Post by jeffolie on Jun 23, 2011 17:58:53 GMT -6
Generics shielded Ct: no warnings needed
Justice Clarence Thomas rarely speaks in open US Sup Ct and rarely writes the majority opinions. Justice Clarence Thomas wrote the majority opinion for the US Sup Ct that upheld federal power over state power to regulate and/or punish generic drug makers when the situation is that a new warning for patients of new dangers is not given.
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About 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the original makers of these brand-name drugs to include an approved and up-to-date warning label that tells doctors and patients of possible side effects or complications.
But in a 5-4 decision, the high court said this duty to warn patients of newly revealed dangers does not extend to the makers of generic drugs. Justice Clarence Thomas said that because the federal Food and Drug Administration must approve changes in the warning labels, the generic makers may not be sued under state liability laws for failing to warn patients of new dangers.
"We find impossibility here," Thomas said, because the federal regulatory law and the state liability law are in conflict. The dissenters said the generic drug makers should notify the FDA and its patients as soon as it receives reports of serious new problems.
The decision in Pliva vs. Mensing throws out lawsuits from two women who developed tardive dyskinesia, a severe neurological disorder, after taking a generic metoclopramide for acid reflux disorder. The drug had been on the market for many years before doctors realized that taking it for more than 12 weeks could trigger the neurological problem.
www.latimes.com/health/sc-dc-0624-court-drugs-20110623,0,293021.story
Justice Clarence Thomas rarely speaks in open US Sup Ct and rarely writes the majority opinions. Justice Clarence Thomas wrote the majority opinion for the US Sup Ct that upheld federal power over state power to regulate and/or punish generic drug makers when the situation is that a new warning for patients of new dangers is not given.
=======================
About 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the original makers of these brand-name drugs to include an approved and up-to-date warning label that tells doctors and patients of possible side effects or complications.
But in a 5-4 decision, the high court said this duty to warn patients of newly revealed dangers does not extend to the makers of generic drugs. Justice Clarence Thomas said that because the federal Food and Drug Administration must approve changes in the warning labels, the generic makers may not be sued under state liability laws for failing to warn patients of new dangers.
"We find impossibility here," Thomas said, because the federal regulatory law and the state liability law are in conflict. The dissenters said the generic drug makers should notify the FDA and its patients as soon as it receives reports of serious new problems.
The decision in Pliva vs. Mensing throws out lawsuits from two women who developed tardive dyskinesia, a severe neurological disorder, after taking a generic metoclopramide for acid reflux disorder. The drug had been on the market for many years before doctors realized that taking it for more than 12 weeks could trigger the neurological problem.
www.latimes.com/health/sc-dc-0624-court-drugs-20110623,0,293021.story