A Medical Device Daily
The Securities and Exchange Commission filed a civil injunctive action against Southwestern Medical Solutions (Tampa, Florida) and three of its executives last week.
Southwestern makes diagnostic devices for the detection of infections and diseases.
The complaint against Southwestern, John Hedges, president/CEO, Richard Powell, VP, and Basil Meecham, a director, alleges that the company published false and misleading statements claiming that FDA had approved its Labguard diagnostic device, that it had received an order for several thousand units of the device, and that it had pending patents and trademarks.
The complaint also alleges that Southwestern submitted false and misleading information about its business to the Pink Sheets, an inter-dealer electronic quotation and trading system in the over-the-counter securities market.
According to the complaint, Hedges, Powell and Meecham were responsible for preparing and disseminating the false statements and information.
In other legal action:
• Immunicor (Norcross, Georgia), a provider of automated instrument-reagent systems to the blood transfusion industry, reported that the first level of an Italian court case against CEO Gioacchino "Nino" De Chirico has concluded.
The tribunal in Milan rendered a guilty verdict in the first-level trial based on an alleged improper cash payment of €13,500 by Immucor's Italian subsidiary to a physician, the company said.
In the Italian criminal court system, at the first and second levels both sides can present evidence and legal arguments and at the third level only legal arguments are considered. De Chirico will be considered innocent until all three levels have been completed, which the company said could take years.
Immucor settled charges against its Italian subsidiary in 2007, and also settled the SEC investigation against the company.
• Occlutech (Jena, Germany), a manufacturer of cardiac occlusion devices, reported a clarification of a Feb. 8 company statement about an opinion it received from the International Association for the Protection of Intellectual Property (AIPPI) with regard to non infringement by Occlutech of certain European intellectual property held by AGA Medical (Plymouth, Minnesota).
According to Occlutech, the opinion it received stating it is not infringing EP 0808138B1 and its Italian part 019020BE/2006 held by AGA was commissioned through the Italian National Group of AIPPI, but not issued by AIPPI International itself.
The opinion was given without the influence of Occlutech and the impartiality of the experts has subsequently been confirmed by the Italian branch of AIPPI, according to the company.