T.H v. Novartis Pharmaceuticals
Annotate this CaseThis suit was brought on behalf of twin minors. They alleged Novartis Pharmaceuticals Corporation knew or should have known physicians prescribed its asthma medication to pregnant women for the off-label purpose of preventing or inhibiting preterm labor. They alleged studies available to Novartis before it sold the rights to its brand-name product in 2001 showed the drug was not effective for tocolysis (inhibiting preterm labor), it could cross the placenta, and it could interfere with fetal development. The twins allegedly sustained neurological injuries in utero as a result of their mother having been prescribed the medication. The minors contended on appeal to the Court of Appeal that despite Novartis having sold its interested in the medication six years after the medication was prescribed, Novartis had a duty to revise the label warnings while it still owned the drug to indicate a risk to fetal development and its failure to do so contributed to their injuries years later. The Court of Appeal concluded the minors demonstrated the could amend their complaint to state a claim under California law for negligent failure to warn and negligent misrepresentation based on acts or omissions by Novartis prior to 2001, which allegedly caused the twins' injuries in 2007. The Court reversed the trial court which held to the contrary and remanded for further proceedings.
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