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Tuesday, May 11, 2010

Glaxo's $60 Million in Avandia Settlements‎

Latest news from Bloomberg suggests that GlaxoSmithKline have agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users.

The full story can be read HERE

I've just highlighted the denials.

“GlaxoSmithKline stands by Avandia and is fully prepared to defend any litigation,” Bernadette King, a company spokeswoman, said in an e-mailed statement.

London-based Glaxo’s decision to settle cases before they comes to trial will save the company time, money and embarrassment, said Richard Nagareda, a Vanderbilt University law professor who teaches classes on mass-tort law.

“It sounds like they’ve beaten down the price on these cases to the point that there isn’t that much benefit from taking them to trial,” Nagareda said in an interview.

Glaxo officials contend former Avandia users who suffered heart attacks can’t link them to the drug and the drugmaker didn’t hide the medicine’s health risks.

Glaxo is “confident that when courts and juries look at actual clinical data, the manner in which we communicated with the FDA and physicians and our openness in posting studies on our website, the facts will support our position,” King, Glaxo’s director of product communications, said in the e-mail.

Andrew Witty, Glaxo’s chief executive officer, said in an interview last week that he was confident about Avandia’s “risk-benefit profile” and the company’s handling of the drug.

“The only thing I ask for is that qualified scientists with the right evidence and data calmly look at the information,” he said. “The company’s done all the right things in terms of sharing that data with the regulators and working with the regulators to update the label.”

In their Avandia suits, consumers contend Glaxo officials refuse to take the drug off the market even though studies have shown it poses an increased risk of heart attack and stroke compared with competing medicines.

A report by two U.S. senators in February noted U.S. Food and Drug Administration regulators urged Glaxo to withdraw Avandia from the market in 2008 because it was causing 500 avoidable heart attacks a month.

The report, by Senators Max Baucus and Charles Grassley, also said Glaxo officials sought to intimidate doctors who criticized the drug. Dr. John Buse, a University of North Carolina Medical School professor, gave presentations highlighting Avandia’s risks, the senators said.

Glaxo officials complained to Buse’s supervisor and threatened to take legal action over the statements, the report said. Buse later agreed to stop criticizing the drug, according to the report.

Glaxo officials rejected the senators’ contentions that it concealed safety information about Avandia or used improper marketing tactics. They said the report contained “errors of fact, omission and inference and shouldn’t have been published.”



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