[W]e have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a). . . . We must also reject [Plaintiffs’] attempt to characterize both the claims at issue in [Lohr] (common-law negligence action against the manufacturer of an allegedly defective pacemaker lead) and the fraud claims here as claims arising from violations of FDCA requirements. Notwithstanding the fact that [Lohr] did not squarely address the question of implied pre-emption, it is clear that the [Lohr] 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 . . . [Lohr] does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.
Buckman, 531 U.S. at 352-53 (there are too many Medtronic-related preemption decisions, so we preferentially use the plaintiff's name).
One reason for downplaying the Buckman angle is that some courts give more than lip service to the “presumption against preemption” that briefly saw its moment in the sun in Wyeth v. Levine, 555 U.S. 555 (2009), before being consigned to 4-4 limbo in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Another reason is that, particularly in state court, some judges simply react poorly (from our perspective) to arguments denominated as “preemption.”
Thus, we’d like to point out that the §337(a) proposition − that private causes of action to enforce claimed FDCA violations are barred − can be advanced just about as effectively under the rubric of “standing” as it can under the rubric of preemption. The United States Supreme Court, for one, has said so. E.g., Federal Election Com’n v. National Conservative Political Action Committee, 470 U.S. 480, 486-88 (1985) (“exclusive” agency enforcement authority means that private parties “do not have standing to bring a private action against another private party” under statute).
More importantly − especially in state court − is that in any given state, there’s probably also going to be precedent that plaintiffs have no “standing” to claim violations of statutes generally (that is, non-FDCA cases) that don’t permit private rights of action. For the heck of it, we’ll take a stab at our home state of Pennsylvania….
OK., we’re back. That didn’t take long. The very first case our search brought up makes the desired point. It involves a contract claim predicated on a violation of some “Nonprofit Law” that doesn’t allow private rights of action. The Pennsylvania Supreme Court held last year:
[Defendant] contends [plaintiffs’] claim fails because a party cannot do indirectly what it cannot do directly; thus, appellants cannot base a breach of contract claim on an alleged Nonprofit Law violation when the Nonprofit Law does not provide for a private cause of action. [Defendant] also claims [plaintiffs’] incorporation argument fails as the entire Nonprofit Law, including [its] standing provisions, would be incorporated into the contract. . . . We find [plaintiffs] lack standing to pursue a common law breach of contract claim in this case.
Petty v. Hospital Service Ass'n of Northeastern Pennsylvania, 23 A.3d 1004, 1013 (Pa. 2011) (emphasis added). There are probably several other Pennsylvania cases for the same proposition in that search, which pulled up 25 cases, but we stopped with the first one since we don’t really care what the particular state statute is. Our point is that it’s relatively easy to find state-law precedent for the proposition that, in the absence of a private right of action, private plaintiffs lack “standing” to claim statutory violations.
With that proposition established in any given state, than the question becomes, what standing precedent is there specifically concerning the FDCA?
Glad you asked.
We’re happy to help. Here are some cases we’ve found (some pre-Buckman) that use the §337(a)’s prohibition against private enforcement as the jumping off point for a conclusion that private plaintiffs claiming FDCA-related violations of whatever sort simply lack standing to assert those claims. Murungi v. Touro Infirmary, 2012 WL 1014811, at *2 (E.D. La. March 21, 2012) (“No private right of action exists under . . . the FDCA, and Plaintiff lacks standing to bring those claims”); Enzymotec Ltd. v. NBTY, Inc., 2011 WL 2601500, at *6 (E.D.N.Y. June 29, 2011) (plaintiff “cannot gain . . . standing by attempting to privately enforce the FDCA”); Stengel v. Medtronic, Inc., 2010 WL 4483970, at *3 (D. Ariz. Nov. 9, 2010) (“§337(a) makes clear that the United States is the only party that has standing to bring such a claim”); Conger v. Danek Medical, Inc., 27 F. Supp.2d 717, 720 (N.D. Tex. 1998) (“plaintiffs would have no standing to assert that defendants engaged in a conspiracy to violate the FDCA because the statute does not provide for a private right of action”); In re Orthopedic Bone Screw Products Liability Litigation, 1997 WL 186325, at *10 (E.D. Pa. April 16, 1997) (same); Martinez Caraballo v. Intermedics, Inc., 886 F. Supp. 974, 979 (D.P.R. 1995) (given the language of §337(a), “plaintiff does not have standing to enforce FDA regulations”); Ginochio v. Surgikos, Inc., 864 F. Supp. 948, 957 (N.D. Cal. 1994) (because no private FDCA right of action exists “summary judgment on the ground of no standing by plaintiff to bring a cause of action to enforce the Food, Drug, and Cosmetic Act is granted”).
So the next time your client is faced with a plaintiff that’s making noise about purported FDCA violations, consider whether it might be useful to raise a "standing" argument in addition to the more usual response that such attempts at private FDCA enforcement are preempted under Buckman.
Oh, yes, and if you win the argument, be sure to let us know.