For over fifty years, the BBC has been chronicling the exploits of that ultimate learned intermediary, Dr. Who. Over the decades, successive Doctors have crossed swords (or sonic screwdrivers) with a wide variety of enemies, from the Master, through Daleks, Cybermen, Zygons, and Mara. But for us, there is no more terrifying foe than the Vashta Nerada. In the episodes “Silence in the Library” and “Forest of the Dead,” these microscopic piranha of the air lurk in the shadows until swarming around their next victim, whom they reduce to skeletal leftovers in seconds. Shortly before the end, those selected for consumption by the Vashta Nerada take on an unusual characteristic – they have two shadows.
Which is similar to how we see Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (“Lohr”). We think that decision is close to the end – in Gallifreyan terms, it has two shadows.
Bexis still remembers when Lohr came down, like it was yesterday. Just a few months before, in the Bone Screw litigation (involving Class II devices), the defendants had won an order holding that probably 85% of the plaintiffs’ allegations were preempted. See In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 221784 (E.D. Pa. April 8, 1996) (interestingly, this decision doesn’t have a red flag, although it should). Bexis had also written an amicus curiae brief in Lohr that articulated the defense position on negligence per se issues (available at 1996 WL 109632). Lohr said good-bye to all that. The section of Lohr concerning what has become the so-called “parallel claims” exception to preemption was 9-0 (in other words, Bexis got skunked). The rest of Lohr, concerning preemption of design and warning claims, was ostensibly 5-4, although Justice Breyer’s concurrence (necessary to make a majority) wasn’t exactly on all fours as to the reasoning.
It’s been over 20 years since Lohr, and that decision hasn’t aged well. We discuss why in this post.
The key to Lohr’s reasoning – particularly in light of the subsequent decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) – is its distinguishing of the FDA pre-market approval (“PMA”) process from the “expedited” §510(k) clearance that the device before the Court had undergone in 1982. 518 U.S. at 480. Pre-market approval was “rigorous” safety review:
Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this “reasonable assurance,” which is known as the “premarket approval,” or “PMA” process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews.
Id. at 477 (emphasis added).
By contrast, “substantial equivalence” clearance for marketing and labeling did not (according to the lead Lohr opinion) impose the same standard as PMA. Section 510(k) – codified as 21 U.S.C. §360(k) and following the FDA procedure detailed in §360c(i) – was viewed as a “grandfathering provision which allows pre-1976 devices to remain on the market without FDA approval.” Lohr, 518 U.S. at 478. It “permits devices that are ‘substantially equivalent’ to pre-existing devices to avoid the PMA process.” Id. A majority in Lohr held that “[t]he § 510(k) notification process is by no means comparable to the PMA process.” Id. at 475-79.
In Lohr, the Court held that preemption under 21 U.S.C. §360k “does not occur in a contextual vacuum. Rather, that interpretation is informed by two presumptions about the nature of pre-emption.” Id. at 485. The “first” and most important of these presumptions in Lohr was:
In all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, . . . we use a “presumption against the pre-emption of state police power regulations” to support a narrow interpretation of such an express command.
Id. (citations and quotation marks omitted) (emphasis added). The second presumption was even more extra-textual – that the Court looks “not only in the [statutory] text,” but also to “the structure and purpose of the statute as a whole” in evaluating congressional “purpose.” Id. at 485-86.
By then, it was clear where Lohr was going. The majority construed the language of §360k(a) “narrowly,” and when that was not enough, it looked to its gestalt conception of the overall purpose of the FDCA, again in preference to the language Congress actually drafted in §360k(a).
Looking at the entire statute, the Lohr lead opinion found no private FDCA cause of action. 518 U.S. at 487. It declared the argument “implausible” that “Congress would have barred most, if not all, relief for persons injured by defective medical devices,” even though that result was what a literal reading of “different from or in addition to” would produce. Id. To avoid that result, it decided:
- “[R]equirement,” as used in §360k(a) should not be given “its widest reasonable meaning” because of the potentially “broad” “scope of the preclusion that would occur.” Id. at 488-89. Instead, the lead Lohr opinion held that preemption “was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions.” Id. at 489. This result could be inferred from silence in the legislative history. Id. at 491.
- Nothing in the “the statutory scheme or the legislative history” – in other words, still more silence – suggested that §510(k) “was intended to do anything other than maintain the status quo,” which included “common-law tort suits,” so the express preemption language could not be taken “literal[ly].” Id. at 494-95.
- A parallel violation claim can “be ‘different from’ the [FDA] rules in a literal sense,” but still escape preemption because it is “narrower” than an FDA requirement, “not broader,” by adding a requirement of negligence. Id. at 495.
- “The presence of a damages remedy does not amount to the additional or different ‘requirement’ that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply” with FDA requirements. Id.
- An FDA regulation, 21 C.F.R. §808.1(d), “interpret[ed] the scope of § 360k’s pre-emptive effect,” and disclaimed preemption of “general” state-law requirements, requiring instead “specific counterpart regulations. Id. at 496-97. Lohr gave that regulation “substantial weight” in its preemption analysis. Id. at 496.
- “[P]re-emption [can] occur only where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be ‘with respect to’ medical devices and ‘different from, or in addition to,’ federal requirements.” Id. at 500.
- FDA “regulations provide that state requirements of ‘general applicability’ are not pre-empted except where they have ‘the effect of establishing a substantive requirement for a specific device.’ Moreover, federal requirements must be ‘applicable to the device’ in question, and, according to the regulations, pre-empt state law only if they are ‘specific counterpart regulations’ or ‘specific’ to a “particular device.’” Id.
As to the particular tort claims brought by the plaintiffs in Lohr, the lead opinion further discounted the scope of the substantial equivalence in §510(k), holding that “[t]he 510(k) process is focused on equivalence, not safety,” and “provide[s] little protection to the public.” Id. at 493 (citation and quotation marks omitted) (emphasis original). Lohr took the position that this process “did nothing more than compare one device to another, already marketed device, requiring only compliance with ‘general standards,’ the lowest level of protection.” Id.
Further, substantial equivalence review “did not ‘require’” the design of the product “to take any particular form for any particular reason.” Id. at 493. Nor were any “labeling and manufacturing requirements” of §510(k) “‘applicable to the device’ in question” because they were “entirely generic” and were “applicable to a host of different devices.” Id. at 498-99 (once again relying on 21 C.F.R. §808.1(d)). “General” state-law product liability claims “are no more a threat to federal requirements than” “fire prevention requirements” or “zoning codes.” Id. at 501.
Therefore, “few, if any, common-law duties have been pre-empted by this statute.” Id. at 502. Even then, to find preemption would “require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement.” Id. at 500.
From the outset uncertainty reigned as to Lohr. Four justices dissented from the entire rationale that departed from the text of §360k(a), and from the ensuing result, except as to design and violation claims. Lohr, 518 U.S. at 509, 513 (dissenting opinion). Justice Breyer’s concurring opinion, necessary to make a majority as to most parts of the opinion, expressly disagreed “that future incidents of MDA pre-emption of common-law claims will be ‘few’ or ‘rare.’” Id. at 508. Justice Breyer based his result largely on the FDA’s regulation restricting the scope of the statute’s preemptive effect. Id. at 505-06.
What happened “next” had actually happened before Lohr, but had not been relevant to Lohr’s 1982-cleared device. In response to precisely the sort of lack-of-safety-review criticism of the original §510(k) process, as had been leveled by the lead Lohr opinion, Congress rewrote that part of the FDCA in 1990 in what is called the “Safe Medical Devices Act” (“SMDA”). Lohr mentioned the SMDA in a footnote that addressed none of its implications. See 518 U.S. at 480 n.4. Here’s the SMDA’s statutory gobbledygook: PL 101-629, November 28, 1990, 104 Stat 4511. After 1990, the new version of §360c(f) read, in pertinent part:
(f) Initial classification and reclassification of certain devices
(1) Any device intended for human use . . . is classified in class III unless–
(A) the device . . . (ii) is substantially equivalent to another device within such type. . . .
(2)(A)(i) Any person who submits a report under section 360(k) [that’s §510k] for a type of device. . . .
(v) . . . may recommend . . . classification in class II, include in the request an initial draft proposal for applicable special controls . . . that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.
(Emphasis original). Thus, the SMDA extended to §510(k) substantial equivalence the same “reasonable assurance of safety and effectiveness” standard that Lohr described as “rigorous” in connection with premarket approval. 518 U.S. at 477.
In the SMDA, all “Class II” devices – the classification for the vast majority of §510(k) devices − were expressly made subject to this “reasonable assurance” standard. To meet this standard, the SMDA also authorized the FDA to impose a wide variety of device specific “special controls”:
(B) Class II, special controls–
A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines . . ., recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.
21 U.S.C. §360c(a)(1)(B) (emphasis added).
The SMDA also revamped the substantial equivalence process itself, expanding 21 U.S.C. §360c(i), defining “substantial equivalence,” so that “safety and equivalence” became an express part of this process. This statutory section is really long and complex, so here are the most relevant excerpts:
- Any “different technological characteristics” in a device “demonstrate[ed]” to be “as safe and effective as a legally marketed device,” by “appropriate clinical or scientific data if deemed necessary by the Secretary” “do not raise different questions of safety and effectiveness than the predicate device.” §360c(i)(1)(A)(ii).
- “[A] submission under section 360(k) of this title . . . shall provide an adequate summary of any information respecting safety and effectiveness.” §360c(i)(3)(A).
See generally Hall & Mercer, Rethinking Lohr: Does “SE” Mean Safe and Effective, Substantially Equivalent, or Both?, 13 MINN. J.L. SCI. & TECH. 737, 747-50 (2012) (discussing SMDA).
Thus, at the time Lohr was decided, the SMDA had already rectified most of the lead opinion’s criticism of the earlier §510(k) process – (1) upgrading the regulatory review standard to the “reasonable assurance of safety and equivalence” level that Lohr praised as “rigorous,” (2) imposing on the FDA the duty to evaluate “safety and effectiveness” in its §510(k) evaluations, and (3) providing the Agency with discretionary authority to issue various types of device-specific “special controls.”
The Supreme Court began receding from Lohr in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), albeit under an implied preemption rationale. Buckman also involved §510(k)-cleared devices, as to which the FDA is “empowered to require additional necessary information” to facilitate the agency’s substantial equivalence determinations. Id. at 348 (citing 21 C.F.R. §870.87(l)). In Buckman a unanimous Court limited Lohr on two fronts. First, the Lohr presumption against preemption was avoided because the “dealings with the FDA,” that were central to the plaintiffs’ fraud and violation claims were “inherently federal in character,” so that “no presumption against pre-emption obtains.” Id. at 348. Second, Buckman used implied preemption to prune the Lohr’s parallel violation claim rationale considerably. Another provision of the FDCA, that Lohr’s gestalt analysis of FDCA purpose had somehow overlooked, established the express intent of Congress to preclude private enforcement of the FDCA by plaintiffs alleging violation claims. “[W]e have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a).” Id. at 352.
[T]he [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim. . . . “[F]raud-on-the-agency claims . . . would not be relying on traditional state tort law [but] . . . [o]n the contrary, the existence of these federal enactments is a critical element in their case.
Id. at 352-53 (emphasis added). Thus, violation claims can’t be “solely” based on FDCA infractions, but must “parallel” existing state tort law. Preemption precludes purported state-law claims that depend on a “federal enactment” as a “critical element” of a private plaintiff’s case.
The Court returned to express preemption in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Further undercutting Lohr, a 7-2 majority dispensed with any presumption against preemption (only the dissent mentioned it, id. at 334). Riegel viewed Lohr as “disclaim[ing] a conclusion that general federal requirements could never pre-empt” and holding only “that no pre-emption occurred in the case at hand based on a careful comparison between the state and federal duties at issue.” Id. at 322. The majority in Riegel thus converted what Lohr had observed about the “rigor” of FDA premarket review into a preemptive holding. The FDA “grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Id. at 318.
[P]remarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review − it is federal safety review. Thus, the attributes that Lohr found lacking in §510(k) review are present here. . . . [P]remarket approval is focused on safety, not equivalence. While devices that enter the market through §510(k) have “never been formally reviewed under the MDA for safety or efficacy,” the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness, §360e(d). And while the FDA does not “‘require’” that a device allowed to enter the market as a substantial equivalent “take any particular form for any particular reason,” the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.
Id. at 323 (Lohr citations omitted) (most emphasis added).
Unrestricted by artificial presumptions, Riegel further rejected Lohr’s crabbed view of “requirements” in §360k(a) – “adher[ing] to the dissent in Lohr, and observing that “[i]n interpreting two other statutes we have likewise held that a provision pre-empting state ‘requirements’ pre-empted common-law duties.” 552 U.S. at 324 (citations omitted). From then on, a statutory “reference to a State’s ‘requirements’ includes its common-law duties.” Id. When plaintiffs raised 21 C.F.R. §808.1(d), to which Lohr’s lead opinion and Justice Breyer’s concurrence had deferred, the Riegel majority gave that regulation the back of their collective hands. It “neither accept[ed] nor reject[ed] the proposition” that a “regulation can properly be consulted to determine the [FDCA’s] meaning,” id. at 329, but blasted this particular regulation as “adding” only “confusion” to the preemption analysis:
[Plaintiffs’] reading of §808.1(d)(1), however, would allow a claim for tortious mislabeling to escape pre-emption so long as such a claim could also be brought against objects other than medical devices. All in all, we think that §808.1(d)(1) can add nothing to our analysis but confusion.
Id. That was a 180° reversal of Lohr. More would follow.
Moreover, the same negative inference from the lead opinion in Lohr, that Congress wouldn’t “without comment, remove all means of judicial recourse” for medical device plaintiffs, didn’t work go over so well in Riegel:
[A]s we have explained, this is exactly what a pre-emption clause for medical devices does by its terms. The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.
Id. at 326 (rejecting Lohr rationale). Even though the FDA in Riegel supported preemption, the majority “found it unnecessary to rely upon that agency view because we think [§360k(a)] itself speaks clearly to the point at issue.” Id. So much for all the ambiguity that Lohr professed to find in the same language.
Finally, Riegel declined to decide anything concerning parallel violation claims, because that issue was waived. Id. at 330 (plaintiffs “made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari”). However, Riegel included some dictum in the paragraph about waiver – “§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements,” id. – that has been universally converted by the lower courts (probably to the surprise and chagrin of the Riegel majority) into an endorsement of the concept of “parallel claims,” something that the Riegel Court in fact declined to decide.
Next, in Wyeth v. Levine, 555 U.S. 555 (2009), a prescription drug implied preemption case not dealing with anything analogous to §360k(a), the presumption against preemption was back in full force. “[I]]n all pre-emption cases, and particularly in those in which Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’” Id. at 565 (quoting Lohr, 518 U.S. at 485). Since Levine dealt with implied preemption and drugs, as opposed to express preemption and medical devices, not much else in Levine is particularly relevant to this post. For completeness, here is a list of every Lohr citation in the 6-3 majority opinion in Levine:
- “While agencies have no special authority to pronounce on pre-emption absent delegation by Congress, they do have a unique understanding of the statutes they administer” Id. at 576-77 (citing Lohr).
That’s it − only this one other Lohr citation in Levine. Moreover, the agency deference decision in Levine was not at all supportive of the deference that Lohr accorded the Agency’s regulation:
[T]he Court has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of pre-emption.
Id. at 576. Otherwise, the majority in Levine evidently did not think that Lohr was particularly relevant to any substantive preemption points, and to that extent we agree.
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (“Mensing”), like Levine, involved implied preemption and prescription drugs, finding preemption extended to bar common-law warning claims concerning generic drugs. For present purposes, that aspect of Mensing doesn’t matter. What does matter is that a majority of the Court refused outright to place reliance on an FDA regulation to interpret the preemptive scope of the FDCA. Mensing completely rejected this pillar of the Lohr decision:
Although we defer to the [FDA’s] interpretation of its regulations, we do not defer to an agency’s ultimate conclusion about whether state law should be pre-empted.
Id. at 613 n.3 (citing Levine, 555 U.S. at 576).
Mensing also rejected Lohr’s refusal to take Congress at its preemptive word. If the manner in which Congress wrote the statute included broad preemption, the Court would not usurp the power of Congress to “fix” what Congress did:
[I]t is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre. . . . We will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.
Id. at 625-26 (citation and quotation marks omitted).
In 2015, a then-obscure appellate judge named Gorsuch decided the PMA medical device preemption case Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015). Judge (now Justice) Gorsuch thus had a close encounter with the mess that Lohr’s refusal to interpret §360k(a)’s preemptive language according to its terms had created over the course of (then) almost two decades. We’ve already discussed these observations at length, so we’ll only hit the highlights here – in another set of bullet points:
- Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a). Caplinger, 784 F.3d at 1336.
- “Section 360k(a) preempts ‘any requirement’ imposed by states on manufacturers that differs from or adds to those found in the FDCA. Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.” Id. at 1337.
- Since Lohr, judges have “struggle[d]” to make sense of medical device preemption, since The Supreme Court’s “divergent views” about §360k(a) have “yielded considerable ‘uncertainty’ among the lower courts.” Id. at 1337-38.
- The “damages remedy” that Lohr found not “different from” FDCA requirements is “nowhere provided for in federal law.” Id. at 1338.
- Lohr’s parallel claims analysis “doesn’t appear in the statute, so its meaning was left entirely to judicial exposition.” Id.
- “Now, you might ask, why isn’t a narrower state law requirement at least ‘different from’ a broader federal requirement − and thus preempted by §360k(a)’s express terms? The Lohr majority acknowledged that a state duty imposing a ‘narrower requirement’ is indeed ‘different from’ the federal rules in a literal sense.’ And when it comes to interpreting the text of a statute, that’s often the sense that matters most.” Id.
- “[A]gain read literally, it would seem ‘any’ federal requirement imposed by the FDCA is capable of preempting any different or additional state requirement. But again the Lohr majority held otherwise,” and instead required a “regulation ‘specific’ to a ‘particular device.’” Id. at 1339.
- Despite the “clear” language of 21 U.S.C. §337(a), “lower courts must now accept . . . the notion that §360k(a) permits private tort suits that do no more than parallel the MDA.” Id.
- All three subsequent Supreme Court decisions – Buckman, Riegel, and Levine – “cut back on the scope of [Lohr’s] initial decision” and “retreated from” Lohr’s rationale. Id. at 1339-40.
- “It’s no small mystery why the same word – ‘any’ − should bear such different meanings in two such similar clauses that lie cheek by jowl in the same statutory subsection.” Id. at 1340.
- “[W]e may find the state law claim preempted only if there exists a device-specific federal requirement, though this test admittedly finds no analogue when it comes to the state requirement clause interpreted in Riegel.” Id.
- Section 360k(a) “specifies its preemptive reach plainly and broadly: any state requirement that adds to federal requirements and that relates to the safety or effectiveness of the device is preempted. No other qualification exists.” Id. at 1345.
- “[I]t is not for this court to revise [§360k(a)] by beating a new path around preemption nowhere authorized in the text of the statute.” Id. at 1347.
- Not just pre-market approval, but “something like it,” should have preemptive effect. Id. at 1339.
Thus, with respect to Lohr, Judge Gorsuch couldn’t “help but wonder if perhaps some of those rules warrant revisiting and reconciliation.” Caplinger, 784 F.3d at 1340. We think that’s a great idea – the sooner the better.
Then, in Lohr’s twentieth anniversary year, the decision’s most important doctrinal underpinning was flat out overruled. As we’ve also discussed before, the Supreme Court abolished the presumption against preemption in express preemption cases where Congress has included language explicit preemption language such as §360k(a):
The plain text of the [preemption clause] begins and ends our analysis. . . . And because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.
Puerto Rico v. Franklin California Tax-Free Trust, ___ U.S. ___, 136 S. Ct. 1938, 1946 (2016) (“Franklin”). Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).
That turned out the lights on Lohr.
Bringing the chronology to a close, earlier this year, the FDA itself reiterated that “safety and effectiveness” was baked into the §510(k) “substantial equivalence” review process by the SMDA. See FDA, “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” (Jan. 17, 2017). Thus, the FDA recognizes that “principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review.” FDA memo at 44 (footnote omitted). Again, we discussed this development in detail when it happened, so we’ll simply summarize the FDA’s views here:
- While “approval application (PMA) . . . and 510(k)) differ in various ways, they all . . . enable FDA to ensure that devices on the market are ones that have been determined by FDA to have a reasonable assurance of safety and effectiveness.” Id. at 40.
- “Congress . . . required FDA to evaluate whether a new device is as safe and effective as a predicate device.” Id. at 44 n.137 (specifically discussing SMDA).
- Under §510(k), “[c]lassification determinations must be based on an evaluation of the safety and effectiveness of the device.” Id. at 41.
- “Class II devices are devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls necessary to provide such assurance.” Id. at 41 n.122.
- “During the 510(k) review, FDA considers the device’s safety and effectiveness in its substantial equivalence determination.” Id. at 43.
- [T]he 510(k) . . . review process reflects a determination of the level of control necessary to provide a ‘reasonable assurance of safety and effectiveness.’” Id. at 44-45.
While the FDA’s 2017 public position on the nature of §510(k) clearance should be quite sufficient, since the SMDA was enacted in 1990 the FDA has issued a variety of other documents that contain similar statements. For instance, in the currently posted discussion of “Regulatory Controls” on the FDA’s website, the description of “special controls” for “class II devices” makes clear that: (1) “[s]pecial controls are regulatory requirements,” and (2) “Special controls are usually device-specific.” The FDA’s “design control” regulation, 21 C.F.R. §820.30(a)(1), provides that, “[e]ach manufacturer of any . . . class II device . . . shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.” This regulation imposes additional requirements on design “development,” “input,” “output,” “review,” “verification,” “validation,” “transfer,” “changes,” and “history.” Id. §§820.30(d-j).
Just the other day the FDA issued a guidance document on when a change to a §510(k) device requires submission of a new notification to the Agency. That guidance reiterates that “whether submission of a new 510(k) is required depends on whether the change could significantly affect the safety or effectiveness of the device.” FDA, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” Guidance for Industry, at 8 (Oct. 25, 2017). Likewise, an FDA working report from 2010 recognized:
[T]he 510(k) program has changed significantly since its inception. The MDA established the premarket notification process as a simple check to assure proper device classification. Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitate innovation in the medical device industry.
FDA, “CDRH Preliminary Internal Evaluations – Volume I, 510(k) Working Group Preliminary Report & Recommendations, at 34 (Aug. 2010) (§4.4 “The Current 510(k) Program”) (available online here) (emphasis added). In many instances, device specific FDA guidance, regulatory manuals, and other similar documents will provide additional regulatory proof of actual preemptive requirements imposed by the Agency upon particular devices or device types.
At this point, Lohr plainly has two shadows from a jurisprudential perspective. Essentially all of the propositions upon which its anti-preemptive rationale was based have been changed by Congress, or overruled by subsequent Supreme Court decisions.
First, The SMDA applied the same pre-market approval “reasonable assurance of safety and effectiveness” standard to §510(k) and gave the FDA the tools – a broad selection of “special controls” − to create the kind of “device specific” controls that preemption under Lohr required. The FDA has recognized on many occasions that safety and effectiveness is at the core of modern “substantial equivalence” determinations.
Second, Riegel held that the identical “rigorous” “reasonable assurance of safety and effectiveness” standard of FDA safety review is broadly preemptive.
Third, Franklin outright abolished the central guiding principle in Lohr − the presumption against preemption in express preemption cases is no more.
Fourth, Lohr’s gestalt approach allowing diffuse, general Congressional purpose to override preemptive statutory provisions has been rejected in Riegel and Mensing. If the statute’s language requires preemption, then that is what Congress “intended” – unless and until Congress changes it.
Fifth, Lohr’s reliance on an agency regulation to constrict the preemptive scope of that agency’s organic statute was questioned in Riegel and Levine before being rejected outright in Mensing.
Sixth, to the extent that Lohr distinguished state statutory/regulatory enactments and state common law in interpreting “requirements” as that term was used in §360k(a), Riegel definitively rejected that distinction.
Seventh, Lohr’s “parallel” claim analysis was restricted in Buckman, and avoided as waived in Riegel. Justice Gorsuch hates all the extra-textual hair splitting that has sprung up around the Riegel dictum, and as a result appears to be the kind of advocate we would want on Court for reconsidering and overruling Lohr.
So what do we need?
We need good cases – not kamikaze motions in MDLs with institutional (at least) bias against preemption. We need cases where the FDA has, in fact, imposed device-specific special controls that specify design, warnings, clinical testing, and other relevant attributes of §510(k) medical devices. Only in such carefully selected cases, and after the compilation of a full regulatory record, will the “careful comparison” that even Lohr recognized could lead to preemption be able carry the day for the defense. That may change later on, once preemption becomes better established in post-SMDA §510(k) cases, but for now we’re not doing ourselves any favors making preemption motions on threadbare records or before judges predisposed to reject preemption arguments.
Lohr should be dead. Long live preemption.