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June 2006, Issue 27
Colacicco v. Apotex, Inc. : Background
In Colacicco, the plaintiff’s wife allegedly was prescribed Paxil and instead took the generic version, paroxetine hydrochloride. Shortly thereafter, she allegedly committed suicide. See id. at *2. Plaintiff sued both Apotex, the manufacturer of the drug his wife actually took, and GSK, the manufacturer of Paxil. Plaintiff’s primary theory against GSK was that GSK should be held liable because the warnings on generic Paxil were identical to those on the name brand version. See id.
Both defendants contended, among other things, that plaintiff’s claim was barred because it is impliedly preempted by federal law and that neither owed plaintiff’s wife a duty of care.1 Id. at *3. In part, both defendants relied on the FDA Final Rule preamble to the 2006 labeling amendments2 to show that federal regulations preempt state tort claims for inadequate warnings.
In response to the defendants’ motions to dismiss, the court requested that the FDA file an amicus brief addressing several preemption-related issues. In its brief, the FDA urged three key points:
Because at the time of the decedent’s death, the FDA rejected claims that adult use of Selective Serotonin Reuptake Inhibitors (“SSRIs”) was associated with increased suicidality, any such warning would have been considered “false and misleading” and the drug would be considered misbranded.3 see id. at *8-9.
Allowing state tort law to impose additional burdens would frustrate the purpose of FDA regulations because it could lead to overwarning and chill the use of beneficial drugs. see id. at *9.
The 2006 Preamble reflects a statement of the FDA’s longstanding views on preemption and that the Food, Drug, and Cosmetic Act (“FDCA”) establishes both a “floor” and a “ceiling” for warnings and state tort law cannot require any further warnings. see id. at *10.