Thursday, November 26, 2015

GSK reportedly agrees to $460 million Avandia settlement

GlaxoSmithKline has reportedly agreed to settle 10,000 lawsuits alleging that its diabetes drug Avandia injured patients, Bloomberg News reported, citing sources “familiar with the accords.”

GSK reportedly agrees to $460 million Avandia settlement


GlaxoSmithKline has reportedly agreed to settle 10,000 lawsuits alleging that its diabetes drug Avandia injured patients, Bloomberg News reported, citing sources “familiar with the accords.”

The settlements come as the Food and Drug Administration begins two days of hearings into the safety of the drug. Tuesday morning U.S. Senators Chuck Grassley (R., Iowa) and Max Baucus (D., Mont.) released documents obtained by investigators that suggest Glaxo hid data that showed Avandia increased the risk of heart attacks, heart failure and strokes - even as it marketed the drug to the public.

Glaxo did not respond to a request for comment on the settlement, saying in an e-mail to Check Up that it could confirm only that it had settled the first suit scheduled for trial in a Philadelphia state court on June 1.

The company added, “We continue to prepare for trials later this year, and are fully prepared to defend any litigation because we are 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.”

The Bloomberg story noted that Glaxo faces about 13,000 Avandia suits in federal and state courts. Its sources said the settlements ranged from $46,000 to $70,000 for individuals depending on the claim.

Glaxo has continued to defend the drug’s safety, and responded to Tuesday’s release by Sens. Baucus and Grassley in a statement that said, in part: “Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading.”

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About this blog
Charlotte Sutton Health and Science Editor, Philadelphia Inquirer
Tom Avril Inquirer Staff Writer, heart health and general science
Stacey Burling Inquirer Staff Writer, neuroscience and aging
Marie McCullough Inquirer Staff Writer, cancer and women's health
Don Sapatkin Inquirer Staff Writer, public health, infectious diseases and substance abuse
Justin D'Ancona
David Becker, M.D. Board certified cardiologist, Chestnut Hill Temple Cardiology
Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Anesthesiologist and Surgical Intensivist in the Philadelphia Area
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