Drugmaker Sued Over Diabetes Pill

-CNN

02/14/2008 — An Oklahoma man is suing drugmaker GlaxoSmithKline in federal court, claiming its popular diabetes pill gave him heart problems that required bypass surgery.

Attorneys for Grove residents Pat and Sandra Kelly allege in the lawsuit that the drugmaker should have known that Avandia was associated with a significant increased risk of heart failure, heart attack and stroke, among other side effects.

The lawsuit was filed Tuesday in U.S. District Court in Pennsylvania and is among several filed across the country targeting Avandia and its manufacturer. The drug, which has been on the market since 1999, helps improve blood sugar regulation in type 2 diabetes patients.

"We're in the early stages of a national pharmaceutical litigation, and it's snowballing," said Los Angeles-based attorney Roger Drake, whose firm is representing the Kellys.

Drake estimated there are "thousands and thousands" of Avandia-related lawsuits yet to be filed.

Nancy Pekarek, spokeswoman for GlaxoSmithKline, said the company stands by Avandia and will defend against any litigation.

"We are certainly confident that when the courts or the juries look at the clinical data, the responsible way in which we communicated that information, and our openness in posting our clinical trial data online, they will see our position," she said.

Pat Kelly, 59, said he took Avandia because it was touted as a lifestyle drug where he wouldn't have to take insulin. Instead, Kelly says, the drug led to painful heart trouble and eventual heart bypass surgery in 2007.

Kelly had more than 40 years in the auction business and frequently traveled across the country for his work, but he says the surgery has sapped his energy and the jobs have dried up.

"To put it bluntly, I went from a hero to a zero," Kelly said Wednesday. "I simply don't have the energy that I did.

"I don't have the stamina I did," he said.

Today, when he reads articles on the potential side effects of the drug, Kelly says he thinks, "my God, how many other people has (the drug) touched?"

Drake calls Kelly's litigation against GlaxoSmithKline a question of "what did they know and what should have they known about this drug."

The lawsuit alleges that the company "had the knowledge, the means and the duty to provide the medical community and the consuming public with more accurate descriptive information and more adequate warnings regarding the association between Avandia and heart failure ..."

Sales of Avandia have dropped in the United States since a report last May by the New England Journal of Medicine that linked the drug to an increased risk of heart attacks.