[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]
[IP] NYTimes.com Article: Guilty Plea by Division of Drug Gia
Guilty Plea by Division of Drug Giant Monitors for Diabetics Found
to Be Defective
December 16, 2000
By MELODY PETERSEN
LifeScan, a subsidiary of Johnson & Johnson, pleaded guilty to
criminal charges yesterday and agreed to pay $60 million in fines
for selling defective blood glucose monitoring devices to diabetics
and submitting false information about the problems to federal
According to the plea agreement, Life- Scan's SureStep blood
glucose monitoring system, which was sold between May 1996
and late 1997, had two defects that caused the device to register
inaccurate readings. Sometimes, when a patient had a
dangerously high glucose level, the device would display an error
message instead of a "HI" warning. Lawyers who have filed a class-
action lawsuit against LifeScan say that at least three diabetics
may have died as a result of the faulty readings on the SureStep
LifeScan admitted in the plea agreement that it failed to describe
the defects to regulators at the Food and Drug Administration when
it was trying to gain clearance to sell its new device. The company
also admitted it had failed to advise customers about the defects
and failed to file the proper reports with the F.D.A. as hundreds of
patients began to complain about the device and the injuries they
"Defective products that give inaccurate or misleading readings will
not be tolerated," said Jane E. Henney, the F.D.A. commissioner,
in a written statement yesterday, "and we will take action against
firms that market them."
While agreeing to the criminal misdemeanor charges brought by
the United States attorney in Northern California, Johnson &
Johnson said that no one at LifeScan had intentionally engaged in
wrongdoing or intentionally sought to mislead consumers or the
government. But the company admitted that the labels on the
meter were deficient, that the company had not properly notified
the government of the problems and that it had been slow to fix
"Mistakes and misjudgments were made," Ralph S. Larsen,
chairman of Johnson & Johnson, wrote in a statement. "We fully
acknowledge those errors and sincerely apologize for them. We
are committed to learning from this experience."
A spokesman for Johnson & Johnson said last night that the
company was aware of two deaths but did not believe the meter
was the cause. Johnson & Johnson said it had corrected the
problems by early 1998 and that in June 1998 it offered to replace
all the defective meters.
According to court documents, during 1996, 1997 and 1998,
LifeScan received more than 2,000 complaints from SureStep
customers of inaccurate low readings and over 700 complaints
regarding error messages, some of which were attributable to high
blood glucose. At least 61 of the error complaints were associated
with illness or injury, including some hospitalizations.
Diabetics can suffer from comas or toxic shock if they do not
immediately lower glucose levels that are too high.
In 1998, dozens of federal agents raided LifeScan's offices in
Milpitas, Calif., taking more than half a million pages of records
relating to the devices.
The company also faces a class- action suit filed by the law firm of
Milberg Weiss Bershad Hynes & Lerach and others that seek
millions of dollars in damages for patients.
According to the plea agreement, LifeScan will be on probation for
three years, with the F.D.A. and the United States Probation Office
overseeing certain aspects of the company's operations.
SureStep was marketed to diabetics who were often visually and
According to court papers, Lifescan learned that SureStep was
defective in 1993, before it submitted information to the F.D.A. to
gain approval to sell it to the public. The company began selling the
device in the United States in May 1996, but did not tell consumers
about the problems until late 1997 or early 1998.
The court papers describe numerous complaints from patients who
were injured after getting faulty readings. In May 1997, the
company's director of clinical evaluations told management that he
believed the company was required to tell federal regulators about
some of the most serious complaints.
The doctor told management, according to court papers, that
SureStep should be immediately recalled because it posed an
unacceptable risk of harm to patients. But management declined to
do that. Instead, the company did not report the complaints that
the doctor had reported until June 1998 when the F.D.A. had begun
its criminal investigation.
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
send a DONATION http://www.Insulin-Pumpers.org/donate.shtml