MILPITAS, Calif. — LifeScan announced a major settlement regarding counterfeit packaged LifeScan blood-glucose monitoring test strips sold by Aristides Spanellis.
The settlement permanently prohibits Aristides Spanellis, a South African distributor, from buying or selling both genuine and counterfeit LifeScan blood-glucose monitoring test strips. Spanellis was one of the alleged architects of a sophisticated international operation in which authentic LifeScan test strips were purchased in such countries as Turkey, Saudi Arabia, Pakistan and Ghana and then illegally repackaged in counterfeit packaging designed to mimic authentic U.S. boxes. These products then were exported to the United States for sale through unauthorized distribution channels at a significant profit.
“In many cases, critical product performance information was altered during this process, including calibration codes, control solution ranges, lot numbers and expiration dates,” stated Roy Albiani, director of LifeScan’s global brand protection and channel compliance team. “This was particularly dangerous for patients using insulin and could result in serious injury.”
The settlement also includes a substantial monetary payment from Spanellis and an even larger financial penalty if he violates the terms of the court-approved permanent injunction.
LifeScan believed the counterfeit packaging scheme ended in 2008 when a number of lawsuits were initiated and court-ordered seizures were obtained in the United States, Europe and Africa. Since that time, there have been no known instances of LifeScan products with counterfeit packaging in the United States.
“Even though we believe we have stopped the flow of LifeScan products with counterfeit packaging into the [United States], it is critical that we continue to pursue any and all perpetrators of these illegal activities to protect patients,” Albiani said.