Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms
Case Against Zantac Marketer Could Strike Out On Faulty Research Behind Carcinogen Claim
Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.
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Review makes clear FDA’s thinking on safety acetaminophen use during pregnancy, but likely won’t sway federal judge from her conclusion that a warning about risks of in utero exposure could be added to drug containing the ingredient and available under an OTC monograph without violating FDA regulations.
Ruling on pre-trial motion in complaint against a Kenvue business in District Court for Southern New York is first in litigation alleging damages from using OTC monograph drug to find against federal preemption of state consumer protection laws and similar regulations.
Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.