Features

Diabetes monitor maker pays $60 million fines, pleads guilty

The Associated Press
Saturday December 16, 2000

SAN JOSE — Lifescan Inc., a leading maker of diabetes monitors, pleaded guilty Friday to federal charges and was ordered to pay $60 million in fines, ending a three-year government investigation of a defective blood-glucose meter. 

Authorities alleged that Lifescan, a Milpitas-based billion-dollar subsidiary of Johnson & Johnson, knew about two defects in the SureStep consumer device but failed to disclose the problems to customers or the Food and Drug Administration before marketing the device in 1996. 

The defects, authorities said, sometimes would cause false readings on the SureStep monitors. One defect sometimes would wrongly indicate high blood sugar levels, and the other defect sometimes would wrongly yield low test results. 

According to court documents, at least 61 of 2,000 customers complaining of the errors between 1996 and 1998 became ill or had to be hospitalized as a result. 

In June 1998, after several whistleblowers already had sparked the federal investigation, Lifescan instituted a voluntary recall of all SureStep meters manufactured prior to July 27, 1997. 

The company was charged with introducing a misbranded medical device, failing and refusing to furnish appropriate notifications to the FDA, and submitting false and misleading reports to the FDA. 

“Consumers are entitled to know, and the law demands, that all companies tell them honestly about problems and defects in medical devices,” said Matt Jacobs, a spokesman for the U.S. Attorney’s Office. “Corporations in the health care field must be held to a high standard about informing patients and the FDA about the dangers of their products.” 

 

Friday, Lifescan pleaded guilty to three misdemeanor counts before Judge Jeremy Fogel in U.S. District Court in San Jose. 

The plea also resolved a separate civil case in which the government successfully won $30.6 million in restitution fees for Medicare funds used in purchases of the defective devices. 

In addition to the fines, Lifescan was placed on probation for three years, during which the FDA will oversee some of the company’s operations. 

In a prepared statement, Johnson & Johnson said Friday “no one at Lifescan engaged in intentional wrongdoing” but admitted its product labeling was deficient and that the company did not properly notify the government of the defects and was slow to remedy the problem. 

“Mistakes and misjudgments were made,” said Ralph S. Larsen, chairman and chief executive officer of Johnson. “We fully acknowledge those errors and sincerely apologize for them.” 

A separate class-action suit filed on behalf of customers who bought the SureStep monitors is pending in federal court in San Jose.