United States: Yes, Virginia (Utah, Actually), There Is §510(k) Medical Device Preemption

Last Updated: May 28 2019
Article by James Beck

We've explained at length why Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is an anachronism with respect to preemption, given the complete overhaul that Congress gave to §510(k). Still, strange things happen when preemption meets product liability, and there seems to be a conspiracy of silence among judges with respect to current FDA §510(k) practices and Lohr's archaic 1982 "grandfathering" process.

But not always.

Thus, today we are discussing Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. April 22, 2019). The product in Kelsey was contact lens disinfectant, which the plaintiff (predictably) claimed was ineffective in preventing a serious eye infection. Id. at *1. We can essentially predict that sort of thing. Plaintiff at risk of condition X takes something designed to prevent it, and presto, the plaintiff demands that the manufacturer effectively becomes an insurer against whatever that risk might be.

But a funny thing happened in Kelsey on plaintiff's way to collecting on her ex post facto free insurance claim.

Preemption.

This product was not grandfathered Lohr-style. Rather it was subject to numerous FDA-imposed "special controls" – specific to this type product. In particular, FDA had issued "guidance" concerning the applicable FDCA-based requirements:

[T]he FDA issued the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products (Guidance). The Guidance "sets forth the general information and special controls FDA believes are needed to assure the safety and effectiveness of contact lens care products. . . ."

Kelsey, 2019 WL 1884225, at *6. "The Guidance 'sets forth the special controls which have been determined at this time . . . to be necessary to provide reasonable assurance of the safety and effectiveness of class II contact lens care products.'" Id. at *7. We won't recite the details, but the guidance covered the product's design, good manufacturing practices, and labeling. Id. at *7-8. However, with respect to labeling, the guidance was ambiguous in certain respects:

There is nothing in the Guidance or the Appendix that defines package insert, specifically requires it to be a separate leaflet or pamphlet, or prohibits it from being printed on the inside of the carton.

Id. at *8.

Reviewing both Lohr and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Kelsey concluded that "there is no automatic preemption" of product liability claims against §510(k) devices. 2019 WL 1884225, at *9. Rather:

"[S]tate and local requirements are pre-empted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device, different from, or in addition to, the specific Food and Drug Administration requirements."

Id. (quoting 21 C.F.R. §808.1(d)). "Special controls" imposed under the current §510(k) process can qualify as preemptive.

Special control documents may provide specific requirements that support a conclusion of preemption of state law claims if they show the federal government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers.

Kelsey, 2019 WL 1884225, at *9 (citations and quotation marks omitted).

In the case of contact lens disinfectant, between a device-specific regulation, 21 U.S.C. §800.10(a), and the aforementioned guidance, there were plenty of preemptive requirements applicable to this device to support preemption. FDA regulation "forbids a manufacturer from making changes in the design specifications, manufacturing processes, labeling, or any other attribute that could significantly affect the safety or effectiveness of the solution without FDA review, comment, and permission." Id. at *10.

Plaintiff tried to escape preemption by arguing that the FDA guidance wasn't mandatory and only provided "recommendations." Id. at *11. Not a bad argument. We've pointed out the non-binding nature of FDA guidance on numerous occasions. But it wasn't the guidance itself, it was the FDA requirements as to which the guidance provided compliance tips that proved preemptive in Kelsey. "The court disagrees as they relate to the design and manufacture of multi-purpose contact lens solution. While the Guidance permits some flexibility in how applicants go about demonstrating their solution meets the safety and efficacy requirements, the solution must meet those requirements to be labeled a multi-purpose solution." Id.

Who says so?

The FDA in allowing the product onto the market, that's who:

[A]ccording to the 510(k) Summary, the FDA determined "[b]ased on the results of the comprehensive preclinical evaluations, [the product] is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse."

Id. Kelsey based its conclusions on a pair of Ninth Circuit decisions, since neither Utah, nor the much smaller Tenth Circuit, had on-point precedent. Id. at *11-12 (citing Degelmann v. Advanced Medical Optics, Inc., 659 F.3d 835, 838-39 (9th Cir. 2011), vacated due to settlement, 699 F.3d 1103 (9th Cir. 2012), and Papike v. Tambrands Inc., 107 F.3d 737, 740 (9th Cir. 1997)). "[T]he Ninth Circuit determined the sterility labeling requirement was a device specific regulation because it specifically required a contact lens solution to meet standalone performance criteria to be labeled 'disinfecting solution.'" Id. at *11.

As to warnings, Kelsey held that, while the §510(k) requirements could be preemptive, the defendant couldn't yet muster the record, given the pleadings-restricted nature of a Rule 12 motion to dismiss. Id. Plaintiff had a rather odd claim, that turned on the location – rather than the language – of the relevant warnings:

Plaintiff does not allege that [the product's] labeling should include different or additional warnings or instructions. Rather, Plaintiff alleges the warnings and instructions should be included on a "package insert," which she defines as a separate leaflet or pamphlet inserted in the carton.

Id. Defendant had instead printed the warning in question on the inside of the package containing the product. Id. at *3. The defendant had a bunch of exhibits that (according to it) showed that the inside-the-box warnings satisfied the FDA's requirements, but the court refused to take judicial notice of them. Id. at *12.

Further, the guidance wasn't device specific as to warnings. "[T]he labeling section of the guideline does not mandate any particular language or warning. Instead, it provides suggestions' for language to assist in preparing labeling." Id. at *13. However, some labeling claims might be ultimately be preempted. Warning claims "would be preempted to the extent . . . based on the label's inclusion of the words 'sterile' or 'disinfecting,'" but not as to the "claim related to the location of the warnings and instructions." Id. Presumably, plaintiff had figured that out, which is why the unusual locational claim was made in the first place.

Thus, preemption barred the design claims in Kelsey even though the product was §510(k) cleared. Preemption also could bar some of warning claims, but not the plaintiff's locational claim. Preemption also barred claims covered by Good Manufacturing Practices, but not against manufacturing defect claims based on allegations of actual contamination. Id. at *10-11 & n.73.

While Kelsey involved a product-specific regulation and FDA guidance document, the court also cited to the FDA's "safety and effectiveness" conclusions made during the clearance process. That's progress. Finally, as a procedural note, Kelsey was not an MDL. That also means that the built-in institutional biases that make preemption arguments an uphill battle in the MDL context didn't exist. We think that's an apt practice pointer. There is a reason that we entitled our post that first laid these arguments out, " In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices."

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

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