Warning Label Lawsuits
The seller of any product has a legal duty to warn consumers of any dangers associated with the use of the product. Of course, there is only a duty to warn of dangers that are known, or should be known, to the seller. There is generally no duty to warn of dangers that should be obvious to an ordinary consumer.
Prescription drugs are no exception; however, the law surrounding them is far more complicated than with other products, because of the involvement of the FDA (the Food and Drug Administration).
Prescription drugs in the U.S. undergo a lengthy approval process by the FDA. The FDA also approves warning labels that go onto drugs. Because most lawsuits about products liability are handled in state courts, and the FDA is a federal agency, there is a potential for conflict. Under the U.S. Constitution, if federal and state laws conflict, federal law takes precedence (known as the “preemption doctrine”).
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, that decision was based on a new (2006) FDA regulation, stating that they intended for their labeling regulations to preempt state law. Other recent cases have reached the opposite conclusion, finding that state law claims for failure to warn can go forward, and 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.
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Last Modified: 06-30-2009 03:31 PM PDT
