ReNu Recall - Bausch & Lomb Knew of ReNu Dangers

Bausch & Lomb Knew of ReNu Dangers

Bausch & Lomb issued a recall of its ReNu with MoistureLoc contact lens solution in May 2006 after more than 100 people contracted the dangerous Fusarium keratitis eye infection. While officials at the Centers for Disease Control have stated that the ReNu recall may have helped to end the Fusarium outbreak, the timeline of events leading up to the ReNu recall shows that Bausch & Lomb might have done much more.

Beginning in July 2005, nearly a year before the ReNu recall, Bausch & Lomb was repeatedly notified by health officials in Asia of an increasing number of cases of Fusarium keratitis infections among users of ReNu with MoistureLoc.

Pressure for a recall
Despite growing pressure for Bausch & Lomb to issue a ReNu recall, the company failed to inform the FDA of the potential danger its product posed to users of RuNu. The first to inform the federal government of the link between Fusarium infections and ReNu with MoistureLoc was Dr. David Chu, an eye doctor from New Jersey, who contacted the CDC after three of his patients who were using ReNu with MoistureLoc were diagnosed with Fusarium keratitis.

The CDC soon began an investigation into potential Fusarium cases linked with ReNu that would eventually grow to more than 100 confirmed infections. Although Bausch & Lomb continued to publicly deny a link between ReNu and the dozens of Fusarium cases, many of the nation’s top retail stores began pulling the product from their shelves.

Bausch & Lomb finally acts
It was only after several reports by the CDC, new reports of Fusarium infections among ReNu users in Europe and the first ReNu lawsuit (filed against Bausch & Lomb in April 2006) that the company finally issued a worldwide recall for ReNu with MoistureLoc on May 15. That same day, the FDA cited Bausch & Lomb with 20 violations of health regulations, including its failure to notify the agency of injury reports from Singapore that were linked to ReNu.

Legal experts say that although more than 100 cases of Fusarium keratitis have been linked to ReNu, thousands of patients may have been infected before the ReNu recall. Estimates of potential damages facing Bausch & Lomb from ReNu lawsuits range from $500 million to $1 billion, although some analysts claim that as more patients come to light, the number may be even higher.