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May 2 – May 8

May 3rd: Two Executives Convicted in Unapproved Sterilization Device Scheme

Two executives of a Mundelein, Ill., company were convicted April 13, 2006, of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in eighteen patients, causing them to lose sight in one eye.

Mr. Ross Caputo was president and CEO of AbTox, and Mr. Robert Riley was the vice-president of regulatory affairs of AbTox, when the company received permission to market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without lumens (tubes) or hinges. The defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of non stainless-steel instruments.

The hospitals that purchased the larger unauthorized units were shown by AbTox the clearance letter for the smaller, authorized unit. These larger units were used in an unauthorized manner, because AbTox marketed them that way, to sterilize complex instruments, including cataract instruments that have small tubes which are used to put solution into the patient’s eye. One unauthorized use was to sterilize ophthalmic instruments that had brass joints which reacted to the sterilizing agent creating a toxic residue. AbTox knew of the reaction but did not advise users or seek proper corrective action. The blindness was caused by a harmful copper acetate residue that remained in the tube of the instrument after sterilization by this machine.

One hundred sixty eight (168) of the unauthorized units were sold to hospitals nationwide, including Department of Veterans Affairs hospitals and other government agencies, totaling over $18 million in sales. Hospitals in Chicago, Ill., Columbia, Mo., and St. Louis, Mo, reported to AbTox that their sterilizer was suspected of causing injuries to several patients. The company failed to notify the FDA about these reports as required. The defendants face significant penalties including incarceration, fines, and restitution. Sentencing will be at a later date. Two other defendants, Mark E. Schmitt, formerly director of marketing of AbTox, and Marilyn M. Lynch, formerly director of clinical services of AbTox, previously pled guilty in this case.

May 4th: Boston Scientific and Angiotech Win Patent Infringement Case against Sahajanand in the Netherlands

Boston Scientific Corporation and Angiotech Pharmaceuticals, Inc. announced today that they received a favorable decision from a Dutch court in a patent dispute against Sahajanand Medical Technologies Pvt. Ltd. Boston Scientific and Angiotech alleged that Sahajanand's Infinnium paclitaxel-eluting stent infringed two claims of an Angiotech patent directed to paclitaxel stents. The Court found that the asserted claims were infringed and valid.

The Court granted Boston Scientific and Angiotech an injunction against Sahajanand, prohibiting the company from selling, bringing onto the market and delivering -- as well as importing, offering or keeping in stock for one of these purposes -- the infringing Infinnium paclitaxel stent in the Netherlands. The Court also ordered Sahajanand to pay damages and/or surrender profits resulting from the infringement. The Court's decision can be appealed by Sahajanand.

May 6th: Irvine Scientific Launches Innovative In Vitro Fertilization Freezing Product, First in the World

Irvine Scientific, a leading medical device/biotechnology company located in Santa Ana, CA announced that the first vitrification product for blastocysts (day 5 human embryos from an in vitro fertilization procedure) is available in the U.S. after recently receiving clearance from the U.S. Food and Drug Administration. The product, known as Blastocyst Vitrification Kit or Vit Kit(TM) is the first medical device of its kind to be introduced in the United States following nearly a five year development and regulatory review process.

Vitrification is an innovative technique for cryopreserving oocytes (eggs) and embryos. This new cryopreservation method results in much higher pregnancy rates than conventional methods. Conventional methods utilize slow freezing techniques which involve steps that could lead to the formation of ice crystals in the cells thus causing damage. Vitrification involves dehydrating the cells and very rapidly cooling them in liquid nitrogen, which avoids any ice crystal formation, thereby eliminating the potential for cell damage.

The Vitrification procedure has been widely used in Europe, Japan and South America with outstanding success. The benefits of Vitrification in these countries have already been realized as a means to preserve fertility for cancer patients who wish to freeze their eggs prior to chemotherapy and for young women who wish to postpone pregnancy while they pursue higher education and/or advance their careers. Dr. Masa Kuwayama, Director of the Kato Clinic in Japan has had clinical success with vitrification with over 13,000 procedures.

If you have any comments regarding this update, please email: info@mdiconsultants.com

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