This section contains the nature of the case and procedural background.

Ps' mother, J.H., was prescribed terbutaline, a generic form of the brand-name drug Brethine, to suppress premature labor during her pregnancy. T.H. and C.H. (Ps) were born full-term, but were diagnosed with developmental delays at three years of age and autism by the time they turned five. Ps allege that those responsible for the terbutaline label knew or should have known-based on studies of the drug's effects in rats and in humans-that the drug posed a serious risk to fetal brain development. They further allege that the drug's label unreasonably failed to include a warning about this risk. Ps sued Ds (Novartis, and aaiPharma). aaiPharma had purchased the rights to and manufactured Brethine using the same label Novartis had used-when Ps' mother was prescribed the generic bioequivalent. Ps claim that D knew or should have known that its warning label failed to alert pregnant women or their physicians to the risk Brethine posed to fetal brain development; that manufacturers of terbutaline were compelled by federal law to include Brethine's deficient label on their own products; that it was foreseeable D's successor (aaiPharma) would not change or update Brethine's deficient label; and that in reliance on the deficient warning label, Ps' mother was prescribed terbutaline, which adversely affected Ps' developing brains in utero. D contends that any such duty should not extend to those who were exposed to terbutaline after D ceased manufacturing Brethine and sold its rights in the drug to aaiPharma. D demurred as it has sold the right to aaiPharma and had stopped manufacturing Brethine. It was granted and Ps appealed. The appeals court reversed and D appealed.

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