US Supreme Court takes up drug labeling lawsuit

The Supreme Court on Monday began studying whether an individual can sue a pharmaceutical company over drug labels that fail to properly warn of dangerous side effects -- a potentially costly precedent for the industry.

A ruling in favor of the plaintiff, in this case a guitarist who lost her right forearm to a badly administered nausea drug, could lead to thousands of similar lawsuits and millions of dollars in damage payments for the pharmaceutical industry.

Musician Diana Levine from Vermont had her forearm amputated in 2000 after doctors injected the anti-nausea drug phenergan intravenously, rather than intramuscularly as recommended, since it proved more efficient in coping with her strong migranes.

The injection, however, was poor administered and some of the drug went into an artery causing gangrene of Levine's hand and forearm.

Levine took the doctor to court and was awarded more than seven million dollars in damages.

Then she decided to go after pharmaceutical giant Wyeth, the maker of phenargen.

She argued that although the Food and Drug Administration (FDA) approved phenargen with a label indicating that intramuscular injection was the preferred method of delivery, and that intravenous injection should have been clearly banned altogether.

The argument is based on the FDA's guiding principle that the risks and benefits of any drug should be fully weighed before approval. The nine Supreme Court justices began debating the case on Monday.

A Vermont jury ruled in Levine's favor and ordered Wyeth to pay her 6.7 million dollars in damages. Wyeth appealed, and the state supreme court backed the lower court decision, prompting the company to go before the highest court in the land.

Wyeth is arguing that because phenargen's label met approval by the FDA, it should be protected from civil liability because federal law pre-empts state law, in this case Vermont's.

Wyeth's lawyers also argued that too many warnings on a label could undermine the sale of medication proven overwhelmingly effective in most cases.

They also suggested that the millions of dollars pharmaceuticals spend on legal proceedings could better be used in drug research and improvement.

Many experts predict the Supreme Court will rule in favor of the pharmaceutical industry to spare them from costly legal wranglings.

On Monday, however, Wyeth lawyer Seth Waxman was grilled by the justices about the dangerous side effects of phenargen.

"How could the FDA conclude that IV push (intravenous) was safe and effective when on the benefit side of this you don't have a life-saving drug, you have a drug that relieves nausea, and on the risk side you have the risk of gangrene?" asked Samuel Alito.

"No matter what benefit there was, how could the benefit outweigh that substantial risk?" joined in Ruth Ginsburg.