Dowhal v. SmithKline Beecham Consumer Healthcare
California Supreme Court
88 P.3d 1 (2004)
- Written by Mary Phelan D'Isa, JD
Facts
Paul Dowhal (plaintiff), acting on behalf of the public, filed an action against manufacturers of over-the-counter nicotine replacement therapy (NRT) products for their failure to place health warnings mandated by California’s Proposition 65. Proposition 65 required a warning to the effect that nicotine is known to cause birth defects or other reproductive harm. The Food and Drug Administration (FDA) at the time required NRT manufacturers to include the warning that nicotine can increase your baby’s heart rate. While the case was pending, the FDA approved another NRT manufacturer’s proposed warning—just for that manufacturer—that nicotine whether from smoking or medication, can harm your baby. The trial court found that the federal law preempted the state law and granted summary judgment for the manufacturers. The court of appeal reversed, and the manufacturers appealed. While the appeal was pending, the FDA proposed that all NRT products contain a uniform pregnancy warning: “If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.”
Rule of Law
Issue
Holding and Reasoning (Kennard, C.J.)
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