FTC Settles Charges against Second Internet Marketer of Inaccurate HIV Tests

November 28, 2005

FTC Settles Charges against Second Internet
Marketer of Inaccurate HIV Tests

Settlement Provides for Full Restitution, Lifetime Ban on Sale of
HIV Tests and Other Devices Not Approved by the FDA

FTC News Release
March 30, 2000

The Federal Trade Commission has announced the settlement of charges that a company that advertised on the Internet, Medimax, Inc., falsely represented that its HIV tests accurately detected the presence of the human immunodeficiency virus (“HIV”) in human blood. This marks the second settlement the FTC has reached in the past four months with online marketers of faulty HIV tests.

“Medimax threatened the lives of consumers who thought they would get accurate HIV test results,” said Jodie Bernstein, Director of FTC’s Bureau of Consumer Protection. “This deception is especially damnable given that it may have kept some consumers from seeking appropriate medical treatment.”

The Commission alleged that Medimax and its president, David M. Rothbart, violated federal law when they represented on their Internet site that their “HIV 1/ 2 Whole Blood Tests” accurately detected HIV infection in human blood. According to the FTC, independent tests conducted by its expert, Dr Niel T. Constantine of the University of Maryland, showed that Medimax’s HIV tests produced false negative results when tested with HIV-positive blood samples.

Under the stipulated final order settling the charges, Medimax and Rothbart are permanently banned from marketing any HIV test, or any other medical device not approved by the US Food and Drug Administration. In addition, Medimax and Rothbart must pay back all the money they received from the sales of their HIV tests and cooperate fully with the Commission in any related investigations.

The Commission vote to authorize the staff to file the Stipulated Final Order for Permanent Injunction and Settlement of Claims was 5-0. The Stipulated Final Order was signed by the Honorable Anne C. Conway of the Middle District of Florida in Orlando on March 22, 2000.

In November 1999, the FTC settled similar charges against Cyberlinx Marketing, Inc. of Las Vegas, Nevada. Cyberlinx agreed to be banned from marketing any HIV tests and to pay back the money it received from the sale of its tests. In addition, on January 13, 2000, the Commission filed a complaint and stipulated preliminary injunction against Alfa Scientific Designs, Inc. of San Diego, California alleging that the company marketed inaccurate HIV tests on the Internet. According to the FTC, Alfa Scientific Designs was the supplier of faulty HIV tests to Medimax.

Currently, there is one HIV home collection test system that is approved by the FDA and legally sold in the United States. This test, AHome Access Express HIV-1 Test System,® manufactured by Home Access Health Corporation, allows consumers to collect a blood sample for testing in the privacy of their home. The sample is then sent to a laboratory for analysis. The results are obtained by calling a toll-free telephone number using an anonymous personal identification number.

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This page was posted on November 28, 2005.