Supreme Court Says No To Generic Drug Design Lawsuits

[Purveyor]

Source: Associated Press

WASHINGTON (AP) -- The Supreme Court says generic drug manufacturers can't be sued in state court for a drug's design defects if federal officials approved the brand-name version the generic drug copied.

The justices voted 5-4 to agree with generic manufacturer Mutual Pharmaceutical Co, Inc., which wanted a $21 million judgment against it dismissed.

A New Hampshire jury gave that to Karen L. Bartlett after she took sulindac, the generic form of the drug Clinoril, in 2004. It caused her outer skin layer to deteriorate and burn off, leaving at least 60 percent of her body as an open wound. She is also now legally blind.


Read more: http://hosted.ap.org/dynamic/stories/U/US_SUPREME_COURT_GENERIC_DRUGS?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2013-06-24-10-16-23

[onehandle]

1. Never mind. I misread the ruling. nt

Last edited Mon Jun 24, 2013, 02:04 PM - Edit history (1)

[pnwmom]

8. Why would this be good for us?

Many drugs are only produced by generic manufacturers now, who often have substandard manufacturing processes. Why shouldn't they be held responsible for what they produce?

[DainBramaged]

2. More corporate protections

why am I not surprised?

[Myrina]

3. Not necessarily ...

....I think it's saying generics can't be sued because the basic chemical makeup wasn't theirs so any faults in the formula isn't theirs, either. IE - sue the original maker (Big Pharma).

Now, whether patients need to sue Big Pharma or if the generic co's do, that I don't know.
And can't guess how it would turn out since Big Pharm has an endless supply of money & lawyers.

[DainBramaged]

4. Generics are not exact copies

I found that out from my pharmacist. When my last blood test from my endocrinologist came back with a 20pt high cholesterol reading than the previous quarter, she guess it was the pill. Sure enough, Target had changed suppliers and he suggested I go back on the original pharmaceutical simvastatin until he finds out more info.


After numerous complaints over the past couple of months, they've gone back to the original generic supplier.

[Myrina]

5. I understand that, but

something in the basic chemical equation of the med has to be the same ... maybe that's what the decision is based on.

Or, on second read - the decision states they can't be sued in state court if the formula was approved by the Fed.
So maybe they're leaning towards kicking the can/jurisdiction...

[DainBramaged]

6. sounds logical

[former9thward]

11. This case was a federal case not a state case.

It was tried in federal district court. In this case a state law demanded the company do something a federal law said not to do. Federal law trumps state law when they are in conflict.

[pnwmom]

9. That's because there's an incorrect assumption that "inactive" ingredients never matter

and that all generic manufacturers have good manufacturing standards.

[blkmusclmachine]

7. .

[happyslug]

10. Here is the actual opinion

http://www.supremecourt.gov/opinions/12pdf/12-142_8njq.pdf

Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are preempted by federal law under PLIVA.