Wednesday, May 23, 2012

The Stryker Affair

Greece is in a political and economic quagmire, JP Morgan is under attack, the Facebook IPO has turned into a laughable moment, and Stryker makes the front page of the Wall Street Journal? As usual, this turns into a teachable moment about how a rigid and victorian Board of Directors can behave.  How sensitive and thin skinned are these people? They actually read Cafe Pharma? Who knows, they probably read TSB. Oh if only to be born again.

It was reported by the WSJ that William U Parfet, Chairman of the Board reported at an April 24, 2012 meeting that "just to clarify, on the behalf of the BOD, we'd like to state that Steve never violated any company policy nor any code of conduct." With that said, this news finally brings to light a teachable moment that leaves many to ask the question, "what in the world is going on at Strykerland?" Initially they snubbed Ned Lipes for the position, Mogul leaves for greener pastures, and MacMillan is pressed into resigning. Over the years TSB has poked fun at Stryker and MacMillan, but what does this say about expectations when it comes to leadership? Is this another of those "do as I say, not as I do" moments? This will not be the first time that any of us have heard of an office romance, but really, the BOD was worried about ITS credibility?  TSB is sure that there will be a difference of opinion, and we will leave it up to our readers. But what does this say about Stryker that hasn't already been said? Are they still stuck in the 50's? Is Thruston Howell III still on the board? Could MacMillan have handled his affair with panache? Asking certain members of the Board for permission to date is the ultimate kiss of death, but then at Stryker pomp and circumstance has always ruled the day. Out of the box, these people are so deep in the box that they might as well be in their coffins, but then again some of them look like zombies.

As for loyalty, it seems that even MacMillan's lieutenants exhibited little discretion. So in closing, we wish MacMillan all the best in his future endeavors, because divorce is a messy situation, and finding someone to love whom loves you is priceless, it might even be worth leaving the confines of Stryker. But TSB looks at it from a different perspective, Stryker's loss is J&J's gain. If Marv Albert was resurrected from the dead, hope springs eternal.  TSB wants to know what our readers think, is this all to do about nothing?




54 comments:

  1. Ivory tower issue. Who cares.

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  2. Innotek was sold for how much ?

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    1. A buck 2.80 - they overpaid!

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    2. a cool 10 million actually.

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    3. Who the hell is innotek

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    4. Did they get to keep their red staplers?

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    5. 10 million seems low...who knows though I heard some of the top reps are leaving?

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    6. "Top reps are leaving" Like who? And honestly why wouldn't they. Innotek has some VERY strong reps. Go cash in on some distributor type commisions that you can get out there. If there relationships are strong, a JnJ/Synthes merger would be the perfect out, or time to approach your key surgeons about a switch. Leave the 8% for someone else and go get yourself 20+

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    7. @ 4:28; agree...they have some strong relationships but from what it sounds like they are getting a pretty fat package in Chicago so why would they leave to go to a BS distributor??

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  3. This is completely offsubject but I'm in a bind. Does anyone have or know how to obtain a scissor jack intervertebral body spreader from alphatech? Or something similar. Please drop an email or link.
    Thanks.

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    1. Suggest calling them. They'd be happy to sell you one.

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    2. Scissor Jack is a Medtronic Product.

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  4. Investigative Spinal Industry Journalist should look a little closer to the two failed spinal total disc replacement trials, CerviCore and FlexiCore. Both Class III trials have been covertly residing in a little known database at the FDA called: Trial of Device Not Approved or Cleared by the USFDA. They were posted under the status called : Delayed Posting defined as a trial device that was NEVER FULLY APPROVED FOR USE OF ANY KIND. For starts: these two defunct devices cost Stryker approximately a half a billion to launc - but when a corporation is in ratio to other orthopedic companies the global size of a Mammoth Elephant, forgets or overlooks the necessity of acquiring a simple Certificate of a Safe Device from the FDA portal Inspection agent for their investigational devices manufactured in a foreign country, you just have to cry at the sheer incompetence of this corporate new product development faux pax.

    This is just the Tip of the Cestas, France CerviCore - FlexiCore Thomas Errico, MD saga of rushing a metal on metal product to market and leaving out the fact that the one metal component, nickel, which has the worst safety record when friction metal wear debris and toxic carcinogenic risks to trial subjects is intentionally concealed. The study continued under the pretense of being fully approved, even after it was registered as a delayed posting on 12/21/2007 - weeks after the FDA wrote the CEO MacMillan a scathing enforcement warning letter concerning findings of a laundry list of known and unknown pathogens adulterating and contaminating all of the medical implant devices stored at the Mahwah plant.

    MacMillan orchestrated the Errico Spine Core Merger in competition to Medtronics approved Spinal TDR devices. Stryker had to cut a few corners that were questionable at best and put a number of CerviCore volunteers at risk by not disclosing the nickel component and failing to follow the Protocol CT - 002-04 for the CerviCore NCT 00588601. Google 'trial device not approved NCT00588601' or visit SpineSupport.org CerviCore Intervertebral Disc Forum.

    Errico was already paid $126,000,000 dollars for the rights to his two designs - there are no FDA exemptions for design controls and facet loading profile testing was never done prior to submitting first application in 2004 which was turned down and would only be approved under certain conditions. A " conditional IDE approval" is not a full approval unless the conditions are complied with - as it turned out, they were not. And Errico never got around to submitting facet loading profile testing until 2011 - 4 years after the device was put in the FDA Black Lock Box in 2007. Also there are now three versions of CerviCore all claiming to be the FDA approved IDE. In fact, none of them are and they are on the Internet solely to provide data for Errico's contract law lawsuit he filed in 2010. The entire Stryker Spine TDR trials are a MIRAGE. The only thing real about the trial is the list of severely injured CerviCore patients who had no idea that nickel was in the disc when they signednthe consent forms and now have severe metallosis. Orthopedic surgeons will not treat these victims for fear of getting caught in the crosshairs between Stryker, FDA reporting of failed class III device, The Errico brothers with possible connections to the Viscogli brothers and being setup to be named in a medical malpractice suit if the patient dies during the revision surgery or is paralyzed.

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    1. Um, these aren't on the market in the US, what's your point?

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    2. Point is, they aren't on the market in US because Stryker intentionally failed to disclose the fact that the CerviCore contained nickel to the research subjects - who were severely injured with a condition called 'metallosis'. Furthermore, Stryker did not report these adverse events to the FDA the entire time they were implanting the device without the IDE being fully approved. Then when Stryker Spine's Mahwah plant was busted in 2007, the FDA suspended it's application for a PMA due to the devices being contaminated with numerous known and unknown pathogens.

      The CerviCore trial was then remanded to the FDA black lock for as a Trial that was NEVER approved. That is my point and by the tone of your comment, you sound like you are an involved guilty party to this sham clinical trial that injured numerous and Stryker reneged on them inadequate consent form and would not pay for the medical expenses to remove the disc like they said they would - because that would have sent up a huge red flag that the trials were never approved and Stryker Spine violated numerous FDA regulations. It is parallel to what the Synthes cabal tried to get away with - conducting unauthorized class III clinical trials and then permanently injuring or killing the subjects in the process. It is only a matter of time when this is going to blow sky high. Stryker did not have a clue about what it was doing with metal on metal devices and they lost the stockholders a boat load of money and put a number of people at risk and who may become paralyzed for the remainder of their lives because of Stryker's criminal conduct during clinical trial research.

      Why is Thomas Errico suing Stryker? That should raise some red flags....

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    3. What the public doesn't realize is that the Stryker pulled the plug ( or rather the FDA told Stryker to pull the plug) on the CerviCore study the very same week in February when MacMillan resigned. Parallel worlds and synchronicity patterns are visible to critical thinkers - not frat boys who sell Stryker products that are mediocre at best and contaminated with known and unknown pathogens due to cheap non- sterile packaging while stored in warehouses that are environmental toxic nightmares.

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    4. Hey, I know it's been two years and all, but if you're still out there, Philomena, I'd like to talk to you. I have a Flexicore implant that's gone bad and I'm getting no help from Stryker.

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    5. Our law firm* is handling FlexiCore litigation, too. You can reach me at Philomena.55@gmail.com for more information.
      * Google CerviCore litigation

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  5. stryker stryker stryker stryker....STRYKER!

    --Lloyd Bridges, "Airplane!"

    anyone at TSB speak jive?

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  6. does Steve's departure affect Globus going public?

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  7. No more anonymous posts??

    http://mashable.com/2012/05/23/internet-anonymity/

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    Replies
    1. Waste of time: You will have 48hrs to post anonymously if it even passes.

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  8. TSB,

    Should this posting not result in a 20% increase in comments, you will be terminated.

    Best,

    Stryker BOD

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  9. Anyone have a good biologic to replace Vitoss? Since Stryker took over the rep never shows up and a surgeon that I work with is done. He said I could have the biz if I find a good product.

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    1. Integra Mozaik, which you can get through their Recon, Spine or Orthobiologics division, Copios from Zimmer and Biocomposites.

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    2. Mozaik is ancient TCP technology, and Copios isn't much better (collagen-based successor to Collagraft). Try a newer technology--Microfuse or InQu or NovaBone or Bacterin (if you want a DBM)...

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    3. Newer Technology? You must be joking on the three examples you've given, especially Novabone, a 10 year old product - the ol' "bioglass" sell. All of those are basic synthetic crap and Bacterin remains a bigger joke than all three combined

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    4. Agree with 6:47 that Notabone and Bacterin don't qualify as new/innovative. What is new or innovative?

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    5. NovaBone is 100% Bioglass less the carrier that does nothing to promote fusion..might inhibit (does anyone believe that works?), and anything from Bacterin is junk! You can't trust the boys at Biostructures as far as you can spit them..not very far. InQu..more smoke than mirrors, but not good!

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    6. who cares if the rep shows up for a case if all he or she is providing are biologics. What's the point of having the extra person in the room?

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    7. Actually, Bacterin’s DBM is an excellent allograft option. Depending on which camp you claim, processed donor bone or synthetics, arguments can be raised either way. Irrespective of ‘personal opinions’ regarding the organization, the OsteoSponge (100% DBM) is 1. a natural biological scaffold that contains human BMPs 2,4,7 with associated IGFs that are viable post sterilization. 2. excellent handling characteristics and 3. priced competently. The stuff actually works and works well. We’ve been selling it for over 2 years with great patient outcomes in PLF and as a IBD filler (over 1000 cases). True the technology has been around for sometime however, it was the winner of the 2009 innovation award and since then has 2 more pier review articles that conclude excellent fusion rates at 5 years. Tried & true may be the better option to newer/innovative.

      BioMininics technology coming down the pipeline looks promising for those in the synthetic camp. Stay tuned…

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    8. Everyone has a cancellous cube. However I will read the Pier Review, I just bought a boat

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    9. This is my sponge cube. There are many others like it, but this one is mine. My sponge cube is my best friend. It is my life. I must master it as I must master my life. Without me, my sponge cube is useless. Without my sponge cube, I am useless. I must sell my sponge cube true. I must sell harder than my enemy, who is trying to kill me. I must out sell him/her before he/she out sells me. I will. Before God I swear this creed: my sponge cube and myself are defenders of my OR, we are the masters of our enemy, we are the saviors of my life. So be it, until there is no enemy, but peace. Amen.

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    10. If your looking for synthetic check out Pioneer Surgical. Their Nanoss product line is pretty nice.

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    11. Biomimetic? Read the news--FDA holding up approval of their product and might ask for new clinical. U won't see Augment for a while and it will be very expensive when it does arrive (have to pay for the PMA somehow).

      Nanoss--more old tech, tho they do put it in a slick-looking syringe.

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    12. Advanced Biologics looks intriguing. They certainly have some audacious claims.

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    13. 10:14 Thank you B. Ratliff for your unbiased posting on Bacterin. Very informative!

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    14. Advanced Biologics is poorly run, run far away from Mr. Cadotte and crew. No distribution/surgeon protection.

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  10. Just curious.....did Big Mac ever get his frequent flyer miles and membership card to the Mile High Club????

    Seems the Stryker BOD keeps on mentioning that Big Mac never violated any company policy nor any code of conduct....when you have to repeat it as often as they do it makes me wonder if they are trying to convince me?????

    Since we had one Jimmy Buffett reference this week - how 'bout another - "that's my story and I'm sticking to it".

    Fins Up!!!!

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    1. Big Mac most definitely got his special sauce on some filet o fish. He's another arrogant CEO that assumed the role through attrition.

      5:54 is right from the BOD- dost thou protest too much?

      Stryker continues to make tremendous mistakes, but hey, they have a lateral system....

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  11. Kill the Medical Device tax!! If you have the time sign the petition. http://no2point3.com/corporate-leaderboard

    Some companies are truly showing their lack of zest to fight this bill. The big dogs need to get back on the porch and do some barking!

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    1. Look at the NUVA culture shine! What's up with MDT, JnJ and Zimmer? Zimmer, 11 signatures? Seriously?

      This is how they get away with this over taxation crap. TSB, how about a post on signing or not signing petitions to fight this tax hike?

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  12. MM,
    Love the Marv Albert reference!! Can watch an NBA game without imagining him all dressed up in panty hose, high heels, a bustier and bright red lip-stick!! Hilarious!

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    1. You have serious problems. Seek help. If you feel that you may act out, call 1-800-WANKERS.

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  13. The deal with the biologics rep not showing up matters because the hospital ran out of product for the second time since the transition. Sometimes another body in the room is good 11:17pm. You must be one of the new Stryker Biologic reps. Stryker is screwing this into the ground just like always.

    LOL!!!

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    1. Not one of the new reps but if it was me I would just make sure the hospital had enough inventory on hand, seems like an easy solution.

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  14. Critical Mass Radio Show: Interspinous spacer implants to be marketed to interventional pain management?

    http://www.vertiflex.net/news-critical-mass.html

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  15. Dumbass actually asked the Board for permission to date someone he was already dating. No one ever said rich men were smart.

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    1. While he was still married--did he think that wasn't going to get back to his wife? Hope she takes him for a bundle. And for the BOD to say that the CEO never violated any code of conduct is ludicrous! Wonder how many of them are steppin' out on their wives.

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  16. If you guys believe this is the real story behind MacMillan's ouster, than you are very naive about the vicious and treachous inner corporate workings. Overall, MacMillan cost Stryker close to a billion dollars due to bad management of corporate assets.

    My theory is that MacMillan conspired with Thomas Errico, MD to sabotage the CerviCore and FlexiCore studies, so that Errico couldmcome back with a breach of contract lawsuit. This lawsuit would be a pretense to syphon $95,000,000.00 from Stryker's accountable funds - and transferred to an attorney trust account after the settlement. The funds would be later used to pay kick backs and would be untraceable tomStryker.

    Read the Errico v Stryker complaint. fact is it has absolutely No Merit. The CerviCore and FlexiCore studies were halted officially sometime in 2007. Shortly after MacMillan received the enforcement warning letter from the FDA on 11/28/2007, Susan Kransey at Stryker Spine submitted the studies into the FDA black box as " trial devices Not approved or cleared by US FDA for any use. CerviCore had a IDE - it was never fully approved and the inspection of the Mahwah plant uncovered all of this foul business. Now there are a number of clinical trial victims who have severe bone infections and metallosis - this is what Stryker is covering up. They know it is a matter of time before the DOJ catches up and a new CEO had to be installed to prevent the world seeing MacMillan marched out of Stryker HQ in handcuffs. His CerviCore sham clinical trial has destroyed a lot of innocent persons spines and life. This level of greed is outright sociopathic and MacMillan is a criminal sociopath who could care less that he has destroyed our spines - his answer to our claim to save our spines the injury becomes permanent was to offer us $10,000.00 grand to shut up and go away. All of us that have been injured by their corporate criminal games have lost our jobs, insurance and cannot care for ourselves or family. Clinical trial screw up are not covered by private ormgovernment insurance plans. We are out of luck and have to wait and see if the government is going to do them right thing thing and prosecute the corporate executives and cabal of surgeons who conspired with MacMillan to set up a charade clinical tril so Errico could have a legal pretense to sue Stryker and extort $95,000,000.00 million dollars from Stryker to hide away and use as a secret slush fund for more scientifically unsound experimentations on human being. PS Stryker waived all of the FDA protocols that would have protected us - but since the cLinical trial master file is protected by Trade Secret Protocol, no one will ever be the wiser.

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  17. Corporate gangsters are corporate gangsters.

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  18. The criminal elite never go to jail. Let's hope they go to hell.

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  19. Correction - as it turns out - Stryker NEVER bothered to file an application for an IDE for the modified CerviCore that was used in the faux trial - and this explains why Stryker Spine had to register the CerviCore CT-002-04 in the Title VIII clinical trial database under code for Delayed Posting as a TRIAL DEVICE NOT PREVIOUSLY APPROVED OR CLEARED BY US FDA FOR ANY USE. This means the device is ROGUE - Illegally implanted into the spines of 288 research subjects.

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