Most Seroquel Diabetes Lawsuits Settled, AstraZeneca Says

AstraZeneca Plc has said that it has settled most of the lawsuits alleging <"">Seroquel can cause diabetes in some patients. The drug maker, said Bloomberg Businessweek, put aside $647 million for some 28,461 Seroquel lawsuits, according to its second-quarter earnings report.

Seroquel was introduced in 1997 to treat psychotic disorders, schizophrenia, and bipolar disorder. In recent years, AstraZeneca has faced thousands of Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk.

There is a reserve of funds, said Businessweek, which AstraZeneca said includes money for about 250 open cases. AstraZeneca sees its settling the Seroquel debacle for under $1 billion as a positive, according to experts who point to drug makers such as Eli Lilly & Company, which paid about $1.2 billion over Zyprexa lawsuits and $1.42 billion in government fines related to allegations that Zyprexa caused diabetes in some patients, said Businessweek.

Last year, AstraZeneca announce it resolved most—about 2/3rds—of the 26,000 Seroquel lawsuits filed nationwide then, said Businessweek. “AstraZeneca is aware of about 250 Seroquel product- liability claims in the United States that have not been settled in principle,” Tony Jewell, a U.S.-based spokesman for AstraZeneca, said in an e-mailed statement, wrote Businessweek.

According to AstraZeneca’s filing, it paid $749 million in legal fees and expenses to defend against Seroquel claims, to date; $134 million is covered by insurance, wrote Businessweek. Last year, AstraZeneca also agreed to pay $520 million to resolve U.S. allegations it illegally marketed Seroquel for uses not approved by the U.S. Food and Drug Administration (FDA), Businessweek added.

The $647 million Seroquel litigation reserve includes money “to account for the current and anticipated future settlement costs regarding the Seroquel product liability claims, past and future defense costs associated with defending the claims since the fourth quarter 2010,” AstraZeneca said in its earnings report, reported Businessweek. The reserve also includes money for lawsuits filed by state attorneys generals over how AstraZeneca marketed Seroquel, the report said. Businessweek pointed out that the drug maker agreed, earlier this year, to pay $68.5 million over claims it deceptively marketed Seroquel in 37 states.

AstraZeneca submitted a request to reject a case brought about by Arkansas Attorney General Dustin McDaniel, which alleged it concealed Seroquel’s health risks when promoting it to residents covered by that state’s Medicaid program. Businessweek just reported that the bid was rejected by the court.

All Seroquel cases filed against AstraZeneca in U.S. federal courts, were consolidated in 2006 in federal court in Orlando, Florida, for pretrial evidence gathering and as part of a Multi- District Litigation program, said Businessweek.

Meanwhile, following a request from the U.S. Food & Drug Administration (FDA), AstraZeneca will be including a new cardiac warning to Seroquel labels, The New York Times recently reported. The revised label indicates that both Seroquel and the extended-release version of the drug, Seroquel XR, “should be avoided” when used with about one dozen other drugs connected to heart arrhythmia, which can lead to sudden cardiac arrest, reported The New York Times.

Earlier this year, we reported that U.S. health regulators ordered cautions be added to ALL antipsychotic drug labels regarding their risk of abnormal muscle movements (extrapyramidal symptoms or EPS) and withdrawal syndromes in newborns when used in pregnancy. The new cautions will apply to older and new generation antipsychotics, including Seroquel.

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