Duane L. Steffey—Expert Witness Testimony 2009-2013

Transcription

EXHIBIT A
STEFFEY DEC. EXHIBIT A, 000010
Duane L. Steffey, Ph.D.
Practice Director and Senior Managing Scientist
Professional Profile
Dr. Duane L. Steffey is a Senior Managing Scientist and Practice Director for Exponent’s
Statistical and Data Sciences practice. Dr. Steffey’s expertise includes the statistical design and
analysis of studies to evaluate the performance of products during development, manufacturing,
and in-service use by customers. He has evaluated issues related to construction materials
(concrete, doors, windows), consumer electronics (computers, phones), drug delivery systems
(syringes, transdermal patches), home appliances (dishwashers, refrigerators), industrial tools,
medical devices (joint implants, stents), motor vehicles, pharmaceuticals, recreational and sports
equipment. His investigations have involved data from engineering and scientific experiments,
sample surveys, observational studies, and a variety of administrative record sources: accident
and injury databases, complaints, field returns, quality audits, replacement part sales, warranty
claims. Dr. Steffey has also applied statistical concepts and methods in evaluating issues arising
from actions, events, processes, products, or services affecting relationships between businesses
and consumers, employees, other companies or individuals, government agencies, and the
environment (including contracts, patents, and regulations).
As a tenured professor of statistics at San Diego State University, Dr. Steffey co-founded and
co-directed the university’s statistical consulting center. He held a prior appointment at the
National Research Council, where he directed studies for federal government clients on census
methodology and the testing and evaluation of military systems. He was also previously
employed in the risk assessment group at Westinghouse Electric Corporation, where he was
engaged in conducting probabilistic safety studies for the commercial nuclear energy industry.
Academic Credentials and Professional Honors
Ph.D., Statistics, Carnegie Mellon University, 1988
M.S., Statistics, Carnegie Mellon University, 1984
B.S., History/Mathematics, Carnegie Mellon University (with honors), 1981
Fellow, American Statistical Association, 2009; Travel Award for Topic Contributed Session,
Section on Statistical Consulting, American Statistical Association, 2008; Chapter Service
Recognition Award, American Statistical Association, 2005; Staff Award, Commission on
Behavioral and Social Sciences and Education, National Research Council, 1995; Nominee,
Timeos Award for University Teaching, San Diego State University, 1990; Summer Faculty
Research Fellowship, San Diego State University, 1990; National Merit Scholarship, Carnegie
Mellon University, 1977–1981
03/12
Publications
Groothuis JR, Fryzek JP, Makari D, Steffey D, Martone WJ. Respiratory syncytial virus
hospitalization trends in infants with chronic lung disease of infancy, 1998–2008. Clinical
Epidemiology, 2011; 3:245–250.
Zhao K, Steffey D, Loud J. Incorporating product retirement in field performance reliability
analysis. Proceedings, 56th Annual Reliability and Maintainability Symposium, Preprint, CDROM, 2010.
Steffey D, Ostarello A, Clevenger J, Villarraga, M. Troubleshooting analyses of production
data. International Journal of Industrial Engineering 2009; 16:206–213.
Zhao K, Steffey D. Analysis of field performance using interval-censored incident data.
Proceedings, 55th Annual Reliability and Maintainability Symposium, Preprint, CD-ROM, 2009.
Eiselstein L, Steffey D, Nissan A, Corlett N, Dugnani R, Kus E, Stewart S. Acceptance criteria
for corrosion resistance of medical devices: Statistical analysis of nitinol pitting in in vivo
environments. Proceedings, International Conference on Shape Memory and Superelastic
Technologies, SMST-2008, pp. 768-780, Stresa, Italy, September 21–25, 2008.
Khanna AJ, Lee S, Villarraga M, Gimbel J, Steffey D, Schwardt J. Biomechanical evaluation of
kyphoplasty with calcium phosphate cement in a 2FSU Vertebral Compression Fracture Model.
Spine J 2008; 8:770–777.
Eiselstein LE, Steffey D, Corlett N, Nissan A. Toward an acceptance criterion for the corrosion
resistance of medical devices: A statistical study of the pitting susceptibility of nitinol.
Proceedings, International Conference on Shape Memory and Superelastic Technologies,
SMST-2007, pp. 279–290, Tsukuba City, Japan, December 3–5, 2007.
Nissan A, Eiselstein LE, Steffey D, Corlett N. Effects of long-term immersion on the pitting
corrosion resistance of nitinol. Proceedings, International Conference on Shape Memory and
Superelastic Technologies, SMST-2007, pp. 271–278, Tsukuba City, Japan, December 3–5,
2007.
Villarraga ML, Cripton PA, Teti SD, Steffey DL, Krisnamuthy S, Albert T, Hilibrand A, Vaccaro
A. Wear and corrosion evaluation in retrieved thoraco-lumbar internal fixation. Spine 2006;
31:2454–2462.
Steffey DL, Fienberg SE, Sturgess RH. Statistical assessment of damages in breach of contract
litigation. Jurimetrics 2006; 46:129–138.
Richards D, Carhart M, Raasch C, Pierce J, Ostarello A, Steffey D. Incidence of thoracic and
lumbar injuries for restrained occupants in frontal collisions. 50th Annual Proceedings,
Association for the Advancement of Automotive Medicine, 2006.
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Gloeckner DC, Moore TLA, Steffey D, Le-Resnick H, Bare C, Corrigan CF. Implications of
vehicle roll direction on occupant ejection and injury risk. 50th Annual Proceedings,
Association for the Advancement of Automotive Medicine, 2006.
Moore TLA, Vijayakumar V, Steffey DL, Ramachandran K, Corrigan CF. Biomechanical factors
and injury risk in high-severity rollovers. 49th Annual Proceedings of the Association for the
Advancement of Automotive Medicine 2005; 133–150.
Dungan JL, Steffey DL. Measurement uncertainty in spectral indices from field
spectroradiometers. Eos Trans. American Geophysical Union 2003; 84:46.
Supernak J, Kaschade C, Steffey D. Dynamic value pricing on I-15 in San Diego: Impact on
travel time and its reliability. Transportation Research Record 2003; 1839:45–54.
Supernak J, Steffey D, Kaschade C. Dynamic value pricing as an instrument of better utilization
of HOT lanes: The San Diego I-15 case. Transportation Research Record 2003; 1839:55–64.
Steffey D, Supernak J, Kaschade C. San Diego’s I-15 value pricing project: Impact on local
businesses. Public Works Management and Policy 2003; 8:99–110.
Supernak J, Golob JM, Golob TF, Kaschade C, Kazimi C, Schreffler EN, Steffey D. San Diego’s
I-15 congestion pricing: traffic-related issues. Transportation Research Record 2002; 1812:43–52.
Supernak J, Golob JM, Golob TF, Kaschade C, Kazimi C, Schreffler EN, Steffey D. San Diego’s
I-15 congestion pricing: attitudinal, behavioral, and institutional issues. Transportation Research
Record 2002; 1812:78–86.
Supernak J, Kaschade C, Steffey D. Factors affecting housing choices in San Diego: Impact of
the I-15 congestion pricing project. 80th Annual Meeting, Transportation Research Board,
Preprint, CD-ROM, 2001.
Anderson M, Daponte BO, Fienberg SE, Kadane JB, Spencer BD, Steffey DL. Sampling-based
adjustment of the 2000 census—A balanced perspective. Jurimetrics 2000; 40:341–356.
Supernak J, Steffey D, Higgins TJ, Kaschade C, Kawada K. San Diego’s I-15 congestion pricing
project: Impact on local businesses. 79th Annual Meeting, Transportation Research Board,
Supernak J, Kaschade C, Steffey D, Kawada K, Higgins TJ. San Diego’s I-15 congestion pricing
project: Impact on local housing choices. 79th Annual Meeting, Transportation Research Board,
Lui K-J, Steffey D. A note on the application of simple linear regression methods for trend
detection at multiple sites and visits. Statistics in Medicine 1993; 12:1125–1139.
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Lui K-J, Steffey D, Pugh JK. Sample size determination for grouped exponential observations: A
cost function approach. Biometrical Journal 1993; 35:677–688.
Huntley D, Nommensen R, Steffey D. The use of specific capacity to assess transmissivity in
fractured-rock aquifers. Journal of Ground Water 1992; 30:396–402.
Steffey D. Hierarchical Bayesian Modeling with elicited prior information. Communications in
Statistics—Theory and Methods 1992; 21:799–821.
Steffey D, Kass RE. Comment on Robinson, G.K., “That BLUP is a Good Thing—The
Estimation of Random Effects.” Statistical Science 1991; 6:45–47.
Kass RE, Steffey D. Approximate Bayesian inference in conditionally independent hierarchical
models (Parametric Empirical Bayes Models). Journal of the American Statistical Association
1989; 84:717–726.
Modell J, Steffey D. Waging war and marriage: Military service and family formation, 1940–
1950. Journal of Family History 1988; 13:195–218.
Books and Book Chapters
Steffey DL. Risk management of construction defects. pp. 1553–1556. In: Encyclopedia of
Quantitative Risk Analysis and Assessment. Melnick E and Everitt B (eds), John Wiley & Sons
Ltd, Chichester, UK, 2008.
Iyer M, Zhao K, Steffey DL. Managing risks of consumer products. pp. 1040–1044. In:
Encyclopedia of Quantitative Risk Analysis and Assessment. Melnick E and Everitt B (eds),
John Wiley & Sons Ltd, Chichester, UK, 2008.
Steffey DL. Homeland security and transportation risk. pp. 830–838. In: Encyclopedia of
Quantitative Risk Analysis and Assessment. Melnick E and Everitt B (eds), John Wiley & Sons
Ltd, Chichester, UK, 2008.
DeVito P, Bryant L, Carswell CM, Donahue M, Fabrizio L, Gamache L, Herrmann D, Qualls A,
Reckase M, Steffey D. NAEP reporting practices: Investigating District-Level and MarketBasket reporting. National Academy Press, Washington, DC, 2001.
Steffey DL, Samaniego FJ, Tran H. Hierarchical Bayesian inference in related reliability
experiments. In: Recent Advances in Reliability Theory: Methodology, Practice, and
Inference. Limnios N and Nikulin M (eds), Birkhauser, Boston, MA, 2000.
Reckase M, Steffey D. Designing a Market Basket for NAEP: Summary of a workshop.
National Academy Press, Washington, DC, 2000.
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Reckase M, Steffey D. Reporting district-level NAEP data: Summary of a workshop. National
Academy Press, Washington, DC, 2000.
Cohen ML, Rolph JE, Steffey DL (eds). Statistics, testing, and defense acquisition: Background
papers. National Academy Press, Washington, DC, 1999.
Cohen ML, Rolph JE, Steffey DL (eds). Statistics, testing, and defense acquisition: New
approaches and methodological improvements. National Academy Press, Washington, DC, 1998.
Cohen ML, Rolph JE, Steffey DL (eds). Statistical methods for testing and evaluating defense
systems. National Academy Press, Washington, DC, 1995.
Steffey DL, Bradburn NM (eds). Counting people in the information age. National Academy
Press, Washington, DC, 1994.
Rolph JE, Steffey DL (eds). Statistical issues in defense analysis and testing: summary of a
workshop. National Academy Press, Washington, DC, 1994.
Steffey DL, Bradburn NM (eds). A census that mirrors America. National Academy Press,
Washington, DC, 1993.
Selected Presentations
Steffey D. Statistical issues in the product life cycle of implantable medical devices.
Conference on Statistical Practice, American Statistical Association, Orlando, FL,
February 17, 2012.
Lau EL, Legg JC, Watson HN, Steffey DL, Mowat FS, Kelsh MK. The problem of missing
data: using imputation methods to facilitate oncology outcomes research. 27th International
Conference on Pharmacoepidemiology and Therapeutic Risk Management, August 17, 2011.
Steffey D. Statistics in the courtroom: concepts and applications. Annual Meeting, Federation
of Defense and Corporate Counsel, Williamsburg, VA, July 27, 2011.
Steffey D, Watson H. Statistical assessment of injury diagnosis and causation. 8th International
Conference on Forensic Statistics, Seattle, WA, July 21, 2011.
Steffey D. Improving the practice of statistics in the Department of Defense. Joint Statistical
Meetings, Vancouver, BC, August 1-5, 2010.
Steffey D. Expanding the role of statistical science in defense and national security. Joint
Statistical Meetings, Washington, DC, August 2–6, 2009.
Steffey D. Exposure to risk from motor vehicles and other consumer products. Joint Statistical
Meetings, Denver, CO, August 3–7, 2008.
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Steffey D. Overarching issues in risk analysis. Joint Statistical Meetings, Salt Lake City, UT,
July 29–August 2, 2007.
Ostarello A, Steffey D. Estimating taint in a population of insurance claims. Joint Statistical
Meetings, Salt Lake City, UT, July 29–August 2, 2007.
Zhao K, Steffey D. To recall or not to recall? Statistical Assessment of Consumer Product
Failure Risk. Joint Statistical Meetings, Salt Lake City, UT, July 29–August 2, 2007.
Steffey D. Interesting times and opportunities for statisticians in academia, industry and
government. Keynote Address, Statistical Careers Day, San Diego Chapter, American Statistical
Association, San Diego, CA, May 5, 2007.
Steffey D. Sequential test designs for estimation of extreme quantiles. EURANDOM,
Workshop on Mathematical Methodologies for Operational Risk, Eindhoven, The Netherlands,
April 16–18, 2007.
Steffey D, Bove R, Fisher J, Cicarelli L, Cargill R, Moore TLA. Characterization of occupant
anthropometry and clearance measures in passenger cars. Joint Statistical Meetings, Seattle,
WA, August 6–10, 2006.
Hood R, Steffey D. The role of statistical science in construction defect litigation. Defense
Research Institute, 10th Annual Meeting, Chicago, IL, October 21, 2005.
Steffey D, Zhao K, Grossman H, Le-Resnick H. Vehicle rollover risk analysis: Metrics and
methods. Joint Statistical Meetings, Minneapolis, MN, August 9, 2005.
Steffey DL, Fienberg SE, Sturgess RH. Statistical assessment of damages in breach of contract
litigation. 6th International Conference on Forensic Statistics, Tempe, AZ, March 18, 2005.
Steffey D, Kelly C. Statistical consulting at SDSU: Meeting the needs of students and clients. 5th
Annual Workshop on Statistical Consulting and Collaboration, Claremont, CA, November 15,
2003.
Singh S, Steffey D. Statistical modeling of individual trip frequency using household surveys of
travel behavior. Joint Statistical Meetings, San Francisco, CA, August 4, 2003.
Shcherbak OV, Steffey D. Predictive modeling of bank portfolio data on home equity products.
Joint Statistical Meetings, San Francisco, CA, August 3, 2003.
Steffey D. Hierarchical space-time models in environmental and ecological applications. 4th
Annual Environmental Science Conference, CEA-CREST, Pasadena, CA, May 30–31, 2003.
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Steffey D, Kazimi C, Supernak J, Kaschade C. assessing air quality along San Diego’s I-15
traffic corridor: Statistical methods for uncertainty analysis. Joint Statistical Meetings, New
York, NY, August 15, 2002.
Steffey D. Design, measurement, and analysis of traffic studies: recent issues and reflections
from the I-15 congestion pricing project. 80th Annual Meeting, Transportation Research Board,
Washington, DC, January 10, 2001.
Steffey DL, Samaniego FJ, Tran H. Hierarchical Bayesian inference in related reliability
experiments. 2nd International Conference on Mathematical Methods in Reliability, Bordeaux,
France, July 6, 2000.
Steffey D. Statistics, testing, and defense acquisition. ITEA International Symposium,
Albuquerque, NM, September 23, 1998.
Steffey D. Counting people in the information age. Council of Professional Associations on
Federal Statistics, Washington, DC, December 1994.
Prior Experience
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Professor, Department of Mathematics and Statistics, San Diego State University,
2003–2006
Associate Professor, Department of Mathematics and Statistics, San Diego State
University, 1993–2003
Instructor and Visiting Scholar, Division of Statistics, University of California, Davis,
Summer/Fall 1998
Study Director, Committee on National Statistics, National Research Council, 1992–
1995
Adjunct Assistant Professor, Graduate School of Public Health, 1989–1992
Assistant Professor, Department of Mathematical Sciences, San Diego State University,
1988–1993
Associate Scientist, Probabilistic Risk Assessment Group, Westinghouse Electric
Corporation, 1981–1983
Project Experience
Construction
Highway: Investigated a claim involving an asphalt contractor and a state department of
transportation. Found that sampling of constructed highway was inadequate to judge
compliance with contract specifications.
Residential: Analyzed data collected from inspected and tested homes in a large community.
Found that inspected homes with visual evidence of distress were overrepresented in the sample
of homes selected for subsequent destructive testing, leading to overstatement of the prevalence
of construction defects in the community.
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Consumer
Marketing Research: Developed methodology to quantify uncertainty in client’s proprietary
metrics for estimating effectiveness of different marketing campaigns for various products.
Telecommunication Services: Analyzed company’s prices and packages, as well as customer
data to characterize distribution of services purchased and assess variation in billing practices.
Employment
Meals and Breaks: Evaluated survey research methods used in estimating economic value of
meal and break periods for a class of employees. Found that estimates were affected by
numerous sources of bias in sample selection, population coverage, and survey non-response, as
well as sources of error in responses to individual questionnaire items.
Wage and Hour: Designed, implemented, and analyzed a sample of employee time records to
estimate variation of actual hours from budgeted hours for the purpose of assessing eligibility
for overtime compensation.
Insurance
Motor Vehicle: Analyzed labor rate survey data to evaluate company’s practices for
reimbursement of claimed repair costs.
Worker’s Compensation: Designed, implemented, and analyzed results from a sample audit of
claims to estimate total economic damages in claim population.
Product Development
Medical Diagnostics: Analyzed client’s biomarker data to assist in developing effective rules
for distinguishing different medical conditions presenting similar clinical symptoms.
Qualification Testing: Designed and analyzed results from accelerated tests to characterize
stress-life relationship and estimate performance of client product under in use conditions.
Product Manufacturing
Acceptance Sampling: Evaluated historical quality control records to assess degree of
compliance with best statistical practices for inspection of finished goods in factory operations.
Troubleshooting Analyses of Production Data: Analyzed output data on manufactured lots,
input data on raw materials, and intermediate data on process characteristics to identify factors
associated with unacceptable variation in end-of-line outcomes.
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Product Reliability and Safety
Recall Investigations: Analyzed field data on incidents and at-risk units to estimate level of and
trends in product performance. Identified specific models, production time periods, and
manufacturing locations with significantly different end-customer experience.
Comparative Risk Analysis: Evaluated in-use performance of manufacturer-specific products
relative to in-use performance of industry products.
Peer Reviewer
National Research Council, National Science Foundation, Journal of the American Statistical
Association, The American Statistician, Statistical Science, Biometrics, Risk Analysis,
Transportation Research Record, Journal of the Air and Waste Management Association, IIE
Transactions on Quality and Reliability Engineering, Journal of Official Statistics,
Communications in Statistics—Theory and Methods, Technometrics, Journal of Business and
Economic Statistics, Annals of the Institute of Statistical Mathematics
Professional Affiliations
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American Statistical Association (Fellow)
Institute of Mathematical Statistics (Member)
Society for Risk Analysis (Member)
Editorial Board, CHANCE Magazine (2006–present)
Program Chair, ASA Section on Risk Analysis (2006–2007)
ASA Council of Chapters Governing Board: Vice-Chair, District 6 (2008–2010),
Nominations Committee Member (2001–2003)
President, San Diego Chapter, American Statistical Association (1999–2003)
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EXHIBIT B
STEFFEY DEC. EXHIBIT B, 000020
Duane L. Steffey—Expert Witness Testimony 2009-2013
Rodolfo Avila, et al., v. Pulte Home Corporation, Superior Court, State of California, County of
Imperial, Case No. ECU05457, Testimony in deposition re: statistical evaluation of plaintiffs’
assessment of construction defects and repair costs. September 10, 2012. Retained by counsel
for defendant.
City Center Construction and Lien Master Litigation, District Court, State of Nevada, County of
Clark, Case No. A-10-612676-B, Testimony in deposition re: statistical evaluation of
destructive testing as a basis for extrapolation. June 28, 2012. Retained by counsel for
subcontractor.
Jose Aldana, et al., v. Pulte Home Corporation, Superior Court, State of California, County of
Imperial, Case No. ECU06086, Testimony in deposition re: statistical evaluation of plaintiffs’
assessment of construction defects and repair costs. January 24, 2012. Retained by counsel for
defendant.
Whirlpool Corporation v. Zoppas Industries de Mexico, Arbitration (no case number),
Testimony in deposition and hearing re: statistical analyses and projections of product field
performance. October 13 and December 9, 2011. Retained by counsel for plaintiff.
Whirlpool Corporation and Maytag Corporation v. Sensata Technologies, Inc., and Texas
Instruments, Inc., Circuit Court, Cook Country, Illinois, Case No. 09 L 1022, Testimony in
deposition re: statistical analyses and projections of product field performance. August 10,
2011. Retained by counsel for plaintiff.
Philadelphia Contributorship Insurance Company a/s/o Anders Skeini and Claudia Tatanelli v.
Electrolux, Inc., United States District Court, Eastern District of Pennsylvania, Case No. 2:10CV-02045, Testimony in deposition re: statistical analysis of dryer fire risk. July 12, 2011.
Retained by counsel for defendant.
Vista Way Village Association v. Oceanside Breeze Ventures, LLC, et al., Superior Court, State
of California, County of San Diego, Case No. 37-2008-00096780-CU-CD-CTL, Testimony in
deposition re: statistical evaluation of plaintiffs’ assessment of construction defects and repair
costs. January 26, 2011. Retained by counsel for defendant.
Karen Russell v. Electrolux Home Products, Inc., United States District Court, Southern District
of New York, Case No. 09-CV-7826-CS, Testimony in deposition re: statistical analysis of
dryer fire risk. November 11, 2010. Retained by counsel for defendant.
Catherine Anderson and Allan Anderson, Jr. v. Macy’s Northeast Inc., et al., Superior Court,
State of New Jersey, County of Mercer, Case No. MER-L-799-08, Testimony in deposition re:
statistical assessment of injury risk. October 29, 2010. Retained by counsel for defendant.
Standard Fire Insurance Co. a/s/o Karen Thomas v. Electrolux Home Products, Inc., United
States District Court, Northern District of Ohio, Case No. 4:08-CV-02486, Testimony in
deposition re: statistical analysis of dryer fire risk. May 27, 2010. Retained by counsel for
defendant.
Donegal Mutual Insurance Co. a/s/o Vanessa Schantz v. Electrolux North America, United
States District Court, Eastern District of Pennsylvania, Case No. 1:08-CV-2171, Testimony in
deposition re: statistical analysis of dryer fire risk. May 11, 2010. Retained by counsel for
defendant.
Arturo Aguayo, et al., v. Correll Estates Development Company, LLC, et al., Superior Court,
State of California, County of Imperial, Case No. ECU03553, Testimony in deposition re:
statistical evaluation of plaintiffs’ assessment of construction defects and repair costs. January
7, 2010. Retained by counsel for defendant.
EXHIBIT C
STEFFEY DEC. EXHIBIT C, 000023
Materials
31465
31466
31467
31468
31469
31470
31471
31472
31473
31474
31475
32165
32166
32167
32646
32650
32651
32652
32653
32654
32665
32666
32667
32668
32669
32670
Grand Total Units
2004-02
NOBELDIRECT 3.0x13mm
NOBELDIRECT 3.0x15mm
NOBELDIRECT NP 3.5x10mm
NOBELDIRECT RP 4.3x10mm
NOBELDIRECT WP 5.0x10mm
NOBELDIRECT® Oval 6.0 6x10mm
NOBELDIRECT® Posterior RP 4.3x8mm
NOBELDIRECT® Posterior WP 5x8mm
NOBELDIRECT® Posterior 6.0 6x8mm
1
1
2004-03 2004-04 2004-05 2004-06 2004-07
1,002
307
292
346
208
484
208
196
146
131
82
25
45
30
54
235
65
99
87
75
59
28
32
25
25
224
68
87
68
61
461
129
152
131
105
76
23
52
24
36
186
73
67
75
57
217
81
76
95
52
48
27
12
18
30
3,074
1,034
1,110
1,045
834
2004-08 2004-09 2004-10 2004-11 2004-12 2005-01 2005-02 2005-03 2005-04 2005-05 2005-06 2005-07 2005-08
230
200
241
244
289
189
127
172
208
238
215
244
163
156
144
165
113
176
100
104
147
131
81
106
159
120
44
17
51
30
34
43
36
34
38
37
15
4
-1
55
-1
88
107
100
68
91
51
81
89
62
39
20
42
45
28
43
43
14
6
20
37
23
9
-1
-1
77
100
144
87
91
66
76
104
53
59
36
11
-15
124
216
211
201
177
80
99
109
154
97
56
23
-15
59
64
59
55
47
8
22
38
50
21
25
2
-2
41
100
112
67
83
53
83
55
66
57
17
21
-11
64
149
127
98
99
42
66
73
78
60
23
2
-13
16
31
22
32
34
14
36
10
15
17
10
4
-3
5
13
30
8
6
6
28
28
13
1
8
8
4
1
1
14
3
14
11
13
121
64
9
123
71
5
9
941
1,173
1,260
1,038
1,164
670
706
843
930
754
1
1
-1
-1
625
830
50
30
7
3
12
9
515
2005-09 2005-10 2005-11 2005-12 2006-01 2006-02 2006-03 2006-04 2006-05 2006-06 2006-07 2006-08 2006-09
59
37
193
159
105
77
125
172
112
117
134
94
63
78
70
59
144
80
51
78
112
68
68
47
64
53
-5
-3
-3
3
-4
-5
-13
4
-5
-9
2
-2
-6
-7
-5
-8
-8
-2
-2
-6
-25
2
-15
-16
-3
-6
-4
-2
-3
-3
-7
-5
-7
-3
-4
-1
-5
0
0
-21
-1
-9
-5
-12
-2
-4
-22
-8
-14
-5
-12
-5
-20
-15
-10
-2
1
4
-16
-19
-20
-12
-16
-19
-4
-3
-4
-6
-6
-5
-1
-6
-5
-4
1
-2
-3
-4
-8
-2
-8
-7
-11
6
-12
-19
-7
-6
-2
-1
1
-12
-9
-3
0
2
-2
-5
-11
-9
-14
0
-8
-1
-1
-5
-1
1
-5
-3
-6
-2
1
-3
-1
-3
-1
11
11
10
12
7
1
11
26
9
11
3
2
14
13
12
10
15
5
6
10
18
10
16
7
3
11
8
5
-1
2
3
3
2
15
-6
3
1
7
3
4
3
-2
5
1
4
1
5
8
-3
3
1
11
12
7
22
-4
1
2
7
11
1
6
2
1
37
39
39
50
17
17
14
38
22
14
6
25
16
54
51
57
59
21
20
16
68
3
31
9
11
0
8
16
3
21
10
4
2
5
4
2
0
2
2
18
6
6
16
3
6
-2
2
3
2
-1
0
5
123
100
23
3
2
41
6
16
17
65
19
-4
47
44
90
109
26
16
11
56
9
31
1
13
26
13
2
14
6
-1
5
0
8
2
1
2
7
2
6
10
1
1
-1
1
2
-6
1
24
19
19
9
2
3
6
23
-3
11
-3
4
0
9
18
14
27
2
2
2
19
0
13
-2
4
5
384
303
588
753
261
200
184
538
187
267
192
197
169
2006-10 2006-11 2006-12 2007-01 2007-02 2007-03 2007-04 2007-05 2007-06 2007-07 2007-08 2007-09 2007-10
66
56
158
73
65
138
71
92
42
49
49
107
37
82
24
93
28
26
85
56
37
40
53
46
94
26
-3
-4
2
-3
-4
-4
-1
0
0
0
0
-1
-10
-4
-5
-4
-3
-12
-2
-2
0
0
0
0
-4
-1
-6
-10
0
0
0
0
-3
-7
-6
-1
-7
-3
0
0
0
0
0
-10
-7
-10
-4
-7
-14
-8
0
0
0
0
0
0
0
0
-4
-3
-9
-2
0
0
0
0
0
-3
-1
-6
-3
1
-1
0
0
0
0
0
-3
-3
-6
1
-1
-8
-2
-5
0
0
0
0
-1
-1
-6
-1
0
0
0
0
21
0
11
6
4
19
-2
2
3
3
-2
0
1
17
5
8
-4
3
9
1
3
15
-2
-2
3
-2
5
1
1
-5
2
1
-6
3
0
1
0
4
4
2
1
1
5
1
3
-2
2
1
3
1
0
7
5
1
1
3
1
14
-1
11
10
39
22
28
13
13
-1
-3
13
0
33
11
5
5
62
22
14
16
10
3
1
8
-10
16
14
-8
0
16
10
3
-1
1
-4
4
-3
-2
18
2
7
3
3
8
7
-6
-2
0
12
0
14
32
22
24
3
8
7
-15
3
11
0
16
32
-3
8
52
18
16
11
14
6
2
9
22
44
8
0
0
5
8
1
5
-1
2
-3
-2
8
-1
7
1
7
0
-3
0
2
-2
11
1
8
11
-3
1
1
-10
7
4
-6
-1
13
0
13
5
1
5
2
9
1
1
-2
-5
199
105
469
198
186
251
151
144
89
144
115
355
120
2007-11 2007-12 2008-01 2008-02 2008-03 2008-04 2008-05 2008-06 2008-07 2008-08 2008-09 2008-10 2008-11
67
52
73
78
49
29
51
79
32
4
42
29
10
44
20
37
42
19
21
14
58
14
12
-15
-7
9
0
0
0
0
0
0
0
0
-1
0
-1
0
0
0
0
-1
0
0
0
0
10
0
0
0
0
0
-1
0
0
-1
-2
0
0
0
0
0
0
-2
0
-1
0
0
0
0
0
-2
0
0
0
0
0
-1
0
0
0
11
14
0
12
-5
1
-4
5
-1
1
-2
4
6
-2
-2
4
-2
6
-3
4
6
-1
-2
0
1
4
-1
-1
1
-3
-2
2
1
-1
7
8
0
-1
-2
-5
2
-5
-2
-3
1
1
3
1
9
3
5
0
-1
0
8
12
17
-4
-3
16
35
9
0
-19
3
-5
4
-2
1
3
-6
-9
5
7
14
12
10
2
-3
-8
-8
-6
-1
-10
3
6
10
-1
-2
3
-3
2
1
2
7
3
6
-2
1
-1
-4
3
12
13
-7
1
10
15
6
9
-1
7
15
-2
-5
1
0
4
-13
3
4
5
17
7
1
3
0
-2
0
1
-8
-3
1
-4
-2
3
2
5
-1
-3
2
-1
0
-1
-1
2
23
3
3
-9
4
1
-2
20
3
-1
2
1
6
5
6
6
-14
3
-3
7
4
3
0
-1
2
180
137
154
101
19
105
138
195
106
10
43
6
13
2008-12 2009-01 2009-02 2009-03 2009-04 2009-05 2009-06 2009-07 2009-08 2009-09 2009-10 2009-11 2009-12
58
24
21
60
5
44
13
10
22
39
10
17
57
11
21
10
9
11
5
0
-1
11
16
5
8
18
-6
0
-3
-1
-2
0
-2
-2
-3
-1
-1
2
2
-1
2
-1
-5
-3
-1
-2
-1
-1
2
4
2
-2
-1
-1
1
1
1
1
53
-4
55
2
-1
1
0
8
4
5
-1
-3
-2
-3
-4
-1
1
-1
-3
0
2
1
1
0
-3
0
-2
5
-6
3
2
0
0
1
0
-1
13
7
3
102
1
0
5
-1
-1
9
2
-1
12
-1
-2
-2
-1
-1
2
-1
-3
-1
-3
12
0
-6
0
-1
8
7
4
-3
1
35
-1
6
42
5
7
0
3
0
-1
3
2
-2
-1
-4
0
-1
1
-1
-1
0
19
1
3
-1
1
1
1
-1
2
1
4
0
1
-1
36
7
0
4
1
1
2
71
-2
-5
-2
-1
-1
-1
0
-2
1
2
8
25
-3
3
1
-5
-5
0
-2
-5
-5
-3
-2
3
53
2010-01 2010-02 2010-03 2010-04 2010-05 2010-06 2010-07 2010-08 2010-09 2010-10 2010-11 2010-12 2011-01
27
19
29
30
28
30
35
28
7
23
25
30
11
9
6
17
7
9
-2
5
4
17
6
7
6
11
-1
-4
-2
-1
3
2
4
2
-1
-2
1
-1
-2
-2
-1
-5
3
-1
0
-1
-1
1
1
4
-2
-1
3
-1
-5
6
6
3
-3
-1
-8
2
4
3
4
-2
-4
-7
-3
-1
-4
-1
-5
2
1
-2
1
5
-2
2
-6
-2
5
1
0
1
46
1
3
1
1
2
1
1
-1
0
-1
-9
-10
-1
-8
-7
-3
2
-1
3
0
1
1
5
1
-1
-1
-3
1
1
-1
0
-1
-2
-2
-2
2
1
0
14
1
53
1
4
39
-2
21
2
35
1
52
3
4
3
-1
30
1
1
28
25
-2
-1
-2
-4
-2
-4
3
-4
7
-3
-3
2
-2
5
5
5
3
36
2
2
2
-1
1
4
-1
2
30
2011-02 2011-03 2011-04 2011-05 2011-06 2011-07 2011-08 2011-09 2011-10 2011-11 2011-12 2012-01 2012-02
29
23
23
-2
24
24
26
9
3
-13
-4
-4
-26
8
7
20
-2
8
11
9
13
1
-15
-5
-4
-13
-1
-1
-2
-1
-1
-1
-1
-3
-3
0
-1
-11
-2
-3
-2
-2
-2
1
-1
1
2
-1
3
2
-1
7
4
4
1
2
9
1
-2
5
8
-2
2
1
2
3
1
4
2
0
-1
1
4
2
7
4
1
-5
4
0
5
1
0
2
-1
2
0
-1
-2
-1
-2
-1
-1
-1
2
-1
2
1
1
1
1
29
52
69
-4
34
44
30
35
-1
1
-3
-2
2
-1
-1
6
5
1
0
5
2
2
-1
4
1
1
0
-1
1
1
-1
0
-1
-1
-43
-3
12
-39
2012-03
2012-04
-7
6
2012-05
1
1
2012-06
2
8
2012-07
-2
-5
2012-08
3
1
-1
7
6
-1
1
1
8
1
2
4
1
1
1
1
1
1
5
4
2
5
14
9
1
1
3
3
1
22
12
Grand Total Units
8,772
1
5,073
539
1,257
411
1,253
2,274
586
1,106
1,278
333
337
312
73
106
176
799
825
99
85
707
760
77
50
219
210
1
27,717
EXHIBIT D
STEFFEY DEC. EXHIBIT D, 000033
Exhibit D—Materials Reviewed
Clinical Research Articles
Albrektsson T, Gottlow J, Meirelles L, Ostman P, Rocci A, Sennerby L (2007).
Survival of NobelDirect implants: an analysis of 550 consecutively placed
implants at 18 different clinical centers. Clin Implant Dent Relat Res, 9:65-70.
Baer R, Shanaman R, Clark P, Medley M (2013). A 3-Year Multicenter Study of
Marginal Bone Level and Soft Tissue Health of a 1-Piece Implant. Implant
Dentistry, 22:366-373.
Finne K, Rompen E, Toljanic J (2007). Clinical evaluation of a prospective
multicenter study on 1-piece implants, part 1: marginal bone level evaluation after
1 year of follow-up. Int J Oral Maxillofac Implants, 22:226-234.
Finne K, Rompen E, Toljanic J (2007). Prospective multicenter study of marginal
bone level and soft tissue health of a one-piece implant after two years. J Prosthet
Dent, 97:S79-S85.
Finne K, Rompen E, Toljanic J (2012). Three-year prospective multicenter study
evaluating marginal bone levels and soft tissue health around a one-piece implant
system. Int J Oral Maxillofac Implants, 27:458-466.
Froum S, Cho S, Elian N, Romanos G, Jalbout Z, Natour M, Norman R, Neri D,
Tarnow D (2011). Survival rate of one-piece dental implants placed with a flapless
or flap protocol-a randomized, controlled study: 12-month results. Int J
Periodontics Restorative Dent, 31:591-601.
Hahn J (2007). Clinical and radiographic evaluation of one-piece implants used
for immediate function. J Oral Implantol, 33:152-155.
Hahn J (2011). Four-year treatment and radiographic outcomes of one-piece
implants used in immediate function: A prospective study in a single private
practice. J Oral Implantol, 37:259-265.
Östman P, Hellman M, Albrektsson T, Sennerby L (2007). Direct loading of
Nobel Direct and Nobel Perfect one-piece implants: a 1-year prospective clinical
and radiographic study. Clin Oral Implants Res, 18:409-418.
Parel S, Schow S (2005). Early clinical experience with a new one-piece implant
system in single tooth sites. J Oral Maxillofac Surg, 63 suppl 2:2-10.
Sennerby L, Rocci A, Becker W, Jonsson L, Johansson L, Albrektsson T (2008).
Short-term clinical results of Nobel Direct implants: a retrospective multicentre
analysis. Clin Oral Implants Res, 19:219-226.
Siepenkothen T (2007). Clinical performance and radiographic evaluation of a
novel single-piece implant in a private practice over a mean of seventeen months.
J Prosthet Dent, 97:S69-S78.
Van de Velde T, Thevissen E, Persson R, Johansson C, De Bruyn H (2009). TwoYear Outcome with Nobel Direct(R) Implants: A Retrospective Radiographic and
Microbiologic Study in 10 Patients. Clin Implant Dent Relat Res, 11:183-193.
Zembic A, Johannesen L.H., Schou S, Malo P, Reichert T, Farella M, Hammerle
CHF (2012). Immediately restored one-piece single-tooth implants with reduced
diameter: one-year results of a multi-center study. Clin Oral Implants Res, 23:4954.
Case Documents (Yamada v. Nobel Biocare)
• Memorandum of Points and Authorities in Support of Plaintiff’s Motion for
an Award of Attorneys’ Fees and Reimbursement of Litigation Expenses,
September 6, 2013
• Declaration of William M. Audet, September 6, 2013 (with exhibits)
• Declaration of Kirk Kleckner, September 6, 2013 (with exhibits)
• First Amended Class Action Complaint, October 8, 2010
Product-Related Documents
• Nobel PerfectTM One-Piece Clinical Procedure & Product Catalog, 2004
• Nobel Direct® One-Piece Clinical Procedure & Product Catalog, 2005

Duane L. Steffey—Expert Witness Testimony 2009-2013

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