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November 3rd, 2008

Preemption case went before Supremes today

Posted by Dana Blankenhorn @ 11:25 am

Categories: Drugs, Ethics, Gadgets, General, Government, Medical Equipment, U.S., state government

Tags: Wyeth, Dana Blankenhorn, FDA, Drug Company, Side Effect, Bush Plan, Legal Times, Federal Government, Professional Development, Regulations

Diana Levine in Charles Eller Studio, Charlotte VermontWhile most of us focused on the Presidential race the Supreme Court heard a case today whose result may be equally sweeping.

(This picture, from InjuryBoard, was taken at the famous Chas Eller musical recording studio in Charlotte, Vermont. Why in a moment.)

In Wyeth vs. Levine, the court is being asked to rule that drug companies can’t be sued for side effects so long as the drugs were approved first by the FDA.

The case involves Diana Levine (above), now 63, who was given Demerol for migraines and Phenergan for nausea in an emergency room then lost an arm (and musical career) to gangrene, apparently a side effect of the Phenergan.

The court is expected to rule she has no right to sue.

But this is really part of a larger battle, with the Bush Administration stacking regulatory agencies and courts with allies who don’t want people to have the right to sue business.

My feeling is that this will lead to illness and death that become matters for the criminal courts. Wyeth executives who skated in civil court, thanks to their friends in Washington, may find themselves behind bars one day.

The Bush plan has been to get rid of regulation then say you can’t sue because the shoddy regulations preempt it. It’s a neat trick. Career officials at the FDA are outraged.

Dangerous side effects are often found only after drugs are approved. This data goes to the drug companies who may choose to cover it up. Now we’re being told they can get away with it.

The Legal Times is out with an editorial saying that an Obama Administration and Democratic Congress could simply pass laws that toss the whole scheme into the waste bin. But judges who believe in the doctrine will remain on the bench for decades. They could simply rule the new law unconstitutional.

That’s what happens when ideology trumps everything else. The damage can last a generation. The preemption debate is not going away, no matter what happens tomorrow.

Dana BlankenhornDana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.

Email Dana Blankenhorn

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  • Talkback
  • Most Recent of 28 Talkback(s)
Not the medication but the method...
I believe I read that it was the instructions from the manufacturer, which specified an injection method that was later felt to have caused the gangrene, that was the focus of this argument. The medic... (Read the rest)
Posted by: docfeetz Posted on: 11/05/08 You are currently: a Guest | | Terms of Use
I have to wonder...  Letophoro | 11/03/08
Under the theory...  DanaBlankenhornZDNet Moderator | 11/03/08
"if civil redress is impossible"  Bill4 | 11/03/08
Could jail the regulators that approved it  John L. Ries | 11/03/08
Gangrene is not a side effect of ....  ShadeTree | 11/03/08
re: Side effects  dmclean@... | 11/04/08
As I said, the Gangrene is ....  ShadeTree | 11/05/08
Gangrene is but one possible side effect.  Letophoro | 11/05/08
Not the medication but the method...  docfeetz | 11/05/08
RE: Preemption case went before Supremes today  jimbo2 | 11/03/08
I suppose it could work if...  John L. Ries | 11/03/08
RE: Preemption case went before Supremes today  Monosdeja | 11/03/08
Did you have some specific objections to his piece?  John L. Ries | 11/03/08
Opinions and Disagreements...  aureolin@... | 11/03/08
It's hard to argue with someone...  John L. Ries | 11/03/08
conversely...  bmerc | 11/04/08
I agree with you Aureolin  DanaBlankenhornZDNet Moderator | 11/05/08
RE: Preemption case went before Supremes today  onrete@... | 11/03/08
RE: Preemption case went before Supremes today  Digital Video Expert | 11/03/08
I think the standing assumption of the Bush Administration is...  John L. Ries | 11/03/08
RE: Preemption case went before Supremes today  Jaynesday | 11/03/08
RE: Preemption case went before Supremes today  perversion2003@... | 11/03/08
RE: Preemption case went before Supremes today  robertcape@... | 11/04/08
RE: Preemption case went before Supremes today  hdowd-list@... | 11/04/08
Very poor summary of the case!  Anton Philidor | 11/05/08
No, it has more wide-ranging significance  DanaBlankenhornZDNet Moderator | 11/05/08
Covering up "bad data" is a bigger problem...  Anton Philidor | 11/05/08
Supreme court can be over-ruled  Keeping Current | 11/05/08

What do you think?

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