US Supreme Court split in Wyeth v/s Levine

05 November 2008

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.