T.H. v. Novartis Pharmaceuticals Corporation

Supreme Court of California · 2017 · Torts

4 Cal. 5th 145 (2017)

Updated July 23, 2026

TortsNegligenceFailure to warnNegligent misrepresentationPrescription drugsdutyRowland factorsforeseeability

Facts

Plaintiffs alleged their mother was prescribed generic terbutaline in 2007 to suppress premature labor and that in utero exposure caused them severe neurological injuries, including autism and developmental delays. They alleged the warning label for Brethine, the brand-name equivalent, failed to warn of known or reasonably knowable risks to fetal brain development and falsely represented the drug as safe for that use. Under federal law, generic terbutaline had to use the same warning label as the brand-name drug, and only the brand-name manufacturer had unilateral authority to strengthen the warning. Novartis had manufactured Brethine and controlled its label until selling the NDA and rights in 2001, but plaintiffs alleged the deficient label remained in use after the transfer and caused their physician to prescribe terbutaline.

Issue

Does a brand-name drug manufacturer owe a duty of care for deficient warning labels to persons injured by the generic bioequivalent, even though the manufacturer did not make the generic drug? If so, does that duty and potential liability automatically end when the brand-name manufacturer transfers the NDA and ceases ownership of the drug before the plaintiff's exposure?

Rule

Under California law, a brand-name drug manufacturer owes a duty of reasonable care to ensure its warning label adequately warns of known or reasonably knowable risks, regardless of whether the injured person was dispensed the brand-name drug or its generic bioequivalent, because the generic label must match the brand-name label and the brand-name manufacturer controls that label. Liability for breach of that duty does not automatically terminate upon transfer of the NDA or sale of the drug rights if the plaintiff can allege that deficiencies existing before the transfer foreseeably and proximately caused the later physical injury.

🔒

See the holding & full analysis

Create a free KwikCourt account to unlock the rest of this brief — and practice the case.

The court's holding and reasoning
Doctrine tests, pitfalls & exam hypotheticals
10 practice questions + 4 AI-graded essays on this case

Free sample · practice this case

Test yourself

One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Sacramento, Dr. Elena Wu prescribed the brand-name anti-nausea drug Solmira to Dana Price during pregnancy, but Dana's insurer required the pharmacy to dispense the generic equivalent made by another company. The generic label was identical to the brand-name label because federal law required sameness, and only the brand-name manufacturer, Redwood Therapeutics, could unilaterally strengthen the warning. Dana's child later suffered a serious congenital neurological injury allegedly associated with a risk Redwood knew or should have known but omitted from the label.

Under California negligence principles as described by the majority, which is the strongest argument that Redwood owed a duty to the child?

Explanation. The majority held that a brand-name manufacturer owes a duty of reasonable care in warning about known or reasonably knowable risks even when the plaintiff was dispensed the generic bioequivalent. The key reasoning is that federal law requires the generic label to match the brand-name label, while only the brand-name manufacturer has unilateral authority to strengthen the warning. That makes harm to generic users foreseeable and closely connected to deficiencies in the brand-name label.