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T.H. v. Novartis

T.H. v. Novartis

Ninety percent of the prescription drugs consumed in the United States are generic forms of brand-name drugs. But under U.S. Supreme Court case law, generic drug companies can’t be sued for failing to warn consumers of the dangers of their drug, no matter how inadequate the label may be. Public Justice was lead counsel before the California Supreme Court in a case filed against a brand name drug company on behalf of twins who were injured in utero by the generic version of the drug that their mother took to control preterm labor. The label of the drug failed to warn that the drug can cause fetal brain damage, and the question in the case is whether plaintiffs who are injured by a generic drug can sue the brand name drug company for negligently misrepresenting the dangers of the generic version of its drug. We argued that the brand name drug company may be held accountable under basic tort law principles, since it was entirely foreseeable to the company that the deficient label it wrote and had the power to change would cause injuries to consumers of the generic version of its drug.

On December 21, 2017, the California Supreme Court issued its decision holding (a) that brand-name manufacturer can be sued for negligently misrepresenting the dangers of generic drugs; and (b) that this duty extends to a former manufacturer who sold the rights to the brand before the plaintiffs were injured by a generic version of the drug. Writing for a unanimous Court on this point, Justice Cuellar held that, because generic manufacturers are “required to follow the brand-name manufacturer’s label to the letter,” a brand-name manufacturer “owes a duty of reasonable care in ensuring that the label includes appropriate warnings, regardless of whether the end user has been dispensed the brand-name drug or the its generic equivalent.” Read more about the ruling and its implications here.

  • Leslie Brueckner
  • Benjamin Siminou

Case Documents