FDA, Drugmakers Take Long Overdue Hit

DIANA LEVINE

The Bush administration embarked on a largely successful course to immunize corporations who make killer medical devices, defense contractors who kill Iraqis, telecoms who let the government spy on its customers and financial institutions who make a killing on the backs of ordinary Americans, and in most instances has been helped by a business-friendly Supreme Court that became integral to that process.

But in a stunning reversal of field, the court yesterday ruled that lawsuits in state courts can fill in for lapses at the national level -- in particular lawsuits that claim drugmakers have not given doctors and patients enough warning about side-effects of medications even thought the Food and Drug Administration approved their use.

Six of the nine justices upheld a verdict of nearly $6.8 million aginst the pharmacetical company Wyeth in the case of Diana Levine, a Vermont woman and musician who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug.

In doing so, the court reinforced the notion that drug companies are primarily responsible for keeping their warning labels up to date and complete -- and may pay for it if they don't -- and that the FDA can't dismiss lawsuits out of hand unless it has a clear mandate from Congress, which it does not.