Lawyers for drug maker Wyeth and the Bush administration told the U.S. Supreme Court that according to a federal law pharmaceutical companies are not liable for harm from medicines that meet the standards set by the Food and Drug Administration and used as the label indicates.

The case in question is of a Vermont female guitarist, Diana Levine, who lost part of an arm after an improperly administered injection of Phenergan, an anti-nausea drug made by Wyeth. Taken as part of treatment for a migraine, the injection injured an artery and therefore had to be amputated. She was awarded in her state $7 million in damages with her attorneys holding Wyeth responsible saying the drug company should have stronger warnings about the potential danger of administering the drug in the way she experienced. In response attorney Seth Waxman, arguing for Wyeth, told the court that the prescribing instructions for the drug, Phenergan, "plainly comprehended and warned about the specific risks" of giving the drug in the way Levine received it. He further added that the company was required to use the FDA-approved warnings and could not have changed them without the agency's permission. Levine's lawyer said, "These kinds of risks come to light frequently with drugs that are on the market, and the need to revise these labels is the duty of the manufacturer," attorney David Frederick said.

The case is to be decided in the U.S. Supreme Court who are to decide if FDA approval preempts state laws and protects companies from legal damages and a decision is expected by the end of June. The court's ruling in the Wyeth case could affect millions of other businesses, the U.S. Chamber of Commerce has said. Justice Antonin Scalia said, "If you're telling me the FDA acted irresponsibly, then sue the FDA. But holding the company liable could lead to manufacturers over warning about beneficial drugs just to avoid lawsuits, he said."It would not promote public safety if you believe that the name of this game is balancing benefits and costs," Scalia said.

Levine’s chances of losing the case are more pronounced as earlier this year the Supreme Court voted 8-1 for the medical device maker Medtronic Inc after a man sued the company for the injury he received due to use of a catheter manufactured by the company during an artery-clearing procedure.

Justice Ruth Bader Ginsburg siding with Levine said, "Considering the huge number of drugs, is the FDA really monitoring every one of these?”  With Phenergan, "the risk of gangrene and amputation is there. No matter what benefit there was, how could the benefit outweigh that substantial risk?" she added.

For years now the pharmaceutical industry has been seeking protection under the federal preemption law, which is favored by the Bush Administration. Drug companies are liable only if they fail to meet the FDA standards regardless of how many injuries or deaths resulting from taking any FDA-approved drug.