Federal Contractor Misconduct Database (FCMD)
Defective Blood Glucose Monitoring Device Criminal/Civil Settlement
Johnson & Johnson subsidiary LifeScan pleaded guilty to charges under the Food, Drug and Cosmetic Act and paid $60 million in fines for selling a defective blood glucose monitoring device and submitting false information about the product to the U.S. Food and Drug Administration (FDA). According to the plea agreement, LifeScan’s SureStep blood glucose monitoring system, which was sold in 1996 and 1997, had defects that caused the device to register inaccurate readings. LifeScan admitted that it failed to describe the defects to the FDA when it sought approval to sell the device, and that it failed to advise customers about the defects. LifeScan also paid $30 million to settle civil False Claims Act allegations.
- Misconduct Type
- Enforcement Agency
- Contracting Party
- Court Type
- Date of Plea