AstraZeneca Seeks To Shield Seroquel Sales Rep Notes, Study Reports In Pending Injury Cases
This article was originally published in The Pink Sheet Daily
Executive Summary
AstraZeneca says internal company information should not be released before personal injury cases go to trial.
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Although personal injury suits alleging that AstraZeneca's Seroquel causes diabetes have not yet gone to trial, plaintiffs' lawyers are pressing the company to release internal documents. A federal judge in Orlando, Fla. is to hold a hearing Feb. 26 on AstraZeneca's motion to keep the documents under seal. They include a portion of Seroquel's (quetiapine) investigational new drug application, sales rep call notes describing meetings with doctors, and clinical trial study reports. The Florida hearing illustrates the problems pharmaceutical companies have in keeping internal documents away from the public eye. While such information usually comes to light eventually in court rulings and government settlements, the plaintiffs in this case are trying to get it out to the public before any cases even go to trial. Often this kind of strategy is a way to bring public attention to the case. The plaintiffs' attorneys obtained the information during discovery in personal injury suits pending before the U.S. District Court for the Middle District of Florida. AstraZeneca won a victory on Jan. 28 when Judge Anne Conway tossed out the first two injury test cases ruling that the plaintiffs had no evidence to support a claim that the atypical antipsychotic Seroquel caused their alleged diabetes. There are approximately 6,000 Seroquel personal injury cases consolidated before the court in multidistrict litigation proceedings. Thousands of additional cases are pending in state courts in Delaware, New Jersey, New York and Missouri. The first of these cases is scheduled for trial in Delaware on April 6. AstraZeneca said it is premature for the plaintiffs to challenge the confidentiality of their internal documents. "Plaintiffs' claims should be tested in court - not tried in a premature and one-sided fashion in the media," an AstraZeneca spokesperson said. The company said that 111 documents are at issue in the Feb. 26 hearing and it is requesting that 65 of these documents remain confidential. Also among these documents is information about alleged personal relationships AstraZeneca's former U.S. medical director for Seroquel, Wayne MacFadden, had with a Seroquel researcher and a medical marketing ghostwriter. Plaintiffs contend that the existence of these relationships calls into question the integrity of scientific work of those involved. AstraZeneca said it opposes efforts to release these documents because they are irrelevant to the litigation. Documents issue is fodder to argue case to the public The battle over the company documents has given one of the lead plaintiffs attorneys, Howard Nations, an opportunity to argue his case to the media. In a Feb. 25 web conference, Nations said that making documents available to the public before trial is in the public interest since the information may be relevant to public safety. Nations repeatedly likened the Seroquel cases to litigation over Lilly's atypical antipsychotic Zyprexa (olanzapine). For example, he said that suits against Lilly showed the company was prescribing Zyprexa for off-label uses. He said that once information came out in Zyprexa litigation Seroquel took the market lead. In January, Lilly reached a $1.4 billion settlement with the Department of Justice over Zyprexa marketing (1 (Also see "Lilly $1.4B Zyprexa Settlement Is Biggest Ever, But Some State Claims Still Pending" - Pink Sheet, 15 Jan, 2009.)). Lilly previously paid more than $1 billion to settle product liability claims that it did not adequately warn of the risk of diabetes. A total of 10,210 Seroquel lawsuits involving approximately 15,461 plaintiff groups have been filed. In additional to personal injury suits, state attorneys general in Montana, South Carolina, Arkansas and Pennsylvania have sued to recover Medicaid money for off-label use of the drug. Those cases were consolidated in the federal multidistrict litigation proceedings in Florida. Nations said that Judge Conway is considering sending the multidistrict litigation cases back to the states from which they originated. As of Dec. 31, AstraZeneca has incurred $512 million in legal costs from the Seroquel litigation. - Brenda Sandburg ([email protected]) |