California Court of Appeals Rules Plaintiffs Can Pursue Claims Against Novartis for Alleged Damages Arising From Ingestion of Generic Drug Six Years After Novartis Divested its Interest
On March 9, 2016, the California Court of Appeals ruled that the plaintiffs’ claims of failure to warn and misrepresentation against Novartis were legally viable. The critical dispute raised by Novartis was that it did not manufacture the prescription medication that allegedly harmed the plaintiffs.
In T. H. v. Novartis Pharms. Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Ct. App. Mar. 9, 2016), two minor plaintiffs alleged that Novartis was liable for neurological injuries they sustained in utero after their mother was prescribed, and consumed, a generic form of Brethine (terbutaline) to control pre-term labor in 2007. Six years earlier, Novartis had sold its interest in the medication. Novartis filed a demurrer, arguing that it owed no duty to the plaintiffs because it did not manufacture the medication consumed by their mother, and had no responsibility for the label or prescribing information in 2007. The plaintiffs opposed the demurrer, and argued that Novartis owed a duty of care to potential patients while it owned and manufactured terbutaline to adequately warn physicians and their pregnant patients that the drug was not effective for tocolysis, nor safe for unborn children. The plaintiffs further argued that their mother’s physician would likely not have prescribed terbutaline in 2007 if Novartis had not encouraged off label use as a tocolytic, and that the warnings by Novartis in 2001 were inadequate. The trial court sustained Novartis’ demurrer, ruling that Novartis owed no duty as a matter of law for claims that arose in 2007.
In overruling the trial court and holding that the plaintiffs were able to state a claim under theories of negligence and negligent misrepresentation, the appeals court relied upon Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 85 Cal. Rptr. 3d 299 (2008), in which the California appeals court held that a brand name drug manufacturer can be held liable for injuries caused, at least in part, by its negligent dissemination of inaccurate information, even when the patient consumed a generic version of the medication manufactured by another company.
The FDA initially approved the use of terbutaline for the treatment of asthma in 1974. In 1976, a Swedish physician who allegedly had ties to the original drug manufacturer (not Novartis), published results of a study which indicated terbutaline was safe and effective for acute and maintenance tocolysis. The original manufacturer allegedly promoted terbutaline as a tocolytic, and its use gained wide acceptance according to the court. However, the court also noted that neither the original manufacturer nor any of its successors, including Novartis, ever sought FDA approval of terbutaline as a tocolytic. Subsequent studies raised questions about the safety and efficacy of terbutaline as a tocolytic, and by 1997, the FDA issued a letter expressing its concerns about the use of terbutaline as a tocolytic agent, and adopted a 1995 warning issued by ACOG. The court further noted that in 2000, the United States Department of Health and Human Services concluded that there was no benefit to using tocolytic treatment for maintenance therapy, and in 2001, a study reported that children exposed to tocolytic treatment had impairment in motor, socio-emotional, and cognitive development.
In making its ruling, the appeals court noted that while Novartis did not own the drug in 2007, it did own the NDA until 2001 and was responsible for the label’s information. While most jurisdictions do not apply “innovator liability” and bar claims by plaintiffs where they did not use a manufacturers product, there are some that do which requires brand-name manufacturers to be prepared to defend such lawsuits.