EDWARDS V. BASEL PHARMACEUTICALS case brief

EDWARDS V. BASEL PHARMACEUTICALS

• P’s husband used prescription nicotine patch and kept smoking, had a nicotine-induced heart attack and died

• court ruled that this is an exception to the learned intermediary rule because FDA required warning to be given directly to the patient.

• Manufacturer should have directly warned consumers that smoking while on the patch was bad.

• Court piggybacking on federal FDA rule.