Preemption (pree-emp-Shen), n. The principle (derivedfrom the Supremacy Clause) that a federal law can supersede or supplant anyinconsistent state law or regulation.
In a very recent 6-3 decision, turning on federal preemption of state law, theSupreme Court held in Wyeth v. Levine that state law consumer safety tortclaims are not preempted by the Federal Drug Administration’s approval of awarning label for the drug and regulations prohibiting changing the label toconform with state law.
In Wyeth, a Vermont jury found that the petitioner, Wyeth, the manufacturer ofthe drug Phenergan, had failed to provide an adequate warning of the riskinjecting the drug via “I.V.-push method” and awarded damages to Diana Levineto compensate her for the infection, and subsequent amputation of her arm. Thejury determined that Levine’s injury would not have occurred if Phenergan’slabel included an adequate warning. Notably, the label clearly warnedpractitioners to use "extreme care" when injecting the drug andexplaining that resultant gangrene requiring amputation are likely” to occurwith the IV-push method.
Wyeth’s attorney’s argued that Levine’s failure-to-warn claims were preemptedby federal law. Phenergan’s labeling had been approved by the FDA. The SupremeCourt rejected Wyeth’s arguments, holding that the agency’s “changes beingeffected” (CBE) regulation permits certain pre-approval labeling changes thatadd or strengthen a warning to improve drug safety, and there was no evidenceto suggest the FDA would have denied Wyeth's request to include a strongerwarning label. The Court also held that requiring Wyeth to comply with astate-law duty to provide a stronger warning does not interfere with Congress’purpose of entrusting an expert agency with drug labeling decisions because thehistory of the FDCA shows that Congress did not intend to preempt state lawfailure-to-warn actions.
In his dissent, Justice Alito noted, “This case illustrates that tragic factsmake bad law.” The jury was presented with the injury to the Plaintiff and notthe benefits to the untold numbers of individuals helped by the drug. Accordingto Justice Alito, “the real issue is whether a state tort jury can countermandthe FDA’s considered judgment that Phenergan’s FDA-mandated warning labelrenders its intravenous (IV) use ‘safe.’” Justice Alito’s dissent urged thatthis case represents, at most, a medical-malpractice claim, and should not be a“’frontal assault’ on the FDA’s regulatory regime for drug labeling” upsetting“the well-settled meaning of the Supremacy Clause and conflict pre-emptionjurisprudence.”
Some see this case as representing a potential increase in products liabilitycases against drug manufacturers. Whereas previously manufacturers could sell adrug with FDA approval under the assumption that the approval provided themsome liability protection, this case has the effect of nullifying thisprotection. Others see this case as a “strategic loss” for the drug companies .However, a ruling by the Supreme Court giving drug companies federal immunityfrom suits under state laws could have provoked a drastic, and worse, responsefrom the Democrat-controlled Congress.
