Manufacturers and suppliers are legally required to place clear and complete warnings of dangers that may not be immediately apparent to the consumer on their products. On the other hand, manufacturers and suppliers have no duty to warn of dangers that a reasonable user should anticipate (e.g. knives are sharp).

Inadequate warnings are actually considered a type of design defect and expose manufacturers and suppliers to product liability. A warning label will be deemed inadequate for the following reasons:

  • The warning fails to specify the risks that the product presents
  • The warning is inconsistent with the product’s purported use 
  • The warning fails to provide adequate reasons for the warning

Are There Special Rules Regarding Food Labeling?

The U.S. Food and Drug Administration (FDA) has the authority to regulate how food is labeled, both in terms of the composition of the food and the authenticity of any purported health benefits. Thus, inadequate or inaccurate labeling on food products exposes manufacturers and suppliers to government sanctions in addition to product liability.

Additional concerns regarding food labeling:

  • Accuracy of nutritional information
  • Accuracy concerning the grade or quality of the product
  • Accuracy of expiration dates

Are There Special Rules Regarding the Labeling of Prescription Drugs?

Prescription drugs in the U.S. undergo a lengthy approval process by the FDA. The FDA also approves the warning labels that go onto drugs. This creates the potential for conflict between state courts, which handle products liability suits, and the FDA, which is a branch of the federal government.

Under the “preemption doctrine” of the U.S. Constitution, if federal and state laws conflict, federal law takes precedence. Thus, a state court is not entitled to rule that a federally approved warning label is inadequate. A recent federal case held that if a warning is approved by the FDA, a claim under state law for failure to warn cannot go forward, under the preemption doctrine.

However, other recent cases have reached the opposite conclusion, permitting state law claims for inadequate labeling to move forward and holding that state law is not preempted by a federal regulation. These conflicting judgments are likely to continue for some time, until Congress or the Supreme Court clarifies when lawsuits over warning labels approved by the FDA can succeed.

Seeking Legal Help

If you have been injured as a result of a company’s failure to place an appropriate warning on a prescription medication, food product, or other consumer product you should speak with an attorney concerning your legal remedies. An experienced personal injury attorney can help you understand your rights and, if necessary, can bring a legal action on your behalf.