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New Jersey Man Admits Distributing
Unapproved HIV Home Test Kits(October 25, 2000)
NEWARK — A Kenilworth man today admitted distributing HIV home test kits by misleading customers into believing that the product was FDA approved, U.S. Attorney Robert J. Cleary announced.
Stanley Lapides, 56, pleaded guilty before District Court Judge Joseph A. Greenaway, Jr. to fraud charges in a one-count Information. Lapides admitted that from October 1997 through March 1999 he mailed approximately 628 ANA-SAL® HIV home test kits from the Maplewood post office to U.S. customers yet neglected to advise these customers that this medical device had not received FDA approval, according to Assistant U.S. Attorney Scott S. Christie.
Lapides was a principal in Newco Associates Ltd. and IHT Ltd., Bahamian companies that distributed the kit, which supposedly tested human saliva for HIV antibodies, believed the causative agent of AIDS, according to the Information.
Lapides solicited orders through www.hivoraltest.com, www.hivsalivatest.com, www.aidstesting.com and www.privacytesting.com and arranged for the manufacturer to fill orders, according to the court documents.
The web sites claimed that the kit yielded results in five minutes, with more than 99 percent accuracy, according to the Information. However, the FDA had not evaluated the product’s safety and conditions for use and considered the kits "misbranded" because they could not bear adequate directions for use.
The FDA did conduct testing on a small number of ANA-SAL® HIV home test kits obtained during the criminal investigation and determined that none of them yielded accurate results, according to Assistant U.S. Attorney Christie.
At a cost of $49.95 each, Lapides generated about $31,368 in revenue through sales of the kits, according to the Information.
The FDA, to date, has not approved any home test kit for HIV antibodies, according to Assistant U.S. Attorney Christie.
Under an Information, a defendant waives the right to have his case presented to a federal grand jury and, instead, pleads guilty to charges presented by the government.
Lapides is scheduled for sentencing at 10:30 a.m. on February 13, 2001. He faces a maximum sentence of three years in prison and a $250,000 fine. He also could be ordered to pay restitution and the costs of prosecution.
Under U.S. Sentencing Guidelines, Judge Greenaway will determine Lapides’ actual sentence based on a formula that takes into account the severity and characteristics of the offense and the defendant's criminal history, if any. Parole has been abolished in the federal system. Under Sentencing Guidelines, defendants who are given custodial terms must serve nearly all that time.
Cleary credited Special Agents of the FDA Office of Criminal Investigation, under the direction of Special Agent in Charge G.S. MaGee, and Postal Inspectors of the U.S. Postal Inspection Service, under the direction of Postal Inspector in Charge J.J. Skidmore of the Newark office, with developing the case against Lapides.
The Government is represented by Assistant U.S. Attorney Christie of the U.S. Attorney's Fraud and Public Protection Division in Newark.
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Defense Attorney:
Joseph R. Rubino, Esq. Millburn###