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T.H. v. Novartis Pharmaceuticals Corporation

Filed 12/21/17 IN THE SUPREME COURT OF CALIFORNIA T.H., a Minor, etc., et al., ) ) Plaintiffs and Appellants, ) ) S233898 v. ) ) Ct.App. 4/1 D067839 NOVARTIS PHARMACEUTICALS ) CORPORATION, ) ) San Diego County Defendant and Respondent. ) Super. Ct. No. 37-2013-00070440- ) CU-MM-CTL ____________________________________) 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. (See Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65.) In this case, we examine whether — and if so, under what circumstances — a brand- name drug manufacturer may be sued under a theory of “warning label” liability when the warning label for its drug was alleged to be deficient, but the plaintiffs were injured by exposure to a generic bioequivalent drug bearing the brand-name drug’s warning label. Plaintiffs’ mother, J.H., was prescribed terbutaline, a generic form of the brand-name drug Brethine, to suppress premature labor during her pregnancy. Plaintiffs T.H. and C.H. were born full term, but were diagnosed with developmental delays at three years of age and autism by the time they turned five. Through their father as guardian ad litem, the minors allege that those responsible SEE CONCURRING AND DISSENTING OPINION 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. Federal law explicitly conveys to the brand-name manufacturer — and only that manufacturer — the responsibility to provide an adequate warning label for both generic terbutaline and its brand-name equivalent, Brethine. As explained in more detail below, only the brand-name drug manufacturer has unilateral authority to modify the drug’s label by adding to or strengthening a warning. Generic drug manufacturers are required to follow the brand-name manufacturer’s label to the letter. Accordingly, the manufacturer of Brethine controlled both the form and content of the terbutaline warning label. Plaintiffs brought suit against defendant Novartis Pharmaceuticals Corporation (Novartis), which manufactured Brethine until December 2001, and aaiPharma Inc. (aaiPharma), which purchased the rights to and manufactured Brethine thereafter — using the same label Novartis had used — when plaintiffs’ mother was prescribed the generic bioequivalent in 2007. Plaintiffs claim that Novartis 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 Novartis’s successor (aaiPharma) would not change or update Brethine’s deficient label; and that in reliance on the deficient warning label, plaintiffs’ mother was prescribed terbutaline, which adversely affected plaintiffs’ developing brains in utero. What Novartis asserts in response is that its duty to provide a safe and adequate warning label for Brethine …
Original document
Source: California Supreme Court