Former in-house attorney and executive at <"http://www.yourlawyer.com/practice_areas/defective_drugs">GlaxoSmithKline has been re-indicted in an ongoing debacle concerning drug marketing practices. Lauren Stevens was charged late last year, but that indictment was dismissed due to prosecution errors, said Reuters, citing the Justice Department.
The former executive with pharmaceutical giant GlaxoSmithKline Plc has been re-charged with obstruction of justice (one count), making false statements (four counts), and falsifying and concealing documents (one count) during a U.S.-based investigation concerning <"http://www.yourlawyer.com/topics/overview/wellbutrin-cardiac-birth-defects-lawyer-lawsuit-attorney">Wellbutrin SR being marketed for weight loss, an unapproved use.
While physicians are legally allowed to prescribe medications for off-label uses, drugmakers are prohibited from marketing drugs for uses not approved by the U.S. Food and Drug Administration (FDA). The terms for the charges against Stevens range from five to 20 years.
The original indictment was filed in November and dismissed this March by a federal judge in Maryland who determined that prosecuting attorneys made errors â€œpresenting the case to the grand jury,â€ wrote Reuters. A grand juror asked prosecutors about the relevancy of Stevens having relied on the advice of other attorneys when she responded to the FDA’s investigation, said court papers, wrote Reuters. The advice received from these lawyers was, explained Reuters, key to Stevensâ€™ case; the judge found the prosecution “either substantially influenced the decision to indict or, at the very least, creates grave doubt as to that decision,” quoted Reuters.
Original charges involved the disgraced former attorney having signed letters to the agency in which false statements were made and the magnitude of Glaxoâ€™s illegal marketing were minimized. In November, Stevens was charged with withholding information concerning Glaxo paying one Vermont physician to speak at 511 events and a Michigan physician to give 488 talks touting Wellbutrinâ€™s off-label uses.
The Justice Department said the new indictment charges are, for the most part, the same as the original charges; however, officials were not able to provide Reuters with a copy. The trial is tentatively scheduled to start sometime this month, said Reuters.
â€œThere is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth,â€ Carmen Ortiz, U.S. attorney for Massachusetts, said in a statement in November, previously quoted by Bloomberg.com. â€œFederal agencies such as the FDA cannot protect the public health if entities and individuals they regulate provide false information,â€ Ortiz added. Among other issues, Stevens sent three false letters in 2003 to the FDA in which she did not disclose that Glaxo directly urged using Wellbutrin for weight loss, that it paid physicians for promotional talks, and that Glaxo held â€œspecial issue boardsâ€ for the purpose of talking about the drugâ€™s unapproved uses.
Studies have pointed to increased risks of miscarriages in pregnant women taking antidepressants and that some have been linked to an increase in serious birth defects, including Wellbutrin. Also, although the risks are not yet fully clear, researchers do warn about potential effects between Wellbutrin and heart birth defects.