Taking Legal Action against Drug Manufacturer?

[Michele01]

I'm interested if anybody has successfully or unsuccessfully sued a drug manufacturer in the UK?

My reason for asking is that I was a Type 2, given Forxiga and within 4 weeks of taking them, was in the High Dependency Unit of the local hospital, given 12 hours to live with severe ketoacidosis. I am now diagnosed as Type 1 and have to inject.

My issue with the drugs manufacturer is that the side effects of the tablets (listed on the leaflet) are tiredness, thirst, extreme fatigue. HOWEVER there was no mention of a possibility of DKA and how the "normal" side effects of the tablets mimic DKA. More importantly, there is also NO mention of the need to test for ketones - something I believe should be mandatory with this drug when first prescribed. As blood glucose readingscan be normal/low when taking these tablets but masks the fact that DKA is happening behind the scenes. A simple urine test, done at home, could detect ketones and potentially save lives.

In the US, the FDA insisted in December 2015 that manufacturers put warnings about DKA in their literature and the European Medicines Agency has asked for a review of this family of drugs.

I know there are a few members in the UK who have been adversely affected by this drug and I was wondering whether any legal action has been taken (for this or any other drug)?

 

[Daibell]

Hi. A few thoughts. Are you sure you were T2 to start with and not a mis-diagnosed T1 which is quite common. If you were actually a T1 then DKA would naturally have been more likely as happened to my 22 yr old nephew who ended up in A&E not knowing he had diabetes at all. This could affect the success of any litigation. A few questions - does the drug mimic DKA or actually cause DKA? Real DKA normally happens when both ketones and blood sugar are very high - not one or the other. Was your blood sugar high when you ended-up in A&E as well as the ketones? You can certainly ask the GP to raise a Yellow Card or do it yourself on the appropriate website. The drug companies have loads of money ready for litigation defence, so think carefully.

 

[Michele01]

Hi - I could well have been T1 all along but I was pre-diabetic in December 2014, chose to start Metformin in March 2015, had horrible side effects and so moved to Forxiga in June 2015. Hospital July 2015 and diagnosed with T1 in November 2015 (cpep test etc). There's no T1 in my family and my father was late onset Type 2. Could I have been T1 all along? Perhaps but I need to see if any definitive tests were run in 2014 and early 2015 to be sure.

In terms of Forxiga - they lowered my blood glucose levels brilliantly and when I was admitted to hospital they were (from memory) hovering around 7. What Forxiga appears to do is lower blood glucose but it's creating DKA behind the scenes. My urine showed 5+++ ketones on admission. So the side effects listed for Forxiga are all the same (virtually) as those you'd expect with DKA.

In terms of yellow card, this was done at the time and I'm officially patient X lol My consultant also prepared a paper that was delivered at a conference and posters and warning letters were sent to local(?) hospitals to warn to run ketone tests and not rely on blood glucose levels.

In terms of the pharmaceutical companies having lots of money and being able to fight litigation, I'm aware of that. In fact I used to work in the chemical manufacturing industry BUT, to me, these tablets are dangerous and need to have adequate warnings and testing in place before prescribing.

 

[tim2000s]

@Daibell, Forxiga causes Euglycaemic DKA - that's the issue, and why the FDA insisted on the labelling change.

http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm

As you can see, it's unusual due to there not being raised glucose levels alongside the high levels of ketones. It's no longer widely recommended for prescription in England any longer due to these concerns - NICE Guideline from December 2015:

1.1 - Dapagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:

• a sulfonylurea is contraindicated or not tolerated or
• the person is at significant risk of hypoglycaemia or its consequences.

1.2 - Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

1.3 - Dapagliflozin in a triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for treating type 2 diabetes, except as part of a clinical trial.

1.4 - People currently receiving dapagliflozin in a dual or triple therapy regimen that is not recommended for them in 1.1 or 1.3 should be able to continue treatment until they and their clinician consider it appropriate to stop.

@Michele01, as @Daibell says, you it's unlikely that you were ever T2. Although you may have been misdiagnosed as such, you are really T1/T1.5 and as a result shouldn't have been put on this drug in the first place due to the known issues.

Recent studies have shown an increase in DKA in trialling SGLT-2 Inhibitors with Type 1 diabetics (although the study method has been called into question as increasing this risk as well): http://www.medscape.com/viewarticle/851309#vp_2

 

[Michele01]

@tim2000s thank you so much for the additional information. I hadn't found the Medscape paper during my search which is very useful.

I agree, I may have been T1 or T1.5 all along BUT what if these tablets damaged my pancreas and turned me from a Type 2 to a Type 1/1.5? I would think that's a possibility but don't know. I'd love to "speak" with others who have had a similar experience but I think we're (thankfully) few and far between in the UK. I know that in the US there are class actions now against the manufacturers.

 

[tim2000s]

@tim2000s thank you so much for the additional information. I hadn't found the Medscape paper during my search which is very useful.

I agree, I may have been T1 or T1.5 all along BUT what if these tablets damaged my pancreas and turned me from a Type 2 to a Type 1/1.5? I would think that's a possibility but don't know. I'd love to "speak" with others who have had a similar experience but I think we're (thankfully) few and far between in the UK. I know that in the US there are class actions now against the manufacturers.

If they had damaged your pancreas, you'd have become a Type 3c!

 

[Molly56]

@tim2000s ..interesting to know that this is no longer recommended as my partner is on these tablets and has been since the middle of last year. It will be interesting to see if he is taken off of these when he next sees the diabetic nurse....so far he does not seem to have had any adverse affects despite my concerns raised in @Michele01 's original warning about these.

Just for the record and to clarify he is currently on Metformin, Forxiga plus insulin (Novorapid 30, 32 units twice a day) for his diabetes medication .....he does not test for ketones as the nurse said that this was not necessary (at one point I specifically asked her at one of his appointments and that was her reply).....personally I disagree with this given the warnings but it is not for me to say this as I am not the patient...

..plus I have recently taken a backward step in helping him to manage his diabetes as I have decided it is a pointless exercise given that he seems to ignore or dismiss any help or advice given by either myself or any medical professionals about this or his other medical conditions....have decided it is a waste of my breath, time and energy and I have better things to do with my life.

As I said at the start though it will be interesting to see if any changes are made to his medication on his next visit further to the changes made in the NICE guidelines that you mention.....watch this space....

 

[phoenix]

I agree that it's likely you were misdiagnosed in the first place rather than it causing you to become T1 (or a T2 dependent upon insulin) Your earliest posts on here seem to show that.
In the US it seems that several of these cases were LADA or very late stage T2 (and therefore with very low insulin levels) http://care.diabetesjournals.org/content/38/9/1638.full
In Japan the people who developed it (and had a recorded precipitating factor and only about half seem to have one) included people who stopped insulin (ie they were already on it) or were sick with something else or restricted calories or carbohydrates .http://onlinelibrary.wiley.com/doi/10.1111/jdi.12401/pdf

I can't help you with your legal question except to say that you don't have to be in the US to benefit from a class action ( I was part of one when Christies was prosecuted in the US about their buyers premium being raised in concert with Sothebys. In that case I didn't have to do anything, just got a surprise letter in the post because the lawyers got my name from the records. Several years later got a cheque for £20! ) I suspect in this case you would have to find an American lawyer who was involved in any such action.

 

[tim2000s]

This might help: http://www.forthepeople.com/class-action-lawyers/invokana-ketoacidosis-lawsuit/

 

[Michele01]

I agree that it's likely you were misdiagnosed in the first place rather than it causing you to become T1 (or a T2 dependent upon insulin) Your earliest posts on here seem to show that.
In the US it seems that several of these cases were LADA or very late stage T2 (and therefore with very low insulin levels) http://care.diabetesjournals.org/content/38/9/1638.full
In Japan the people who developed it (and had a recorded precipitating factor and only about half seem to have one) included people who stopped insulin (ie they were already on it) or were sick with something else or restricted calories or carbohydrates .http://onlinelibrary.wiley.com/doi/10.1111/jdi.12401/pdf

I can't help you with your legal question except to say that you don't have to be in the US to benefit from a class action ( I was part of one when Christies was prosecuted in the US about their buyers premium being raised in concert with Sothebys. In that case I didn't have to do anything, just got a surprise letter in the post because the lawyers got my name from the records. Several years later got a cheque for £20! ) I suspect in this case you would have to find an American lawyer who was involved in any such action.

Thank you @pheonix. I had NO idea that UK and US cases could be linked. I know exactly where I'm going now!

 

[Michele01]

This might help: http://www.forthepeople.com/class-action-lawyers/invokana-ketoacidosis-lawsuit/

Thanks again @tim2000s. I had found that info which is what made me wonder whether to go ahead.

Just out of interest - what on earth is a Type 3c???? I've never heard of that!

 

[tim2000s]

Just out of interest - what on earth is a Type 3c???? I've never heard of that!

There's a forum for that!

 

[Michele01]

@tim2000s thanks again. I've just had a quick scan of the forum. I'm not sure how it's diagnosed and have asked the question there. My CPEP in November showed little or no insulin production by the pancreas but I'm unsure whether that's "normal" for a type 1. Since diagnosis, I've very much been left to my own devices and have had to research. There's so much information (and misinformation) that it's a bit of a minefield. Thankfully in December my care has been changed to another consultant so I'm hoping I'll get more guidance moving forward.

 

[tim2000s]

My CPEP in November showed little or no insulin production by the pancreas but I'm unsure whether that's "normal" for a type 1.

That's normal for most T1s, yes.

 

[DavidGrahamJones]

I'm interested if anybody has successfully or unsuccessfully sued a drug manufacturer in the UK?

There seems to be a class action in the US but nothing in the UK. Astro Zeneca are relying heavily on this drug to produce literally billions in revenue over the next 7 - 8 years.
I wish I could suggest something, we need something akin to the "ambulance chasers" (is that what they're called), you know, the "have you had an accident at work" merchants, to do something when and if drugs manufacturers screw up.

 

[Michele01]

There seems to be a class action in the US but nothing in the UK. Astro Zeneca are relying heavily on this drug to produce literally billions in revenue over the next 7 - 8 years.
I wish I could suggest something, we need something akin to the "ambulance chasers" (is that what they're called), you know, the "have you had an accident at work" merchants, to do something when and if drugs manufacturers screw up.

@DavidGrahamJones Astra Zeneca are an enormous company and if I'm honest, I dislike the ambulance chasers BUT I also strongly believe that products should be thoroughly tested before going to market and warnings, no matter whether a problem has been found in 1 person or 100, should be widely reported in a timely manner. I don't believe that Astra Zeneca have done that. I was exceptionally lucky but others may not be as fortunate. Drugs are a part of our lives and the manufacturers have a responsibility to the end users. I believe that (like most businesses), profit will play a big part in what happens.

 

[DavidGrahamJones]

@DavidGrahamJones Astra Zeneca are an enormous company and if I'm honest, I dislike the ambulance chasers BUT I also strongly believe that products should be thoroughly tested before going to market and warnings, no matter whether a problem has been found in 1 person or 100, should be widely reported in a timely manner. I don't believe that Astra Zeneca have done that. I was exceptionally lucky but others may not be as fortunate. Drugs are a part of our lives and the manufacturers have a responsibility to the end users. I believe that (like most businesses), profit will play a big part in what happens.

I'm not supporting Astro Zeneca in any way, form or manner, quite the opposite. If I hear of something in the UK like the class action in the US I'll let you know. I have a few pharmaceutical companies I'd like to sue myself.
I'm not excusing them but this is what happens when they have to get things to market as quickly as possible because the patent life is so short, especially after clinical trials. As I say, it's not an excuse, just a fact.

 

[Michele01]

I'm not supporting Astro Zeneca in any way, form or manner, quite the opposite. If I hear of something in the UK like the class action in the US I'll let you know. I have a few pharmaceutical companies I'd like to sue myself.
I'm not excusing them but this is what happens when they have to get things to market as quickly as possible because the patent life is so short, especially after clinical trials. As I say, it's not an excuse, just a fact.

@DavidGrahamJones Don't worry David I knew exactly what you meant. I just didn't want this thread to look like I was on a quest hence my response! There actually is a class action in the US and I phoned the solicitors (Morgan & Morgan) today and they're not interested in helping anybody in the UK (either in the class action or not).

 

[DavidGrahamJones]

. . . . . they're not interested in helping anybody in the UK

The UK "ambulance chasers" seem to be more geared up towards personal claims against individuals. I've looked at a couple and it looks like a minefield. I truly wish I could be more helpful.
I took a drug called Rosiglitazone that caused my liver function to deteriorate all of a sudden. It has now returned to what the GP calls normal, after well over 10 years. It also helped me gain a lot of weight which I could have done without.

 

[Ettta]

@Daibell, Forxiga causes Euglycaemic DKA - that's the issue, and why the FDA insisted on the labelling change.

http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm

As you can see, it's unusual due to there not being raised glucose levels alongside the high levels of ketones. It's no longer widely recommended for prescription in England any longer due to these concerns - NICE Guideline from December 2015:

1.1 - Dapagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:

• a sulfonylurea is contraindicated or not tolerated or
• the person is at significant risk of hypoglycaemia or its consequences.

1.2 - Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

1.3 - Dapagliflozin in a triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for treating type 2 diabetes, except as part of a clinical trial.

1.4 - People currently receiving dapagliflozin in a dual or triple therapy regimen that is not recommended for them in 1.1 or 1.3 should be able to continue treatment until they and their clinician consider it appropriate to stop.

@Michele01, as @Daibell says, you it's unlikely that you were ever T2. Although you may have been misdiagnosed as such, you are really T1/T1.5 and as a result shouldn't have been put on this drug in the first place due to the known issues.

Recent studies have shown an increase in DKA in trialling SGLT-2 Inhibitors with Type 1 diabetics (although the study method has been called into question as increasing this risk as well): http://www.medscape.com/viewarticle/851309#vp_2

What's DKA?