Smith & Nephew Hip Implants
The 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.
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COURT DOCUMENTS & FILINGS:
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.
- Corporate Integrity Agreement Between U.S. Dept Health & Human Services and S&N – September 27, 2007
- Criminal Complaint Filed – United States of America vs. S&N – September 27, 2007
- Civil Settlement – Between United States of America and S&N – September 27, 2007
- Deferred Prosecution Agreement – Between United States of America and S&N – September 27, 2007
- Deferred Prosecution Agreement – Between U.S. Dept. of Justice and S&N – February 1, 2012
- 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.
- FDA to S&N: Birmingham Hip Modular Head (BHMH) Deficiencies – December 12, 2005
- FDA to S&N: Withdrawal of Premarket Notification (510(k)) for BHMH – March 2, 2006
- Smith & Nephew Birmingham Hip Modular Head (BHMH) Surgical Technique – 2009
- FDA to S&N – Email re S&N BH modular head system, list of deficiencies placing the document on hold – December 18, 2009
- S&N to FDA – Letters re BHMH premarket notification withdrawal – February 24, 2010
- S&N Part 806 Report to FDA of R3 Metal Liner Withdrawal – June 20, 2012
- S&N to FDA: “Withdrawal of the metal liner of the R3 Acetabular System” – June 20, 2012
- “Important-Advisory-Notice” for S&N Modular Femoral Head – March 19, 2015
- Letter From S&N’s Jason Sells to FDA – S&N Advisory Notice Re. S&N Modular Femoral Heads – November 16, 2015
Kip 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.