Seroquel (Quetiapine) Marketing and Products Liability Litigation Lawsuit

Seroquel (Quetiapine) Marketing and Products Liability Litigation

• Product: Seroquel (quetiapine), an atypical antipsychotic

• Manufacturer: AstraZeneca

• Docket: MDL 1769

• Outcome: settlement (2010) — Department of Justice off-label marketing case

• MDL status: terminated

The product

Quetiapine, sold under the brand name Seroquel, is an atypical antipsychotic that was developed in 1985 and approved by the FDA in 1997 for the treatment of schizophrenia. Indications were later expanded to acute mania and bipolar depression in bipolar disorder, and in 2009 the extended-release formulation was approved as an add-on treatment for major depressive disorder. AstraZeneca marketed the drug, which works by blocking a range of receptors, including dopamine and serotonin receptors.

At low doses, quetiapine acts largely as a sedating antihistamine, and that calming effect led to widespread off-label prescribing as a sleep aid — a pattern of use that drew sustained scrutiny over whether the drug's risks were being weighed properly in populations, including elderly patients, for which it was not approved. The drug is now available in generic form and remains one of the most frequently prescribed antipsychotics in the United States.

The alleged harm

The adverse events at the center of the litigation spanned the known risk profile of antipsychotics and the specific concerns about quetiapine: weight gain and elevated blood sugar and other metabolic effects, QTc prolongation, movement disorders such as tardive dyskinesia, and neuroleptic malignant syndrome, a rare and potentially fatal reaction. Use in older patients with dementia carries an increased risk of death, a risk that regulatory warnings highlighted. Because low-dose quetiapine was so widely prescribed for insomnia and sedation, the alleged injuries ran across a wide range — from slurred speech and chronic insomnia to death. Roughly ten thousand lawsuits against AstraZeneca alleging that quetiapine caused such harm were reported as filed.

The litigation

Patients who experienced serious adverse events while taking quetiapine brought product-liability actions against AstraZeneca, and the federal cases were centralized as In re Seroquel Products Liability Litigation, MDL 1769.

A separate track of the dispute concerned promotion rather than the drug's chemistry. In April 2010, the U.S. Department of Justice resolved a case against AstraZeneca over aggressive off-label marketing of Seroquel. Per the Department of Justice's press release, the company was alleged to have recruited doctors to serve as authors of articles that were in fact ghostwritten by medical literature companies, about studies the doctors had not conducted, and then to have used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

Resolution

The settlement recorded for this entry in 2010 is the resolution of the Department of Justice's off-label marketing case, not of the products-liability claims themselves. The archived record does not document the outcome of the consolidated products-liability action, and this entry reflects the record as preserved: the docket record shows the MDL as terminated, while the disposition of the underlying claims is not established in the sources listed below.

The Seroquel matter is frequently discussed as a landmark enforcement action against off-label promotion, and the ghostwriting allegations in particular are often cited in debates about the integrity of the medical literature.