In a recent SCOTUS ruling, the high court decided 6-3 (Alito, Roberts, Scalia dissenting) that pharma companies which rely on the FDA approval of their drugs’ dosing and administrations cannot pre-empt state laws if significant adverse effects are encountered.  In Wyeth v. Levine, Diana Levine sued the drug manufacturer Wyeth under Vermont state law for inadequate drug labeling which resulted in her developing gangrene and her arm being amputated. Wyeth makes the drug Phenergan for the treatment of nausea. It is administered by injection into a vein. If injected into a patient’s artery instead of a vein it causes irreversible gangrene. There are two methods for injecting the drug into a vein, one of which is significantly more likely to result in accidental contamination of an artery. Wyeth was aware of this danger. The decision essentially serves as a warning to pharma companies who consider FDA approvals as de facto rules on their products, regardless of the necessity to comply with individual states’ laws. | LINK

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