• Guest - w'd love to know what you think about the forum! Take the 2025 Survey »

Taking Legal Action against Drug Manufacturer?

If you are really keen to bring a claim against the manufacturers the first step would be to have a discussion with a solicitor - I would contact maybe Thompsons or Slater & Gordon - I have no idea whether you actually can claim against the manufacturers and I suspect the solicitors may consider a claim against the hospital/your GP for not testing for keytones earlier. A decent claimant solicitors should have a free chat about whether there is a potential claim & whether you are eligible for a no win no fee agreement.

Have you had a GAD test?
 
Last edited by a moderator:
I imagine some of the issues in UK will be firstly the prospect of finding a practising lawyer, in the correct field who knows anything about this drug is likely to be very low. Secondly, it would seem unlikely there would be masses of people impacted in the way you have been, in order to make the investment in learning about diabetes and this drug even potentially worthwhile. Thirdly, it would be expensive, because you (and anyone else you could find to join with you) would be paying for the lawyer's training/research.

Finally, to then consider the prospect of finding a lawyer content to embrace the niche learning/research, and to do all of that at their own expense, pending a compensation payment to you seems unlikely. Without any proven action - here or elsewhere - he's taking a gamble the findings would be in your favour, but also that you would be awarded adequate compensation to cover his bill, never mind any reparation to yourself.

Sadly, medical negligence suits, whether against a pharmaceutical company or practitioner are pretty hard to bring about, take a long time, cost a lot of money and can sometimes end up being a matter of opinion. One man's negligence is another's systematic approach that didn't reach the correct conclusion quickly enough.

Good luck, whatever you decide to do.
 
Sorry, have just seen in your other thread that you are GAD positive, so (not a doctor,but pretty sure) the thing that has made you type 1 is your immune system not the drug.

It sounds like the only injury you have suffered as a result of the drug is the DKA and admission to HDU. Assuming you are fully recovered (and I hope you are fully recovered!) that's not an injury that's worth an awful lot of money. I have no doubt it was a horrible experience but if you were admitted in DKA, treated with insulin & discharged within a couple of days/weeks with no lasting effects (apart from the type 1 do which you would have had anyway) it just isn't worth very much money.

Given that it would be quite a complex claim, it may not be worth it. However, I'd still find someone to chat to to see if you can get a CFA - where the deal is your solicitor will only get paid if you win (& if you win, the defendant pays your costs). Let the solicitor decide whether it's worth the gamble or not.
 
Michele01 said:
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)?
Click to expand...

Your problem is the drug is marketed for people with type2 diabetes, you were misdiagnosed as you are in fact type1 thus you are contemplating suing the wrong people.
 
catapillar said:
Sorry, have just seen in your other thread that you are GAD positive, so (not a doctor,but pretty sure) the thing that has made you type 1 is your immune system not the drug.

It sounds like the only injury you have suffered as a result of the drug is the DKA and admission to HDU. Assuming you are fully recovered (and I hope you are fully recovered!) that's not an injury that's worth an awful lot of money. I have no doubt it was a horrible experience but if you were admitted in DKA, treated with insulin & discharged within a couple of days/weeks with no lasting effects (apart from the type 1 do which you would have had anyway) it just isn't worth very much money.

Given that it would be quite a complex claim, it may not be worth it. However, I'd still find someone to chat to to see if you can get a CFA - where the deal is your solicitor will only get paid if you win (& if you win, the defendant pays your costs). Let the solicitor decide whether it's worth the gamble or not.
Click to expand...

Can you imagine a lawyer taking on a whole learning (about diabetes and drugs) to fight an low potential return on an action that's never been fought, never mind won before? At c£400 an hour, that's asking the lawyer to invest massively.

Sadly in disputes the person with the deepest pockets often wins, one way or another. It seems likely the manufacturer's coffers are bigger than the OP's.
 
Thank you all for your replies. I've done some research and this is what I've found:

1. This is not a medical negligence claim. It's classed as product liability (ie the manufacturers failed to advise of the potential for DKA or provide information regarding testing for ketones). Product liability is similar to claims against manufacturers of faulty breast implants or currrently there's one for hip joints. I'm assuming it's helpful that there's a class action in the US at the moment - as some of their findings may be helpful (or not).

2. There are specialist product liability solicitors and it's finding the most suitable one. I've been given the number of one so will give them a call.

3. I understand why the majority are saying that I could have been Type 1 all along but this is knowledge with hindsight and may not be correct - it *could* have been the damage caused by the drug. Unfortunately, it's a bit of a crystal ball - unless my consultant ran tests before the Forxiga was prescribed (and I know he did a ton of blood tests - I just don't know which) that confirm whether I was Type 1/1.5 all along then the court has to decide on the medical evidence presented.

4. Whether or not my claim is worth £5 or £5m at the end of the day I believe the manufacturer has been negligent in not advising prescribing doctors correctly. There's been evidence for almost a year now (albeit with a fairly small number of cases in the UK - much larger in the US) that this drug can have dramatic consequences. Reading this forum, there are a number of people who took the drug for a short period but stopped because of side effects (tiredness, extreme thirst etc) and it could be that they were in the early stages of ketoacidosis without knowing it. I know there was one other person on this forum who was admitted to hospital with DKA.

I feel (and I know that newly diagnosed people can find it difficult to adjust) that the tablets have given me a life sentence of injecting. To go from pre-diabetic to DKA and Type 1 in less than a year is just too quick to process so I guess I'm in a state of trying to adjust. I'll get there (I have to)! So this isn't about money for me. This is about getting the multi million pound manufacturers to act responsibly.
 
I will be following this with interest and wish you every success. You seem to have built a good case already and are very self-aware. I'm afraid I can't help with your initial questions except that when I had a medical negligence claim some 20 years ago against a non-UK health authority, I found Penningtons solicitors (now Penningtons Manches) extremely knowledgeable and helpful.

I also tried Forxiga very briefly and although I tolerated it well and had no side effects, I took myself off it after 4 weeks after doing my own research on the drug and not liking what I read. I would not touch it again.
 
Michele01 said:
Thank you all for your replies. I've done some research and this is what I've found:

1. This is not a medical negligence claim. It's classed as product liability (ie the manufacturers failed to advise of the potential for DKA or provide information regarding testing for ketones). Product liability is similar to claims against manufacturers of faulty breast implants or currrently there's one for hip joints. I'm assuming it's helpful that there's a class action in the US at the moment - as some of their findings may be helpful (or not).

2. There are specialist product liability solicitors and it's finding the most suitable one. I've been given the number of one so will give them a call.

3. I understand why the majority are saying that I could have been Type 1 all along but this is knowledge with hindsight and may not be correct - it *could* have been the damage caused by the drug. Unfortunately, it's a bit of a crystal ball - unless my consultant ran tests before the Forxiga was prescribed (and I know he did a ton of blood tests - I just don't know which) that confirm whether I was Type 1/1.5 all along then the court has to decide on the medical evidence presented.

4. Whether or not my claim is worth £5 or £5m at the end of the day I believe the manufacturer has been negligent in not advising prescribing doctors correctly. There's been evidence for almost a year now (albeit with a fairly small number of cases in the UK - much larger in the US) that this drug can have dramatic consequences. Reading this forum, there are a number of people who took the drug for a short period but stopped because of side effects (tiredness, extreme thirst etc) and it could be that they were in the early stages of ketoacidosis without knowing it. I know there was one other person on this forum who was admitted to hospital with DKA.

I feel (and I know that newly diagnosed people can find it difficult to adjust) that the tablets have given me a life sentence of injecting. To go from pre-diabetic to DKA and Type 1 in less than a year is just too quick to process so I guess I'm in a state of trying to adjust. I'll get there (I have to)! So this isn't about money for me. This is about getting the multi million pound manufacturers to act responsibly.
Click to expand...


Whilst it is unfortunate, at best, that the manufacturer doesn't appear to have made the potential side effects as clear as they should, it seems to me your anger is about ending up as T1. On that basis I would say the root cause of your DKA could also have been your undiagnosed T1 being "amplified" by the drug interaction.

I think the manufacturer would fight hard that you appear to have been misdiagnosed and reject your claim.

My points about the lawyer learning curve is probably equally, if not more, relevant whatever class of claim you claim in that it is likely even fewer product liability lawyers (than med neg) will have any clue about diabetes, never mind the complexities you will be fighting.

In your shoes, I might be considering a change of focus.

Good luck, whatever you decide.
 
AndBreathe said:
Whilst it is unfortunate, at best, that the manufacturer doesn't appear to have made the potential side effects as clear as they should, it seems to me your anger is about ending up as T1. On that basis I would say the root cause of your DKA could also have been your undiagnosed T1 being "amplified" by the drug interaction.

I think the manufacturer would fight hard that you appear to have been misdiagnosed and reject your claim.

My points about the lawyer learning curve is probably equally, if not more, relevant whatever class of claim you claim in that it is likely even fewer product liability lawyers (than med neg) will have any clue about diabetes, never mind the complexities you will be fighting.

In your shoes, I might be considering a change of focus.

Good luck, whatever you decide.
Click to expand...

@AndBreathe I apologise if I'm coming across as angry. That wasn't my intention.

I realise it would be the easy option to look at the consultant who prescribed the tablets BUT the warnings weren't issued until the 2nd week I was on them (although to be fair I have no idea whether there were earlier warnings). I'm desperately unhappy that I'm Type 1. I keep hoping there's a way back but from everything I've read I've got a better chance of riding a unicorn to work! :)

In terms of finding a solicitor who may be able to help - it's not impossible. I'm sure there are diabetic lawyers and some who work in product liability who may not need too much education. In all honesty, lawyers rely on consultants so they will take advice. In some ways, having less knowledge means less fixed ideas or assumptions so it can be a bonus!
 
Michele01 said:
So this isn't about money for me. This is about getting the multi million pound manufacturers to act responsibly.
Click to expand...

Unfortunately, a claim via the courts is not the most effective way to get any change in behaviour or an apology. If that's what you are trying to achieve I'd be more inclined to campaign to the regulator to impose the requirement for DKA warnings as it sounds like they have done in the US.
 
CarbsRok said:
As your GAD test showed you are type 1 http://www.diabetes.co.uk/forum/threads/type-2-now-type-1.90103/

You are wasting your time. Basically the medics gave you the wrong drugs. Insulin is the treatment for type1 diabetes.
Click to expand...
I agree. GAD means you were a mis-diagnosed Late onset T1 and that the fault was due to the prescriber giving you the drug without tests to exclude T1 and assuming you were a T2. This mis-diagnosis is quite common (was for me). Many GPs just assume T2 when you are older and many don't even know that T1 can come on at any age. It's why NICE in it's latest guidelines now tell GPs to consider T1 when the patient is slim at diagnosis. The presence of GAD anti-bodies excludes the possibility that the drug damaged the pancreas i.e. it would have been the anti-bodies. The drug company correctly said to only use with T2; the prescriber guessed the diagnosis and got it wrong. Sue the prescriber if anyone.
 
catapillar said:
Unfortunately, a claim via the courts is not the most effective way to get any change in behaviour or an apology. If that's what you are trying to achieve I'd be more inclined to campaign to the regulator to impose the requirement for DKA warnings as it sounds like they have done in the US.
Click to expand...

@catapillar - thank you that's very good advice.
 
CarbsRok said:
As your GAD test showed you are type 1 http://www.diabetes.co.uk/forum/threads/type-2-now-type-1.90103/

You are wasting your time. Basically the medics gave you the wrong drugs. Insulin is the treatment for type1 diabetes.
Click to expand...

@CarbsRok you seem to be focusing on the wrong thing. I don't feel that I'm wasting my time in wanting the drug manufacturers to be very clear about what their product can do AND the very easy precautionary measures that could go hand in hand when prescribing the drug. This isn't about money or suing anybody just to try to get money. I'm not an ambulance chaser.. I don't have a voice with the manufacturers and had assumed that taking legal action would be the only sure fire way to get them to change the information available to prescribers. Another route has been suggested by Catapillar that I will look into.
 
tim2000s said:
If they had damaged your pancreas, you'd have become a Type 3c!
Click to expand...
No sorry @tim2000s not necessarily at all. Most people who have diabetes linked to a 'damaged pancreas' are a type 2, the pancreas would have had to have been near as **** it destroyed to be type 3C. A question based only on my ignorance more than anything - surely if the Forxiga was linked to DKA then the damage to the pancreas would be limited to the endocrine system otherwise there would have been identifiable organ damage/failure which would be the cause if 3C?
 
Michele01 said:
@AndBreathe I apologise if I'm coming across as angry. That wasn't my intention.

I realise it would be the easy option to look at the consultant who prescribed the tablets BUT the warnings weren't issued until the 2nd week I was on them (although to be fair I have no idea whether there were earlier warnings). I'm desperately unhappy that I'm Type 1. I keep hoping there's a way back but from everything I've read I've got a better chance of riding a unicorn to work! :)

In terms of finding a solicitor who may be able to help - it's not impossible. I'm sure there are diabetic lawyers and some who work in product liability who may not need too much education. In all honesty, lawyers rely on consultants so they will take advice. In some ways, having less knowledge means less fixed ideas or assumptions so it can be a bonus!
Click to expand...

I think anger surrounding a life changing diagnosis is quite natural and extremely common, so I didn't make any further value judgement than that.

To be honest, it seems like your timing with the drugs is most unfortunate. If "....the warnings weren't issued until the 2nd week...." you were on them, then they probably have a get out of jail free card for that alone.

On the point of lawyers relying on Consultants. Of course they will use expert witnesses, but they must understand the argument they are fighting or else they would be unable to form or deliver such argument. Can you imagine how the manufacturer's experts could run rings around a lawyer in court who didn't understand the technical nuances of his own argument?

I'm not a lawyer, but the more I read it seems the unluckier you got.
 
mrspuddleduck said:
This is interesting
https://www.gov.uk/drug-safety-upda...n-empagliflozin-risk-of-diabetic-ketoacidosis
Worth scrolling down and clicking on the link 'reports of diabetic acidosis' reporting incidents where blood sugars were only slightly raised thus atypical of dka.
Click to expand...

@mrspuddleduck this is exactly what happened to me. My blood sugars were 7 on admission to hospital but my ketones were 5++++ and my blood PH was 7.0 which is classed as a medical emergency. This is why this drug is dangerous. I was very nearly sent home and it was only because an on call GP was worried about the ketones that they begrudgingly admitted me to the ward for further blood tests. The blood sugar readings can mask the damage the drug is doing behind the scenes. I know I keep banging on about it but all the manufacturer has to do is recommend to prescribers that ketone test strips are given to patients at least for the first 2-4 weeks taking the medicine.
 
Back
Top