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  • #31
    Originally posted by Pooka1 View Post
    The appellate court upheld the dismissal of plaintiffs' law suit against several medical/professional associations. So the plaintiff's claims did not carry the day but nor did the defendants' defense as far as I can tell (they didn't get costs).

    http://biotech.law.lsu.edu/cases/dev...93_F3d_781.htm



    So the bottom line here is the medical/professional societies were not liable as claimed by plaintiffs whereas in the Spinecor case, there is evidence they certified Wong et al. and then later claimed they didn't when the results were bad for the brace.

    The two situations are completely distinguishable, mutually irrelevant, and go counter to what you appear to be alluding to... the case in Spinecor (i.e., the medical societies' position was upheld). If the Spinecor case puts you in mind of the this pedicle screw case then I suggest you haven't read the case. I've posted it if you do want to read the decision.
    I agree that I may have been speaking of apples and oranges - somehow the apple did remind me of the orange :-)

    The orange - certainly deserving of its own thread.

    The Spinecor controversy remains to see final proof one way or the other (real or imagined).

    Comment


    • #32
      pedicle screw law suits

      I found this short page about this subject

      http://www.sheller.com/SubPage.asp?SubPageID=76

      in case anyone's interest is peaked. Unfortunately the link on the page to a timeline of pedicle screw problems is broken.

      The large AcroMed settlement dealt with defective screws, not screws in general.
      Sharon, mother of identical twin girls with scoliosis

      No island of sanity.

      Question: What do you call alternative medicine that works?
      Answer: Medicine


      "We are all African."

      Comment


      • #33
        Got it using wayback...

        http://web.archive.org/web/200805040.../pedicle1.html

        Only goes through 1998 though. It would be good to see what happened after 1998 to the present.
        Sharon, mother of identical twin girls with scoliosis

        No island of sanity.

        Question: What do you call alternative medicine that works?
        Answer: Medicine


        "We are all African."

        Comment


        • #34
          Originally posted by Pooka1 View Post
          The appellate court upheld the dismissal of plaintiffs' law suit against several medical/professional associations. So the plaintiff's claims did not carry the day but nor did the defendants' defense as far as I can tell (they didn't get costs).

          http://biotech.law.lsu.edu/cases/dev...93_F3d_781.htm


          That was an interesting case - most of the original plaintiffs were referred to local courts (as I remember). Its not so much the respondents that concern me in such cases - as it is the patients. Were you able to find the actual final court document? Here is an original court document (circa 2000 which I believe was appealed):

          http://www.state.il.us/court/Opinion...ML/1982670.htm

          The ruling in 2000 was: Accordingly, the judgment of the trial court granting summary judgment in favor of plaintiffs is affirmed. Plaintiffs being: Atlantic Mutual and Centennial Insurance companies vs. American Academy of Orthopedic Surgeons and Scoliosis Research Society


          My point is (the apple/orange thing): controversy - happens.

          I would like to see any actual court documents following 2000 on this one - just color me curious.


          Last edited by mamamax; 12-06-2009, 01:23 PM.

          Comment


          • #35
            Originally posted by mamamax View Post
            That was an interesting case - most of the original plaintiffs were referred to local courts (as I remember). Its not so much the respondents that concern me so much in such cases - as it is the patients. Were you able to find the actual final court document? Here is the original (circa 2000 which I believe was appealed):

            http://www.state.il.us/court/Opinion...ML/1982670.htm
            This appears to be the related case of the societies' insurers not wanting to pay out on the underlying case which I think is moot because the societies won that case. Not really sure though.
            Sharon, mother of identical twin girls with scoliosis

            No island of sanity.

            Question: What do you call alternative medicine that works?
            Answer: Medicine


            "We are all African."

            Comment


            • #36
              And I'm not sure either - can't seem to pull up any original court documents following 2000 - when judgment was awarded to the insurance companies, according to this original court document in 2000:

              http://www.state.il.us/court/Opinion...ML/1982670.htm


              Quite a controversy when reading this document with a keen eye.

              If there exists no following court documents - then this would have been the final ruling handed down in 2000.
              Last edited by mamamax; 12-06-2009, 03:21 PM.

              Comment


              • #37
                The bottom line is that pedicle screws are not fundamentally flawed and are arguably the most important breakthrough in being able to straighten and derotate spines back to a normal position while almost completely avoiding pesudoarthroses

                whereas

                Spinecor is looking to be fundamentally flawed as a treatment of AIS (so far) though not as a treatment for JIS or pain in adults (so far).

                You are an example where it has helped your pain. We will see if it halts your progression (if you had any) after you come out of the brace.
                Sharon, mother of identical twin girls with scoliosis

                No island of sanity.

                Question: What do you call alternative medicine that works?
                Answer: Medicine


                "We are all African."

                Comment


                • #38
                  Fundamentally - pedicle screws are class III devices - do you know the definition of that?

                  Anyway, my point is - controversy happens - everywhere.

                  Spinecor treatment is only looking to be flawed because you say it is - not necessarily because it is.

                  Any treatment today can only be defined as successful or unsuccessful over the course of the majority of the patient lifetimes involved ... we have a long way to go before establishing that.

                  In the meantime, of course, we are all entitled to our opinions - and our personal choices.

                  Comment


                  • #39
                    Originally posted by mamamax View Post
                    [COLOR="Navy"]Fundamentally - pedicle screws are class III devices -
                    That's wrong. You read that in one of the old papers. Check its status now.

                    Pedicle screws work as advertised. Spinecor does not.
                    Sharon, mother of identical twin girls with scoliosis

                    No island of sanity.

                    Question: What do you call alternative medicine that works?
                    Answer: Medicine


                    "We are all African."

                    Comment


                    • #40
                      ok - I do see they have been upgraded to Class II .. that is good, they must have gone through changes to make them safer - very good news. Spinecor is Class I bty and does work for many.

                      A recall in 2008 I see .. controversy - everywhere!

                      http://www.accessdata.fda.gov/script..._DT=2008-10-28
                      Last edited by mamamax; 12-06-2009, 04:52 PM.

                      Comment


                      • #41
                        FDA - Pedicle screws are safe and effective for scoliosis.

                        http://www.accessdata.fda.gov/script...fm?fr=888.3070

                        Let's see if Spinecor can show the same eventually.
                        Sharon, mother of identical twin girls with scoliosis

                        No island of sanity.

                        Question: What do you call alternative medicine that works?
                        Answer: Medicine


                        "We are all African."

                        Comment


                        • #42
                          Originally posted by Pooka1 View Post
                          FDA - Pedicle screws are safe and effective for scoliosis.

                          http://www.accessdata.fda.gov/script...fm?fr=888.3070

                          Let's see if Spinecor can show the same eventually.
                          In reading that FDA document: http://www.accessdata.fda.gov/script...fm?fr=888.3070

                          It looks like they can be considered either Class II or Class III depending upon their use. For example: Class III when used in conjunction with fusion in the treatment of degenerative disc disease.
                          (b)Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

                          (2) Class III (premarket approval), when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

                          Comment


                          • #43
                            I said they have been found to be safe and effective for scolisois. They are Class II for scoliosis.

                            I don't know why you brought up pedicle screws on this thread about Spinecor. Apples and oranges in terms of proven safety and efficacy... pedicle srews have proven themselves for scoliosis.

                            That said, I predict Spinecor will be found safe and effective for pain in adults and possibly JIS but we will have to wait and see what the future holds.
                            Sharon, mother of identical twin girls with scoliosis

                            No island of sanity.

                            Question: What do you call alternative medicine that works?
                            Answer: Medicine


                            "We are all African."

                            Comment


                            • #44

                              I was simply discussing the document you brought up to illustrate safety - which in my case (degenerative disc disease) does change the ball game to Class III, it appears (from the FDA document you presented).

                              I brought pedicle screws up to illustrate that controversy exists everywhere (evidenced as recent as 2008 in a large recall). Your comments about Spinecor, and your personal, rather spirited, opinions remind me of that.

                              At the end of the day - treatment choice is a matter of personal choice, and if we let controversy become our guiding light - we would get nowhere.
                              Last edited by mamamax; 12-06-2009, 05:48 PM.

                              Comment


                              • #45
                                But pedicle screws are not controversial. Spinecor is. That's why it was a non sequitor in this thread.

                                And when did I ever say people can't choose their treatment?
                                Sharon, mother of identical twin girls with scoliosis

                                No island of sanity.

                                Question: What do you call alternative medicine that works?
                                Answer: Medicine


                                "We are all African."

                                Comment

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