US Supreme Court rules against Wyeth over FDA pre-emption

9 March 2009

The Supreme Court of the USA has upheld - with a six to three decision -  a $6.7-million jury award to a musician who lost her arm because of a  complication arising from an incorrectly-administered injection of an  anti-nausea medication. The Court rejected the argument from US drug  major Wyeth, the manufacturer of Phenergan (promethazine), that  compliance with Food and Drug Administration labeling requirements  pre-empt state tort law.

The law suit, Wyeth versus Levine, means that arguments concerning a  jury's fitness to "second-guess" the ability of the FDA to determine the  safety of a drug were rejected, despite an almost identical case  concerning medical devices being decided in favor of the manufacturer.

Initial reports indicating the margin of the win for the original  plaintiff, six votes in favor, indicates that either the  conservative-minded Supreme Court Justices were divided, or that they  have taken into account the public mood, as expressed by the recent  election of President Barack Obama, the first Democrat to win an  outright majority of the popular vote since 1976.

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