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# Reject ‘Innovator Theory of Liability’: WLF
- URL: https://www.fdaweb.com/reject-innovator-theory-of-liability-wlf/
- Published: 2016-12-15T12:00:00.000Z
- Updated: 2026-09-14T21:55:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137584

The Washington Legal Foundation (WLF) is asking the California Supreme Court to reject a lower state court’s finding that Novartis could be held liable for injuries suffered by twins in utero after their mother took a generic version of an asthma medication (terbutaline) made by another company. A WLF *amicus* [brief](http://www.wlf.org/upload/litigation/briefs/WLFBriefNovartis.pdf?ref=fdaweb.com) says the lower court ruled despite the fact that Novartis manufactured only the branded version of the drug, the company had divested itself of the branded drug six years before the generic medicine was taken in this case, and Novartis had developed the drug to treat a condition other than the off-label use of delaying pre-term labor for which it was prescribed in this case.

“The lower court startlingly embraced a little-known doctrine of ‘innovator liability’ by concluding that plaintiffs could state failure-to-warn and misrepresentation claims against Novartis for injuries stemming from drugs that Novartis did not sell and no longer makes,” the advocacy organization said in a media [statement](http://wlf.org/litigating/case%5Fdetail.asp?id=882&ref=fdaweb.com).

The brief says that a ruling in favor of the company would not leave injured consumers without legal recourse. And it says that preempting state tort liability is necessary to accomplish Congress’ policy objectives that are in federal law. “State courts are in no position to reevaluate and balance the various conflicting concerns that drove Congress to the carefully calibrated liability regime that it has created for generic and branded drug manufacturers,” WLF says.