California Supreme Court to hear appeal of controversial drug liability case

By Brent Zell | Jun 23, 2016

SAN FRANCISCO – Imagine Taco Bell being sued by someone who got sick from eating food from Chipotle.

Kimberly Stone, president of the Civil Justice Association of California, used that example when describing T.H. vs. Novartis Pharmaceuticals Corp., a case up for appeal before the California Supreme Court.

The case is another battle in the ongoing fight in the state over what constitutes grounds for litigation in the drug industry, particularly when it comes to what a drug manufacturer is liable for.

The petition for review of the case by the state Supreme Court was filed April 19 and granted June 8. According to the case’s docket, the question to be argued before the court is:  “May the brand name manufacturer of a pharmaceutical drug that divested all ownership interest in the drug be held liable for injuries caused years later by another manufacturer's generic version of that drug?”

The case in question centered on an asthma drug taken by a woman who was pregnant with twins. According to, the plaintiffs’ mother was prescribed terbutaline – which was manufactured by Novartis until 2001 – to help her with uterine contractions and premature labor while she was pregnant in 2007. Both those uses were off-label. The twins were born with autism, and Novartis was sued instead of the company that made the drug the mother used with the allegation that the drug’s use caused the autism.

The case was dismissed in trial court, but that decision was overturned on appeal. According to a disposition in March from the state’s 4th Appellate District, the appeals court concluded that the complaint could be amended “for negligent failure to warn and negligent misrepresentation based on acts or omissions by Novartis prior to 2001.”

That was where Stone drew her example to the Mexican-food chain-restaurant industry.

“Can I sue Taco Bell when Chipotle made me sick? I didn’t eat the Taco Bell taco; I ate the Chipotle burrito. But Taco Bell existed before Chipotle, and Chipotle is copying Taco Bell,” she said.

In the 4th Appellate District disposition, that court used the case of Conte vs. Wyeth as a guidepost. The 2008 case in the state’s 1st District said that a brand-name drug maker should “shoulder its share of responsibility for injuries caused, at least in part by its negligent … dissemination of inaccurate information” – even though the patient in this case was affected allegedly by a generic version of the maker’s drug that was made by another company, according to

“In Conte vs. Wyeth, even though Wyeth did not make the product that the plaintiff took, which is generally a necessary requirement prior to a product-liability lawsuit, the court held that mere foreseeability was sufficient to create the duty that would allow a lawsuit to proceed,” Stone said.

The Wyeth case remains a standard in California, even though, as Michael F. Healy, a partner at Sedgwick LLP in San Francisco, wrote in 2011, more than 20 other states “have expressly rejected its holding.”

“Most of the other states have found a much-more traditional and common-sense ruling that product manufacturers have no duty to people who don’t buy their products,” Stone said. “In other words, no, you can’t sue Taco Bell when Chipotle made you sick.”

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California Supreme Court Civil Justice Association of California

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