Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply Stengel v. Medtronic Inc., 704 F.3d 1224, 1228-31 (9th Cir. 2013) (en banc) – an even worse case (#2 on the same list) – Ramirez held, basically, that allegations of off-label use/promotion eliminated preemption altogether, even for Class III pre-market approved products.
When the device is not being used in the manner the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to pre-empt the application of state law designed to provide that protection.
Fortunately, Ramirez has proven to be an outlier, with numerous decisions, several even in the same District of Arizona, considering and rejecting Ramirez’s meat axe approach to preemption. See Angeles v. Medtronic, Inc., 863 N.W.2d 404, 413 (Minn. App. 2015) (“Ramirez has been rejected by most federal district courts that have reviewed this issue”); Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300, 314 (App. 2014) (“[w]e find the approach taken in Ramirez unpersuasive”), app. dismissed & opinion ordered published, 331 P.3d 178 (Cal. 2014); McCormick v. Medtronic, Inc., 101 A.3d 467, 486 n.13 (Md. App. 2014) (“Ramirez has been almost universally rejected”); Shuker v. Smith & Nephew PLC, 211 F. Supp.3d 695, 701 n.5 (E.D. Pa. 2016) (“this Court considered but declined to follow” Ramirez); Jones v. Medtronic, 89 F. Supp.3d 1035, 1051 (D. Ariz. 2015) (“this Court joins the majority of courts in rejecting Ramirez”); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619, 627 (W.D. Mich. 2015) (Ramirez “has been rejected by numerous district courts”); Wright v. Medtronic, Inc., 81 F. Supp.3d 600, 610-11 (W.D. Mich. 2015) (same as Thorn); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015) (“the Court disagrees with the reasoning in Ramirez”); Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *10 (E.D. Pa. March 31, 2015) (“the Ramirez decision has been widely criticized by other district courts reviewing allegations of off-label promotion of PMA-approved devices”); Arvizu v. Medtronic Inc., 41 F. Supp.3d 783, 790. Ariz. 2014) (“the Court finds the reasoning of [decisions rejecting Ramirez] to be more persuasive”); Martin v. Medtronic, Inc., 32 F.Supp.3d 1026, 1036 (D. Ariz. 2014) (“join[ing] the majority of other courts which have rejected Ramirez to the extent that it holds that the preemption analysis does not apply to claims based on off-label promotion”); Beavers-Gabriel v. Medtronic, Inc., 15 F.Supp.3d 1021, 1035 (D. Haw. 2014) (“however, Ramirez has been rejected − for good reason − by numerous courts”); Schouest v. Medtronic, Inc., 13 F. Supp.3d 692, 700 (S.D. Tex. 2014) (Ramirez “read Riegel too narrowly”); Scovil v. Medtronic, Inc., 995 F.Supp.2d 1082, 1096, n.12 (D. Ariz. 2014) (“respectfully disagree[ing] with [the] ruling in Ramirez”); Arthur v. Medtronic, Inc., 2014 WL 3894365, at *5 (E.D. Mo. Aug. 11, 2014) (Ramirez’s “reasoning has been rejected by several courts”); Brady v. Medtronic, Inc., 2014 WL 1377830, at *4 (S.D. Fla. April 8, 2014) (applying “the traditional preemption analysis to [plaintiff’s] off-label marketing claims” contrary to Ramirez); Houston v. Medtronic, Inc., 2014 WL 1364455, at *5 (C.D. Cal. April 2, 2014) (“the Ramirez holding is not consistent with the text of §360k(a), the scope of federal requirements imposed on Class III devices, or Ninth Circuit precedent”); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *4 (N.D. Ala. Oct. 31, 2013) (Ramirez is “inapposite” and “of no assistance” to plaintiff).
Now the FDA has jumped into the fray, and its view of preemption and allegations of off-label use is no more favorable to Ramirez – and to plaintiffs trying to oust preemption of PMA devices – than these judicial decisions. The sharpest-eyed of our readers may have noticed the two citations above to relatively recent district court opinions in a case called Shuker. It so happens that Shuker is currently on appeal, and following oral argument, the Third Circuit Court of Appeals invited the FDA to provide its views on the preemption question. Last week, the FDA did so. You can find a copy of the FDA’s amicus brief in Shuker here.
Apparently, in Shuker the plaintiffs allege that the defendant was somehow responsible for Mr. Shuker’s surgeon creating a hybrid hip prosthesis construct that included some components of a Class III PMA system and others belonging to a Class II system cleared under the FDA’s “substantial equivalence” (“§510k”) process. FDA amicus br. at 3-4. This hybrid construct was an off-label use. Id. at 4. Exactly how the individual Class III and Class II component used in the construct are alleged to have contributed to the plaintiffs’ injuries appears totally unclear, but we do know that the Class III component was later recalled. Id.
That causes the plaintiffs a big problem. On the one hand, they would love to smear the defendant with the recall, and wave it around like a bloody shirt. On the other hand, the Class III component – because it was PMA approved – brings the powerful preemption defense into play. So plaintiffs invoked off-label use to try to have their cake and eat it too.
The FDA did not agree.
Rather, the agency advised that “[t]he district court correctly held that §360k(a) applies to a component of a premarket-approved device even when the component is put to an unapproved use.” Id. at 6. First, the FDA clarified the status of device “components” under the FDCA::
The component of the premarket-approved device is itself a “device” under the FDCA, and FDA’s approval imposes device-specific requirements with respect to that component. The...
