Law

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Last month, we discussed Estes v. Lanx, Inc., 2015 WL 9462964 (N.D. Miss. Dec. 23, 2015), and mentioned that the court had left a bit of unfinished business behind – having raised sua sponte the question of whether the plaintiff's assertions that the device lacked proper FDA clearance was preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

 

A lot of you were interested.  That post has received over 1000 hits.

 

The other shoe has now dropped.

 

In Estes v. Lanx, Inc., 2016 WL 211691 (N.D. Miss. Jan. 14, 2016), the court held that, yes indeed, a product liability claim grounded in an attack on the validity of the FDA's §510k device clearance is barred under Buckman.  Buckman, of course, interposed implied preemption against claims that are nothing more than attempts to enforce purported Food, Drug & Cosmetic Act ("FDCA") "violations," because the statute limited enforcement to the United States government.  531 U.S. at 549 n.4 (citing 21 U.S.C. §337(a)).  Buckman then distinguished the "parallel claim" concept enunciated in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996):

 

[Lohr's] claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.  In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements.  Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.

 

531 U.S. at 532-33 (Lohr citation omitted) (emphasis original).  "The conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted."  Estes, 2016 WL 211691, at *1 (citation and quotation marks omitted).

 

Buckman thus killed the Estes improper FDA clearance claim.  Whatever else one can say about that claim, if the FDCA didn't exist, there wouldn't be any requirement of FDA clearance for the defendant allegedly to have violated.  Therefore, that claim "exist[ed] solely by virtue of the FDCA":

 

Plaintiff's claims here are premised on [defendant's] failure to submit a standalone 510(k) premarket notification. . . .  [Plaintiff] contends that the [product] should not have been available for use because it was not cleared by the FDA, and that [defendant] was negligent in releasing the system without proper FDA clearance or fraudulently concealed that fact. . . .  Accordingly, Plaintiff's fraud claim is based and premised on [defendant's] alleged violation of the FDCA.  Plaintiff's fraud claim solely arises out of the alleged violation of the FDCA, not state substantive law.  Thus, Plaintiff's claims are preempted.

 

Id. at *2 (citations omitted).  That's about as straightforward as one can get.  If, when the FDCA is removed from the picture, the basis for the state-law claim goes away as well, then there never was any claim to start with.  Buckman sees to that.

 

James M. Beck (bio)

+1 215 851 8168

jmbeck@reedsmith.com

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