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Kip Petroff is a lawyer located in Dallas, TX. He is currently focusing on representing people injured by Smith & Nephew hip implants.

September 23, 2018

FREE CONSULTATION

972-294-7530

Smith & Nephew Hip Implant Legal Page

Smith & Nephew Hip Implants

Smith & Nephew Hip Implant Legal InformationThe purpose of this section is to provide resources to anyone interested in knowing what is happening in the hip implant legal and regulatory world related to Smith & Nephew’s metal hip implants.. This information is not comprehensive or complete; it is just a sampling of some general information that is available related to Smith & Nephew’s metal hip implants. Comments or questions about this page or specific legal questions can be submitted via the Contact Form.

Please click the + sign below to open each topic:

COURT DOCUMENTS & FILINGS:

  1. Order for Continuance and DPA – September 28, 2007
  2. Criminal Information – February 6, 2012
  3. Deferred Prosecution Agreement – February 15, 2012
  4. First General Order in the MDL for the BHR cases – Signed April 24, 2017
  5. Joe Mink v. Smith & Nephew – June 26, 2017
  6. MDL Case Management Order # 1 – Signed June 28, 2017
  7. MDL Case Management Order # 4. Settlement Counsel – Signed July 20, 2017
  8. MDL Case Management Order # 3 – Signed August 3, 2017
  9. MDL Case Management Order # 5. Direct Filing and Short Form Complaint. – Signed August 3, 2017
  10. Case Management Order # 2. MDL Common Benefit Order – Filed and signed August 23, 2017
  11. Walter and Vivian Shuker v. Smith & Nephew – March 1, 2018
  12. Memorandum Opinion on BHR Preemption – March 26, 2018
  13. S & N’s Answer to BHR Master Complaint – Filed April 27, 2018
  14. S & N’s submission for Scheduling Order for BHR Track Cases – Filed April 30, 2018
  15. Order Exempting SN from Answering THA Complaints – May 3, 2018
  16. Civil Docket for Case #: 3:17-cv-00012-AWT – June 12, 2018
  17. Memorandum Opinion from Spellman v. Smith & Nephew, Inc. – June 13, 2018
  18. June 20, 2018 Status Conference Agreements – June 20, 2018
  19. Memorandum re: Ex Parte Contacts with Treating Physicians – June 20, 2018
  20. Consent Motion for Fact Sheets – June 20, 2018
  21. Order re: Ex Parte Contacts with Treating Physicians – June 20, 2018
  22. Smith & Nephew’s Memorandum in Support of MTD due to the SOL – Filed June 20, 2018
  23. Updated List of BHR and THA Track Cases as of July 23, 2018 – July 23, 2018
  24. Plaintiffs’ Response to Smith & Nephew’s MTD due to the SOL – Filed July 30, 2018
  25. MDL Order Confirming Results of July 25, 2018 Status Conference – July 31, 2018
  26. First Amendment to CMO # 8. (Facts Sheet Answers in the MDL). – August 1, 2018
  27. Master Amended Complaint for Plaintiffs with BHR Cups, Mod Fem Heads, and Stems – Filed August 14, 2018
  28. Smith & Nephew’s Reply Memorandum in Support of MTD due to the SOL – Filed August 21, 2018
  29. Status Conference Proposed Agenda for August 29, 2018 hearing – Filed August 24, 2018

SMITH & NEPHEW (S&N) CRIMINAL PROCEEDINGS:

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

SMITH & NEPHEW (S&N) REGULATORY PROBLEMS:

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
Smith & Nephew Hip Implant Legal QuestionnaireKip Petroff focuses on representing people who have suffered serious injury after having received a Smith & Nephew hip implant.

Legal and Regulatory information will be provided in this section. This page is for your information only and it is not intended to prove or show anything. It is simply a collection of some legal and regulatory information that might help you get started on whatever research you are undertaking. This information is posted chronologically as a way to keep track of the items. We have come full circle with metal on metal hip implants – over 100 different types of metal implants used for hip replacements obtained FDA approval or clearance in the first decade of this century and almost all those implants have been removed from the market in the second decade. It’s another regulatory disaster!

Comments or questions about this page can be submitted via the Contact Form. Kip will try to find an answer to your hip implant legal question if he doesn’t already know the answer.

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