St. Mary's Law Journal


Frank Scaglione


Although generic drugs are beneficial to consumers because they are offered as a more cost effective alternative to brand-name prescriptions, brand-name manufacturers are vulnerable to potential lawsuits because of generic drugs. Under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), generic manufacturers are able to quickly enter the market following the termination of a brand-name drug’s patent. As a result of the Hatch-Waxman Act, 75% of all drugs on the market are generic. The Hatch-Waxman Act, however, also requires generic drug manufacturers to duplicate the brand-name drug’s warning label. As an unintended consequence, injuries have resulted because of a generic drug’s defective warning labels. A majority and minority view concerning the issue of liability have emerged. Under the majority view, brand-name manufacturers cannot be held liable for harm caused because of the generic drug. The minority view, however, has justified holding brand-name manufacturers liable based on the theory that the generic prescription was done in reliance of the brand-name’s warning label.

More needs to be done to prevent brand-name manufacturers from being held liable for the harm caused by generic drugs. Although brand-name drugs can produce revenue in the millions during the patent’s term, this is necessary to offset the expenses of product testing. If brand-name manufacturers were required to consider potential liability because of generic drugs, the manufacturer may choose to leave the market. If drug manufacturers leave the market, the public will lose the potential benefit of the manufacturers’ research and innovation. Therefore, lawmakers must pass legislation that expressly preempts state tort law which may hold brand-name manufacturers liable, and remove the requirement that generic drug manufacturers must duplicate the brand-name drug’s warning label.


St. Mary's University School of Law