Ketek Lawsuit News

01/31/2008 - The House Energy and Commerce Committee’s investigation into sanofi-aventis’ controversial antibiotic Ketek gained steam as the panel voted on subpoenas covering individuals and numerous agency documents.

The individuals subpoenaed are current FDA criminal investigators Robert West and Douglas Loveland, former investigator Robert Ekey and clinical research associate Ann Marie Cisneros, who testified before the subcommittee in February 2007 that sanofi-aventis was aware of fraud committed in the Ketek (telithromycin) clinical trial known as Study 3014.

The clinical investigator in that trial, Anne Kirkman-Campbell, was sentenced to 57 months in prison for fraud associated with the study. Kirkman-Campbell enrolled patients in the study on days when the office was closed, enrolled her entire staff in the study and blatantly forged consent documents, according to Cisneros.

The documents to be subpoenaed include, but are not limited to, all communications among senior staff at the FDA, the agency’s Office of Legislative Affairs, the HHS Office of Legislative Affairs and Budget and the HHS Office of the General Counsel, “including communications from the FDA Office of Chief Counsel to Commissioner von Eschenbach and his senior staff.”

If you or a loved one have experienced liver damage, liver failure, or Stevens Johnson Syndrome as a result of Ketek side effects contact the Ketek attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and attorneys are standing by to answer any questions you may have regarding Ketek side effects, a possible Ketek class action lawsuit, or any other type of Ketek litigation.