A Medical Device Daily

What appears to be the first in what may likely be a long lineup of class actions against Bausch & Lomb (b&L; Rochester, New York) was reported yesterday.

The suit was filed in the U.S. District Court for the Eastern District of New York on behalf of all users of a contact solution called ReNu with MoistureLoc, alleging that the product has been linked to a serious fungal infection by the Centers for Disease Control and Prevention and the FDA. The action represents those “who consistently used this product for 30 days or longer, resulting in a serious corneal infection known as fusarium keratitis, an infection of the cornea,“ according to the complaint.

Public health warnings were issued because of serious infections occurring in contact lens wearers who also used this product, and it was withdrawn from all retailer shelves last week.

The warnings, according to the complaint, came after the CDC interviewed 26 patients suspected of fusarium keratitis, all of which were users of the ReNu with MoistureLoc Solution.

On April 13 B&L recommended that consumers switch to another contact lens solution and issued a recall of all ReNu with MoistureLoc manufactured in the U.S.

In other legalities: iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions to detect breast cancer, reported that it received a favorable arbitration decision on Case No. 13133Y00865, “R2 Technology and Shih-Ping Wang vs. iCAD.“

In this case, brought by R2 (Sunnyvale, California), an iCAD competitor, R2 iCAD's alleged that iCAD infringed two of its patents. A panel of three arbitrators rejected all of R2's claims, finding that iCAD did not infringe any patent asserted by R2, the company said.

W. Scott Parr, iCAD's president and CEO, called the decision “a tremendous win“ for iCAD and also “for the premise that computer aided detection should be affordable and accessible to all women at risk of breast cancer.“

In response to the arbitration commenced by R2, iCAD asserted in a counterclaim that R2 infringed several iCAD patents. The arbitrators found that R2 did not infringe on those patents.

iCAD offers a range of CAD systems, it says, for the high, mid and low volume mammography markets. It says it provides “the most frequently selected CAD solution for film-based and digital breast screening.“