Aug. 15 (Bloomberg) -- Consumers should be allowed to sue drugmakers for failing to warn of dangers even if prescribing literature for a drug was approved by regulators, six current and former editors of the New England Journal of Medicine said in a brief filed with the U.S. Supreme Court.

The brief, filed in the case Wyeth v. Levine, was the first to be signed by every editor-in-chief of the medical journal, Marcia Angell, one of the former editors, said today. The Supreme Court is reviewing a $6.8 million award to musician Diana Levine, who lost her arm after being injected with Wyeth's anti-nausea treatment Phenergan.

The Vermont Supreme Court upheld the jury award to Levine, who says Wyeth should have warned against the injection method that caused gangrene in her right arm. Wyeth contends that the lawsuit is barred because the Food and Drug Administration approved the medicine's prescribing information. The case will test whether federal drug laws should trump state laws, known as ``preemption.''

``We all agree that preemption is a terrible idea, especially given the fact that the FDA no longer adequately performs its function of assuring that new drugs are reasonably safe and effective,'' Angell said today in a phone interview. ``If drug companies know that they are likely to end up in court, they might be more careful, less cavalier about safety.''

The Supreme Court has scheduled opening arguments for Nov. 3. The case follows an 8-1 vote in February in which the justices put new limits on lawsuits against makers of medical devices whose products were cleared for sale under a full FDA review.

Share Price

Wyeth, of Madison, New Jersey, gained 46 cents, or 1.1 percent, to $43.29 at 4 p.m. in New York Stock Exchange composite trading. Doug Petkus, a spokesman for the company, declined to comment about the journal editors' brief.

The FDA's oversight of drug safety has been criticized by lawmakers and consumer groups who say it shouldn't have taken years to identify side effects from drugs such as GlaxoSmithKline Plc's diabetes pill Avandia and Merck & Co.'s recalled painkiller Vioxx. The agency has since toughened its standards for new drugs, approving 19 last year, the fewest since 1983.

``As journal editors, we see a lot of research on new drugs so we are aware of the pitfalls on new drugs,'' said Gregory Curfman, the New England Journal's executive editor, in a phone interview today. Without lawsuits, ``it is highly likely that the drug pipeline for our country is going to be less safe.''

FDA Commissioners

Former FDA commissioners Donald Kennedy and David Kessler also filed a brief with the Supreme Court yesterday supporting Levine. The agency lacks the resources and organization to police all estimated 11,000 approved medicines, so patients who are injured should have the right to sue the drugmakers, they said.

``FDA is not in a position to reliably guard against harm against every drug that it approves so there's no reason why its act of approval should immunize patients from gaining access to the courts,'' Kennedy said today in a phone interview. ``It seems fundamentally and deeply unfair to me.''

Regulators try to balance ``the importance of notifying users of potential dangers while not discouraging appropriate use of beneficial drugs through over-warning,'' the FDA said today in a statement. Interfering with these standards ``would create chaos and confusion for patients and health-care providers trying to make the best, most well-informed choices on whether to pursue particular therapy.''

The case is Wyeth v. Levine, 06-1249, U.S. Supreme Court.

-- Editors: Larry Liebert, Angela Zimm

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: August 15, 2008 17:25 EDT