Posted: 11-06-11 Categories:
Avandia News
Avandia Settlements

Glaxo to pay $3 billion settlement of Avandia, U.S. sales cases

The attorneys at no longer are accepting new Avandia cases.

GlaxoSmithKline (GKS) has entered into a settlement agreement to pay the U.S. government $3 billion to resolve several civil and criminal investigations into the drug company.

The settlement will cover the Justice Department investigation into GSK’s development and marketing of its controversial diabetes drug Avandia, which has been linked to increased risks of heart attack, stroke, congestive heart failure (CHF), and sudden cardiac death. It also covers allegations that GSK defrauded the Medicaid program and marketed some of its drugs illegally.

The settlement relates to an eight-year-old government investigation into Glaxo’s marketing and sales of several prescription drugs, including Wellbutrin and SSRI antidepressant Paxil between 1997 and 2004. Issues included how Glaxo represented Paxil suicide risks and whether Glaxo promoted off-label uses for Wellbutrin. Government investigators also examined medical education and drug trials funded by Glaxo as well ways the company potentially influenced doctors.

The final terms of the settlement are still being negotiated. GSK expects to pay the U.S. government in 2012.

The $3 billion settlement “is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today,” Glaxo CEO Andrew Witty said in a statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”

Glaxo’s full statement may be viewed here.

The attorneys at no longer are accepting new Avandia cases.

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