| FDA greenlights new wrinkle treatment |
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| Thursday, 02 November 2006 | |
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The FDA approval is a huge step forward for Artes, but the company is still under investigation by the FDA for alleged illegal use of the product before receiving its approval. An alleged client, Elizabeth Sandor, filed a lawsuit in 2005 complaining that Gottfried Lemperle, co-founder of the company, injected ArteFill into her facial wrinkles in 2002 after telling her that the product had been approved by the Food and Drug Administration. Sandor alleges in her lawsuit that the injections and treatment disfigured her. At the time of the alleged incident, Mr. Lemperle was a licensed dermatologist in Germany but not in the United States. The FDA is also examining unrelated, anonymous complaints made in 2003 and 2004 that Gottfried Lemperle's son, Stefan promoted the unapproved use of ArteFill, and provided a list of doctors in and around San Diego who would provide treatments with the product to interested clients, according to a company filing with the SEC. Both the company, Artes and Gottfried and Stefan Lemperles have denied all of the allegations in the lawsuit, which is on hold pending the outcome of the FDA investigation. |
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