The U.S. Supreme Court case PLIVA, Inc., et al., v. Gladys Mensing in 2010 revolved around the issue of whether generic drug manufacturers could be held liable for not adequately labeling their products with safety warnings, even though federal law requires them to use the same labels as their brand-name equivalents. Gladys Mensing had taken a generic version of a medication and suffered severe side effects which she claimed were not sufficiently warned about on the label. The court ruled in favor of PLIVA and other petitioners (generic drug manufacturers), stating that they cannot independently change their labels from those approved by the FDA for brand-name drugs; hence they couldn't be sued under state laws requiring different or additional warning information than what was federally mandated.

In the dissenting opinion for PLIVA, Inc., et al. v. Gladys Mensing, Justice Sotomayor argued that federal law does not prevent generic drug manufacturers from updating their labels to include new safety information and thus they should be held accountable for failing to do so. She contended that the majority's decision was based on an incorrect understanding of federal drug regulations and would leave consumers without any legal recourse if they were harmed by inadequate warnings on generic drugs. The justice also expressed concern about creating a two-tiered system where brand-name drug users could sue for inadequate warnings but generic drug users could not, despite both groups being equally deserving of protection under the law.