United States: FDA Weighs In On Off-Label Use And Preemption

Last Updated: September 22 2017
Article by James Beck

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.

Id. at 991.

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 manufacturer generally may not deviate from those requirements without prior approval from FDA, regardless of the uses to which the component may be put by third parties. Because the component is subject to device-specific federal requirements, §360k(a) expressly preempts any state requirements "with respect to" the component that are "different from, or in addition to," those device-specific federal requirements.

Id. (emphasis added). Thus, all components of a pre-market approved device system are themselves PMA devices for preemption purposes, and that status doesn't change because of off-label use.

With respect to other components, if they are "not subject to device-specific federal requirements," then they are "outside the scope of §360k(a)," and claims limited to them "are not expressly preempted." Id. To the extent those components are §510k cleared, they "generally" (but apparently not necessarily always) not entitled to preemption. Id. at 7.

The fact that off-label use (which the FDA calls "unapproved use" in its letter) is possible for a device does not allow – let alone allow the common law to require – a manufacturer of a PMA device to change its design or labeling (read: warnings) or manufacturing processes without prior FDA approval:

As a general matter, the device-specific requirements that attach to a medical device through premarket approval apply even when the device is put to an unapproved use. Once a device receives premarket approval, the FDCA generally prohibits the manufacturer from making, without FDA permission, changes that would affect the safety or effectiveness of the device. . . . Those requirements apply irrespective of the use to which the device is ultimately put. The possibility that a physician may choose to use a device for an unapproved purpose − something the FDCA contemplates, see 21 U.S.C. §396 − does not authorize a manufacturer to vary the design, the manufacture, or (with limited exceptions) the labeling of the device in anticipation of that use. Such variation would violate federal law.

Id. (emphasis added). Thus, the general rule that alterations that significantly affect a device's "safety or effectiveness" require FDA preapproval exists "irrespective" of off-label use.

The FDA observed that "most" courts recognize that PMA imposes "requirements" – and therefore preemption – on medical devices "even when the device is put to an unapproved [off-label] use." Id. at 7-8 (citations omitted). The agency also recognized something this Blog has repeatedly pointed out, that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the case in which the United States Supreme Court recognized broad PMA preemption, itself involved an off-label use. FDA amicus br. at 8 ("Riegel itself involved an off-label use of the device in question"). The FDA advised that, "[s]imply put, once a device receives premarket approval, it remains subject to federal requirements for purposes of §360k(a) regardless of how it is used." Id.

Nor did it matter that the off-label use was only of a "component" rather than of an entire device system. The PMA "requirements" applicable to that component as a "device" "apply equally when third parties put the [component] to an unapproved use with components of another device" even if the other device is §510(k) cleared. Id.

Defendants generally may not deviate from the requirements imposed through premarket approval regardless of how the liner is used. Claims touching on those requirements therefore implicate §360k(a) even when a component of an approved device is put to the type of unapproved use here at issue.

Id.

Preemption of such claims is not only the law, but is good policy:

The conclusion that §360k(a) applies in this context also makes sense as a matter of policy. Congress entrusted FDA with determining which device designs should be approved for marketing, as well as how approved devices should be labeled to provide medical professionals with appropriate safety information. Section 360k(a) acknowledges FDA's judgment in this respect and prevents States from pursuing competing judgments that would impose different or additional requirements on approved devices. That provision also protects manufacturers that have complied with detailed federal requirements from being subjected to liability under state law for doing what federal law required. Manufacturers must generally adhere to the specifications established through premarket approval, even if healthcare practitioners subsequently exercise their judgment and employ the device for an unapproved use.

Id. at 9 (emphasis added). The FDA recognized the precedent cited at the beginning of this post – those cases criticizing Ramirez – as being "consistent" with the Agency's preemption analysis. Id.

Thus, the FDA advised that plaintiffs can't go after the recalled PMA component, but are limited to claims concerning the non-PMA components of the construct only. Id. at 10 ("§360k(a) requires a court to parse a plaintiff's claims to determine whether the state-law requirements that underlie them are indeed directed at the premarket-approved component"). "[A] component that did not receive premarket approval and is not otherwise subject to device-specific federal requirements" is not subject to express preemption under §360k(a). The FDA "t[oo]k[] no position" on whether such claims were actually alleged, although they conceivably could be. Id. at 12.

As for implied preemption, the FDA noted that "defendants did not raise implied preemption in their dispositive motions below, nor . . . in their original appellate briefing." FDA amicus br. at 13. Assuming that implied preemption was nonetheless at issue, the Agency confirmed:

[T]he existence of an express-preemption provision such as §360k(a) does not ordinarily alter the normal operation of implied-preemption principles. Accordingly, state-law medical-device claims that are not expressly preempted remain subject to challenge on implied preemption grounds

Id. (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001)).

The FDA then briefly explored what many courts (but not the FDA) have called the "narrow gap" between express and implied preemption in PMA cases. Implied preemption impacts two types of claims that are not expressly preempted: (1) "parallel" claims; and (2) claims concerning "generally applicable federal requirements that do not trigger the operation of §360(k)." FDA amicus br. at 14. Purportedly parallel claims are preempted when they "have features that intrude impermissibly on the operation or enforcement of the FDCA, as where they represent an attempt to enforce the federal scheme, rather than asserting independent state-law requirements." Id. As for "generally applicable" claims, "on a case-by-case basis," "divergent state requirements may stand as an obstacle to the operation or objectives of the federal scheme and may be impliedly preempted on that basis." Id. The FDA did not get any more specific than that as to implied preemption, noting instead that failure to report claims had been dismissed as inadequately pleaded, and therefore avoiding that issue. Id. at 14 n.7.

What takeaways can we, as defense counsel, extract from the FDA's filing? How about these:

  • Ramirez was wrongly decided. Off-label use does not affect the applicability of preemption at all. FDA amicus br. at 6-9.
  • PMA preemption applies to PMA components – period. Id. at 7-10.
  • "[T]he FDCA generally prohibits the manufacturer from making, without FDA permission, changes that would affect the safety or effectiveness of the device." Id. at 7. That should help with Mensing/Bartlett preemption.
  • Implied preemption operates independently of express preemption, so that manufacturers of devices not subject express preemption under §360k(a) can still assert implied preemption "on a case-by-case basis." Id. at 14. Also good for Mensing/Bartlett, particularly in the device context.
  • Ostensibly "parallel" claims are preempted where they "intrude impermissibly on the operation or enforcement of the FDCA." Id. The FDA likes Buckman.
  • No state generally bans off-label promotion, only the FDCA, so "promotion" based claims involving off-label use are likely to be impliedly preempted. In fact, we just saw another one of these the other day. See Markland v. Insys Therapeutics, Inc., 2017 WL 4102300, at *9 (M.D. Fla. Sept. 15, 2017).
  • The FDA twice carefully qualified its discussion of §510(k) devices, recognizing that express preemption could exist where such a device was "otherwise subject to device-specific federal requirements." FDA Amicus br. at 6, 12. Good for limiting Lohr "on a case-by-case" basis.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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