Calif. Top Court to Mull Brand Liability for Generics

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By Julie A. Steinberg

June 14 — California's highest court will review whether Novartis Pharmaceuticals Corp. may be held liable for injuries allegedly caused by a generic version of a branded asthma drug it no longer owns ( T.H. v. Novartis Pharm. Corp., Cal., No. S233898, review granted 6/8/16 ).

At issue is a March appeals court decision allowing claims for failure-to-warn and misrepresentation, based on Novartis's alleged conduct before it sold the rights to the branded drug, Brethine (44 PSLR 318, 3/28/16).

California has been in the extreme minority in allowing plaintiffs who used generic drugs to sue makers of their branded counterparts.

The plaintiffs are twins whose mother was prescribed terbutaline, a generic version of Brethine, in 2007 during pregnancy. The children's autism was diagnosed when they were 3.

After Novartis sold the rights to Brethine in 2001, other companies began marketing terbutaline for the unapproved use of preventing preterm labor.

The plaintiffs contended Novartis had a duty, while it still owned the drug, to revise the label to indicate a risk to fetal development. They alleged its failure to do so contributed to their injuries years later.

The appeals court applied an earlier decision, Conte v. Wyeth Inc., 2008 BL 252980, 168 Cal.App.4th 89 (Cal. Ct. App. 2008)(36 PSLR 1140, 11/17/08). In that case, an appeals court said Wyeth, maker of Reglan, could be held liable to a plaintiff who used a generic version of its reflux drug.

The state's top court declined to review Conte.

Thorsnes Bartolotta McGuire represents the plaintiffs.

Hollingsworth LLP and Morrison & Foerster represent Novartis.

To contact the reporter on this story: Julie A. Steinberg in Washington at jsteinberg@bna.com

To contact the editors responsible for this story: Steven Patrick at spatrick@bna.com and Nicholas Datlowe at ndatlowe@bna.com