OT - Warfarin question again

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Ozchrissy
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OT - Warfarin question again

Post by Ozchrissy » June 18th, 2017, 6:42 pm

I was going through my Consent Form relating to my valve trial last night and noticed that there is provision for me to get compensation for injury or illness from the trial.

This is the relevant provisions under Australian law.

https://medicinesaustralia.com.au/files ... elines.pdf

I have had two TIA's from low Warfarin Levels and also the major bleed in my abdomen from high Warfarin levels. This is not going to go away and I face the risk of the next bleed being in my brain or other major organs.

My main issue is that I have asked the Doctors involved in the trial to supply me with the home Warfarin monitoring system but they have stated they do not have the money to do that. It would probably cost them $1000 to set me up and about $200 a month for the strips. Of course this has led me to re-read my contract and subsequently find this legislation. A company that was paid $400 million for the valve (Twelve) and also the new company (Medtronics) who bought them out, couldn't give a damn about me as the patient. I also know there have been deaths and from what I have heard, they all seem to be related to blood clotting and bleeding.

I really need honest opinions, my argument is that I would not be on the Warfarin if I didn't get the new valve, therefore the risk I am experiencing with the blood issues is a result of the procedure. This to me seems to be covered in the compensation provisions.

Do you think I have a point, do you think I am just trying to get back at them because of the issues I am experiencing, etc.
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

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Ozchrissy
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Re: OT - Warfarin question again

Post by Ozchrissy » June 19th, 2017, 4:59 am

Rang around and got no-where today, so sent this letter to Medtronics who now own the Company. What do you think I will achieve if anything???????


Re-Medtronics/Twelve Transcatheter Mitral Valve Replacement System.

I am the first person in Australia to receive the above system in October 2015. I received my replacement valve at the Alfred Hospital, Melbourne, Australia with Professor Stephen Duffy and Dr Tony Waldron.
Since receiving the valve I have had two TIA's and recently was Hospitalized for an abdominal bleed. I am very sensitive to Warfarin and my INR levels have NEVER been stable since the insertion of the valve. I am extremely compliant with all the needs of taking Warfarin, but was unaware of the effect of Anti-biotics on my levels. I also had contracted a chest infection which caused me to cough more than usual. However, my warfarin levels have often been as high as 7 and as low as 1.4. There is no explanation of why my levels are so unpredictable and there appears to be no way to address the issue.

It would be a huge safety net for me to be able to do home monitoring, which would enable me to keep a closer watch on my INR levels. This system is not covered by our Medicare system. The device to do the monitoring is $800 and the cost of the testing strips would be about $200 per month. This cost to me personally would not be affordable. I am a Disability pensioner.

I have been in contact with the Medical Team at the Alfred Hospital and have been advised that there is no provision to enable me to have closer monitoring of my INR.

My point is that if I did not have the Valve, then I would not need the Warfarin, therefore I would not be a risk of another major bleed. Next time it could be my brain or other major organ and be fatal.

I believe that the Trial and the manufacturers have a moral responsibility to support me and to enable me to maintain a quality of life. I am not asking for something that is not necessary, and also is exorbitantly expensive considering the investment made by Medtronics into the device. My data is still being collected for your information, including the recent bleeding episode. All I am asking for is a way to keep me safe. I believe I am important and am not just a statistic on your research paper. Also if I die, it will be another death added to your statistics which I am sure will be seen as something that was foreseen and also preventable. I am not asking for a lot, just the ability to keep a close watch on my own health.

In my Consent Form there is in Paragraph 17 reference to provision for Complaints and Compensation set up by the Medical Device Industry and agreed to by Twelve Australia P/L. https://medicinesaustralia.com.au/files ... elines.pdf

I am sure that I fall into the provisions of these guidelines. Since my abdominal bleed I have been extremely anxious of when my next bleed will occur. Also I was extremely anxious after my TIA's. I am on Warfarin as a result of complications with blood due to my Valve. If I didn't have the valve, I would not be on the Warfarin, and therefore not at risk of dying of a stroke or a major bleed.

I honestly believe that I am entitled to this Unit and compensation according to the guidleines referenced above. I am only 63 years old and I am a very compliant patient. To have to live daily with the risk of a major bleed, stroke or death, is not anyway to lead your life.

I hope you will take my request into consideration, I am the first in Australia to receive the valve, and I am sure there are people who would be disgusted with the lack of resources that I am receiving from a Multi Million Dollar Company. My Health and that of other participants in the trial should be the major priority. We are the guinea pigs, we are the ones taking the biggest risk in all this, and help with our medical needs should be a major priority.
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

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freckles1880
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Re: OT - Warfarin question again

Post by freckles1880 » June 19th, 2017, 8:47 am

I don't how to advise you. Very few of us have been put on warfarin due to valve replacement. I was put on it right after my heart attack and was told that warfarin would help me not get a stroke.

I am not sure what you were told.

In my area there are dozens of TV ads wanting us to sue someone for something we may have taken or received. It is more of the attorneys wanting money than helping us.

wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 53+ years and my eldest daughter.

mykidsmom
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Re: OT - Warfarin question again

Post by mykidsmom » June 19th, 2017, 9:16 am

Your concerns are valid chrissie..and your letter to metronics is well stated and well thought out..and being honest to give you the device to check your levels would work out less costly for them than paying legal bills from being sued and maybe having to make a legal payment..I think you are right...i dont see why they shouldnt give you the machine..all the information from your health is theirs really and its in their interest to keep you safe...

go for it.
I think.....Therefore I am.!!!!!

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KansasAl
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Re: OT - Warfarin question again

Post by KansasAl » June 19th, 2017, 1:09 pm

1.4 Compensation should only be paid for the more serious injury of an enduring and disabling character (including exacerbation of an existing condition) and not for temporary pain or discomfort or less serious or readily curable complaints.

Just what is your enduring(ongoing) and disabling injury?

What did you achieve? Probably pissing off the people trying to save your life. If you really feel abused you can quit the trial anytime you want and go it alone.

Good luck. Alan

I should probably add that in the US (in your case Medtronic) pays the hospital (in your case The Alfred) X number of dollars per patient to conduct the trial. That is what they mean by "no money in the budget". No money for toys not specifically called for.

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freckles1880
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Re: OT - Warfarin question again

Post by freckles1880 » June 19th, 2017, 4:36 pm

Sorry I may have been a little insensitive when I first responded. Being on the meds I am on I sometimes can't think straight.

I know we are in different countries but when I looked at the self administered INR testing I needed to pay a co-pay that if I remember right was about $100 to get the machine, then $10 a month for the strips. The doctors charges were from -0- to a $10 co-pay to read/ chart the information. I felt I was better off to just keep going to the blood lab.

I just don't know if you would succeed going after Medtronic or pleading with your doctors.

It is so hard to prove who did what and who said what, what papers were signed or not.

Good Luck

wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 53+ years and my eldest daughter.

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Ozchrissy
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Re: OT - Warfarin question again

Post by Ozchrissy » June 19th, 2017, 5:56 pm

I know that it seems that I am suing the Company, but it is in my Consent Agreement and the Company had to agree with the provisions before the trial was approved. So I am only drawing on what is available to me.

Al, as usual I will ignore your posts, if they were constructive I would take note, but again nothing but sarcasm. I wonder what you would do if you were in my position, I am sure you would not just sit back and wait for your next bleed. I am sure you would have something to say about it all.

We in Australia are not litigators and this does not even go before a Court.

The following paragraphs from the guidelines I believe are relevant to me:

1.2 Compensation should be paid when, on the balance of probabilities, the
injury was attributable to the administration or use of a product under trial or
any clinical intervention or procedure provided for by the protocol that would
not have occurred but for the inclusion of the Subject in the trial.


1.4 Compensation should only be paid for the more serious injury of an enduring
and disabling character (including exacerbation of an existing condition) and
not for temporary pain or discomfort or less serious or readily curable
complaints. Now if the ongoing risk of Stroke or Bleed is not a permanent serious injury I don't know what is. Do I have to die before it is acknowledged that it is dangerous.

1.5 Where there is an adverse reaction to a product under trial and injury is
caused by a procedure adopted to deal with that adverse reaction,

compensation should be paid for such injury as if it were caused directly by
the product under trial.

As you can see, I believe that I do fall into the categories covered by the Guidelines agreed to by the company prior to the commencement of the trial. If I did not need the Warfarin because the valve causes clots, then I would not be in this position. There have been others on the trial who have died from bleeds and strokes. I am not the only person, according to my Trial Nurse, who is having issues with blood. It is a KNOWN problem with the valve procedure.

Also I am not suing them for big $$$$$$ just for the provision of a device that would help me monitor my INR and keep me safer. To me it is in their interest too Helen to keep me safe. If I do suffer a major bleed or stroke, after this request, I am sure Lauren will have grounds to sue them for far more than a monitor.

If we do take part in trials, even though we are willing participants, I still believe that the Companies involved do have a responsibility to keep us alive. What I am requesting is not Over the Top in terms of cost, nor is it fanciful, it is something that is available that can assist me to monitor my INR and also give me peace of mind. Why shouldn't I be able to achieve that??????
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

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freckles1880
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Re: OT - Warfarin question again

Post by freckles1880 » June 20th, 2017, 9:22 am

Ozchrissy wrote: Also I am not suing them for big $$$$$$ just for the provision of a device that would help me monitor my INR and keep me safer. To me it is in their interest too Helen to keep me safe. If I do suffer a major bleed or stroke, after this request, I am sure Lauren will have grounds to sue them for far more than a monitor.

If we do take part in trials, even though we are willing participants, I still believe that the Companies involved do have a responsibility to keep us alive. What I am requesting is not Over the Top in terms of cost, nor is it fanciful, it is something that is available that can assist me to monitor my INR and also give me peace of mind. Why shouldn't I be able to achieve that??????
Yes I agree with you Chrissy. They need to share what they can as well as they like to take what they want to.

wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 53+ years and my eldest daughter.

garya
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Re: OT - Warfarin question again

Post by garya » June 20th, 2017, 10:16 am

Unless you are with a really big group suing for big dollars, companies like Medtronic really don't care much. You are an expense that simply reduces their income taxes. Nowadays, companies expect to be sued whether they deserve it or not. In fact frivolous lawsuit expenses are now budgeted in to a product before a product goes on the market.

But aside from that, I might have approached Alfred and Medtronic using the "team method." The team consisting of you, Alfred, the doctors and Metdtronics want to develop a successful product. To do that, they need you alive and healthy and if you have a problem, others that follow might have the same problem, so what is the best way for "the team" to all work together so others who follow do not have problems. As a "team player" you are prepared work with them to test out methods that could be helpful for the success of their product.

slk123
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Re: OT - Warfarin question again

Post by slk123 » June 20th, 2017, 3:55 pm

Looking at the contract and reading specifically 1.5, I believe you are owed some kind of compensation. But for the valve, you would not be bleeding. Therefore, the trial should pay. You're requesting compensation to be a home monitoring kit which is not unreasonable. I believe you are in your right to ask for this and take the necessary steps to try and get it.

Your letter was great and I hope it gets to the right person. That's one thing I've found in dealing with problems....needing to find the RIGHT person who has the AUTHORITY to make the DECISION. And in getting to that person, you might just encounter those dolts who say, "There's nothing I can do." And they leave out the part where they should say, "....but I know who you should contact...."

Keep pressing on, Chrissy!!!!
Best wishes,
Stacey

CHF Jan 2016
ICD Nov 2014
LBBB Nov 2014
Sudden cardiac arrest Nov 2014
Arrhythmia Aug 1982

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Ozchrissy
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Re: OT - Warfarin question again

Post by Ozchrissy » June 20th, 2017, 7:39 pm

I had a terrible day yesterday, but the team at the Alfred jumped into action. The two doctors who are in charge of the trial and my local cardiologist have put their heads together and are working something out for me. ALSO, TWELVE, THE ORIGINAL COMPANY WHO DEVELOPED THE VALVE HAVE OFFERED TO ASSIST ME AS NEEDED. How about that eh.

It does pay to have a hissy fit every now and again. I must admit it has been a big emotional roller coaster with this latest bleeding, and it all came out with my enquiring about the monitor and being told "nothing they could do". I am still very "precious" today, but am starting to feel rational again. Must admit a day of crying, ranting and feeling sorry for myself has made me feel much better today.

They did mention changing my meds to Plavix, but that is just as bad. I get bleeding under my skin with that and when I am on it I have welts all over my arms. That is a constant reminder that I am at risk of bleeding, and I wonder what is happening to my internal organs. Also with the Plavix if I have a bleed, there is not quick fix. At least with Warfarin they can administer Vitamin K, but with Plavix it is just a matter of wait and see and of course blood transfusions until it leaves my system.

It is all moving forward, I see my own long term GP on Thursday, and will have a big chat with him and possibly a cry on his shoulder.

I can see something positive coming out of this, so for those who say that the trial doctors and the big Companies will not come to the party, in my circumstances, they look like their are trying to help me. Obviously they don't want me to die, and they have taken this bleeding episode seriously. Also it looks like Twelve had also taken it seriously too, but no word from Medtronics.

This is the paragraph referring to Twelve from the Alfred. "A contact from Twelve has also confirmed with me that they have received your email and that they are awaiting confirmation from Dr Walton as to what is going to be the best and safest medication plan for you and what they can then assist with.


The story continues, but I am hopeful that I will get further assistance from the parties involved in all this. It is relevant to the trial, and hopefully will help others who down the track will be in my situation. One drug they have suggested, just got another email now, is Pradaxa, so hopefully that will be a very viable alternative and it will put an end to my Warfarin nightmare. However I checked up on Pradaxa and it is NOT RECOMMENDED FOR ARTIFICIAL VALVES. moodbad Big conversations with the big boys coming up.
https://www.drugs.com/pradaxa.html
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

slk123
Posts: 633
Joined: January 27th, 2015, 8:00 am
Location: Northern Illinois

Re: OT - Warfarin question again

Post by slk123 » June 20th, 2017, 8:32 pm

I am so happy they are willing to work with you and quickly for that matter! Hats off to you for your persistence!!!
Best wishes,
Stacey

CHF Jan 2016
ICD Nov 2014
LBBB Nov 2014
Sudden cardiac arrest Nov 2014
Arrhythmia Aug 1982

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freckles1880
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Re: OT - Warfarin question again

Post by freckles1880 » June 21st, 2017, 5:21 am

I am also happy that it appears that things are going to work out for you.

Every case is different but I wonder what the results would have been in another country?

wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 53+ years and my eldest daughter.

Grammaram
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Re: OT - Warfarin question again

Post by Grammaram » June 21st, 2017, 12:02 pm

I've been following your posts - so sorry you are having to go through this! It's bad enough having the live with the condition - but the treatment stalemates only add to the frustration. I sense that all you are asking for is a way in which to feel you have some sort of part in your treatment - and the ability to maintain some sense of control over what is going on in your life. I don't think what you are asking is beyond reason.
Do you know if you have a tissue or mechanical valve? Are you on Warfarin to prevent clots from forming on the valve, or is it related to atrial fibrillation? (I seem to remember you developing AFib after your valve procedure.) I currently take Eliquis because of AFib, but I'm wondering if that will change to Warfarin should I get a valve replacement (seeing surgeon next week). I had the understanding that tissue valves do not require long-term blood thinners; mechanical valves do. The AFib would still necessitate the use of a blood thinner. Either way, it sounds like you are stuck being on a blood thinner. Wishing you the best!
angelwatch

Margaret wavhi
Congenital Heart Disease - Tetralogy of Fallot - repaired Sept. 1966
Medtronic Evera S DR Implanted May 22,2014

abas
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Re: OT - Warfarin question again

Post by abas » June 21st, 2017, 12:22 pm

I do not know about alternative blood thinners and valves. Is Pradaxa or Eliquis or Xarelto contra indicated because they are simply not approved, tested enough? Supposedly one couldn't ever have a MRI with an ICD. Might same concept apply with these warfarin alternates?

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