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Wednesday, July 14, 2010

GlaxoSmithKline Agrees to Settle 10,000 Claims

GlaxoSmithKline is approaching its first Avandia trial, scheduled for October in Philadelphia. There are about 13,000 lawsuits against the company, claiming that Glaxo concealed Avandia’s cardiac risks.

Now Glaxo, Britain’s largest pharmaceutical company, has agreed to settle about 10,000 of those suits for $460 million. That is about $46,000 for each case. Glaxo had been budgeting in case it had to pay $500,000 per case, so this is good news for them.

Plaintiff’s lawyers are also pleased with this deal, since it is prompt and the cases have been dragging on for about three years already.

Avandia (rosiglitazone) is a drug for type two diabetes – that is, adult onset diabetes. It is meant to control blood sugar levels but has some severe effects on heart function.

New FDA Safety Panel

An FDA panel of 33 people is set to meet starting next Tuesday, July 20, for two days. Its purpose is to discuss Avandia’s safety and whether its diabetes benefits outweigh its potential cardiac harm or not. It may decide among three courses of action:

  • That Avandia should be pulled from the market;
  • That Glaxo should add more labeling to the Avandia bottles; or
  • That Glaxo should create programs for monitoring patients on Avandia

Diabetes is becoming more widespread and more people are needing a drug like Avandia or one of its competitors such as Actos. Since Avandia came onto the market in 1999, it has been widely used and earned about $1.1 billion for Glaxo just in 2009. Before 2007, it earned even more each year, until the first FDA panel met to review its safety.

According to news reports, many people will be watching to see the results of the panel’s decision next week. Medical professionals are interested, as are drug company investors. If Avandia is pulled from the market, investors may re-evaluate the risks of investing in medications of this type. If it is kept on the market, the FDA will have to devise a standard, or protocol, for that decision – is Avandia more risky than Actos? If not, why is Actos still on the market?

Seamus Fernandez, the managing director of pharmaceuticals at the investment bank Leerink Swann stated:

  • "At a certain point, the FDA just has to say, 'We just have to cut our losses and move on, it's taking too many resources'."

Have you been harmed by an FDA-approved drug? If you are wondering about your legal options, please contact us today for a free case review.

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posted by Benjamin A. Irwin at 10:06 AM

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