A Medical Device Daily

Lead plaintiffs in the Cyberonics Securities Litigation in the U.S. District Court for the Southern District of Texas, reported filing of the first amended class action complaint on behalf of purchasers of Cyberonics (Houston) securities during the period Feb. 5, 2004, through Aug. 1, 2006, inclusive.

Investors who purchased Cyberonics securities during the expanded period and suffered damages may move the Court for consideration to be appointed as a lead plaintiff in about 60 days.

The first amended complaint charges that Cyberonics and certain of its current and former officers and directors failed to disclose and misrepresented material information known to defendants regarding FDA review and approval of the use of the company's Vagus Nerve Stimulation (VNS) device to treat depression, the marketability of the VNS device and medical insurance payers coverage decisions for the device.

The amended complaint also alleges improper conduct related to the award of stock option grants to certain senior officers, including that the options were fraudulently backdated and that the company had flawed and defective internal controls over accounting and for the options. This resulted in the improper reporting of executive compensation and expenses and violated generally accepted accounting practices.

In other legalities: The law firm of Motley Rice (Mount Pleasant, South Carolina), together with co-counsel Wexler Toriseva Wallace, reported filing suit against Davol (Cranston, Rhode Island), manufacturer of the Composix Kugel Mesh Patch, a device used in hernia repair, in Superior Court in the State of Rhode Island. The suit was filed on behalf of Jimmy Warren of St. Charles County, Missouri, whose inserted Kugel Mesh Patch, the suit alleges, failed following a product recall, causing severe abdominal pain and resulting in bowel dissection surgery to remove the failed patch.

Additional defendants in the case include C.R. Bard (Murray Hill, New Jersey), Davol's parent company.

In early 2004, Warren underwent hernia repair surgery, during which he received a Kugel Mesh Patch. The following year, Davol recalled many of the patches under an FDA Class I recall. In 2006, the recall was expanded to include the patch inserted in Warren. Following his surgery, Warren developed abdominal tenderness, and according to the complaint, another hernia developed in Warren in April 2006. During surgery to repair the second hernia, a piece of the failed Kugel Mesh patch was discovered adhered to Warren's bowel and he was subjected to a prolonged bowel dissection, leaving him with chronically inflamed bowels, as well as ongoing physical pain and mental anguish.

The suit alleges that manufacturers of the Kugel patch were aware of the high degree of complication and failure rate of the product.