T.H. v. Novartis Pharm. Corp.

199 Cal. Rptr. 3d 768, 245 Cal. App. 4th 589, 2016 Cal. App. LEXIS 179
CourtCalifornia Court of Appeal, 4th District
DecidedMarch 9, 2016
DocketD067839
StatusPublished
Cited by1 cases

This text of 199 Cal. Rptr. 3d 768 (T.H. v. Novartis Pharm. Corp.) is published on Counsel Stack Legal Research, covering California Court of Appeal, 4th District primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
T.H. v. Novartis Pharm. Corp., 199 Cal. Rptr. 3d 768, 245 Cal. App. 4th 589, 2016 Cal. App. LEXIS 179 (Cal. Ct. App. 2016).

Opinion

McCONNELL, P.J.

INTRODUCTION

*594May Novartis Pharmaceuticals Corporation (Novartis), a former manufacturer of a brand-name asthma medication, be liable in negligence for neurological injuries allegedly sustained by twin minors in utero after their mother was prescribed and consumed a generic form of the medication nearly six years after Novartis sold its interests in the medication?

The minors allege Novartis 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 allege 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 minors more clearly contend on appeal 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.

We conclude the minors have demonstrated they can 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 or contributed to the minors' injuries in 2007. In reaching our conclusion, we follow the rationale of Conte v. Wyeth, Inc. (2008) 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299 (Conte ), which applied common law principles of duty and foreseeability to conclude a brand-name pharmaceutical manufacturer should "shoulder its share of responsibility for injuries caused, at least in part by its negligent ... dissemination of inaccurate information" even though the patient consumed a generic version of the medication manufactured by another company. (Id. at pp. 103, 109-110, 85 Cal.Rptr.3d 299.)

*595We reject Novartis's invitation to follow other state authorities, which have held a brand-name manufacturer cannot be held liable under any theory for an injury caused by a product other than its own. We also reject Novartis's contention Conte is no longer viable after the Supreme Court decision in O'Neil v. Crane Co. (2012) 53 Cal.4th 335, 342, 135 Cal.Rptr.3d 288, 266 P.3d 987 (O'Neil ), which held a pipe and valve manufacturer may not be held liable in strict liability or negligence for harm caused by separate products manufactured by other companies, even if those products were used in conjunction with the pipes and valves. The O'Neil court did not mention, let alone overrule Conte,supra, 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299, and, even if a product liability analysis could apply, the facts alleged in this case fall within an exception recognized by the Supreme Court for harm to which the defendant's product substantially contributed. We reverse and remand with directions for the trial court to enter a new order sustaining the demurrer with leave to amend the negligence and negligent misrepresentation causes of action.

*771FACTUAL AND PROCEDURAL BACKGROUND1

A

Terbutaline sulfate (terbutaline ) was originally developed and released for use as a bronchodilator in the 1970s. It is a beta-agonist or beta-mimetic drug designed to act upon the beta-2 receptors located in smooth muscle tissue to cause muscles to relax. The United States Food and Drug Administration (FDA) approved the use of terbutaline for the treatment of asthma in 1974. Novartis subsequently obtained a license to manufacture and market the oral form of terbutaline under the trade name Brethine and it owned the new drug application (NDA) for this brand-name drug until 2001.

Drug manufacturers allegedly perceived an opportunity to market terbutaline as a tocolytic to relax uterine smooth muscle tissue to prevent or inhibit preterm labor. A 1976 study by a Swedish physician, allegedly with ties to the original drug manufacturer, published results of a study of 30 women indicating terbutaline was safe and effective for acute (24-48 hours) and maintenance (after 48 hours) tocolysis. The original manufacturer allegedly promoted terbutaline as a tocolytic and its use for this purpose gained wide acceptance. However, neither the original manufacturer nor any of its successors or licensees sought FDA approval for the use of terbutaline as a tocolytic.

*596B

Studies began to question the safety and efficacy of using terbutaline as a tocolytic. In 1978, a study published in the British Journal of Obstetrics and Gynecology by researchers from Johns Hopkins School of Public Health questioned the validity of the Swedish report stating "relevant information about the effect of drugs on the mother and infant was too scanty to make conclusions about side effects possible." It noted "[d]ata from other sources show that labor inhibitors are potentially dangerous" and "may unfavorably alter the fetal, placental, or maternal circulation." The study indicated, "the role of drugs aimed at preventing or delaying premature birth is not yet established, and further good clinical trials are urgently needed." The following year, the FDA ordered discontinuation of protocols for intravenous terbutaline use. A study in the Journal of Obstetrics and Gynecology reported pregnant patients who received acute tocolysis experienced pulmonary edema and congestive heart failure and several neonatal complications were reported including "hypoglycemia, hypotension, hypocalcemia, and death."

In 1982, military clinical investigators found the Swedish study could not be replicated. When they compared patients who had been given terbutaline for tocolytic therapy with patients given a placebo they found "[n]o significant difference in prolongation of pregnancy, birth weight, development of [respiratory distress syndrome ], or infant survival." A 1984 study from the University of Southern California found similar results.

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Cite This Page — Counsel Stack

Bluebook (online)
199 Cal. Rptr. 3d 768, 245 Cal. App. 4th 589, 2016 Cal. App. LEXIS 179, Counsel Stack Legal Research, https://law.counselstack.com/opinion/th-v-novartis-pharm-corp-calctapp4d-2016.