Bausch & Lomb Inc, the maker of defective Renu with MoisturLoc Contact Lens Solution, now faces 573 product liability lawsuits stemming from eye infections caused by the recalled product. Those lawsuits include 550 individual lawsuits and a consolidated federal class action suit. According to a regulatory disclosure filed by Bausch & Lomb yesterday, those lawsuits have been filed in various federal and state courts in the US, as well as in courts outside the country.
Bausch & Lomb’s legal troubles began in 2006, when Renu with MoistureLoc was linked to Fusarium Keratitis, a rare eye infection that had the potential to cause blindness. The company pulled MoistureLoc from Asian markets in February 2006, and did the same in U.S. in April, before finally issuing a worldwide recall on May 15, 2006.
As of June 30, 2006, the Centers for Disease Control (CDC) had confirmed 164 cases of the eye infection. The same report said that those infected were 20 time more likely to have used the MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that that contact lens solution appeared to have poor disinfectant qualities.
In October of 2006, the FDA issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant. That warning letter was similar to one issued during a 2002 inspection of that plant, when the FDA discovered paint chips in rooms where containers of eye care products were filled. The 2002 warning letter also raised concerns that Bausch & Lomb did not have adequate procedures in place to test that the contact lens solutions manufactured at the plant contained adequate amounts of preservatives and disinfectants to insure their quality.
Analysts have estimated that Bausch & Lomb could face potential liabilities of as much as $1 billion over lawsuits stemming from the MoistureLoc debacle, although some have predicted that the amount will be much higher.
Bausch & Lomb is also facing the potential of lawsuits on a much different front, arising from the company’s proposed merger with a private equity firm. On May 16, the company announced that it had agreed to be acquired by Warburg Pincus for about $4.5 million. Soon after, public shareholders sued Bausch & Lomb and its directors challenging the acquisition, alleging that the price is inadequate. The plaintiffs in each of those suits are seeking class action status.
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