$90 million settlement reached in Avandia case

Ohio is expected to receive $3 million; company accused of misrepresenting to physicians and prescribers drug's cardiovascular risks and safety profile.
Norwalk Reflector Staff
Nov 16, 2012

Ohio Attorney General Mike DeWine announced Thursday that he and 37 other Attorneys General reached a $90 million settlement with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its diabetes drug, Avandia. Ohio is expected to receive $3 million.

The Attorneys General allege that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting to physicians and prescribers Avandia's cardiovascular risks and safety profile.

"We are pleased to have reached this settlement with GlaxoSmithKline," said Attorney General DeWine. "It is vital that drug companies market and promote their products properly to ensure patient safety."

As part of the settlement, which has been presented to the Lucas County Common Pleas Court for approval, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. Under the settlement, GSK may not:

* Make any false, misleading, or deceptive claims about any diabetes drug;

* Make comparative safety claims not supported by substantial evidence or substantial clinical experience;

* Present favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;

* Promote investigational drugs; or

* Misuse statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials.

The settlement also has the following terms that are effective for at least eight years:

* GSK must post summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;

* GSK shall post summaries of GSK-sponsored clinical trials of diabetes products within eight months of the primary completion date;

* GSK shall register and post all GSK-sponsored clinical trials as required by federal law; and

* GSK shall comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals.

Funds received by Ohio will be placed into the Consumer Protection Enforcement Fund. A copy of Ohio's filing is available by clicking on the link below.

In addition to Ohio, the other states filing individual settlements include Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.