Sunday, December 11, 2011

What is the Story with the Hip explants (hip removed after revision.) Part 1 of 2

Now that I am getting a bit better, I will begin the testing on two things:
  •  The explanted hip
  •  DNA testing (Fish).
I started with the explant thinking this was going to be a simple process.  Should have known better.  Sounds simple: take the hip and the fluids  and send them to your lab of choice for analysis or if you have a lawyer, their lab of choice.

First thing I did was to review the MDL protocol that apparently governs the hip explants and here is what I found after reading the explant preservation order which is located here:  http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197
/ExplantPreservationOrder.pdf :
  • The explant order covers both the explant and the tissue and blood samples IF retrieved during the surgery.  This is important because in my case, I had a lot of synovial fluid that will contain information if sent to the proper lab.
  • "The parties agree".....well,  the "parties" referred to are the lawyers on the mutidistrict litigation committee who represent the plaintiffs and then of course the defendant, Depuy.  It is important to keep this in mind for a point which I will make in part two of this post.
    • This "agreement" was made because there was apparently a  dispute about who should get the explanted hips; the patients (or their lawyers) or Depuy or both. 
  • The explant order provides for the preservation of hips and surrounding tissue which may constitute evidence related to the design or manufacturing claim which patients may assert in litigation.
  • The explant has to be preserved (there is no definition of what that means other than an attached exhibit A to detail what it might imply...more on this in part two of this post.)
  • If the counsel of record for the plaintiff (what if there is no counsel of record?) desires to inspect the device, they may send it to a lab of their choice.  ABSENT THAT CHOICE BY COUNSEL OF RECORD FOR THE PLAINTIFF, DEPUY WILL MAKE ARRANGEMENTS FOR THE EXPLANTED DEVICE TO SENT TO THEIR LAB (ORTHOPEIDC HOSPIAL IN  LA.)
    • So what does this imply for devices that are not a party to the MDL?  Does this mean that the patients who are not represented are automatically under some kind of decree which automatically allows Depuy to come in and take the evidence?
As I read this 9 page order, either the plaintiff's lawyer or Depuy has a right to take this hip first.  The court seems to have provided the opportunity to have both sides examine this evidence now.  Further, the courts provided that the parties agree to exchange the results of the testing done.

The order than attached an exhibit A which contained an exemplar of how the explant review should be conducted (more on this in part two of this post tomorrow.)

I have just requested my hip.  I have no response yet as to where it is nor whether the fluids and tissue samples have even been saved.  I know the hip was saved but I paid little attention to the protocol under which is was to be maintained.

Here are my questions:

1)  There is little health privacy  law in existence called HIPAA which is supposed to keep information regarding the patent's medical information private and secure.  I wonder if because I had no lawyer who is monitoring this process and who said, "we want to analyze this hip first", if Depuy was  then given the right by this MDL ruling that they could just come in and take it?  I have no idea what the answer to this is.

2)  If my expant is not governed by the MDL because I filed no suit, is the explant process covered anyway by this judicial order?

3)  It appears from reading this  order that the surgeons must store the actual implant but it is not clear to me that they are compelled to store the fluids unless directed to do so prior to the surgery?  Yikes!

4) So there seems to be 3 types of evidence:
  • explant
  • The fluids (snynovial fluids and or whole blood serum)
  • The tissue samples
Now why in the heck would the directive require that the device be saved and preserved but the remaining evidence had to be specified prior to the surgery as to whether it should be preserved or not?  This makes no sense whatsoever.

Why wouldn't an orthopedic surgeon be required to ask the patient in each and every case whether the  non explant evidence should be preserved?  No one asked me this question.  Maybe this is why I thought the Path results were useless.  It appeared to me that no real tests were done other than a cancer path  test.

Boy, oh boy oh boy, every time I go to turn up a new card in this ordeal, I find nothing but more questions about this process.

Stay tuned to part two of this in which I raise issues about what this MDL committee and Depuy agreed to in terms of testing.

Stacy tuned as to whether someone is going to hand over this explant, the tissue and blood samples over to me.

Ya know what I would do for those of you who have not had the surgery, make sure that you provide in witting to the surgeon that you want all three pieces of evidence saved (blood serum, tissues and synovial fluids.)  don't take any chances that someone is watching out for your.  Just send in a written directive to the surgeon prior to the surgery.

It's all evidence for goodness sakes.  Who in their right mind would destroy the evidence?  don't assume anything.

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