Manufacturer of Defective Glucose Monitors Pleads Guilty

LifeScan will pay a fine of US$29.4 million and an additional $30.6 million in civil settlement to the U.S. government.

The glucose monitoring systems sold between May 1996 and late 1997 had two defects that caused the monitor to register inaccurate readings, sometimes showing an error message instead of a "HI” warning. Another problem related to test strips manufactured before March 1998, which could yield false low test results if the test strip containing the blood sample was not completely inserted into the meter. LifeScan says these problems were corrected in 1997 and early 1998 and notes that the company offered in June 1998 to replace all affected monitors free of charge.

LifeScan acknowledges introducing an adulterated and misbranded medical device, failing to provide appropriate notifications and information to the U.S. Food and Drug Administration (FDA), and submitting false and/or misleading reports to the FDA. The company says nobody at LifeScan engaged in intentional wrongdoing or intentionally sought to mislead consumers or the government. However, LifeScan does admit that the Surestep product labeling was deficient, and that the company did not properly notify the government of those deficiencies and was slow to remedy them.

"Mistakes and misjudgments were made,” said Ralph S. Larsen, chairman and CEO of J&J. "We fully acknowledge those errors and sincerely apologize for them.”



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