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On December 15, 2000, after a three-year government investigation, LifeScan, Inc., a Johnson & Johnson company, entered a plea of guilty to three misdemeanor charges relating to a federal government investigation of its SureStep Blood Glucose Meter. LifeScan will pay a fine of $29.4 million and an additional $30.6 million in civil settlement to the government.
Problems discovered with the SureStep included:
In June 1998, LifeScan offered to replace all affected SureStep meters free of charge.
According to a December 15, 2000 Johnson and Johnson press release, through this settlement, "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 press release adds, "The basis of this misdemeanor plea was that no one at LifeScan engaged in intentional wrongdoing or intentionally sought to mislead consumers or the government. But LifeScan admits that the SureStep product labeling was deficient, that the company did not properly notify the government of those deficiencies and was slow to remedy them completely."
Ralph S. Larsen, chairman and chief executive officer of Johnson & Johnson, admits mistakes and misjudgments were made.
"We fully acknowledge those errors and sincerely apologize for them," said Larsen. "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."
0 comments - Mar 1, 2001
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