Lawyers focus on lens solution lawsuits.

A product with a unique formula and a specific use whose maker kept it on the market while user reports of injury mounted--it's an old story. But Bausch & Lomb didn't learn the lesson, according to plaintiff lawyers representing people who suffered eye damage after using the company's ReNu with MoistureLoc to clean their contact lenses.

Introduced in late 2004, the multipurpose solution for cleaning, rinsing, disinfecting, and storing soft contact lenses made about $100 million in sales in 2005. But reports of Fusarium keratitis--a severe fungal infection of the cornea potentially leading to corneal scarring and blindness--began to circulate among users of the solution, first surfacing in July 2005 in Singapore and later in Hong Kong.

Bausch & Lomb recalled the product from Asian markets in February 2006 but did not alert U.S. users or the FDA to the problem. The FDA originally approved ReNu with MoistureLoc as a medical device under [section]510(k) of the Food, Drug, and Cosmetic Act.

The FDA's list of risk factors for Fusarium keratitis includes "chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use." As reports of eye infections by contact lens users multiplied, the agency launched an investigation that linked a higher risk of developing Fusarium keratitis to those who used the ReNu solution compared with those who used other multipurpose contact lens solutions.

On April 10, 2006, the FDA and the Centers for Disease Control and Prevention (CDC) issued a joint press release alerting consumers and health care professionals to the risk. Bausch & Lomb voluntarily withdrew ReNu with MoistureLoc from the U.S. market three days later and issued a worldwide withdrawal on May 15.

The contact lens solution's connection with infection is still under investigation. "After an extensive investigation involving thousands of tests, millions of dollars, and collaboration with government agencies, health authorities, and independent experts, there is no evidence of product contamination, tampering, counterfeiting, or sterility failure," company Chairman and CEO Ronald Zarrella said at the recall. "That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances."

At the time of the recall, the CDC said it had received reports of 109 cases of suspected fungal keratitis in 17 states. At press time, it had finished investigating 30 cases. In 26 of them, the patient had used ReNu with MoistureLoc in the month before the infection; eight required corneal transplants.

"This product was extremely unique in terms of its formulation. It really set the stage for some catastrophic events to take place among the users of it," said plaintiff attorney Jason Mark of Great Neck, New York, who cochairs an AAJ litigation group concentrating on Bausch & Lomb contact lens cases.

Hundreds of suits have been filed against Bausch & Lomb alleging negligence, failure to warn, and defective design for users who developed eye infections, as well as economic loss for users who had to throw out the recalled product.

Cases have been consolidated in multidistrict litigations (MDLs) in South Carolina (ReNu was made at a plant in Greenville), where U.S. District Judge David Norton is handling pretrial coordination for at least 80 cases (In re Bausch & Lomb Inc. Contact Lens Solution Prods. Liab. Litig., MDL 1785 (D.S.C. transferred Aug. 14, 2006)), and in New York (the company is headquartered in Rochester), where Supreme Court Judge Helen Freedman will coordinate efforts. Individual cases are also pending in state courts around the country.

The MDLs are currently in the discovery stage.

"My firm has elected to really focus on the state court strategy in these cases," said Mark. Filing cases in New York, where the defendant "resides," will prevent it from removing the cases to federal court, he said.

ReNu with MoistureLoc didn't go through the FDA premarket assessments that drugs do, said Mark, so "we don't believe that there's going to be as extensive a set of document production in this case as you might see in a more traditional pharmaceutical case. We believe that discovery can be completed in a very efficient manner and on an efficient track."