WASHINGTON, June 22 — The Washington, D.C.-based law firm of Schmidt & Clark, LLP, is announcing the results of an inspection conducted by the U.S. Food and Drug Administration where investigators determined that a subsidiary of Abbott Park, Ill.-based Abbott Laboratories Inc. (NYSE: ABT) failed to disclose multiple reports of a serious parasitic eye infection for more than a year.
In an Associated Press story reported June 20, 2009, Schmidt & Clark Managing Partner Michael Schmidt says the documents reveal the link between Acanthamoeba Keratitis and a popular contact lens solution sold by Irvine, Calif.-based Abbott Medical Optics (“AMO”), an Abbott Labs subsidiary.
“It confirms our suspicion that AMO knew, or should have known, that there was a significant increase in Acanthamoeba Keratitis cases associated with Complete MoisturePlus,” Mr. Schmidt says in the article.
According to the report obtained under the Freedom of Information Act, inspectors from the FDA discovered that AMO failed to disclose at least nine reported cases of the sight-threatening eye infection Acanthamoeba Keratitis among users of the company’s Complete MoisturePlus contact lens solution.
According to the FDA report, AMO began receiving complaints of serious corneal infections in February 2006, but those reports were not disclosed until an FDA inspection in late May and early June 2007. The Centers for Disease Control launched its own investigation after receiving increasing reports of the rare infection.
AMO finally recalled Complete MoisturePlus in May 2007 after the Centers for Disease Control released data showing that users of the product were seven times more likely to be infected with Acanthamoeba Keratitis than those who never used Complete MoisturePlus. The FDA subsequently categorized the withdrawal as a Class I recall, a status reserved for situations where there is a reasonable probability that the recalled product will cause serious health problems or deaths.
Currently, more than 150 former users of Complete MoisturePlus are pursuing injury lawsuits against AMO in Orange County Superior Court, including some victims who have lost sight or suffered eye removal. An undetermined number of people suffered vision loss and eye injuries as result of their use of Complete MoisturePlus. To learn more about Acanthamoeba Keratitis or the Complete MoisturePlus Recall please visit the Schmidt & Clark website at www.schmidtandclark.com.