretting, corrosion and XX fatigue that are contained within scientific publications. These same publications are part of the general scientific literature and were, or should have been available to the design engineers employed by Wright Medical at the time the modular Profemur prosthetic hip was designed.

34 The initiating cause of the failure of the subject  FRE 403 (re-presentation Sustained: Wright Medical prosthetic hip was a phenomenon of cumulative evidence, ______ called "fretting." The physical evidence that this phenomenon in fact occurred is in the form of waste of time) damage unique to fretting discovered during  FRE 403 (prejudicial); Overruled: examination of the subject failed prosthesis. Dr. Laser Design, 2007 WL XX Brad James (Opinion 1, page ii of his report) agrees 735763 at *4 that fretting and the associated phenomena of corrosion and fatigue caused fracture of the subject implant. Through my education and experience, I am aware that this failure phenomenon has been known to the scientific community for decades. The Metals Handbook, Published by the American Society for Metals in 1948, on page 6, defines fretting corrosion. Another peer reviewed text book titled Mechanical Metallurgy, authored by George Dieter, and published by McGraw Hill in 1961, on page 322, contains a section on "Fretting", and states "Fretting is the surface damage which results when two surface in contact experience slight periodic relative motion". It also states "Fatigue cracks often start in the damaged areas". There are numerous other peer reviewed technical publications describing the detrimental effects of fretting and the associated corrosion and fatigue phenomenon in the scientific literature in the time period prior to the time in 2001 or 2002 when the Wright Medical modular Profemur prosthetic hip

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: was designed. 35 The detrimental aspects of "fretting" described in  FRE 403 (prejudicial); Sustained: 4 the scientific literature was, or should have been Laser Design, 2007 WL _______ known to Wright Medical engineers and designers when they designed the modular Profemur 735763 at *4 prosthetic hip, and elected to incorporate into the design, two metal surfaces pressed into contact, the exact condition that must exist in order for the fretting phenomenon to even be a potential cause of failure. By electing to design a modular neck and stein combination into the prosthetic hip, Wright Medical introduced into the device, a well known and publicized mechanism of failure that would not exist absent the modular design. This very mechanism of failure caused fracture of the neck of the subject prosthetic hip that failed when implanted in Mr. Tucker.

36 There is considerable evidence that Wright Medical  FRE 403 (prejudicial); Sustained: was aware of the potential for failure by fretting Laser Design, 2007 WL _______ prior to the design and manufacture of the modular profemur prosthetic hip. 735763 at *4 Wright's expert, Dr. Brad Overruled: James, in his report on page 5, includes a section XX titled "Fretting-induced fatigue is a relatively common issue in modular hip implants." In the second paragraph of that section, he states "Fretting, corrosion and fatigue are well-known issues (emphasis added) in modular implants, such as the subject device." He then references eight scientific publications, with publication dates of 1994, 2007, 1999,1993, 1996, 1997, 2008, and 1997. Six of the eight were published before Wright Medical placed the modular Profemur prosthetic hip into the stream of commerce. All of these deal directly with fretting damage in modular prosthetic hips, rather than fretting in general, and should have been known to Wright Medical engineers and designers prior to designing the modular Profemur hip.

37 Wright Medical's expert, Dr. James admits that  FRE 403 (prejudicial); Sustained: "modular orthopedic implants are well known to be Laser Design, 2007 WL _______ susceptible to fretting and fretting-induced fatigue, modular systems allow distinct advantages in terms 735763 at *4 of fitting patient anatomy." This statement does not identify the specific advantages of fitting patient anatomy, or why these advantages outweigh the disadvantages of pain and suffering to the patient resulting from failure of the device by the well known mechanism of fretting and fretting induced Overruled: XX

Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection: fatigue. 40 One of the textbooks used in my course on  FRE 403 (prejudicial); Sustained: 4 Engineering Design at Arizona State University is Laser Design, 2007 WL _______ referenced in my rebuttal report. The title of that book is 735763 at *4 entire section on "Ethics in Engineering." The ethical responsibility of a design engineer requires that the product designed be analyzed for potential hazards. This same textbook includes an entire chapter on Risk and Reliability which includes a section on Hazard Analysis. With respect to the potential hazard of sudden and unanticipated failure by fatigue, this textbook describes three commonly accepted approaches to product design. One approach is termed Infinite-Life Design; the second is Safe-Life Design; and the third is Damage-Tolerant Design. These approaches allow a designer to understand those factors that influence the fatigue life of any product, and when properly applied through analysis and testing, enable the designer to predict with a reasonable degree of accuracy the anticipated lifetime of the product. This is all related to the ethical responsibility of the design engineer, to produce products that are free of hazards and safe for use by consumers, regardless of their intended use of the product. Training in engineering ethics was part of my educational curriculum, and part of my responsibilities as a university professor during my 40 years of teaching engineering course at Arizona State University.

41 As part of the requirements for my design course, I  FRE 403 (prejudicial); Sustained: 20 used other authoritative peer reviewed reference Laser Design, 2007 WL _______ publications such as the Standard Handbook of Machine Design, Second Edition. This reference 735763 at *4 Overruled: contains a chapter titled "Safety." That chapter XX ends with the following summary: "The designer or manufacturer of a product has a moral, ethical and legal obligation to provide safe products. If that is not enough motivation, there is a matter of enlightened self-interest. There are three aspects to this obligation: (1) The product must be made safe. (2) If it is not possible to design out all hazards, guarding must be provided. (3) If complete and proper guarding cannot be provided, appropriate directions and warnings must be provided. It is absolutely unacceptable to use a warning in a situation where safe design or proper guarding is 5 "Engineering Design, A Materials and Overruled: Processing Approach." That textbook, contains an XX Hendrickson Declaration Evidentiary Objection(s) Ruling on the Objection:

possible". I have had knowledge of these ethical 3 responsibilities of design engineer since my years as student many years ago. 4 5 Truman's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection: 6 Truman's Opinion That Wright Medical's Testing  FRE 402 (irrelevant) Sustained: Was Inadequate  FRE 403 (more prejudicial ______ than probative) Truman Report: Finding Nos. 5, 6, 14, 15 (pp. 47-  FRE 702(a) (not helpful to Overruled: 7 8 48); pp. 12-16, 19, 25-30; 31, 46-47trier of fact) XX 9  FRE 702(d); Unreliable: Contradicted By 10 Witnesses Own Report

and Sworn Testimony Truman's Opinions Regarding Cobalt Chromium  FRE 402 (irrelevant) Sustained:  FRE 403 (more prejudicial ______ Truman Report: Finding Nos. 8, 11, 14, 15 (p. 48); than probative) 12 13 pp. 21, 31-32, 35, 46  FRE 702(a) (not helpful to Overruled: 14 the trier of fact) XX  FRE 702(c) (not the 15 product of reliable 16 principles and methods)  FRE 702(d) (does not apply 17 principles and methods to the facts of the case; 18 Contradicted By Witnesses Own Report 19 and Sworn Testimony)

Truman's Opinion that Various Surface Treatments  FRE 403 (more prejudicial Sustained: Could Have Avoided Injury than probative)

 FRE 702(a) (not helpful to

Truman Report: Finding Nos. 9, 11, 14, 15 (p. 48); the trier of fact) Overruled: pp. 31-33  FRE 702(c) (not the XX product of reliable principles and methods)

Truman's Opinions Regarding Acceptable Rates of  FRE 402 (irrelevant) Sustained: 25 Failure  FRE 403 (more prejudicial ______ than probative) 26 Truman Report: Finding Nos. 3, 15 (pp. 47-48);  FRE 702(a) (not helpful to Overruled: 27

pp. 36-42 the trier of fact) XX (but sustained as to  FRE 702(c) (not the the ultimate Truman's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection: product of reliable issue of what 3 principles and methods) is acceptable)  FRE 702(d) (does not apply the principles and methods to the facts of the 4 5 case) 6 Truman's Conclusion that Warnings Were  FRE 403 (more prejudicial Sustained: Inadequate 7 than probative) ______  FRE 702(a) (not helpful to Truman Report: Finding Nos. 12, 13, 14, 15 (p. the trier of fact) Overruled: 48); pp. 16, 19, 20, 42-47  FRE 702(c) (not the ______ 8 Truman Rebuttal Report: p. 3 product of reliable principles and methods) RESERVED*fn1  FRE 702(a) - not qualified 11 to offer opinion as to warnings because witness 12 is an engineer, not a medical doctor, surgeon, 13 or other individual who 14 treats patients. Gebhardt v. Mentor Corp., 15 F. 15 App'x 540, 541-42 (9th Cir. 2001); Squires v. 16 Goodwin, 829 F.Supp.2d 1041, (D. Colo. 2011) 17 (finding proposed expert 18 had no experience designing product 19 warning labels); Magoffe v. JLG Indus. Inc., 2008 20 WL 2967653 (D. N.M. 2008) (engineer not 21 qualified to offer opinions 22 as to warnings); Bourelle v. Crown Equipment 23 Corporation, 220 F.3d 532, 538 (7th Cir. 2000) 24 (holding "Only a physician or someone 25 with specialized 26 knowledge would be

Truman's Opinions in Report and Rebuttal Evidentiary Objection(s) Ruling on the Objection: qualified to determine whether the warning was inadequate"). Truman's Conclusion that the Profemur® was  FRE 402 (irrelevant) Sustained: Unreasonably Dangerous  FRE 403 (more prejudicial ______ than probative) Truman Report: Finding Nos. 1, 2 (p. 47); pp. 28,  FRE 702(a) (not helpful) Overruled: 30, 47 XX Truman Opinion that Alcohol and Alcohol Abuse  FRE 403 (more prejudicial Sustained: Played No Role in Failure than probative) ______  FRE 702(a) (not helpful to Truman Report: Finding No. 4 (p. 47) the trier of fact) Overruled:

Truman Rebuttal Report: Findings (p.4); pp. 3-4  FRE 702(c) (not the XX product of reliable principles and methods) Truman Declaration Evidentiary Objections Ruling on the Objection: 2. My Engineer's Report dated September 19, 2012,  FRE 403 (re-presentation Sustained: 15 ("Truman Report") and my rebuttal report dated of cumulative evidence, ______ September 23, 2012, ("Truman Rebuttal") are waste of time) incorporated herein by reference and are attached Overruled: hereto as Exhibit "B." XX 5. My methodologies for coming to the conclusions  FRE 403 (not helpful to Sustained: 18 contained in my Report and Rebuttal Report are trier of fact) ______ sound and well supported by peer-reviewed  FRE 702(a) (qualification published scientific and medical literature and to provide opinion Overruled: textbooks that I cite in my reports and discuss testimony) XX further in this declaration. 6 My curriculum vita lists my work experience, but  FRE 403 (prejudicial); Sustained: does not specifically list all of the areas that I Laser Design, 2007 WL ______ have experience in within that work experience. 735763 at *4 A person knowledgeable of the biomechancial Overruled: engineering field, who reviewed my education XX and work experience, would reasonably assume that I have significant experience with the issue of labeling.

7. I have been an engineer in the orthopaedic industry  FRE 403 (re-presentation Sustained: for over 32 years. of cumulative evidence, _______ waste of time) Truman Declaration Evidentiary Objections Ruling on the Objection: Overruled:

8. In those years I have been a designer, development  FRE 403 (prejudicial); Sustained: team member, and more recently a consultant to the Laser Design, 2007 WL _______ industry. As part of my responsibilities I have been 735763 at *4 involved in both the creation and review of Overruled: warnings and precautions provided in package XX inserts and surgical techniques for well over a dozen orthopaedic product lines for at least 12 different orthopaedic companies.

9. As part of the development teams, I routinely  FRE 403 (prejudicial); Sustained: complete failure modes and effects analyses, Laser Design, 2007 WL _______ risk estimates and identify and apply methods 735763 at *4 to reduce risk of hazards and harm. This work Overruled: is complete with the development team, which XX includes engineers, marketing personnel, surgeons, and medical reviewers. 10. The warnings provided in package inserts  FRE 403 (prejudicial); Sustained: for new products are reviewed by the design Laser Design, 2007 WL _______ teams. In my career I have been a member of 735763 at *4 many such teams. Overruled:

11. Through my experience and training in reviewing,  FRE 403 (prejudicial); Sustained: 17 writing, and discussing warnings with team Laser Design, 2007 WL _______ members and with orthopaedic surgeons I am 735763 at *4 qualified to comment on the adequacy of the Overruled: information contained in Wright Medical's IFUs XX and promotional materials. I am qualified to write and interpret the warnings as an industry expert, and have done so in the past. 12. In my report, I provided a reasonable alternative  FRE 403 (re-presentation Sustained: 22 warning that is used by Exactech. Additionally, of cumulative evidence, _______ Wright Medical's 230 pound weight restriction for waste of time) its current, more durable, Profemur Modular Neck  FRE 403 (prejudicial); Overruled: is a more reasonable alternative to the non- Laser Design, 2007 WL XX definitive warnings initially provided with the 735763 at *4 titanium Profemur Modular necks. 13. Exactech's Accumatch M modular femoral  FRE 403 (prejudicial); Sustained: 26 stem, a titanium alloy product whose design is Laser Design, 2007 WL _______ stronger than the Wright ProFemur, 735763 at *4 contraindicates the Accumatch M femoral Overruled:

Truman Declaration Evidentiary Objections Ruling on the Objection: stems for moderately active to vigorously active patients weight greater than 250 lb. (Source: Exactech's Accumatch M brochure, ©2006 #711-06-30, Rev C 0506). 14. The warning pages supplied by Wright for this  FRE 403 (re-presentation Sustained: device were insufficient concerning weight of cumulative evidence, _______ and/or activity restrictions to prevent implant waste of time) overload, failure, and patient injury. Overruled:

RESERVED

15a Stating that obesity or high activity  FRE 403 (re-presentation Sustained: levels can lead to implant fracture in an of cumulative evidence; _______ Instructions for Use (IFU) documents is waste of time) an insufficient warning for the Overruled: following reasons: ______ (a) This statement provides no definitive RESERVED guideline to the physician as to how much weight or how much activity this product can withstand. There were no specific weight or activity restrictions in Wright's IFUs for the ProFemur neck implants prior to 2010. Given that there are several peer reviewed articles supporting the effectiveness of total hip implants in heavier or obese individuals, despite an increase in complications, more information concerning the relative endurance limit or specific implants is needed for the surgeon to make an informed choice of appropriate implants for use in heavier or high-demand, high-activity patients. In addition, Wright did not contraindicate the use of this product in high demand patients (heavy patients, active patients). In fact, Wright clearly marketed their hip products for use in high demand patients and their brochures appeared to show comparatively greater strength to selected (weaker) devices. [Wright advertisements/patient testimonials]. Wright's technical brochures and testimonials imply to consumers (surgeons and their patients) that this product had been designed and tested for high demand situations.

read the IFU documents provided with the of cumulative evidence; _______ 15 implants in the packaging. Simply placing an waste of time) 4 b ambiguous warning on a document that is not Overruled: routinely read is an insufficient method to assure ______ patient safety. Among other things, surgeon-to- surgeon training, and salesman-to-surgeon training RESERVED tips, promotions/educational brochures, physician letters, and literature or literature reviews (when available) are more effective in communicating and clarifying such critical issues to surgeons. 15 (c) The warnings provided at the time that  FRE 403 (re-presentation Sustained: c Tucker's procedure was completed simply did not of cumulative evidence; ______ 10 provide sufficient information concerning the waste of time) capability of this implant or the risk of fracture of Overruled: ______ weight and activity level limitations, as per RESERVED Exactech's guidance, and/or comparative strength or endurance data with a clinical relevance discussions should have been provided by Wright. 16 In MH179-703, Rev.0904, Wright Medical  FRE 402 (irrelevant, not Sustained: 15 advertised that in 19 years of clinical use there relevant time period) XX were no fractures in the implanted Profemur Necks,  FRE 403 (prejudicial); and they boasted that over 50,000 had been Laser Design, 2007 WL Overruled: implanted. However, the Wright Medical design 735763 at *4 ______ control and regulatory documentation documents  FRE 702(a) (lack of that several ProFemur necks had fractured in 1985- qualification, no 2004 time frame. This mis-information implies to foundation) the surgeon that there is no risk of fracture of the ProFemur modular neck. A true and correct copy of MH179-703 is attached hereto as Exhibit "C."

17 In my experience working with surgeons, if  FRE 702(a) (lack of Sustained: ______ weight or for patients performing a specific set of  FRE 403 (prejudicial); Overruled: higher demand actives; they will generally seek out Laser Design, 2007 WL ______ a product that does have sufficient strength for 735763 at *4 patients with those requirements. If surgeons are RESERVED not informed of strength limitations of a device in specific terms, they have no reason to select an alternative, especially when the new device is claimed to be the same as a device with 19 years free of fractures in clinical use, as this product was

Truman Declaration Evidentiary Objections Ruling on the Objection: (b) It is well known that surgeons do not routinely  FRE 403 (re-presentation Sustained: 3 5 6 7 8 9 11 12 this device in high demand patients. Specific 13 14 16 17 18 19 20 21 22 surgeons are specifically informed that a product qualification, no does not have sufficient strength for a specific foundation) 23 Truman Declaration Evidentiary Objections Ruling on the Objection: described by Wright Medical. 18 As discussed in my Report and obtained from  FRE 403 (re-presentation Sustained:

Wright Medical's own website, there are at least of cumulative evidence; _______ three Wright Medical brochures that imply waste of time, irrelevant) superior strength of the ProFemur hip when Overruled: compared to other hips. XX 19 Wright marketed their Metal-on-Metal ("MoM")  FRE 402 (irrelevant) Sustained: 7 products for use in active individuals. Refer to:  FRE 403 (re-presentation _______ CONSERVE Total Hip System with BFHTM of cumulative evidence;

Technology Big Femoral Heads iBFHTM) Restore waste of time, irrelevant, Overruled: an Active Lifestyle. Case Study, Harold S. Boyd, prejudicial does not relate XX M.D. and Younger age patient testimonials, Wright to Profemur® product or website (e.g., Jimmy Connors, Evelyn, Gary, Jon, specific failure at issue) Kevin, Larry, Mark, Rick). 20 Gregory Tucker was a moderately-active/active  FRE 403 (re-presentation Sustained: 12 46-year-old when his hip implant failed. His of cumulative evidence; _______ weight was within the normal distribution of waste of time, irrelevant) today's U.S. population, which was one of Overruled: Wright's target markets for this product. Tucker XX was not unforeseeably heavy for a total hip implant patient. Tucker did not act or react improperly in a manner that caused his injury. 22 A failure rate of either 0.30% or 0.47%, as claimed  FRE 402 (irrelevant) Sustained: by Wright, is not an acceptable failure rate in the XX (as to the component of an artificial hip. waste of time, prejudicial, but not as to irrelevant not related to the rate) relevant time frame) Overruled:

2 The North American long neck fracture rate was  FRE 402 (irrelevant) Sustained: 3 calculated by Wright to be 0.546% (55 out of  FRE 403 (re-presentation _______ 22 every 10,000) when 146 fractures had occurred as of cumulative evidence; of November 18, 2010, this computes to 1 in 183 waste of time, prejudicial, Overruled: long necks fracturing. irrelevant not related to XX relevant time frame) 24 Wright has stopped distributing titanium Profemur  25 FRE 402 (irrelevant) Sustained: modular necks in North America, and has replaced  FRE 403 (re-presentation _______ them with cobalt chrome necks. of cumulative evidence; waste of time, prejudicial, Overruled: irrelevant not related to XX

 FRE 403 (re-presentation industry for the fracture of the modular neck of cumulative evidence; conclusion, relevant time frame) 28 Assuming, as Wright predicted, that modular neck  FRE 402 (irrelevant) Sustained: 15 fractures continued in 2012 at the rate of 6.5 a  FRE 403 (re-presentation _______ month, 78 additional fractures will have occurred of cumulative evidence; in 2012. waste of time, prejudicial, irrelevant not related to Overruled: XX relevant time frame)

29 With 58% of the fractures occurring in the U.S.,  FRE 402 (irrelevant) Sustained: 19 and 89% of the fractures being long necks, there  FRE 403 (re-presentation ______ will be approximately 40 additional long neck of cumulative evidence; fractures reported in the U.S. in 2012, for a total of waste of time, prejudicial, Overruled: 173 U.S. long neck fractures. This is a U.S. long irrelevant not related to XX neck fracture rate of approximately 1.15% (173 relevant time frame) U.S. long neck fractures; 15,060 U.S. long neck sales), or a fracture rate of 1 out of every 81 long necks implanted in the U.S.

30 The total number of fractured ProFemur necks is  FRE 402 (irrelevant) Sustained: nearly 346 in mid-2012, and a rate of 8.7 fractures  FRE 403 (cumulative ______ per month indicates a total of 372 fractures by year evidence; waste of time, end, and about 192 U.S. long neck fractures for a irrelevant - not related to Overruled: U.S. long neck fracture rate of 1.27% by year end. relevant time frame; XX misquotes own report which claims 8.5 per Truman Declaration Evidentiary Objections Ruling on the Objection: relevant time frame)

25 In its December 3, 2010 Modular Neck update,  FRE 402 (irrelevant) Sustained: Wright Predicted that neck fractures would  FRE 403 (re-presentation _______ continue at the rate of 6.5 per month. of cumulative evidence; waste of time, prejudicial, Overruled: irrelevant not related to XX relevant time frame) 26 As of December 1, 2011, the long neck fracture  FRE 402 (irrelevant) Sustained: rate is 0.88%.  FRE 403 (re-presentation _______ of cumulative evidence; waste of time, prejudicial, Overruled: irrelevant not related to XX relevant time frame)

27 Based upon review of FDA MAUDE reports for  FRE 402 (irrelevant) Sustained: fractured components between December 2011  FRE 403 (re-presentation _______ and October 2012, the monthly fracture rate is of cumulative evidence; greater than what Wright predicted in 2010, waste of time, prejudicial, Overruled: averaging about 8.7 per month. irrelevant not related to XX Truman Declaration Evidentiary Objections Ruling on the Objection: month)  FRE 403 (prejudicial), Laser Design, 2007 WL 735763 at *4

31 To a device manufacturer, the failure rate that has  FRE 402 (irrelevant) Sustained: evolved, and is projected for the life of the product  FRE 403 (prejudicial); XX is what is material. Laser Design, 2007 WL 735763 at *4 Overruled: 32 The present and projected fracture rates of the  FRE 402 (irrelevant) Sustained: Wright Medical Titanium long modular neck  FRE 403 (cumulative XX exceed what is an acceptable rate of fracture in the evidence; waste of time, industry for an artificial femoral neck or an prejudicial, irrelevant not Overruled: artificial femoral stem, and is an unacceptable related to relevant time ______ failure rate. frame) 33 While the precise combination of stem model and  FRE 402 (irrelevant - not Sustained: neck model should not be particularly relevant to related to relevant time _______ the industry in calculating and evaluating the frame;) significance of failure rate of these modular neck  FRE 403 (prejudicial), Overruled: devices, it does appear from the data cited by Laser Design, 2007 WL XX Wright's experts that the use of a modular neck 735763 at *4 with the Profemur stem results in failure rates more than 50% higher than the fracture rates of modular necks across all stems. 34 The failure rates relied on by Wright Medical and  FRE 403 (prejudicial) Sustained: 18 their experts Dr. James and Dr. Ochoa contain Laser Design, 2007 WL _______ several rates that are not similar and are not 735763 at *4 comparable to the fracture rate of Wright Medical's Overruled: long necks. XX 37 In Wright's original 510(k) application for  FRE 403 (irrelevant, Sustained: 21 clearance to market these devices Wright prejudicial) Laser Design, _______ represents that the Profemur hip system is Intern. 2007 WL 735763 substantially similar to five other hip systems, the at *4 Overruled: Wright Infinity, Portland Orthopedic Margron, XX Zimmer ZMR hip system, OTI Omega II, and Link-Link MP. [Exhibit 14 to Wright's 510(k) application. WMT 849-852.] The neck fracture rates of those systems which Wright represents to be "substantially similar" are not offered by Dr. James.

38 Of the articles cited by Dr. James and Dr. Ochoa,  FRE 402 (irrelevant) Sustained: Truman Declaration Evidentiary Objections Ruling on the Objection:

only the Grupp article analyses a hip system with a  FRE 403 (re-presentation modular neck, the Metha Short Hip System of cumulative evidence; Overruled: Prostheses, made in Germany and never authorized waste of time, prejudicial) XX for distribution in the United States by the FDA. That system initially had a titanium (Ti6A14V) neck and stem, the same as the Wright Profemur modular implants in issue here, and appears to have a modular junction in the stem similar to that of the Profemur. A true and correct copy of the article is attached hereto as Exhibit "F." 39 The Metha modular neck failure rate is supportive  FRE 402 (irrelevant) Sustained: 9 of that design being defective, and how a  FRE 403 (re-presentation _______ reasonable manufacturer should have responded to of cumulative evidence; notice of such a defect. waste of time, irrelevant, Overruled: prejudicial) XX 40 The Grupp article shows that the Metha Short Hip  FRE 402 (irrelevant) Sustained: 12 had a failure rate of 1.4%. The article shows that  FRE 403 (re-presentation _______ the Metha titanium modular necks implanted from of cumulative evidence;

August 2004 to November 2006 fractured on waste of time, irrelevant, Overruled: average at 24 months (0.7 - 4.0 years) after XX prejudicial, involves implantation. After the third fracture Aesculap AG, irrelevant time period) the manufacturer of Metha, replaced its titanium necks with cobalt chrome necks in November of 2006. Aesculap removed the product from the market when there was a failure rate of only 0.06% (3 fractures out of 5,000 implants.) The manufacturer also published the results of their failure analyses at least three tunes in peer reviewed literature to benefit the general orthopaedic community.

41 Wright Medical documents [WMT_TUC 00874-  FRE 402 (irrelevant) Sustained: 21 885, 00939-950] disclose that Wright Medical  FRE 403 (re-presentation _______ Europe marketed over 50,000 modular necks over of cumulative evidence; the period of 1986-2002. Product complaints were waste of time, irrelevant, Overruled: recorded over the period of January 1997 - October prejudicial, involves XX 2006. It received notice of seven neck breakages irrelevant time period) (fracture) of its titanium modular necks in that  FRE 702 (Not helpful to time. The causes of the failures included micro trier of fact) movements, fretting, and metal fatigue

Truman Declaration Evidentiary Objections Ruling on the

Objection:

42 Unlike Metha, who immediately discontinued  FRE 403 (re-presentation Sustained: 3 titanium modular* necks after notice of only 3 of cumulative evidence; _______ failures, Wright continued to manufacture and waste of time, irrelevant) distribute titanium modular necks, with the  FRE 702 (Not helpful to Overruled: predictable result that fractures continued to occur trier of fact) XX

43 An article by Kishida is cited by Dr. James and Dr.  FRE 402 (irrelevant) Sustained: Ochoa for the claim that the Lubeck total hip has a  FRE 403 (re-presentation _______ 2.5% failure rate. A true and correct copy of that of cumulative evidence; article is attached here to as Exhibit "G." This waste of time, irrelevant) Overruled: German made hip system was not approved for use XX in the United States by the FDA, and the device does not have a modular neck. The device had a high failure rate with fractures occurring in the middle third of the stem, not the neck area. The fractures were attributed to the small core diameter of the stem and the lack of proximal stability. These fractures are not the result of micromotion and fretting corrosion, and are unrelated to the failure mechanism at issue. 44 An article by Gotze is cited by Dr. James to support  FRE 402 (irrelevant) Sustained: 15 a claim of a 3.0% failure rate in the Lubeck Total  FRE 403 (re-presentation ______ Hip, the same device discussed in the preceding of cumulative evidence; paragraph. The article concluded that the high- waste of time, irrelevant) Overruled: fracture rate of the stem is unacceptable. A true and XX correct copy of the article is attached hereto as Exhibit "H." 45 An article by Busch is cited by Dr. James and Dr.  19 FRE 403 (re-presentation Sustained: Ochoa for a claim that DePuy Solution and the of cumulative evidence; ______ Smith & Nephew Echelon Hips had failure rates of waste of time, irrelevant) 2.3%. This is a misrepresentation of the article and Overruled: its data. The article identified 5 fractured femoral XX sterns out of 219 revision surgeries. In other words, there was a fracture rate of 2.3% in the revision surgeries studied. No information was provided regarding the total sales of the hip. Additionally, the hips studied did not have modular necks, and the failures occurred in the body of the stern, not the neck region. A true and correct copy of the article is attached hereto as Exhibit "1." 46 To calculate the true fracture rate of the DePuy  FRE 403 (prejudicial), Sustained: 27

Solution and the Smith & Nephew Echelon Hips, Laser Design, 2007 WL ______ the total number of hips sold would need to be 735763 at *4 in increasing numbers and rates of fracture.

Truman Declaration Evidentiary Objections Ruling on the Objection: known, not just those that are being revised due to Overruled: a failure. Without this information comparing this XX "fracture rate" to Wright Medical's fracture rate is disingenuous. 47 An article by Goldberg is cited by Dr. James and  FRE 403 (prejudicial), Sustained: Dr. Ochoa for the claim that the DePuy S-Rom has Laser Design, 2007 WL _______ a failure rate of 10%. The article is again being 735763 at *4 misrepresented. The "mechanical" failure rate of Overruled: the S-Rom cited by Dr. Goldberg references an XX article by Chandler for that data. A reading of the Chandler article shows that this study was based on a population of 48 patients with 52 total hip revisions among them. "Mechanical loosening" had occurred in 5 hips out of the 52 for a 10% rate. The mechanical loosening was a lack of fixation of the stern. The DePuy S-Rom also does not have a modular neck. A true and correct copy of the article is attached hereto as Exhibit "J." 48 An article by Heck is cited Dr. James and Dr.  FRE 403 (re-presentation Sustained: 14 Ochoa for the claim that the American Association of cumulative evidence; _______ of Hip and Knee Surgeons Survey had determined waste of time, irrelevant) a failure rate of 0.27%. The article lists 23 device Overruled: manufacturers by name. The study included 64,483 XX metallic femoral components. A total of 172 stem fractures were reported, with only three manufacturers and the "unknowns" accounting for more than 91% of the fractures. Sixteen manufactures reported no femoral stern fractures. The article states that the FDA has been concerned with the medical device regulatory process and the lack of sufficient safeguards. A true and correct copy of the article is attached hereto as Exh "K." 49 With regards to the fracture rate presented by the  FRE 403 (prejudicial), Sustained: 22 Heck article, this rate is half that of the North Laser Design, 2007 WL _______ American experience of Wright's Profemur long 735763 at *4 neck as of November 18, 2010, and one fourth of Overruled:

the current known fracture rate of Wright's Profemur long neck. 50 An article by Callaghan is cited by Dr. James for  FRE 403 (prejudicial), Sustained: 26 the claim that All Mayo Clinic hip replacements Laser Design, 2007 WL _______ had a failure rate of 0.6% and that the Charnley- 735763 at *4 Mueller hip had a 11% failure rate. The data for the Overruled: Chamley-Meuller hip was from 1974. Again the XX Truman Declaration Evidentiary Objections Ruling on the Objection:

data is misrepresented by Wright Medical's experts. The 11% failures rate was derived from six fractures of the femoral stem out of 56 replacement arthroplasties. Again this fracture rate is not the fracture rate of implanted hips and does not concern the modular neck. The Mayo experience is based on an article published in 1981. As stated in the article, because of improvements in materials and design, the fracture rate was zero for the improved devices introduced in 1976. A true and correct copy of the article is attached hereto as Exhibit "L." 51 An article by Carlsson is cited by Dr. James and  FRE 403 (prejudicial), Sustained: 10 Dr. Ochoa regarding data from a Swedish hospital Laser Design, 2007 WL _______ in the early 1970s showing a failure rate of 0.67%. 735763 at *4 The article reports 14 stem fractures of the first Overruled: generation with a fiat back, which was made of XX wrought air-melted 316-L stainless steel and all came from the same manufacturer. These hip devices from the 1970s are not substantially similar to the modern artificial hip stem and neck and are not an appropriate comparison. A true and correct copy of the article is attached hereto as Exhibit "M."

52 An article by McNeur is cited by Dr. James and Dr.  FRE 403 (prejudicial), Sustained: 19 Ochoa to support a claim that a 1.86% failure rate Laser Design, 2007WL _______ of a Charnley type is similar to Wright. The article 735763 at *4 dicusses 1023 hip replacements of the Charnley Overruled: type from 1968 to 1980. There were 19 reported XX fractures of the femoral stem for a failure rate of 1.86% (19 fractures out of 1023 hip replacements). This was not a modular device, and the fracture did not occur in the neck region of the device. A true and correct copy of the article is attached hereto as Exhibit "N." 53 To summarize the above discussion of the  FRE 403 (prejudicial), Sustained: "comparative" failure rates provided by Dr. James Laser Design, 2007 WL _______ and Dr. Ochoa are not comparable to the fracture 735763 at *4 rate of Wright's Profemur necks, except for the Overruled: Metha Short Hip discussed in the Grupp Article. To XX Truman Declaration Evidentiary Objections Ruling on the

Objection: compare, we would need to know the total number of hip devices implanted for each hip device discussed in the above articles. 54 I will be testifying that Wright employed  FRE 402 (irrelevant) Sustained: 5 insufficient testing prior to commercially marketing  FRE 403 (re-presentation _______ its titanium ProFemur modular necks in the United of cumulative evidence; states. It was not until Wright received notice of waste of time, irrelevant) Overruled: many field failures of its device that they stepped- XX up the testing to remedy the deficiency in testing.

This is supported by the discovery materials, documents relied on by Wright's experts, and additional information that has incrementally become available in this and other Wright Medical modular fracture cases in which I have been retained as a biomechanical engineering expert. 55 Wright should have known the weight of the  FRE 403 (re-presentation Sustained: 12 patient population and should have tested to assure of cumulative evidence; _______ the product could withstand the loads applied by waste of time, irrelevant) those patients. Wright failed to do both. There is Overruled: XX 6 7 8 9 10 11 13 14 15 16 nothing inconsistent about these facts in my report or in my opinions, in this case or the other Wright fracture cases for which I have been retained as an expert. 56 Wright should have known that heavier, more  FRE 403 (re-presentation Sustained: 17 active, high demand patients have an increased risk of cumulative evidence; _______ of fracture due to the increases loads produced. The waste of time, irrelevant) information was available in the medical literature and should have been accounted for in designing Overruled: the hip implant. XX 57 My discussion in my report concerning the  FRE 403 (re-presentation Sustained: corrosion issues, metal ions, and taper in taper of cumulative evidence; ______ junctions is gleaned from peer-reviewed literature, waste of time, irrelevant) and is supported by the literature cited. Overruled: XX 58 My discussion in my report on the issue of  FRE 403 (re-presentation Sustained: 24 corrosion simply points out yet another deficiency of cumulative evidence; ______ in the Wright testing prior to commercial launch in waste of time, irrelevant) the U.S. My report itemized more than one design Overruled: remedy that could have applied together or XX separately to achieve suitable strength and endurance for use in Wright modular necks.

biomechanical engineering materials and processes. 61 Reduced fretting and increased fatigue life of a  FRE 403 (re-presentation Sustained: 19 CoCr ProFemur neck combined with the ProFemur of cumulative evidence;

stems is supported by the discovery documentation waste of time, irrelevant, produced by Wright in this and other similar cases, prejudicial, involves Overruled: by the literature cited (e.g. Grupp et al.) And the irrelevant time period) XX discussion of fracture rates in detail in this declaration, by the subsequent testing completed by Wright, and by the fact that Wright no longer sells their Ti alloy ProFemur necks in the U.S. The testing completed by Wright after the products failed should have been done before the implants were launched in the U.S.

Truman Declaration Evidentiary Objections Ruling on the

Objection:

59 The design team has the responsibility to test their  FRE 403 (prejudicial), Sustained: products for the ability to withstand the end use Laser Design, 2007 WL ______ environment. Without building the products, 735763 at *4 processing with the proposed surface finishing Overruled: treatments on the specific geometries, and without XX testing them appropriately, the design team cannot predict durability. 60 Surface treatments such as shock peening, roller  FRE 403 (re-presentation Sustained:

burnishing, and surface hardening/coatings have of cumulative evidence; long been used to enhance the fatigue life of waste of time) devices, including orthopaedic implants. Wright's  FRE 702(a) (not helpful to Overruled: claim in its motion to exclude my testimony that the trier of fact) XX the use of such processes to enhance the fatigue life  FRE 702(c) (not the of an implant is not based on reliable principles is product of reliable absurd because these treatments are well principles and methods) documented and have long been used to enhance fatigue life. This is a basic of materials science information. Surface treatments (including simple things like smooth finishes) are done all the time and do improve fatigue strength. This demonstrates that whoever is speaking for Wright on this point does not have an understanding of basic

Truman Declaration Evidentiary Objections Ruling on the Objection: 62 After the products failed, testing of both titanium  FRE 403 (re-presentation Sustained: 3 and chrome-cobalt ProFemur modular necks was of cumulative evidence; _______ completed. Comparing the results, the cobalt waste of time, irrelevant, chrome alloy assemblies demonstrated significantly prejudicial, involves Overruled: higher 107 cycle endurance strengths when irrelevant time period) XX compared to the titanium neck alloy assemblies. ASTM 2068-01 did not specify an endurance requirement for ISO 7206-6:1992 fatigue tests. ASTM 2068-03 included a new requirement for the fatigue performance of the head and neck region of the stemmed femoral components per ISO 7206-6:1992 of 5340 N (1200 lb). There was no reason that this higher 10' cycle endurance limit of 5340 N (12001b), or greater, could not have been required of this design in the ISO 7206-6:1992 tests prior to Mr. Tucker receiving his implant. Via testing completed as a result of numerous premature product fracture complaints, Wright later realized that the load levels described by the older testing standards, and ISO 7206 6:1992, and ISO 7206- 4:1989 standards were not high enough to simulate the forces imposed on implants by heavy-weight patients engaged in high levels of activity. Consequently, Wright changed the weight guidance on their package inserts to reflect that "higher than normal rates of early failure of the long offset PROFEMUR Titanium Modular necks have been observed for heavyweight (>230 lb) patients ... Alternative devices, such as cobalt chrome modular necks ... may also be considered for these patients." To summarize, before Mr. Tucker was implanted with the ProFemur device, Wright had the knowledge and ability to determine whether the ProFemur device could adequately withstand a higher demand load, but it did not.

63 Wright released their current CoCr modular necks  FRE 403 (re-presentation Sustained: without including a warning concerning an of cumulative evidence; _______ increased risk of acetabular loosening due to the waste of time, irrelevant, Overruled: use of CoCR as the neck material, and prejudicial, involves XX acknowledged that they have not seen research irrelevant time period, supporting an increased risk of acetabular cup irrelevant product) loosening due to the use of the CoCR neck as opposed to a titanium alloy neck.

Truman Declaration Evidentiary Objections Ruling on the Objection: 64 The literature does not support an increase  FRE 403 (prejudicial), Sustained: 3 incidence of acetabular loosening due to the Laser Design, 2007 WL _______ stiffness of cobalt chromium neck on the femoral 735763 at *4 stem. Overruled: XX 65 Prior to the introduction of neck down-sizing and  FRE 403 (re-presentation Sustained: 6 modularity introduced by Wright and other of cumulative evidence; _______ orthopaedic companies in the late 1990s and early waste of time, irrelevant, 2000s, implant neck fractures were rare. The no context provided) Overruled: McNeur Article States: Over the years there have XX been improvements in both materials and design, with the result that failure because of fracture is less likely. Improved prostheses of the Charnley type were introduced into this country in 1976, and, since that time, there have been no fractures of the femoral stern in patients fitted with the new type of prostheses. In the absences of severe damage to the implant during installation, the risk of premature fatigue fractures of a prosthesis due to mechanical overload and severe fretting can be virtually eliminated through sound engineering design, manufacturing, and development processes combined with appropriate indications, contraindications and provision of appropriate weight and activity limitations. 66 Even though current ISO and ASTM test  FRE 403 (re-presentation Sustained: 18 performance standards were initially developed for of cumulative evidence; _______ average size and moderate activity patients, they waste of time, irrelevant, are insufficient for devices intended to be used in prejudicial, involves Overruled: heavier active individuals. In order to help their irrelevant time period) XX orthopaedic surgeons understand the capabilities and limitation of the devices, Wright had a responsibility to disclose that the device had not been tested to assure endurance when used in higher demand patients. Furthermore, Wright did not meet the recommended neck strength recommendations of ASTM F 2068-03 as discussed in my report.

67 The current ASTM tests, while simpler and useful  FRE 403 (re-presentation Sustained: for direct comparison to predicate devices, are not of cumulative evidence; _______ sufficient to characterize the performance of a waste of time, irrelevant) device in high demand patients, especially ones Overruled: like the ProFemur implant with a high degree of XX

Truman Declaration Evidentiary Objections Ruling on the

Objection: modularity, used with or without MoM articulations. 68 Wright could have and should have completed the  FRE 403 (re-presentation Sustained: same analyses completed prior to the release of of cumulative evidence; _______ their CoCr neck prior to launching their Ti alloy waste of time, irrelevant, necks in 2003. They should have used geometry out of context) Overruled:

changes or surface enhancement processes to XX increase the endurance capabilities of their Ti alloy necks and they should have applied appropriate and definitive weight and activity limitations to the Ti alloy necks prior to marketing them as discussed in my report. 69 To summarize my opinion as discussed and shown  FRE 403 (re-presentation Sustained: in my report, this declaration, and my testimony in of cumulative evidence; _______ other similar Wright Medical fracture cases, for waste of time, irrelevant) which I have been retained as biomechanical Overruled: engineering expert, that the Profemur hip system XX and long neck were defectively designed by not using CoCr for the long neck, not using available surface treatments to increase fatigue strength, not properly testing the implant, and failing to provide adequate warnings. Had Wright used CoCr in the long neck from the beginning, applied available surface treatments to the titanium neck, properly tested the implant for heavier-active individuals in the U.S., or provided adequate warnings and contraindications the fracture rate of the Profemur Long Necks would have been much lower.

70 To further summarize, it is my opinion that the  FRE 403 (prejudicial), Sustained: 20 risks of Wright Medical's titanium alloy long neck Laser Design, 2007 WL ______ outweigh the general benefits described by 735763 at *4 Wright's experts in active-heavy individuals, such Overruled: as Mr. Tucker. As a result, the fracture rate of the XX titanium long neck continues to rise. 71 In my rebuttal report, I discuss the issue raised by  FRE 403 (re-presentation Sustained: defendant's experts regarding Mr. Tucker's alcohol of cumulative evidence; ______ use. waste of time, irrelevant) Overruled:

Truman Declaration Evidentiary Objections Ruling on the

Objection:

72 As a professional engineer with over 32 years of  FRE 403 (prejudicial), Sustained: 3 experience in the field of biomechancial Laser Design, 2007 WL ______ engineering and designing of medical devices I am 735763 at *4 familiar with the in vivo activities of the end user Overruled: that may affect the performance of implanted XX medical devices, including risks associated with alcohol use or misuse. As a designer, development team member, and consultant to the industry, my responsibilities have involved completing failure modes and effects analyses, risk estimates and identifying and applying methods to reduces risk of hazards and harm. 73 A large part of my engineering practice includes  FRE 403 (prejudicial), Sustained: 10 biomechanics analyses. It is well known in the Laser Design, 2007 WL _______ injury biomechanics community that many health 735763 at *4 conditions, including aging and alcoholism, can Overruled: directly or indirectly alter tissue injury thresholds. I XX routinely document and consider the health status of the injured party when opining on whether forces in a particular incident were sufficient to cause a specific injury. I am well qualified to do this. In some soft tissue or bone injury cases it is helpful to have a specialist, such as a toxicologist, an immunologist or a medical doctor address the biochemical mechanisms in a specific disease state, which result in tissue degradation. However, such a specialist is not required in this case because the issue at hand is the fracture of the metallic implant.

74 In Mr. Tucker's case, the neck of his ProFemur  FRE 403 (prejudicial), Sustained: implant prematurely fractured. I specifically Laser Design, 2007 WL _______ address the failure of the metallic components, not 735763 at *4 the failure of human tissues in this case. For Overruled: example, I am not opining about the force to cause XX a specific soft tissue or bone injury in Mr. Tucker. No specific bone or soft tissue injuries related to alcohol use caused the metallic neck component to fail. Mr. Tucker's healing potential and health status were altered by his alcohol use, but that is not what caused the metallic component to fracture.

75 In Mr. Tucker's case, his alcohol misuse played a  FRE 403 (re-presentation Sustained: 27 role in his hip osteonecrosis which lead to his total of cumulative evidence; _______ hip replacement. Had he not had the Wright waste of time, irrelevant, Truman Declaration Evidentiary Objections Ruling on the Objection: implants installed he would not have been able to out of context) Overruled: load them. However, since he them implanted [sic], XX they should have been strong enough to support him or the [sic] should have been contraindicated for a person of his size and activity level. 76 While there is evidence that outcomes may be  FRE 403 (prejudicial), Sustained: 6 poorer in persons with alcohol misuse, there is no Laser Design, 2007 WL _______ evidence that the forces applied to his hip were 735763 at *4 significantly higher or significantly more frequent  FRE 702 (Not adequately Overruled: (higher number of cycles) than should have been XX related to facts at bar, not expected for any other person, with or without helpful to trier of fact) alcohol misuse.

78 In general alcohol misuse may alter quality of life,  FRE 403 (prejudicial), Sustained: healing potential, and general health status. In some Laser Design, 2007 WL _______ instances, the implants may be more likely to be 735763 at *4 loosened, and the bone may be more likely to be Overruled: injured. However, Mr. Tucker's medical records do XX not identify bone injury or loosening as an issue for Mr. Tucker.

79 Mr. Tucker may have been more prone to  FRE 403 (re-presentation Sustained: stumbling or falling on occasion, but these are of cumulative evidence; _______ expected or foreseeable or normal events of waste of time, irrelevant, insufficient force to cause an implant to fracture. out of context) Overruled: Generally the implant is overloaded, fractures, and  FRE 702 (Not qualified, XX caused the patient to fall due to sudden loss of not helpful to trier of fact) stability. 80 The implant in Mr. Tucker cracked due to  FRE 403 (re-presentation Sustained: 19 mechanical overload and fretting, and the crack of cumulative evidence; _______ propagated, over time and with use, until the cross waste of time, irrelevant, section was too small to withstand normal loading. out of context) Overruled: At that time the remaining section suddenly XX fractured.

81 To summarize, it is my opinion that the alcohol use  FRE 403 (re-presentation Sustained: by Mr. Tucker played a role in his osteonecrosis of cumulative evidence; _______ that led to the need for a hip implant and that the waste of time, irrelevant, concerns associated with alcohol use and hip out of context) Overruled: implants are not present in Mr. Tucker's medical XX records. The alcohol use did not significantly increase the loads on the hip implant and the implant cracked due to mechanical overload and fretting, eventually resulting in fracture of the neck.

Declaration of Thomas M. Gray Evidentiary Objection(s) Ruling on the Objection: 26 Attached hereto as Exhibit S is a true and correct  FRE 403 (prejudicial); Sustained: 3 copy of an email from Debby D. Daurer of Wright Laser Design, 2007 WL _______ Medical Technology that is available as part of the 735763 at *4 4 public record on pacer in Wollant v. WMT, Case  FRE 403 (prejudicial) as to Overruled: No. 1:10-CV-3104-DME-BNB, which was Exhibit -- subject to ______ 5 attached as Exhibit 11 to Plaintiff's opposition to pending motion to seal in WITHDRAWN 6 Wright Medical Technology's motion to exclude that court by Defendant testimony (Doc. No. 186). The Wollain court (see Dkt. No. 7 denied a motion to seal the exhibits. (2012 U.S. 112) Dist. LEXIS 171081 (2012)) The information is still part of this the public records as of the date of the signing of this declaration. The document is 8 9 incorporated herein by reference as if set forth in 10 full at this point.

This Order terminates Dkt. No. 62, 63, and 67. IT IS S O

O RDERED.


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