PHOENIX (Thursday, March 10, 2011) -- Attorney General Tom Horne today announced Arizona has received the largest-ever pharmaceutical payout in Arizona history - nearly $2.1 million - as part of the largest-ever multi-state consumer protection-based pharmaceutical settlement.
Horne stated: “This settlement sends a powerful message to drug companies that deceptive practices will not be tolerated. The health and safety of consumers is vitally important, especially where medications are necessary for the well-being of the patient.”
Arizona, along with 37 other Attorneys General, reached a record $68.5 million dollar settlement with AstraZeneca Pharmaceuticals LP arising from alleged deceptive marketing of the antipsychotic drug, Seroquel. The payment to Arizona is $2,093,327.
The complaint, filed today along with a Consent Judgment, alleges that AstraZeneca engaged in false and deceptive practices when it marketed Seroquel for unapproved or off-label uses; failed to adequately disclose the drug’s potential side effects to health care providers; and withheld negative information contained in scientific studies concerning the safety and effectiveness of Seroquel.
In addition to the $68.5 million payment, the terms of the Consent Judgment include injunctive provisions that the states identified in their investigation. The Consent Judgment requires that AstraZeneca not promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses (uses that are not approved by the U.S. Food and Drug Administration). The Consent Judgment also requires AstraZeneca to do the following:
- Publicly post its payments to physicians on a website;
- Ensure that it does not give financial incentives to marketing and sales personnel for off-label marketing;
- Ensure that its sales personnel do not promote Seroquel to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use; and
- Atypical anti-psychotics, including Seroquel, can produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia and other severe conditions.
Although a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. As alleged, AstraZeneca unlawfully marketed Seroquel for a number of off-label uses, including for use in pediatric and geriatric populations, specifically in nursing homes for Alzheimer’s Disease and Dementia. The States also alleged that AstraZeneca marketed Seroquel for anxiety, depression, sleep disorders, and post traumatic stress disorders even though the FDA had not approved Seroquel as a treatment for these conditions at the time AstraZeneca marketed Seroquel.
In addition to Arizona, the Attorneys General of the following states and the District of Columbia participated in the settlement: California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
This matter was handled by AAG Noreen R. Matts.