[2] Even though they are still quoted, statements in Medtronic v. Lohr[3], which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what the FDA does. To borrow from Perry Mason, today they are irrelevant, incompetent and immaterial because they describe a temporary process the FDA used in 1982 and say nothing about the permanent process used today to ensure the safety and effectiveness of devices.

A court decision undermined by subsequent events in caselaw has been called a “derelict on the waters of the law.” [4] What Lohr says about safety fits that description. The statements are a “derelict” that need to sink and never surface again. Until they disappear, they will remain a trap for the unwary, a confuser of courts and a continuing mischief to manufacturers who have met FDA safety standards and want juries to know that.

Classification Matters

In 1976, Congress directed the FDA to use medical panels to classify medical device types according to the risk they present, and it specified procedures the FDA should use to provide reasonable assurance of the safety and effectiveness of each class of device. One example of a device type is surgical mesh. The medical panels, whose qualifications were dictated by Congress, published their proposed classifications in the Federal Register, along with citations to the medical studies on which they relied. After notice and comment, the FDA set the classification for each device type:

• Class I contains the lowest risk devices and usually they can be sold without seeking FDA permission.
• Class II contains devices that may need some regulation but do not “present a potential unreasonable risk of illness or injury.”[5] To sell a Class II device, a manufacturer must file a 510(k) notice, which establishes that it is at least equivalent in safety and effectiveness to an existing Class II device.[6] The manufacturer can only sell the device after the FDA reviews the 510(k) and grants a form of permission called “clearance.”[7] The FDA can impose special controls, such as a guidance, on Class II devices, but is not required to do so.
• Class III devices may, among other things, “present a potential unreasonable risk” that requires the manufacturer to offer independent evidence of safety and effectiveness sufficient to satisfy an FDA process the statute calls “approval.”[8]

The system is, in effect, a form of triage.[9] It can be compared to a hospital emergency room. Patients who are not really sick get no treatment. Patients who have an illness that medicine will cure get sent home with medicine. Patients who are gravely ill go to the operating room for surgery. The ultimate goal for each category is to cure the illness.

No one would say that the patient who had surgery was healthier when all was said and done just because that patient went to the operating room. The goal for all patients is the same, i.e., to get well. Similarly, in the end, the FDA’s reasonable assurance of safety and effectiveness is the same for all device types no matter which class they belong in or how much FDA scrutiny an individual device receives.

Two Different Uses of 510(k)

Congress established a permanent process for the clearance of Class II devices using §510(k). Pursuant to that process, a manufacturer submits a 510(k) notice to the FDA, which establishes that a new device is equivalent in safety and effectiveness to a predicate device with the same classification, i.e., Class II for a Class II device type. The FDA then takes into account the earlier medical panel classification process, the contents of the 510(k) and the regulatory record of the predicate device and other devices of the same type. It then decides whether to allow the device to be marketed.

This was not the process at issue in Lohr, which instead addressed a temporary FDA process. When the device regulations first took effect in 1976, Congress allowed previously unregulated devices to stay on the market until the FDA could get its regulatory program underway. To permit new devices to compete with those previously sold, it provided that manufacturers could sell new devices after filing a 510(k) that established the new device was equivalent in safety and effectiveness to one sold in 1976—all the manufacturer had to do before selling the device was file the notice and FDA permission was not required before marketing.[10]

The opportunity to market a new device based on equivalence to a 1976 device ended when the FDA either classified the device type as I or II or, in the case of a Class III device type, issued an order requiring manufacturers to submit the device for premarket approval. After that, either equivalence to a Class I or II device or premarket approval was required.

The Supreme Court’s Lohr decision concerned a device marketed in 1982 pursuant to the transitional process. The question before the Court was whether the FDA clearance process preempted state law tort suits that sought to establish different safety standards. The statute expressly preempts state “requirements,” which differ from federal requirements.[11] The Court held that there was no preemption because the clearance process at issue in Lohr did not impose federal requirements specific to the device.[12]

The Supreme Court emphasized in passing the lax nature of the transitional clearance process Congress had created to handle the temporary problem. The Court called the process “grandfathering” and said it simply required equivalence to a device sold in 1976 that had never been specifically reviewed for safety. Clearance, it said, was based on “equivalence,” not safety, adding that the device had “never been formally reviewed under the MDA for safety or efficacy.” For good measure, it cited evidence that the FDA clearance process on average took only 20 hours and contrasted that with a much greater time afforded to the review of Class III approval applications.[13]

Unfortunately, the Supreme Court imprecisely called the clearance process “510(k) clearance” without any attempt to distinguish transitional, and therefore temporary use, of 510(k) from the permanent use of 510(k) to clear devices in Class II. The permanent use was not before the Lohr Court, so the omission is understandable, but it has resulted in a great deal of confusion and mischief. That mischief was compounded by the FDA’s decades-long delay in classifying devices, which had the result of continuing the transitional process for several types of devices for a very long time.

None of Lohr’s Criticisms of Clearance Apply to Class II Devices Today

While the Lohr Court’s comments about safety were true with respect to the transitional use in 1982 at issue in that case, they are dramatically untrue if applied to permanent use of 510(k) to clear devices in Class II. For those devices:

• There has been a review of the device type by a medical panel for safety and efficacy and, after notice and comment, the type has been placed in Class II by a regulation with the force of law. That means the device does not “present a potential unreasonable risk of illness or injury” that would require it to be in Class III. This is a “formal review” and thus an express safety determination. The Lohr device was in Class III, not Class II.
• The manufacturer of a new device, unlike the manufacturer in Lohr, must obtain FDA permission before marketing any such device, and permission is required any time there would be a substantial change in the safety or efficacy of a prior design.[14]
• To obtain FDA permission, which is another “formal review,” the manufacturer must show equivalence in safety and effectiveness to an existing device in Class II. That is a safety determination.[15] The FDA will have a regulatory history for the existing device and for other devices of the same type. Equivalence to a device sold in 1976 for which there is no regulatory history is insufficient.
• When the medical panel classification process, the notice and comment procedure, the regulatory history of the equivalent device and the requirement that the FDA affirmatively grant permission are considered, it is obvious that the 20-hour estimate for the transitional 510(k) process at issue in Lohr is irrelevant to the permanent 510(k) process Congress intended and the FDA now uses.

For many years this distinction did not seem to be important because the classification process had not been completed and litigation focused on the Class III devices that presented the greatest potential risk. But after the Supreme Court held that the Class III approval process preempted state law claims,[16] the litigation focus shifted to Class II devices.

Courts Have Mistakenly Assumed Lohr is Still Relevant

While an early ruling in a pedicle screw case recognized the significance of Class II classification,[17] the court in charge of the multidistrict pelvic mesh litigation committed the mistake of assuming that Lohr correctly described the 510(k) process at issue in those cases. On that basis it held that, even where state law made regulatory compliance relevant, evidence of FDA clearance was inadmissible because it did not “go to” safety and effectiveness and undue trial time would be consumed explaining the limited nature of the 510(k) process as described in Lohr.[18]

The district court thus excluded the evidence without ever expressly addressing the actual 510(k) process in those cases, which involved medical panel placement of all surgical mesh in Class II in 1982, a regulation adopting that classification in 1988, clearance of devices in issue beginning in 1996 based on equivalence to existing regulated Class II devices, a special 2011 medical panel which examined the pelvic mesh devices specifically and then FDA action on its recommendations, which reclassified some devices but kept others in Class II, a legal determination that they did not present a potential unreasonable risk.[19]

Unwilling to contradict the trial court on a matter so fundamental to the management of the cases, three federal appellate courts affirmed the exclusion of the evidence. The opinions, more fully treated elsewhere,[20] made multiple mistakes. In the first case, the Fourth Circuit took its cue solely from Lohr, mistakenly saying the device at issue had been cleared based on an unregulated 1976 device, wrongly assuming the manufacturer could choose 510(k) to take advantage of a lower safety standard and called FDA conclusions about safety and effectiveness “mere boilerplate.”[21]

None of this was accurate. Under the law at the time of clearance, the pelvic mesh devices were based on equivalence to regulated Class II devices, not unregulated devices sold in 1976; the FDA, not the manufacturer, fixed 510(k) as the proper review path because it had determined the devices did not present a potential unreasonable risk; and the FDA’s conclusions were not “boilerplate.” They instead were what Congress legally required the FDA to find when it granted permission by either process to market any device, i.e., reasonable assurance of safety and effectiveness.

Other court opinions, when they attempted in some way to address the clearance evidence for the individual devices, made equally glaring mistakes. In one case, the Fourth Circuit said the FDA pelvic mesh advisory committee in 2011 had not made any findings or looked at anything other than literature.[22] Neither of those assertions was correct.[23] In another case, the Eleventh Circuit looked only to Lohr, saying clearance was not “safety regulation,” and rejecting the defendant’s arguments about the classification process by saying they came too late in the briefing.[24] A state court decision mentioned the fact that the device in question had been cleared as a Class II device but wrongly concluded that this was only “marginally relevant.”[25] The Seventh Circuit, the only court to address the classification process in any detail, took an FDA statement that mesh was too risky to be in Class I, chopped out qualifying language and turned it into a declaration that the FDA had never found reasonable safety and effectiveness at all.[26] That was also incorrect.

Even though the district court’s exclusion of the evidence rested on a fundamental legal error that was alone sufficient to show an abuse of discretion, the appellate opinions erroneously deferred to the district court’s additional belief that, under Fed. R. Evid. 403, any slight relevance clearance might have had to safety was outweighed by a potential for jury confusion.[27] But the only reason for confusion was the mistaken reliance on Lohr. Lohr says nothing about clearance of Class II devices and so Lohr’s questions are irrelevant and inadmissible when discussing the clearance of a Class II device.

The pelvic mesh litigation is not the only litigation in which the language of Lohr has mesmerized lower courts and wreaked havoc. Courts considering the safety of other devices have incorrectly assumed that clearance can be based on an unregulated 1976 predicate,[28] or commented that only “approval” ensures safety while 510(k) “clearance” does not.[29]

The latter claim is wrong as a matter of law. The same standard applies to all three classes. FDA regulation is to provide, in the Supreme Court’s words, “reasonable assurance of safety and effectiveness,” [30] for all device classes because that is the uniform statutory standard.[31] When the classification process is taken into account, this makes sense—less risk means less regulation but the result, reasonable assurance, is the same. Saying that more regulation means more safety is like saying that patients sent to the surgical suite are healthier than those sent home with medicine when in fact they both end up in good health.

A similar mistake that is sometimes made is to seize on language in Lohr that says 510(k) clearance is an “exception” to the approval requirement.[32] That was literally true in Lohr where, but for the transitional exception, the Class III device would have been subject to an approval requirement. But it is not true for Class II devices—they are never subject to an approval requirement because they do not present a potential unreasonable risk.

Sometimes this claim that approval is superior is also wrongly bolstered by citation to an FDA regulation that prohibits calling the 510(k) process “approval.” But all that means is that under the statute the processes are technically called two different things, not that one is superior to another.[33] In both cases, FDA permission is required before marketing.

The Prohibition Against Changes to a Device Without FDA Permission is a Preemptive “Requirement” not in Effect at the Time of Lohr

That is not all. Lohr held that the 510(k) process at issue there did not impose requirements “specific to a particular device” that would preempt state tort law pursuant to § 360k. However, under current law, it is a “requirement” of the clearance process that a manufacturer cannot change a device in a way that affects safety and effectiveness without filing a new 510(k) and getting FDA permission.[34] That comes within the common sense meaning of a requirement specific to a particular device. There is a “requirement” that there be no substantial change without FDA permission. It also implicates the principle that state law cannot impose tort liability if a change found in a proposed alternative design would require the “permission or assistance” of the FDA.[35] For these reasons, the assertion that 510(k) does not impose a “requirement” is as misleading as Lohr’s comments on 510(k) and safety.[36]

As Jeffrey K. Shapiro of Hyman, Phelps & McNamara, PC has put it, courts should not “continue to recycle the same mischaracterizations of the 510(k) process.”[37] What is needed is a judge willing to study the statute and regulations, as well as the actual facts of the case presented, and, perhaps after asking the FDA for its views, to label these aspects of Lohr as the derelicts they are and bury them at sea. So far, no court has been willing even to ask the FDA for its views.

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[1] This article is based on Luther T. Munford, Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question, 76 Food & Drug L.J. 6 (2021) [hereinafter “Courts v. FDA”].

[2] The authors and their firm, Butler Snow LLP, represent Ethicon in the pelvic mesh litigation discussed in this article. The views expressed in this article are those of the authors and are not made on behalf of Ethicon or any party.

[3] Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

[4] Lambert v. California, 355 U.S. 225, 232 (1957) (Frankfurter, J. dissenting).

[5] 21 U.S.C. § 360c(a)(1)(C)(ii)(II).

[6] 21 U.S.C. § 360c(f)(1)(A)(ii)(II).

[7] 21 U.S.C. § 360(k); 21 C.F.R. § 807.100.

[8] 21 U.S.C. § 360e; 21 C.F.R. § 807.97.

[9] See Jeffrey K. Shapiro, Substantial Equivalence Premarket Review: The Right Approach for Most Medical Devices, 69 Food & Drug L.J. 365, 367–68 (2014) (suggesting the triage analogy).

[10] 21 U.S.C. § 360c(f)(1)(A)(i).

[11] 21 U.S.C. § 360(k).

[12] Medtronic, Inc. v. Lohr, 518 U.S. 470, 495–97 (1996).

[13] Id. at 490, 493, 478-479.

[14] 21 U.S.C. §§ 360c(a)(3)(B), 360c(f)(1)(A)(ii)(II).; 21 C.F.R. § 807.81(a)(3).

[15] This is especially true since Congress in 1990 promulgated a statutory definition of substantial equivalence and prohibited marketing without FDA clearance. See FDA, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 27, 2014), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k (“The 510(k) Program”).

[16] Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008) (approval of Class III device triggers express preemption).

[17] Talley v. Danek Medical, Inc., 179 F.3d 154, 161 (4th Cir. 1999) (reclassification into Class II meant spinal screws were “safe to market”); Hegna v. E.I. du Pont de Nemours and Co., 806 F. Supp. 822 (D. Minn. 1992) (evidence that device was in Class II after medical panel action was evidence of “the reasonableness of the party’s actions”).

[18] Cisson v. C.R. Bard, Inc., 86 F. Supp. 3d 510 (S.D. W. Va. 2015), aff’d sub nom. In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., MDL No. 2187, 810 F.3d 913 (4th Cir. 2016).

[19] See Courts v. FDA, supra, n. 1, at 18-22.

[20] Id. at 23-33.

[21] Id. at 23-25 (discussing In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., MDL No. 2187, 810 F.3d 913 (4th Cir. 2016)).

[22] Courts v. FDA, supra, n.1, at 25-27 (discussing Huskey v. Ethicon, Inc., 848 F.3d 151 (4th Cir. 2017), cert. denied, 138 S. Ct. 107 (2017)).

[23] Courts v. FDA, supra, n. 1, at 28-29 (discussing Campbell v. Bos. Sci. Corp., 882 F.3d 70 (4th Cir. 2018)).

[24] Courts v. FDA, supra, n. 1, at 27-28 (discussing Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304, 1310-11 (11th Cir. 2017)).

[25]  Courts v. FDA, supra note 1, at 29 (discussing Carlino v. Ethicon, Inc., 208 A.3d 92 (Pa. Super. Ct. 2019), reargument denied, June 12, 2019).

[26]  Courts v. FDA, supra, n. 1, at 29–30 (discussing Kaiser v. Johnson & Johnson, 947 F.3d 996, 1005-06, 1018 (7th Cir. 2020)).

[27] Courts v. FDA, supra, n. 1, at 28-29 (discussing Campbell v. Bos. Sci. Corp., 882 F.3d 70 (4th Cir. 2018)). But see In re Bard IVC Filters Prods Litig., 2021 WL 4305864 at *10 (N.D. Ariz. Sept. 2021) (510(k) evidence admissible with limiting instruction).

[28] See, e.g., McClellan v. I-Flow Corp., 776 F.3d 1035, 1038 (9th Cir. 2015) (pain pump) (“This provision exempts a device from the ‘reasonable assurance of safety’ requirement if the manufacturer shows that the device is ‘substantially equivalent’ to a grandfathered device.”).

[29] See, e.g., Richardson v. Wright Medical Technology Inc., 2021 WL 5998517, at *5 (D. Ariz. Dec. 17, 2021) (“510(k) process focuses on equivalence rather than safety) (artificial hip); Kline v. Zimmer, Inc., 2018 WL 1980957, at *9 (Cal. Ct. App. Apr. 27, 2018)(artificial hip)(510(k) “does not determine whether a product is safe and effective”).

[30] FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134 (2000) (“Regardless of which category FDA chooses, there must be a ‘reasonable assurance of the safety and effectiveness of the device’”).

[31] 21 U.S.C. §360c(a)(1)(B).

[32] Medtronic v. Lohr, 518 U.S. at 477.

[33] 21 C.F.R. §807.97. See Courts v. FDA, supra, n. 1, at 32-33 (noting that regulation was adopted in 1976 before statute required FDA to give permission before 510(k) device could be marketed).

[34]  21 C.F.R. 807.81 (a)(3)(510(k) required where device would be “significantly changed or modified in design, components, method of manufacture or intended use”). See also FDA, The 510(k) Program, supra n.17.

[35]  PLIVA, Inc. v. Mensing, 564 U.S. 604, 623–24 (2011).

[36] Ralph F. Hall and Michelle Mercer, Rethinking Lohr: Does “SE” Mean Safe and Effective, Substantially Equivalent, or Both?, 13 Minn. J.L. Sci. & Tech 737, 771, 789 (2012) (post-Lohr changes to 510(k) clearance mean that it now imposes preemptive “requirements”).

[37] Jeffrey K. Shapiro, Is the 510(k) Process as Worthless as the Federal Courts Seem to Believe?, https://www.thefdalawblog.com/2017/07/is-the-510k-process-as-worthless-as-the-federal-courts-seem-to-believe/.

Finis