Sunday, July 29, 2012

Stryker, Pomona Hospital and OP-1

Where's Steve MacMillan when you need him?  Considering that Stryker finally sold off OP-1 to Olympus in a deal that smelled fishy and included the V Brothers, once again Stryker just can't rid itself of its Albatross, also known as  OP-1. On July 25th, 2012, it was reported in various media outlets that more than a dozen patients may have be the subjects of secret medical experimentation (that sounds nefarious) alleged to have taken place at Pomona Valley Hospital, in Pomona California.  A letter dated July 24th, 2012 was issued by the attorney for the plaintiff, April C. Cabana to the Office for Human Research Protection at the United States Department of Health and Human Services.

Based on the aforementioned complaint, once again, we are revisiting the off-label use of OP-Putty and Calstrux.  Even though the complaint seems to absolve Stryker, it seems that the Almighty Stryker can't get rid of that dog OP-1. The allegations in this complaint center around the truff, as Mike Tyson would say, regarding Pomona Valley Hospital at first denying that an IRB had not been approved by the hospital.  Unfortunately for Pomona and the surgeon involved, recently obtained documents suggest that there was a "secret research project" taking place at the hospital regarding OP-1 and Calstrux. It seems that the hospital's Vice-Chair person asked the lead investigator "if efficacy is obvious should the research project and randomization be continued." 

At issue are State and Federal laws and regulations that mandate that researchers receive informed consent of subjects or patients prior to enrolling them in a research project. The complaint states that Ms. Cabana was never informed that she was going to be enrolled as a subject in this project.  As many of you are aware, surgeons can use their professional discretion for off-label use.  The smoking gun seems to be the correspondence between the hospital and Ms. Cabana's surgeon.  So how did Pomona, the surgeon, and Ms. Cabana get to this point?  OP-1 a potent bone morphogenic protein supposedly delivered the knock out blow by accelerating boney growth in and around her nerves resulting in remedial surgery that was not successful. Not only does Ms. Cabana suffer agonizing pain, she is on permanent disability. But this raises a greater concern.  If Ms. Cabana was made aware of being enrolled in the so-called "research project,"and that OP-1 and Calstrux would be used, would she had  the acumen to make an educated decision about the use of these products during her initial surgery?  Consumer Medicine?  Bah Humbug! Once again, the Cabana case brings to light the complexities that exist in modern day spine surgery, successful fusion no matter at what cost.  How many Ms. Cabana's exist that we never hear of?  Based on this complaint, there are potentially a few more to be reckoned with since Pomona had at least 16 other patients enrolled in the OP-1/Calstrux project.

So TSB must ask the proverbial question, what happens to Pomona? What happens to Dr. Famous? Does the government have the "chutzpah" to take action or will they attempt to quietly deal with this, sweeping it under the rug.  TSB doesn't know about our readers, but knowing what we know, if this was my loved one, there would be some serious ass kicking going on. 

Money, Money, Money, Money
Some people got to have it,
Hey, hey, some people really need it
Hey listen to me, y'all do thangs, do thangs, do thangs, bad things with it
Talkin' 'bout cash money, dollar bills y'all come on now.

91 comments:

  1. Wow, can't believe I turned off women's field hockey in the Olympics to take a gander at TSB.

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  2. Woman's Field Hockey, now there's a real sport, what's next pro tennis and basketball, even the Olympics are tainted, Holy Crapola Batman

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  3. Sounds like Pomona Valley and Dr. Mesiwala have their feet in the fire. Information from
    http://www.scpr.org/news/2012/07/25/33464/pomona-hospital-allegedly-conducted-experiments-pa/
    provides one with the letters of the IRB from Pomona Hospital. It is clear Pomona knew about the IRB. If indeed Dr. Mesiwala did perform surgery without proper consent he could be looking at jail time. There must have been a pay off from Stryker to Mesiwala in some form or another. Time will tell as other patients come out of the woodwork. It will be interesting to see if Pomona fesses up and provides the names of the other 16 patients.

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    1. FYI, get your head out of your ass and continue checking the facts. As more unfolds you people are going to be surprised... this just posted by a US Legal Expert on www.scpr.org:



      Off label use of an FDA approved medication or device is perfectly legal and at the discretion of the doctor, though it is wise to let the patient know that's what is happening. It is not experimentation.
      Medications and devices approved for HDE (humanitarian device exemption) can also be used; this is a conditional FDA approval and generally the manufacturer requires the IRB to be aware. Again, not an experiment.
      Before jumping to conclusions, it is also important to remember that drugs and devices have side effects. Sometimes these become apparent after FDA approval and drugs are withdrawn. Again, not an experiment.

      What happened to this patient is devastating and unfortunate. But the manufacturer already admitted to deceptive practices. Don't judge the hospital or the doctor until you know what they were told by the manufacturer.

      And your ears should prick up whenever a lawyer uses terms like "Frankensteinesque." Someone is hoping to win the lottery.

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    2. Blah blah blah... sounds like you are a doctor from another group trying to justify your existence. LOL... this I know as I have called on you from a different device company... shame on you for trying to bring your dirty laundry and your vendetta against Dr. Mesiwala into this shame of a case. Seriously... everyone knows he's so much more talented than you that you have to try everything in your power to make him look bad. You aren't fooling us. We will stand behind him no matter what. Why do you think we will never set foot in your office again? You aren't good enough.

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    3. MSM...are you writing these ridiculous posts yourself for added entertainment value? If not, this may just sum up why Dr. Mesiwala and Pamona find themselves in the mess they're in. This poor biatch (and it definitely sounds like a whiney chick) is actually someone Dr. Mesiwala depends upon for interoperative guidance and clinical support! Maybe it really isn't his fault.

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    4. Money makes people do foolish and irrational things, considering Stryker's past record with the U.S. DOJ and FDA related to OP-1, yes facts are facts, the onus is now on the good doctor and Pomona Hospital to prove that they did everything by the book. As for Stryker, why do any of you believe they sold OP-1 to Olympus, as TSB said it was their Albatross. Based on the document links from the original story, there are many questions without answers, maybe we need exposure. Stryker wasn't fined $15 million for nothing and 3 or 4 people didn't plead guilty because they had nothing better to do. You people live in a fantasy world

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  4. Given all the negative press with OP-1, why would this surgeon / hospital want to conduct this research unless there was some form of incentive to do so? From what I know, nothing goes at this hospital without some type of external motivation.

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    1. Nothing goes on anywhere without "external motivation."

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    2. Why do you think there was research... from the documentation it looks as though the surgeon used it correctly and the fact that Ms. Cabana's body didn't react the way it was supposed to is unfortunate... but seriously.... innocence until proven guilty... see the newest revelations on HDE's and the FDA... pertinent info that the plaintiff's greasy haired attorney failed to state publicly.... according to FDA guidelines... the HDE was used correctly and legally. Do your fact checking people... don't embarrass us as humans. Use whatever brain God gave you.

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    3. Really??? Seriously??? You have to be kidding!!!! According to FDA guidelines a IRB has to have a consent unless the procedure is a emergency and there are no other treatment options...... Only then is a consent not needed!!! Really!!!! Seriously!!!! Get your fact straight!!!

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    4. Well, time has come around and the "good doctor" is crap. We have pulled our heads out of our asses and now it's Mesiwala's time to eat crow. Check out the trouble he has created over the years have come back to haunt him. Really!

      CBS Today 9/25 Story
      http://www.cbsnews.com/news/federal-prosecutors-target-physician-owned-companies-that-profit-from-unnecessary-procedures/

      Modern Health Care
      http://www.modernhealthcare.com/article/20140920/MAGAZINE/309209981/doc-owned-device-distributors-targeted-by-feds#

      Becker Spine
      http://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/22201-pods-under-attack-5-things-to-know


      Glovsky complaint
      http://projects.scpr.org/longreads/selling-the-spine/docs/azike_v_mesiwala.pdf

      Dept of Justice 9/8/14
      http://www.justice.gov/opa/pr/united-states-pursues-claims-against-neurosurgeon-spinal-implant-company-physician-owned

      Complaint: USA vs Reliance/Pike/Berry/Sabit 81 page document on PDF
      http://www.corporatecrimereporter.com/wp-content/uploads/2014/09/sabit.pdf

      Becker Spine Review PODs under attack
      http://www.beckersasc.com/news-analysis/pods-under-attack-5-things-to-know.html

      U.S. Joins Whistleblowers’ Case Involving Spinal Implants
      http://www.whistleblowerquitamlawyerblog.com/tag/anti-kickback-statute

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  5. Seeing how there aren't any dead patients to our knowledge can we eliminate that (ex) Synthes employees wrote up the protocol?

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    1. Now that was funny 5:28

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    2. Or Danek BMP folks

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  6. Until corporate executives (who know exactly what is going on down the ladder) are spending more time in jail this will continue.

    The pendulum surrounding off label promotion has swung so far from reality jail time will be the only thing to swing it back to the middle.

    Corporate fines are a drop in the bucket compared to profits earned. So historically it has been worth the risk for corporate executives to improve the bottom line.

    Patient safety? Not even an after thought with these companies.

    It seems spine blogger is on to exposing this. Keep it up!

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    1. As long as you are talking about the medical device company I agree... but when innocent doctors and hospitals are dragged into this, it's a call for attention. When a rep misrepresents info to a hospital and in turn a surgeon, who's at fault?? The rep or company should be. Really? A secret experiment? This is so far fetched I'm embarrassed of our media.

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  7. Why is it that the CEO is never held responsible? As the Captain of the Ship is anyone buying into the argument that they are not aware of what is going on? Come on people, when sales begin to spike over night, no one is questioning why? Prior to the deal, sales were growing at an average rate. So typical, always go after the little guy. Who sets the expectations? Who sets the quotas, Who steers the ship? There are more reasons for people stepping down than "it's time to retire and the CEO has done a tremendous job." On top of that they are given a golden parachute. The only thing golden should be a swift boot in the ass. Just look at Orthofix, no one knew what was going on? Give us a break.

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  8. Prosecutors are going for bottom up investigations. They have found it easier to get plea deals from sales representatives in exchange for inside information than to start at the top.

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  9. Take a look at this other physician associated with Dr. Mesiwala www.basicspine.com. I have never seen a study on inSRT stem cell injections having any benefit for spine conditions. My guess is that this is a cash only procedure. These sham procedures are going to destroy our industry.

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    1. Obviously you have no medical background whatsoever. OR... could it be that you are a competing surgeon trying to start drama by stating your opinion. I'm a rep and I've dealt with numerous doctors... one of which is Dr. Mesiwala... he is by far one of the most by the book surgeons I've ever known. On the other hand... there are a few neurosurgeons we won't do business with as they continually violate every ethical law known to man.

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    2. Dr. Ty is one of the greediest sleaze bags I have ever met. Ask any rep that has had dealings with him and they will say the same thing. He treats his checkbook and not the patient.

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    3. Dr. Ty is extremely respected throughout the medical community. Whoever wrote the comment above obviously doesn't know Dr. Ty very well - or maybe you're just bitter that he doesn't want to use your instrumentation.

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    4. if you havent heard of a story doesnt mean that its a sham, it just means you havent been following up on your CMEs. time to do some reading and catch up. stem cell use for therapeutic purposes is being evaluated across the board in a wide spectrum of health conditions now before you start taking personal jabs without actually knowing something, grow up and catch up on your reading.

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    5. Stem cell use might have some validity at some point in time. For now it's just a gimmick. The Atlas LLC POD, which Dr. Ty is a member, may be just the reason he is in a stem cell research program. Good deal, a gimmick and he gets money back from the POD.

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  10. I'm still trying to figure out how Stryker is implicated in this case. Didn't they sell off this product? MSM has shown his disdain for Stryker in the past. Using them in the title of the blog seems to be personal and a reach. What am I missing? Shouldn't it read Olympus, Pomano and OP-1.

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    1. I was just thinking the same thing! MSM must have been fired by 'Almighty Stryker" at one time...

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    2. Not if the product was implanted while Stryker owned OP-1, how is Olympus involved if the surgery was prior to their acquisition of OP-1?

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    3. Boy Wonder 10:37 the surgery was performed in 2008, who owned OP-1 then? The answer is December 2010, before you question TSB, know your facts and read the legal complaint, and oh by the way, you Stryker He Men have pretty thin skin, don't cha? He Men LMAO

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    4. Stryker Biotech owned it at the time. However no wrong doing was found on the west coast... only on the east coast. This case is trying to bring the alleged misrepresentation to the west coast... however in this case, the OP1 was used correctly and legally. It's a shame that people don't do research. It's a shame that greedy attorney's will rule the world someday:

      Fwd post from the KPCC news site:


      Off label use of an FDA approved medication or device is perfectly legal and at the discretion of the doctor, though it is wise to let the patient know that's what is happening. It is not experimentation.
      Medications and devices approved for HDE (humanitarian device exemption) can also be used; this is a conditional FDA approval and generally the manufacturer requires the IRB to be aware. Again, not an experiment.
      Before jumping to conclusions, it is also important to remember that drugs and devices have side effects. Sometimes these become apparent after FDA approval and drugs are withdrawn. Again, not an experiment.

      What happened to this patient is devastating and unfortunate. But the manufacturer already admitted to deceptive practices. Don't judge the hospital or the doctor until you know what they were told by the manufacturer.

      And your ears should prick up whenever a lawyer uses terms like "Frankensteinesque." Someone is hoping to win the lottery.

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  11. Sometimes I like to gather up all of my stuffed animals, a butter knife, some scotch tape, and play super fun time hospital. Poor Mr. Snuggles is in desperate need of a revision at L4-L5. I hope he'll make it through OK. Sadly, I'm usually dressed up like Winnie-the-Pooh, standing there pantless in my cherry red mesh half t-shirt with my fingers stuck in the honey pot. When will I learn?

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    1. You just keep trying don't you.

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    2. It can't hurt to try, at least thats what Mr. Snuggles says...

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    3. Seriously? Grow up.

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    4. Hahahahahahaha....

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    5. This guy knows exactly the kind of attention that this story, and you sorry pseudosurgeons deserve. You are all so fundamentally, psychologically broken, that you actually think your opinion or your impact on anything matters. The Honey Pot dude is real, he knows you are all a bunch of Winnie the PooH's. Actually, Winnie is more real than you guys, he is on a journey and enjoying the adventure. You tools think you are the destination...

      SUCK IT EVERYONE EXCEPT THE HONEY POT DUDE.

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  12. please for the love of all that is good, let there be an FDA Critical Path Initiative / AHRQ mandated study pitting fusion against physical therapy so that this entire industry may implode and restart from scratch.

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    1. please for the love of all that is good let the uneducated hear the other side of the story before passing judgement. Your comment is a disgrace to this country's educational system.

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  13. Sounds a heck of a lot like Infuse side effects to me. Maybe all BMPs should be considered dangerous.

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  14. Ahhhhh...Dr. Mesiwala! I'm so shocked to hear he is linked to such a thing. Could this be the same guy who is so responsibly performing 12 to 15 bilateral SI Joint fusions per month using SI Bone's iFUSE system? Most doc's down here in San Diego struggle to perform 10 lumbar decompressions in a month, but that's because they're not properly trained to identify, differentiate and treat low back pain the way he is. He's just that good! Are you kidding me? Give him the benefit of the doubt. It really doesn't have anything to do with a stock option grant or consulting agreement. Those are just appropriate, well deserved forms of compensation for his in depth, time tested (since Nov. 2011), Neurosurgical training and experience with the SI Joint. Here come the Health Plans Ali, hide those books!!!

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    1. Thank you for your comment! I was just going to post the same thing. As a fellow doctor that was trained on the iFuse I tend to disbelieve this story as it is told and feel that there is a lot more to it that what has been covered by the media. This is one of the most by the book doctors I have ever known. I think the story is a hopeless attack on an innocent doctor due to a company's misrepresentation of a product. Innocent until proven guilty was the last I heard in the US

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    2. Wow...5:09, just in case you haven't come to realize it yet, this was one of the most sarcastic posts slapping you right in the face. Yes, poking fun at how ridiculous any surgeon fusing bilateral SI Joints with that frequency is. Are you really a doctor?!? You're kidding right?

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    3. wow 8:07 who the heck are you? old school? technology is moving forward. SI fusions were horrible back in the day, now there is a new method. time to catch up on those CMEs!

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    4. wow when will people finally learn si problems can be fixed by fusion. don't blame the man because he is ahead of the curve and doing more than most.

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  15. Just to clarify to all you who don't know how to do a little research and get your facts straight...

    Off label use of an FDA approved medication or device is perfectly legal and at the discretion of the doctor, though it is wise to let the patient know that's what is happening. It is not experimentation.
    Medications and devices approved for HDE (humanitarian device exemption) can also be used; this is a conditional FDA approval and generally the manufacturer requires the IRB to be aware. Again, not an experiment.
    Before jumping to conclusions, it is also important to remember that drugs and devices have side effects. Sometimes these become apparent after FDA approval and drugs are withdrawn. Again, not an experiment.

    What happened to this patient is devastating and unfortunate. But the manufacturer already admitted to deceptive practices. Don't judge the hospital or the doctor until you know what they were told by the manufacturer.

    And your ears should prick up whenever a lawyer uses terms like "Frankensteinesque." Someone is hoping to win the lottery.

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  16. I like turtles.

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  17. A surgeon or doctor can use any product that they want in an off label manner. If the manufacturer of that device has not disclosed material information regarding that product they do not have all the information necessary to make an informed decision. If they can't make an informed decision how can the patient? Failing to report adverse events, failure to disclosure complications during trials etc. The manufacture has a duty to disclose all information. Good and bad. Good data as well as poor data. Then the doctor can make an informed decision and as a result so can the patient. Is this not about protecting the public?

    The manufacturer also cannot promote/sell that product for an off label use. No baiting the doctors, providing one-sided studies, nondisclosure of poor outcomes in studies, failing to reveal financial ties the surgeon may have to a company, training on off label use paid for by the company and the list goes on.

    Companies need to be accountable for this and the FDA sees the only way to do this is to prosecute and jail those executives that by-pass laws put in place to protect the public. Lawyers are also figuring out that manufacturer have some liability when they have been less than honest with doctors, hospitals, or the federal government. The patient suffers and this is starting with the companies that are making these products and then promoting for un-intended, unapproved uses.

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  19. Boooooring.

    Suck it, drugs masquerading as devices. Just suck it!

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  20. This story is completely ridiculous and this is why (if anyone cares):
    1. Spinal fusion is not 100% successful (not even close), and some people do not heal properly, and this is very unfortunate.
    2. OP-1 Putty is an FDA approved product under a humanitarian Use Device exemption (HDE).
    3. HDE’s must be approved for use by each hospital’s Institutional Review Board (IRB). The IRB approval is usually good for one year, and then an “IRB Renewal” form is completed by the surgeon or staff, and the IRB approves it for another year.
    4. 99% of what IRB’s do is review and approve actual “Research Studies”. There are not that many HDE products on the market, therefore IRB’s do not usually have HDE specific annual “IRB Renewal” forms nor do they use language specific to HDE products.
    5. Most of the time IRB’s refer to OP-1 Putty as a “Research Study” (as they did in this instance) because that is the way they describe the other 99% of what they approve and renew and that is just “IRB Speak”. The “IRB Renewal” forms usually ask the surgeon, “How many patients have been enrolled in this study since its inception?” In this instance the surgeon had used OP-1 seventeen times in approximately 3 years – so he indicates 17 on the “IRB Renewal” form.
    6. The FDA does not even require a separate “Informed Consent” be given to each patient when an HDE product is used because HDE’s are FDA approved and not part of a “Research Study.”
    7. THIS IRB KNEW PERFECTLY WELL THAT OP-1 PUTTY WAS NOT PART OF ANY “RESEARCH STUDY” IN ITS HOSPITAL.
    8. This either very dishonest or completely confused attorney (for this extremely unfortunate young woman) gets a hold of a couple of the “IRB Renewal” forms that refer to OP-1 Putty as a “Research Study”.
    9. The attorney then claims that his client was part of a secret “Research Study”, and was treated in a “Frankensteinesque” manner.
    10. Every news organization in the world just goes along with these allegations because honest and ethical journalism died and was buried many years ago.
    11. Most people immediately believe the story because of our nation’s obsession with having to find fault for everything, and concoct dramatic conspiracy theories.
    12. The hospital, surgeon, and manufacturer get dragged through the mud over either a dishonest claim or complete misunderstanding.
    13. This poor young women is still disabled, but the attorney gets his face all over the news while portraying himself as a hero for the down trodden.
    14. BOTTOM LINE: NO SUCH STUDY EVER TOOK PLACE. But does anyone really care about the truth anymore?

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    1. This is an attempt at justice for a victim you your industry's vulgar greed and junk science.

      Like Medtronic they will weasel out of this with a fine... maybe and the victim may get a few bucks but that is all figured into the company's risk management.

      Truth? You want truth? The medical device industry is just one more example of how corrupt the entire medical industry is. The fact that there are 3 ADRs mad in the US and act like the real thing made in the US but not available to American show just how evil your industry and its FDA enforcers are.

      Unfortunately lawyer are the only defense patients have since there is not regulatory agency that protects them from the chaotic and greedy industry. Imagine that... health is an industry and therein lies the problem.

      No conspiracy here boy. It's a fact. Your industry sucks. Americans are test subjects for many drugs and medical devices. They fact that you idiot would even consider putting metal on metal implants in people and then do it shows just how sinister you greedy industry is.

      You may not look as stupid it you stop trying to defend the indefensible.

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  21. I am sick of our industry being shit on. This case is 100% bullshit, and it's scum lawyers that drive up the cost of healthcare.

    I have every hospital demanding discounts, with the attitude that our industry is their enemy. In The rest of the world the distributors are required to purchase all of the implants and instruments and resell them to the hospitals. Because the company only has to cover manufacturing costs and R&D they can sell a lot cheaper. Because the U.S. market requires manufacturers to store, ship, market etc. our prices are higher. I offered a hospital bottom pricing if they were willing to purchase implants and inst and assume responsibility for storage, shipping, inventory etc. they rejected the proposal even though the pricing was well below their construct pricing. I did this to make a point to them that they are shit heads and do not understand business. They cannot have their cake and eat it too. How about they track outcomes, become the best in the world and demand higher payments from the insurance companies? They are lazy and truly have no clue on becoming profitable.

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    1. You industry is SHIT shithead.

      The crap your "industry" sells looks like something that you can by at a hardware store accept maybe what you get at the hardware store is a bit more sanitary.

      Your industry is a cluster fuck and you are blaming regulations that were instituted by members of your industry because you suck as a salesman and can't close the deal.

      The hospital rejected you because they got a better deal/bribe/kickback. Learn to play the game son.

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    2. Actually I already have all the business the proposal was to prove a point that if you want cheap they have to take a risk. I said nothing about regulations,simply different global business practices.

      The indications for a TDR are very narrow and are not the answer for a majority of the patient population. You obviously have no clue what you are talking about. MOST spinal fusion patients do very well and are free of crippling pain post op. You are an angry person that that bitches and has no real solutions. If you get some therapy you can get past the anger and dedicate your life to curing spinal disorders. I assure you if a solution is found no regulation will stop it as the financial upside is enormous.

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    3. @ AnonymousJuly 31, 2012 9:50 AM

      The failure rate for fusions is high if you listen to patients and not the industry hype.

      Here is a solution. Defer to the CE for approval of all drugs and devices and nuke the FDA.

      There are solutions and Americans travel to Europe and India in droves for them. They are called them M6, DCI,Neo Disk, Nucleus Implants, Disco Gel and Ozone diskectomy none of which are available in the US.

      The industry looks at the bottom line and sees that fusions cause heterotrophic ossification and a far higher rate than the good ADRs along with pushing the fast forward button adjacent for adjacent DDD. Motion constraining, shock absorbing ADR hurt business and that is why they are not used in the US where patients are cash cows and disease is seen as an opportunity for profit.

      This is the 21st century and the implantation of flexible spacers should have been done 40 years ago. It ain't rocket science so stop making it sound like it is. Stop drinking and serving the industry Kool Ade.

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    4. Shock absorbing devices have been around for a long time and the materials would not hold up the wear. I assure you if the technology you speak of is so incredible the companies would have studies in every journal. You are implying that the companies manufacturing these devices do not want the technology to progress. Even if they were approved the patients that fit the criteria is very small. If a company found an actual cure for all spine disorders they would not bury it because of the financial upside.

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  22. I have a suggestion for Pomona. Jail. Then again there are 3 motion constraining shock absorbing ADRs that could probably have fixed the patient.

    Medtronic did even sleazier thing with them BMP Infuse. There were a bunch of fines and lawsuits but justice was not done. What sort of justice should be done in lieu of the fact justice will not be done? I call it do it yourself justice.

    It is only a matter of time until one of these victims goes postal.

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    1. I agree with your point but i'm having trouble understanding it. Are you suggesting the entire city of Pomona goes to jail? Or that Pomona should build a jail for its residents? Either way, great thoughts comrade!

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    2. I think you could benefit from an enema AnonymousJuly 31, 2012 9:15 AM but stick the tube in your ear. Of course you have trouble understanding, you have sold the part of your brain that makes you human to the highest bidder and they got is cheap since they did not get much in the bargain. People like you come real cheap. Maybe if you suck enough butt they will make you a manager.

      Jail? I think what would solve the problem would be a firing squad for the medical industry and the FDA.

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    3. Bally, I think I get it now. So if you are in a firing squad or part of the FDA you should ask Pomona to build a jail for you? Oh sorry, I forgot if you are part of the entire "medical industry" you should also ask Pomona to build a jail for you. Since it's industry wide, should female practitioners ask for separate women's facilities? I really agree with your suggestions, especially from a legal standpoint. Last questions, in terms of the becoming a manager, is it the butt sucking quantity or quality that would make someone a premier candidate? For example, if candidate A sucks butt every single day with marginal effort versus candidate B who sucks butt once a week but gives 110%, in your opinion who should get the job? Great thoughts all around!

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  23. Obamacare will fix all this. But wait, the ONE problem that Obamacare didn't address is the slimy dirtbag attorneys who raise the cost of all our healthcare by driving up insurance rates and forcing defensive medicine via extra tests that aren't required. So nevermind, Obamacare isn't going to fix it.

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  24. Listening to you amateurs jockey back and forth on the clinical and regulatory aspects of surgery is sickening. Let the docs figure it out. You should just focus on knowing your systems, check your sets before surgery, give your docs your credit cards at the Olympic Gardens so they can pretend they are 'players' while paying fo the hot chicks they couldn't get while majoring in geekdom, and keep your mouths shut. QUIT TAKING YOURSELVES SO SERIOUSLY.

    A screw is a screw, an allograft is an allograft, and a new biologic/drug is a time bomb. We all know that the system is broken, and it will not be fixed until all you pretentious cocks (reps, management and docs) realize that you are inconsequential.

    Get real, so we can get on with the important stuff.


    Oh yeah, and SUCK IT egomaniacs.

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    2. Herpes rearing his ugly head again.

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  25. You must have a really weak stomach if reading two strangers talk about medicine makes you sick. Do a google search for irritable bowel syndrome, sounds like that might be what you have. Glad I could help, good luck!

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  26. what is the scoop on the S I Bone RIF?

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  27. Does anyone else find it odd that the plaintiff's first surgery was a buttLIF (Trans1) with OP-1 packed around it...yet Trans1 somehow doesn't get named in the suit? Without BMP, that little technique can barely fuse! Their reps would go broke without infuse or OP-1.

    wtf would get you to do case #2 with a BMP when case #1 resulted in unwanted growth is a mystery to a simpleton like me. That buttLIF must've been totally collapsed; else why not just do a little decompression?

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  28. Oh boy...Trans1, SI Bone, Dr. Mesiwala, Dr. Ty, Pemona Hospital, suspect impropriety and off label surgery! Does anyone else smell that common denominator...'cause she really STANKS!

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  29. Globus Medical IPO is here. What's the stock is worth?

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  30. Replies
    1. Really? How much is lobster per pound?

      Delete
    2. $3.00....fisherman won't even fish it is so low.

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    3. Is that before or after their reverse split?

      http://www.marketwatch.com/story/globus-medical-announces-1-for-325-reverse-stock-split-2012-07-31

      Delete
  31. TSB is actually pretty good considering it was reported that GMED would offer 11 million plus shares at roughly $16-$18, hey TSB you weren't a fisherman in your past life

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  32. I wonder what Kelly Clarkson would do say?

    ReplyDelete
    Replies
    1. I am sooooo glad you asked. I think Kelly said it best on her 1983 live album, "Can't Hold Back". During her performance of her #1 hit song, "Slow Ride", she says, "I wear this crown of shit, Upon my liar's chair, Full of broken thoughts,
      I cannot repair."

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  33. BUY LOW SELL HIGH AND GET OUT OF DODGE WHILE THE GOING IS GOOD

    ReplyDelete
  34. The next big scandal in Biologics in Spine..stem cells! No one knows what problems they can inflict upon a patient. We'll see five to ten years down the raod when all the problems present themselves in patients. Hope all the companies selling stem cells has lots of money set aside for lawsuits!

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  35. So every patient that doesn't heal properly is now considered a victim?? You're making broad sweeping generalizations about the entire U.S. health care industry, when I'm speaking to a very specific accusation about one surgeon, one hospital, and one manufacturer, by one lawyer; therefore, your counter-argument is completely illogical. Unlike the judicial system where you're from, or lack there of, ours is supposed to view each accusation on it's own merit. I'm not saying that our industry is perfect, but I will defend the accused in this specific situation because I know these allegations are complete bullshit. Coming soon: the counter-suit filed against this attorney.

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  36. this entire discussion board sounds like a damn tribunal. shut up already! and if you wanted to gossip this much and create such a fuss you might as well have become the soul sucking lawyers that prevent any actual practice of medicine!

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  37. This is tip of iceberg! Stryker has been involved in covert research for a while now. Have you ever wondered why Stryker Spine never launched their two MoM motion preservation spinal implants: CerviCore and Flexicore? It never received a fully approved IDE. And Stryker continued to implant these devices long after it was discovered that they had been contaminated with known and unknown pathogens before they left the warehouse in Mahwah, NJ. Both studies were remanded to the "trial of device not approved or cleared by the US FDA" for any use whatsoever, under a delayed posting on 12/21/2007. The CerviCore disc was implanted into my cervical C5C6 in 2008, months after the study was ordered to the FDA secret black box. The CerviCore discs may have been coated with OP 1 without FDA approval. Stryker never disclosed the material fact that the CerviCore disc contained "nickel" , and if the study was legit, the FDA required that all subjects be prescreened for "metal allergies" as well as infections prior to qualification. None of the protocol was followed by any of the Stryker surgeons and people were herded into the faux studies without a prescreening or meeting the inclusion exclusion criteria. After all is said and done, Stryker may soon go down in history as a criminal Nazi like multinational device corporation using unwitting people as guinea pigs and destroying their spines with absolute impunity. When I filed my claim first asking Stryker to remove the disc, after 8 tumors developed, they refused to remove it - as it would be evidence of their crime (covert implantation of an unapproved Class 3 spinal device) - and instead attempted to bribe me with an offer of $10,000.00 to sign a release from liability. If anyone on this blog knows anything about "legitimate research and clinical trials", you would know that a sponsor or anyone connected with any FDA approved research is prohibited from trying to coerce a "research subject" into signing off on liability if one is injured by a researchy device.
    MacMillan should be in prison for the remainder of his life -- the damage he has caused to the spines of hundreds of innocent persons who were deceived by Stryker Surgeons is on par with the damage that Nazi doctors did to innocent victims in the slave camps.

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  38. Spine Surgery Apollo Hospital Chennai, Spine Surgery India, Spine Surgery Cost In India Info On Cost Spine Surgery Delhi Chennai India, Affordable Spine Surgeons India, Spine Surgery Apollo Hospitals Mumbai India, Spine Surgeon India, Spine Surgery Center India, Spine Surgery Doctor India, Spine Surgery Clinic India.Here i suggest peoples to go INDIA for srgery, then you must search for Spine surgery India, Laser spine surgery India, Best spine surgeon India, Spine surgery best hospital India & spine surgery cost india

    ReplyDelete
  39. All patients of anterior cervical neck implants have been deceived into paying for the surgery needed to remove broken implanted devices. TITAN SPINE AS OF SEPT., 2014 gives a warranty on their implant hardware and they are permanently implanted. Why did the FDA allowed this to happen and what are they now doing about this-----because they are not protecting the patient from having to pay for broken screws and plates and 2nd surgery to remove them. WHAT DO YOU THINK ABOUT THIS---------------

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  40. Well, the upshot of this case. Everyone had to pay. Pomona Valley Hospital, Mesiwala and Stryker all had to pay a ton of money to Ms. Cabana. Settled out of court and a non-disclosure arrangement so the final outcome would not be too much of an embarrassment to those involved. Suck eggs, eat crow cause you are dirty.

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