June 4, 2014—Oregon Attorney General Ellen Rosenblum and 44 Attorneys General reached a $105 million settlement with GlaxoSmithKline (GSK), LLC to resolve allegations that the pharmaceutical company unlawfully promoted and misrepresented the asthma drug, Advair®, and antidepressant drugs, Paxil® and Wellbutrin®. Rosenblum and Illinois Attorney General Lisa Madigan’s offices led the effort to reach the settlement. As a lead state, Oregon will receive $3,769,000 of the settlement.
“Oregonians deserve to have factual and honest information about a drug they are considering buying and taking,” said Attorney General Rosenblum. “This settlement sends a clear message to pharmaceutical companies and their sales teams that the Attorneys General throughout the country will not tolerate them making misrepresentations to consumers concerning their products.”
The Complaint and Consent Judgment filed in Multnomah County Circuit Court today alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of the drugs. The Consent Judgment requires GlaxoSmithKline to reform its marketing and promotional practices. Specifically, GSK should not continue to:
- Make any written or oral claim that is false, misleading, or deceptive about the covered products;
- Make promotional claims, not approved or permitted by the Food and Drug Administration, that a covered GSK product is better, more effective, safer, or has less serious side effects than has been demonstrated by substantial evidence or clinical experience;
- Present favorable information or conclusions from a study that is inadequately designed, or furnish significant support for such information or conclusions, when presenting information about a clinical study on covered GSK products in any promotional materials;
- Provide samples of covered GSK products to healthcare professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled product for an off-label use; or
- Disseminate information describing any off-label use of a covered GSK product, unless such information and materials are consistent with FDA regulations and FDA Guidances for Industry.
The Consent Judgment requires GSK to continue its Patient First Program through at least March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing. The Judgment also requires scientifically trained personnel to be ultimately responsible for developing and approving unbiased and non-promotional responses to health care provider questions.
Oregon and Illinois led the Executive Committee, which also includes Attorneys General from Arizona, Florida, Maryland, Pennsylvania, Tennessee, and Texas.
Oregon has led two previous multi-state settlements with GlaxoSmithKline in 2011 for $40 million and in 2012 for $90 million. These settlements recovered an additional $1.9 million and $3.9 million for the state. Another multi-state settlement with GSK in 2012 returned $6.7 million to the Oregon Medicaid program. In total, Oregon has recovered more than $16 million from GSK.
Attorney General Rosenblum commended the excellent work of Assistant Attorney General David Hart and his DOJ team. Hart has successfully led every Oregon Department of Justice consumer protection multi-state fraud case in recent memory.
Kristina Edmunson, Department of Justice, Kristina.Edmunson@doj.state.or.us, 503-378-6002