Degelmann v. Advanced Medical Optics
In this case, a panel of the Ninth Circuit held that a “guidance document” issued by the Food and Drug Administration that states non-binding recommendations for contact lens solutions established “requirements” that preempt state-law claims brought by consumers against the manufacturer of a contact lens solution that was associated with a high rate of infection. In a petition for rehearing, the plaintiff asked the Court to reconsider whether an FDA guidance document establishes preemptive requirements within the meaning of the Medical Device Amendments’s preemption provision, 21 U.S.C. § 360k(a). Public Citizen filed an amicus brief in support of the petition for rehearing because it was concerned that the panel’s decision, holding that an FDA guidance document establishes “specific requirements” for the device at issue, misunderstood the nature of guidance documents issued by the FDA and, as a result, wrongly expanded the preemptive scope of the MDA. In response to the petition for rehearing, the court requested the views of the FDA about whether the preemptive effect of the guidance document. The day before the FDA’s brief was due, the parties settled the case. The Ninth Circuit then vacated the panel decision.