Proposed Avandia Settlement Would Pay U.S. $3B for Off-Label Marketing
GlaxoSmithKline and the federal government have reached a tentative $3 billion settlement over Avandia marketing charges, alleging that the company promoted the controversial and dangerous diabetes drug for uses that were not approved by the FDA or determined to be safe and effective.
The Avandia settlement was announced on Thursday in a statement by Glaxo officials, who said they expect to finalize terms of the agreement next year, along with other cases that it defines as its most significant U.S. liabilities. If approved, the blockbuster settlement would be the largest ever for a drug company accused of illegal marketing.
The U.S. Department of Justice (DOJ) has accused GlaxoSmithKline of trying to secretly market Avandia for uses other than what it was approved for by the FDA, an illegal tactic known as off-label marketing. The DOJ began investigating Glaxo in 2004 for both off-label marketing and Medicaid fraud.
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Learn MoreThe DOJ has not commented on the proposed settlement or the charges, and it is not clear whether the settlement would address the Medicaid fraud charges, which claim Glaxo overcharged the government.
Previously, the largest off-label marketing settlement was held by Pfizer, which paid the federal government $2.3 billion in 2009 for illegally marketing a number of drugs, including Bextra. At that time it was the largest criminal fine in U.S. history.
Critics of pharmaceutical companies have called for fines to be larger, enough to financially hurt the companies and thus deter illegal activities. They have also called for more corporate executives to face actual jail time over illegal business decisions.
Avandia was first introduced in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug was used by millions of diabetics throughout the world before sales began to plummet in mid-2007, after a study published by the New England Journal of Medicine highlighted the potential Avandia heart risks.
A “black box” warning was added to Avandia in the United States in November 2007, but many critics continued to argue that the warning was not strong enough and called for an Avandia recall to be issued because the risks appeared to greatly outweigh any benefit provided by the medication.
Despite a growing body of evidence pointing to increased risk of heart attacks and death on Avandia, the FDA decided in September 2010 not to recall Avandia in the United States. Instead, the FDA allowed the medication to remain on the market with severe restrictions on who can use the product.
In May, the FDA put those restrictions on Avandia in place, announcing that the medication will only be available from select pharmacies by mail order and special educational programs will be required before the drug can be prescribed.
In recent years, GlaxoSmithKline has faced thousands of Avandia lawsuits that were filed throughout the United States by individuals who allege that the drug maker failed to adequately warn about the risks associated with Avandia. Thousands of individuals have received a settlement for Avandia injuries, a number of cases are still pending in courts throughout the country.
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5 Comments
calvinAugust 18, 2012 at 4:30 pm
why do whistle blowers get millions when the people who are injured only get a few thousand?and why does the gov.get anything they was not hurt by the drug.
RandyNovember 29, 2011 at 9:39 pm
My mother passed away about two years ago now and told me before she died that her medicine (Avandia) was causing problems. She had a Heart Attack after that and died in the operating room. How in the world can a Judge say that up to $72,000.00 is enough compensation for the loss of my mom. Based on all that I read, this Drug is to blame and I hope someone will take charge and punish this Company [Show More]My mother passed away about two years ago now and told me before she died that her medicine (Avandia) was causing problems. She had a Heart Attack after that and died in the operating room. How in the world can a Judge say that up to $72,000.00 is enough compensation for the loss of my mom. Based on all that I read, this Drug is to blame and I hope someone will take charge and punish this Company and force them to compensate our loss to the fullest allowed by law. Money will never replace my mom, but these amounts being offered are an insult.
sandraNovember 11, 2011 at 6:52 pm
my husband was taking avandia in 07 and was hospitalized for chf brought on by the avandia,, my husband talked to the lawyer a few days ago and they told him that we would recieve a letter in the next week or so telling us what the settlement amount is that was offered,, i just wonder if gsk has thought of the fact , that the ones who now have chf will have it for the rest of their lives,,, i have[Show More]my husband was taking avandia in 07 and was hospitalized for chf brought on by the avandia,, my husband talked to the lawyer a few days ago and they told him that we would recieve a letter in the next week or so telling us what the settlement amount is that was offered,, i just wonder if gsk has thought of the fact , that the ones who now have chf will have it for the rest of their lives,,, i have been reading and all that i can find is that the settlement amounts are between 46000 and 72000,, personally I dont think that is justice at all , especially for the ones who lost their loved ones because of the drug,,, also the ones who will be affected for the rest of thier lives should be compensated for the future problems that they will have
AllenNovember 8, 2011 at 4:41 pm
With GSK settlement with the Gov, what does this mean to current cases. Does mean that they will settle this month (Nov. 2011)?
DanielNovember 7, 2011 at 4:08 pm
Eli Lilly Zyprexa Olanzapine issues linger. PTSD treatment for Veterans found ineffective. The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease. The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. Y[Show More]Eli Lilly Zyprexa Olanzapine issues linger. PTSD treatment for Veterans found ineffective. The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease. The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays.One in 145 adults died in clinical trials of those taking the antipsychotic drug Zyprexa. This was Lilly's # 1 product over $ 4 billion per year sales,moreover Lilly also make billions on drugs that treat the diabetes often that has been caused by the zyprexa! --- Daniel Zyprexa victim activist and patient.