2014

Statement on LifeScan's SURESTEP Meter

    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"
 warning.
     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.

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