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To: Secret Agent Man

Don’t get too bent out of shape over this, which actually happened in june 2012, a year ago....

The drug company was a generic maker, and the drug was a simple NSAID drug with a zillion warnings on the label but the warnings did not include the medical name for the particular diagnosed skin issue that the patient developed, although it did include many conditions like it, just not this particular one...

The Generic maker is required by state law to have the same label as the original med it is substituting...so it could not have changed the label legally should it have wanted to so it falls back on the Feds to change the label on the original and they did not do it....so....

The generic makers was found to be immune from the suit as it could not have complied because of government regs...

In any case.....frankly the woman would have gotten the condition regardless of the label...she apparently reacted to it as the warning label warned her might happen...Never heard of the med....sounds like one of those 12 hr nsaids...I never use the crap..


11 posted on 07/17/2013 8:46:01 PM PDT by Cold Heat (Have you reached your breaking point yet? If not now....then when?)
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To: Cold Heat
Right, how can a generic drug manufacturer be held liable for its product lacking a particular warning when, by federal law, said manufacturer is not permitted to change the labeling that was approved for the original brand-name manufacturer?

It seems the feds have created this issue. Perhaps generic manufacturers should be permitted to add to, but not take away from, warning labels that were approved for the original manufacturer.

16 posted on 07/17/2013 8:56:22 PM PDT by 101stAirborneVet
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