IBJNews

Judge rejects Guidant's defibrillator plea deal

Back to TopCommentsE-mailPrintBookmark and Share

A federal judge has rejected Guidant Corp.'s guilty plea to charges it hid defects in heart defibrillators, after some doctors and patients complained about the deal.

U.S. District Judge Donovan Frank in St. Paul, Minn., Tuesday rebuffed the Boston Scientific Corp. unit’s plea agreement with prosecutors and suggested the company should be placed on probation for failing to disclose defects with its heart devices to regulators. Boston Scientific agreed to plead guilty to two misdemeanors and pay $296 million to settle a U.S. Justice Department probe.

“At a minimum, the public’s interest in accountability would be served by Guidant and Boston Scientific being placed on probation,” Frank said in his 37-page ruling.

Guidant is the coronary products company spun off from Indianapolis-based Eli Lilly and Co. in the 1990s and acquired by Boston Scientific in 2006.

Prosecutors said in court papers Guidant officials learned as early as 2002 that some of the implantable defibrillators had a tendency to short circuit and caused users’ deaths. The company didn’t disclose the defects for more than three years, the government said.

Paul Donovan, a Boston Scientific spokesman, didn’t immediately return calls for comment on the judge’s ruling.

Boston Scientific halted all sales of heart-rhythm devices in March because of an erroneous filing with regulators. The U.S. Food and Drug Administration cleared the company to begin selling defibrillators again April 15. The company’s devices are implanted in patients’ bodies to shock hearts back into normal rhythm.

Natick, Mass.-based Boston Scientific, the world’s second-largest heart-device maker, is cutting as many as 1,300 jobs because it expects sales growth for drug-coated stents and defibrillators to slow. Minneapolis-based Medtronic Inc. is the world’s largest maker of heart-rhythm devices.

Boston Scientific shares fell the most in 17 months on March 15 after the company said it halted all 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.

Guidant issued a June 2005 recall that was eventually expanded to 109,000 defibrillators. Lawyers for patients contend the company knew as early as June 2002 that the devices were flawed and hid the defects to protect sales.

Boston Scientific agreed in 2007 to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in its defibrillators.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. A Tilted Kilt at a water park themed hotel? Who planned that one? I guess the Dad's need something to do while the kids are on the water slides.

  2. Don't come down on the fair for offering drinks. This is a craft and certainly one that belongs in agriculture due to ingredients. And for those worrying about how much you can drink. I'm sure it's more to do with liability than anything else. They don't want people suing for being over served. If you want a buzz, do a little pre-drinking before you go.

  3. I don't drink but go into this "controlled area" so my friend can drink. They have their 3 drink limit and then I give my friend my 3 drink limit. How is the fair going to control this very likely situation????

  4. I feel the conditions of the alcohol sales are a bit heavy handed, but you need to realize this is the first year in quite some time that beer & wine will be sold at the fair. They're starting off slowly to get a gauge on how it will perform this year - I would assume if everything goes fine that they relax some of the limits in the next year or couple of years. That said, I think requiring the consumption of alcohol to only occur in the beer tent is a bit much. That is going to be an awkward situation for those with minors - "Honey, I'm getting a beer... Ok, sure go ahead... Alright see you in just a min- half an hour."

  5. This might be an effort on the part of the State Fair Board to manage the risk until they get a better feel for it. However, the blanket notion that alcohol should not be served at "family oriented" events is perhaps an oversimplification. and not too realistic. For 15 years, I was a volunteer at the Indianapolis Air Show, which was as family oriented an event as it gets. We sold beer donated by Monarch Beverage Company and served by licensed and trained employees of United Package Liquors who were unpaid volunteers. And where did that money go? To central Indiana children's charities, including Riley Hospital for Children! It's all about managing the risk.

ADVERTISEMENT