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Only five days after our recent post highlighting the possible no-private-right-of-action implications of the (to us, anyway) obscure Astra USA, Inc. v. Santa Clara County, California, 563 U.S. 110 (2011), case, the Fourth Circuit applied it along the lines we had speculated could be helpful to defendants.  Bauer v. Elrich, ___ F.4th ___, 2021 WL 3502643 (4th Cir. Aug. 10, 2021).

That being said, Bauer was about as far from product liability as you can get and still be discussing a civil case.  Rather, its anti-immigration litigation pursued by the kooky (see this post) Judicial Watch group.  Trouble was, the statute this plaintiff was purporting to enforce, 8 U.S.C. §1621(a), doesn’t include a private right of action, which is similar to the situation in Astra.  To get around this rather serious lack of standing, the plaintiffs purported to assert state-law “taxpayer standing.”

Recognizing that Section 1621 does not authorize private enforcement, the plaintiffs styled their claim as arising under the Maryland common law doctrine of taxpayer standing . . ., which permits taxpayers to seek the aid of courts, exercising equity powers, to enjoin illegal and ultra vires [governmental] acts.

Bauer, 2021 WL 3502643, at *1.

Didn’t work.

The “state law” basis of the suit was a fig leaf.  The substance of the purported claim was so thoroughly federal that Bauer found federal subject matter jurisdiction under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005), which doesn’t happen very often.  2021 WL 3502643, at *3.  But from our point of view that was merely the preliminary.

The Fourth Circuit brought Astra to bear because that state-law fig leaf of “taxpayer standing” couldn’t cover the failure of Congress (as in the FDCA) to provide a private right of action.  “Taxpayer standing,” the court recognized “does not grant any substantive rights . . ., but merely confers standing in state court for taxpayers to enforce a right or obligation imposed by some other provision of law.”  Id. at *4.  The substance of these plaintiffs’ alleged claims was entirely created by the federal statute that did not allow for private enforcement.  Id.  That was “fatal.”  Id.  “[L]ike substantive federal law itself, private rights of action to enforce federal law must be created by Congress.”  Id. (quoting Comcast Corp. v. National Ass’n of African American-Owned Media, 140 S Ct. 1009, 1015 (2020) (emphasis added by Bauer).

As such, Bauer found Astra directly on point, despite its “different regulatory context.”  2021 WL 3502643, at *5.  Astra “declined” a supposedly state-law claim “that was ‘in substance one and the same’ as a suit to enforce the governing statute directly.”  Id. (quoting Astra).  Allowing an identical state-law claim would “render[] meaningless” the statutory “absence of a private right to enforce.”  Id. (also quoting Astra).  “[T]he same reasoning applie[d].”  Id.

The essence of the plaintiffs’ claim, and their sole theory of wrongdoing, is that the County defendants’ implementation . . . violated Section 1621, which does not authorize private enforcement.  The plaintiffs cannot use the procedural mechanism of Maryland taxpayer standing to bring a claim that is “one and the same” as a purported enforcement action brought directly under Section 1621.

Id. (another Astra cite omitted).  Astra “characterized the plaintiff’s contract claim as ‘one and the same’ as a suit brought directly under the [federal] statute, despite the fact that a contract claim involved different elements.”  Id. n.6.

Importantly, that conclusion was not affected by two pre-Astra decisions, Clark v. Velsicol Chemical Corp., 944 F.2d 196 (4th Cir. 1991), and Mulcahey v. Columbia Organic Chemicals Co., 29 F.3d 148 (4th Cir. 1994), which involved state-law “negligence per se” claims of the sort we see in our prescription medical product liability litigation.  Bauer, 2021 WL 3502643, at *5.  Those cases only involved whether federal-law-based negligence per se claims could create subject matter jurisdiction (the Grable issue), not whether an enforceable claim existed.  Id.  Even if they did, the negligence per se claims in those older cases only used federal standards as “evidence” that a pre-existing “state law duty had been violated.”  Id. at *6.  The duty postulated in Bauer was entirely federal because taxpayer standing “does not confer any substantive rights.”  Id.  Taxpayer standing was not “akin to a negligence per se claim that relies on a federal standard of care.”  Id.  Case dismissed.

Bauer got us thinking about one of our least favorite recent drug/device rulings – the “MDL madness” in In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2021 U.S. Dist. Lexis 100041 (D. Md. May 17, 2021), which we decried here.  That’s also in the Fourth Circuit.  What we found peculiarly vexing about this BHR decision was the purported creation of a “state law” duty-to-report cause of action even though there was no dispute that the affected state’s law had never recognized such a claim.

[Defendant’s cases] follow a developing line of federal case law that requires plaintiffs alleging failure to warn claims against a medical device manufacturer to point to a specific and traditional state law duty to report information to the FDA (or at least to a regulatory body) in order to establish a parallel state law duty that survives preemption.  This court declines to adopt similar reasoning.

2021 U.S. Dist. Lexis 100041, at *53.

This flat-out refusal to follow state law, which BHR did not contest had never recognized a tort based on failure to report to a government agency in any context, puts BHR in the Bauer rather than in the negligence per se category of cases in the Fourth Circuit.  There is no existing state-law duty to report in BHR that the FDCA’s reporting obligations could define more precisely under a negligence per se rationale.  No, instead the reporting duty, as in Bauer, arises entirely with the FDCA, and is thus improperly “one and the same” – to use the language of both Astra and Bauer.

As we argued in our prior post, BHR engaged in blatant Erie violations in recognizing duty-to-report claim unsupported by existing state law.  Bauer provides another avenue for vindicating Erie.