A Medical Device Daily

MedicalCV (Minneapolis) said that it has entered into a settlement agreement in which it will pay J Giordano Securities Group (New York) $750,000 in cash. Without admitting any liability or wrongdoing, the parties entered into the settlement agreement to resolve the disputes stemming from the parties’ December 2004 engagement agreement.

“Although we firmly believe that J Giordano’s claims were without merit, we determined, after careful consideration, to enter into the settlement agreement to avoid the costs, uncertainty and management resource allocation issues associated with protracted legal proceedings,” said Marc Flores, president/CEO of MedicalCV.

The dispute originally stemmed from a December 2004 engagement agreement. MedicalCV previously paid J Giordano Securities Group cash commissions of $573,000 and issued a warrant for the purchase of 114,600 shares of common stock in connection with a private placement that generated gross cash proceeds of $13.6 million in April 2005. In the arbitration, J Giordano Securities Group claimed it was entitled to alleged damages of $3,346,565 plus reimbursement for reasonable expenses, interest, costs and attorneys’ fees.

“With hearings scheduled for this week, our board determined it was in the best interests of our company and our shareholders to settle the matter rather than spending more to fight it, tying up management resources, and risking an adverse outcome,” Flores said.

MedicalCV makes laser-based surgical ablation systems.

In other legalities: Leading a group of organizations, the Advanced Medical Technology Association (AdvaMed; Washington) said it filed a joint amicus brief Friday in the U.S. Supreme Court in the matter of Riegel v. Medtronic, Inc. arguing that the FDA should continue to be the sole regulator of medical devices. The brief says that no other legislative or regulatory entity is better positioned than the FDA to ensure the timely access to safe and effective medical devices.

The brief also contends that allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies. Joining AdvaMed are DRI, Medmarc Insurance Group and the Medical Device Manufacturers Association (Washington).

“The safety and efficacy of medical technologies are best determined by FDA scientists — not by lawsuits filed in courtrooms throughout the country. It was the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies. Encouraging states to insert state court liability suits into the process would undermine the science-based approach to approvals currently in place and would likely result in inconsistencies in standards and delayed access to products,” said Christopher White, AdvaMed executive VP and general counsel.

Medtronic (Minneapolis) said in a statement back in June (Medical Device Daily, June 27, 2007) when the U.S. Supreme Court agreed to hear the case that the decision to take up the case means that “for the first time the Supreme Court will decide whether a patient is precluded from seeking state court remedies against the manufacturer of a device approved by the FDA through its rigorous pre market approval [PMA] process.”