The Scarlet Golf Shirt: ‘I Violated The FDCA’
12 CommentsBy Ed Silverman // November 2nd, 2007 // 7:24 am
Could this be a new fashion trend? A Birmingham, Alabama man who pleaded guilty to misdemeanor charges of violating the federal Food, Drug and Cosmetic Act has agreed to wear a yellow T-shirt or golf shirt bearing the inscription of “I WAS CONVICTED OF VIOLATING THE FDCA” as part of his punishment. However, he only has to wear such a shirt at seminars he must attend to learn better behavior.
Federal prosecutors say that James Lee, 62, the chief executive officer of Advanced Medical Systems, directed the manufacture of a catheter and sold the catheter without obtaining FDA approval in 2005, The Birmingham News reports. Lee was originally charged in a 12-count felony indictment. His sentence resulted from his guilty plea to two misdemeanor offenses, neither of which required any intent to mislead or defraud, according to his attorney, Jim Sturdivant. “He maintained all along that he did not intend to violate the law or regulation,” he tells the paper.
The US Attorney who pursued the case, Alice Martin, says no patients were harmed by the unapproved catheters, but was, nonetheless, emphatic that Lee could have harmed public health. “Devices which have not been approved for sale potentially pose health risks for the general public,” Martin said in a statement.
In his agreement with prosecutors, Lee agreed to pay a $2,000 fine, serve one year’s probation and attend 24 hours of educational instruction. Federal officials weren’t available to discuss the shirt’s role in his punishment or the type of classes Lee must attend. But if this approach is adopted by federal prosecutors in Boston, where numerous fraud cases have been pursued against drugmakers, perhaps off-label promotion would decrease? Meanwhile, what do you think about this sentence?
Is this cruel and unusual punishment?
- No (67%, 16 Votes)
- Yes (33%, 8 Votes)
Total Voters: 24
Loading ...Hat tip to FDA Law blog
The Scarlet Golf Shirt: ‘I Violated The FDCA’ » golfxing.com
[...] Original post by Ed Silverman [...]
Lisa Van S
Ed at Pharmalot
As you know, I have always been a defender of an Individuals right to free speech,but one should never have to be subjected to “SEXUAL HARASSMENT”.
I have always enjoyed a good jab,when its done out of “GOOD”,”CLEAN”,fun. But last night “BOB”,”AGAIN” crossed that line.
Pharmalot has the ability to protect women from being “SEXUALLY HARASSED” on its site,and I am asking you to do so..
I am asking Pharmalot,which is owned by the New Jersey
Starledger to restrict “BOB” from commenting on this site.
The Scarlet Golf Shirt: ‘I Violated The FDCA’ » golfxing.com
[...] Original post by Ed Silverman [...]
Chris
What a bizarre, if not creative punishment. In comparison with the recent Chinese FDA transgressor who was executed the golf shirt seems reasonable, although for a different ‘crime’ admittedly.
Jack
aren’t we protected against cruel and UNUSUAL punishment?
James
This is not cruel and unusual punishment, as it is part of a probation agreement. If he didn’t want to wear the shirt, he could just choose to go to jail. He’s choosing this.
Health Blog : CEO Breaks FDA Law, Dons Shirt of Shame
[...] intend to violate the law or regulation,” his lawyer said. The Health Blog saw this story on Pharmalot, which picked it up from the FDA Law Blog. Permalink | Trackback URL: [...]
Jack
I still think it counts as unusual punishment. A country might allow a prisoner to reduce their sentence by five years by donating one of their kidneys, but the US does not permit this sort of thing. Just because the state gives the prisoner the choice of a more usual punishment doesn’t make it unconstitutional.
James
Give me a break, Jack–you’re not comparing a shirt to having an organ removed, are you?
Ultimately, you can think what you want, but the U.S. Court system (the people who interpret the Eighth Amendment) disagrees w/ you–see Shawn Gementera v U.S.
Bob
Lisa-Give me a break.
Maybe when you stop slandering pharmaceutical companies, and stop pushing your stupid little agenda, will peopl eleave you alone.
Grow up.
Lisa Van S
Good Morning,..Bob,
“Stop pushing your stupid little agenda, will people leave you alone”, that will never happen,…BOB. When have I ever slandered the Pharmaceutical Industry?…If they have a tarnished reputation, then they only have themselves to blame.
Yes Bob, I grew up… I am no longer “GULLABLE”
Fashion and Clothing Tips
Fashion and Clothing Tips…
I couldn’t understand some parts of this article, but it sounds interesting…