Britain’s AstraZeneca wins first trial in case alleging psychiatric drug Seroquel caused harm

AstraZeneca wins 1st trial over alleged drug harm

TRENTON, N.J. — AstraZeneca PLC’s blockbuster psychiatric drug Seroquel did not trigger diabetes in a Vietnam veteran, a jury ruled Thursday in the first trial out of thousands of cases alleging the powerful drug caused diabetes.

The British drugmaker said a jury in Middlesex County Superior Court in New Jersey voted 7 to 1 in favor of the company, after deliberating for seven hours over the past two days. Judge Jessica Mayer in New Brunswick presided over the trial, which included 15 days of testimony.

The case was brought by Ted Baker, 61, who developed diabetes after taking Seroquel for about three years and blamed it on the drug.

Baker, of Bastrop, La., took Seroquel from 2001 through 2006 for depression and posttraumatic stress disorder. He was diagnosed with diabetes in 2004.

“The jury found … that AstraZeneca’s Seroquel label provided prescribing doctors adequate warning with respect to the risk of diabetes,” Arthur Brown, outside counsel for AstraZeneca, told The Associated Press in an interview.

Perry Weitz, head of the Weitz & Luxenberg firm which represented Baker, said his attorneys are reviewing possible grounds for appeal.

Seroquel is officially approved for treating schizophrenia and bipolar disorder, but it is widely prescribed for unapproved uses, including other psychiatric conditions and insomnia. Partly because of all that so-called off-label use, the drug brought in $4.9 billion last year, making it the company’s second-best seller. It’s been on the market since 1997.

Last fall, the company said it had reached a $520 million settlement in principle to end a federal investigation of alleged improper marketing of Seroquel, including promoting it for unapproved uses. The settlement is still pending.

Like other drugs in the widely used class called atypical antipsychotics, Seroquel carries a host of serious warnings, including risk of developing high blood sugar, diabetes complications, cholesterol problems and suicidal thoughts and behavior.

AstraZeneca “had proof that Seroquel caused diabetes and they never warned about it until they were forced to by the FDA,” Weitz said.

Seroquel’s label, the fine-print package insert approved by the Food and Drug Administration, states there is an association between the drug and development of diabetes. A key issue in the trial was when the company adequately warned doctors and patients about the risk.

Weitz said that wasn’t until after Baker developed diabetes.

According to AstraZeneca, diabetes was listed starting in 1997 as an adverse event in the package insert. In January 2004, the company says that was upgraded to a more prominent position in the lengthy insert under the heading “Warnings.”

Other drugs in the class, which generates more than $15 billion a year in revenue, carry similar warnings. Competing drugs include Johnson & Johnson’s Risperdal, Eli Lilly & Co.’s Zyprexa, Pfizer Inc.’s Geodon and Bristol-Myers Squibb’s company’s Abilify.

AstraZeneca faces product liability lawsuits involving about 22,100 plaintiff groups, generally alleging that Seroquel caused diabetes. Cases involving about 3,460 additional plaintiff groups had been filed but not yet served as of December 2009, according to the company’s annual report.

Many of the cases are consolidated in federal court in the Middle District of Florida, under Judge Anne Conway.

Previously, nine Seroquel cases brought by plaintiffs in New Jersey, Delaware and Florida were dismissed before the start of a trial. About 2,660 other cases have been dismissed either by a judge’s order — some over questions about the qualifications of expert plaintiff witnesses — or by the plaintiff withdrawing the case.

Weitz compared the Seroquel lawsuits to the massive litigation Merck & Co. faced over its former painkiller Vioxx. It ended nearly 50,000 personal injury lawsuits with a $4.85 billion settlement.

“AstraZeneca will spend billions unless … they try to get this settled,” Weitz said.

AstraZeneca’s U.S. shares slipped 1 cent to $44.69 in afternoon trading in New York.