A landmark decision may arise from a pre-emption lawsuit the U.S. Supreme Court will hear involving a musician whose arm was amputated as a result of anti-nausea drug made by Wyeth which was injected into her artery and led to gangrene.

A Vermont court had earlier awarded the 62-year old musician, Diana Levine, $6.7 million damage. Wyeth appealed the case to the Supreme Court, which is set to hear the case in November.

The court ruling will have an impact on similar cases, which have grown in number of the years. In 2005, 17,000 cases involving Food and Drug Administration-approved drugs and devices that turned out to be unsafe were filed against drug companies.

In their defense, pharmaceutical firms are citing the doctrine of pre-emption, which prohibits injured consumers from suing in state courts if the products which caused their injury passed FDA standards. It leaves people like Levine the federal courts to settle the issue.

New York University law professor Catherine Sharkey confirms federal pre-emption cases are the fiercest battles in product liability law these days. "The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an undisputably muddled area of law," Sharkey explained to the New York Times.

When the Supreme Court starts its new term on Oct. 6, it is slated to hear a second pre-emption case involving cigarette labels.

It is not just drug makers who cited the pre-emption doctrine, but also business groups that often argue using the principle to protect their enterprises from lawsuits.

Levine wants Wyeth to add a stronger warning to the FDA-approved medication. Wyeth answered the firm could not change the label on Phenergan, the drug in question, because it may expose the drug company to violation of federal laws.

The Vermont Supreme Court, in 2006, ruled that federal law is a minimum standard, not a maximum benchmark, for state regulation. The pharmaceutical industry argues that it is more sensible if experts from the FDA and not jurors made the decision if a drug is safe.

Lawyer Ted Olson, who represents Medtronic, asked, quoted by the Los Angeles Times, "Do we really want a jury in Peoria or Santa Fe deciding whether the design of a medical device needs to be changed?"