Every now and then, an administrative law decision – usually involving the FDA – contains something that’s useful to our product liability defense practices. In that light we offer Cytori Therapeutics, Inc. v.FDA, ___ F.3d ___, 2013 WL 1164775 (D.C. Cir. March 22, 2013). The device in Cytoriwas a §510k “substantial equivalent” device (for extracting stem cells from fat), except that the FDA held that it wasn’t. And that was the whole point of the decision, as the aggrieved manufacturer appealed the FDA’s not substantially equivalent (“NSE”) letter in the courts.  

For a discussion of the administrative law impact of Cytori, we refer you to the FDA Law Blog. We’re only interested in the case because an NSE letter is essentially the FDA’s administrative decision that, in order to be marketed, a medical device is required to go through the PMA process rather than through §510k clearance. As we all know, the PMA process is preemptive (Riegel), whereas the §510k clearance process is not (Lohr).

Plaintiffs in product liability cases often argue that this or that piece of a PMA-approved device system was already/should be treated as a §510k device, and thus preemption should not be recognized. That’s where Cytorican come in handy. Why? Because the DC Circuit holds that deference is to be afforded to FDA decisions determining whether medical devices require either PMA or §510k clearance.

Using the“arbitrary and capricious” standard of the Administrative Procedures Act, the district court concluded the FDA’s decision was reasonable, and also cautioned that in such cases, courts should be careful not to unduly second-guess an Agency’s scientific judgments. The criteria separating PMA from §510k are scientifically oriented and explicitly based on the resolution of safety-related issues:

[A] device must meet two core criteria to be substantially equivalent to a currently marketed device. First, the device must have “the same intended use as the predicate device.” Second, the new device must also have “the same technological characteristics as the predicate device” or, if not, the submitted data must establish that the new device is both equally “safe and effective as a legally marketed device” and “does not raise different questions of safety and effectiveness than the predicate device.”

Cytori, 2013 WL 1164775, at *4 (citations to 21 U.S.C. §360c(i)(1)(A) omitted). The FDA’s determination of the proper approval process for a device to undergo involves an application of science to regulation and is not one for a court to “second-guess”:

FDA concluded and explained that [two types of tissues are different] and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment under the guise of the APA’s arbitrary and capricious standard. After careful review, we find FDA’s assessment both reasonable and reasonably explained.

Id. at *5. As federal courts may not re-evaluate an FDA regulatory decision that a device requires PMA in the administrative context, we would argue that a fortiori courts applying state law should not engage in similar second-guessing in product liability litigation.

A second aspect of Cytori is also potentially useful. “[T]he FDA focused on one component” of the device system, under another regulatory prong –whether anything “raise[d] different questions of safety” from the predicate device (that is, the device against which the “substantial equivalence”determine is being made). Cytori, 2013 WL 1164775, at *5. Because that component (a certain enzyme) raised such different safety questions, it was proper for the FDA to require PMA for the entire device system:

Because the enzyme has been approved only for [a different] use, the scientists at FDA identified “different questions of safety” − and reasonably raised concerns about the impact the . . . enzyme might have on cells that may be reintroduced into the human body. . . . In short, FDA reasonably concluded and reasonably explained that the [device system] did not meet either the “intended use” requirement or the“technological characteristics” requirement for a substantial equivalence determination.

Id. at *6. Thus, if one component of a device requires PMA, the whole device does.

We see plaintiffs attacking this aspect of PMA approval all the time, most frequently with certain hip implants, but elsewhere as well. To avoid preemption, plaintiffs ask courts to reject routine FDA administrative practice for something the FDA does not do – allow a component that was previously cleared for labeling and marketing under §510k, to retain that status even though, when incorporated into a larger device system, the device system as a whole required PMA approval. It’s an argument that plaintiffs almost always lose. See Bass v. Stryker Corp., 669 F.3d 501, 508 (5th Cir. 2012); Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, at *12-13 (D.N.J. March 18, 2013); Gross v. Stryker Corp., 858 F. Supp.2d 466, 486-88 (W.D. Pa. 2012); Duggan v. Medtronic, Inc., 840 F. Supp.2d 466, 471-72 (D. Mass. 2012); Wilhite v. Howmedica Osteonics Corp., 833 F. Supp.2d 753, 762-63 (N.D. Ohio 2011); Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443, 451-52 (E.D. Pa. 2011); Lewkut v. Stryker Corp., 724 F. Supp.2d 648, 654-57 (S.D. Tex. 2010); Cornwell v. Stryker Corp., 2010 WL 4641112, at *3 (D. Idaho Nov. 1, 2010); Phillips v. Stryker Corp., 2010 WL 2270683, at *5 (E.D. Tenn. June 3, 2010); Riley v. Cordis Corp., 625 F. Supp.2d 769, 780 (D. Minn. 2009).

As well they should, which is where Cytori comes in. The D.C. Circuit has held, specifically in a device system vs. component situation, that that FDA decisions to classify entire systems as PMA are conclusive whenever they are “reasonable.” Since courts undertaking direct review of an FDA decision whether premarket approval is required for a device, based on the characteristics of a single component, are not allowed to overrule the FDA, neither should common-law courts where same type of FDA determinations are called into question more obliquely by tort plaintiffs.