United States: New FDA Draft Guidance Helps Define The Scope Of §510(k) Medical Device Preemption

Last Updated: August 22 2016
Article by James Beck

Earlier this month the FDA issued a draft guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device." It's long, and anyone interested in reviewing the whole thing can download it from the FDA's website here. Our interest in this draft guidance, as product liability litigators defending FDA-regulated products, is primarily due to the Agency's numerous statements about when changes to the design and warnings of 510(k) medical device obligates their manufacturers to resubmit their products for additional FDA clearance prior to marketing.

As we've already discussed in much more detail in our September, 2015 " In Case of Good Judge, Break Glass" post, if a product change requires prior FDA review and assent, then that change cannot be mandated by common law tort actions. The Supreme Court stated in PLIVA v. Mensing, 564 U.S. 604 (2011), "The question for 'impossibility' [preemption] is whether the private party could independently do under federal law what state law requires of it." Id. at 620. The new FDA draft guidance is all about when product changes to 510(k) devices require prior submission and Agency clearance:

This guidance, when finalized, will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (also referred to together as "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 C.F.R. §807.81(a)(3) for submission and clearance of a new 510(k).

Draft Guidance at 3 ("Scope") (emphasis added).

Initially, we remind everyone that this document is both a "guidance" and a "draft." It is subject to comment and is not final. Even when final it has no legally binding effect. But the guidance does interpret legally binding regulations that, as we discussed in our "Break Glass" post, mandate prior FDA review and clearance of changes to 510(k) devices. The guidance is useful in that it provides a more comprehensive explication of the regulations, and thus more useful understanding of when a requirement for prior FDA submission of a device change gives rise to implied impossibility preemption under Mensing, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Wyeth v. Levine, 555 U.S. 555 (2009).

Here are the principles that we think are most important to that determination.

First, any change that significantly affects a 510(k) device's safety or effectiveness – and thus essentially any change that could support a causation argument in product liability – requires the submission of a new 510(k) device notification and prior FDA clearance:

Modifications made with intent to significantly affect safety or effectiveness of a device – If a manufacturer modifies their device with the intent to significantly improve the safety or effectiveness of the device (for example, in response to a known risk, adverse events, etc.), a new 510(k) is likely required. Changes that are not intended to significantly affect the safety or effectiveness of a device, however, should still be evaluated to determine whether the change could significantly affect device safety or effectiveness.

Draft Guidance at 4 (emphasis original).

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the §807.81(a)(3) threshold, "could significantly affect the safety or effectiveness of the device," or constitutes a "major change or modification in the intended use of the device."

Id. at 9 (quoting regulations).

[T]he first question is always whether the change is being made with the intent to significantly improve the safety or effectiveness of the device, for example, in response to a known risk, adverse event, etc. (Figure 1 – Main Flowchart). If so, then the change likely "could significantly affect safety or effectiveness" and a new 510(k) likely must be submitted.

Id. at 10.

Second, any change that involves an off-label use – that is, a change affecting the "intended use" of the device – also requires submission of a new 510(k) device notification and prior FDA clearance:

The concept of intended use has particular relevance in determining whether a device can be cleared for marketing through the premarket notification (510(k)) process or must be evaluated in a premarket approval application (PMA) or a de novo request for classification under section 513(f)(2) of the FD&C Act. Manufacturers should recognize that, per section 372513(i) of the FD&C Act, if a particular labeling change results in a different intended use of the device, the device would not be substantially equivalent and a PMA or a de novo submission would be required to market the device.

Draft Guidance at 11 (emphasis added).

Changes in the indications for use section of labeling raise more Agency concern than any other aspect of labeling. In fact, most changes in this part of the labeling that affect the substance, meaning, or scope of the indications for use – referred to here as "substantive changes" – could significantly affect safety or effectiveness and will require the submission of a new 390 510(k).

Id. at 12.

[I]f a design change significantly affects how a device may be used, a new 510(k) is likely required.

Id. at 25.

Third, changes to the composition of the device that affect its safety or effectiveness require requires submission of a new 510(k) device notification and prior FDA clearance:

Manufacturers should consider whether the material change could affect the performance of the device by affecting its strength, hardness, etc. Manufacturers should also consider whether the new material could be affected by any labeled cleaning, disinfection, or sterilization process of the device. If the answer to this question is yes, manufacturers should . . . consider whether the change could significantly affect the safety or effectiveness of the device.

Draft Guidance at 31.

Fourth, certain other label changes also require submission of a new 510(k) device notification and prior FDA clearance:

Deletion or modification of a contraindication usually requires the submission of a new 510(k) prior to effecting the change.

Draft Guidance at 16.

If the change significantly affects the device's risk profile, a new 510(k) is likely required.

Id. at 17 (note, that in many "risk profile" changes, the changes being effected ("CBE") process would be available, thus precluding preemption under Levine).

Finally, the draft guidance also discusses a wide variety of other device alterations that could trigger an obligation to submit a new 510(k) notification to the FDA, such as changes to sterilization (pp. 21-22), that could conceivably be relevant in specific litigation situations. Any of our defense-side colleagues facing a peculiar claim should review the entire guidance to see if prior FDA action is required by whatever change the plaintiff is demanding.

When we wrote our " Break Glass" post back almost a year ago, there were only a few district court cases applying Mensing/Bartlett preemption outside of generic drugs. Now there is a lot more helpful precedent (see our post-Levine preemption cheat sheet). We have several new cases preempting branded drug design defect cases because prior FDA approval of major changes is required. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (affirming a decision cited in our prior post); Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016); Fleming v. Janssen Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2016 WL 3180299 (W.D. Tenn. June 6, 2016); Barcal v. EMD Serono, Inc., 2016 WL 1086028 (N.D. Ala. March 21, 2016); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035 (S.D. Ohio 2015); and Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio 2015) (which had been decided before our earlier post, but we didn't know about yet).

Mensing/Bartlett preemption has also been extended to OTC drugs. Batoh v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2016 WL 922779 (D. Conn. March 10, 2016).

Branded drug warning claims involving information not subject to the CBE exception to prior FDA approval of significant changes has also been recognized. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015) (information wasn't "new"); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2016 WL 2840215 (D.S.C. May 6, 2016) (information related to efficacy, not safety).

Mensing/Bartlett preemption has even been applied outside of the FDCA altogether – to bar airplane design claims requiring prior FAA approval – in Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016).

It's inevitable – barring a change in the composition of the Supreme Court that leads to the overturning of Mensing and Bartlett – that implied impossibility preemption will come to 510(k) medical devices. Three circuits (1st, 3rd, and 6th) have already applied it outside of generic drugs. Unlike express preemption (such as Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)), implied preemption isn't limited to the express terms of particular statutes, and as we discussed in the " Break Glass" post, express and implied preemption operate independently of one another, so Lohr doesn't restrict the operation of implied preemption.

For us, this is the reason that the FDA's 510(k) draft guidance is important (although it does other things, too, like debunking the bogus argument that 510(k) clearance doesn't involve"safety"). Since the key to impossibility preemption, as Mensing held "is whether the private party could independently do under federal law what state law requires of it," the draft guidance provides a wealth of FDA regulatory explanation of why certain types of changes to the design, labeling, and other features of 510(k) medical devices necessitate prior FDA clearance − and thus cannot be demanded by plaintiffs in common-law product liability litigation.

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

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