Attorney General Martha Coakley and 37 Attorneys General Reach a Landmark $68.5 Million Settlement with AstraZeneca Pharmaceuticals
The settlement, filed today in Suffolk Superior Court, includes a payment of over $2 million to the Commonwealth. The payment includes $250,000 for attorneys' fees and investigative costs, and over $1million to fund programs that lower health care costs for Massachusetts residents, combat unlawful marketing practices in the health care market, or otherwise benefit health care consumers.
The settlement resolves the Attorney General's complaint, which also was filed today in Suffolk Superior Court. The complaint alleges that AstraZeneca engaged in unfair and deceptive practices when it marketed Seroquel for uses that had not been approved by the U.S. Food & Drug Administration (FDA), failed to adequately disclose the drug's potential side effects to health care providers, and withheld negative information about Seroquel's safety and efficacy.
"When pharmaceutical companies market drugs for uses that have not been shown to be safe or effective, they put consumers at risk and increase health care costs," Attorney General Martha Coakley said. "This settlement helps ensure that consumers will be protected from misleading marketing that can result in the unnecessary and unsafe use of prescription drugs."
In addition to the $68.5 million payment, the consent judgment includes provisions that address specific concerns identified in the investigation, which began three years ago. Along with other prohibitions and requirements, the consent judgment specifically requires AstraZeneca to:
- Publicly post its payments to physicians on a website;
- Take steps to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing;
- Take steps to ensure that AstraZeneca sales personnel do not promote the drug to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use; and
Although physicians may prescribe drugs for off-label uses, pharmaceutical manufacturers are prohibited from marketing their products for such uses. As alleged in the complaint, AstraZeneca unlawfully marketed Seroquel for unapproved uses in children and the elderly, and for Alzheimer's disease, dementia, anxiety, depression, sleep disorders, and post traumatic stress disorder. AstraZeneca promoted Seroquel for these uses even though Seroquel was not, at the time it was marketed, approved for the treatment of these conditions, and AstraZeneca had not established that Seroquel was safe and effective for these uses.
Atypical antipsychotics, 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.
Last year, the Attorney General's Medicaid Fraud Division also resolved claims against AstraZeneca for its marketing of Seroquel, obtaining an $18.8 million payment to the Massachusetts Medicaid Program as a result of a joint state-federal fraud investigation.
Today's settlement is the latest in a series of consumer protection settlements resolving complaints of illegal marketing by the makers of atypical antipsychotics, including Pfizer Inc., for its marketing of Geodon, and Eli Lilly and Company, for its marketing of Zyprexa.
Assistant Attorney General Sarah Ragland of Attorney General Martha Coakley's Health Care Division handled the case for the Commonwealth. In addition to Massachusetts, the Attorneys General of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, 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.