Seroquel Suit Settled for $68.5M
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EmailTRENTON – N.J. Attorney General Paula T. Dow announced a whopping $68.5 million, multi-state settlement with pharmaceutical giant AstraZeneca. It resolves allegations the company deceptively marketed its anti-psychotic drug Seroquel®.
“This is an important settlement for all New Jersey residents,” said Attorney General Dow. “This case sends a message that we take seriously the duty pharmaceutical companies have to supply clear, accurate and complete information about their products to health care providers, and to market their products without deception or misleading claims.”
Seroquel® and similar "atypical anti-psychotics" can produce dangerous side effects including:
- weight gain
- hyperglycemia
- diabetes
- cardiovascular complications
- increased risk of mortality in elderly patients with dementia.
Other problems have arisen in recent years. A report in British Medical Journal in 2005 showed that Seroquel® (generic name: quetiapine) was ineffective in reducing agitation among Alzheimer's patients, whose usage of the drug constituted 29% of sales. In fact, Seroquel® was found to worsen cognitive functioning in elderly patients with dementia.[1]
“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas R. Calcagni, Acting Director of the Division of Consumer Affairs.
“The importance cannot be overstated, when the health and safety of New Jersey residents are at stake,” Calcagni said.
Following a three-year investigation by the participating states, the Delaware-based AstraZeneca agreed not to promote Seroquel® in a false, misleading or deceptive manner, including for “off-label” uses, which are not approved by the U.S. Food and Drug Administration. In addition to the overall $68.5 million payment, terms of the settlement include provisions that address specific concerns identified in the states’ investigation. The agreement specifically requires AstraZeneca to:
- Publicly post its payments to physicians on a Web site
- Have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing
- Have policies in place to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel® for an FDA-approved use
- Cite to Seroquel®’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel® by highlighting symptoms only
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.
AstraZeneca allegedly marketed Seroquel® for a number of off-label uses, including for use in geriatric populations, specifically in nursing homes for Alzheimer’s Disease and dementia, as well as for anxiety, depression, sleep disorders, and post traumatic stress disorder. AstraZeneca promoted Seroquel® for such uses even though Seroquel® was not, at the time it was marketed, approved for treatment of these conditions, and AstraZeneca had not established that Seroquel® was safe and effective for these uses. Atypical anti-psychotics, including Seroquel®, can produce dangerous side effects including weight gain, hyperglycemia, diabetes, cardiovascular complications and increased risk of mortality in elderly patients with dementia.
Under the settlement agreement, New Jersey will receive approximately $1.85 million. Thirty-six states and the District of Columbia also are party to the settlement, described as the largest-ever multi-state, consumer-protection-based pharmaceutical settlement.
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A Verified Complaint, filed in New Jersey Superior Court today along with a Final Consent Judgment memorializing the settlement, charges that AstraZeneca engaged in unfair and misleading practices when it marketed Seroquel® for unapproved or off-label uses. The Complaint also alleges that AstraZeneca failed to adequately disclose the potential side effects of Seroquel® to health care providers, and withheld negative information contained in scientific studies regarding the safety and efficacy of Seroquel®.
In addition to New Jersey, the following states and the District of Columbia participated in the settlement: Florida, Illinois, Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Money paid to New Jersey as a result of the AstraZeneca settlement will be used for consumer protection initiatives. Deputy Attorney General Gina M. Betts, assigned to the Division of Law’s Consumer Fraud Prosecution Section, handled the matter on behalf of the State.
For more information on Seroquel®, visit the AstraZeneca Website.
Source:
- Ballard, C.; Margallo-Lana, M.; Juszczak, E.; Douglas, S.; Swann, A.; Thomas, A.; O'Brien, J.; Everratt, A. et al. (2005). "Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial". BMJ 330 (7496): 874. doi:10.1136/bmj.38369.459988.8F. PMC 556156. PMID 15722369.
- The State of New Jersey, Department of Law and Public Safety, Office of the Attorney General
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