Saturday, Aug. 23, 2008 | 2:06 a.m.
Many of the recent criticisms of the Food and Drug Administration have been directed toward one of the agency’s most important responsibilities: determining whether prescription drugs are safe before they are allowed on the market.
It is within this context that a case to be heard by the U.S. Supreme Court in November is attracting attention, including from the editors of the New England Journal of Medicine.
The case was brought by a Vermont musician, Diana Levine. In 2000 a doctor injected the drug phenergan into her right arm to treat nausea. The injection was not administered properly and half of her arm had to be amputated.
She sued Wyeth, the drug’s manufacturer, and was awarded $6.8 million by a Vermont jury, a verdict upheld by the Vermont Supreme Court. As The Wall Street Journal reported, the courts agreed “Wyeth hadn’t sufficiently warned the public and doctors about the drug’s dangers if improperly injected.”
Wyeth appealed to the U.S. Supreme Court, stating the FDA — a federal agency — had approved the drug’s label, which did not specifically warn about all known injection risks. In a potentially landmark argument — soundly rejected by the majority of the Vermont Supreme Court — Wyeth says federal law preempts state courts from hearing liability suits alleging “failure to warn” if the products involved were sold with federally approved labels.
Editors of the New England Journal of Medicine and plaintiffs’ attorneys say a ruling affirming Wyeth’s view would deal a near-mortal blow to product liability suits in both state and federal courts.
We agree with the medical journal editors, who say that taking away consumers’ right to sue would also take away a strong incentive for the FDA and the pharmaceutical industry to be open about a drug’s potential for causing harm. In citing 23 drugs withdrawn from the market since 1997, the editors state the obvious: The FDA and drug companies haven’t always been completely open or correct in their labeling, even when the risk of lawsuits has been present.
Preserving the right of consumers to sue will keep federal agencies and manufacturers more honest — and the public more protected.