News Release
U.S. Department of Justice
United States Attorney
District of Rhode Island
March 3, 2008
Company & president penalized $1,000,000 for misleading marketing of unapproved drug
A federal judge has fined White Broadman, Inc., a Florida based company, $794,334 for misleading marketing of an unapproved new drug. The company and its president, James Mienik, also forfeited $205,000. The company marketed a product designed to treat erectile dysfunction.
United States Attorney Robert Clark Corrente announced the fine and forfeiture, which Chief U.S. District Court Judge Mary M. Lisi imposed in U.S. District Court, Providence on February 29.
In November, Mienik and Paul Romano, a part owner of the company, pleaded guilty to federal charges, admitting that the company had marketed a new drug with the intent to mislead, and that they had misbranded a drug.
At the plea hearing, Assistant U.S. Attorney Terrence P. Donnelly said the government could prove that, from 2001 until 2004, the company engaged in a direct mail marketing campaign for an over-the-counter drug called, variously, “Penetrex” and “Penetrin.” The stated purpose of the product was to treat erectile dysfunction.
White Broadman sent out several mass mailings promoting the drug. The solicitations listed an East Greenwich address, but that was merely a mail drop, and the company did not have any facilities or operations in Rhode Island. The defendants arranged to have orders that customers mailed to the East Greenwich address forwarded to company offices in Florida.
Assistant U.S. Attorney Donnelly said the solicitation was misleading in several respects:
∙ R.T. Edwards, identified as White Broadman’s “Director of Research and Development,” does not exist;
∙ The solicitation bore a photograph, purportedly of White Broadman’s urological science laboratories in East Greenwich, which was actually a picture of buildings at the University of Florida;
∙ It cited fictitious customers’ experiences, contained fabricated “attending physician’s diagnosis & treatment recommendations,” and asserted claims of clinical tests that had not been performed.
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Mienik and Romano misbranded Penetrin/Penetrex by identifying it as a dietary supplement rather than a drug.
The U.S. Postal Inspection Service, the Food and Drug Administration, Office of Criminal Investigations, the FBI, and the Internal Revenue Service, Criminal Investigations, conducted the investigation.
Contact: 401-709-5032 Thomas.connell@usdoj.gov