Washington: The US Supreme Court has questioned pharmaceutical behemoth Wyeth (WYE) and a plaintiff in a case about whether the US Food and Drug Administration's (FDA) regulation of labelling drugs prevents consumers from suing companies.

Case history:
Diana Levine went for treatment to a clinic for a severe migraine. Her arm had to be amputated after she got gangrene when she was injected in April 2000 with Wyeth's Phenergan nausea medication. The drug was inadvertently injected into an artery, seriously damaging it, and doctors later amputated her arm.

Now, the state of Vermont and another 46 US states are asking the US Supreme Court to uphold a Vermont Supreme Court ruling that made Wyeth pay $6.8 million to Levine. A jury had awarded the sum to Levine after she sued Wyeth. Wyeth appealed against the ruling, and the Vermont Supreme Court had upheld the lower court's ruling in 2006.

Now, the US Supreme Court is hearing the appeal against the award in favour of Levine, a 63-year old professional musician, who now uses a prosthetic arm to play her guitar.

Arguments:
The case is one of the most hotly contested cases of the Supreme Court's term. The Bush Administration is supported the drug manufacturer's contention that the lawsuit should thrown out of court, since federal law preempts such state court claims.

Justices are now hearing oral arguments from both sides to arrive at the appropriate point where FDA-approved labelling starts to protect drug companies from lawsuits over their products.

A Vermont court, while awarded Levine $6.7 million as compensation from Wyeth, had accepted her argument that Wyeth should have put stronger warnings on the label. Countering her argument, Wyeth said that its label was approved by the FDA, arguing that it couldn't have updated the drug's label without first getting FDA approval.

To that arguments, the justices contended that Wyeth ''could have gone back to the FDA anytime" to update the label, and ''simply didn't do it."
As part of the arguments, Seth P Waxman, Wyeth's attorney said that the FDA was aware that improperly administering Phenergan through an intravenous (IV) push method, which was the method in Levine's case, could result in problems, while saying that the drug's label carried warnings about that.

Levine's attorney David C Frederick countered that argument saying that the FDA never expressly compared risks and benefits of one method of administering the drug over others, and that the FDA's warning on the label was weak. Frederick also said that the onus was on drug makers to update their drug labels to ensure that they reflect the current status of all risks and benefits, while going on to say that the company should have known at least since the 1970s that the IV-push method to administer Phenergran put patients at high risk.

Justice Antonin Scalia then questioned whether the burden was on the FDA, and not Wyeth, to ensure the label properly reflected associated risks with the drug, seeming to find some logic in Wyeth's position. He was reported as saying, "If you're telling me the FDA acted irresponsibly, then sue the FDA." He was saying that holding the company liable in such cases could lead to a situation where manufacturers over-warn about beneficial drugs just to avoid lawsuits.

However, Justice Ruth Bader Ginsburg expressed concern that the FDA does not always make the right decision about whether a medicine is too dangerous, or has proper warnings in place, as argued by Levine's lawyers. She questioned, "Considering the huge number of drugs, is the FDA really monitoring every one of these?"

A decision in the case is expected by the end of June 2009.