A Medical Device Daily
A 69-year-old woman lost her eye because of her use of a contact lens solution from Bausch & Lomb (B&L; Rochester, New York), according to charges issued in a news conference yesterday by a Florida law firm.
The woman, a South Florida resident, was at the news conference, which was clearly pitched to the general press and played up the suffering she had experienced leading up to the operation to remove an eye. She is a grandmother and members of her family also were present to offer their support.
She told reporters that she hadn't realized the connection between the initial problems with her eye and use of the lens cleaning solution until reports concerning the product's association with outbreaks of fungal keratitis began appearing in newspapers and she began receiving calls from friends.
Her attorney noted that B&L had taken its cleaning solution product off the market in Asia months before it was recalled from the shelves of U.S. drugstores, and he charged that B&L had provided “namby pamby” information to the public concerning the outbreaks and possible associations with its product.
The company “let the public down,” he said, even though it has yet to be established the exact cause of the outbreaks of infection or the exact connection with the cleaning solution. His basic charge was the company had placed “a defective product into the stream of commerce,” thereby costing the woman her eye.
He suggested even larger problems – and lawsuits – to come, putting the number of Americans using soft contact lenses at 30 million. He said that one purpose of the news conference was to raise public awareness and “save others from going through the nightmare she has.”
Last month, B&L recalled its shipment of the product ReNu with MoistureLoc after health officials in Singapore discovered 39 cases of a dangerous fungal infection, fusarium keratitis, in patients who had used the solution. Just before the shipment suspension, the FDA issued another warning indicating an increasing number of fungal infections by contact lens wearers.
In other legalities:
• Varian Medical Systems (Palo Alto, California) and Resonant Medical (Montreal) reported that they have resolved the patent issues between them and settled their outstanding litigation in return for what they called “certain payments” to Varian. The amount of the payments will not be disclosed, they said.
The companies said they have taken steps to achieve interoperability between some of their radiotherapy products, providing for the testing of connectivity and data interchange between the 4D Integrated Treatment Console for Varian's Clinac and Trilogy medical linear accelerators, and Resonant's Restitu platform.
In the fall of 2005, Varian and SAS Praxim of France filed a complaint against Resonant at the U.S. International Trade Commission as well as related litigation in the Federal District Court in the state of Washington. As part of this settlement, all patent and litigation issues between the companies have been settled.
• QuadraMed (Reston, Virginia) and MedCath (Charlotte, North Carolina) reported that the companies have reached an out-of-court agreement regarding the lawsuit pending between them.
With the settlement, QuadraMed has agreed to pay MedCath $2 million. Additionally, the companies said they will exchange mutual releases and dismiss their claims against each other.
QuadraMed will fund the settlement amount from its available cash.
In addition to amounts already recorded as of Dec. 31, 2005 and amounts covered by insurance, QuadraMed will record a charge of about $1 million related to this settlement in its three-month period ended March 31, 2006.
QuadraMed is a provider of healthcare information technology and services, from clinical and patient information management to revenue cycle and health information management.
MedCath, which is focused on the diagnosis and treatment of cardiovascular disease, owns and operates hospitals in partnership with cardiologists and cardiovascular surgeons.