A Diagnostics & Imaging Week

Leading a group of organizations, the Advanced Medical Technology Association (AdvaMed; Washington) said it filed a joint amicus brief 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 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) in June said in a statement, 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.”

In other legalities: OraSure Technologies (Bethlehem, Pennsylvania) reported the results of its arbitration with Prestige Brands (Irvington, New York)./font>

Since April 2003, Prestige has exclusively distributed OraSure’s cryosurgical wart removal product in the U.S. under the name Compound W Freeze Off.

The arbitration arose after Prestige acquired the Wartner cryosurgical wart removal product line in September 2006. Wartner competes directly in the domestic market against the Freeze Off product, in violation of a non-compete provision contained in the companies’ distribution agreement.

According to OraSure, the arbitration panel concluded that Prestige’s acquisition of Wartner breached the non-compete provision, that OraSure is entitled to an award of its legal fees and share of arbitrators’ costs and that all counterclaims asserted by Prestige are rejected. The panel also found that the parties’ distribution agreement will terminate on Dec. 31 and that OraSure is not entitled to receive other compensatory damages.

“As we expected, Prestige was found to have breached the non-compete provision of our distribution agreement and we are pleased that we will receive an award of our legal fees,” said Douglas Michels, OraSure’s president/CEO. “The arbitration panel’s decision to deny compensatory damages is disappointing as is the termination of our agreement with Prestige. Since we understood that termination of the agreement was possible, we have been evaluating alternative product and distribution options and are preparing to implement these strategies to keep our cryosurgical product in the U.S. [over-the-counter] market.”

During its third quarter investor earnings call, scheduled for Oct. 30, the company said it would update its financial guidance for 2007 to reflect business developments, including the expected impact of the Prestige arbitration decision.

OraSure makes oral fluid specimen collection devices and tests and other diagnostic products.