Continuing frustration for victims of banned diabetic medication

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Avandia was made available on the NHS in 2000 and regularly prescribed to sufferers of type 2 diabetes, who were having difficulties controlling their blood sugars with standard medication. The drug is manufactured by GSK and is intended to make the body more responsive to its own naturally produced insulin, thereby enabling better control of blood sugars.  
However in 2007, an American scientist raised concerns that Avandia could cause heart attacks. This led to further studies being carried out, which showed that those patients on Avandia were at significantly higher risk of suffering from stroke, heart failure and heart attack, than those diabetic patients who were not on the medication. On the back of these studies, the licence for Avandia was revoked in September 2010 by the European Medicines Agency, and is no longer available in the UK. It is available in the US, but there are significant restrictions on its prescription.

Following on from this, thousands of compensation claims were launched by individuals and their families, who believed that they had been injured or bereaved as a result of the drug. A number of very large multi-party actions were commenced in the US as well as in Europe.

In July 2012, GSK pleaded guilty to charges in a federal Pennsylvania court that it failed to report clinical data on Avandia, which indicated concerns over the effect that the drug had on cardiac function. The pharmaceutical company reached an agreement with the Department of Justice to pay a $3 billion settlement. The agreement, which also included charges over the company’s marketing of Paxil (Seroxat) and Wellbutrin (Bupropion), is the largest health care fraud settlement in U.S. history.

Tens of thousands of cases have now been settled by GSK in the US, and there has been no finding made at a court trial as yet. However, GSK state that the settlement agreements are made on economic grounds, and continue to assert that the company acted appropriately and responsibly in its management of Avandia. The Telegraph reported  yesterday that the company intends to defend the legal claims being brought against GSK in the UK.

This is of course devastating news for the families affected by Avandia. The paper reports that the company has already set aside £6 million for legal fees to contest the litigation. The individuals affected and their families simply do not have this level of funds available and the fear is that this "inequality of arms" will mean that those who have suffered because they were prescribed this medication, will ultimately not be able to obtain the justice that they deserve. At present, some of the families have obtained legal representation under a conditional fee agreement. This means that if the claims are unsuccessful, or have to be abandoned for whatever reason, the law firms representing the families will not be paid for the work that they have undertaken over many years. There are very few law firms in the current economic climate that are able to risk this level of funds, when the Defendant company has indicated that it is willing to spend such vast amounts of money on litigation costs..

Why though, if there has been found to be sufficient evidence of the potentially harmful effects of the drug to result in withdrawal in Europe, and if GSK has pleaded guilty to a failure to disclose information in the US and has entered into agreements to settle many thousands of claims in the US, would the company continue to fight the litigation in the UK?  

I cannot of course comment on behalf of GSK, but, if I were to take a cynical point of view, it would seem that the reason has to be financial. The funding arrangements for compensation claims brought in the US are very different to those in the UK. It is possible that GSK are simply taking a calculated risk that the UK law firms will either run out of money or be unable to secure sufficient financial backing to continue to pursue the claims on behalf of their clients.

If a case were to go to trial in the UK, and the company found to be legally responsible for the injuries that the Claimant alleged were due to Avandia, this would set a legal precedent, "opening the floodgates" for thousands of more potential litigants to whom GSK would be required to pay compensation. If however no claim is able to come to trial, because the law firm concerned is not able to finance this, no such precedent is set and each case has to be fought on its own merits, with the financial implications that this involves.

Pharmaceutical companies, including GSK, have done wonders with medical and scientific research over previous decades to combat the effects of naturally occurring disease, and they are to be applauded for this. Without these companies society would still be suffering from the effects of smallpox and the HIV virus would still mean a death sentence. It is accepted that almost all drugs have side effects on the body, but it is imperative that when knowledge of additional risks arises, this is disseminated so that patients and prescribing doctors can make an informed choice.

Claimant personal injury and clinical negligence solicitors and barristers have had to endure a vast amount of negative press in the past few years. It should be remembered though that we work for individual clients who have had their lives adversely affected by the actions of others, and we seek to obtain monetary compensation to put them back in the position that they would otherwise have been in, but for those actions. No amount of money can restore their former health, or in some cases, their life, but we try to do what we can to improve their quality of life or to acknowledge to their families, the harm that was done. 

Where mistakes have been made, these should be globally acknowledged and appropriate compensation paid. It should not be about economics. This is about the health and lives of individuals.

Kym Provan

Head of the South Coast 
Clinical Negligence team

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