"Avandia was not properly tested and that improper testing led to what I would call, a putting-your-head-in-the-sand philosophy," Goldenberg says. He alleges that "Basically, GlaxoSmithKline just ignored information that was coming in about the number of risks that were showing up with this drug. Therefore, congestive heart failure, heart attack, and strokes, were all things that were occurring with this drug that they chose to ignore."
Goldenberg says that a 2007 study published in the New England Journal of Medicine found that Avandia's side effects increase the risk of a heart attack by 43 percent. Then, the FDA conducted an analysis and found the risk of heart attacks increased by 38 percent with Avandia use.
"Experts estimated that over 100,000 heart attacks could have been caused by Avandia since 1999," Goldenberg says. "In July, 2007, an advisory panel of experts was convened by the FDA. They looked at the different risks associated with Avandia. The panel voted that Avandia increases risks of heart attacks. The advisory panel recommended the harshest warning possible [a "black box warning"] for the drug.
"So, in essence," Goldenberg alleges, "you have thousands of people injured by this drug and a lot of them don't understand that it was the drug that caused their problems."
"The biggest concern I have is that drugs that are given to people need to be safe. No drug is perfectly safe, but at least they should warn people about the actual risks. Avandia users were already at an increased risk of heart attack—they have type 2 diabetes. To potentially increase that risk by more than 40 percent is almost outrageous. A pharmaceutical company should know better."
According to Goldenberg, Avandia's manufacturers knew that the drug used in Avandia had a risk profile that increased the cardiovascular risk (the risk of heart attacks and strokes). Goldenberg alleges that GSK then chose not to do testing to try to isolate that risk. The drug's information was then submitted to the FDA, who approved this in the absence of any knowledge about the potential cardiovascular risk with the drug.
"The manufacturer was sticking its head in the sand and hoping nothing happened and no one noticed," Goldenberg says. "It was not until other independent studies, like the one published in the New England Journal of Medicine in 2007, found that these significant cardiovascular risks were not disclosed by the company." So, Goldenberg suggests, "The pharmaceutical company chose not to properly test the drug. They knew if they did test they would find an increased risk of heart attacks and strokes."
Goldenberg says that a serious concern is that the statute of limitations for filing lawsuits against GlaxoSmithKline is running out. The black box warning was put on Avandia on November 14, 2007, so for many states the statute of limitations expires on November 14, 2009. It is important to note that is the deadline for filing lawsuits, not for contacting an attorney.
READ MORE AVANDIA LEGAL NEWS
Goldenberg & Johnson represents clients nationwide. The firm has been involved in pharmaceutical cases and medical device cases for over 25 years and has helped thousands of injured people recover. The firm has been involved in some of the largest settlements and litigations in the US. Goldenberg & Johnson has the expertise and resources to quickly screen cases to understand whether or not a claim is viable against Avandia's manufacturer.