109.  FTC v. Alfa Scientific Designs, Inc., (SD Cal January 13, 2000)

Defendant: Alfa Scientific Designs, Inc.

Type:  Defective HIV Home Test Kits

Alfa Scientific allegedly sold deceptive HIV test kits online to distributors such as Medimax, named previously in an FTC action. Alfa Scientific’s Web site offered test kits in bulk and claimed that its HIV tests detected HIV antibodies in human whole blood or serum with "very high specificity and sensitivity." However, according to an FTC expert’s report, in most instances, when tested with HIV-positive whole blood samples, Alfa Scientific's tests produced false negative results.

The FTC filed suit, claiming that the company misrepresented that its tests accurately detected HIV infection, in violation of Section 5(a) and 12 of the FTC Act. Alfa Scientific stipulated to a preliminary injunction that prohibits it from advertising or selling any HIV test kits and from misrepresenting any material facts about, or the accuracy of, any HIV test kit pending a full trial.

On January 16, 2001, the Commission announced that it had settled its lawsuit against Alfa Scientific, and amended its complaint to name as additional defendants Alfa Scientific's President, Naishu Wang, M.D., Ph.D., and the company's Chief Executive Officer, David F. H. Zhou, M.D., Ph.D. The Commission alleged in its amended complaint that Alfa, Wang and Zhou violated federal law when they represented on their Internet site that their "Alfa HIV-1/2 Rapid Tests" accurately detected HIV infection in human blood. According to the FTC, independent tests showed that Alfa's HIV tests produced false negative results when tested with HIV-positive whole blood samples.

The settlement prohibits Alfa, Wang and Zhou from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. Food and Drug Administration, including any claims regarding the accuracy of the tests. The settlement also requires the defendants to notify the Commission of any complaints or refund requests in the future and allows the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.

http://www.ftc.gov/opa/2000/01/alfa.htm (press release - complaint/prelim injunction)