Lawyers for a Vietnam veteran who is among the thousands of patients suing AstraZeneca over claims that Seroquel caused diabetes and other ailments have requested the release of confidential documents about the drug’s side effects, AP business writer Linda Johnson reports.
Lawyers obtained the documents in question during the discovery process, and say they contain “internal company analyses of safety data on Seroquel that the lawyers believe FDA staff and advisers have never seen.” The judge in the case has set late March deadlines for the consideration of related motions, deadlines which take into consideration an April 8 FDA hearing FDA on the safety of proposed additional uses of Seroquel.
Lawyers for Ted Baker, 60, of Bastrop, La., have asked New Jersey Superior Court Judge Jamie Happas to unseal 19 specific documents – out of roughly 2.85 million generated so far in the litigation – so that they can present them to the FDA advisory panel members at the hearing.
“We think it’s important that they have the benefit of what we have learned,” Ellen Relkin, one of Baker’s lawyers, told The Associated Press in an exclusive interview Wednesday. “What we believe the FDA does not have are internal memos where they analyze the studies (and state) their real opinions or concerns about the data.”
According to Johnson’s report, “plaintiffs lawyers believe the drug causes Type 2 diabetes through two mechanisms: stimulating appetite and significant weight gain, and by raising levels of blood sugar and cholesterol.”
