The Drug Price Competition and Patent Restoration Act of 1984, known as the Hatch-Waxman Amendments, allows manufacturers to begin developing generic versions of patented, brand-name pharmaceuticals while the patent terms are in force, and to bring those generic versions to market as soon as the patent terms expire. The generic versions are to mimic the brand-name drug in every respect; thus, they are produced at a significantly reduced cost, and those savings are passed on to generic drug consumers. Under federal regulations, a generic drug's label must also mimic that of the brand-name drug, and generic drug manufacturers may not change their label to warn of a newly discovered risk unless the brand-name manufacturer does so first. Under the constitutional doctrine of impossibility preemption, any state law that imposes requirements that would make it impossible for an actor to comply with both state and federal law is trumped, or preempted, by federal law.
Three decisions of the Supreme Court of the United States construe the relationship between state tort laws and federal drug labeling regulations. These decisions reveal a dichotomy that is stark, and frankly, quite absurd: alleged injuries that result from consumption of generic drugs are not subject to the same tort principles under state laws as those that result from consumption of brand-name drugs. Thus, generic drug consumers lack any legal remedy when injured as a result of their drugs' faulty labeling. This Comment argues that a two-part legislative solution will most effectively resolve this dichotomy. First, Congress can, and should, impose liability on generic manufacturers for faulty labeling (to which they are not currently subject). Second, Congress should provide generic drug manufacturers with the option to implead the brand-name manufacturer to most appropriately place liability on the responsible party
Getting Even Less than What They Paid for: The Plight of Generic Drug Consumers Under the Levine-Mensing Dichotomy,
U. Colo. L. Rev.
Available at: https://scholar.law.colorado.edu/lawreview/vol86/iss1/5