Healthy Skepticism Library item: 13833

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Publication type: news

Eder A.
Astra CEO in London trial will take stand
Delaware Online 2008 Jun 20
http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20080620/BUSINESS/806200327/1003

Abstract:

AstraZeneca faces 8,440 cases over Seroquel risks

Full text:

The chief executive of AstraZeneca PLC is set to be deposed today regarding allegations the company hid the risk that its anti-psychotic drug Seroquel could cause diabetes in users.

David Brennan, who led AstraZeneca’s U.S. unit in Fairfax before being appointed CEO of the London-based drug maker in 2006, will answer questions in London from attorneys representing thousands of plaintiffs across the Unites States.

“A lot of very good people have been severely injured for the rest of their life because of the conduct of this company and the effect of this drug,” said attorney Paul Pennock of the New York firm Weitz & Luxenberg, which is handling about 2,500 Seroquel cases in federal and state courts.

In all, AstraZeneca said it faces 8,440 personal injury lawsuits from more than 12,000 plaintiffs over Seroquel, a drug developed in Delaware by AstraZeneca’s corporate predecessor Zeneca Group.

The lawsuits include a consolidated case in federal court in Florida, for which Brennan is giving his deposition, as well as clusters of state court cases in Delaware, New Jersey, New York and Missouri. Pennock said the first cases are likely to go to trial next spring.

AstraZeneca said Seroquel, part of a class of drugs known as atypical anti-psychotics, has helped millions of people suffering from mental illnesses lead healthy lives.

The company said the nature of the plaintiffs’ alleged injuries is unclear and little or no information about the alleged injuries was provided in the complaints.

“AstraZeneca intends to litigate these cases on the merits and will defend the cases vigorously,” company spokesman Tony Jewell said.

Pennock said the team of plaintiffs’ attorneys, from several law firms across the country, believes the evidence at trial will show that AstraZeneca knew Seroquel could potentially cause high blood sugar levels, weight gain and diabetes; that the company hid the dangers; and that it avoided studying the issue to limit evidence of the risks.

AstraZeneca added a warning about the risk of hyperglycemia and diabetes to Seroquel’s label in 2004 at the urging of the U.S. Food and Drug Administration.

Pennock said as many as 70 percent of Seroquel prescriptions were for “off-label” uses, meaning the FDA has not approved the drug for those uses. Seroquel is approved for the treatment of schizophrenia and bipolar disorder, but AstraZeneca is asking the FDA also to approve its once-daily version of the drug, Seroquel XR, for depression and anxiety disorder.

At least three states, including Pennsylvania, have sued AstraZeneca over its marketing of Seroquel, the company’s No. 2 drug with more than $4 billion in sales last year.

Jewell said AstraZeneca promotes its medications in accordance with FDA regulations. Doctors are free to prescribe medications as they see fit.

“That’s their decision based on their medical judgment about the needs of their patients,” Jewell said.

Eli Lilly & Co. has paid at least $1.2 billion to settle product liability claims with more than 31,000 people over Zyprexa, another atypical antipsychotic. AstraZeneca said in a financial filing in January that it had incurred legal costs of about $200 million, and that it expects its product liability insurance to cover its legal costs in the cases.

Pennock, who said AstraZeneca’s attorneys have refused to discuss a settlement, said he thought Seroquel litigation could cost the drug maker as much as $10 billion.

On Thursday, Pennock’s firm released information on a lawsuit filed in New Jersey on behalf of a New York City paramedic who was injured at the World Trade Center on Sept. 11, 2001.

The law firm said the paramedic was prescribed Seroquel for post-traumatic stress disorder and later developed type 2 diabetes.

“His case is emblematic of the problem,” Pennock said.