ReNu Lawyers - Litigation Timeline Update from Renu Lawyer

May 17, 2006 FDA finds Bausch and Lomb didn't follow the rules. FDA says 35 cases were not reported properly. Bausch & Lomb denies the allegations and said it communicated promptly and directly with the FDA regarding reports the company received about fusarium infections. On Tuesday, the FDA released the findings of an inspection team that was at the Greenville plant from March 22 until May 15. In a report, the team faulted Bausch & Lomb in 20 procedural areas. ReNue Lawyers allege that inspectors said Bausch & Lomb failed to:

• Do a complete design plan for the ReNu with MoistureLoc product.
• Follow procedures to prevent contamination of equipment and product.
• Properly define and document procedures for controlling environmental conditions.
• Implement procedures to control storage of product in storage areas and stock rooms.
• Conduct quality control audits.
• Implement procedures to prevent problems during handling of product.
• Ensure appropriate design, construction, placement, and installation of manufacturing equipment.
• Properly document maintenance activities.

Still, the FDA said that while the team's observations at the plant may indicate deviations from current good manufacturing practice, they do not necessarily support a connection between ReNu with MoistureLoc and the fungal infections.

May 15, 2006 Bausch Lomb is permanently removing its Greenville-made ReNu with MoistureLoc Baush and Lomb contact lens solution from the worldwide market after concluding the product's formula may increase the risk of fungal eye infections in certain unusual circumstances. Problems with the solution were reported in the United States, Singapore, Hong Kong, and Malaysia -- all markets served by the Greenville plant. The U.S. Food and Drug Administration dispatched a team of investigators to the plant March 22, and on April 10, Bausch Lomb said it had stopped shipments of ReNu with MoistureLoc from the plant. The company and the FDA said they believe they've solved the mystery and that it lies in the chemical properties of ReNu with MoistureLoc in the manufacturing process at the Greenville plant. Exhaustive testing revealed that ReNu with MoistureLoc, under certain conditions, such as if the bottle cap is left open, allows a polymer film to form, and the Fusarium fungus, found just about everywhere, can survive on the film, insulated from alexidine, the disinfectant in ReNu with MoistureLoc. The fungal infections appear to be related to the design of this particular solution and don't stem from a problem with the manufacturing and the way in which the product leaves the facility.

April 20, 2006 Bausch Lomb class action lawsuits likely in multiple states. In Miami, a ReNu lawyer is seeking class action status for a lawsuit against Bausch & Lomb for ReNu eye infections. In the lawsuit, ReNu lawyers allege that plaintiffs have suffered painful eye fungus injections. These infections permanently scarred the cornea of the Bausch Lomb class action plaintiff, a woman who used its contact lens solution. The lawsuit follows a similar Bausch & Lomb class action suit filed in New York, that also alleges the company failed to remove the fungus from the Renu with MoistureLoc eye solution and/or caused the fungus to grow in the manufacturing process.

April 15, 2006 The company asks retail stores to take ReNu with MoistureLoc Bausch and Lomb contact lens solution made in the Greenville plant off the shelves temporarily but did not request that the solution be returned to the company. CEO Ron Zarrella said neither the company nor the FDA had discovered contamination at the plant after nearly three weeks of testing. The company's request that retailer pull its product did not apply to other Bausch & Lomb products or ReNu with MoistureLoc made outside the United States. The request came as several U.S. retailers led by Wal-Mart., Walgreen, and CVS Corp., were pulling the ReNu Bausch and Lomb contact lens solution with MoistureLoc solution off their shelves on their own.

The company stopped shipments of MoistureLoc in the United States when the CDC said it was scrutinizing 109 reports of fungal keratitis infections in patients in 17 states over the past 10 months.

April 12, 2006 Bausch & Lomb said that neither the company nor any of the five federal inspectors had found any evidence that contact lens solution made at its Greenville plant is connected to eye fungus infections after nearly three weeks of testing. The company also doesn't have any plans to furlough or lay off any of the approximately 450 workers at the Pelham Road facility, even though it halted shipments of solution made there. CEO Ron Zarrella said that tests have been conducted on samples of solution made at the plant, solution from store shelves, and solution used by victims who became infected and none have revealed evidence of the fungus. He said test results of swabs taken in non sterile areas of the plant aren't back from labs, but it won't be surprising if they are positive because the Fusariam fungus is found just about everywhere. Zarrella told analysts the company is ramping up production of another contact lens solution now that some retailers are pulling ReNu with MoistureLoc from their shelves but it wasn't immediately clear how that might affect the Greenville plant.

April 12, 2006 Singapore: 36 more cases of fusarium keratitis reported since the last update in late February (then 39 cases). In total, 75 cases of fungal corneal infection with a history of contact lens use have been reported.

April 10, 2006 Bausch & Lomb stopped shipping product to U.S. stores but said stores could continue to sell existing product until supplies ran out. "There's no indication there is a formula problem here," CEO Zarrella said.

March 31, 2006 Bausch and Lomb is collaborating in a surveillance program and scientific investigation to track and investigate the incidence of the infection with health authorities and leading experts around the world including the United States.

March 22, 2006 FDA begins inspection of Bausch & Lomb, Greenville, S.C. plant.

March 18, 2006 Eight victims required corneal transplants to avert blindness. Only 30 cases investigated thus far. Of those 30 cases, 28 wore soft contacts and all but two used ReNu products. Five of the 26 who used ReNu also used other solutions.

March 8, 2006 A New Jersey ophthalmologist reports three cases of rare fungal infection, fusarium keratitis to the CDC within the last three months. The U.S. investigation begins.

February 20, 2006 Bausch Lomb voluntarily suspends sales in Singapore, Malaysia, and Hong Kong after 29 cases of fungal keratitis are found in Asia since November 2005.

December 2005 Bausch & Lomb mentions but downplays the Hong Kong incident to the FDA.

November 2005 Hong Kong health officials tell Bausch & Lomb about the noted increase in hospital admissions due to contact-lens-related keratitis from June to September 2005.

June 15, 2005 First reported fusarium case reported in the United States

Anapol Schwartz Weiss Cohan Feldman & Smalley, Michael Monheit, Esq. and Kevin Marciano Esq. are lawyers handling ReNu cases (ReNu Lawyers)