DERRICK C. BOSLEY, SR. v. 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
Case No. C21-1683-MLP
IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WASHINGTON AT SEATTLE
October 3, 2023
Jurisdiction is vested in this Court by virtue of and pursuant to
CLAIMS AND DEFENSES
The Plaintiff will pursue the following claims at trial:
- First Cause of Action - Washington Product Liability Act, Unsafe Design, Strict Liability.
- 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:
- Plaintiff‘s Complaint fails, in whole or part, to state a claim upon which relief may be granted.
- Plaintiff fails to, and cannot, present evidence to support his claims against the Defendants. NOTE: Plaintiff objects to this asserted defense.
- Plaintiff fails to meet his burden to show that Defendants are liable for his alleged injuries. NOTE: Plaintiff objects to this asserted defense.
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. - 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.
- 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.
- Plaintiff‘s alleged damages, if any, are barred in whole or in part by Plaintiff‘s failure to mitigate such damages.
- Plaintiff‘s causes of action are barred by the applicable statutes of limitation, statutes of repose, doctrines of laches and/or estoppel.
- 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. 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. - 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.
- Plaintiff‘s damages, if any, are barred or limited by the payments received from collateral sources.
- Plaintiff‘s causes of action are barred by the learned intermediary doctrine.
- Plaintiff‘s claims are barred by the doctrines of informed consent, release and waiver.
- 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.
- 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).
- If the ATTUNE® product is unsafe in any way, it was unavoidably unsafe. 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 (1996). - 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.
- 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.
- 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.
- Plaintiff‘s claims should be dismissed, reduced, offset, or barred in accordance with the principles of comparative negligence.
- 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
The following facts are admitted by the Parties:
- 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. - 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.
- 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.
- Dr. Barrett recommended Plaintiff proceed with a revision surgery.
- The pre-operative and post-operative diagnosis for Plaintiff‘s March 19, 2019 revision surgery was “failed fixation of left total knee.”
- 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.
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.
135. The Defendants manufactured and sold the ATTUNE Device knowing the 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.
140. The Defendants were under a duty to issue such warnings or instructions as a reasonably prudent manufacturer would issue in the same or similar circumstances 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
(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.
(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 Testimony | √ if by Deposition |
|---|---|---|---|
| Peter Bonutti, MD Bonutti Clinic 1303 W Evergreen Ave Suite 200 Effingham, Illinois 62401 | Will testify. | Expert opinion previously provided and all matters relating thereto. Nature and cause of failure of Plaintiff‘s left knee Attune tibial base and defective design of Attune tibial base as set forth in Expert Report. | |
| Michael F. Arrigo 620 Newport Center Drive Suite 1100 Newport Beach, CA 92660 | Will testify. | Expert opinion previously provided and all matters relating thereto. Usual, customary and reasonable charges for pain care and left knee revision surgery as set forth in Expert Report. |
| Witness | Status | Nature of Expected Testimony | √ if by Deposition |
|---|---|---|---|
| Michael Ries, M.D., Sc.M. c/o Defendants | Will Testify. | Expert opinion previously provided and all matters relating thereto. The design, function, safety, and effectiveness of the ATTUNE® based on preclinical testing, registry data, and scientific literature. The risks associated with total knee arthroplasties. | |
| Chantal E. Holy, Ph.D., MSc. c/o Defendants | Will Testify. | Expert opinion previously provided and all matters relating thereto. Registry data and scientific literature setting forth the causes of and revision rates for total knee arthroplasties. Risks associated with total knee arthroplasties and prevalence in the scientific literature and registry data. |
OTHER WITNESSES
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 Testimony | √ if by Deposition |
|---|---|---|---|
| Derrick C. Bosley 12046 69th Ave S Seattle WA 98178 | Will testify. | Left and right knee implant surgeries; failure of left knee implant; left knee revision surgery; post left knee implant surgery disability, pain, pain treatment, dependence on and addiction to pain medication, effects on wife and family, relationships with same, quality of life; treatment for | |
| Sandra Bosley 12046 69th Ave S Seattle WA 98178 | Will testify. | Left and right knee implant surgeries; failure of left knee implant; left knee revision surgery; post left knee implant surgery disability, pain, pain treatment, dependence on and addiction to pain medication, effects on wife and family, relationships with same, quality of life; treatment for reduction of dependence on pain medication and withdrawal from same; continuing and long terms effects of failure of left knee implant | |
| Liam Rowley c/o Defendants | Will testify by 30(b)(6) deposition testimony. | 30(b)(6) deposition testimony; agreement with Dr. Bonutti‘s Expert Witness Report and article relating to omission of surface roughness and undercut cement pockets of predecessor Sigma in the subject tibial base; and all matters listed on Second Amended Attachment A to Third Amended Notice of Defendants’ Deposition Pursuant to | |
| Dr. Daniel Hoeffel, MD c/o Defendants | Will testify by 30(b)(6) deposition testimony. | 30(b)(6) deposition testimony; agreement with Dr. Bonutti‘s Expert Witness Report and article relating to omission of surface roughness and | |
| Alexey Ryskin, MD Seattle Pain Relief 10564 5th Avenue NE #304 Seattle, WA 98125 | Possible witness only. | Plaintiff‘s pain, pain medication dependence and addiction, pain relief and pain medication reduction treatment. | |
| Navdeep Kaur, MD VIVAA 1301 4th Ave NW #302, Issaquah, WA 98027 | Possible witness only. | Plaintiff‘s pain, pain medication dependence and addiction, pain relief and pain medication reduction treatment. | |
| Zachary Kile, PA-C or other representative Anesis Spine & Pain Care 801 SE 16th Street, Ste 121 Renton, WA 98057 | Possible witness only. | Plaintiff‘s pain, pain medication dependence and addiction, pain relief and pain medication reduction treatment. | |
| William P. Barrett, MD Proliance Orthopedic Surgeons 4011 Talbot Road S., #300 Renton, WA 98055 | Possible witness only. | Plaintiff‘s left knee examinations, surgeries and records; and disposal of Plaintiff‘s left knee implant; selected portions of deposition testimony; and Valley Medical Center‘s purchase from Defendants of Attune Knee System implanted in Plaintiff‘s left knee | |
| Jana Flener, PA c/o Counsel for Defendants | Possible witness only. | Plaintiff‘s left knee examinations, surgeries and records; including, but not limited to, Plaintiff‘s 1-29- | |
| Christian Campbell 4037 SE 11th St., Renton, WA 98058 (Paralegal to Plaintiff‘s Counsel) | Will testify. | MAUDE reports research findings on loosening /debonding of subject tibial base, source and obtaining of Openpayments.cms.gov Listing of Payments to Dr. William P. Barrett, MD, 2015-2022 and FDA 510(k) K101433 and K170806 Applications and Summaries | |
| Representative of Valley Medical Center 400 S 43rd St Renton, WA 98055 | Possible witness only. | Valley Medical Center‘s purchase from Defendants of Attune Knee System implanted in Plaintiff‘s left knee |
(b) On behalf of Defendants:
| Witness | Status | Nature of Expected Testimony | √ if by Deposition |
|---|---|---|---|
| William P. Barrett, MD Proliance Orthopedic Surgeons 4011 Talbot Road S., #300 Renton, WA 98055 | Will testify | Plaintiff‘s total knee arthroplasties and revision surgery. Plaintiff‘s comorbidities and risks for surgery. The ATTUNE® device. | |
| Jana Flener, P.A. c/o Defendants | Possible witness only | Plaintiff‘s total knee arthroplasties and revision surgery. Plaintiff‘s comorbidities and risks for surgery. | |
| Liam Rowley, M.S. c/o Defendants | Will Testify | 30(b)(6) testimony. | |
| Daniel Hoeffel, M.D. c/o Defendants | Will Testify | 30(b)(6) testimony. |
(a) Plaintiff‘s Exhibits
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 1 | Plaintiff‘s Proliance Surgeon‘s Medical Records | Stipulated | Stipulated | ||
| 2 | Plaintiff‘s Proliance Surgeon‘s Billing Records | Stipulated | Disputed | FRE 402; FRE 403; FRE 802 | |
| 3 | Plaintiff‘s Valley Medical Center Medical Records | Stipulated | Stipulated | ||
| 4 | Plaintiff‘s Valley Medical Center Billing Records | Stipulated | Disputed | FRE 402; FRE 403; FRE 802 | |
| 5 | Plaintiff‘s VIVAA Medical Records | Stipulated | Stipulated | ||
| 6 | Plaintiff‘s Anesis Spine & Pain Care Medical Records | Stipulated | Stipulated | ||
| 7 | Plaintiff‘s Anesis Spine & Pain Care Billing Records | Stipulated | Disputed | FRE 402; FRE 403; FRE 802 | |
| 8 | Plaintiff‘s Seattle Pain Relief Medical Records | Stipulated | Stipulated | ||
| 9 | Plaintiff‘s Seattle Pain Relief Billing Records | Stipulated | Disputed | FRE 402; FRE 403; FRE 802 | |
| 10 | Plaintiff‘s x-rays 10/9/2014 | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation/ excerpt); FRE 802 |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 11 | Selected Medical Records | Disputed | Disputed | Duplicative of Exhibits No. 1, 3, 13, 16, 21, 22, 23, 24; Attorney Work Product (compilation, highlighting, notes); FRE 802 | |
| 12 | FDA 510(k) K101433 Summary (2010) | Disputed | Disputed | FRE 802; No Certification of Authenticity; Foundation; FRE 402; FRE 403 | |
| 13 | Implants Inventory 8/13/2014 left knee implant | Disputed | Disputed | Duplicative of Exhibit No. 3; Attorney Work Product (compilation/ excerpt); FRE 802 | |
| 14 | DePuy Outcomes Tracking System Knee Device Log | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation/ excerpt); FRE 802 |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 15 | Valley Medical Center - Surgical Implant Record | Disputed | Disputed | Duplicative of Exhibit No. 3; Attorney Work Product (compilation/ excerpt); FRE 802 | |
| 16 | Operative Report, William P. Barrett, MD 8/13/2014 | Disputed | Disputed | Duplicative of Exhibits No. 1, 3; Attorney Work Product (compilation/ excerpt); FRE 802 | |
| 17 | Left Knee Pain Treatments after Implant | Disputed | Disputed | Duplicative of Exhibits No. 1, 5, 6; Attorney Work Product (compilation/ excerpt); FRE 802 | |
| 18 | Plaintiff‘s x-rays 1/29/2015 | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation/ excerpt); FRE 802 |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 19 | Plaintiff‘s x-rays 1/23/2019 | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation/ excerpt); FRE 802 | |
| 20 | 1/23/2019 Jana Flener PA-C X-ray Findings Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 | |
| 21 | 3/12/2019 David Gifford PA-C Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 | |
| 22 | Operative Note, William P. Barrett, MD 3/25/2019 (for 3/19/2019), including but not limited to Preoperative and Postoperative Diagnoses | Disputed | Disputed | Duplicative of Exhibits No. 1, 3; Attorney Work Product (compilation/ excerpt, highlighting); FRE 802 | |
| 23 | 3/21/2019 Discharge Summary | Disputed | Disputed | Duplicative of Exhibit Nos. 1, 3; Attorney Work Product (compilation); FRE 802 |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 24 | 3/21/2019 Final Diagnoses | Disputed | Disputed | Duplicative of Exhibit Nos. 1, 3; Attorney Work Product (compilation, highlighting, notes); FRE 802 | |
| 25 | Photograph Fig. 1 Bonutti et al J Knee Surg 2017 | Disputed | Disputed | MIL; FRE 702/Daubert; FRE 402; FRE 403; FRE 802; Attorney Work Product | |
| 26 | Photographs Figs. 2,3,4 Bonutti et al J Knee Surg 2017 | Disputed | Disputed | MIL; FRE 702/Daubert; FRE 402; FRE 403; FRE 802; Attorney Work Product | |
| 27 | Photographs Figs.1, 2,3,4 Bonutti J Knee Surg 2018 | Disputed | Disputed | MIL; FRE 702/Daubert; FRE 402; FRE 403; FRE 802; Attorney Work Product | |
| 28 | Fig. 1 Arthroplasty Today 17 (2022) | Disputed | Disputed | MIL; FRE 702/Daubert; FRE 402; FRE 403; FRE 802; Attorney Work Product |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 29 | Fig. 2 Arthroplasty Today 17 (2022) | Disputed | Disputed | MIL; FRE 702/Daubert; FRE 402; FRE 403; FRE 802; Attorney Work Product | |
| 30 | FDA 510(k) K170806 Summary (2017) | Disputed | Disputed | MIL; FRE 802; No Certification of Authenticity; Foundation; FRE 402; FRE 403 | |
| 31 | Dr. William P. Barrett Testimonial Video notes | Disputed | Disputed | MIL; FRE 802; Foundation; FRE 402; FRE 403 | |
| 32 | Openpayments.cms.gov Listing of Payments to Dr. William P. Barrett, MD, 2015-2022 | Disputed | Disputed | MIL; FRE 802; Foundation; FRE 402; FRE 403 | |
| 33 | Defendants’ Response to Interrogatory No. 3 | Stipulated | Disputed | Duplicative of Exhibit No. 48; Attorney Work Product (excerpt/compilation) | |
| 34 | Attune Package Insert | Stipulated | Stipulated | ||
| 35 | Deposition of William Barrett, M.D. Bosley v. DePuy Synthes Sales, Inc., et al. April 27, 2023 | Stipulated | Disputed | FRE 802 |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 36 | Peter M. Bonutti, MD, FACS Curriculum Vitae | Stipulated | Disputed | FRE 802; MIL | |
| 37 | 30(b)(6) Deposition of Liam Rowley Bosley v. DePuy Synthes Sales, Inc., et al. May 23, 2023 | Stipulated | Disputed | FRE 802 | |
| 38 | Deposition of 30(b)(6) Daniel P. Hoeffel, M.D., Bosley v. DePuy Synthes Sales, Inc., et al. June 6, 2023 | Stipulated | Disputed | FRE 802 | |
| 39 | William P. Barrett, MD picture from Defendants’ ATTUNE promotional video, Surgeon Design Team | Disputed | Disputed | FRE 802; Foundation; MIL; FRE 402; FRE 403 | |
| 40 | Jana Flener, PA-C, 9-18-2013 Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 | |
| 41 | Jana Flener, PA-C, 1-9-2014 Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 |
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 42 | Olivia Kenyon, PA-C, 7-24-2014 Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 | |
| 43 | Derrick Bosley BMI-Weight Chart, 8-17-2012 to 2-21-2019 | Disputed | Disputed | Attorney Work Product (compilation); FRE 802 | |
| 44 | William P. Barrett, MD, 10-30-2014, Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 | |
| 45 | William P. Barrett, MD, 1-29-2015, Note | Disputed | Disputed | Duplicative of Exhibit No. 1; Attorney Work Product (compilation); FRE 802 | |
| 46 | DePuy Defendants’ Responses to Plaintiff‘s Requests for Admission | Stipulated | Disputed | Foundation; FRE 402; FRE 403 | |
| 47 | William P. Barrett Testimonial Video | Disputed | Disputed | FRE 802; Foundation; MIL; FRE 402; FRE 403 | |
| 48 | Defendants’ Response to Plaintiff‘s First Interrogatories | Stipulated | Disputed | Foundation; FRE 402; FRE 403 |
| 49 | Derrick C. Bosley, Sr., Hospital Services Account Detail, 8-13-2014 to 8-15-2014 | Disputed | Disputed | Duplicative of Exhibit No. 4; Attorney Work Product (compilation); |
| 50 | NOTICE OF INTENT TO OFFER RECORDS AT TRIAL OR HEARING – Anesis Spine and Pain Care | Stipulated | Disputed | Substance of proposed exhibit is duplicative of Exhibits No. 6 and 7; |
| 51 | NOTICE OF INTENT TO OFFER RECORDS AT TRIAL OR HEARING – Proliance Surgeons | Stipulated | Disputed | Substance of proposed exhibit is duplicative of Exhibits No. 1 and 2; |
| 52 | NOTICE OF INTENT TO OFFER RECORDS AT TRIAL OR HEARING – Seattle Pain Relief | Stipulated | Disputed | Substance of proposed exhibit is duplicative of Exhibits No. 8 and 9; |
PRETRIAL ORDER - C21-1683-MLP - 21
| 53 | NOTICE OF INTENT TO OFFER RECORDS AT TRIAL OR HEARING – VIVAA PLLC | Stipulated | Disputed | Substance of proposed exhibit is duplicative of Exhibit No. 5; |
| 54 | NOTICE OF INTENT TO OFFER RECORDS AT TRIAL OR HEARING – Valley Medical Center | Stipulated | Disputed | Substance of proposed exhibit is duplicative of Exhibits No. 3 and 4; |
| 55 | Seract Payments Received | Disputed | Disputed | MIL; |
| 56 | Columbia Physical Therapy Ledger 2018 | Stipulated | Disputed | |
| 57 | Expert Witness Report of Peter Bonutti, MD | Stipulated | Disputed | MIL; |
| 58 | Expert Witness Report of Michael Arrigo | Stipulated | Disputed | MIL; |
PRETRIAL ORDER - C21-1683-MLP - 22
| Without waiving Plaintiff’s objections to Defendants’ proposed exhibits which Defendants did not list in their Amended Pretrial Statement in accordance with LCR 16(i) but have listed in this proposed Pretrial Order, Plaintiff lists, as Learned Treatises, Periodicals, or Pamphlets the following articles cited in the Expert Witness Report of Peter Bonutti, MD, on which Dr. Bonutti may rely or to which he may refer in his testimony at trial pursuant to | Disputed | Disputed | |
| https://onlinelibrary.wiley.com/doi/pdf/10.1111/ans.16046; | Disputed | Disputed | |
| https://read.qxmd.com/keyword/173027 | Disputed | Disputed |
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| https://www.drugwatch.com/knee-replacement/depuy-attune/ | Disputed | Disputed | |
| https://www.cureus.com/articles/66018-early-aseptic-failure-of-the-tibial-component-cement-interface-in-attune-total-knee-arthroplasty-a-report-of-three-cases | Disputed | Disputed | |
| https://online.boneandjoint.org.uk/doi/abs/10.1302/1358-992X.2020.9.067; | Disputed | Disputed | |
| https://www.arthroplastyjournal.org/article/S0883-5403(20)30827-5/pdf | Disputed | Disputed | |
| https://pdfs.semanticscholar.org/b088/f2909e1d352b8680e2ab28f2afe5fd2e461d.pdf?_ga=2.39694947.1934483757.1675538345-981525284.1675538345 | Disputed | Disputed | |
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508148/ | Disputed | Disputed | |
| https://www.arthroplastyjournal.org/article/S0883-5403(17)30737-4/fulltext | Disputed | Disputed |
PRETRIAL ORDER - C21-1683-MLP - 24
| https://pubmed.ncbi.nlm.nih.gov/36209439/ | Disputed | Disputed | |
| https://pubmed.ncbi.nlm.nih.gov/29896562/ | Disputed | Disputed | |
| https://www.mattioli1885journals.com/index.php/actabiomedica/article/download/8997/8361/40668 | Disputed | Disputed | |
| https://scholarlypublications.universiteitleiden.nl/access/item%3A3483966/download | Disputed | Disputed | |
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5994597/ | Disputed | Disputed | |
| https://www.arthroplastyjournal.org/article/S0883-5403(20)31163-3/fulltext | Disputed | Disputed | |
| Without waiving Plaintiff’s objections to Defendants’ proposed exhibits which Defendants did not list in their Amended Pretrial Statement in accordance with LCR 16(i) but have | Disputed | Disputed |
PRETRIAL ORDER - C21-1683-MLP - 25
| listed in this proposed Pretrial Order, Plaintiff lists, as Learned Treatises, Periodicals, or Pamphlets the following articles not cited in the Expert Witness Report of Peter Bonutti, MD, but on which Dr. Bonutti may rely or to which he may refer in his testimony pursuant to | |||
| https://pubmed.ncbi.nlm.nih.gov/28591930/ | Disputed | Disputed | |
| https://www.cureus.com/articles/66018-early-aseptic-failure-of-the-tibial-component-cement-interface-in-attune-total-knee-arthroplasty-a-report-of-three-cases#!/ | Disputed | Disputed | |
| https://www.jnjmedtech.com/en-US/product/attune-s-technology | Disputed | Disputed | |
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6446526/ | Disputed | Disputed |
PRETRIAL ORDER - C21-1683-MLP - 26
| https://patents.google.com/patent/US9498342B2/en?oq=9498342 | Disputed | Disputed | |
| https://www.mddionline.com/news/how-510k-submission-can-affect-your-patent | Disputed | Disputed | |
| https://pubmed.ncbi.nlm.nih.gov/22425300/ | Disputed | Disputed | |
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776517/ | Disputed | Disputed | |
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508148/ | Disputed | Disputed | |
| https://www.arthroplastyjournal.org/article/S0883-5403(21)00168-6/fulltext | Disputed | Disputed | |
| https://www.vumedi.com/video/is-cement-past-its-time-uncemented-total-knee-its-time-has-come-again-seriously/ | Disputed | Disputed | |
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9633442/ | Disputed | Disputed |
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| 403 | |||
| https://www.researchgate.net/figure/Attune-left-and-Attune-S-right-tibia-components-with-additional-cement-pockets_fig1_359868315 | Disputed | Disputed | |
| https://pubmed.ncbi.nlm.nih.gov/22425300/ | Disputed | Disputed | |
| https://www.mddionline.com/news/how-510k-submission-can-affect-your-patent | Disputed | Disputed | |
| https://patents.google.com/patent/US9498342B2/en?oq=9498342 | Disputed | Disputed |
(b) Defendants’ Exhibits
| Ex. # | Description | Authenticity | Admissibility | Objection | Admitted |
|---|---|---|---|---|---|
| 101 | Expert Report of Michael Ries, M.D., Sc.M. | Stipulated | Disputed | ||
| 102 | Curriculum Vitae of Michael Ries, M.D., Sc.M. | Stipulated | Disputed | Duplicative; Not Listed in Amended Pretrial Statement (hereinafter “NLAPS“) |
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| 103 | Expert Report of Chantal E. Holy, Ph.D., MSc. | Stipulated | Disputed | ||
| 104 | Curriculum Vitae of Chantal E. Holy, Ph.D., MSc. | Stipulated | Disputed | Duplicative; Not listed in NLAPS | |
| 105 | Plaintiff‘s Initial and Supplemental Responses to DePuy Defendants Requests for Production | Stipulated | Disputed | ||
| 106 | Plaintiff‘s Initial and Supplemental Responses to DePuy Defendants Interrogatories | Stipulated | Disputed | ||
| 107 | Anesis Spine & Pain Care Records (BosleyRecords001262-001388; BosleyProduction000036-000254; BosleyProduction001636-001777; BosleyNOIProduction000747-000888) | Stipulated | Stipulated | ||
| 108 | Columbia Physical Therapy Services Records (BosleyProduction001778-001855) | Stipulated | Stipulated | ||
| 109 | Dr. Azar Sadeghalvad Records (BosleyProduction002013-002021) | Stipulated | Stipulated | ||
| 110 | Kaiser Permanent Approval for Revision Surgery (BosleyProduction 000334-335) | Stipulated | Stipulated | NLAPS |
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| 111 | Paul Brown, M.D. Records (BosleyProduction001856-1890) | Stipulated | Stipulated | ||
| 112 | Proliance Surgeon‘s Records (BosleyRecords001139-001261; BosleyProduction 001891-002012; BosleyNOIProduction000130-000251) | Stipulated | Stipulated | ||
| 113 | Richard Ludwig, M.D. Medical Records (BosleyProduction004051; BosleyProduction004492-004496) | Stipulated | Stipulated | ||
| 114 | Seattle Hand Surgery Group Records (BosleyProduction002022-002040) | Stipulated | Stipulated | ||
| 115 | Seattle Pain Relief Records (BosleyProduction002041-002140) | Stipulated | Stipulated | ||
| 116 | Swedish Medical Center Records (BosleyRecords001385-001388) | Stipulated | Disputed | ||
| 117 | Valley Medical Center Records (BosleyProduction002141-003291; BosleyRecords000001-001138; BosleyRecords001587-002001) | Stipulated | Stipulated |
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| 118 | VIVAA Records (BosleyProduction003494-004050; BosleyNOIProduction000258-000746) | Stipulated | Stipulated | ||
| 119 | 2006 Misc. Pharmacy Records (BosleyProduction004231-004238) | Stipulated | Disputed | ||
| 120 | 2009 Misc. Pharmacy Records (BosleyProduction004208-004210) | Stipulated | Disputed | ||
| 121 | 2013 Misc. Pharmacy Records (BosleyProduction004162-004163; BosleyProduction004166-004195) | Stipulated | Disputed | ||
| 122 | Appris Health Pharmacy Records (BosleyProduction004159-004161) | Stipulated | Disputed | ||
| 123 | EnterpriseRx Pharmacy Records (BosleyProduction000338-000339) | Stipulated | Disputed | ||
| 124 | Fred Meyer EasyFill Pharmacy Records (BosleyProduction000336-000337; BosleyProduction000340-000362; BosleyProduction004142-004158) | Stipulated | Disputed | ||
| 125 | Plaintiff‘s Prescription Records (BosleyProduction004055-4253) | Stipulated | Disputed |
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| 126 | Rite Aid Pharmacy Records (BosleyProduction 004078-004094; BosleyProduction 004104-004126; BosleyProduction004201-004207) | Stipulated | Disputed | ||
| 127 | Walgreens Pharmacy Records (BosleyProduction000255; BosleyProduction000257-000275; BosleyProduction 004055-4077; BosleyProduction004196-004200) | Stipulated | Disputed | ||
| 128 | Bosley v. C.I. Earll Co., Case Records (BosleyvEarll000001-000049) | Stipulated | Disputed | ||
| 129 | Chapter 13 Bankruptcy Records (BosleyChapter13Production000001-000291) | Stipulated | Disputed | ||
| 130 | Purdue Pharma LP, Personal Injury Claimant Proof of Claim Form for Derrick Bosley (BosleyProduction000001-000016) | Stipulated | Disputed | ||
| 131 | Sandra Bosley Purdue Pharma Claim (SandraBosleyPurduePharmaClaim000001-000020) | Stipulated | Disputed | ||
| 132 | “Timeline of My Surgeries” (BosleyProduction000256) | Stipulated | Disputed | NLAPS |
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| 133 | Plaintiff‘s Tax Returns 2009-2021(BosleyProduction004292-4356) | Stipulated | Stipulated | ||
| 134 | Correspondence between Plaintiff‘s Counsel and Experts (BosleyProduction 004357-004491) | Stipulated | Disputed | NLAPS; Attorney Work Product; | |
| 135 | All records and documents produced by Plaintiff in response to DePuy Defendants’ Requests for Production (BosleyProduction000001-004496; BosleyNOIProduction000001-000888; BosleyChapter13Production000001-000291; SandraBosleyPurduePharmaClaim000001-20; Bosley v Oaks000001-000006; Bosley v Earll000001-000049; Bosley3rdSuppProduction000001-000021; Chapter13Dockets000001-000009; SnohomishClerkPapers000001-19) | Stipulated | Disputed | Duplicative; | |
| 136 | DePuy Complaint File (DBOSLEY_000000001-DBOSLEY_00006587) | Disputed | Disputed | NLAPS; |
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| 137 | DePuy DHRs (DBOSLEY_00006588-DBOSLEY_00006719) | Disputed | Disputed | NLAPS; | |
| 138 | Defendants’ April 21, 2023 Production (DEPATT_000000001-DEPATT_00760251) | Stipulated | Disputed | NLAPS | |
| 139 | ATTUNE® Package Insert | Stipulated | Stipulated | ||
| 140 | ATTUNE® Surgical Technique Brochure | Stipulated | Disputed | NLAPS | |
| 141 | ATTUNE® Instructions for Use (DEPATT_0140104-DEPATT_00140199) | Stipulated | Disputed | NLAPS | |
| 142 | American Joint Replacement Registry: 2022 Annual Report | Disputed | Disputed | NLAPS | |
| 143 | Australian Orthopaedic Association National Joint Replacement Registry: Hip, Knee & Shoulder Arthroplasty: 2022 Annual Report | Disputed | Disputed | NLAPS | |
| 144 | The New Zealand Joint Registry - Twenty-Three Year Report - January 1999 to December 2021 | Disputed | Disputed | NLAPS | |
| 145 | National Joint Registry 19th Annual Report. 2022 | Disputed | Disputed | NLAPS |
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| 146 | Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-Term Results of Total Knee Arthroplasty with Contemporary Distal Femoral Replacement. The Journal of bone and joint surgery American volume. 2019. | Stipulated | Disputed | ||
| 147 | Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, et al. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013;28(8 Suppl):116-9. | Stipulated | Disputed | ||
| 148 | DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-88. | Stipulated | Disputed | ||
| 149 | Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in medicine. 2002;21(11):1539-58. | Stipulated | Disputed |
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| 150 | Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557-60. | Stipulated | Disputed | ||
| 151 | IntHout J, Ioannidis JPA, Borm GF. The Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis is straightforward and considerably outperforms the standard DerSimonian-Laird method. Bmc Med Res Methodol. 2014;14. | Stipulated | Disputed | ||
| 152 | Vasarhelyi EM, Petis SM. Use of National Joint Registries to Evaluate a New Knee Arthroplasty Design. J Arthroplasty. 2020;35(2):413-6. | Stipulated | Disputed |
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| 153 | Lewis PL, Graves SE, de Steiger RN, Campbell DG, Peng Y, Hatton A, et al. Does Knee Prosthesis Survivorship Improve When Implant Designs Change? Findings from the Australian Orthopaedic Association National Joint Replacement Registry. Clin Orthop Relat Res. 2020;478(6):1156-72. | Stipulated | Disputed | ||
| 154 | Abdel MP, Ledford CK, Kobic A, Taunton MJ, Hanssen AD. Contemporary failure aetiologies of the primary, posterior-stabilised total knee arthroplasty. Bone Joint J. 2017;99-B(5):647-52. | Stipulated | Disputed | ||
| 155 | Sharkey PF, Lichstein PM, Shen C, Tokarski AT, Parvizi J. Why are total knee arthroplasties failing today--has anything changed after 10 years? J Arthroplasty. 2014;29(9):1774-8. | Stipulated | Disputed |
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| 156 | Cherian JJ, Jauregui JJ, Banerjee S, Pierce T, Mont MA. What Host Factors Affect Aseptic Loosening After THA and TKA? Clinical orthopaedics and related research. 2015;473(8):2700-9. | Stipulated | Disputed | ||
| 157 | Ryu KJ. CORR Insights(R): What Host Factors Affect Aseptic Loosening After THA and TKA? Clinical orthopaedics and related research. 2015;473(8):2710-1. | Stipulated | Disputed | ||
| 158 | Inacio MC, Cafri G, Paxton EW, Kurtz SM, Namba RS. Alternative bearings in total knee arthroplasty: risk of early revision compared to traditional bearings: an analysis of 62,177 primary cases. Acta orthopaedica. 2013;84(2):145-52. | Stipulated | Disputed | ||
| 159 | Namba RS, Cafri G, Khatod M, Inacio MC, Brox TW, Paxton EW. Risk factors for total knee arthroplasty aseptic revision. The Journal of arthroplasty. 2013;28(8 Suppl):122-7. | Stipulated | Disputed |
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| 160 | van Otten TJM, van Loon CJM. Early aseptic loosening of the tibial component at the cement-implant interface in total knee arthroplasty: a narrative overview of potentially associated factors. Acta Orthop Belg. 2022;88(1):103-11. | Stipulated | Disputed | ||
| 161 | Torino D, Damsgaard C, Kolessar DJ, Hayes DS, Foster B, Constantino J, et al. Tibial Baseplate-Cement Interface Debonding in the ATTUNE Total Knee Arthroplasty System. Arthroplast Today. 2022;17:165-71. | Stipulated | Disputed | ||
| 162 | Coles T, Williams V, Dwyer K, Mordin M. Psychometric Evaluation of the Patient‘s Knee Implant Performance Questionnaire. Value Health. 2018;21(11):1305-12. | Stipulated | Disputed |
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| 163 | Coles TM, Dwyer KA, Mordin M, Williams V, Clatworthy M, Yates P, et al. Psychometric Evaluation Of The Patient‘s Knee Implant Performance (PKIP) Questionnaire For The Assessment Of Primary Total Knee Arthroplasty. Value Health. 2014;17(7):A568. | Stipulated | Disputed | ||
| 164 | Lewis S, Price M, Dwyer KA, O‘Brien S, Heekin RD, Yates PJ, et al. Development of a scale to assess performance following primary total knee arthroplasty. Value Health. 2014;17(4):350-9. | Stipulated | Disputed | ||
| 165 | Willburger RE, Oberberg S. Early and mid-term results with the ATTUNE total knee replacement system compared to PFC Sigma: a prospective comparative study. J Orthop Surg Res. 2022;17(1):509. | Stipulated | Disputed |
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| 166 | Vanitcharoenkul E, Unnanuntana A. Midterm functional recovery of Total knee arthroplasty patients compared between the ATTUNE knee system and the press fit condylar (PFC) SIGMA knee system. BMC Musculoskelet Disord. 2021;22(1):620. | Stipulated | Disputed | |
| 167 | Ranawat CS, White PB, West S, Ranawat AS. Clinical and Radiographic Results of Attune and PFC Sigma Knee Designs at 2-Year Follow-Up: A Prospective Matched-Pair Analysis. J Arthroplasty. 2017;32(2):431-6. | Stipulated | Disputed | |
| 168 | Martin JR, Jennings JM, Watters TS, Levy DL, McNabb DC, Dennis DA. Femoral Implant Design Modification Decreases the Incidence of Patellar Crepitus in Total Knee Arthroplasty. J Arthroplasty. 2017;32(4):1310-3. | Stipulated | Disputed |
| 169 | Bonutti PM, Khlopas A, Chughtai M, Cole C, Gwam CU, Harwin SF, et al. Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant-Cement Interface. J Knee Surg. 2017;30(5):435-9. | Stipulated | Disputed | |
| 170 | Sandberg JM, Gray I, Pearlman A, Terlecki RP. An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration‘s Reclassification of transvaginal mesh. Investig Clin Urol. 2018;59(2):126-32. | Stipulated | Disputed | |
| 171 | Giaretta S, Berti M, Micheloni GM, Ceccato A, Marangoni F, Momoli A. Early experience with the ATTUNE Total Knee Replacement System. Acta Biomed. 2019;90(12-s):98-103. | Stipulated | Disputed |
| 172 | Kaptein BL, den Hollander P, Thomassen B, Fiocco M, Nelissen R. A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design. Bone Joint J. 2020;102-b(9):1158-66. | Stipulated | Disputed | |
| 173 | Murphy JD, Braunlich PR, Judson Iv WR, Harker JN, Baumann PA. Early Aseptic Failure of the Tibial Component-Cement Interface in ATTUNE® Total Knee Arthroplasty: A Report of Three Cases. Cureus. 2021;13(12):e20582. | Stipulated | Disputed |
| 174 | Total knee arthroplasty in the outpatient vs inpatient settings: impact of site of care on early postoperative economic and clinical outcomes. Mantel J, Ruppenkamp JW, Cantu M, Holy CE. J Orthop Surg Res. 2023 Apr 4;18(1):273. doi: 10.1186/s13018-023-03750-4. | Stipulated | Disputed | |
| 175 | Outcomes of surgical versus nonsurgical treatment for multiple rib fractures: A US hospital matched cohort database analysis. Shiroff AM, Wolf S, Wu A, Vanderkarr M, Anandan M, Ruppenkamp JW, Galvain T, Holy CE. J Trauma Acute Care Surg. 2023 Apr 1;94(4):538-545. doi: 10.1097/TA.0000000000003828. Epub 2022 Nov 15. | Stipulated | Disputed |
| 176 | Longitudinal Rates, Patient Risk Factors, and Economic Impact of Superficial and Deep Incisional Surgical Site Infection After Primary and Revision Total Hip Arthroplasty: A U.S. Retrospective Commercial Claims Database Analysis. Edmiston CE Jr, Spencer M, Gunja NJ, Holy CE, Ruppenkamp JW, Leaper DJ. Surg Infect (Larchmt). 2023 Mar 20. doi: 10.1089/sur.2022.376. Online ahead of print. | Stipulated | Disputed | |
| 177 | Real-world 2-year clinical and economic outcomes among patients receiving a medial collared, triple tapered primary hip system versus other implants for total hip arthroplasty. Diaz R, Mantel J, Ruppenkamp J, Cantu M, Holy CE. Curr Med Res Opin. 2023 Mar 3:1-9. doi: 10.1080/03007995.2023.2181150. | Stipulated | Disputed |
| 178 | Resource utilization and costs for robotic-assisted and manual total knee arthroplasty - a premier healthcare database study. Alton TB, Chitnis AS, Goldstein L, Rajappan SK, Gupta A, Michnacs K, Holy CE, Hoeffel DP. Expert Rev Med Devices. 2023 Mar 2:1-9. doi: 10.1080/17434440.2023.2185135. | Stipulated | Disputed | |
| 179 | Longitudinal rates, risk factors, and costs of superficial and deep incisional surgical-site infection (SSI) after primary and revision total knee arthroplasty: A US retrospective claims database analysis. Edmiston CE Jr, Spencer M, Gunja NJ, Holy CE, Ruppenkamp JW, Leaper DJ. Infect Control Hosp Epidemiol. 2023 Feb 2:1-9. doi: 10.1017/ice.2023.10. | Stipulated | Disputed |
| 180 | Risk and economic burden of surgical site infection following spinal fusion in adults. Edmiston CE Jr, Leaper DJ, Chitnis AS, Holy CE, Chen BP. Infect Control Hosp Epidemiol. 2023 Jan;44(1):88-95. doi: 10.1017/ice.2022.32. Epub 2022 Mar 24. | Stipulated | Disputed | |
| 181 | Incidence, costs and post-operative complications following ankle fracture - A US claims database analysis. Vanderkarr MF, Ruppenkamp JW, Vanderkarr M, Parikh A, Holy CE, Putnam M. Page 2 of 7 BMC Musculoskelet Disord. 2022 Dec 26;23(1):1129. doi: 10.1186/s12891-022-06095-x. | Stipulated | Disputed |
| 182 | Cost-Effectiveness of Cement Augmentation Versus No Augmentation for the Fixation of Unstable Trochanteric Fractures. Joeris A, Kabiri M, Galvain T, Vanderkarr M, Holy CE, Plaza JQ, Tien S, Schneller J, Kammerlander C. J Bone Joint Surg Am. 2022 Nov 16;104(22):2026-2034. doi: 10.2106/JBJS.21.01516. Epub 2022 Oct 4. | Stipulated | Disputed | |
| 183 | Risk of Mortality for Proximal Femoral Fracture in Patients With and Without COVID-19. A Retrospective Cohort Study. Holub A, Jornet-Gibert M, Ruppenkamp J, Holy CE, Daccach J, Torner P, Caba-Doussoux P, Muñoz Vives JM. Geriatr Orthop Surg Rehabil. 2022 Nov 10;13:21514593221138656. doi: 10.1177/21514593221138656. eCollection 2022. | Stipulated | Disputed |
| 184 | Risk of retinal detachment and exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US. Londhe AA, Holy CE, Weaver J, Fonseca S, Villasis-Keever A, Fife D. PLoS One. 2022 Oct 6;17(10):e0275796. doi: 10.1371/journal.pone.0275796. eCollection 2022. | Stipulated | Disputed | |
| 185 | Demographic and clinical profile of patients treated with proximal femoral nails - a 10-year analysis of more than 40,000 Cases. Finkemeier CG, Holy CE, Ruppenkamp JW, Vanderkarr M, Sparks C. BMC Musculoskelet Disord. 2022 Sep 1;23(1):828. doi: 10.1186/s12891-022-05772-1. | Stipulated | Disputed |
| 186 | Assessment of risk and economic burden of surgical site infection (SSI) posthysterectomy using a U.S. longitudinal database. Edmiston CE Jr, Bond-Smith G, Spencer M, Chitnis AS, Holy CE, Po-Han Chen B, Leaper DJ. Surgery. 2022 May;171(5):1320-1330. doi: 10.1016/j.surg.2021.11.034. Epub 2021 Dec 29. | Stipulated | Disputed | |
| 187 | Hospitalization for computer-assisted hexapod ring fixation application - analyses of patient variability, peri-operative complications, hospital costs, and discharge status. Reid JS, Vanderkarr M, Ray B, Chitnis A, Holy CE, Sparks C. BMC Musculoskelet Disord. 2022 Mar 5;23(1):211. doi: 10.1186/s12891-022-05171-6. | Stipulated | Disputed |
| 188 | Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis. Holy CE, Zhang S, Perkins LE, Hasgall P, Katz LB, Brown JR, Orlandini L, Fessel G, Nasseri-Aghbosh B, Eichenbaum G, Egnot NS, Marcello S, Coplan PM. Regul Toxicol Pharmacol. 2022 Mar;129:105096. doi: 10.1016/j.yrtph.2021.105096. Epub 2021 Dec 10. | Stipulated | Disputed | |
| 189 | Surgical treatment, complications, reoperations, and healthcare costs among patients with clavicle fracture in England. Wolf S, Chitnis AS, Manoranjith A, Vanderkarr M, Plaza JQ, Gador LV, Holy CE, Sparks C, Lambert SM. Page 3 of 7 BMC Musculoskelet Disord. 2022 Feb 9;23(1):135. doi: 10.1186/s12891-022-05075-5. | Stipulated | Disputed |
| 190 | Two-year clinical and economic burden, risk and outcomes following application of software-assisted hexapod ring fixation systems. Reid JS, Vanderkarr M, Ray B, Chitnis A, Holy CE, Sparks C. BMC Musculoskelet Disord. 2022 Jan 3;23(1):25. doi: 10.1186/s12891-021-04934-x. | Stipulated | Disputed | |
| 191 | Comparison of clinical effectiveness of fenestrated and conventional pedicle screws in patients undergoing spinal surgery: a systematic review and meta-analysis. Yagi M, Ogiri M, Holy CE, Bourcet A. Expert Rev Med Devices. 2021 Oct;18(10):995-1022. doi: 10.1080/17434440.2021.1977123. Epub 2021 Sep 23. | Stipulated | Disputed |
| 192 | Carcinogenic assessment of cobalt-containing alloys in medical devices or cobalt in occupational settings: A systematic review and meta-analysis of overall cancer risk from published epidemiologic studies. Zhang S, Holy CE, Eichenbaum G, Perkins LE, Hasgall P, Katz LB, Brown JR, Orlandini L, Fessel G, Nasseri-Aghbosh B, Egnot NS, Zhou M, Beech R, Marcello SR, Coplan PM. Regul Toxicol Pharmacol. 2021 Oct;125:104987. doi: 10.1016/j.yrtph.2021.104987. Epub 2021 Jul 3. | Stipulated | Disputed |
| 193 | Treatments, cost and healthcare utilization of patients with segmental bone defects. Norris BL, Vanderkarr M, Sparks C, Chitnis AS, Ray B, Holy CE. Injury. 2021 Oct;52(10):2935-2940. doi: 10.1016/j.injury.2021.01.016. Epub 2021 Jan 14. | Stipulated | Disputed | |
| 194 | Risk of aortic aneurysm and dissection following exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US. Londhe AA, Holy CE, Weaver J, Fonseca S, Villasis A, Fife D. PLoS One. 2021 Aug 16;16(8):e0255887. doi: 10.1371/journal.pone.0255887. eCollection 2021. | Stipulated | Disputed |
| 195 | The Authors Reply. Leaper DJ, Holy CE, Edmiston CE Jr. Dis Colon Rectum. 2021 Jul 1;64(7):e399. doi: 10.1097/DCR.0000000000002093. | Stipulated | Disputed | |
| 196 | Evaluation of Cost, Payments, Healthcare Utilization, and Perioperative and Post-Operative Outcomes of Patients Treated with Posterior Lumbar Spinal Surgery Using Open versus Minimally Invasive Surgical Approaches. Holy CE, Corso KA, Bowden DE, Erb MJ, Ruppenkamp JR, Coombs S, Pracyk JB. Med Devices (Auckl). 2021 Jun 15;14:173-183. doi: 10.2147/MDER.S311774. eCollection 2021. | Stipulated | Disputed |
| 197 | Intramedullary Nail Breakage and Mechanical Displacement in Patients with Proximal Femoral Fractures: A Commercial and Medicare Supplemental Claims Database Analysis. Chitnis AS, Ray B, Sparks C, Grebenyuk Y, Vanderkarr M, Holy CE. Med Devices (Auckl). 2021 Feb 9;14:15-25. doi: 10.2147/MDER.S288188. eCollection 2021. | Stipulated | Disputed | |
| 198 | Healthcare resource utilization and costs for hip dislocation following primary total hip arthroplasty in the medicare population. Mantel J, Chitnis AS, Ruppenkamp J, Holy CE, Daccach J. J Med Econ. 2021 Jan-Dec;24(1):10-18. doi: 10.1080/13696998.2020.1854989. | Stipulated | Disputed |
| 199 | Assessment of the Risk and Economic Burden of Surgical Site Infection Following Colorectal Surgery Using a US Longitudinal Database: Is There a Role for Innovative Antimicrobial Wound Closure Technology to Reduce the Risk of Infection? Leaper DJ, Holy CE, Spencer M, Chitnis A, Hogan A, Wright GWJ, Po-Han Chen B, Edmiston CE Jr. Dis Colon Rectum. 2020 Dec;63(12):1628-1638. doi: 10.1097/DCR.0000000000001799. | Stipulated | Disputed |
| 200 | Survival analysis for all-cause revision following primary total hip arthroplasty with a medial collared, triple tapered primary hip stem versus other implants in real-world settings. Chitnis AS, Mantel J, Ruppenkamp J, Bourcet A, Holy CE. Curr Med Res Opin. 2020 Nov;36(11):1839-1845. doi: 10.1080/03007995.2020.1822309. Epub 2020 Sep 22. | Stipulated | Disputed | |
| 201 | The economic burden of infections following intramedullary nailing for a tibial shaft fracture in England. Galvain T, Chitnis A, Paparouni K, Tong C, Holy CE, Giannoudis PV. BMJ Open. 2020 Aug 26;10(8):e035404. doi: 10.1136/bmjopen-2019-035404. | Stipulated | Disputed |
| 202 | High-concentration nonavian high-molecular-weight hyaluronan injections and time-to-total knee replacement surgery. Etter K, Chitnis AS, Holy CE, Gray FS, Manalac FJ, Bisson B, Bhattacharyya SK. J Comp Eff Res. 2020 Aug;9(11):795-805. doi: 10.2217/cer-2019-0128. Epub 2020 Jul 9. | Stipulated | Disputed | |
| 203 | Long bone fractures: treatment patterns and factors contributing to use of intramedullary nailing. Chitnis A, Ray B, Sparks C, Grebenyuk Y, Vanderkarr M, Holy CE. Expert Rev Med Devices. 2020 Jul;17(7):731-738. doi: 10.1080/17434440.2020.1779055. | Stipulated | Disputed |
| 204 | Defining readmissions among patients undergoing open reduction and internal fixation (ORIF) in claims database analyses. Chitnis AS, Nandwani P, Ruppenkamp J, Vanderkarr M, Holy CE. Curr Med Res Opin. 2020 Jan;36(1):83-89. doi: 10.1080/03007995.2019.1667315. Epub 2019 Oct 7. | Stipulated | Disputed | |
| 205 | Complications and its impact in patients with closed and open tibial shaft fractures requiring open reduction and internal fixation. Chitnis AS, Vanderkarr M, Sparks C, McGlohorn J, Holy CE. J Comp Eff Res. 2019 Dec;8(16):1405-1416. doi: 10.2217/cer-2019-0108. Epub 2019 Nov 22. | Stipulated | Disputed |
| 206 |
Impact of patient comorbidities on surgical site infection within 90 days of primary and revision joint (hip and knee) replacement. Edmiston CE Jr, Chitnis AS, Lerner J, Folly E, Holy CE, Leaper D. Am J Infect Control. 2019 Oct;47(10):1225-1232. doi: 10.1016/j.ajic.2019.03.030. Epub 2019 May 7. | Stipulated | Disputed | |
| 207 |
Surgical treatment, complications, and reimbursement among patients with clavicle fracture and acromioclavicular dislocations: a US retrospective claims database analysis. Putnam M, Vanderkarr M, Nandwani P, Holy CE, Chitnis AS. J Med Econ. 2019 Sep;22(9):901-908. doi: 10.1080/13696998.2019.1620245. Epub 2019 Jun 6. | Stipulated | Disputed |
| 208 |
Real-world impact of the high concentration non-avian high molecular weight hyaluronan on pain medication use among osteoarthritis patients. Chitnis AS, Etter K, Holy CE, Gray FS, Manalac FJ, Bisson B, Bhattacharyya SK. Curr Med Res Opin. 2019 Sep;35(9):1523-1527. doi: 10.1080/03007995.2019.1596670. Epub 2019 Apr 1. | Stipulated | Disputed | |
| 209 |
Complications in type III open tibial shaft fractures treated with open reduction and internal fixation. Chitnis AS, Vanderkarr M, Sparks C, McGlohorn J, Holy CE. J Comp Eff Res. 2019 Aug;8(11):907-915. doi: 10.2217/cer-2019-0040. Epub 2019 Jun 7. | Stipulated | Disputed |
| 210 |
Reoperations in intramedullary fixation of pertrochanteric hip fractures. Chitnis AS, Vanderkarr M, Ruppenkamp J, Lerner J, Holy CE, Sparks C. J Med Econ. 2019 Jul;22(7):706-712. doi: 10.1080/13696998.2019.1600526. Epub 2019 Apr 11. | Stipulated | Disputed | |
| 211 |
Medical resource utilization and costs for intraoperative and early postoperative periprosthetic hip fractures following total hip arthroplasty in the medicare population: A retrospective cohort study. Chitnis AS, Mantel J, Vanderkarr M, Putnam M, Ruppenkamp J, Holy CE, Bridgens J. Medicine (Baltimore). 2019 Jun;98(25):e15986. doi: 10.1097/MD.0000000000015986. | Stipulated | Disputed |
| 212 |
Cost and effectiveness of prescribing emollient therapy for atopic eczema in UK primary care in children and adults: a large retrospective analysis of the Clinical Practice Research Datalink. Moncrieff G, Lied A, Nelson G, Holy CE, Weinstein R, Wei D, Rowe S. BMC Dermatol. 2018 Oct 29;18(1):9. doi: 10.1186/s12895-018-0076-y. | Stipulated | Disputed | |
| 213 |
Medical resource utilization and costs for total hip arthroplasty: benchmarking an anterior approach technique in the Medicare population. Kamath AF, Chitnis AS, Holy C, Lerner J, Curtin B, Lochow S, DeCook C, Matta JM. J Med Econ. 2018 Feb;21(2):218-224. doi: 10.1080/13696998.2017.1393428. Epub 2017 Nov 3. | Stipulated | Disputed |
| 214 |
Prevalence and Occupation of Patients Presenting With Dysphonia in the United States. Benninger MS, Holy CE, Bryson PC, Milstein CF. J Voice. 2017 Sep;31(5):594-600. doi: 10.1016/j.jvoice.2017.01.011. Epub 2017 Apr 13. | Stipulated | Disputed | |
| 215 |
Prevalence of atopic disease in patients with eosinophilic esophagitis. Benninger MS, Strohl M, Holy CE, Hanick AL, Bryson PC. Int Forum Allergy Rhinol. 2017 Aug;7(8):757-762. doi: 10.1002/alr.21968. Epub 2017 Jun 14. | Stipulated | Disputed | |
| 216 |
Acute Rhinosinusitis: Prescription Patterns in a Real-World Setting. Benninger MS, Holy CE, Trask DK. Otolaryngol Head Neck Surg. 2016 May;154(5):957-62. doi: 10.1177/0194599816630310. Epub 2016 Mar 1. | Stipulated | Disputed |
| 217 |
Variation in Delivery of Sinus Surgery in the Medicaid Population across Ethnicities. Woodard T, Sindwani R, Halderman AA, Holy CE, Gurrola J 2nd. Otolaryngol Head Neck Surg. 2016 May;154(5):944-50. doi: 10.1177/0194599816628460. Epub 2016 Feb 23. | Stipulated | Disputed | |
| 218 |
Impact of medically recalcitrant chronic rhinosinusitis on incidence of asthma. Benninger MS, Sindwani R, Holy CE, Hopkins C. Int Forum Allergy Rhinol. 2016 Feb;6(2):124-9. doi: 10.1002/alr.21652. Epub 2015 Dec 1. | Stipulated | Disputed | |
| 219 |
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| 220 |
Early versus delayed endoscopic sinus surgery in patients with chronic rhinosinusitis: impact on health care utilization. Benninger MS, Sindwani R, Holy CE, Hopkins C. Otolaryngol Head Neck Surg. 2015 Mar;152(3):546-52. doi: 10.1177/0194599814565606. Epub 2015 Jan 8. | Stipulated | Disputed | |
| 221 |
In-office balloon catheter dilation: analysis of 628 patients from an administrative claims database. Sillers MJ, Lay KF, Holy CE. Laryngoscope. 2015 Jan;125(1):42-8. doi: 10.1002/lary.24885. Epub 2014 Sep 17. | Stipulated | Disputed | |
| 222 |
The impact of endoscopic sinus surgery on health care use in patients with respiratory comorbidities. Benninger MS, Holy CE. Otolaryngol Head Neck Surg. 2014 Sep;151(3):508-15. doi: 10.1177/0194599814536369. Epub 2014 Jun 3. | Stipulated | Disputed |
| 223 |
Endoscopic sinus surgery provides effective relief as observed by health care use pre- and postoperatively. Benninger MS, Holy CE. Otolaryngol Head Neck Surg. 2014 May;150(5):893-900. doi: 10.1177/0194599814522419. Epub 2014 Feb 10. | Stipulated | Disputed | |
| 224 |
The impact of balloon catheter dilation on frequency of sinus surgery in the United States. Holy CE, Ellison JM, Schneider C, Levine HL. Med Devices (Auckl). 2014 Apr 28;7:83-9. doi: 10.2147/MDER.S60054. eCollection 2014. | Stipulated | Disputed | |
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Efficacy of mesenchymal stem cell enriched grafts in an ovine posterolateral lumbar spine model. Gupta MC, Theerajunyaporn T, Maitra S, Schmidt MB, Holy CE, Kadiyala S, Bruder SP. Spine (Phila Pa 1976). 2007 Apr 1;32(7):720-6; discussion 727. doi: 10.1097/01.brs.0000258863.40984.32. | Stipulated | Disputed | |
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In vivo bone engineering in a rabbit femur. Fialkov JA, Holy CE, Shoichet MS, Davies JE. J Craniofac Surg. 2003 May;14(3):324-32. doi: 10.1097/00001665-200305000-00010. | Stipulated | Disputed | |
| 229 |
All-Cause Revision and Aseptic Loosening Following Total Knee Replacement: Meta-Analysis of Registry Outcomes and Analysis of NJR Data dated April 21, 2020 | Stipulated | Disputed | |
| 230 |
Meta-Analysis of Attune Registries PowerPoint dated March 24, 2020 | Stipulated | Disputed | |
| 231 |
NJR Implant Bespoke Report for Attune (PS RP) dated March 11, 2020 | Stipulated | Disputed | |
| 232 |
NJR Implant Bespoke Report for Attune (PS FB) dated March 11, 2020 | Stipulated | Disputed | |
| 233 |
NJR Implant Bespoke Report for Attune (CR FB) dated March 11, 2020 | Stipulated | Disputed |
| 234 |
NJR Implant Bespoke Report for Attune (CR RP) dated March 11, 2020 | Stipulated | Disputed | |
| 235 |
AAOS Report re: Attune FB Devices dated February 13, 2020 | Stipulated | Disputed | |
| 236 |
ERPD Data Summary for Attune Tibia dated December 5, 2019 | Stipulated | Disputed | |
| 237 |
Data from New Zealand Joint Registry | Stipulated | Disputed | |
| 238 |
Data from Geneva Registry | Disputed | Disputed | |
| 239 |
Data from Dutch Registry | Disputed | Disputed | |
| 240 |
AOANJRR Report re: Attune dated June 13, 2019 | Stipulated | Disputed | |
| 241 |
MARCQI Report – Summary and Review of DePuy Synthes Products and Class Trends dated January 2019 | Stipulated | Disputed | |
| 242 |
DePuy Attune Clinical Evidence Website – https://www.jnjmedtech.com/en-US/product/attune-knee-system/attune-evidence | Stipulated | Disputed |
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Wong, J., Ries, M.D.: Total Knee Arthroplasty. In: Rehabilitation for the Postsurgical Orthopaedic Patient 3rd ed. (Magnusson J, ed), Elsevier, 2011. | Stipulated | Disputed |
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Hughes KF, Ries MD, Pruitt LA.: Structural Degradation of Acrylic bone Cements due to in Vivo and Simulated Aging. J Biomed Mate. Res, 1; 65A: 126-135, 2003. | Stipulated | Disputed | |
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Graham, J., Ries, M.D., and Pruitt, L.: Effect of Bone Porosity on Mechanical Integrity of the Bone Cement-Interface. J. Bone Joint Surg; 85A: 1901-1908, 2003. | Stipulated | Disputed |
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| 251 |
Robertsson O, Sundberg M, Sezgin EA, Lidgren L, W-Dahl A. Higher Risk of Loosening for a Four-Pegged TKA Tibial Baseplate Than for a Stemmed One: A Register-based Study. | Stipulated | Disputed | |
| 252 |
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Silva JD, Nunes B, Duarte F, Raposo F, Valente L, Antunes A, Olivera P, Sousa A. Effect of tibial alignment in early failure in total knee arthroplasties. Rev Chirurgie Orthop Traumat, 102, S80, 2016. | Stipulated | Disputed | |
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Cawley DT, Kelly N, McGarry JP, Shannon FJ. Cementing techniques for the tibial component in primary total knee replacement. Bone Joint J, VOL. 95-B, No. 3, MARCH 2013 | Stipulated | Disputed | |
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Vanlommel J, Luyckx JP, Labey L, Innocenti B, De Corte R, Bellemans J. Cementing the Tibial Component in Total Knee Arthroplasty Which Technique is the Best? J Arthroplasty, 26 No. 3 2011, 492-496. | Stipulated | Disputed | |
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Foran JRH, Whited BW, Sporer SM. Early Aseptic Loosening With a Precoated Low-Profile Tibial Component. J Arthroplasty, 26, 1445-1450, 2011. | Stipulated | Disputed | |
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Ries C, Heinichen M, Dietrich F, Jakubowitz E, Sobau C, Heisel C. Short-keeled Cemented Tibial Components Show an Increased Risk for Aseptic Loosening. Clin Orthop Relat Res (2013) 471:1008-1013 | Stipulated | Disputed |
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Hansen, E.N., Ries, M.D.: Principles of Revision Total Knee Arthroplasty. In: The Knee Reconstruction, Replacement, and Revision (Parvizi, J., ed), dtp data trace, Brooklandville, MO, 2012, pp 79-1; 79-18. | Stipulated | Disputed | |
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Sporer SM, Callaghan JJ, Olejniczak JP, et al. The effects of surface roughness and polymethylmethacrylate precoating on the radiographic and clinical results of the Iowa hip prosthesis. A study of patients less than fifty years old. J Bone Joint Surg, 81A, 481-492, 1999. | Stipulated | Disputed | |
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Crowninshield RD, Brand RA, Johnston RC, Milroy LC. The Effect of Femoral Stem Cross-Sectional Geometry on Cement Stresses in Total Hip Reconstruction. Clin Orthop Rel Res, 146; 71-77, 1980. | Stipulated | Disputed | |
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| 275 | Ries, M.D. (editor): Revision Total Knee Arthroplasty (video). AAOS Surgical Techniques in Orthopaedics. American Academy of Orthopaedic Surgeons, Rosemont, IL, 2004. | Stipulated | Disputed | |
| 276 | Ries, M.D.: Revision Total Knee Arthroplasty In: AAOS Comprehensive Orthopaedic Review (Lieberman, J.R., ed.), Rosemont, IL, 2009, pp 1057-1066. | Stipulated | Disputed | |
| 277 | Ranawat CS, White PB, West S, Ranawat AS. Clinical and Radiographic Results of Attune and PFC Sigma Knee Designs at 2-Year Follow-Up: A Prospective Matched-Pair Analysis. J Arthroplasty, 32:431-436, 2017. | Stipulated | Disputed |
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| 279 | Martin JR, Jennings JM, Watters TS, Levy DL, McNabb DC, Dennis DA. Femoral Implant Design Modification Decreases the Incidence of Patellar Crepitus in Total Knee Arthroplasty. J Arthroplasty, 32: 1310-1313, 2017. | Stipulated | Disputed | |
| 280 | Toomey SD, Daccach JA, Shah JC, Himden SE, Lesko JP, Hamilton WG. Comparative Incidence of Patellofemoral Complications Between 2 Total Knee Arthroplasty Systems in a Multicenter, Prospective Clinical Study. J Arthroplasty, 32: S187-S192, 2017. | Stipulated | Disputed |
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| 282 | Lewis PL, Graves SE, Dphil, de Steiger RN, Campbell DG, Peng Y, Hatton A, Lorimer M. Does Knee Prosthesis Survivorship Improve When Implant Designs Change? Findings from the Australian Orthopaedic Association National Joint Replacement Registry. Clin Orthop Relat Res, 478: 1156-1172, 2020. | Stipulated | Disputed | |
| 283 | Kelly BC, Owen JR, Shah JC, Johnson AJ, Golladay GJ, Kates SL. A Biomechanical Comparison of the Effect of Baseplate Design and Fat Marrow Infiltration on Tibial Baseplate Pullout Strength. J Arthroplasty, 36: 356 -361, 2021. | Stipulated | Disputed |
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| 296 | Begum FA, Kayani B, Magan AA, Chang JS, Haddad FS. Current concepts in total knee arthroplasty : mechanical, kinematic, anatomical, and functional alignment. Bone Jt Open, 2: 397-404, 2021. | Stipulated | Disputed |
| 297 | Kerkhoffs GM, Servien E, Dunn W, Dahm D, Bramer J, Haverkamp D. The Influence of Obesity on the Complication Rate and Outcome of Total Knee Arthroplasty. A Meta-Analysis and Systematic Literature Review. Journal Bone Joint Surg, 94:1839-1844, 2012. | Stipulated | Disputed | |
| 298 | Gao ZX, Long NJ, Zhang SY, Yu W, Dai YX, Xiao C. Comparison of Kinematic Alignment and Mechanical Alignment in Total Knee Arthroplasty: A Meta-analysis of Randomized Controlled Clinical Trials. Orthop Surg, 12:1567-1578. 2020. | Stipulated | Disputed | |
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| 300 | Refsum AM,a Nguyen UV, Gjertsen JE, Espehaug B, Fenstad A, Lein RK, Ellison P, Høl PJ, Furnesa O. Cementing technique for primary knee arthroplasty: a scoping review. Acta Orthop, 90: 582–589, 2019. | Stipulated | Disputed | |
| 301 | Wall CJ, Vertullo CJ, Kondalsamy-Chennakesavan S, Lorimer MF, de Steiger RN. A Prospective, Longitudinal Study of the Influence of Obesity on Total Knee Arthroplasty Revision Rate. Results from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg, 104: 1386, 2022. | Stipulated | Disputed | |
| 302 | DePuy Attune Clinical Evidence Website – https://www.jnjmedtech.com/en-US/product/attune-knee-system/attune-evidence | Stipulated | Disputed | |
| 303 | UK Registry Data (2016-2022) | Disputed | Disputed | |
| 304 | Australian Registry Data (2016-2022) | Disputed | Disputed |
(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.
(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.
MICHELLE L. PETERSON
United States Magistrate Judge
FORM APPROVED
s/James J. Purcell_____________
Attorney for Plaintiff
s/Erin M. Pauley______________
Attorney for Defendants