Understanding Avandia and Lawsuit Settlements
is a diabetic drug that belongs to a group of drugs called Thiazolidinedinedione. It is a drug that works in the body by reducing insulin resistance. It also aids the body to efficiently use the insulin produced. It has been a choice for many people who suffer from diabetes. There are more than 20 million people who suffer from diabetes in the U.S alone. It therefore comes as no surprise when over four million people took Avandia in the U.S which resulted in more than $2.2 billion in sales. At that time, it was deemed to be safe to use after it predecessor, Rezulin, was pulled from the market after it was found out that it caused severe liver failure.
Side effects caused by Avandia
However; it did not turn out to be as safe as earlier concluded. It was found out that it had some very serious side effects. One such side effect was cardiovascular. Food and Drug scientists state that more than 10,000 heart attacks was associated with the use of Rosiglitazone, which is its the generic name. This is because it causes the risk of heart attack occurrence by close to 43 percent. It can also double the risks involved with heart failure after using the drug for one year. This was concluded after a clinical trial was conducted that consisted of people using Rosiglitazone and a placebo. More people died of using the drug as opposed to the ones using the placebo. What is more shocking is that GlaxoSmithKline were aware of the cardiovascular side effects but however chose to turn a blind eye to it despite several doctors pointing it out.
To make matter worse, cardiovascular side effects are not the only risk that comes with using Rosiglitazone. It also may increase the occurrence of bone fractures. Studies have shown that those who use Avandia have a higher chance of getting bone structures. The risk triples after using it for more than two years. The Archives of Internal Medicine on April 2008 found out that those who had been using the drug for twelve months were twice as likely to be affected by bone fractures as opposed to those who had not been using it. The Canadian Medical Association Journal also found out that female patients were undergoing long term treatment could potentially be more prone to bone fractures.
It was also published by Pharmacoepidemilogy and Drug Safety that Avandia was linked to liver failure. It was however not common as deaths caused by liver failure between 1997 and 2006 were found to be 11. There have also been claims that it can cause Macular Edema which is vision loss. After all these side effects were brought out to the light, FDA decided to publicize the heart risks associated with the drug in 2007. They also made it a requirement that a black-box warning should be placed on Avandia drugs warning of heart failure risks. The warning makes users aware that Avandia may cause and worsen heart failure in certain patients. Some public officials also wanted the drug removed from the market. In 2010, sales were stopped in Europe due to the heart risks.
Avandia Lawsuits and Settlements
There have been numerous Avandia lawsuits filed stating that GlaxoSmithKline failed in informing patients about the life threatening symptoms that were linked to use of the drug. Among the symptoms were, stroke, heart attack, heart failure, vision loss, bone fractures and death.
The Consumer Group in October 2008, filed a petition that requested for Avandia to be recalled from the market. In their petition, they pointed out the side effect that the drug was associated with liver failure in patients using it. . They pointed out 12 such cases that had resulted in liver failure, 12 of which the result was death.
Another lawsuit was filed by South Carolina in May 2011 who claim that GlaxoSmithKline mislead customers of the potential side effects caused by the drug. They also claim that GlaxoSmithKline was negligent in claiming that the drug did not increase heart risk and that they were misleading in their marketing. However, GlaxoSmithKline said that it stands by the medication and the marketing of the drug.
Settlements for Patients who Have Taken Avandia
Since these lawsuits would have cost a great deal of money to GlaxoSmithKline not forgetting the amount of time that will be wasted in going to courts, GlaxoSmithKline decided to settle many of these cases outside court. In May 2010, they agreed to pay $60 million that would be used in the settlement of more than 700 cases. They later agreed on a $460 million settlement that was used in the settlement of more than 10,000 cases. In 2011, they agreed to settle a further $250 million that was used in settlements of 5500 death claims. In February, 2012, the judge who was presiding over Avandia MDL announced that the settlements progress was satisfactory and that the focus would now be on settling the remaining cases by litigation. Over 50,000 cases have been taken care of so far.
Despite GlaxoSmithKline efforts to settle the many cases, it has been subjected to a lot of critism. They have been criticized for suppressing the information pertaining to the health risks involved. Pleading guilty to charges that it had failed on reporting clinical data on Avandia did little help to their reputation. They agreed to pay $3 billion in settlement after pleading guilty on the charges.. This settlement also included charges associated with the marketing of Wellbutrin and Paxil. This has been recorded as the largest healthcare fraud settlement in the U.S history. Due to the numerous lawsuits that keep increasing, GlaxoSmithKline has decided to set aside funds, $6.4 billion that will be used to settle the many cases filed against them. They are still dealing with a lot of cases as 3800 cases are still pending in federal MDL. Though they have already settled many cases, they may not be able to settle all the cases as more are being filed every day in court. However, the funds set aside may be able to get them out of their troubles and ensure that they settle all the cases filed against them.