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plaintiffnegligenceappeal
plaintiffnegligenceliabilityappealtrial

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T.H. v. Novartis Pharmaceuticals Corp., 4 Cal.5th 145, 407 P.3d 18, 226 Cal.Rptr.3d 336, Prod.Liab.Rep. (CCH) P 20,252, 17 Cal. Daily Op. Serv. 12,163, 2017 Daily Journal D.A.R. 12,115

Facts

The plaintiffs, T.H. and C.H., were born with developmental delays and autism after their mother was prescribed terbutaline, a generic version of the brand-name drug Brethine, to suppress premature labor. They alleged that Novartis, the manufacturer of Brethine, failed to provide adequate warnings about the risks of the drug to fetal brain development, despite knowing or having reason to know of these risks. The plaintiffs contended that the warning label for terbutaline was deficient and that Novartis's failure to update the label foreseeably caused their injuries.

Plaintiffs' mother, J.H., was prescribed terbutaline, a generic form of the brand-name drug Brethine, to suppress premature labor during her pregnancy.

Issue

Whether a brand-name drug manufacturer owes a duty to warn about the risks of its drug to individuals who were prescribed its generic equivalent.

Whether a brand-name drug manufacturer has the duty under state law to warn of the risks about which it knew or reasonably should have known, regardless of whether the consumer is prescribed the brand-name drug or its generic bioequivalent.

Rule

A brand-name drug manufacturer has a duty under state law to warn of the risks associated with its drug, regardless of whether the consumer is prescribed the brand-name drug or its generic bioequivalent.

Under California law, a brand-name drug manufacturer has a duty to warn of known or reasonably knowable adverse effects arising from an individual's use of its drug.

Analysis

The court determined that Novartis, as the brand-name manufacturer, had a legal obligation to ensure that the warning label for Brethine was adequate and that this duty extended to the users of its generic equivalent, terbutaline. The court found that the plaintiffs could allege that Novartis's failure to update the warning label foreseeably caused their injuries, and that the duty to warn did not terminate simply because Novartis sold its rights to the drug.

In our view, plaintiffs have indeed shown that they could allege a cause of action against Novartis for warning label liability.

Conclusion

The California Supreme Court affirmed the Court of Appeal's decision, allowing the plaintiffs to amend their claims for negligence and negligent misrepresentation against Novartis.

We therefore affirm the Court of Appeal, which had directed the trial court to enter an order sustaining Novartis's demurrer with leave to amend plaintiffs' negligence and negligent misrepresentation causes of action.

Who won?

The plaintiffs prevailed in the appeal, as the court ruled that they could proceed with their claims against Novartis based on the duty to warn.

The Court of Appeal reversed and directed that the order sustaining the demurrer be modified to grant plaintiffs leave to amend their causes of action for negligence and negligent misrepresentation.

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