In light of the strong public interest in the availability and affordability of prescription medications, the extensive regulatory system of the United States Food and Drug Administration (FDA), and the avenues of recovery available to plaintiffs by claiming inadequate warning, mismanufacture, improper marketing, or misrepresenting information to the FDA, a broad grant of immunity from strict liability claims based on design defects is extended to FDA-approved prescription drugs in Utah.
The deceased's daughter brought the action charging that she shot and killed her mother as a result of ingesting the drug Halcion, a prescription drug manufactured by defendant manufacturer to treat insomnia. The daughter claimed that the manufacturer failed to adequately warn of adverse side effects, and the drug was defectively designed. She argued that whether a drug was "unavoidably unsafe" must be determined on a case-by-case basis, with a determination in each case of whether the specific drug's benefit exceeded its risk at the time it was distributed.
Did Utah adopt the "unavoidably unsafe products" exception to strict products liability?
The court concluded that a broad grant of immunity from strict liability claims based on design defects should be extended to FDA-approved prescription drugs in Utah. The public policy of supporting the research and development of new drugs required a holding that the FDA-approved prescription medication was an "unavoidably unsafe product." Therefore, manufacturers of those drugs would not be liable for a claim based on defective design.