I. SALES REPS:

1. 1. 1. Smith & Nephew Code of Conduct March 2009
      2. Childress Sales Rep Agreement

II. HOSPITALS:

1. 1. • coming soon

III. SURGEONS:

1. 1. 1. Hip Task Force Issues and Recommendations
      2. Hemi Head Carton List

IV. PRODUCT SAFETY:

1. 1. • coming soon

V. MANUFACTURING AND TESTING:

1. 1. •  coming soon

1. Order for Continuance and DPA – Filed September 28, 2007
2. Brooks Depo Exhibit 3. Affidavit in Support of Smith & Nephew’s Motion to Dismiss – Filed July 24, 2009
3. Brooks Depo Exhibit 4. Sales Rep Sworn Declaration – Filed August 12, 2009
4. Brooks Depo Exhibit 6. Sales Rep Original Petition Against Smith & Nephew – Filed July 24, 2009
5. Criminal Information – Filed February 6, 2012
6. Deferred Prosecution Agreement – Filed February 15, 2012
7. Raab Protective Order – February 9, 2016
8. First General Order in the MDL for the BHR cases – Signed April 24, 2017
9. Joe Mink v. Smith & Nephew – Filed June 26, 2017
10. MDL Case Management Order # 1 – Signed June 28, 2017
11. MDL Case Management Order # 4. Settlement Counsel – Signed July 20, 2017
12. MDL Case Management Order # 3 – Signed August 3, 2017
13. MDL Case Management Order # 5. Direct Filing and Short Form Complaint. – Signed August 3, 2017
14. S&N’s Motion to Maintain Protection of Confidential Documents – August 14, 2017
15. Case Management Order # 2. MDL Common Benefit Order – Filed and signed August 23, 2017
16. Plaintiffs’ Motion to Compel Production of Unredacted Documents and Privilege Log – October 20, 2017
17. Walter and Vivian Shuker v. Smith & Nephew – Filed March 1, 2018
18. Memorandum Opinion on BHR Preemption – Filed March 26, 2018
19. S & N’s Answer to BHR Master Complaint – Filed April 27, 2018
20. S & N’s submission for Scheduling Order for BHR Track Cases – Filed April 30, 2018
21. Order Exempting SN from Answering THA Complaints – Filed May 3, 2018
22. Civil Docket for Case #: 3:17-cv-00012-AWT – Filed June 12, 2018
23. Memorandum Opinion from Spellman v. Smith & Nephew, Inc. – Filed June 13, 2018
24. June 20, 2018 Status Conference Agreements – Filed June 20, 2018
25. Memorandum re: Ex Parte Contacts with Treating Physicians – Filed June 20, 2018
26. Consent Motion for Fact Sheets – Filed June 20, 2018
27. Order re: Ex Parte Contacts with Treating Physicians – Filed June 20, 2018
28. Smith & Nephew’s Memorandum in Support of MTD due to the SOL – Filed June 20, 2018
29. Updated List of BHR and THA Track Cases as of July 23, 2018 – Filed July 23, 2018
30. Plaintiffs’ Response to Smith & Nephew’s MTD due to the SOL – Filed July 30, 2018
31. MDL Order Confirming Results of July 25, 2018 Status Conference – Filed July 31, 2018
32. First Amendment to CMO # 8. (Facts Sheet Answers in the MDL). – Filed August 1, 2018
33. Master Amended Complaint for Plaintiffs with BHR Cups, Mod Fem Heads, and Stems – Filed August 14, 2018
34. Smith & Nephew’s Reply Memorandum in Support of MTD due to the SOL – Filed August 21, 2018
35. Status Conference Proposed Agenda for August 29, 2018 hearing – Filed August 24, 2018
36. THA Master Amended Consolidated Complaint – Filed August 14, 2018
37. Court Hearing Agenda – September 25, 2018 – Filed September 21, 2018
38. Proposed Deposition Protocol – Filed November 2, 2018
39. THA Motion to Dismiss, Memo, and Exhibits – Filed November 9, 2018
40. Proposed Agenda – November 28, 2018 – Filed November 26, 2018
41. Proposed Hearing Agenda – December 19, 2018 – Filed December 17, 2018
42. Order After Status Conference on December 19, 2018 – Filed January 9, 2019
43. Plaintiffs’ First Amended Petition Against Sales Reps and Surgeon – Filed April 12, 2019
44. List of State Court Cases Against Smith & Nephew as of May 14, 2019 – Filed May 14, 2019
45. Plaintiffs’ Response in Opposition to Motion for Federal-State Court Coordination – Filed May 14, 2019
46. Order on Motion to Dismiss THA Track Cases – Filed August 14, 2019
47. Memorandum Of Remand – Dated August 22, 2019
48. Memorandum Of Remand Sales Rep Liability – Dated August 22, 2019
49. Second Revised CMO No. 1 appointing Lead Counsel – Signed September 24, 2019
50. Order Confirming Results of 09.25.2019 Status Conference – Filed September 26, 2019
51. MDL Court Opinion Re: California Statute of Limitations – Filed October 17, 2019
52. Plaintiffs’ Response to S&N’s Motion for Entry of Confidentiality Orders – October 22, 2019
53. Kemp Amended Confidentiality Order – November 22, 2019
54. MDL Court Opinion Denying Motion for Interlocutory Appeal – Filed November 27, 2019
55. Proposed Agenda for March 5, 2020 Status Conference – Filed March 2, 2020
56. Motion for CMO Number 16 – Filed March 2, 2020
57. Proposed Order on CMO Number 16 – Filed March 2, 2020
58. S&N’s Motion for Protection – April 16, 2020
59. S&N’s Supplemental Motion for Protection – April 17, 2020
60. Plaintiffs’ Response to Motion for Protection – April 20, 2020
61. Plaintiffs’ Opposition to Motion for Protection / Motion to Compel – April 23, 2020
62. MDL Memo Re: Remote Proceedings for an extended time – Filed April 27, 2020
63. MDL Court Opinion Re: Ex Parte Contacts with surgeons and treaters – Filed April 27, 2020
64. S&N’s Reply to Opposition to Motion for Protection – April 30, 2020
65. S&N’s Opposition to Amended Motion to Compel – May 1, 2020
66. Smith & Nephew Motion Opposing Remote Depositions in the MDL – Filed May 18, 2020
67. Plaintiffs’ Brief on Remote Depositions in the MDL – Filed May 21, 2020
68. Proposed Agenda for May 27. 2020 MDL Status Conference by Zoom – Filed May 22, 2020
69. Order on Motions Heard on May 4, 2020 – May 29, 2020
70. Plaintiff’s Amended Motion for Production of Non-Privileged, Relevant Info. – June 3, 2020
71. S&N’s Motion for Protection from Pending & Further Written Disc. & Motion to Strike Untimely Disc. – June 5, 2020
72. S&N’s Motion to Quash Deposition / Motion to Strike Jay Mabrey – June 5, 2020
73. Plaintiffs’ Combined Response And Opposition To Motion To Quash / Motion To Strike Jay Mabrey – June 10, 2020
74. Plaintiff’s Response to Motion for Protection – June 11, 2020
75. S&N’s Reply to Combined Response And Opposition To Motion To Quash / Motion To Strike Jay Mabrey – June 12, 2020
76. S&N’s Reply to Response to Motion for Protection – June 12, 2020
77. Order Denying S&N’s Motion To Quash / Motion To Strike Jay Mabrey – June 30, 2020
78. Plaintiffs’ Motion for Sanctions – July 2, 2020
79. S&N’s Opposition to Plaintiff’s Amended Motion for Production of Non-Privileged, Relevant Info. – July 2, 2020
80. S&N’s Supplement to Opposition to Plaintiff’s Amended Motion – July 6, 2020
81. Plaintiff’s Notice of Filing of Rule 11 Agreement re: Sales Rep & Surgeon Training Corporate Rep Depos. – July 14, 2020
82. S&N’s Opposition to Plaintiffs’ Motion for Sanctions – July 29, 2020
83. Plaintiffs’ Reply to S&N’s Opposition to Motion for Sanctions – August 3, 2020
84. Letter Ruling re:  In Camera Review of Privilege Log Documents – September 15, 2020
85. Notice of Filing of Updated Listings of Pending BHR and THA Track Cases in Federal BHR MDL – October 12, 2020
86. Active BHR Track Cases Filed in MDL 2775 as of October 11, 2020 – October 12, 2020
87. Active THA Track Cases Filed in MDL 2775 as of October 11, 2020 – October 12, 2020
88. Defendants’ Motion for Temporary Restraining Order and Order to Show Cause – Oct 12, 2020
89. Declaration in Support of TRO – Oct 12, 2020

Over the years, Smith & Nephew has been caught violating federal law multiple times. Smith & Nephew is a repeat player with the U.S. government, entering into two separate deferred prosecution agreements since 2005. This section provides some of the publicly-available deferred prosecution agreements and settlement agreements that Smith & Nephew entered into with the U.S. government after getting caught violating federal law by over-paying surgeons to use its devices both domestically and abroad. Let me know if you are aware of other criminal activities involving Smith & Nephew’s hip implants. I’ll gladly add more information to this section. It helps everyone to share as much information as possible about this company’s bad acts.

1. US Department of Justice “News” – five companies in hip and knee industry avoid prosecution by agreeing to compliance rules and monitoring – September 27, 2007
2. Corporate Integrity Agreement – September 27, 2007
3. Corporate Integrity Agreement Between U.S. Dept Health & Human Services and S&N – September 27, 2007
4. Criminal Complaint Filed – United States of America vs. S&N – September 27, 2007
5. Civil Settlement – Between United States of America and S&N – September 27, 2007
6. Deferred Prosecution Agreement – Between United States of America and S&N – September 27, 2007
7. Federal Bureau of Investigation – August 19, 2008
8. US Department of Justice “News” – monitoring and deferred prosecution agreements terminated with companies in hip and knee replacement industry – March 30, 2009
9. Deferred Prosecution Agreement – Between U.S. Dept. of Justice and S&N – February 1, 2012
10. FCPA (Foreign Corrupt Practices Act) Charge Filed Against S &N – February 6, 2012

In this section I will provide some information about Smith & Nephew’s questionable regulatory activities involving hip implants. This is another area where there is abundant evidence to analyze. Smith & Nephew, like many device companies, took advantage of federal medical device regulations by trying to gain a 510(k) “clearance” for dubious devices instead of getting them “approved” through the more rigorous Premarket Approval process. By using the 510(k) “clearance” process, the FDA did not determine that these devices were safe and effective, but only that they were “substantially equivalent” to already-approved or -cleared devices. Worse, Smith & Nephew failed to convince the FDA to clear a metal hip system for them after three attempts over more than five years, so they used their sales reps to promote unlawful uses despite the FDA orders. Smith & Nephew happily and aggressively sold unapproved hip systems in this manner for about five years in this country before it became obvious there were big problems with these unapproved devices. They hastily withdrew them from the market as the FDA started to focus on metal hips, and they ultimately avoided FDA scrutiny for their metal hips because they never obtained clearance or approval in the first place. Smith & Nephew’s scheme has allowed them to avoid FDA scrutiny because FDA generally can’t regulate what was never approved or cleared. Future additions to this portion of the website will provide more information about Smith & Nephew’s metal hip implant regulatory shenanigans.

1. Chicago MDL Paper + 3 Attachments – May 23, 2018
2. No Sell Letters – Various Dates

1. FDA to S&N:  Birmingham Hip Modular Head (BHMH) Deficiencies – December 12, 2005
2. FDA to S&N: Withdrawal of Premarket Notification (510(k)) for BHMH – March 2, 2006
3. Smith & Nephew Birmingham Hip Modular Head (BHMH) Surgical Technique – 2009
4. FDA to S&N – Email re S&N BH modular head system, list of deficiencies placing the document on hold – December 18, 2009
5. S&N to FDA – Letters re BHMH premarket notification withdrawal – February 24, 2010
6. S&N Part 806 Report to FDA of R3 Metal Liner Withdrawal – June 20, 2012
7. S&N to FDA: “Withdrawal of the metal liner of the R3 Acetabular System” – June 20, 2012
8. “Important-Advisory-Notice” for S&N Modular Femoral Head – March 19, 2015
9. Letter From S&N’s Jason Sells to FDA – S&N Advisory Notice Re. S&N Modular Femoral Heads – November 16, 2015

1. Chicago “Bet the Company” MDL Seminar + What’s So Special About Smith & Nephew Metal Hip Implant Cases? – May 23, 2018
2. Don’t Shoot from the Hip: Navigating Medical Device Mass Torts in Multidistrict Litigation – September 26, 2018