NEW BRUNSWICK, N.J., Dec. 15 /PRNewswire/ -- LifeScan, Inc., a Johnson &
Johnson (NYSE: JNJ) company, today 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.
This plea ends a three-year government investigation of the way LifeScan
addressed two problems associated with the SURESTEP product in 1997. SURESTEP
is one of several LifeScan meters that enable people with diabetes to
self-monitor their blood sugar levels. Because of a software problem in
SURESTEP meters manufactured before August 1997, individuals with very high
blood sugar sometimes would receive an error message instead of a "HI"
The other 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. The error message
issue affected the SURESTEP Consumer Meter, and the strip insertion issue
affected both the SURESTEP Consumer Meter as well as the SURESTEP PRO, a
system used in hospitals. No other LifeScan products were affected.
It is important to note that these problems were corrected in 1997 and
early 1998, and that in June 1998 LifeScan offered to replace all affected
SURESTEP meters free of charge.
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 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.
"Mistakes and misjudgments were made," said Ralph S. Larsen, Chairman and
Chief Executive Officer of Johnson & Johnson. "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."
SOURCE LifeScan, Inc.