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Monday, April 05, 2010 10:23 PM


Judge Holds Off Ruling After Boston Scientific Admits Hiding Problems With Implantable Heart Defibrillators


Boston Scientific admits it failed to disclose short-circuiting problems with its defibrillators. Some users died as a result. But hey, anything for a profit, especially when penalties are low. Please consider Judge Holds Off Boston Scientific Unit Plea in Probe.

A federal judge reserved ruling on a guilty plea by Boston Scientific Corp.’s Guidant unit to charges it hid problems with its implantable heart defibrillators, citing objections raised by plaintiffs suing the company.

U.S. District Judge Donovan Frank in St. Paul, Minnesota, said today he will rule on the plea and a related settlement within three weeks when he decides whether to put the company on probation and order restitution.

The medical device-maker agreed to plead guilty to two misdemeanors for excluding defibrillator-malfunction reports from product updates sent to doctors and failing to alert the U.S. Food and Drug Administration to the defects. Boston Scientific agreed to pay $296 million in November to settle a U.S. Justice Department probe of the unit’s handling of the devices.

Prosecutors said in court papers that Guidant officials learned as early as 2002 that some of the defibrillators had short-circuiting problems that led to some users’ deaths. The company didn’t disclose the defects for more than three years, the government added in the filings.

Last month, Boston Scientific halted all sales of heart-rhythm devices because of an erroneous filing with regulators.

“When a corporation who makes life-saving devices lies to the FDA, that puts the implantees and others at risk,” Charles Zimmerman, an attorney for plaintiffs, said during today’s hearing. “Today Guidant comes before the court and asks you to accept a plea of guilty in which they admit they have lied.”

Boston Scientific’s shares fell the most in 17 months on March 15 after the company said it stopped sales of defibrillators because of a documentation error. The devices brought in $1.79 billion last year, or 22 percent of Boston Scientific’s revenue, according to data compiled by Bloomberg.

The company’s heart pacemakers and defibrillators are implanted in patients’ bodies to shock hearts back into normal rhythm.
Earlier today I commented that Pfizer Caught Illegally Marketing Bextra. However, the Feds would not prosecute because "Pfizer Is Too Big To Nail".

Pfizer got off with a fine, while Boston Scientific plead guilty to two misdemeanors. As long as companies get off with insignificant penalties, do not expect corporate behavior to improve.

In poetic justice of sorts, Boston Scientific paid $27 billion for Guidant in 2006. The market cap for Boston Scientific is currently $11 billion.

Mike "Mish" Shedlock
http://globaleconomicanalysis.blogspot.com
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