Bosley v. DePuy Synthes Sales Inc

8 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WASHINGTON 9 AT SEATTLE DERRICK C. BOSLEY, SR. ) Case No. C21-1683-MLP 11 Plaintiff, ) ) PRETRIAL ORDER ) 12 ) vs ) 13 ) DEPUY SYNTHES SALES, INC. d/b/a/ ) DEPUY SYNTHES JOINT ) RECONSTRUCTION; DEPUY ) ) ORTHOPAEDICS, INC.; DEPUY ) INTERNATIONAL LIMITED; JOHNSON ) & JOHNSON; JOHNSON & JOHNSON ) SERVICES, INC.; JOHNSON & JOHNSON ) INTERNATIONAL; MEDICAL DEVICE ) BUSINESS SERVICES, INC.; DEPUY, ) INC.; DEPUY SYNTHES PRODUCTS, ) ) INC.; DEPUY SYNTHES, INC.; DEPUY ) IRELAND UNLIMITED COMPANY; ) DEPUY SYNTHES JOHNSON & ) JOHNSON IRELAND LTD.; AND ) RELATED ENTITIES A, B AND C, ) 22 ) ) 23 Defendants. )

1 JURISDICTION 2 Jurisdiction is vested in this Court by virtue of and pursuant to 28 U.S.C. §1332 in that the amount in controversy alleged exceeds $75,000.00, exclusive of interest and costs, and this is an action by an individual Plaintiff against Defendants1 who are citizens of different states.

7 CLAIMS AND DEFENSES The Plaintiff will pursue the following claims at trial: 9 1. First Cause of Action - Washington Product Liability Act, Unsafe Design, Strict Liability.

2. Fifth Cause of Action - Washington Product Liability Act, Failure to Warn.

The Defendants intend to assert certain affirmative defenses that they will pursue at trial and in response to Plaintiff’s claims, including, but not limited to, the following: 1. Plaintiff’s Complaint fails, in whole or part, to state a claim upon which relief may be granted.

17 2. Plaintiff fails to, and cannot, present evidence to support his claims against the Defendants. NOTE: Plaintiff objects to this asserted defense.

20 3. Plaintiff fails to meet his burden to show that Defendants are liable for his alleged injuries. NOTE: Plaintiff objects to this asserted defense.

25 1 In submitting this Joint Pretrial Order, Defendants do not waive and expressly reserve their objections to the entirety of Plaintiff’s pretrial disclosures, which were due (per LCR 16(h)) on August 10, 2023, but which were not served on Defendants until August 24, 2023.

1 4. Plaintiff fails to provide reliable expert testimony to support his claim that Defendants’ alleged conduct caused his injuries. Bruns v. PACCAR, Inc., 890 P. 2d 469, 477 (Wash. Ct. App. 1995). NOTE: Plaintiff objects to this asserted defense.

5 5. Plaintiff knowingly and voluntarily assumed any and all risks associated with the use of the ATTUNE® product at issue in this case and was subjectively aware of facts which cover any and all risks. Such assumption of the risks bars in whole or in part the damages Plaintiff seeks to recover in this case.

10 6. Plaintiff’s alleged injuries attributable to the use of the ATTUNE® product in this case, if any, were not legally caused by the ATTUNE® product, but instead were legally caused by intervening and superseding causes or circumstances.

7. Plaintiff’s alleged damages, if any, are barred in whole or in part by Plaintiff’s failure to mitigate such damages.

8. Plaintiff’s causes of action are barred by the applicable statutes of limitation, statutes of repose, doctrines of laches and/or estoppel.

9. Plaintiff’s claims are barred in whole or in part because the ATTUNE® product was, at all relevant, times manufactured and sold consistent with available technology, scientific knowledge, and the state of the art, and in compliance with all federal, state, and local laws and regulations, and was accompanied by product information and warnings that were reasonable, full and adequate and in accordance with FDA regulating requirements and the state of medical and scientific knowledge then in existence.

26 Compliance with such codes, statutes, rules, regulations and standards demonstrates that due care was exercised with respect to the design, manufacture, testing, marketing and sale of the ATTUNE® product, and that Defendants are entitled to a presumption that the ATTUNE® product is neither defective, nor unreasonably dangerous. Plaintiff’s claims and any recovery are accordingly barred.

6 10. Plaintiff’s claims should be diminished in whole or in part by the amount paid to Plaintiff by any party or non-party with whom Plaintiff has settled or may settle.

11. Plaintiff’s damages, if any, are barred or limited by the payments received from collateral sources.

12. Plaintiff’s causes of action are barred by the learned intermediary doctrine.

13 13. Plaintiff’s claims are barred by the doctrines of informed consent, release and waiver.

14. Upon information and believe, if Plaintiff incurred any injuries or damages as a result of Plaintiff’s use of the ATTUNE® product, which Defendants deny, such injuries or damages were due to an alternative cause, without any negligence or culpable conduct by the Defendants. NOTE: Plaintiff objects to this asserted defense.

15. To the extent Plaintiff’s claims are based on alleged misrepresentations or omissions made to the FDA, such claims are barred pursuant to Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341 (2001).

16. If the ATTUNE® product is unsafe in any way, it was unavoidably unsafe.

26 Plaintiff’s action is, therefore, barred by Comment K of §402A of the Restatement (Second) of Torts and/or other applicable law. See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 2 (1996).

17. Plaintiff’s injuries and damages, if any, were proximately caused by the negligence or fault of Plaintiff, or persons or parties whose identities are unknown at this time, and such comparative negligence or fault is sufficient to proportionately reduce or bar Plaintiff’s recovery.

18. Even if there was negligence on its part in the manufacture and sale of the ATTUNE® product, which Defendants expressly deny, such negligence was not the proximate or producing cause of the alleged injuries or damage.

19. The injuries and damages claimed by Plaintiff, if any, were caused in whole or in part by the acts or omissions of persons or entities over whom Defendants have no control or right of control.

20. Plaintiff’s claims should be dismissed, reduced, offset, or barred in accordance with the principles of comparative negligence.

21. Plaintiff’s claims are barred in whole or in part under Sections 2, 4, 6(c), and 6(d) of the Restatement (Third) of Torts: Product Liability.

ADMITTED FACTS 23 The following facts are admitted by the Parties: 24 1. On October 2, 2013, Plaintiff underwent a right total knee arthroplasty to treat his osteoarthritis. As part of the total knee arthroplasty procedure, his surgeon, Dr. William Barrett, implanted the ATTUNE® Knee System, which was designed, manufactured, and sold by the Defendants.

2. Plaintiff underwent a left total knee arthroplasty on August 13, 2014 to treat the osteoarthritis in his left knee. During this August 13, 2014 arthroplasty surgery, Plaintiff was implanted with the ATTUNE® Knee System in his left knee.

3. On January 23, 2019, Plaintiff returned to Dr. Barrett’s office complaining of left knee pain and was seen by Jana Flener, PA-C, who ordered x-ray imaging of Plaintiff’s left knee.

4. Dr. Barrett recommended Plaintiff proceed with a revision surgery.

5. The pre-operative and post-operative diagnosis for Plaintiff’s March 19, 2019 revision surgery was “failed fixation of left total knee.”

6. On March 19, 2019, Plaintiff underwent a revision of his left knee wherein the ATTUNE® Knee System that was implanted in his left knee on August 13, 2014 was removed and replaced.

17 ISSUES OF LAW The following are the issues of law to be determined by the court: (a) Whether Defendants are liable to Plaintiff under the Washington Product Liability Act for Plaintiff’s harm and damages resulting from the allegedly defective design of the tibial component of the ATTUNE® Knee System implanted in his left leg in 2014, as set forth in his Second Amended Complaint, proximately caused by the fact that the Attune Device was not reasonably safe as designed.

1 (b) Whether Defendants are liable to Plaintiff under the Washington Product Liability Act for damages resulting from their alleged failure to warn Plaintiff’s surgeon, Plaintiff2, and Valley Medical Center, the alleged purchaser of the ATTUNE® Knee Systems that were implanted in Plaintiff’s knees, of the alleged risks associated with the ATTUNE® Knee System and, in particular, the tibial base thereof. Plaintiff’s Second Amended Complaint alleges: 8 135. The Defendants manufactured and sold the ATTUNE Device knowing the 9 device would then be implanted in patients in need of a knee prostheses.

136. In the course of doing so, Defendants advertised, marketed and promoted the ATTUNE to consumers, including the medical community, the hospital, Plaintiff s implanting surgeon, and Plaintiff, and therefore had a duty to warn them of the risks associated with the use of the ATTUNE.

15 140. The Defendants were under a duty to issue such warnings or instructions as a 16 reasonably prudent manufacturer would issue in the same or similar circumstances 17 but failed to do so. Defendants object to Plaintiff’s second proposed issue of law to the extent it includes Valley Medical Center, as Valley Medical Center is not a Defendant or party to this case, no claims or allegations were asserted by Plaintiff against Valley Medical Center, and the Court As of the date of filing this Pre-Trial Statement (September 12, 2023), Defendants’ motion for summary judgment remains pending. One of the issues pending before the Court in Defendants’ motion for summary judgment is the applicability of the learned intermediary doctrine. Under the learned intermediary doctrine, the Defendants’ duty to warn extends only to the Plaintiff’s physician. In filing this Pre-Trial Statement, Defendants do not waive and expressly reserve all arguments and defenses as to the applicability of the learned intermediary doctrine, which they intend to address further in pre-trial and trial briefings.

1 rejected this theory of liability as it pertains to Valley Medical Center at the hearing on Defendants’ motion for summary judgment. (c) Whether Plaintiff’s claims are barred by the applicable statute of limitations.

Note: Plaintiff objects to this issue of law.

EXPERT WITNESSES (a) Each party shall be limited to the expert witnesses previously listed in their respective Rule 26(a)(2) disclosures.

9 (b) The name(s) and addresses of the expert witness(es) to be used by each party at the trial are, and the issue upon which each will testify is3: (1) On behalf of Plaintiff: Witness Status General Nature of Expected √ if by 13 Testimony Deposition Peter Bonutti, MD Will testify. Expert opinion previously Bonutti Clinic provided and all matters 1303 W Evergreen relating thereto. Nature and Ave cause of failure of Plaintiff’s Suite 200 left knee Attune tibial base Effingham, Illinois and defective design of Attune 62401 tibial base as set forth in Expert Report.

Michael F. Arrigo Will testify. Expert opinion previously 620 Newport Center provided and all matters Drive relating thereto. Usual, Suite 1100 customary and reasonable Newport Beach, CA charges for pain care and left 92660 knee revision surgery as set 22 forth in Expert Report.

3 Defendants’ Motion to Exclude the Report and Opinions of Plaintiff’s Expert, Dr. Bonutti, remains pending. In filing this Pre-Trial Statement, Defendants do not waive and expressly reserve all arguments and objections to Plaintiff’s introduction of the report and opinions of Dr. Bonutti at trial.

1 (2) On behalf of Defendants: Witness Status Nature of Expected √ if by Testimony Deposition Michael Ries, M.D., Will Testify. Expert opinion previously Sc.M. provided and all matters c/o Defendants relating thereto. The design, function, safety, and 5 effectiveness of the ATTUNE® based on 6 preclinical testing, registry data, and scientific literature.

7 The risks associated with total knee arthroplasties.

8 Chantal E. Holy, Will Testify. Expert opinion previously Ph.D., MSc. provided and all matters c/o Defendants relating thereto. Registry data and scientific literature setting 10 forth the causes of and revision rates for total knee 11 arthroplasties. Risks associated with total knee 12 arthroplasties and prevalence in the scientific literature and 13 registry data.

15 OTHER WITNESSES 16 The names and addresses of witnesses, other than experts, to be used by each party at the time of trial and the general nature of the testimony of each are: (a) On behalf of Plaintiff: Witness Status General Nature of Expected √ if by 20 Testimony Deposition Derrick C. Bosley Will testify. Left and right knee implant 12046 69th Ave S surgeries; failure of left knee Seattle WA 98178 implant; left knee revision surgery; post left knee implant 23 surgery disability, pain, pain treatment, dependence on and 24 addiction to pain medication, effects on wife and family, relationships with same, 26 quality of life; treatment for 1 reduction of dependence on pain medication and withdrawal from same; lost of potential earning capacity; continuing and long terms 4 effects of failure of left knee implant.

5 Sandra Bosley Will testify. Left and right knee implant 12046 69th Ave S surgeries; failure of left knee Seattle WA 98178 implant; left knee revision 7 surgery; post left knee implant surgery disability, pain, pain 8 treatment, dependence on and addiction to pain medication, 9 effects on wife and family, relationships with same, quality of life; treatment for 11 reduction of dependence on pain medication and 12 withdrawal from same; continuing and long terms 13 effects of failure of left knee implant Liam Rowley Will testify by 30(b)(6) deposition testimony; c/o Defendants 30(b)(6) deposition agreement with Dr. Bonutti’s testimony. Expert Witness Report and 16 article relating to omission of surface roughness and 17 undercut cement pockets of predecessor Sigma in the subject tibial base; and all 19 matters listed on Second Amended Attachment A to 20 Third Amended Notice of Defendants’ Deposition Pursuant to Fed. R. Civ. P. 22 30(B)(6) designated by Defendants to be addressed by 23 this witness.

Dr. Daniel Hoeffel, Will testify by 30(b)(6) deposition testimony; MD 30(b)(6) deposition agreement with Dr. Bonutti’s c/o Defendants testimony. Expert Witness Report and article relating to omission of 26 surface roughness and 1 undercut cement pockets of predecessor Sigma in the subject tibial base; and all matters listed on Second Amended Attachment A to 4 Third Amended Notice of Defendants’ Deposition 5 Pursuant To Fed. R. Civ. P. 30(B)(6) designated by Defendants to be addressed by 7 this witness.

Alexey Ryskin, MD Possible witness Plaintiff’s pain, pain Seattle Pain Relief only. medication dependence and 10564 5th Avenue NE addiction, pain relief and pain #304 medication reduction Seattle, WA 98125 treatment.

Navdeep Kaur, MD Possible witness Plaintiff’s pain, pain VIVAA only. medication dependence and 1301 4th Ave NW addiction, pain relief and pain #302, Issaquah, WA medication reduction 98027 treatment.

13 Zachary Kile, PA-C or Possible witness Plaintiff’s pain, pain other representative only. medication dependence and Anesis Spine & Pain addiction, pain relief and pain Care medication reduction SE 16th Street, treatment.

16 Ste 121 Renton, WA 98057 William P. Barrett, Possible witness Plaintiff’s left knee MD only. examinations, surgeries and Proliance Orthopedic records; and disposal of Surgeons Plaintiff’s left knee implant; 4011 Talbot Road S., selected portions of deposition #300 testimony; and Valley Medical Renton, WA 98055 Center’s purchase from 22 Defendants of Attune Knee System implanted in 23 Plaintiff’s left knee Jana Flener, PA Possible witness Plaintiff’s left knee c/o Counsel for only. examinations, surgeries and Defendants records; including, but not 26 limited to, Plaintiff’s 1-29- 1 2015 and 1-23-2019 x-rays and 1-23-2019 x-ray findings Christian Campbell Will testify. MAUDE reports research 4037 SE 11th St., findings on loosening Renton, WA 98058 /debonding of subject tibial (Paralegal to base, source and obtaining of Plaintiff’s Counsel) Openpayments.cms.gov 5 Listing of Payments to Dr. William P. Barrett, MD, 2015- 2022 and FDA 510(k) 7 K101433 and K170806 Applications and Summaries Representative of Possible witness Valley Medical Center’s Valley Medical Center only. purchase from Defendants of 400 S 43rd St Attune Knee System Renton, WA 98055 implanted in Plaintiff’s left knee (b) On behalf of Defendants: Witness Status Nature of Expected √ if by Testimony Deposition William P. Barrett, Will testify Plaintiff’s total knee MD arthroplasties and revision surgery. Plaintiff’s Proliance Orthopedic comorbidities and risks for Surgeons surgery. The ATTUNE® 4011 Talbot Road S., device.

18 #300 Renton, WA 98055 Jana Flener, P.A. Possible witness Plaintiff’s total knee c/o Defendants only arthroplasties and revision surgery. Plaintiff’s comorbidities and risks for surgery.

Liam Rowley, M.S. Will Testify 30(b)(6) testimony. c/o Defendants Daniel Hoeffel, M.D. Will Testify 30(b)(6) testimony. c/o Defendants 1 EXHIBITS (a) Plaintiff’s Exhibits Plaintiff’s Exhibits Ex. # Description Authenticity Admissibility Objection Admitted Plaintiff’s Proliance Surgeon’s Medical Stipulated Stipulated 7 Records Plaintiff’s Proliance FRE 402; 2 Surgeon’s Billing Stipulated Disputed FRE 403; Records FRE 802 Plaintiff’s Valley 10 3 Medical Center Stipulated Stipulated Medical Records 11 Plaintiff’s Valley FRE 402; Medical Center Stipulated Disputed FRE 403; 12 Billing Records FRE 802 Plaintiff’s VIVAA 13 5 Stipulated Stipulated Medical Records 14 Plaintiff’s Anesis Spine & Pain Care Stipulated Stipulated 15 Medical Records Plaintiff’s Anesis FRE 402; Spine & Pain Care Stipulated Disputed FRE 403; Billing Records FRE 802 Plaintiff’s Seattle 18 8 Pain Relief Medical Stipulated Stipulated Records 19 Plaintiff’s Seattle FRE 402; Pain Relief Billing Stipulated Disputed FRE 403; Records FRE 802 21 Duplicative of Exhibit 22 No. 1; Attorney 23 10 Plaintiff’s x-rays Disputed Disputed Work 10/9/2014 Product (compilation/ 25 excerpt); FRE 802 1 Duplicative of Exhibits 2 No. 1, 3, 13, 16, 21, 22, 23, 24; 11 Selected Medical Disputed Disputed Attorney Records Work 5 Product (compilation, highlighting, notes); FRE 8 FRE 802; No Certification 9 FDA 510(k) of K101433 Summary Disputed Disputed Authenticity; (2010) Foundation; 11 FRE 402; FRE 403 12 Duplicative of Exhibit 13 No. 3; Implants Inventory Attorney 8/13/2014 left knee Disputed Disputed Work 15 implant Product (compilation/ 16 excerpt); FRE 802 17 Duplicative of Exhibit No. 1; 19 DePuy Outcomes Attorney Tracking System Disputed Disputed Work 20 Knee Device Log Product (compilation/ excerpt); 22 FRE 802 1 Duplicative of Exhibit 2 No. 3; Valley Medical Attorney Center - Surgical Disputed Disputed Work 4 Implant Record Product (compilation/ 5 excerpt); FRE 802 Duplicative 7 of Exhibits No. 1, 3; 8 Operative Report, Attorney William P. Barrett, Disputed Disputed Work 9 MD 8/13/2014 Product (compilation/ excerpt); 11 FRE 802 Duplicative 12 of Exhibits No. 1, 5, 6; 13 Left Knee Pain Attorney Treatments after Disputed Disputed Work Implant Product 15 (compilation/ excerpt); 16 FRE 802 Duplicative 17 of Exhibit No. 1; Attorney Plaintiff’s x-rays 19 18 Disputed Disputed Work 1/29/2015 Product 20 (compilation/ excerpt); FRE 802 1 Duplicative of Exhibit 2 No. 1; Attorney 3 Plaintiff’s x-rays 19 Disputed Disputed Work 1/23/2019 4 Product (compilation/ 5 excerpt); FRE 802 Duplicative 7 of Exhibit No. 1; 1/23/2019 Jana 8 Attorney Flener PA-C X-ray Disputed Disputed Work 9 Findings Note Product (compilation) ; FRE 802 11 Duplicative of Exhibit 12 No. 1; 3/12/2019 David Attorney 13 21 Gifford PA-C Note Disputed Disputed Work Product (compilation) 15 ; FRE 802 Duplicative Operative Note, 16 of Exhibits William P. Barrett, No. 1, 3; 17 MD 3/25/2019 (for Attorney 3/19/2019), Work 18 22 including but not Disputed Disputed Product limited to 19 (compilation/ Preoperative and excerpt, Postoperative 20 highlighting) Diagnoses ; FRE 802 Duplicative 22 of Exhibit Nos. 1, 3; 23 3/21/2019 Discharge Attorney 23 Disputed Disputed Summary Work 24 Product (compilation) ; FRE 802 1 Duplicative of Exhibit 2 Nos. 1, 3; Attorney 3/21/2019 Final Work 24 Disputed Disputed 4 Diagnoses Product (compilation, 5 highlighting, notes); FRE 7 MIL; FRE 702/Daubert; 8 FRE 402; Photograph Fig. 1 FRE 403; 25 Bonutti et al J Knee Disputed Disputed FRE 802; Surg 2017 Attorney Work 11 Product MIL; FRE 12 702/Daubert; FRE 402; 13 Photographs Figs. FRE 403; 2,3,4 Bonutti et al J Disputed Disputed FRE 802; 14 Knee Surg 2017 Attorney 15 Work Product 16 MIL; FRE 702/Daubert; 17 FRE 402; Photographs Figs.1, FRE 403; 18 27 2,3,4 Bonutti J Knee Disputed Disputed FRE 802; Surg 2018 19 Attorney Work 20 Product MIL; FRE 702/Daubert; 22 FRE 402; Fig. 1 Arthroplasty FRE 403; 28 Disputed Disputed 23 Today 17 (2022) FRE 802; Attorney 24 Work Product 1 MIL; FRE 702/Daubert; 2 FRE 402; Fig. 2 Arthroplasty FRE 403; 29 Disputed Disputed Today 17 (2022) FRE 802; 4 Attorney Work 5 Product MIL; FRE 802; No 7 FDA 510(k) Certification of K170806 Summary Disputed Disputed 8 Authenticity; (2017) Foundation; 9 FRE 402; FRE 403 MIL; FRE 11 Dr. William P. 802; Barrett Testimonial Disputed Disputed Foundation; 12 Video notes FRE 402; FRE 403 13 Openpayments.cms. MIL; FRE gov Listing of 802; Payments to Dr. Disputed Disputed Foundation; 15 William P. Barrett, FRE 402; MD, 2015-2022 FRE 403 16 Duplicative of Exhibit No. 48; Defendants’ 18 33 Response to Stipulated Disputed Attorney Work Interrogatory No. 3 Product (excerpt/com 20 pilation) Attune Package 21 34 Stipulated Stipulated Insert 22 Deposition of William Barrett, 23 M.D. Bosley v. 35 Stipulated Disputed FRE 802 DePuy Synthes 24 Sales, Inc., et al.

April 27, 2023 1 Peter M. Bonutti, FRE 802; MD, FACS Stipulated Disputed 2 Curriculum Vitae MIL 30(b)(6) Deposition of Liam Rowley 37 Bosley v. DePuy Stipulated Disputed FRE 802 Synthes Sales, Inc., 5 et al. May 23, 2023 Deposition of 30(b)(6) Daniel P. 38 Hoeffel, M.D., Stipulated Disputed FRE 802 Bosley v. DePuy 8 Synthes Sales, Inc., et al. June 6, 2023 9 William P. Barrett, MD picture from FRE 802; Defendants’ Foundation; 11 39 ATTUNE Disputed Disputed MIL; FRE promotional video, 402; FRE 12 Surgeon Design 403 Team 13 Duplicative of Exhibit No. 1; 15 Jana Flener, PA-C, Attorney 40 Disputed Disputed 9-18-2013 Note Work 16 Product (compilation) ; FRE 802 18 Duplicative of Exhibit 19 No. 1; Jana Flener, PA-C, Attorney 20 41 1-9-2014 Note Disputed Disputed Work Product (compilation) 22 ; FRE 802 1 Duplicative of Exhibit 2 No. 1; Olivia Kenyon, PA- Attorney 42 Disputed Disputed C, 7-24-2014 Note Work 4 Product (compilation) 5 ; FRE 802 Attorney 6 Derrick Bosley Work BMI-Weight Chart, 43 8-17-2012 to 2-21- Disputed Disputed Product (compilation) 2019 ; FRE 802 Duplicative 9 of Exhibit No. 1; 10 William P. Barrett, Attorney MD, 10-30-2014, Disputed Disputed 11 Note Work Product 12 (compilation) ; FRE 802 13 Duplicative of Exhibit No. 1; William P. Barrett, 15 45 MD, 1-29-2015, Disputed Disputed Attorney Work Note 16 Product (compilation) 17 ; FRE 802 18 DePuy Defendants’ Foundation; Responses to 46 Stipulated Disputed FRE 402; 19 Plaintiff’s Requests FRE 403 for Admission 20 FRE 802; Foundation; 21 William P. Barrett 47 Disputed Disputed MIL; FRE Testimonial Video 22 402; FRE 23 Defendants’ Foundation; Response to 24 48 Plaintiff’s First Stipulated Disputed FRE 402; FRE 403 Interrogatories 1 Duplicative of Exhibit 2 Derrick C. Bosley, No. 4; Sr., Hospital Attorney 49 Services Account Disputed Disputed Work Detail, 8-13-2014 to 4 8-15-2014 Product (compilation) 5 ; FRE 802 Substance of proposed 7 NOTICE OF exhibit is INTENT TO duplicative 8 OFFER RECORDS of Exhibits AT TRIAL OR Stipulated Disputed No. 6 and 7; 9 HEARING – Anesis FRE 402; Spine and Pain Care FRE 403; F.R.E. 902(11) Attorney 11 Work Product 12 Substance of proposed 13 NOTICE OF exhibit is INTENT TO duplicative OFFER RECORDS of Exhibits 15 51 AT TRIAL OR Stipulated Disputed No. 1 and 2; HEARING – FRE 402; 16 Proliance Surgeons FRE 403; F.R.E. 902(11) Attorney 17 Work Product NOTICE OF Substance of 19 INTENT TO proposed OFFER RECORDS exhibit is 20 AT TRIAL OR duplicative HEARING – Seattle of Exhibits Pain Relief F.R.E. Stipulated Disputed No. 8 and 9; 22 902(11) (to be FRE 402; provided upon FRE 403; 23 transmission of Attorney records to Work 24 Defendants) Product 1 Substance of proposed 2 NOTICE OF exhibit is INTENT TO duplicative OFFER RECORDS of Exhibit 53 AT TRIAL OR Stipulated Disputed No. 5; FRE HEARING – 402; FRE 5 VIVAA PLLC 403; F.R.E. 902(11) Attorney Work Product NOTICE OF Substance of 8 INTENT TO proposed OFFER RECORDS exhibit is 9 AT TRIAL OR duplicative HEARING – Valley of Exhibits Medical Center Stipulated Disputed No. 3 and 4; 11 F.R.E. 902(11) (to FRE 402; be provided upon FRE 403; 12 transmission of Attorney records to Work 13 Defendants) Product MIL; FRE 14 Seract Payments 55 Disputed Disputed 402; FRE Received 15 403 Columbia Physical FRE 402; 16 56 Therapy Ledger Stipulated Disputed FRE 403; 2018 FRE 802 MIL; FRE 18 702/Daubert; FRE 402; Expert Witness 19 FRE 403; Report of Peter Stipulated Disputed FRE 802; 20 Bonutti, MD Attorney Work Product 22 MIL; FRE 402; FRE 23 Expert Witness 403; FRE Report of Michael Stipulated Disputed 802; 24 Arrigo Attorney Work Product 1 Without waiving Plaintiff’s objections 2 to Defendants’ proposed exhibits which Defendants 4 did not list in their Amended Pretrial 5 Statement in accordance with 6 LCR 16(i) but have listed in this proposed Pretrial 8 Order, Plaintiff lists, as Learned Treatises, 9 Periodicals, or FRE 802; Foundation; Pamphlets the 10 Disputed Disputed MIL; FRE following articles 402; FRE 11 cited in the Expert 403 Witness Report of 12 Peter Bonutti, MD, on which Dr. 13 Bonutti may rely or to which he may refer in his 15 testimony at trial pursuant to FRE 16 Rule 803(18), which Expert Witness 17 Report is listed in Plaintiff’s Pretrial Statement and this 19 exhibit list: FRE 802; 20 https://onlinelibrary. Foundation; wiley.com/doi/pdf/1 Disputed Disputed MIL; FRE 21 0.1111/ans.16046; 402; FRE FRE 802; 23 Foundation; https://read.qxmd.co Disputed Disputed MIL; FRE m/keyword/173027 24 402; FRE 1 FRE 802; https://www.drugwat Foundation; 2 ch.com/knee- Disputed Disputed MIL; FRE replacement/depuy- 402; FRE 3 attune/ 4 https://www.cureus. com/articles/66018- 5 early-aseptic-failure- FRE 802; of-the-tibial- Foundation; component-cement- Disputed Disputed MIL; FRE 7 interface-in-attune- 402; FRE total-knee- 403 8 arthroplasty-a- report-of-three-cases 9 FRE 802; https://online.bonean Foundation; 10 djoint.org.uk/doi/abs Disputed Disputed MIL; FRE /10.1302/1358- 11 992X.2020.9.067; 402; FRE 12 https://www.arthropl FRE 802; astyjournal.org/articl Foundation; 13 e/S0883- Disputed Disputed MIL; FRE 5403(20)30827- 402; FRE 5/pdf 403 15 https://pdfs.semantic scholar.org/b088/f29 16 09e1d352b8680e2ab FRE 802; 28f2afe5fd2e461d.p Foundation; df?_ga=2.39694947. Disputed Disputed MIL; FRE 18 1934483757.167553 402; FRE 8345- 403 19 981525284.1675538 20 FRE 802; https://www.ncbi.nl Foundation; m.nih.gov/pmc/articl Disputed Disputed MIL; FRE 22 es/PMC9508148/ 402; FRE 23 https://www.arthropl FRE 802; astyjournal.org/articl Foundation; 24 e/S0883- Disputed Disputed MIL; FRE 5403(17)30737- 402; FRE 4/fulltext 403 1 FRE 802; https://pubmed.ncbi. Foundation; 2 nlm.nih.gov/362094 Disputed Disputed MIL; FRE 39/ 402; FRE 4 FRE 802; https://pubmed.ncbi. Foundation; 5 nlm.nih.gov/298965 Disputed Disputed MIL; FRE 62/ 402; FRE 7 https://www.mattioli FRE 802; 1885journals.com/in Foundation; 8 dex.php/actabiomedi Disputed Disputed MIL; FRE ca/article/download/ 402; FRE 9 8997/8361/40668 403 https://scholarlypubl FRE 802; ications.universiteitl Foundation; 11 eiden.nl/access/item Disputed Disputed MIL; FRE %3A3483966/downl 402; FRE 12 oad 403 FRE 802; 13 https://www.ncbi.nl Foundation; m.nih.gov/pmc/articl Disputed Disputed MIL; FRE es/PMC5994597/ 402; FRE 15 403 https://www.arthropl FRE 802; 17 astyjournal.org/articl Foundation; e/S0883- Disputed Disputed MIL; FRE 18 5403(20)31163- 402; FRE 3/fulltext 403 Without waiving 22 Plaintiff’s objections to Defendants’ FRE 802; 23 proposed exhibits Foundation; which Defendants 24 did not list in their Disputed Disputed MIL; FRE Amended Pretrial 402; FRE 25 Statement in 403 accordance with 26 LCR 16(i) but have 1 listed in this proposed Pretrial 2 Order, Plaintiff lists, as Learned Treatises, 3 Periodicals, or Pamphlets the 4 following articles not cited in the Expert 5 Witness Report of Peter Bonutti, MD, 6 but on which Dr. Bonutti may rely or 7 to which he may refer in his testimony 8 pursuant to FRE Rule 803(18) at trial: 9 FRE 802; https://pubmed.ncbi. Foundation; 10 nlm.nih.gov/2859193 Disputed Disputed MIL; FRE 11 0/ 402; FRE 12 https://www.cureus.c om/articles/66018- 13 early-aseptic-failure- FRE 802; of-the-tibial- 14 Foundation; component-cement- Disputed Disputed MIL; FRE 15 interface-in-attune- 402; FRE total-knee- 16 arthroplasty-a-report- of-three-cases#!/ https://www.jnjmedte FRE 802; 18 ch.com/en- Foundation; 19 US/product/attune-s- Disputed Disputed MIL; FRE technology 402; FRE 20 403 FRE 802; 21 https://www.ncbi.nl Foundation; m.nih.gov/pmc/articl Disputed Disputed MIL; FRE es/PMC6446526/ 402; FRE 23 403 FRE 802; 2 https://patents.google Foundation; .com/patent/US9498 Disputed Disputed MIL; FRE 3 342B2/en?oq=94983 402; FRE 5 https://www.mddionl FRE 802; ine.com/news/how- Foundation; 510k-submission- Disputed Disputed MIL; FRE 7 can-affect-your- 402; FRE patent 403 FRE 802; 9 https://pubmed.ncbi. Foundation; nlm.nih.gov/2242530 Disputed Disputed MIL; FRE 0/ 402; FRE 11 403 https://www.ncbi.nl FRE 802; 12 m.nih.gov/pmc/articl Foundation; es/PMC8776517/ Disputed Disputed MIL; FRE 13 402; FRE 14 403 https://www.ncbi.nl FRE 802; 15 m.nih.gov/pmc/articl Foundation; es/PMC9508148/ Disputed Disputed MIL; FRE 16 402; FRE https://www.arthropl FRE 802; 18 astyjournal.org/articl Foundation; e/S0883- Disputed Disputed MIL; FRE 19 5403(21)00168- 402; FRE 6/fulltext 20 403 https://www.vumedi.

21 com/video/is- FRE 802; cement-past-its-time- Foundation; 22 uncemented-total- Disputed Disputed MIL; FRE knee-its-time-has- 402; FRE 23 come-again- 403 seriously/ 24 https://www.ncbi.nl FRE 802; m.nih.gov/pmc/articl Foundation; 25 Disputed Disputed es/PMC9633442/ MIL; FRE 26 402; FRE 1 403 https://www.research gate.net/figure/Attun 3 e-left-and-Attune-S- FRE 802; right-tibia- Foundation; 4 components-with- Disputed Disputed MIL; FRE additional-cement- 402; FRE 5 pockets_fig1_359868 403 https://pubmed.ncbi. FRE 802; nlm.nih.gov/2242530 Foundation; 0/ 8 Disputed Disputed MIL; FRE 402; FRE 9 403 https://www.mddionl 10 FRE 802; ine.com/news/how- Foundation; 11 510k-submission- Disputed Disputed MIL; FRE can-affect-your- 402; FRE 12 patent 13 https://patents.google FRE 802; .com/patent/US9498 Foundation; 342B2/en?oq=94983 Disputed Disputed MIL; FRE 42 402; FRE (b) Defendants’ Exhibits Defendants' Exhibits Ex. # Description Authenticity Admissibility Objection Admitted Expert Report of FRE 402; Michael Ries, M.D., Stipulated Disputed FRE 403; 22 Sc.M. FRE 802 Duplicative; 23 Not Listed in Curriculum Vitae of Amended 102 Michael Ries, M.D., Pretrial Sc.M. Stipulated Disputed Statement (hereinafter 26 “NLAPS”) 1 Expert Report of FRE 402; Chantal E. Holy, Stipulated Disputed FRE 403; 2 Ph.D., MSc. FRE 802 Curriculum Vitae of Duplicative; of Chantal E. Holy, Stipulated Disputed Not listed in 4 Ph.D., MSc. NLAPS Plaintiff’s Initial and 5 Supplemental Responses to DePuy FRE 402; Defendants Requests Stipulated Disputed FRE 403 7 for Production Plaintiff’s Initial and 8 Supplemental Responses to DePuy Stipulated Disputed FRE 402; 9 Defendants FRE 403 Interrogatories Anesis Spine & Pain 11 Care Records (BosleyRecords0012 12 62-001388; BosleyProduction00 107 0036-000254; BosleyProduction00 Stipulated Stipulated 1636-001777; 15 BosleyNOIProductio n000747-000888) 16 Columbia Physical Therapy Services Records Stipulated Stipulated 18 (BosleyProduction0 01778-001855) 19 Dr. Azar Sadeghalvad 109 Records Stipulated Stipulated (BosleyProduction0 02013-002021) 22 Kaiser Permanent Approval for 110 Revision Surgery Stipulated Stipulated (BosleyProduction 24 000334-335) NLAPS 1 Paul Brown, M.D.

Records 111 (BosleyProduction0 Stipulated Stipulated 01856-1890) Proliance Surgeon’s 4 Records (BosleyRecords0011 5 39-001261; BosleyProduction 001891-002012; Stipulated Stipulated 7 BosleyNOIProductio n000130-000251) 8 Richard Ludwig, M.D. Medical 9 Records (BosleyProduction0 04051; Stipulated Stipulated 11 BosleyProduction00 4492-004496) 12 Seattle Hand Surgery Group 114 Records Stipulated Stipulated (BosleyProduction0 02022-002040) 15 Seattle Pain Relief Records 16 (BosleyProduction0 Stipulated Stipulated 02041-002140) Swedish Medical 116 Center Records FRE 402; (BosleyRecords0013 Stipulated Disputed FRE 403; 19 85-001388) F RE 802 Valley Medical 20 Center Records (BosleyProduction0 02141-003291; 22 BosleyRecords0000 01-001138; Stipulated Stipulated 23 BosleyRecords0015 87-002001) 1 VIVAA Records (BosleyProduction0 118 03494-004050; BosleyNOIProductio Stipulated Stipulated n000258-000746) 4 2006 Misc.

Pharmacy Records FRE 402; 119 (BosleyProduction0 FRE 403; 04231-004238) Stipulated Disputed FRE 802 2009 Misc.

7 120 Pharmacy Records FRE 402; (BosleyProduction0 FRE 403; 8 04208-004210) Stipulated Disputed FRE 802 2013 Misc.

9 Pharmacy Records (BosleyProduction0 121 04162-004163; FRE 402; 11 BosleyProduction00 FRE 403; 4166-004195) Stipulated Disputed FRE 802 12 Appris Health Pharmacy Records FRE 402; 122 (BosleyProduction0 FRE 403; 04159-004161) Stipulated Disputed FRE 802 EnterpriseRx 15 Pharmacy Records FRE 402; (BosleyProduction0 FRE 403; 16 00338-000339) Stipulated Disputed FRE 802 Fred Meyer EasyFill Pharmacy Records 18 (BosleyProduction0 00336-000337; 19 BosleyProduction00 0340-000362; FRE 402; 20 BosleyProduction00 FRE 403; 4142-004158) Stipulated Disputed FRE 802 Plaintiff’s 125 Prescription Records FRE 402; (BosleyProduction0 FRE 403; 23 04055-4253) Stipulated Disputed FRE 802 1 Rite Aid Pharmacy Records 2 (BosleyProduction 004078-004094; 126 BosleyProduction 4 004104-004126; FRE 402; BosleyProduction00 FRE 403; 5 4201-004207) Stipulated Disputed FRE 802 Walgreens Pharmacy Records 7 (BosleyProduction0 00255; 8 BosleyProduction00 0257-000275; 9 BosleyProduction 004055-4077; FRE 402; BosleyProduction00 FRE 403; 11 4196-004200) Stipulated Disputed FRE 802 Bosley v. C.I. Earll 12 Co., Case Records FRE 402; (BosleyvEarll00000 FRE 403; 13 1-000049) Stipulated Disputed FRE 802 Chapter 13 Bankruptcy Records 129 (BosleyChapter13Pr FRE 402; oduction000001- FRE 403; 16 000291) Stipulated Disputed FRE 802 Purdue Pharma LP, Personal Injury 18 Claimant Proof of Claim Form for 19 Derrick Bosley FRE 402; (BosleyProduction0 FRE 403; 20 00001-000016) Stipulated Disputed FRE 802 Sandra Bosley Purdue Pharma 131 Claim (SandraBosleyPurdu FRE 402; 23 ePharmaClaim00000 FRE 403; 1-000020) Stipulated Disputed FRE 802 24 "Timeline of My Surgeries" 132 (BosleyProduction0 26 00256) Stipulated Disputed NLAPS 1 Plaintiff's Tax Returns 2009- 133 2021(BosleyProduct ion004292-4356) Stipulated Stipulated NLAPS; 4 Correspondence Attorney between Plaintiff's Work 134 Counsel and Experts Product; (BosleyProduction FRE 401; 004357-004491) Stipulated Disputed FRE 402 7 All records and documents produced 8 by Plaintiff in response to DePuy 9 Defendants’ Requests for Production 11 (BosleyProduction0 00001-004496; 12 BosleyNOIProductio n000001-000888; 13 BosleyChapter13Pro duction000001- 000291; 15 SandraBosleyPurdue PharmaClaim00000 16 1-20; Bosley v Oaks000001- 17 000006; Bosley v Earll000001- 000049; 19 Bosley3rdSuppProd uction000001- 20 000021; Chapter13Dockets00 21 0001-000009; Duplicative; SnohomishClerkPap FRE 401; ers000001-19) Stipulated Disputed FRE 402 23 DePuy Complaint File NLAPS; 24 (DBOSLEY_000000 FRE 401; 001- FRE 402; DBOSLEY_000065 FRE 403; 26 87) Disputed Disputed FRE 802 1 DePuy DHRs NLAPS; (DBOSLEY_000065 FRE 401; 137 88- FRE 402; DBOSLEY_000067 FRE 403; 19) Disputed Disputed FRE 802 4 Defendants' April 21, 2023 Production 5 (DEPATT_0000000 01- DEPATT_00760251 7 ) Stipulated Disputed NLAPS ATTUNE® Package 8 Insert Stipulated Stipulated ATTUNE® Surgical 140 Technique Brochure Stipulated Disputed NLAPS ATTUNE® Instructions for Use 141 (DEPATT_0140104 - 12 DEPATT_00140199 ) Stipulated Disputed NLAPS American Joint 142 Replacement Registry: 2022 15 Annual Report Disputed Disputed NLAPS Australian 16 Orthopaedic Association National Joint Replacement 18 Registry: Hip, Knee & Shoulder 19 Arthroplasty: 2022 Annual Report Disputed Disputed NLAPS 20 The New Zealand Joint Registry - Twenty-Three Year 22 Report - January 1999 to December 23 2021 Disputed Disputed NLAPS National Joint 145 Registry 19th Annual Report. 2022 Disputed Disputed NLAPS 1 Wyles CC, Tibbo ME, Yuan BJ, 2 Trousdale RT, Berry DJ, Abdel MP.

Long-Term Results 4 of Total Knee Arthroplasty with 5 Contemporary Distal Femoral Replacement. The Journal of bone and joint surgery 8 American volume. FRE 803(18); 2019. Stipulated Disputed N LAPS 9 Schroer WC, Berend KR, Lombardi AV, Barnes CL, 11 Bolognesi MP, Berend ME, et al.

12 Why are total knees failing today?

13 Etiology of total knee revision in 2010 and 2011. J 15 Arthroplasty.

2013;28(8 FRE 803(18); 16 Suppl):116-9. Stipulated Disputed N LAPS DerSimonian R, 17 Laird N. Meta- analysis in clinical 148 trials. Control Clin 19 Trials. FRE 803(18); 1986;7(3):177-88. Stipulated Disputed N LAPS 20 Higgins JP, Thompson SG.

Quantifying 22 heterogeneity in a meta-analysis.

23 Statistics in medicine.

24 2002;21(11):1539- FRE 803(18); 58. Stipulated Disputed N LAPS 1 Higgins JP, Thompson SG, 2 Deeks JJ, Altman DG. Measuring 150 inconsistency in 4 meta-analyses. BMJ.

2003;327(7414):557 FRE 803(18); 5 -60. Stipulated Disputed NLAPS IntHout J, Ioannidis JPA, Borm GF. The 7 Hartung-Knapp- Sidik-Jonkman 8 method for random effects meta-analysis 9 is straightforward and considerably outperforms the 11 standard DerSimonian-Laird 12 method. Bmc Med Res Methodol. FRE 803(18); 13 2014;14. Stipulated Disputed N LAPS Vasarhelyi EM, Petis SM. Use of 15 National Joint Registries to 152 Evaluate a New Knee Arthroplasty 17 Design. J 18 Arthroplasty. FRE 803(18); 2020;35(2):413-6. Stipulated Disputed N LAPS 1 Lewis PL, Graves SE, de Steiger RN, 2 Campbell DG, Peng Y, Hatton A, et al.

Does Knee 4 Prosthesis Survivorship 5 Improve When Implant Designs 153 Change? Findings from the Australian Orthopaedic 8 Association National Joint Replacement 9 Registry. Clin Orthop Relat Res.

2020;478(6):1156- FRE 803(18); 11 72. Stipulated Disputed NLAPS Abdel MP, Ledford 12 CK, Kobic A, Taunton MJ, 13 Hanssen AD.

Contemporary failure aetiologies of 15 the primary, posterior-stabilised 16 total knee arthroplasty. Bone 17 Joint J. 2017;99- FRE 803(18); B(5):647-52. Stipulated Disputed NLAPS Sharkey PF, 19 Lichstein PM, Shen C, Tokarski AT, 20 Parvizi J. Why are total knee 155 arthroplasties failing today--has anything changed after 10 23 years? J Arthroplasty. FRE 803(18); 24 2014;29(9):1774-8. Stipulated Disputed NLAPS 1 Cherian JJ, Jauregui JJ, Banerjee S, 2 Pierce T, Mont MA.

What Host Factors Affect Aseptic 156 Loosening After THA and TKA?

5 Clinical orthopaedics and related research. FRE 803(18); 2015;473(8):2700-9. Stipulated Disputed N LAPS Ryu KJ. CORR 8 Insights(R): What Host Factors Affect 9 Aseptic Loosening After THA and TKA? Clinical 11 orthopaedics and related research. FRE 803(18); 12 2015;473(8):2710-1. Stipulated Disputed NLAPS Inacio MC, Cafri G, 13 Paxton EW, Kurtz SM, Namba RS.

Alternative bearings 15 in total knee arthroplasty: risk of 16 early revision compared to 17 traditional bearings: an analysis of 62,177 primary 19 cases. Acta orthopaedica. FRE 803(18); 20 2013;84(2):145-52. Stipulated Disputed NLAPS Namba RS, Cafri G, Khatod M, Inacio 22 MC, Brox TW, Paxton EW. Risk 23 factors for total knee arthroplasty aseptic 24 revision. The Journal of arthroplasty.

2013;28(8 FRE 803(18); 26 Suppl):122-7. Stipulated Disputed NLAPS 1 van Otten TJM, van Loon CJM. Early 2 aseptic loosening of the tibial component at the cement- 4 implant interface in total knee 5 arthroplasty: a narrative overview of potentially associated factors.

Acta Orthop Belg. FRE 803(18); 8 2022;88(1):103-11. Stipulated Disputed N LAPS Torino D, 9 Damsgaard C, Kolessar DJ, Hayes DS, Foster B, 11 Constantino J, et al.

Tibial Baseplate- 161 Cement Interface Debonding in the 13 ATTUNE Total Knee Arthroplasty System. Arthroplast 15 Today. 2022;17:165- FRE 803(18); 71. Stipulated Disputed NLAPS 16 Coles T, Williams V, Dwyer K, Mordin 17 M. Psychometric Evaluation of the Patient's Knee 19 Implant Performance Questionnaire.

20 Value Health.

2018;21(11):1305- FRE 803(18); 21 12. Stipulated Disputed NLAPS 1 Coles TM, Dwyer KA, Mordin M, 2 Williams V, Clatworthy M, Yates P, et al.

4 Psychometric Evaluation Of The 5 Patient's Knee Implant Performance (PKIP) Questionnaire For The Assessment Of 8 Primary Total Knee Arthroplasty. Value 9 Health. FRE 803(18); 2014;17(7):A568. Stipulated Disputed N LAPS Lewis S, Price M, 11 Dwyer KA, O'Brien S, Heekin RD, Yates 12 PJ, et al.

Development of a 13 scale to assess performance following primary 15 total knee arthroplasty. Value 16 Health. FRE 803(18); 2014;17(4):350-9. Stipulated Disputed NLAPS 17 Willburger RE, Oberberg S. Early and mid-term results 19 with the ATTUNE total knee 165 replacement system compared to PFC 21 Sigma: a prospective comparative study. J Orthop Surg Res. FRE 803(18); 23 2022;17(1):509. Stipulated Disputed NLAPS 1 Vanitcharoenkul E, Unnanuntana A.

2 Midterm functional recovery of Total knee arthroplasty 4 patients compared between the 166 ATTUNE knee system and the press fit condylar (PFC) SIGMA knee system. BMC 8 Musculoskelet Disord. FRE 803(18); 9 2021;22(1):620. Stipulated Disputed N LAPS Ranawat CS, White PB, West S, 11 Ranawat AS.

Clinical and 12 Radiographic Results of Attune 13 and PFC Sigma Knee Designs at 2- Year Follow-Up: A 15 Prospective Matched-Pair 16 Analysis. J Arthroplasty. FRE 803(18); 17 2017;32(2):431-6. Stipulated Disputed NLAPS Martin JR, Jennings JM, Watters TS, 19 Levy DL, McNabb DC, Dennis DA.

20 Femoral Implant Design Modification 168 Decreases the Incidence of Patellar Crepitus in Total 23 Knee Arthroplasty. J Arthroplasty. FRE 803(18); 24 2017;32(4):1310-3. Stipulated Disputed NLAPS 1 Bonutti PM, Khlopas A, Chughtai 2 M, Cole C, Gwam CU, Harwin SF, et al. Unusually High 4 Rate of Early Failure of Tibial Component 5 in ATTUNE Total Knee Arthroplasty System at Implant- Cement Interface. J Knee Surg. FRE 803(18); 8 2017;30(5):435-9. Stipulated Disputed NLAPS Sandberg JM, Gray 9 I, Pearlman A, Terlecki RP. An evaluation of the 11 Manufacturer And User Facility Device 12 Experience database that inspired the 13 United States Food and Drug Administration's 15 Reclassification of transvaginal mesh.

16 Investig Clin Urol. FRE 803(18); 2018;59(2):126-32. Stipulated Disputed NLAPS 17 Giaretta S, Berti M, Micheloni GM, Ceccato A, 19 Marangoni F, Momoli A. Early 20 experience with the ATTUNE Total 21 Knee Replacement System. Acta Biomed.

23 2019;90(12-s):98- FRE 803(18); 103. Stipulated Disputed NLAPS 1 Kaptein BL, den Hollander P, 2 Thomassen B, Fiocco M, Nelissen R. A randomized 4 controlled trial comparing tibial 172 migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma 8 design. Bone Joint J.

2020;102-b(9):1158- FRE 803(18); 9 66. Stipulated Disputed NLAPS Murphy JD, Braunlich PR, 11 Judson Iv WR, Harker JN, Baumann 12 PA. Early Aseptic Failure of the Tibial 173 Component-Cement Interface in ATTUNE® Total 15 Knee Arthroplasty: A Report of Three 16 Cases. Cureus. FRE 803(18); 2021;13(12):e20582. Stipulated Disputed NLAPS 1 Total knee arthroplasty in the 2 outpatient vs inpatient settings: impact of site of care 4 on early postoperative 5 economic and clinical outcomes.

Mantel J, Ruppenkamp JW, Cantu M, Holy CE.

8 J Orthop Surg Res.

2023 Apr 9 4;18(1):273. doi: 10.1186/s13018- FRE 803(18); 023-03750-4. Stipulated Disputed NLAPS 11 Outcomes of surgical versus 12 nonsurgical treatment for 13 multiple rib fractures: A US hospital matched 15 cohort database analysis.

16 Shiroff AM, Wolf S, Wu A, Vanderkarr 17 M, Anandan M, Ruppenkamp JW, Galvain T, Holy CE.

19 J Trauma Acute Care Surg. 2023 Apr 20 1;94(4):538-545. doi: 21 10.1097/TA.000000 22 0000003828. Epub FRE 803(18); 2022 Nov 15. Stipulated Disputed NLAPS 1 Longitudinal Rates, Patient Risk Factors, 2 and Economic Impact of Superficial and Deep 4 Incisional Surgical Site Infection After 5 Primary and Revision Total Hip Arthroplasty: A U.S. Retrospective Commercial Claims 8 Database Analysis.

Edmiston CE Jr, 9 Spencer M, Gunja NJ, Holy CE, Ruppenkamp JW, 11 Leaper DJ.

Surg Infect 12 (Larchmt). 2023 Mar 20. doi: 13 10.1089/sur.2022.37 6. Online ahead of FRE 803(18); print. Stipulated Disputed NLAPS 15 Real-world 2-year clinical and 16 economic outcomes among patients 17 receiving a medial collared, triple tapered primary hip 19 system versus other implants for total hip 20 arthroplasty.

Diaz R, Mantel J, 21 Ruppenkamp J, Cantu M, Holy CE.

Curr Med Res Opin.

23 2023 Mar 3:1-9. doi: 10.1080/03007995.2 FRE 803(18); 24 023.2181150. Stipulated Disputed NLAPS 1 Resource utilization and costs for 2 robotic-assisted and manual total knee arthroplasty - a 4 premier healthcare database study.

5 Alton TB, Chitnis AS, Goldstein L, 178 Rajappan SK, Gupta A, Michnacs K, Holy CE, Hoeffel 8 DP.

Expert Rev Med 9 Devices. 2023 Mar 2:1-9. doi: 10.1080/17434440.2 FRE 803(18); 11 023.2185135. Stipulated Disputed NLAPS Longitudinal rates, 12 risk factors, and costs of superficial 13 and deep incisional surgical-site infection (SSI) after 15 primary and revision total knee 16 arthroplasty: A US retrospective claims 179 database analysis.

Edmiston CE Jr, Spencer M, Gunja 19 NJ, Holy CE, Ruppenkamp JW, 20 Leaper DJ.

Infect Control Hosp 21 Epidemiol. 2023 Feb 22 2:1-9. doi: FRE 803(18); 10.1017/ice.2023.10. Stipulated Disputed NLAPS 1 Risk and economic burden of surgical 2 site infection following spinal fusion in adults.

4 Edmiston CE Jr, Leaper DJ, Chitnis 5 AS, Holy CE, Chen BP.

Infect Control Hosp Epidemiol. 2023 Jan;44(1):88-95. doi: FRE 401; 8 10.1017/ice.2022.32. FRE 803(18); Epub 2022 Mar 24. Stipulated Disputed NLAPS 9 Incidence, costs and post-operative complications 11 following ankle fracture - A US 12 claims database analysis.

13 Vanderkarr MF, Ruppenkamp JW, 181 Vanderkarr M, 15 Parikh A, Holy CE, Putnam M.

16 Page 2 of 7 BMC Musculoskelet 17 Disord. 2022 Dec 26;23(1):1129. doi: 10.1186/s12891- FRE 803(18); 19 022-06095-x. Stipulated Disputed NLAPS 1 Cost-Effectiveness of Cement 2 Augmentation Versus No Augmentation for 4 the Fixation of Unstable 5 Trochanteric Fractures.

Joeris A, Kabiri M, Galvain T, 182 Vanderkarr M, Holy 8 CE, Plaza JQ, Tien S, Schneller J, 9 Kammerlander C.

J Bone Joint Surg Am. 2022 Nov 11 16;104(22):2026- 2034. doi: 12 10.2106/JBJS.21.01 516. Epub 2022 Oct FRE 803(18); 13 4. Stipulated Disputed NLAPS Risk of Mortality for Proximal Femoral 15 Fracture in Patients With and Without 16 COVID-19. A Retrospective 17 Cohort Study.

Holub A, Jornet- Gibert M, 19 Ruppenkamp J, Holy CE, Daccach J, 20 Torner P, Caba- Doussoux P, Muñoz 21 Vives JM.

Geriatr Orthop Surg Rehabil. 2022 Nov 23 10;13:21514593221 138656. doi: 24 10.1177/215145932 FRE 401; 21138656. FRE 803(18); eCollection 2022. Stipulated Disputed NLAPS 1 Risk of retinal detachment and 2 exposure to fluoroquinolones, common antibiotics, 4 and febrile illness using a self- 5 controlled case series study design: Retrospective analyses of three large healthcare 8 databases in the US.

Londhe AA, Holy 9 CE, Weaver J, Fonseca S, Villasis- Keever A, Fife D.

11 PLoS One. 2022 Oct 6;17(10):e0275796.

12 doi: 10.1371/journal.pon FRE 401; 13 e.0275796. FRE 803(18); eCollection 2022. Stipulated Disputed NLAPS Demographic and 15 clinical profile of patients treated with 16 proximal femoral nails - a 10-year 17 analysis of more than 40,000 Cases.

Finkemeier CG, 185 Holy CE, Ruppenkamp JW, 20 Vanderkarr M, Sparks C.

21 BMC Musculoskelet Disord. 2022 Sep 1;23(1):828. doi: FRE 401; 23 10.1186/s12891- FRE 803(18); 022-05772-1. Stipulated Disputed NLAPS 1 Assessment of risk and economic 2 burden of surgical site infection (SSI) posthysterectomy 4 using a U.S. longitudinal 5 database.

Edmiston CE Jr, Bond-Smith G, Spencer M, Chitnis AS, Holy CE, Po- 8 Han Chen B, Leaper DJ.

9 Surgery. 2022 May;171(5):1320- 1330. doi: 11 10.1016/j.surg.2021. FRE 401; 11.034. Epub 2021 FRE 803(18); 12 Dec 29. Stipulated Disputed NLAPS Hospitalization for 13 computer-assisted hexapod ring fixation application - 15 analyses of patient variability, peri- 16 operative complications, 17 hospital costs, and discharge status.

Reid JS, Vanderkarr 19 M, Ray B, Chitnis A, Holy CE, Sparks 20 C.

BMC Musculoskelet 21 Disord. 2022 Mar 22 5;23(1):211. doi: FRE 401; 10.1186/s12891- FRE 803(18); 23 022-05171-6. Stipulated Disputed NLAPS 1 Site-specific cancer risk following cobalt 2 exposure via orthopedic implants or in occupational 4 settings: A systematic review 5 and meta-analysis.

Holy CE, Zhang S, Perkins LE, Hasgall P, Katz LB, Brown JR, Orlandini L, 8 Fessel G, Nasseri- Aghbosh B, 9 Eichenbaum G, Egnot NS, Marcello S, Coplan PM.

11 Regul Toxicol Pharmacol. 2022 12 Mar;129:105096. doi: 13 10.1016/j.yrtph.2021 FRE 401; .105096. Epub 2021 FRE 803(18); Dec 10. Stipulated Disputed NLAPS 15 Surgical treatment, complications, 16 reoperations, and healthcare costs 17 among patients with clavicle fracture in England.

19 Wolf S, Chitnis AS, Manoranjith A, 189 Vanderkarr M, Plaza JQ, Gador LV, Holy 21 CE, Sparks C, Lambert SM.

Page 3 of 7 23 BMC Musculoskelet Disord. 2022 Feb 24 9;23(1):135. doi: FRE 401; 10.1186/s12891- FRE 803(18); 022-05075-5. Stipulated Disputed NLAPS 1 Two-year clinical and economic 2 burden, risk and outcomes following application of 4 software-assisted hexapod ring 5 fixation systems.

190 Reid JS, Vanderkarr M, Ray B, Chitnis A, Holy CE, Sparks 7 C.

8 BMC Musculoskelet Disord. 2022 Jan 9 3;23(1):25. doi: FRE 401; 10.1186/s12891- FRE 803(18); 021-04934-x. Stipulated Disputed NLAPS 11 Comparison of clinical effectiveness 12 of fenestrated and conventional pedicle 13 screws in patients undergoing spinal surgery: a systematic 15 review and meta- analysis.

16 Yagi M, Ogiri M, Holy CE, Bourcet A.

17 Expert Rev Med Devices. 2021 Oct;18(10):995- 19 1022. doi: 10.1080/17434440.2 FRE 401; 20 021.1977123. Epub FRE 803(18); 2021 Sep 23. Stipulated Disputed NLAPS 1 Carcinogenic assessment of 2 cobalt-containing alloys in medical devices or cobalt in 4 occupational settings: A 5 systematic review and meta-analysis of overall cancer risk from published epidemiologic 8 studies.

Zhang S, Holy CE, 9 Eichenbaum G, Perkins LE, Hasgall P, Katz LB, Brown 11 JR, Orlandini L, Fessel G, Nasseri- 12 Aghbosh B, Egnot NS, Zhou M, Beech 13 R, Marcello SR, Coplan PM.

Regul Toxicol 15 Pharmacol. 2021 Oct;125:104987.

16 doi: 10.1016/j.yrtph.2021 FRE 401; 17 .104987. Epub 2021 FRE 803(18); Jul 3. Stipulated Disputed NLAPS 1 Treatments, cost and healthcare utilization 2 of patients with segmental bone defects.

4 Norris BL, Vanderkarr M, 5 Sparks C, Chitnis AS, Ray B, Holy CE.

Injury. 2021 Oct;52(10):2935- 8 2940. doi: 10.1016/j.injury.202 FRE 401; 9 1.01.016. Epub 2021 FRE 803(18); Jan 14. Stipulated Disputed NLAPS Risk of aortic 11 aneurysm and dissection following 12 exposure to fluoroquinolones, 13 common antibiotics, and febrile illness using a self- 15 controlled case series study design: 16 Retrospective analyses of three 194 large healthcare databases in the US.

Londhe AA, Holy 19 CE, Weaver J, Fonseca S, Villasis 20 A, Fife D.

PLoS One. 2021 21 Aug 16;16(8):e0255887. doi: 23 10.1371/journal.pon FRE 401; e.0255887. FRE 803(18); 24 eCollection 2021. Stipulated Disputed NLAPS 1 The Authors Reply.

Leaper DJ, Holy CE, 2 Edmiston CE Jr. Dis Colon Rectum.

3 195 2021 Jul 4 1;64(7):e399. doi: FRE 401; 10.1097/DCR.00000 FRE 803(18); 5 00000002093. Stipulated Disputed NLAPS Evaluation of Cost, Payments, 7 Healthcare Utilization, and 8 Perioperative and Post-Operative 9 Outcomes of Patients Treated with Posterior 11 Lumbar Spinal Surgery Using Open 12 versus Minimally Invasive Surgical 13 Approaches.

Holy CE, Corso KA, Bowden DE, Erb 15 MJ, Ruppenkamp JR, Coombs S, 16 Pracyk JB.

Med Devices 17 (Auckl). 2021 Jun 15;14:173-183. doi: 10.2147/MDER.S31 FRE 401; 19 1774. eCollection FRE 803(18); 2021. Stipulated Disputed NLAPS 1 Intramedullary Nail Breakage and 2 Mechanical Displacement in Patients with 4 Proximal Femoral Fractures: A 5 Commercial and Medicare Supplemental Claims Database Analysis.

8 Chitnis AS, Ray B, Sparks C, 9 Grebenyuk Y, Vanderkarr M, Holy CE.

11 Med Devices (Auckl). 2021 Feb 12 9;14:15-25. doi: 10.2147/MDER.S28 FRE 401; 13 8188. eCollection FRE 803(18); 2021. Stipulated Disputed NLAPS Healthcare resource 15 utilization and costs for hip dislocation 16 following primary total hip arthroplasty 17 in the medicare population.

198 Mantel J, Chitnis 19 AS, Ruppenkamp J, Holy CE, Daccach J.

20 J Med Econ. 2021 Jan-Dec;24(1):10- 21 18. doi: FRE 401; 22 10.1080/13696998.2 FRE 803(18); 020.1854989. Stipulated Disputed NLAPS 1 Assessment of the Risk and Economic 2 Burden of Surgical Site Infection Following 4 Colorectal Surgery Using a US 5 Longitudinal Database: Is There a Role for Innovative Antimicrobial Wound Closure 8 Technology to Reduce the Risk of 9 Infection?

Leaper DJ, Holy CE, Spencer M, Chitnis 11 A, Hogan A, Wright GWJ, Po-Han Chen 12 B, Edmiston CE Jr. Dis Colon Rectum.

13 2020 Dec;63(12):1628- 1638. doi: FRE 401; 15 10.1097/DCR.00000 FRE 803(18); 00000001799. Stipulated Disputed NLAPS 1 Survival analysis for all-cause revision 2 following primary total hip arthroplasty with a medial 4 collared, triple- tapered primary hip 5 stem versus other implants in real- world settings.

Chitnis AS, Mantel J, Ruppenkamp J, 8 Bourcet A, Holy CE.

Curr Med Res Opin.

9 2020 Nov;36(11):1839- 1845. doi: 11 10.1080/03007995.2 020.1822309. Epub FRE 803(18); 12 2020 Sep 22. Stipulated Disputed NLAPS The economic 13 burden of infections following intramedullary 15 nailing for a tibial shaft fracture in 16 England.

Galvain T, Chitnis 201 A, Paparouni K, Tong C, Holy CE, Giannoudis PV.

19 BMJ Open. 2020 Aug 20 26;10(8):e035404. doi: FRE 401; 21 10.1136/bmjopen- FRE 803(18); 2019-035404. Stipulated Disputed NLAPS 1 High-concentration nonavian high- 2 molecular weight hyaluronan injections and time- 4 to-total knee replacement surgery.

5 Etter K, Chitnis AS, Holy CE, Gray FS, 202 Manalac FJ, Bisson B, Bhattacharyya SK.

8 J Comp Eff Res.

2020 9 Aug;9(11):795-805. doi: 10.2217/cer- FRE 401; 2019-0128. Epub FRE 803(18); 11 2020 Jul 9. Stipulated Disputed NLAPS Long bone fractures: 12 treatment patterns and factors 13 contributing to use of intramedullary nailing.

15 Chitnis A, Ray B, Sparks C, 203 Grebenyuk Y, Vanderkarr M, Holy 17 CE.

Expert Rev Med Devices. 2020 19 Jul;17(7):731-738. doi: FRE 401; 20 10.1080/17434440.2 FRE 803(18); 020.1779055. Stipulated Disputed NLAPS 1 Defining readmissions among 2 patients undergoing open reduction and internal fixation 4 (ORIF) in claims database analyses.

5 Chitnis AS, Nandwani P, 204 Ruppenkamp J, Vanderkarr M, Holy CE.

8 Curr Med Res Opin.

2020 Jan;36(1):83- 9 89. doi: 10.1080/03007995.2 FRE 401; 019.1667315. Epub FRE 803(18); 11 2019 Oct 7. Stipulated Disputed NLAPS Complications and 12 its impact in patients with closed and open 13 tibial shaft fractures requiring open reduction and 15 internal fixation.

Chitnis AS, 16 Vanderkarr M, Sparks C, 17 McGlohorn J, Holy CE.

J Comp Eff Res.

19 2019 Dec;8(16):1405- 20 1416. doi: 10.2217/cer-2019- FRE 401; 21 0108. Epub 2019 FRE 803(18); Nov 22. Stipulated Disputed NLAPS 1 Impact of patient comorbidities on 2 surgical site infection within 90 days of primary and 4 revision joint (hip and knee) 5 replacement.

Edmiston CE Jr, Chitnis AS, Lerner J, Folly E, Holy CE, Leaper D.

8 Am J Infect Control.

2019 9 Oct;47(10):1225- 1232. doi: 10.1016/j.ajic.2019.

11 03.030. Epub 2019 FRE 803(18); May 7. Stipulated Disputed NLAPS 12 Surgical treatment, complications, and 13 reimbursement among patients with clavicle fracture and 15 acromioclavicular dislocations: a US 16 retrospective claims database analysis.

17 207 Putnam M, Vanderkarr M, Nandwani P, Holy 19 CE, Chitnis AS.

J Med Econ. 2019 20 Sep;22(9):901-908. doi: 21 10.1080/13696998.2 FRE 401; 22 019.1620245. Epub FRE 803(18); 2019 Jun 6. Stipulated Disputed NLAPS 1 Real-world impact of the high 2 concentration non- avian high molecular weight hyaluronan 4 on pain medication use among 5 osteoarthritis patients.

Chitnis AS, Etter K, Holy CE, Gray FS, Manalac FJ, Bisson 8 B, Bhattacharyya SK.

9 Curr Med Res Opin.

2019 Sep;35(9):1523- 11 1527. doi: 10.1080/03007995.2 FRE 401; 12 019.1596670. Epub FRE 803(18); 2019 Apr 1. Stipulated Disputed NLAPS 13 Complications in type III open tibial shaft fractures 15 treated with open reduction and 16 internal fixation.

Chitnis AS, 17 Vanderkarr M, Sparks C, McGlohorn J, Holy 19 CE.

J Comp Eff Res.

20 2019 Aug;8(11):907-915.

21 doi: 10.2217/cer- FRE 401; 22 2019-0040. Epub FRE 803(18); 2019 Jun 7. Stipulated Disputed NLAPS 1 Reoperations in intramedullary 2 fixation of pertrochanteric hip fractures.

4 Chitnis AS, Vanderkarr M, 5 Ruppenkamp J, Lerner J, Holy CE, Sparks C.

J Med Econ. 2019 Jul;22(7):706-712.

8 doi: 10.1080/13696998.2 FRE 401; 9 019.1600526. Epub FRE 803(18); 2019 Apr 11. Stipulated Disputed NLAPS Medical resource 11 utilization and costs for intraoperative 12 and early postoperative 13 periprosthetic hip fractures following total hip arthroplasty 15 in the medicare population: A 16 retrospective cohort study.

17 Chitnis AS, Mantel J, Vanderkarr M, Putnam M, 19 Ruppenkamp J, Holy CE, Bridgens J.

20 Medicine (Baltimore). 2019 21 Jun;98(25):e15986.

22 doi: FRE 401; 10.1097/MD.000000 FRE 803(18); 23 0000015986. Stipulated Disputed NLAPS 1 Cost and effectiveness of 2 prescribing emollient therapy for atopic eczema in UK 4 primary care in children and adults: 5 a large retrospective analysis of the Clinical Practice Research Datalink.

Moncrieff G, Lied- 8 Lied A, Nelson G, Holy CE, Weinstein 9 R, Wei D, Rowe S.

BMC Dermatol.

2018 Oct 29;18(1):9.

11 doi: FRE 401; 10.1186/s12895- FRE 803(18); 12 018-0076-y. Stipulated Disputed NLAPS Medical resource 13 utilization and costs for total hip arthroplasty: 15 benchmarking an anterior approach 16 technique in the Medicare 17 population.

Kamath AF, Chitnis 213 AS, Holy C, Lerner 19 J, Curtin B, Lochow S, DeCook C, Matta 20 JM.

J Med Econ. 2018 21 Feb;21(2):218-224. doi: 10.1080/13696998.2 FRE 401; 23 017.1393428. Epub FRE 803(18); 2017 Nov 3. Stipulated Disputed NLAPS 1 Prevalence and Occupation of 2 Patients Presenting With Dysphonia in the United States.

4 Benninger MS, Holy CE, Bryson PC, 5 Milstein CF. J Voice. 2017 Sep;31(5):594-600. doi: 10.1016/j.jvoice.201 FRE 401; 8 7.01.011. Epub 2017 FRE 803(18); Apr 13. Stipulated Disputed NLAPS 9 Prevalence of atopic disease in patients with eosinophilic 11 esophagitis.

Benninger MS, 12 Strohl M, Holy CE, Hanick AL, Bryson 215 PC.

Int Forum Allergy Rhinol. 2017 15 Aug;7(8):757-762. doi: FRE 401; 16 10.1002/alr.21968. FRE 803(18); Epub 2017 Jun 14. Stipulated Disputed NLAPS 17 Acute Rhinosinusitis: Prescription Patterns 19 in a Real-World Setting.

20 Benninger MS, Holy CE, Trask DK.

21 216 Otolaryngol Head Neck Surg. 2016 May;154(5):957-62.

23 doi: 10.1177/019459981 FRE 401; 24 6630310. Epub 2016 FRE 803(18); Mar 1. Stipulated Disputed NLAPS 1 Variation in Delivery of Sinus 2 Surgery in the Medicaid Population across Ethnicities.

4 Woodard T, Sindwani R, 5 Halderman AA, Holy CE, Gurrola J 2nd.

Otolaryngol Head Neck Surg. 2016 8 May;154(5):944-50. doi: 9 10.1177/019459981 FRE 401; 6628460. Epub 2016 FRE 803(18); Feb 23. Stipulated Disputed NLAPS 11 Impact of medically recalcitrant chronic 12 rhinosinusitis on incidence of asthma.

13 Benninger MS, Sindwani R, Holy 218 CE, Hopkins C.

15 Int Forum Allergy Rhinol. 2016 16 Feb;6(2):124-9. doi: FRE 401; 10.1002/alr.21652. FRE 803(18); 17 Epub 2015 Dec 1. Stipulated Disputed NLAPS Geographic variation of endoscopic sinus 19 surgery in the United States.

20 Rudmik L, Holy CE, Smith TL.

21 Laryngoscope. 2015 Aug;125(8):1772-8. doi: FRE 401; 23 10.1002/lary.25314. FRE 803(18); Epub 2015 Apr 17. Stipulated Disputed NLAPS 1 Early versus delayed endoscopic sinus 2 surgery in patients with chronic rhinosinusitis: 4 impact on health care utilization.

5 Benninger MS, Sindwani R, Holy CE, Hopkins C.

Otolaryngol Head Neck Surg. 2015 8 Mar;152(3):546-52. doi: 9 10.1177/019459981 FRE 401; 4565606. Epub 2015 FRE 803(18); Jan 8. Stipulated Disputed NLAPS 11 In-office balloon catheter dilation: 12 analysis of 628 patients from an 13 administrative claims database.

14 221 Sillers MJ, Lay KF, 15 Holy CE.

Laryngoscope. 2015 16 Jan;125(1):42-8. doi: FRE 401; 10.1002/lary.24885. FRE 803(18); 17 Epub 2014 Sep 17. Stipulated Disputed NLAPS The impact of endoscopic sinus 19 surgery on health care use in patients 20 with respiratory comorbidities.

21 Benninger MS, Holy CE.

Otolaryngol Head 23 Neck Surg. 2014 Sep;151(3):508-15.

24 doi: 10.1177/019459981 FRE 401; 4536369. Epub 2014 FRE 803(18); 26 Jun 3. Stipulated Disputed NLAPS 1 Endoscopic sinus surgery provides 2 effective relief as observed by health care use pre- and 4 postoperatively.

Benninger MS, Holy 223 CE.

Otolaryngol Head Neck Surg. 2014 May;150(5):893- 900. doi: 8 10.1177/019459981 FRE 401; 4522419. Epub 2014 FRE 803(18); 9 Feb 10. Stipulated Disputed NLAPS The impact of balloon catheter 11 dilation on frequency of sinus 12 surgery in the United States.

13 Holy CE, Ellison JM, Schneider C, Levine HL.

15 Med Devices (Auckl). 2014 Apr 16 28;7:83-9. doi: 10.2147/MDER.S60 FRE 401; 17 054. eCollection FRE 803(18); 2014. Stipulated Disputed NLAPS Why the confusion 19 about sinus headache?

20 Levine H, Setzen M, Holy C.

21 Otolaryngol Clin North Am. 2014 Apr;47(2):169-74.

23 doi: 10.1016/j.otc.2013.1 FRE 401; 24 1.003. Epub 2014 FRE 803(18); Jan 11. Stipulated Disputed NLAPS 1 Efficacy of mesenchymal stem 2 cell enriched grafts in an ovine posterolateral 4 lumbar spine model.

Gupta MC, 5 Theerajunyaporn T, Maitra S, Schmidt 226 MB, Holy CE, Kadiyala S, Bruder SP.

8 Spine (Phila Pa 1976). 2007 Apr 9 1;32(7):720-6; discussion 727. doi: FRE 401; 10.1097/01.brs.0000 FRE 803(18); 11 258863.40984.32. Stipulated Disputed NLAPS Bone grafts prepared 12 with selective cell retention technology 13 heal canine segmental defects as effectively as 15 autograft.

Brodke D, Pedrozo 227 HA, Kapur TA, Attawia M, Kraus 17 KH, Holy CE, Kadiyala S, Bruder SP.

19 J Orthop Res. 2006 May;24(5):857-66. FRE 401; 20 doi: FRE 803(18); 10.1002/jor.20094. Stipulated Disputed NLAPS 1 In vivo bone engineering in a 2 rabbit femur.

Fialkov JA, Holy CE, Shoichet MS, 228 Davies JE.

J Craniofac Surg.

5 2003 May;14(3):324-32. doi: FRE 401; 7 10.1097/00001665- FRE 803(18); 200305000-00010. Stipulated Disputed NLAPS 8 All-Cause Revision and Aseptic 9 Loosening Following Total Knee Replacement: 11 Meta-Analysis of Registry Outcomes 12 and Analysis of NJR Data dated April 21, FRE 803(18); 13 2020 Stipulated Disputed NLAPS Meta-Analysis of Attune Registries FRE 401; 15 PowerPoint dated FRE 803(18); March 24, 2020 Stipulated Disputed NLAPS 16 NJR Implant Bespoke Report for 231 Attune (PS RP) 18 dated March 11, FRE 803(18); 2020 Stipulated Disputed NLAPS 19 NJR Implant Bespoke Report for 232 Attune (PS FB) dated March 11, FRE 803(18); 2020 Stipulated Disputed NLAPS 22 NJR Implant Bespoke Report for 233 Attune (CR FB) dated March 11, FRE 803(18); 24 2020 Stipulated Disputed NLAPS 1 NJR Implant Bespoke Report for 234 Attune (CR RP) 3 dated March 11, FRE 803(18); 2020 Stipulated Disputed NLAPS 4 AAOS Report re: Attune FB Devices 235 dated February 13, FRE 803(18); 2020 Stipulated Disputed NLAPS ERPD Data 236 Summary for Attune Tibia dated FRE 803(18); 8 December 5, 2019 Stipulated Disputed NLAPS Data from New 237 Zealand Joint FRE 803(18); Registry Stipulated Disputed NLAPS Data from Geneva FRE 803(18); 11 Registry Disputed Disputed NLAPS Data from Dutch FRE 803(18); 12 Registry Disputed Disputed NLAPS AOANJRR Report re: Attune dated FRE 803(18); 14 June 13, 2019 Stipulated Disputed NLAPS MARCQI Report – 15 Summary and Review of DePuy 241 Synthes Products and Class Trends FRE 803(18); dated January 2019 Stipulated Disputed NLAPS 18 DePuy Attune Clinical Evidence 19 Website – https://www.jnjmedt 242 ech.com/en- US/product/attune- knee-system/attune- FRE 803(18); 22 evidence Stipulated Disputed NLAPS 1 Evans JT, Walker RW, Evans JP, 2 Sayers A, Whitehouse MR. How long does a 4 knee replacement last? A systematic 5 review and meta- analysis of case series and national registry reports with more than 15 years 8 of follow-up.

Lancet, 9 2019DOI:https://doi. org/10.1016/S0140- FRE 803(18); 6736(18)32531-5 Stipulated Disputed NLAPS 11 Beswick AD, Wylde V, Gooberman-Hill 12 R, Blom A, Dieppe P. What proportion 13 of patients report long-term pain after total hip or knee 15 replacement for osteoarthritis? A 16 systematic review of prospective studies 17 in unselected patients. BMJ Open FRE 803(18); 2012; 2: e000435. Stipulated Disputed NLAPS 19 Wong, J., Ries, M.D.: Total Knee 20 Arthroplasty. In: Rehabilitation for 245 the Postsurgical Orthopaedic Patient 3rd ed. (Magnusson 23 J, ed), Elsevier, FRE 803(18); 2011. Stipulated Disputed NLAPS 1 Hughes KF, Ries MD, Pruitt 2 LA.:Structural Degradation of Acrylic bone 4 Cements due to in Vivo and Simulated 5 Aging. J Biomed Mate. Res, 1; 65A: FRE 803(18); 126-135, 2003. Stipulated Disputed NLAPS 7 Schroer WC, Berend KR, Adolph AV, 8 Barnes CL, Bolognesi MP, 9 Berend ME, Ritter MA, Nunley RM.

247 Why are total knees 11 failing today?

Etiology of total 12 knee revision in 2010 and 2011. J 13 Arthroplasty, 28: FRE 803(18); 116-119, 2013. Stipulated Disputed NLAPS Ries MD, Young E, 15 Al-Marashib L, Goldstein P, 16 Hetherington A, Petrieb T, Pruitt L.

17 248 In vivo behavior of acrylic bone cement in total hip 19 arthroplasty. Biomat, FRE 803(18); 27; 2006, 256-261. Stipulated Disputed NLAPS 20 Graham, J., Ries, M.D., and Pruitt, L.: Effect of Bone 22 Porosity on Mechanical Integrity 23 of the Bone Cement- Interface. J. Bone 24 Joint Surg; 85A: FRE 803(18); 1901-1908, 2003. Stipulated Disputed NLAPS 1 Carpenter W, Hamilton DH, 2 Luthringer T, Buchalter D, Schwarzkopf R. The 250 Evolution of Cement Fixation in Total 5 Knee Arthroplasty.

Surg Technol Int, 2019 Nov FRE 803(18); 10;35:355-362. Stipulated Disputed NLAPS Robertsson O, 8 Sundberg M, Sezgin EA, Lidgren L, W- 9 Dahl A. Higher Risk of Loosening for a 251 Four-Pegged TKA 11 Tibial Baseplate Than for a Stemmed 12 One: A Register- FRE 803(18); based Study. Stipulated Disputed NLAPS 13 Buller LT, Rao V, Chiu YF, Nam D, McLawhorn AS.

15 Primary Total Knee Arthroplasty 16 Performed Using High-Viscosity 252 Cement is Associated With Higher Odds of 19 Revision for Aseptic Loosening. J 20 Arthroplasty, 2020 Jun;35(6S):S182- FRE 803(18); 21 S189. Stipulated Disputed NLAPS 1 Pittman GT, Peters CL, Hines JL, 2 Bachus KN.

Mechanical bond strength of the 253 cement-tibial component interface 5 in total knee arthroplasty. J Arthroplasty, FRE 803(18); 21:883-888, 2006. Stipulated Disputed NLAPS Bini SA, Chen Y, 8 Khatod M, Paxton EW. Does pre- 9 coating total knee tibial implants affect the risk of aseptic 11 revision? Bone Joint J, 2013 Mar;95- FRE 803(18); 12 B(3):367-70. Stipulated Disputed NLAPS Arsoy D, Pagnano 13 MW, Lewallen DG, Hanssen AD, Sierra RJ. Aseptic tibial 15 debonding as a cause of early failure in a 16 modern total knee arthroplasty design.

17 Clin Orthop Relat 18 Res, 2013 FRE 803(18); Jan;471(1):94-101. Stipulated Disputed NLAPS 19 Kutzner I, Hallan G, Høl PJ, Furnes O, 20 Gøthesen O, Figved W, Ellison P. Early aseptic loosening of 22 a mobile-bearing total knee 23 replacement. Acta Orthop. 2018, 89: FRE 803(18); 24 77–83. Stipulated Disputed NLAPS 1 Cheng K, Pruitt L, Zaloudek C, Ries 2 MD. Osteolysis Caused by Tibial Component 4 Debonding in Total Knee Arthroplasty.

5 Clini Orthop Rel Res, 443; 2006, 333- FRE 803(18); 336. Stipulated Disputed NLAPS 7 Silva JD, Nunes B, Duarte F, Raposo F, 8 Valente L, Antunes A, Olivera P, Sousa 9 A. Effect of tibial alignment in early failure in total knee 11 arthroplasties. Rev Chirurgie Orthop 12 Traumat, 102, S80, FRE 803(18); 2016. Stipulated Disputed NLAPS 13 Parisi T, Jennings J, Dennis D. Coronal Alignment in TKA: 15 Traditional Principles Versus 16 New Concepts.

Reconstructive Rev, 17 8, 2018, DOI: 18 http://dx.doi.org/10. FRE 803(18); 15438/rr.8.2.213 Stipulated Disputed NLAPS 19 Keohane D. High rate of tibial 20 debonding and failure in a modern knee arthroplasty: A 22 cause for concern.

Orthopaedic 23 ProceedingsVol.

100-B, No. FRE 803(18); 24 SUPP_16 Stipulated Disputed NLAPS 1 Cawley DT, Kelly N, McGarry JP, 2 Shannon FJ.

Cementing techniques for the 261 tibial component in primary total knee 5 replacement. Bone Joint J, VOL. 95-B, No. 3, MARCH FRE 803(18); 2013 Stipulated Disputed NLAPS Vanlommel J, 8 Luyckx JP, Labey L, Innocenti B, De 9 Corte R, Bellemans J. Cementing the Tibial Component in 11 Total Knee Arthroplasty Which 12 Technique is the Best? J Arthroplasty, 13 26 No. 3 2011, 492- FRE 803(18); 496. Stipulated Disputed NLAPS Foran JRH, Whited 15 BW, Sporer SM.

Early Aseptic 16 Loosening With a Precoated Low- 17 Profile Tibial Component. J Arthroplasty, 26, FRE 803(18); 19 1445 –1450 , 2011. Stipulated Disputed NLAPS Ries C, Heinichen 20 M, Dietrich F, Jakubowitz E, Sobau C, Heisel C. Short- 22 keeled Cemented Tibial Components 23 Show an Increased Risk for Aseptic 24 Loosening. Clin Orthop Relat Res (2013) 471:1008– FRE 803(18); 26 1013 Stipulated Disputed NLAPS 1 Kopinski JE, Aggarwal A, Nunley 2 RM, Barrack RL, Nam D. Failure at the Tibial 4 CementImplant Interface With the 5 Use of High- Viscosity Cement in Total Knee Arthroplasty. J Arthroplasty, . 2016 8 Nov;31(11):2579- FRE 803(18); 2582. Stipulated Disputed NLAPS 9 Cerquiglini A, Henckel J, Hothi H, Allen P, Lewis 11 J,Eskelinen A, Skinner J, 12 Hirschmann MT, Hart AJ. Analysis of 13 the Attune tibial tray backside. A comparative 15 retrieval study. Bone Joint Res FRE 803(18); 16 2019;8:136–145. Stipulated Disputed NLAPS Bonutti PM, Klopas 17 A, Chugtai M, Cole C, Gwam CU, Harwin SF, Whited 19 B, Omiyi DE, Drumm JE.

20 Unusually high rate of early failure of 21 tibial component in ATTUNE total knee arthroplasty system 23 at implant-cement interface. J Knee 24 Surg, 30, 435-439, FRE 803(18); 2017. Stipulated Disputed NLAPS 1 Ries, M.D., Nunley, R.M.: Revision 2 Total Knee Arthroplasty. In: AAOS 4 Comprehensive Orthopaedic Review 5 2, pp1305-1316, AAOS, Rosemont, FRE 803(18); IL, 2014. Stipulated Disputed NLAPS 7 Hansen, E.N., Ries, M.D.: Principles of 8 Revision Total Knee Arthroplasty. In: The 9 Knee Reconstruction, 269 Replacement, and 11 Revision (Parvizi, J., ed), dtp data trace, 12 Brooklandville, MO, 2012, pp 79-1; 79- FRE 803(18); 13 18. Stipulated Disputed NLAPS Jasty M, Maloney WJ, Bragdon CR et 15 al. The initiation of failure in cemented 16 femoral components of hip arthroplasties. FRE 401; FRE 17 J Bone Joint Surg, 803(18); 73A, 551-558, 1991. Stipulated Disputed NLAPS Ong A, Wong KL, 19 Lai M, et al. Early failure of precoated 20 femoral components in primary total hip arthroplasty. J Bone FRE 401; 22 Joint Surg, 84A, FRE 803(18); 786-792, 2002. Stipulated Disputed NLAPS 1 Sporer SM, Callaghan JJ, 2 Olejniczak JP, et al.

The effects of surface roughness 4 and polymethylmethacry 5 late precoating on the radiographic and clinical results of the Iowa hip prosthesis.

A study of patients 8 less than fifty years old. J Bone Joint FRE 401; FRE 9 Surg, 81A, 481-492, 803(18); 1999. Stipulated Disputed NLAPS Crowninshield RD, 11 Brand RA, Johnston RC, Milroy LC. The 12 Effect of Femoral Stem CrossSectional 273 Geometry on Cement Stresses in Total Hip 15 Reconstruction. Clin FRE 401; FRE Orthop Rel Res, 803(18); 16 146; 71-77, 1980. Stipulated Disputed NLAPS Berry DJ, Harmsen 17 WS, Ilstrup DM.

The natural history of debonding of the 19 femoral component from the cement and 20 its effects on long term survival of the 21 Charnley total hip 22 replacements. J bone FRE 401; FRE oint Surg 80A, 715- 803(18); 23 721, 1998. Stipulated Disputed NLAPS 1 Ries, M.D. (editor): Revision Total Knee 2 Arthroplasty (video).

AAOS Surgical Techniques in 4 Orthopaedics.

American Academy 5 of Orthopaedic Surgeons, FRE 803(18); Rosemont, IL, 2004. Stipulated Disputed NLAPS 7 Ries, M.D.: Revision Total Knee 8 Arthroplasty In: AAOS 276 Comprehensive Orthopaedic Review (Lieberman, J.R., 11 ed.), Rosemont, IL, FRE 803(18); 2009, pp 1057-1066. Stipulated Disputed NLAPS 12 Ranawat CS, White PB, West S, 13 Ranawat AS.

Clinical and Radiographic 15 Results of Attune and PFC Sigma 16 Knee Designs at 2- Year Follow-Up: A 17 Prospective Matched-Pair Analysis. J 19 Arthroplasty, FRE 803(18); 32:431-436, 2017. Stipulated Disputed NLAPS 1 Indelli PF, MD, Pipino G,, Johnson 2 P, Graceffa A, Marcucci M.m Posterior-stabilized 4 total knee arthroplasty: a 5 matched pair analysis of a classic and its evolutional design. Arthroplasty Today 2, 193- 198, FRE 803(18); 8 2016. Stipulated Disputed NLAPS Martin JR, Jennings 9 JM, Watters TS, Levy DL, McNabb DC, Dennis DA.

11 Femoral Implant Design Modification 12 Decreases the Incidence of Patellar 13 Crepitus in Total Knee Arthroplasty. J Arthroplasty, 32: FRE 803(18); 15 1310-1313, 2017. Stipulated Disputed NLAPS Toomey SD, 16 Daccach JA, Shah JC, Himden SE, 17 Lesko JP, Hamilton WG. Comparative Incidence of 19 Patellofemoral Complications 20 Between 2 Total Knee Arthroplasty 21 Systems in a Multicenter, Prospective Clinical 23 Study. J Arthroplasty, 32: FRE 803(18); 24 S187-S192, 2017. Stipulated Disputed NLAPS 1 Vasarhelyi EM, Petis SM. Use of 2 National Joint Registries to Evaluate a New 4 Knee Arthroplasty Design. J 5 Arthroplasty, 35: FRE 803(18); 413-416, 2020. Stipulated Disputed NLAPS Lewis PL, Graves 7 SE, Dphil, de Steiger RN, Campbell DG, 8 Peng Y, Hatton A, Lorimer M. Does 9 Knee Prosthesis Survivorship Improve When 282 Implant Designs Change? Findings 12 from the Australian Orthopaedic 13 Association National Joint Replacement Registry. Clin 15 Orthop Relat Res, 478: 1156-1172, FRE 803(18); 16 2020. Stipulated Disputed NLAPS Kelly BC, Owen JR, 17 Shah JC, Johnson AJ, Golladay GJ, Kates SL. A 19 Biomechanical Comparison of the 283 Effect of Baseplate Design and Fat 21 Marrow Infiltration on Tibial Baseplate Pullout Strength. J 23 Arthroplasty, 36: FRE 803(18); -361, 2021. Stipulated Disputed NLAPS 1 Tracey RW, Akram F, Della Valle CJ, , 2 Sporer SM, Berger RA, Gerlinger TL.

Clinical Outcomes 284 in Isolated Tibial Revision With 5 Cruciate Retaining Total Knee Arthroplasty. J 7 Arthoplasty, 36: FRE 803(18); 2536-2540, 2021. Stipulated Disputed NLAPS 8 Batailler C, MalemoY, Demey 9 G, Kenney R, Lustig S, Servien E, P. Cemented vs 11 Uncemented Femoral 12 Components: A Randomized, 13 Controlled Trial at Years Minimum Follow-Up. J 15 Arthroplasty 35: FRE 803(18); 2090-2096, 2020. Stipulated Disputed NLAPS 16 Limberg AK, Tibbo ME, Ollivier M, 17 Tammachote N, Abdel MP, Berry DJ. Factors 19 Affecting the Risk of Aseptic Patellar 20 Complications in Primary TKA 21 Performed with Cemented All- Polyethylene 23 Patellar Resurfacing. FRE 803(18); JBJS 2022 Stipulated Disputed NLAPS 1 Menken LG, Fleuriscar J, Weiner 2 T, Berliner ZP, Rodriguez JA.

Aseptic Tibial 287 Implant Loosening After Total Knee 5 Arthroplasty: Preventable?J Am Acad Orthop Surg, FRE 803(18); 2021. Stipulated Disputed NLAPS van Otten TJM, van 8 Loon CJM. Early aseptic loosening of 9 the tibial component at the cement- implant interface in 288 total knee arthroplasty: a 12 narrative overview of potentially 13 associated factors.

Acta Orthop Belg. FRE 803(18); 2022 Stipulated Disputed NLAPS 15 Hampton CB, Berliner ZP, Nguyen 16 JT, Mendez L, Smith SS, Joseph AD, 17 Padgett DE, Rodriguez JA.

18 289 Loosening at the 19 Tibia in Total Knee Arthroplasty: A 20 Function of Cement Mantle Quality? J FRE 803(18); 21 Arthroplasty. 2020 Stipulated Disputed NLAPS 1 van Hamersveld KT, Perla Mheen PJ, 2 Nelissen RGH. The Effect of Coronal Alignment on Tibial 4 Component Migration Following 5 Total Knee Arthroplasty: A Cohort Study with Long-Term Radiostereometric 8 Analysis Results. J Bone Joint Surg, 9 101A: 1203-1212, FRE 803(18); 2019. Stipulated Disputed NLAPS Tew M, Waugh W: 11 Tibiofemoral alignment and the 291 results of Knee replacement. J Bone 13 Joint Surg. FRE 803(18); 1985;67B; 551-556. Stipulated Disputed NLAPS Lotke PA, Ecker 15 ML; Influence of positioning of the 292 prosthesis in total knee replacement. J 17 Bone Joint Surg. FRE 803(18); 1977;59A; 77-79. Stipulated Disputed NLAPS Bargren 1JH, Blaha 19 MD, Freeman MAR: Alignment in total 20 knee arthroplasty: Correlated biomechanical and 22 clinical observation.

1983; Clin Orthop FRE 803(18); 23 173; 178-183. Stipulated Disputed NLAPS 1 Berend ME, Ritter MA, Meding JB, 2 Faris PM, Keating EM, Redelman R, Faris GW, Davis 294 KE; Tibial component failure 5 mechanisms in total knee arthroplasty.

Clin Orthop. FRE 803(18); 2004;428; 26-34. Stipulated Disputed NLAPS Garceau SP, Pivec 8 R, Teo G, Chisari E, Enns PA, Weinblatt 9 AI, Aggarwal VK, Austin MS, Long WJ. Increased Rates 11 of Tibial Aseptic Loosening in 12 Primary Cemented Total Knee 13 Arthroplasty With a Short Native Tibial Stem Design.

15 Journal American Academy of 16 Orthopaedic Surgeons 30: e640- FRE 803(18); 17 e648, 2022. Stipulated Disputed NLAPS Begum FA, Kayani B, Magan AA, 19 Chang JS, Haddad FS. Current concepts 20 in total knee arthroplasty : 296 mechanical, kinematic, anatomical, and 23 functional alignment. Bone Jt 24 Open, 2: 397-404, FRE 803(18); 2021. Stipulated Disputed NLAPS 1 Kerkhoffs GM, Servien E, Dunn W, 2 Dahm D, Bramer J, Haverkamp D. The Influence of Obesity 4 on the Complication Rate and Outcome 297 of Total Knee Arthroplasty. A Meta-Analysis and Systematic Literature Review.

8 Journal Bone Joint Surg, 94:1839-1844, FRE 803(18); 9 2012. Stipulated Disputed NLAPS Gao ZX, Long NJ, Zhang SY, Yu W, 11 Dai YX, Xiao C.

Comparison of 12 Kinematic Alignment and 13 Mechanical Alignment in Total Knee Arthroplasty: 15 A Meta-analysis of Randomized 16 Controlled Clinical Trials. Orthop Surg, FRE 803(18); 17 12:1567-1578. 2020. Stipulated Disputed NLAPS Menken LG, Fleuriscar J, Weiner 19 T, Berliner ZP, Rodriguez JA.

20 Aseptic Tibial Implant Loosening 299 After Total Knee Arthroplasty: Preventable? Journal 23 American Academy of Orthopaedic 24 Surgeons 29: 326- FRE 803(18); 330, 2021. Stipulated Disputed NLAPS 1 Refsum AM,a Nguyen UV, 2 Gjertsen JE, Espehaug B, Fenstad A, Lein RK, Ellison 4 P, Høl PJ, Furnesa O. Cementing 5 technique for primary knee arthroplasty: a scoping review. Acta Orthop, 90: 582– FRE 803(18); 8 589, 2019. Stipulated Disputed NLAPS Wall CJ, Vertullo 9 CJ, Kondalsamy- Chennakesavan S, Lorimer MF, de 11 Steiger RN. A Prospective, 12 Longitudinal Study of the Influence of 13 Obesity on Total Knee Arthroplasty Revision Rate.

15 Results from the Australian 16 Orthopaedic Association National 17 Joint Replacement Registry. J Bone Joint Surg, 104: FRE 803(18); 19 1386, 2022. Stipulated Disputed NLAPS DePuy Attune 20 Clinical Evidence Website – 21 https://www.jnjmedt ech.com/en- US/product/attune- 23 knee-system/attune- FRE 803(18); evidence Stipulated Disputed NLAPS 24 UK Registry Data FRE 803(18); (2016-2022) Disputed Disputed NLAPS Australian Registry FRE 803(18); 304 Data (2016-2022) Disputed Disputed NLAPS 2 ACTION BY THE COURT (a) This case is scheduled for trial before a jury on October 10, 2023, at 9 a.m. (b) Trial briefs shall be submitted to the court on or before September 26, 2023. (c) Jury Instructions requested by either party shall be submitted to the Court on or before September 26, 2023. Suggested questions of either party to be asked of the jury by the Court on voir dire shall be submitted to the Court on or before September 26, 2023.

9 (d) This order has been approved by the parties as evidenced by the signatures of their counsel. This order shall control the subsequent course of the action unless modified by a subsequent order. This order shall not be amended except by order of the court pursuant to agreement of the parties or to prevent manifest injustice.

DATED this 3rd day of October, 2023.

15 A 16 MICHELLE L. PETERSON United States Magistrate Judge FORM APPROVED s/James J. Purcell_____________ Attorney for Plaintiff s/Erin M. Pauley______________ Attorney for Defendants