Paying the Price

Feb 1, 2001 12:00 PM, Richard Park

LifeScan Pleads Guilty in Glucose Meter Investigation, Ordered to Pay $60M

New Brunswick, N.J.

LifeScan will pay a fine and civil settlement totaling $60 million after pleading guilty to charges resulting from a federal investigation into flaws in its Surestep blood glucose meter.

The plea ended a three-year investigation into how LifeScan, a Johnson & Johnson company, addressed problems associated with Surestep in 1997. Because of a software problem in meters produced before August 1997, diabetics with very high blood sugar would occasionally receive an error message instead of a "HI" warning. Another problem related to test strips manufactured before March 1998 could yield false low-test results if the test strip containing the blood sample was not completely inserted into the meter. The error message issue affected the Surestep Consumer Meter, while the strip insertion issue affected the Consumer Meter and the Surestep Pro.

LifeScan noted that it corrected the problems in 1997 and early 1998. In addition, in June 1998, the company offered to replace all faulty meters at no cost.

Under the court settlement, LifeScan acknowledged introducing an adulterated and misbranded medical device, failing to provide appropriate notifications and information to the Food and Drug Administration, and submitting false and/or misleading reports to the FDA. The company also admitted that the Surestep labeling was deficient, that it did not properly notify the government of those deficiencies and that it was slow to remedy them completely.

"Mistakes and misjudgments were made," said Ralph Larsen, Johnson & Johnson's chairman and chief executive officer. "We fully acknowledge those errors and sincerely apologize for them. LifeScan products and services have enhanced the lives of millions of people with diabetes. It took years of hard work to earn their confidence and trust. We are committed to learning from this experience and doing everything in our power to be worthy of that trust."