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Thom Mrozek (213) 894-6947 |
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Release No. 07-120
September 26, 2007
MAN ARRESTED ON CHARGES THAT, DESPITE COURT ORDER AND PRIOR GRAND JURY INDICTMENT, HE CONTINUED TO SELL TO DENTISTS ADULTERATED AND UNAPPROVED MEDICAL DEVICES
A man who until recently lived in San Dimas has been arrested on charges contained in a second indictment that accuse him of selling devices designed to clean dental equipment, even though they are not approved by the FDA, he was previously ordered to stop selling the devices and he was previously indicted for similar conduct.
John Bowen, 72, who runs Asepsis, Inc., was arrested in court Monday afternoon following a hearing in the related criminal case filed last year. Appearing in federal court in Los Angeles late Monday, Bowen was ordered detained at least until a hearing scheduled for this afternoon in United States District Court. At that hearing, the government will ask a United States Magistrate Judge to hold Bowen without bond because he has continued to sell his unapproved devices, despite being repeatedly warned that he was prohibited from doing so.
The new indictment, which was filed September 13, also charged Autumn Toth, who allegedly served as the public face for Bowen’s business so they could hide from dentists the fact that he has repeatedly been ordered to cease doing business. Toth, 40, surrendered to federal authorities on Monday, and she was later released on a $15,000 bond.
The new indictment charges Bowen and Toth with conspiracy, five counts of mail fraud, three counts of adulteration of medical devices, one count of failing to register an establishment used in the processing of medical devices, and five counts of contempt of court for willfully violating Bohen’s conditions of release on bond. The new indictment is the latest in a series of court actions against Bowen in relation to his sale of equipment he marketed under the names of SteriSafe and Asepsis.
Dentists use various tools to clean and repair teeth, and those tools can become contaminated with saliva and blood. The tools must be sterilized and disinfected between uses in patients’ mouths. The Food and Drug Administration must approve any medical device that is used to sterilize or disinfect dental tools. A medical device is called “adulterated” if it is marketed prior to receiving FDA approval.
After seeking and failing to obtain approval to sell his devices in the 1990s, Bowen marketed his devices – which he often called “autoclaves” – under the name SteriSafe, which were promoted for use in doctors’ offices, AIDS patient home care, tattoo parlors and needle exchange programs. In 1998, the government filed a lawsuit against Bowen, and a federal judge issued a permanent injunction barring Bowen from manufacturing and distributing the devices until the FDA approved the products. Later that year, Bowen allegedly sent letters to his customers advising them to cover-up the “SteriSafe” label with another label saying “Asepsis Autoclave High Level Flushing Disinfector.”
In 2002, according to court documents, Bowen began marketing a new device that he called Asepsis II and Asepsis GPA. This device also was never approved by the FDA, but Bowen has allegedly continued to sell the devices.
A federal grand jury indicted Bowen in February 2006 (see: http://www.usdoj.gov/usao/cac/news/pr2006/021.html). He is currently scheduled to go to trial in that case in November before United States District Judge Christina A. Snyder.
After the February 2006 indictment, Bowen was released on bond and, as a condition of his release, he and his associates were barred from “the sale, transfer, exchange, or repair of any item or service (including machines and water ampules) to any person or entity involved in the dental profession.”
Nevertheless, according to the new indictment, Bowen, with Toth’s assistance, sold devices, and provided supplies and repair services to dental offices across California and in Missouri.
After investigators this summer visited the South Los Angeles warehouse where Bowen manufactured his devices, he and Toth vacated their San Dimas apartment, from where they ran Asepsis, and moved to Excelsior Springs, Missouri. Bowen now splits his time between Missouri and Pacific Palisades.
An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.
There is no maximum sentence for the contempt of court charges contained in the indictment.
Following this afternoon’s detention hearing for Bowen, both he and Toth are scheduled to be arraigned on the new indictment on Monday.
The cases against Bowen and Toth are the result of an investigation by the Food and Drug Administration’s Office of Criminal Investigations and the United States Postal Inspection Service. The cases are being jointly prosecuted by the United States Attorney’s Office in Los Angeles and the Justice Department’s Office of Consumer Litigation.
"The protection of the American public is a high priority for the U.S. Postal Inspection Service and the FDA," said Inspector in Charge B. Bernard Ferguson. "This investigation exemplifies the success of law enforcement partnerships in the investigation of a multi-jurisdictional case."
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Release No. 07-120
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