In Caplinger v. Medtronic, Inc., No. 12-cv-630, 2013 WL 453133 (W.D. Ok. Feb. 6, 2013), the district court rejected plaintiff’s argument that medical device claims premised on off-label promotion automatically escape express preemption under § 360k of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act.
In rejecting this argument, the Court held that the federal requirements imposed by the pre-market approval (PMA) process for Class III medical devices applied to the device, rather than to a particular use: “nothing in § 360k(a) suggests that the preemption analysis somehow depends on how the device is being promoted to be used.” 2013 WL 453133, at *10. The Court thus held that off-label promotion allegations are subject to preemption under the MDA. The Court then held that plaintiff’s off-label claims were impliedly preempted under Buckman because they did not validly “parallel” a state law claim and were “not genuinely equivalent” to the state law duty to provide adequate warnings. 2013 WL 453133, at *10 n.4. Rather, the Court stressed, “the concept of ‘off-label use’ is a creature of the FDCA, is defined by the FDCA, and is not a part of Oklahoma substantive law.” Id. at *11.
Courts are divided on this issue but Caplinger will be helpful precedent for medical device manufacturer defendants arguing preemption of off-label claims.