I am sharing my latest experience with a large law firm that did represent me up until yesterday. I received a message the firm was dropping my case via Smith & Nephew ( Birmingham Hip Resurfacing device) because Smith & Nephew can hide behind the preemption law and the law firm didn’t want to tackle this issue. Unless the victims of the BHR device band together and find a law firm that has the ability and desire to tackle this huge issue Smith & Nephew will not be held accountable. My device and I were not meant to be, it is this device that has taken away my quality of life. I will never walk again without the use of a walker, a custom shoe that is 2” higher than my good side, a lockdown brace. I am grate full to be alive.
This preempt law is allowing a company, Smith and Nephew to hurt people and not be held accountable. Here are some facts you may want to know: in 2006 Smith & Nephew filed a pma application with the FDA and they were denied approval for these reasons : the partial inventor of the device Dr. McMinn was in complete control of his patient group of 2385 people (no US testing, group was all out of this country) he had a financial interest ( once approved he reportedly received a package valued at $191 million dollars) the test data used in the application came strictly from McMinn and his controlled group. The FDA didn’t like the smell of things so they voted no. In 2006 Smith & Nephew reapplied using all the same data, and made some adjustments in their applications so in conformed to the requirements of the pma and its approval. I can only guess because the FDA won’t release information that is pertinent in order to prove the information provided to the FDA was not accurate, in other words bullshit. They probably made McMinn a consultant and not an employee, that would distance him from the company which would allow him to make the monies he received. The FDA still wasn’t real keen on the facts provided by McMinn and his single controlled group. When asked about this he reportedly told the FDA that there were 140 surgeons in 23 countries using the BHR at that time. Complete bull, the FDA took his word and never verified his comments. Resultantly the device was approved, thus they can market a device, if it malfunctions and hurts me or you, tough luck the preemption law protects them from accountability. What happened to the HUMAN BEING factor, that gets lost. After all market share and rate of return to the investor is the most important issue.
This same company is a repeat offender of paying kickbacks, they have been fined here and abroad, the United States of America is in court suing this company today on a whistleblower case. ( you can read about it by typing in USA vs Smith & Nephew.
Unless we get copies of these applications as to the approval of the BHR there are a lot of innocent injured people that are being denied accountability and justice and compensation by our own Government.
This is not in justice for all this is downright wrong, unless we put our efforts together they will continue to do this over and over again.
In addition to all of this we, yes you and me are the test rats that are providing data as to adversities and good and no one ever told us we were going to be the lab rats, WHY because the disclosure laws as they are written say they don’t have to tell us anything that they don’t want to.
I am open for any comments as to your thoughts or ideas on pursuing this matter.
Howard Sadwin (email@example.com)
- Smith and Nephew payments to 236 Sugeons & Institutions in the USA (earlsview.com)
- 40′s Woman Ruined by Smith & Nephew Hip Implant (earlsview.com)
- Michael’s BHR disaster – life in tatters – when will it stop! (earlsview.com)
- Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk (earlsview.com)
- Stuart’s Story – Gets Worse – Beware Metal on Metal Hell (earlsview.com)
- Smith & Nephew Misses Where It Counts (fool.com)
- FDA: ‘Streamlined’ Reporting Process re: Ortho/Rehab/Device Committee Meeting (earlsview.com)
- Smith & Nephew’s profit rises after restructuring (thisislondon.co.uk)
- Medical Device Maker Agrees To $16.8M Penalty In Bribery Case (legaltimes.typepad.com)
- MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee (earlsview.com)