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[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


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 
physically impaired.  

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.  
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