The Food and Drug Administration (FDA) imposes strict requirements on drug labeling in an effort to ensure patients clearly understand the risks of using a given drug. In fact, the FDA must approve the content of product labels as part of the release process for any pharmaceutical. But since federal law typically supersedes state law that may carry more strict labeling requirements, patients can lose vital rights if they suffer injury when the FDA approves a product label that fails to warn consumers of a known side effect of a product.
In a 2008 Vermont personal injury case against Wyeth Pharmaceuticals, plaintiff Diana Levine claimed injury on grounds of failure to warn after receiving an injection of the anti-nausea drug Phenergan®, which caused arterial damage that required amputation of her arm. Ms. Levine received an award to compensate her for medical expenses, pain and suffering and the loss of her livelihood as a professional musician.
Wyeth took the case to the Superior Court of Vermont, which denied their motion for a new trial in spite of FDA approval of the labeling. In a 6-3 decision, the United States Supreme Court upheld the right of patients to use the most common argument of failure to warn when pursuing product liability claims against pharmaceutical manufacturers.
While the FDA and other federal agencies may set overall standards to help protect consumers from unsafe products, those standards do not override higher standards set by states. Anyone who suffers injury from an unsafe product should consult with a product liability attorney with significant experience advocating for consumer rights within state and federal courts.