A Medical Device Daily

Co-Lead counsel for the Plaintiffs' Steering Committee in the Guidant Medical Device Litigation yesterday reported that an amended settlement agreement has been obtained on behalf of 8,550 patient plaintiffs who asserted claims against Guidant, Boston Scientific (Natick, Massachusetts) and others in the suit.

With the amended agreement, Boston Scientific will pay an additional $45 million over the original agreement.

The amended settlement expands a prior agreement obtained in July 2007, which had provided for a recovery of $195 million to settle over 5,600 claims. After additional injured patients stepped forward, the agreement has been amended to provide that Boston Scientific will pay compensation of up to $240 million.

Guidant — now Boston Scientific's cardiac rhythm management unit — recalled more than 100,000 of the ICD products between 2005 and 2006 which were at risk for failure.

With the recalls, patients implanted with the devices were faced with the difficult decision of having the devices explanted and replaced, or not having an explant and dealing with the continuing concern that the device could fail. Thus, besides asking for the coverage of explant/reimplant expenses, many patients claimed pain and suffering.

Those filing the suit had claimed that Guidant knowingly sold them the defective ICD devices over a period of three years.

The settlement mediation sessions were conducted before U.S. Magistrate Judge Arthur Boylan in Minneapolis over a 15-month period.

Charles Zimmerman, co-lead attorney for the Plaintiffs' Steering Committee, said that the amended agreement "is great news for the patient plaintiffs and will provide them and their families with substantial relief.

"Beyond this, the settlement serves the public good by highlighting that transparency and full and proper disclosure are paramount to the public and to those regulatory bodies entrusted to protect the public's interests, particularly in the areas of public health and safety.

He added: "It also highlights the need for continued and stronger regulatory oversight of companies that are in the business of manufacturing and selling life-saving devices to consumers. We believe that with these results, the settlement will truly benefit all parties."

As a result of the amendment, proceedings in Minnesota state court — like the trials in the bellwether cases in the MDL — have been stayed.

Commenting on the amended agreement, Boston Scientific said it believes that the claims covered by it constitute substantially all currently asserted claims in the U.S. arising from the 2005 and 2006 product communications.

"We are pleased with this amendment, which is in the best interest of all involved," said Jim Tobin, president/CEO ofBoston Scientific.

The new settlement total is in addition to $16.75 million that Boston Scientific said in August it would pay to settle investigations into the defibrillator problems by attorneys general in 35 states and Washington D.C..

In other legalities: Oculus Innovative Sciences (Petaluma, California) reported that the U.S. District Court for the Northern District of California has issued a ruling affirming that the company's intellectual property rights for the Microcyn Technology are enforceable.

Hoji Alimi, CEO and chairman of Oculus, said, "We were confident that we could defend our intellectual property rights and this is confirmed by the ruling. We now have positive legal precedent in the United States, Japan, Mexico, and elsewhere throughout the world where the Microcyn Technology platform has been introduced, that our intellectual property rights are fully enforceable."

Oculus filed suit in the U.S. District Court for the Northern District of California against Nofil and Naoshi Kono, Nofil CEO, for breach of contract, misappropriation of trade secrets and trademark infringement. In February, Nofil filed an answer and cross-complaint and subsequently filed two amendments to the cross-complaint.

In an order issued Nov. 14, the court granted Oculus' motion to dismiss Nofil's cross-complaint with prejudice, and it ruled in favor of Oculus on its claims for breach of contract, misappropriation of trade secrets and unfair competition and issued an injunction barring Nofil from using Oculus' IP and from manufacturing product using the Microcyn Technology for anyone other than Oculus.

The court also ordered an accounting and disgorgement of profits to Oculus. The court will hold an evidentiary hearing in January, at which time Oculus will present evidence in support of its damage claim against Nofil.

Oculus manufactures products based upon the Microcyn Technology, intended to help prevent and treat infections in chronic and acute wounds. The Microcyn platform is a controlled, slow-release solution containing active chlorine and other gases resulting in a biocompatible technology to treat a range of pathogens, including antibiotic-resistant strains of bacteria, viruses, fungi and spores.