FDA, Food & Drug Administration, hip resurfacing, McMinn, Nephew, Nephew Smith, Smith, UNited States
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)
I forgot to mention: FIRST quarter earnings for Smith & Nephew 2012 $ 239 million dollars
What a shocker, Howard! But they’re HELPING people, man, and they need to get these products on the market ASAP in order to do that! Yes, it’s horseshit but they’ve got the money, and that’s who wins the rigged game now. Every game, every where, every time.
Howard- This is very sad news. Could you not as a citizen of the U.S. file a FOIA with the FDA to retrieve the 2004 S & N application for the BHR?
jane, that would involve many dollars here just for the legal work, and you might still lose out after throwing $$ at it. My application (the 510k ‘pass-it-now because it looks like those other ones’) was simply a letter from S&N to the FDA, and no law firm appears to want even my case — which because of the 510k slipshod approval seems like a slam-dunk to me. Unbelievable!
I just received the following message today when I checked my email:
Dear Mr. Brooks,
I obtained an update on your file. [DELETED IN CASE LAWYERS GET SHITTY] have determined to not pursue any Smith & Nephew claims wherein any component consists of a Birmingham device. There may be other firms with a different opinion, so I recommend you consult with another firm as soon as possible. I will also send you a letter in the mail advising you of same. I am sorry to communicate this to you in writing, however I did not want to call you too early.
So here we have a large firm — actually two firms that work in tandem — refusing to take even the 510k BHR THA! I can’t believe it! I am apoplectic and beside myself. How can these bastards destroy a person’s body and get away with it? So yeah, like your post says, these law firms want only the low-hanging Depuy fruit right now, so it appears we may have to wait for Smith and Nephew to recall their product. I can tell you this, every person in my town is going to read and/or hear about this now!
I agree something must be done, so I’m going to contact all television stations and newspapers out here and see if anything comes of it.
It will be awhile before I come back on here, as my recently revised THA has taken a serious turn for the worse, and I have experienced incredible pain — bony pain down near my rear end (that means the pelvis and the acetabular cup to me). The pain was so intense (after I apparently took a step incorrectly) — that I’m back on the walker, can’t bend over at all again (after finally getting better last week) and loaded up with pain relievers. I have an expedited appointment with my surgeon next week, and almost went back to the emergency room again (been there twice since my surgery due to metalosis/necrosis. My leg swelled up so big it looked like a python that had swallowed an alligator. I had severe pain for three weeks (pitting edema) that migrated down my leg past my knee (On the revision side). The doctor has no explanation, but agrees it MAY have something to due with the toxicity of the implant and the cutting loose all of the dead and/or contaminated flesh. It MAY have something to do with it — really, doc? Is that your careful diagnosis? Your a pitiful disgrace to your profession, and it will now take all of the restraint I can muster not to verbally blow this guy out of his chair next Tuesday, friggin’ ‘Bonesmith’!
I am so pissed off right now I can’t even think right, these bastards! And mine’s not even a PMA approved device! Good God, how can this be happening, where the agency put in place to protect us (FDA, aka Failed Device Administration) has been bought and sold by lobbying firms like AdvaMed, who like all other lobbyists in our country are simply ‘investing’ money in members of Congress to get the results they desire. What country is this we’re living in, man?
I may go after the hospital for negligence, as no warning was given to me about metal ions and my records say it was. But I have obtained a copy of the actual consent form and there is no mention on it at all, so the hospital has essentially falsified records to cover their behinds. My records say two different things, and that is highly unethical. This is a prestigious hospital so they won’t like the article my newspaper wants to print about me (My lawyers, the ones who dropped me, insisted I didn’t give an interview with my name, so the medical reporter’s editor wouldn’t let him do it. That will now change post haste.
If that fails I’m going to picket the hospital who did the work by wearing a sandwich-board sign while supported by my walker, with the letters this hospital injures people and lies on their records to protect themselves.
I guess we have to hang in there, but I don’t feel like doing that right now.
So do I, Brooks! I’ve had 4 operations since 2007 and now have been dropped as if my life, before and after, is in ruins. So far we have:
“All Smith & Nephew devices should be recalled!”
let’s keep cool; I’m angry as hell too, but get out of everyone’s way cause this is my karma that’s exploding, and I don’t want anyone else to be hurt, so I’m holing up . . . as I have done for the past 3 years. You can write me at mickey@TheKarmaPress.com.
My son is graduating from Georgetown Univ in D.C. on the 19th, then he can advise me as he prepares to work in the Dept. of Justice as a Presidential Management Fellow. This can’t be our end.
Mickey, I’m so sorry that these bastards don’t recall their products. If there was anything I could do I would, other than continue to talk to everyone I know about it and come on here. Even a BHR with a generic Co-Cr Head and long femoral stem (both 510k’d) may not be enough to ‘win’ in this thing, as the Evil Ones will not do anything without a serious fight. I don’t know, they might be the last company with MoM — maybe Cormet as well? — to somehow avoid recall in the face of horrible surgical consequences.
Your son could sure be an asset in all of this, but It’s like every single branch and aspect of government is corrupted by dollars. Every regulating committee guy goes to work for the people he regulated. Or the revolving door of lobbyists who come straight from the halls of government knowing how to get to government guys who are doing the job they just left do what they want, write laws they like, and write ’em their way.
I don’t think there’s any corporation that is too big to bribe, too big too receive subsidies (corporate welfare), to big, of course, to be exempt from the laws that govern the common man. Profits before people, these people make the mafia look innocent by comparison.
You just gotta try to hang in there, as I’ve been doing for a while too these past years. Who knows when justice will be meted in this atrocious affair, but I feel certain it finally will. The pressure is starting to pick up on the FDA, as the public getting wise to this guinea pig game they didn’t tell us we were playing. A lot of people I talk to know of MOM or a MOM victim, or they will by the time I leave.
And as regards the vaunted PMA and ‘case law’ which is supposed to be settled, how is it that individual states are basically undoing matters already adjudicated by the Supremes? It’s happening all across the US right now. So why can’t we, by the same logic, contravene ‘established precedent’, rendering it null and void on state level in emulation of what for all intents and purposes looks to be a subversion of democracy. I mean, if states are getting away with such digressions from settled law, why can’t S&N be sued in a state that decides it wants to play that game, wants a different set of rules too. By such reasoning, Scalia and Friends’, (A new show on Fox),and their well-considered 2008 decision (for their corporate sponsors) in Riegel v. Medtronic, Inc., [552 U.S. 312] shouldn’t even be considered! I’m just saying if any states’ Attorney General decides maybe he has to jump in because his wife got a BHR, then ‘presto things change-o’. I truly feel it could [and I think will] happen.
I’ve just had to let this balloon go ,and maybe things are starting to go my way but nothing against The Empire of the mighty S&N is by any means a sure bet. This simply cannot stand, and more and more people hear of MOM each day. Maybe they’re not calling all BHR people yet, but that position seems untenable. The day will come, or a progressive state will find a way to circumvent it (Like certain states are now ignoring Constitutional Law).
Thanks, Earl, for your moral support. It’s taken me 3 days in danger of becoming a wild raging woman (I’ve just secluded myself so as not to project my anger on someone else . . . the injustice of it all!. According to Tibetan Buddhism, this would not have happened to me unless I did something violent like this to someone else in a past life. I have learned. So I have to let go of this baloon and like you just let it drift away
Anonimus Victim said:
Suggest you study a more worldly view as per Rupert Sheldrake or Lynne McTaggart to understand how the Universe and the Morphic field /Morphic resonance work. You will see that much of the beliefs of formal religions and the modern world do not hold water. That we are enlightened beings and have to move on from the past belief systems. Youtube Rupert Sheldrake. Also tune into Regenerative Medicine and you will see there is hope for all those of us who have or still are suffering don’t let your anger get in the way and drag you further and deeper along the road of being a victim. The Laws in USA are manipulative and always will be just don’t play along with it you cannot fight the established the insanity in this country. You don’t seriously believe your own salvation and survival can happen through the courts??!! forget that! Your future lies in your self and how you think of it.
You and me both. I must have run over a million Chinamen in a past life!!!
Focus on the future. It is all we can influence.
We have similar interests in books: check out The Holographic Universe by Michael Talbott and The Universe is a Single Atom, the report of the annual Mind-Life Conference with famous thinkers and H.H. the Dalai Lama.
O, am I learning about acceptance!!! You hit the nail on the head.
Thanks for the heads up! Will do!
Earl, when I focus on the future, I stumble in the present
Yes. We have this challenge called character building! Just didn’t realise my damn character needed so much building!!! Grrrr…
Whoops, Brooks, my last comment was to you, not Earl (though he’s always welcome.
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Michael Monheit said:
Howard, I agree with much of what you post. However, I take issue with the characterization that the problem is in finding “a law firm that has the ability and desire to tackle this huge issue.” Law firms would love to take on Smith Nephew for your problem, if the status of the laws and FDA regulations were otherwise. The US Supreme Court, in RIEGEL v. MEDTRONIC, INC. has had the last word on this issue. So what you really should be pushing for is “the victims of the BHR device band together and find” legislators that have “the ability and desire to tackle this huge issue.”
Lawyers are not dodging this job. It is not a job lawyers can accomplish. Rather, the job that now needs to be done is legislative, given the Supreme Court’s holding in Riegel. We need a change in the law and that will require congressional action and changes to FDA regulations.
Michael, from my perspective it appears you may be talking of an issue separate from Howard’s intent (Regarding the comment you ”took issue with”). Indeed, as MOM victims we are engaged on two different fronts: Laws and their enforcement. Legislators of course make the laws and must “tackle th[e] huge issue\” involved in changing them, but lawyers help ensure those same laws are strictly followed. They then have the ability to address the issues involving the lives ruined by these MOM devices that were implanted in them via the legal channel. In most cases, these toxic devices were implanted without warning of potential problems and their consequences, (i.e. metalosis/necrosis, disability, etc.). Lawyers (and their victimized clients) can help hasten the needed changes to existing laws through the illumination of these problems in the courts. Bringing to daylight these grievances may also help force the institutions that were in place to protect these patients to reconsider the failures in their current approval policies.
In the case of nearly every MOM person utilizing this site, we have all seen a consistently similar \’plethora of problems\’ that are common among us. The huge legal task assisting those patients whose product has yet been recalled, and a legal redress of the harm done them seems what Howard is speaking of here (I may be wrong, but have spoken with Howard via email many times). His life was quite nearly destroyed by a product the FDA allowed to be used in his living body that was never tested in a living body! Hip simulators have proven terribly ineffective in the 510k approval process, but we do read that S&N’s Oxinium MOM implant’s results on that helpful machine resulted in a much lower amount of metal debris. That doesn’t seem to have mattered that much once implanted, however, once placed next to flesh and bone.
I personally am at work on both fronts (as are most people here), speaking with lawyers to seek legal remedy for the injustices and injuries I have suffered, and writing letters and calling my representatives at home and in Washington. I have submitted a report on the metalosis that was caused through the articulation of metal surfaces in the device in my body, to the FDA and Medical Device Panel.
I am only speaking for myself here, (which is all one can ever do), and your points are well taken. However, it seems to me that the more victims whose experiences are revealed in the courts that enforce our existing laws are more the likely to help facilitate the changes needed in these same laws. All metal on metal should be removed from the market, and those who are severely injured or disabled as a result are living proof of such a need. Unquestionably, they deserve recompense where warranted — they would see justice done.
The more who are recognized, the stronger grows the case for withdrawing these devices from the worldwide medical device marketplace. In this endeavor our routes are limited, considering our lack of a \’lobbying\’ voice in DC. (Some in the US feel as if their laws are now actually \’written\’ on \’K\’ Street). And there\’s recently news that the large medical device manufacturers (Pharmaceutical Conglomerates) are looking at ways of helping speed the FDA approval process, by graciously helping fund such efforts.
By the way, might I inquire as to what model implant was used in your hip arthroplasty, and was it MOM? How has it performed for you?
At any rate, best of luck to you
Michael Monheit, Esq. - Philadelphia Lawyer at Anapol Schwartz said:
Brooks, Great points. We are on the same side of this issue, wanting to hold the manufacturers to account for those that they have already harmed — giving those victims a voice and a day in court to seek justice. And clearly we both want a better process for product approval — one that does not result in the manufacturers having undue influence over the approval process. My only point was that what stands in the way of Howard is not a lack of lawyer desire, but an unfortunate (and “perhaps” politically predictable) legal precedent that has been made by our US Supreme Court. There have been a series of recent decisions by this court that take away rights of individuals, diminish the rights of states, and increase protections for and the influence of corporations. For example in another recent decision, the Supreme Court held that generic drug manufacturers have no independent duty to warn and thus cannot be held responsible for the inadequate warnings of the name brand medication.
I agree with you that “the more victims whose experiences are revealed in the courts that enforce our existing laws are more the likely to help facilitate the changes needed in these same laws.” The problem is that in the Riegel case the Court held that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration. So basically in Howard’s situation, the US Supreme Court has held that his case is pre-empted by Federal Law. No matter how many cases like his try to go forward, they will all meet the same result under Riegel. So the effort, energy, money and time would be better directed at changing the law (legislation) rather than trying to get recourse through filing lawsuits that would be ultimately dismissed.
I totally agree that “all metal on metal should be removed from the market, and those who are severely injured or disabled as a result are living proof of such a need. Unquestionably, they deserve recompense where warranted — they would see justice done.” The question is how we can accomplish that end! I am a lawyer in Philadelphia, and many of my clients are fighting this battle. And many like Howard have been turned away because with Riegel we do not know of a way to pursue their claims in court. All we can do is help make those stories known through other means, like this blog, letters to congress, testimony in front of the FDA, and so forth.
The Smith and Nephew MoM resurfacing has not worked for me. I am sick. And now I’ve been dropped from a case with Joe Lyons Firm and Palantino firm (with Ben Gordon), even as they advertise for cases against S&M???
That is not good. They need to be up front with their criteria.
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Paul Boot said:
Me too, just had my case dropped by my attorneys due to PMA restrictions and now Statute of Limitations times me out too. It seems the attorneys and corporations are the only winners permitted. The bureaucracy is designed to protect them rather than individual. My revision surgeon in San Francisco told me mine was the worst case of Metallosis and extensive necrosis that had seen, loss of soft tissue and legions as thick as his middle finger filled with black fluid the consistency of spent motor oil, running from my hip to my knee and into my groin. And I cannot get compensation to over my future medical needs let alone the lost years since my 2004 implant.
Is there anyone out there that cares or can help us victims – NO!!! It’s a free country anything goes in the USA
Michael Monheit, Esq. 866-761-1385 said:
Preemption is awful. It precludes these claims. Saddest of all, it takes a regulatory scheme that was intended to protect consumers and turns it upside down by preempting claims against the manufacturers. There is something you can do – vote for politicians who are willing to change the FDA regulations so that you can exercise your 7th Amendment right to a civil trial by jury.
Vote against any politicians who claims that we need tort reform due to “frivolous lawsuits.” That is a phrase pushed upon the public by the US Chamber of Commerce. Ask anyone who has been harmed by these products – it is not the frivolous lawsuits that they want to eliminate. It is only the meritorious ones that they are after.
They have succeeded all to often in denying access to those who are hurt the most! We need legislators who will change the regulations so that (1) all products go through rigorous pre-market screening, (2) all products be subject to publicly mandated and available post market surveillance, and (3) all manufacturers of drugs and devices (including generic) be held accountable in civil court jury trials for the harm they cause by unsafe products.
Paul Boot said:
Thanks Micheal, Regrettably, being only an alien resident I am only permitted to pay Tax but not allowed to vote. Isn’t that how the war of independence started!! “No Taxation without representation ” apart from that I’m 100percent with you.
But I am also conscious of the fact that in this country it is money that counts and sways the lawmakers and politicians – they used to call it bribery, but now it’s business as usual. Yes I’m synical but very patient and hopefull of change in the lifetime of my Grandchildren, though not in mine without an uprising or revolution. Too late for most I regret – the Juggernaut is on the roll
Dear Anymous victim:
Based on the content of your post above, it seems illogical that you would still refer to your ‘self’ as victim. Your advice is no doubt sincere and well taken, but when a person loses their income, home, etc., where will they find sanctuary, where will they regain a safe place needed to allow them to read such illuminating authors as those you have provided. How might they pay to keep the lights on.
What of those who’s vision has deteriorated such that reading is a very difficult task, or they can find no posistion of comfort to enjoy activities they used to, inspirational reading perhaps primary among them.
Each person here has a degree of disabilty and/or such a tumultous life that they might not be able to simply enjoy a good read any longer. My eye prescription has changed twice in two years, and at 59 it had not changed for at least five years before my MOM implant and revision. E-books only seem to blind me further after a period and bring severe headaches (As does print on paper).
My thoughts drift to Taoism at the moment, and as Lao Tzu said in the opening line of the Tao Te Ching: “The Tao that can be spoken (written) is not the true Tao”.
What does that statement imply to you?
I do believe you are trying to help, so I personally thank you for your contibution here. The overarching point is that their are degrees of disabily that preclude some of us from pursuing your heartfelt reccomendations.
“I only know that I do not know.”
I should have written ‘Anonymous’ Victim. Not proofreading as well these days, my cognitive skills diminished.
But one of my new found pleasures as a nearly crippled recluse is engaging in lively dialog with my……Self. And the dogs do appear enlightened……
I think your position has merit, and my own personal feeling is that we are indeed where we are for karmic reasons having to do with an endless cycle of birth and rebirth, known as Samsara, or a ‘continuous flow’ on “The Wheel of Life”. New discoveries in Quantum Mechanic have not replaced such eternal truths embraced by Masters upon whom the world’s religions are based, but actually serve to reinforce them. They scientifically identify us a pure energy, our bodies merely vehicles which transport this inextinguishable nature of ours to and fro. And here we find ourselves, at the Moment. (What if there were only one Moment, and our bodies merely aged around it, with time merely a construct of man, primarily to catch the five o’clock out of Penn Station or to get us to the church on time. Who knows? I don’t ‘know’ anything, all I write or think is merely speculative — but has your consciousness changed one whit since you first appeared on this Earth?
And let me emphasize that these are but my opinions, and I have nothing which I might ‘suggest’ you read. I do not presume myself well-informed enough to ‘teach’ others via recommended reads or beliefs, but would merely ‘point’ to Anonymous the ‘Tao of Physics’, a groundbreaking book written by a sub-atomic particle physicist that quite nearly started all of the buzz that Ruppert and Lynne have recently expounded upon. But that is by no means a suggestion, just a though based on 45 years of pursuing the subject of why I exist (Not a favorite of many of my friends and relationships).
In ‘The Tao of Physics’, Fritjof Capra draws definitive parallels between Eastern Mysticism and Quantum Mechanics, actually validating what the ancients have been trying to convey for millennia. It is not The Nazarene or Gautama or Krishna or Zoroaster who might have been wrong, but rather the interpretations of their teaching that are distorted and often transcribed long after their deaths by their adherents, or in the case of Christianity, Constantine at Nicaea). Hence the folly (and damage (being) done) by organized religions.
From my perspective (one human), the authors Capra, Sheldrak, McTaggart, Lipton, Chopra, Braden, Hawkins et. al., are all on the same page as the original words and teachings of the maters listed above, again on whom these respective religions were constructed. These beings didn’t require a particle accelerator to confirm what they knew in their bones.
So we have to practice acceptance, as it is our first and foremost task, one that allows us to maintain sanity in the face of these trials and tribulations.
And in my bones, I know this nightmare will work itself out for all of us — and yes, release the balloons of worry, anger and fear (I’m always talking to myself when I write such things)! But who else?
Ah yes — Let me run it by the dogs…….
PS — Earl, I promise not to wade into this arena again on your site!
Earl- I had my hip resurfaced in 2007 with a Smith and Nephew Birmingham Metal on Metal Implant. With out going into all my medical problems, as it turns out I have one of the mislabeled Acetabulum Cup Sizes 54 mm Implanted in me, and I am having revision surgery in march 2014. I just found out about this in Feb. 2014, do I have legal rights for compensation, did the statute of limitations run out, or does it fall under the preemption law.
sorry to hear about this. You would need to seek legal advice on the legal compensation question. One would certainly hope that you do. Why has it taken so long for a recalled cup to be found in you I wonder?