Inspections, Compliance, Enforcement, and Criminal Investigations
June 19, 2009: Medical Director of Serono Labs Charged with Causing the Dissemination of Adulterated Computer Software Devices to Promote Sales of AIDS Drug
Boston, MA... A medical director of Serono Laboratories, Inc., was charged today in federal court with three counts of causing the dissemination of adulterated computer software devices used to interpret bioelectrical impedance analysis (BIA) test results in order to diagnose AIDS wasting and to increase sales of an AIDS wasting drug. The BIA software devices had not been approved by the U.S. Food and Drug Administration (FDA) to diagnose AIDS wasting and were therefore adulterated as their safety and efficacy had not been established for this purpose.
United States Attorney Michael J. Sullivan; Kim A. Rice, Special Agent in Charge of the Metro-Washington Field Office of the U.S. Food and Drug Administration's Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services - Office of Inspector General; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division; James M. Benages, Regional Director of the U.S. Department of Labor's Employee Benefits Security Administration; and Joseph Finn, Special Agent in Charge of the U.S. Postal Service, Office of Inspector General - Boston Field Office, announced today that NORMA MUURAHAINEN, M.D., Ph.D., 56, of Hull, Massachusetts, was charged in an Information with three misdemeanor counts of causing the introduction into interstate commerce of adulterated computer software devices.
“The Information filed today alleges that DR. MUURAHAINEN, a medical director in the business unit at Serono Labs responsible for selling the drug Serostim (which was approved for the treatment of AIDS wasting), caused the dissemination of BIA software devices to the sales force and physicians for the purpose of diagnosing AIDS wasting, without the devices having received the necessary approvals from FDA," stated U.S. Attorney Sullivan. "Physicians who serve as medical directors of pharmaceutical or biotech corporations are in a unique position of knowledge and responsibility, and must ensure that medical diagnosis and treatment decisions are not based on diagnostic tools whose medical effectiveness and safety have not been established. When prescriptions are written based on tests performed with unapproved medical devices, the public is exposed to the risk of receiving potentially unnecessary and harmful drugs," concluded Sullivan.
According to the Information, DR. MUURAHAINEN was a medical director at Serono Laboratories, Inc. ("Serono Labs") from December of 1997 to the present. As medical director, DR. MUURAHAINEN, along with others at Serono Labs and the medical device manufacturer, RJL Sciences, Inc., (“RJL”), caused the introduction into interstate commerce of bioelectrical impedance analysis (“BIA”) computer software packages for use in calculating body cell mass and diagnosing AIDS wasting.
The BIA is a portable device that measures the rate at which low levels of electrical current pass through the body, generating measurements which, when applied to mathematically calculated prediction equations, have been used to estimate body composition. The Information alleges that demand for Serostim began to drop significantly immediately after it was launched in 1997, as a result of a decline in the incidence and prevalence of AIDS wasting. The disease state of AIDS wasting, for which Serostim was tested and approved by FDA, consisted of profound involuntary weight loss and loss of lean body mass in AIDS patients, and did not include loss of body cell mass. Use of BIA computer software that purported to measure loss of body cell mass enabled DR. MUURAHAINEN, Serono Labs and RJL, to expand the market for Serostim beyond the disease state for which the drug had been tested and approved.
The computer software devices were adulterated in that, approval from the FDA had not been obtained to be used for the purpose of diagnosing AIDS wasting before the software packages were disseminated to the sales force, physicians and used for reimbursement purposes with the state Medicaid agencies and other payors. As medical director, DR. MUURAHAINEN was in a position to provide guidance and advice to Serono Labs. She assisted in training its sales force to use the BIA so that they could directly administer BIA tests on patients and induce doctors to rely on the test results in order to determine whether to prescribe Serostim. DR. MUURAHAINEN also assisted Serono Labs in convincing state Medicaid agencies and other payors to reimburse for the drug based on BIA tests performed with the adulterated software.
RJL and its president, Rudolph J. Liedtke, pled guilty to conspiring with Serono Labs to disseminate the adulterated BIA software devices in April 2005, and await sentencing. Serono Labs pled guilty to engaging in the conspiracy to disseminate adulterated devices in December of 2005 and agreed to pay a total of $704,000,000 to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell its drug, Serostim, used to treat AIDS wasting, a condition involving profound involuntary weight loss in AIDS patients. That global resolution is the third largest health care fraud recovery by the United States.
If convicted on these charges, DR. MUURAHAINEN faces up to 3 years imprisonment, to be followed by 3 years of supervised release and a $ 300,000 fine.
The case was investigated by the U.S. Food and Drug Administration's Office of Criminal Investigations; the Department of Health and Human Services' Office of Inspector General, Office of Investigations; the Federal Bureau of Investigation; the Department of Labor's Employee Benefits Security Administration; and the U.S. Postal Service's Office of Inspector General. It was prosecuted by Assistant U.S. Attorney Mary Elizabeth Carmody in Sullivan's Health Care Fraud Unit and Trial Attorney Sondra L. Mills in the Department of Justice's Office of Consumer Litigation.
The details contained in the Information are allegations. The defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.