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Attorney General J.B. Van Hollen and 37 Other Attorneys General Reach a $90 Million Settlement with GlaxoSmithKline LLC Concerning Avandia

 

MADISON — Attorney General J.B. Van Hollen announced today that he and 37 other Attorneys General reached a $90 million Consent Judgment with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its diabetes drug Avandia®, with Wisconsin receiving $2,024,775.48. The Attorneys General allege that GlaxoSmithKline engaged in untrue, deceptive, and misleading practices by misrepresenting Avandia's cardiovascular risks and safety profile.

 

“It is unlawful in the State of Wisconsin to make false and deceptive representations about the material effects of a drug,” Van Hollen said. “When aggressive pharmaceutical marketing misrepresents known risks of a drug or deceptively markets positive attributes of a drug that are not supported by the scientific data, consumers and doctors alike are unable to make informed choices about the risks of taking the medication. These violations of the law can have dangerous consequences and will be prosecuted by this office.”

 

As part of the Consent Judgment, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. Under the Consent Judgment, 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 Consent Judgment 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 International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for Manuscripts submitted to Biomedical Journals.

 

Under the settlement Wisconsin shall receive $2,024,775.48.

 

The investigation was led by the Attorneys General of Oregon and Illinois with an Executive Committee consisting of the Attorneys General of Arizona, Florida, Maryland, Pennsylvania, Tennessee, and Texas. Also participating in the settlement are Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, Washington and Wisconsin.

 

The State was represented by Assistant Attorney General Lara Sutherlin.

 

Copies of the Complaint and Consent Judgment are available at the following links:

Summons and Complaint

Consent Judgment