United States: Guest Post – 510(k) Clearance Of A Class II Device Can Be, As A Matter Of Law, A Finding Of No Potential Unreasonable Risk.

Last Updated: March 11 2019
Article by James Beck

Today's guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht. We hope he's right. As always, our guest posters deserve 100% of the credit (and any blame) for their thoughts published here. We only provide the forum.

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In Merck Sharp & Dohme Corp. v. Albrecht, the Solicitor General as amicus curiae argues that judges, not juries, are best suited to evaluate the scope of an FDA determination. Brief of the United States as Amicus Curiae Supporting Petitioner, Merck Sharp & Dohme Corp. v. Albrecht, (No. 17-290), 2018 WL 4562163 (filed Sept. 20, 2018). Judges, he says, "are trained and experienced in construing legal documents and are far better equipped to understand agency decisions in light of the governing statutory and regulatory context." Id. at *15.

To support his argument, he cites the Administrative Procedure Act's statement that a reviewing court shall "determine the meaning or applicability of the terms of an agency action," 5 U.S.C. § 706, and precedent that has looked to judges to interpret the meaning of prior adjudications. See id. at 18-20.

While that case has nothing to do with either medical devices in general or 510(k) clearance in particular, Supreme Court agreement with the Solicitor General on this point could radically alter the way courts view the admissibility of 510(k) clearance, at least where Class II devices are concerned. To gain 510(k) clearance, unless the FDA decides that more is required, the manufacturer need only establish that a new device is as safe and effective as an existing lawfully marketed device. No other evidence of safety and effectiveness is required in the absence of FDA action.

At present, courts have treated the meaning of 510(k) clearance as a subject for warring expert testimony as to its meaning, as discussed here on the blog (discussing In re Cook Medical, Inc. IVC Filters Mktg., Sales Practices and Prod. Liab. Litig., 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018)). In other cases evidence of clearance has been excluded, with one explanation being the mistaken theory that the evidence was of such slight probative value that the battle was best avoided. In re C.R. Bard, Inc. MDL No. 2187, 810 F.3d 913, 922 (4th Cir. 2016). [Ed. note: Other cases, collected and discussed here, admit evidence of FDA device clearance.]

But if the United States Supreme Court decides that preemption issues are treated as purely legal, the courts will be forced to examine the statutory context that controls Class II clearance using 510(k). That context shows that such a clearance is almost always an FDA "determination" that the device, with whatever special controls that the FDA ultimately imposes, does not present a potential unreasonable risk of illness or injury. Nothing could be more relevant to a product liability claim.

To begin at the beginning, in 1976 Congress directed the FDA to engage in a sort of regulatory "triage." Triage sorts patients according to the seriousness of their injuries and gives them different levels of care. The FDA's statutory scheme sorts devices according to the seriousness of the risks they present and requires different levels of premarket review.

More precisely, Congress directed the FDA to engage medical panels to classify medical devices according to their need for regulation. Congress specified the qualifications the panel members were to have. 21 USC § 360c(b). The FDA methodically proceeded over the ensuing decades to classify device types into classes I, II or III according to the risk they present. It convened the panels, held hearings, published panel recommendations, entertained comments from the public, and fixed the classifications.

Devices that present little risk, such as tongue depressors, were put in Class I and do not need FDA review before they are sold to the public.

Moderate risk devices, such as surgical suture, were put in Class II and, if not exempt, must be "cleared" by the FDA before they are marketed. To gain Class II clearance, the manufacturer must show in a §510(k) submission that they are as safe and effective as an existing Class II legally marketed device that presents a moderate risk.

Finally, devices that may "present a potential unreasonable risk of illness or injury" or are for sustaining life, such as a pacemaker, were put in Class III and generally must be "approved" by the FDA based on extensive independent evidence of their safety and effectiveness. 21 U.S.C. § 360c(a)(1)(C).

On its face, this is a reasonable way to regulate medical devices. In fact, Congress stated in the statute that it believed this system of classification and review provided "reasonable assurance" of safety and effectiveness for each class of medical device. 21 U.S.C. § 360c(a)(1)(A), (B), (C).

It is encouraging, but not necessary, to observe that the FDA's sorting of devices seems to have worked. Even though they receive less FDA scrutiny, "cleared" devices of moderate risk are less likely to result in a serious recall than "approved" devices that may present an unreasonable risk. One study showed that while 510(k) cleared devices constitute 98% of all devices, they account for only 71% of serious recalls. And the 2% of devices that are PMA-approved made up 19% of serious recalls. Jeffrey Shapiro, Substantial Equivalence Premarket Review: The Right Approach for Medical Devices, 69 Food & Drug L.J. 365, 389-390 (2014).

But that is not all. According to the statute, placement in Class II is itself a determination of safety. If a device is a Class II device, then, with special controls, it usually does not present "an unreasonable risk of illness or injury" that would require it to be in Class III. 21 U.S.C. §360c(a)(1)(C). The FDA has made that determination based on the initial work of a medical panel and information in the §510(k) which confirmed that the specific device fell within the panel's classification of the device type. Otero v. Zeltiq Aesthetics, Inc., 2018 WL 3012942 *3 (C.D. Cal. June 11, 2018). This can be confirmed when the decision classifying the device type expresses the opinion that there is no unreasonable risk, or uses words to that effect.

In other words, clearance of a moderate risk device using 510(k) is normally a sign of relative safety, even though the FDA review of more risky Class III devices is more rigorous. That is what the statute says, and experience seems to bear that out.

If the Supreme Court should agree that the interpretation of an FDA decision is a matter of law for the court, then in any case involving a Class II device, the defendant should be entitled to an instruction on the meaning of that decision.

If the FDA decision classifying the device type rests on a finding of no unreasonable risk then, as a matter of law, the defendant should be entitled to an instruction that "The United States Food and Drug Administration has cleared this device for marketing as a Class II device. That clearance is a determination that there is reasonable assurance of its safety and effectiveness and that, with whatever special controls may have been imposed, the device does not present a potential unreasonable risk of illness or injury."

Such an instruction would, of course, be radically different from the treatment courts have recently given §510(k) clearance. Those courts have not only mistakenly allowed juries to decide the meaning of §510(k) clearance, but they have done so in part because of fundamental legal error in the way they have examined §510(k) clearance.

The fundamental error of those courts has been to overlook the distinction between the normal use of §510(k) to clear devices of a type placed in Class II, and the increasingly rare transitional use of §510(k) to clear devices in Class III based on a pre-1976 predicate.

The use of pre-1976 predicates originated in an interim provision Congress adopted in 1976, when the statutory scheme was new. Congress put all implantable devices in Class III as presenting an unreasonable risk pending medical panel review to reclassify them. Then, anticipating that it would take medical panels a long time to do their work – and has taken more than 40 years – it allowed these devices to be "cleared" using §510(k) if they could be shown to be equivalent to a device on the market in 1976. This process, unlike the normal use of §510(k), did not involve any medical panel review and did not require equivalence to a classified device.

This increasingly rare scenario was what the Supreme Court addressed in Medtronic v. Lohr, 518 U.S. 470, 477 n.3 (1996), which, quite incorrectly, has been taken as being representative of all FDA clearance decisions. But it is not. In fact, now that the medical panel reviews of devices with a potential high risk appear to have been almost completed, the scenario is not representative of practically anything that the FDA is still doing today. See FDA, FDA Has Taken Steps to Strengthen The 510(k) Program 7 (November 2018).

Where a device has been placed in Class II in what is now the ordinary fashion − based on equivalence in safety and effectiveness to a predicate device placed by a medical panel in Class II because its risks are reasonable − that decision, as a matter of simple statutory interpretation, is a determination of safety. Even if juries are free to disagree with it, they should not be allowed to ignore it. What the Supreme Court tells us in Merck Sharp & Dohme Corp. may have effects far beyond the resolution of the case at hand.

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

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